U.S. CONSUMER PRODUCT SAFETY COMMISSION

Staff Workshop On Potential Ways To Reduce Third Party Testing Costs Through Determinations Consistent With Assuring Compliance

A UDIO TRANSCRIPTION

Thursday, April 3, 2014

9:00 a.m.

Na tional Product Testing and Evaluation Center 5 Research Place Room 103

- 105 Rockville, Maryland 20850

Diversified Reporting Services, Inc. (202) 467

- 92002

STAFF: Jacqueline Campbell, Division of Flammability and Combustion, Directorate for Engin eering 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., Dire ctor, 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, T oy 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 Associatio n Hailey Mann, American Plastic Toys Ami Gadhia, Consumers Union3

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 Services4

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. 1 3

Panel ists 17 Dave Owen 1 8 Sanjeev Gandhi , Ph.D. 2 2 Al Kaufman 30 Sheila Millar 40 Kyra Mumbauer 4 6 Discussion 5 3

AFTERNOON SESSION 9 8

IV. LEAD AND ASTM 8 ELEMEN TS, Patricia Adair, Moderator 9 8

Staff Presenta t ion : Kristina Hat lelid , Ph.D., M.P.H. 9 9

Panel ists Nikki Brown , Ph.D. 103 Bill Perdue 1 10 Mark Fellin 11 8 Al Kaufman 12 2 Hailey Mann 12 9 Sanjeev Gandhi , Ph.D. 13 3 Discussion 13 5

V. DISCU SSION, Neal Cohen, Moderator 17 6

Panel ists : Ami Gadhia 17 8 Randa ll Hertzler 18 2 Rebecca Mond 18 4 Rachel Weintraub 18 6

VI. CLOSING REMARKS, Jacqueline Campbell 20 95

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

I. INTRODUCTORY REMARKS 2

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

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

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

welcome all of you here today to participate in the 6

discussion about burden reduction from third

- party testing, 7

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

through a couple of hou sekeeping things. I know you guys 9

have gotten a lot of e

- mails from me, recently. So you know 10

who I am here. 11

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

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

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

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

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

Also, in the case of emergency, we just want to

-- we're 17

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

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

the building and where to meet up. 20

Just a real quick reminder about cell phones. If 21

you could go ahead and silence your cell phone, that would 226

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

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

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

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

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

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

lobby. 7

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

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

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

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

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

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

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

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

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

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

the staff presentation. Thank you, Randy. 18

[Slide presentation.] 19

II. INTRODUCTION 20

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

everyone. I' m Randy Butturini from the Office of Hazard 227

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

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

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

potential ways to reduce third

- party te sting burdens. 4

On the previous slide we have the disclaimer at 5

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

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

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

presentations by people who are non

- members of CPSC staff 9

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

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

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

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

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

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

your badge from this far away. 16

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

the agenda you have, "Introductory remark s followed by 18

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

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

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

by the panelists that are up here; and after that, there 228

will be this question and answer period to get further 1

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

that. 3

When people are speaking, for these microphones, 4

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

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

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

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

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

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

panelists and us here. 11

Lunch break followed by the other two sessions 12

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

burden reduction through determinations, and then closing 14

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

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

additional research, additional research that scientifically 17

defensible, that provides the widest scope of relief, 18

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

affecting compliance. 20

A nd what's the purpose of this research, this 21

research we want to have to point towards possible 229

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

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

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

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

potential rulemaking. 5

The scope of this is limited to burden reduction 6

through determinations, not even burden reduction through 7

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

on the determinations part of this. So questions about 9

certification, questions about test methods, questions about 10

content limits, definitions and other things will just be 11

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

intere sting today in this particular venue. 13

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

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

of 2008 established contents on lead and concentration 16

limits for 6 p hthalates in children's toys and chi ldcare 17

articles, and also established wherever the current version 18

of ASTMF 963

-- right now it's version 11

-- and it has a 19

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

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

14(a) to t he CPSIA, and that's where some of the burden 2210

comes in: Third

- party testing for compliance to appropriate 1

safety rules. 2

However, Public Law came out, P.L. 112

- 28 came out 3

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

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

one of the magic words are consistent with assuring 6

compliance. Can we reduce the burden consistent with 7

assuring compliance with applicable rules? So the burden 8

reduction is in regards to compliance that we're dea ling 9

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

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

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

followed up by a request for information regarding a third

13

party testing of these items. 14

That's what the Commission wanted to focus on 15

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

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

Register Notice, the docket number, CPSC 2011

- 0081, and 18

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

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

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

response. There's your opportunity to go to the 2211

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

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

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

of assurance

4

t here's another magic word

- irrespective of their 5

manufacturing, and without requiring third

- party testing. 6

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

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

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

third

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

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

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

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

not having third

- party testing. 14

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

with determination. We are also looking for another magic 16

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

applicable safety rules. What sort of things are we 18

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

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

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

product? What happens if you introduce recycled materials? 2212

This is especially true among plastics of certain types. 1

What happens there with a high degree of assurance of 2

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

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

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

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

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

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

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

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

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

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

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

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

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

pictures, because conceiv ably underneath the little train, 16

there is actually some of the 8 elements leaking out 17

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

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

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

to come back up and moderate this. 21

MS. CAMPBELL: And I will immediately hand this 2213

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

presentation on p hthalates. Thank you, Joel. 2

[Slide presentation.] 3

III. PHTHALATES 4

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

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

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

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

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

that of a Phthalate molecule. 10

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

look for evidence to support a possible determination of how 12

we could identify material s that do not and will not contain 13

prohibited p hthalates in concentrations above 0.1 percent

. 14

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

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

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

regardless of the manufacturing process

-- the potential for 18

contamination or any other factor

-- would continue in the 19

future to comply with the p hthalates limit as it continues 20

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

manufacturers for the highest quality products, but also for 2214

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

well? 2

What kind of follow

- up activities should be 3

required to assure continued compliance of a material ? What 4

other technical, practical or implementation issues should 5

we consider before possibly recommending p hthalates 6

determinatio ns? And as Randy pointed out, also, what 7

materials would provide the greatest cost savings if we made 8

the determination, and why is that? 9

Back in 2009, the Commission issued a statement of 10

policy of materials that may contain phthalates

. It's a big 11

lis t of different materials, things like PVC, polyurethane 12

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

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

you want to follow

- up and read that, that's the reference. 15

As far as materials th at may contain p hthalates, we actually 16

still would like to know more. 17

What materials should always require third

- party 18

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

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

evidence, what information would tell us that? What 21

specific data or other information is sufficient for us to 2215

say this is a material that might contain p hthalates and 1

should not have a determination, should require third

- party 2

testing? 3

About two years ago we held a p hthalate symposium 4

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

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

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

of some of the complexity of considering determinations for 8

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

different bars

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

blue on our screen; but, for instance, for poly

- oxy

11

methylene, POM, there's a line here showing 33 percent. 12

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

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

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

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

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

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

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

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

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

There were some p h thalates present or there were phthalates 2216

present as what Intertek describes as failing rates in all 1

of these materials, these types of materials. 2

Complexities aside, though, we are interested in 3

conforming plastics. What materials are there that are used 4

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

these requirements, that always conform to the p hthalates 6

limits ? We also need information and evidence about the 7

possibility that those materials might end up containing or 8

being exposed to prohibited p hthalates. 9

Information such as the potential use of recycled 10

content in these plastics, or some other way p hthalates may 11

be included at non

- compliant levels, maybe through the 12

addition of colorants or other additives. We are looking 13

for in formation about the possibility or likelihood of 14

contamination of component parts or finished products with 15

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

can we be assured the continued manufacture

-- again, 17

regardless of where it's made

-- would continue to be 18

compliant with the p hthalates limit ?” 19

How can the Commission address potential new 20

applications or new methods of production of plastics? 21

Maybe we find a plastic that never has p hthalates in it, 2217

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

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

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

get the p hthalates in there? How can we address that in the 4

future? What other technical, practical or implementati on 5

issues should CPSC consider before making recommendations 6

regarding p hthalates determinations? And, what would be the 7

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

were to recommend and adopt a determination, especially 9

considering that i t still requires that you comply with the 10

underlying standards? 11

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

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

until after they complete their presentations, and then 14

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

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

Unfortunately, we will not be able to accommodate questions 17

from our web

- casting public, but again, if you have 18

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

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

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

Toy Industry Association, Sheila Millar from Keller and 2218

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

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

presentation up. 3

PANEL: Slide presentations. 4

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

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

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

No w I'm going to go through the first part rather quickly, 8

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

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

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

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

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

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

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

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

butter jars, wrapped like vegetable wrap, and more 17

importantly they're used in medical applications. 18

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

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

vinyl blood bags plasticized with BOP. Blood bags last 21

longer than glass and, of course, they don't break. Now, 2219

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

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

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

b ranched or isoalcohol. 4

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

is Di(2

- ethylhexyl) phthalate (DEHP). These are gas 6

chromatograms of the different phthalates. You can see that 7

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

isomers . They look like a probability distribution. For 9

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

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

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

parts per million, because you h ave so many different 13

isomers that it's difficult to quantitate. 14

All right. These are chemicals, so you have 15

physical properties, density, viscosity, 4 point flashpoint 16

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

viscosity fairly low, le ss than 100 centipoise. Core point 18

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

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

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

that if you put a drop on the table and come back 20 years 2220

later, they'll still be there. 1

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

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

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

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

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

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

mainly for wire and cable. Acrylics is for basically 8

coatings as well as nitro cellulose lacquer. Urethane is 9

both a thermal plastic polyvinyl acetate for adhesives, and 10

the polyvinyl butyral. 11

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

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

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

these a pplications. Olefins like polyethylene, the 15

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

materials that are crystalline. So the phthalates are not 17

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

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

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

something else, and rigid PVC you can have anti

21

plasticization, which means your plastic will get stiffer 2221

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

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

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

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

solubility parameter of the polymer, compare that to the 5

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

close you usually have solubility. Something like nylon has 7

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

they're not really soluble in nylon. 9

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

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

And for looking at specific polymers, The Handbook Of 12

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

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

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

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

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

Thank you very much. 18

[Applause.] 19

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

announce that we will be putting all of these pre sentations 21

up on SlideShare after the workshop, probably sometime next 2222

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

Thank you. 2

[Slide presentation.] 3

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

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

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

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

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

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

session is also about lead and soluble heavy metals. 10

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

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

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

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

stakeholders. Here for the goal of reducing third

- party 15

testing burden is looking at the intrinsic material 16

properties to make the determination of what could be 17

considered as a positively stuff plastics or other 18

materials, looking at the manufacturing processes, knowing 19

the inherent characteristics of those materials

-- let's say 20

resin stage

-- and any further downstream processing and 21

use. And I should also say downstream abuse of those

- what 2223

started out as a pure polymer, and when i t's built into a 1

molded plastic form and what goes into there. 2

That's where the real world starts to get 3

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

we need to look at the whole supply chain characteristics 5

and what happens from when w e come over some kind of 6

considerations that could be considered for making some 7

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

not to compromise the compliance, and it should provide 9

tangible savings in terms of the testing cost. 10

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

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

vinyl and vinyl

- like soft materials, and some of these 13

considered as suspect materials for having phthalates. So 14

the goal is to create a positive list for ex empt plastics 15

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

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

is on the left

- hand side. Pull up some basic commodity 18

plastics that I used in a consumer applications. 19

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

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

tons of plastic that are produced in this consumer 2224

application space, and what is the distribution of those 1

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

all types of different consumer applications, not 3

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

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

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

may look different fr om some other data, which may be a 7

little bit more granular. 8

One of my colleagues pointed out the PVC may not 9

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

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

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

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

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

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

at for a positive type of exemption

-- POM, PBT, 16

poly carbonate

-- knowing the chemistry of these polymers, as 17

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

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

be considered, based on the anecdotal data also

-- specific 20

industry data that they could be exempt

-- could be deemed 21

exempt or considered for that. 2225

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

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

common consumer applications. They are either engineering 3

plastics and other types of applications. So would that 4

provide any kind of tangible cost

- saving by itself, having 5

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

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

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

saving, that's something to be examined. 9

We also wanted to look at some empirical data that 10

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

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

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

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

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

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

description is not detailed enough for u s to break it down 17

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

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

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

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

highlighted section s on plastics and rubbers, and rubber is 2226

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

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

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

a very high molecular level that was s hown by Intertek two 4

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

However, we do see

-- if I show the second chart 6

here

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

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

less than on e percent across different types of plasticizers 9

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

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

are below the failure limit. 12

So if I add all of those different types of 13

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

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

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

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

detection space, so they are detec ted, but they are below 18

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

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

possible contamination in the process line that has 21

transferred over into the materials that are coming to our 2227

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

mixing that is taking place at some stage. 2

However, since they are less than one percent, 3

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

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

scenario that may be attributed to this high number of 6

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

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

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

the material as fair rates. 10

Now, so, what are the other practical and 11

technical considerations that can be looked at? Practical 12

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

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

flows from upstream supplier in the form of some guaranty 15

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

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

that is based on without any validation built into that 18

process. And what particular companies who are vertical in 19

their operation

-- you know

-- they have the down

- stream, 20

upstream control in their supply chain to exercise that. 21

And that bill of materials can carry a lot of weight, and it 2228

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

differen t types of formulators out there? 2

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

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

considerations that again go back to the material, intrinsic 5

properties we talked about in previous discussions at o ther 6

forums about Shore hardness being one of the surrogate 7

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

and therefore the presence of plasticizer in some content, 9

as some content. 10

However, there are potential issues with that, 11

especial ly in case of styrenics. You know, there are 12

materials that could be considered rigid based on Shore 13

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

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

could still have about one percent p lasticizer in those 16

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

say particularly styrenics. 18

Then I was looking at some of the research while 19

preparing for this meeting. You know. Glass solution 20

temperature is a really intrinsic material p roperty, and 21

that's a very particular polymer chemistry tone, which 2229

speaks to the transition of the material when it changes 1

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

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

of the plastic izers facilitate by giving their pliability 4

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

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

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

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

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

of those. 10

So that's a material characteristic, physical 11

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

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

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

thermo mechanical properties database that needs to be 15

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

some more information about the importance of this glass 17

that isn't transition ed and pictured as a characteristic 18

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

of content of phthalates in plastic. 20

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

discussion, I'll wrap up. Thank you. 2230

[Applause.] 1

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

from TIA who will follow

- up. Thanks. 3

MR. KAUFMAN: Thanks, Jacqueline. 4

[Slide presentation.] 5

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

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

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

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

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

interest in industry, and we are thankful for the 11

opportunity to speak on it today. 12

First of all, ve ry quickly, a little bit about the 13

Toy Industry Association. We are the trade association for 14

North American based manufacturers and porters, licensors 15

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

have associate members who are inventors, des igners, test 17

laboratories and other service providers to the industry. 18

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

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

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

We have over 750 members w ho are involved in some 2231

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

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

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

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

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

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

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

There are an estimated 3 billion units sold every 8

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

500,000

-- a little over a half a million FTE jobs in the 10

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

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

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

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

doesn't advance safety. 15

We believe that we are still dealing with some of 16

the unintended consequences of CPSIA and one of those 17

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

require d that isn't telling us something, that anything that 19

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

talk about today. 21

First of all, we've provided information to CPSC 2232

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

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

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

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

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

presentation, I had a conversation with th e staff and 6

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

going to blow through that very quickly. 8

Proposal 1: "To screen materials based on their 9

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

based on their specific composi tion." And we have 11

rationales for that based on process knowledge and process 12

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

and material producer supplied bills of substance, and then 14

also evidence based on absence of in

- testing carried out by 15

our members. 16

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

quickly

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

-- 18

the current definition of accessibility for phthalates is 19

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

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

on whether you can touch something. And since the issue for 2233

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

that anything you can touch necessarily presents a risk of 2

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

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

relief. 5

Proposal 2: "Utilize rigidity as an initial means 6

of screening materials for exclusion from phthalates 7

testing." Phthalates

-- they're added to mater ials for 8

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

make them flexible. So rigid materials typically do not 10

contain phthalates at appreciable levels. And, Shore 11

hardness, we think

-- I've got a little disagreement with 12

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

proxy for rigidity. It can eliminate

-- it can define 14

materials which should not contain phthalates. 15

On the other hand, there are some materials which 16

do not

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

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

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

are very open to having conversations with the staff about 20

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

glass transition temperature, flexural modulus comes to mind 2234

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

those conversations. 2

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

test that would eliminate the reason or the requirement to 4

test for phthalates, which is an ex p ensive and slow test. 5

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

and the materials that are listed

-- and we'll get to a list 7

of candidate materials in a moment

-- utilize petroleum or 8

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

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

For instance, we talked about PLA. 11

Sanjeev mentioned it briefly. It's produced with 12

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

phthalates in those materials o r in the raw feed stocks. 14

The resin producers tightly control how much extraneous 15

material gets in there, because these materials are 16

polymerized in reactors at very high temperature and 17

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

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

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

about controlling what goes into these materials. 21

Polyolefins, polyethylene, polypropylene, et 2235

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

Phthalates are not miscible with the polyolefins, and you 2

would know right away if there was some contamination that 3

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

molding polyethylenes and polypropylenes do not have 5

phthalates in their plan t , and so there is no opportunity 6

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

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

In the case of the thermoplastic polyesters, 9

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

styrenics don't utilize plasticizers to attain their 11

physical properties. In other words, typically what will 12

occur is to get greater impact resistance in a styrenic 13

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

1,3

- Butadiene. That's synt hetic rubber. And so the amount 15

of rubber that's in there determines its physical 16

properties, not the amount of plasticizer. 17

And then some materials are plasticized, for 18

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

plasticized with the regulated phthalates. And in many 20

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

have sort of moved away from phthalates in general as a 2236

plasticizer for these materials. 1

Proposal 3, "Exclusions based on composition." 2

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

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

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

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

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

finding the restricted phthalates and other phthalates. 8

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

coating on something that looks like vinyl or pleather. 10

That's very often plasticized with phthalates. 11

Polyvinylidene chloride someti mes goes under the 12

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

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

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

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

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

can come to that would indicate that those materials are 18

extremely unlikely to contain the restricted phthalates. So 19

these are all potentially plasticized with the restricted 20

ortho

- phthalates. 21

S o this is a list of materials that we believe should 2237

be candidates for exclusion based on their composition, 1

simply because phthalates are not typically utilized in 2

rendering them flexible. And there are not opportunities, 3

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

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

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

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

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

impact polystyrene, polypropylene and polyethylene, if we 9

can get some sort of categorical material exclusion for 10

those materials, those are among the largest materials by 11

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

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

materials do have specialty applications within toys. 14

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

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

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

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

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

automated system that will look at bills of material and 20

bills of substance from the suppliers and the raw materials 21

suppliers that in dicate that these phthalates are not in 2238

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

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

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

these materials that were in the database. We lo oked at the 4

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

because I know there is some concern that manufacturers 6

might be switching to other phthalates to avoid the 7

restrictions, we actually expanded that list to some other 8

likely candidate, pht halate esters, ortho

- phthalates. And, 9

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

phthalates were only found in 34 cases. 11

One case was phenyl formaldehyde. It was a 12

thermalset resin, which is very uncommon in the toy 13

industry. It is typica lly used for electrical goods. One 14

was in a non

- polymer liquid formulation, but the balance was 15

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

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

knowledge of the material and the process , certainly gives 18

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

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

The phthalates that we looked for, obviously, we 21

looked at the restricted ones, and we also looked at some 2239

others that mig ht serve as substitutes, if someone were 1

looking to avoid the restricted list and look at other 2

phthalates as plasticizers. We also looked at di

- methyl and 3

di

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

not typically used as plasticizers, th ere's been some 5

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

some products. 7

And so these are the frequency of evaluations that 8

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

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

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

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

indicates that the phthalates are just not present. All 13

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

indicated by cast number w hich phthalate was found in which 15

material. 16

So in summary the accessibility determinations, we 17

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

today. We think certain materials probably should always be 19

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

either based on their rigidity or on their material 21

composition. They should be exempt from routine 2240

certification testing, because we know a lot about the 1

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

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

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

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

threshold of a high degree of assurance. 6

The cost to industry to test these materials where 7

ph thalates are not present is about $25 million annually. 8

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

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

are seeking relief from is needless testing that tells us 11

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

Thank you. 13

[Applause.] 14

MS. CAMPBELL: Thank you, Al. 15

I would like to welcome Sheila Millar up now. 16

[Slide presentation.] 17

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

thank the Commissioners and the staff for organizing this 19

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

assure compliance while reducing the burden of test costs. 21

So I'm here today representing the Fashion, Jewelry and 2241

Accessories Trade Association. Let me just start, very 1

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

about 225 members; most of their members are small 3

businesses. 4

FJATA led the drafting of the Children's Jewelry 5

Safety Standard, which has been recognized by the 6

Commission, especially in terms o f the cadmium limits, 7

establishing an appropriate safety standard. And I want to 8

recognize Kris Hatlelid and the work of her group in 9

developing the background research that led to the cadmium 10

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

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

subcommittee in updating those standards. 13

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

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

industry affected by phthalates testing? An d it's because 16

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

interest in phthalates

-- the requirements for testing for 18

toys and childcare articles

-- has begun imposing testing 19

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

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

action to recognize exemptions, which establish the lack of 2242

the presence of regulated phthalates at levels that will 1

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

for products that are n't subject to the compliance 3

obligation. 4

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

to see these testing requirements affecting children's 6

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

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

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

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

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

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

children's jewel ry. 13

So you can see these are some bracelet sets. 14

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

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

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

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

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

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

the jewelry industry

-- and what's very common in many of 21

the toy industry membership as well

-- is if you can't 2243

control the manufacturing, because you're buying products 1

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

each component. 3

Because the cost of testing for phthalates is so 4

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

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

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

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

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

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

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

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

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

is so important to industry as a whole. 14

The smaller the industry, the smaller the run of 15

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

more it hits the ultimate consumer in the pocketbook, 17

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

industry, because the requirement in the supply chain for 19

testing phthalates is one of relatively recent duration, we 20

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

but what we do have is very consistent with the data that Al 2244

outlined this morning. 1

When phthalates are present

-- and there are 2

certain types of flexible jewelry, children's jewelry

-- 3

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

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

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

mi ght be plasticized with an ortho

- phthalate. But the 7

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

very consistent with what Joel outlined and what Sanjeev 9

outlined, unlike the toy industry. 10

Because the test requirements are relatively 11

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

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

types of plastics

-- and again, most of these are rigid 14

plastics

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

present. Either they're non

- detectable, or the highest 16

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

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

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

for a colorant, or else could be contamination somew here 20

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

limit. 2245

So we think that that provides some good, 1

supporting documentation that supports Al's outline of 2

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

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

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

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

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

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

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

likely to contain phthalates. 10

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

certain types of plastics like flexible PVCs, certain types 12

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

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

think that this type of information provides a high degree 15

of assurance that you can exclude materials within the 16

plastics category as not likely to contain phthalates. 17

Issuing a rule th at recognizes this point, will not just 18

help the regulated companies, the regulated toy and 19

childcare industry, but will have much more significant 20

effect in reducing the overall test burden and costs that 21

are affecting consumers today beyond the categorie s of 2246

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

it back to Jacqueline. 2

[Applause.] 3

MS. CAMPBELL: Thank you, Sheila. 4

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

just one moment, Kyra Mumbauer. 6

[Slide presentation.] 7

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

Senior Director of Global Regulatory Affairs for the Society 9

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

want to thank the Commission for organizing this workshop

-- 11

this is a great help to us

-- an d for giving us an 12

opportunity to reiterate some of the recommendations that 13

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

testing burden to our members, and ensure the ongoing 15

compliance of plastic childcare articles and children's 16

products w ith the phthalate limits. 17

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

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

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

many technical experts within the plastics industry. And as 21

questi ons arise, I'll be happy to take them back to our 2247

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

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

industry supply chain. 3

We have material suppliers who sell resins, 4

colorants and ad ditives, recyclers who sell post

- consumer 5

and post

- industrial materials, processors, both large and 6

small who fabricate plastic consumer products and 7

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

brand owners now who sell consumer products an d package 9

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

beginning of the rulemaking process for the associate 11

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

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

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

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

my comments brief to the extent they duplicate some that 16

have already been made. The first and chief misconception 17

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

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

in types of questions that our members are receiving from 20

retailers and other end customers. This misconception is 21

that all plastic materials used in children's products and 2248

childca re articles must be tested to ensure compliance with 1

the phthalate limits. 2

Some of this confusion appears to be due to a 3

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

policy in 2009 for testing of component parts with respect 5

to Section 10 8 of the CPSIA, and then the 2011 notice of 6

requirements for accreditation of third

- party, conformity 7

assessment bodies. 8

The 2009 statement of policy, which we looked at 9

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

contain the restricted or tho

- phthalates in excess of a 11

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

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

even mention any plastics among those materials. So that 14

was of concern. 15

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

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

materials that will not contain the restricted ortho

18

phthalates in excess of the specified limit. So, you know, 19

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

how or why continued manufacture, regardless of origin, 21

would continue to be compliant with the phthalates limit. 2249

And what other technical, practical or implementation issues 1

should CPSC staff consider before possibly making 2

recommendations to the Commission regard ing a phthalates 3

determination for a plastic. 4

What our members have assured us is that ortho

5

phthalate plasticizers may be intentionally added to 6

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

polyvinylidine chloride, chlorinated polyvinyl chlori de, and 8

thermoset polyurethanes to make these materials flexible. 9

They will not be added , t he ortho

- phthalates will not be 10

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

as contaminants at levels higher than a thousand parts per 12

million, beca use they actually compromise the rigidity of 13

these materials and affect the performance of the final 14

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

Ortho

- phthalates are also incompatible with many 16

plastic materials as we've heard, and some of t hose will be 17

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

colleagues at the Toy Industry Association who undertook the 19

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

really just confirms what our organization has reiterated 21

for years that phthalates are not added to rigid, plastic 2250

products. 1

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

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

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

greater, and including the other resins into which these 5

ortho

- phthalates that are being restricted would not be 6

added. 7

There is a further misconception that cross

8

contamination may lead to the unintentional presence of the 9

restricted ortho

- phthalates in a great deal of plastic 10

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

strong incentive not to allow this to happen. Plastic 12

manufacturers, including those using recycled materials, are 13

making sure that phthalates would not be present at these 14

elevated levels, beca use it affects the end performance of 15

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

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

these are the materials that are most widely used in 18

children's products: polypropylene, polyethy lene, 19

polystyrene, acryilonitrile, butadiene and styrene. 20

On a further note, PVC is also incompatible with 21

these materials. And we've learned that North American 2251

m anufacturers by and large are not running PVC and these 1

other materials in the same mold ing facilities. PVC, when 2

actually blended with these other materials, can cause very 3

serious problems , y ou know. It will chemically attack some 4

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

processing temperatures used are much higher than those for 6

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

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

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

resin. 10

So what we've understood from manufacturers, and 11

also recycle rs, is that they take care and introduce careful 12

process controls in to their manufacturing to ensure that 13

there wouldn't be cross

- contamination. Gaylords are 14

carefully marked. Folks on the floor are trained very 15

carefully. In the event that there were a cross

16

contamination, most cases you'd see off

- spec parts being 17

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

the manufacturing floor that a problem had occurred. In 19

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

have to go throug h a careful purging process in order to 21

start up again. 2252

So manufacturers are not looking to fall into 1

those situations where they would have a costly shut

- down, 2

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

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

recommendation is that the Commission please specify that 5

rigid plastic materials with Shore A hardness of 90 or 6

greater will not contain the restricted phthalates in excess 7

of specified limits. 8

We also ask that the Commissi on publicly identify 9

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

suggested positive list that will not contain the restricted 11

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

we would prefer that this be done through a rulemaking 13

pr ocess so that the entire stakeholder community will be 14

aware and our retailer customers and others will be 15

consistent in observing them. 16

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

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

to g et any questions addressed that you may have from here 19

forward. Thanks. 20

[Applause.] 21

MS. CAMPBELL: Thank you, Kyra. 2253

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

discussion and questions. Just real quickly I want to 2

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

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

before you speak, I think for the panelists

-- the 5

transcriptionist has it

-- but if you come up to ask a 6

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

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

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

remember to turn off your microphone. 10

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

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

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

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

questions. Joel, go ahead. 15

DISCUSSION 16

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

for the talks. They're very helpful, but one thing t hat 18

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

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

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

Kyra, about the difficulties in quality if they were to be 2254

unintentionally incor porated. You know, I'd like to know, 1

and perhaps the members of the plastics industry association 2

could help provide some technical data on things like how 3

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

phthalate content versus Shore hardness for PV C in different 5

shapes and geometries, different filler contents that could 6

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

talking about, if these things get in? 8

You mention PVC in the st r eam being incompatible. 9

We regulate products that are low er quality than some of 10

your me mbers produce as well as those that are of the 11

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

reports, we will recall

-- or not necessarily recall, but 13

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

samples for phthalates than the Toy Industry Association's 15

testing showed in PVC. 16

So how off

- spec would these things be? If you 17

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

in the recycle stream that might , but regrind or 19

contamination elsewhere in the plant. But what about those 20

other things like coatings and adhesives, and things like 21

that, that might be in the recycle stream. If you could get 2255

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

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

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

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

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

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

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

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

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

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

interdiction efforts at the ports have don e a good job of 11

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

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

is an inherently unstable material because of the chlorine 14

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

temperatures. It requires very special equipment 16

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

hard chrome

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

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

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

materials. Same for the screw in the injection molding 21

machines

-- usually chrome. So if you are a processor and 2256

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

mix

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

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

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

particularly on the rigid grades. 5

So we have had some information from manufacturers 6

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

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

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

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

high temperature, it immediately degrades. You get an 11

evolution of that hyd rochloric acid vapor and a lot of other 12

nasty pyrolysis products, and you know right away that 13

there's a problem. 14

So getting PVC mixed back into the stream is 15

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

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

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

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

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

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

adhes ives or coatings should be exempted. We know that very 2257

often paints that are applied to flexible substrates do 1

contain phthalates, because the paint film itself has to 2

remain flexible. 3

Polyvinyl acetate adhesives, as Dave referred to, 4

I mean we know t hat PVA and acrylic adhesives typically do 5

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

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

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

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

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

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

nauseum. Does that answer all of your questions? 12

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

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

experiences from your members could be brought to us as 15

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

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

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

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

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

like that. 21

MS. CAMPBELL: Okay. Go ahead, Randy. 2258

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

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

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

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

phthalate being typically greater than 200 degrees C. Are 5

you talking about the temperature whic h it combusts, or does 6

that mean something else? 7

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

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

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

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

flash point. 12

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

in your presentation you talk about Shore hardness issues. 14

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

Shore hardness to determine phthalates cont ent? 16

MR. GANDHI: Yeah. Shore hardness is a non

17

intrinsic material property. It's something that manifests 18

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

there are external factors that influence the determination 20

of the net outcome of that Sh ore hardness measurement. So, 21

typically, thickness could be one of the big factors. You 2259

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

different material properties or mechanical properties come 2

out to be. 3

So Shore hardness, in particul ar, in case of thin 4

materials and thick materials as they are used in that 5

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

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

deemed to be an original material and qualify against the 8

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

same Shore hardness determination when you have that actual 10

material tested in finished form because of the thickness 11

effects. 12

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

well, I think Sanjeev is abs olutely correct when you are 14

talking about materials that are significantly lower than 90 15

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

it uses a penetrometer and it's a spring

- loaded needle. And 17

so the device measures the distance that that needle 18

penetrates into the material. 19

So for something which is above 90, which is 20

essentially rigid material, the thickness effects that 21

Sanjeev mentions are much less critical. In other words, if 2260

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

quarter

- inch thick or a half

- inch thick. On the other hand, 2

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

Shore A, absolutely thickness becomes very critical at that 4

point. 5

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

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

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

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

percent, you can discriminate using the Shore hardness test 10

between compliant and noncompliant materia ls. 11

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

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

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

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

essentially rigid mater ials or stiff enough to resist the 16

penetration of the needle. There are actually definitions, 17

and I believe ASTM F963 actually contains a definition of 18

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

and check. In other words, the flexible m aterials are 20

defined as less than 70, so. 21

MR. BUTTURINI: Do you have like experimental data 2261

of compliant and noncompliant materials that you measure the 1

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

know, 90 is where the interesting thing s happen, or 3

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

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

or some other number. 6

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

In other words, I think there's general agreemen t that a 8

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

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

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

hardness and test data indicating absence of phthalates. 12

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

essentially indicates a rigid material, and rigid materials 14

are known not to have phthalates added as plasticizers. 15

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

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

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

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

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

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

put together ?” You know, this plus this, and here's some 2262

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

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

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

in the future be compliant. So when statemen ts are made 4

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

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

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

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

scient ific, empirical, scientifically defensible

-- another 9

special word from our operating plan

-- body of knowledge 10

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

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

makes sense that a determina tion can be made for these 13

materials or these materials under these circumstances, or 14

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

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

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

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

industry

-- the toy industry

-- has done a lot of the work 19

there to establish through test data the absence of the 20

presence of prohibited phthalates in excess of the amounts. 21

The relatively small amo unt of data that the jewelry 2263

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

don't have the cross

- polymerization of the type of plastic. 2

Kyra's presentation I think outlined the typical 3

process considerations, and because of how you make 4

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

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

flexible versus rigid products is small. And because we 7

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

historically contained the ort ho

- phthalates

-- and that is 9

changing as well

-- the reason that you don't mold anything 10

in the same plant with PVC would be equally true, regardless 11

of where you were making the product. 12

I think it's also clear that for children's 13

products, while ther e may be some specialty products that 14

are made with recycled plastics, it's very rare. It's not 15

at all common in the jewelry industry, for example. Al can 16

speak to the toy industry, but I think it's more of a 17

specialty niche where they advertise the prod ucts as made 18

from recycled content. And because of the lead issue, you 19

typically

-- at least with toy industry folks that I'm 20

familiar with

-- would not use the mixed plastic stream. 21

So you would try to get a clean plastic stream 2264

like HDPE laundry det ergent jugs as your source material, 1

and then make whatever you're going to make. But you're not 2

bringing in PVC for the same contamination reasons that Kyra 3

explained. And because the process problems relate to what 4

happens if you have PVC resin in your stream, it's a lot of 5

incentive to avoid that by good process controls up front. 6

MR. KAUFMAN: And if I could add to that, I think 7

Sheila is absolutely correct. The use of recycled material 8

in the toy industry, at least, is relatively limited. And 9

the reason for that is that because toys are so highly 10

regulated and have to meet a number of physical properties: 11

drop tests, torque tension, et cetera, using recycled 12

materials. Every time a material goes through a heat 13

history

-- every time it's molded

- - you end up with some 14

degradation of the physical properties of that material. 15

And so it doesn't make sense for people to take that risk in 16

most cases. So they usually use virgin material. 17

The only recycled material, I guess, if you can 18

call it that is that for instance if you mold something the 19

screws and the runners are typically reground and fed back 20

into the system at controlled rates, no more than 10 percent 21

usually. But that's really the only use of what you could 2265

call recycled material. It's not post consumer. It's too 1

important and too critical for people to know exactly what 2

they're molding their product out of. 3

DR. RECHT: Well I guess going back to Kyra, I 4

think your industry, again, might be able to provide 5

information if you could go back to them. Again, we've 6

talked about these quality problems at these different 7

levels. Manufacturers have problems take place at their 8

plants. I worked in industry as a manufacturer before, and 9

sometimes we made off quality product; and, eventually, you 10

learn if I add this much of this, this is what happens. So, 11

again, if we could get data on what those Shore hardness 12

versus accident al phthalate contaminations are, things like 13

that, that would be helpful. 14

You know. On the use of recycled conten t, again, 15

if any of you can look beyond just your member base but to 16

the worldwide production, among the samples we see that we 17

test here from port surveillance, there are samples that 18

appear to have recycled content. We find three or four 19

different phtha lates in the same, component part on a dollar 20

toy. It seems unlikely to be engineered to that extent that 21

they want one percent of this one and three percent of that 2266

one. So, you know, if you can help us with the wider look 1

at that, we'd appreciate it. 2

MS. MILLAR: Yeah. I think we can definitely go 3

back and get more information for you on that. One thing I 4

will mention is that one of our members had said that in the 5

past there were concerns about flexible parts coming in from 6

other parts of the world , potentially not being manufactured 7

up to specification using the material requested. It was 8

difficult in some cases to distinguish between what was 9

supposed to be a TPE and was, in fact, made with a cheaper 10

PVC plus the size with phthalates. But across the board

-- 11

and we can get the data on hardness. 12

To the extent possible, we'll work on that. But, 13

really, what I think we're asking is for rigid plastics 14

there wouldn't be that same issue. Just anywhere in the 15

world you wouldn't see people with the incentive to try to 16

run different materials with PVCs that could be plus the 17

size with the phthalates in the same plant. So I think 18

that's really where the rigid distinction is really key for 19

us. 20

DR. HATLELID: My name is Kris Hatlelid. I'm a 21

toxicolo gist with the CPSC. And your response just reminded 2267

me of something that I jotted down earlier, and it has to do 1

with the questions we had in the FR notice about practical 2

implementation issues, and that has to do with problems with 3

or mistakes with ident ity of a material. And, of course, 4

we're dealing with a lot of overseas manufacturers. So the 5

folks who are responsible for compliance in this country 6

weren't standing in the plant. So what is the sense of 7

mistakes in identity if we're talking about kno wn phthalate 8

containing materials are possible and known not phthalate 9

containing materials? 10

MR. KAUFMAN: Yeah. I think

-- if I understand 11

the question correctly, Kris, I think you're asking if you 12

exclude certain materials, let's say that the Commis sion 13

decides to exclude materials by composition. How do you 14

confirm that those are actually the materials being used? 15

And, again, that comes down to good manufacturing practice 16

and good process control. 17

And even if you are in a situation where you'r e 18

receiving something from an outside supplier

-- and you 19

didn't witness it being produced

-- I would expect that you 20

would take reasonable steps to confirm that material 21

identity. On the other hand, using portable FTIR to 2268

identify materials, or in the ca se of polyolefins, all you 1

really have to do is throw it in a glass of water. If it 2

floats, it's a polyolefin. 3

[Laughter.] 4

MR. KAUFMAN: I mean those are the sorts of things 5

that could provide significant testing relief, because the 6

phthalate test, as Sheila mentioned, is quite expensive. It 7

takes several days. And so we're really looking for 8

something. We're not saying don't test anything. What 9

we're looking for is something that is much less expensive 10

and much faster that would allow us to make a decision with 11

a reasonable degree of assurance

-- a high degree of 12

assurance

-- that phthalates are not there. 13

MS. MILLAR: Let me add one more point to what Al 14

said, and that's there is a market reality here for any 15

children's product, which is sub ject to a lot of testing. 16

There has been a great effort with the responsible 17

manufacturers to deal with the supply chain. So I think 18

it's customary, for example, in the jewelry industry, 19

because they're testing products after they purchase it, 20

after they 're made. They're made overseas. They come over 21

here. They're tested before they go onshore and then are 2269

often retested here in the U.S. So you have that double

1

check. But it's pretty much a two

- strikes rule. 2

If you fail once, you're on sort of a special 3

watch. A supplier who fails twice is typically dropped, and 4

that word does get out through the supply chain. So the 5

suppliers actually have an enormous incentive, also because 6

of the efforts of AQSIQ to promote safety and compliance 7

within China, for example, where a lot of these products are 8

made. And so we've seen evidence that the AQSIQ folks are 9

also evaluating products, evaluating plants and evaluating 10

processing to assure that the products that are produced in 11

China will meet standards for the U.S. market so that China 12

doesn't get a black eye. 13

So I think there are some additional market 14

realities that are at play here that are useful to keep in 15

mind. They're not the same as data, but there is a lot of 16

testing, and there are ways

-- and sometimes very simple 17

ways

-- as Al has described, to double

- check the identity of 18

the material. 19

MR. BUTTURINI: I have a question for Mr. Kaufman. 20

In your presentation you're talking about the rationale for 21

things to have determinations made on them. And part of the 2270

rationale was evidence from process, knowledge and process 1

controls. And I wrote down on my notes, "Does everyone do 2

this?" That would be one of things that we'd want to know 3

about, because you could understand. You know, a body of 4

kno wledge would be we think everybody does this because of

.... 5

There's the magic word, again, "because of," you know, this 6

and this and this. It costs too much to do it any other 7

way. You get the best quality this way

-- whatever the 8

rationales are on this t hing. 9

If the members of the TIA, which represent 85 10

percent of the U.S. market do this, well you might know 11

about 85 percent pretty directly, because you can just ask 12

them. And what we're interested in knowing is what do we 13

know about the people that aren't the members of TIA? And I 14

don't want to say what they're up to, but what sort of 15

processes and things they're working on. 16

And I just have one other question. I want to get 17

this clear. Evidence and review of materials supplied bills 18

of substan ce. Other people in manufacturing would call that 19

a bill of materials? 20

MR. KAUFMAN: Actually, it's one step below the 21

bill of materials. In other words, the bill of materials 2271

tells you what, for instance, that high impact polystyrene 1

is used to mold a particular part. You go one level below 2

to the bill of substance, and that high impact polystyrene 3

is broken down to all of the components that make it up. 4

And that's what it was based on. 5

MR. BUTTURINI: And, typically, this is a 6

question. Typical ly, I assume that producers who supply 7

bills of substance are not third

- party tested. They don't 8

send their material to a third

- party laboratory. They 9

develop the information themselves in

- house. Is that right? 10

MR. KAUFMAN: They develop the informati on in

11

house, and they don't typically send it to a third

- party 12

laboratory. In fact, that's one of the issues that we do 13

run into. So thank you for bringing that up. Most resin 14

suppliers have invested tremendous amounts of money in

- house 15

laboratories to characterize and qualify their materials. 16

And, in fact, many of our manufacturing members indicate 17

that they get certifications f ro m their suppliers saying 18

that phthalates are not present. 19

However, they can't rely on that as part of the 20

component part testing rule, because it was not tested at a 21

third

- party laboratory. It was tested at the in

- house 2272

laboratory of the resin supplier. And, again, these 1

suppliers have tremendous incentives to know what they're 2

dealing with, because they're risking a plan t explosion if 3

there are things in there that they don't know about. And 4

so they're very, very careful about what the inputs are. 5

They're very, very careful about characterizing the 6

materials to make sure that it meets all of the 7

specifications that it n eeds to meet, that it meets impact 8

strength, that it meets melt

- flow index, clarity, any number 9

of physical properties that are going to be critical to 10

their customers. 11

MS. MILLAR: Maybe I can ask one question for the 12

staff, and that is on lead

. Y ou e xempt stainless steel of 13

certain grades. So how does the staff determine which 14

grades of steel, because they don't have to be third

- party 15

tested, would qualify, and could that same approach be 16

applied to exempt phthalates? 17

MR. BUTTURINI: Well our metal lurgist isn't here 18

to explain that explicitly. I can give general details in 19

that composition of stainless steels was determined. And if 20

you look at industry documents that talk about steels

-- 21

this type and that type and all the different numbers of 2273

thi s sort of thing and the other thing

-- and all the way to 1

differentiate in the UBS numbering system is one that's 2

used, it overlaps with several other systems. They list 3

materials, and the materials include, of course, iron and 4

carbon, and phosphorous and sulfur and the other things that 5

make up whatever steel you're making. 6

And then there's another category of either other 7

undefined, or they actually list particular materials, 8

including lead. And they'll say "less than" such and such 9

amount, because less than will not affect the chemical and 10

mechanical properties you're looking for in that kind of 11

steel. So if steel is qualified as a particular UBS number 12

type steel, then it was considered to have less than that 13

amount. 14

There are a couple of stee ls, stainless steels, 15

especially, that have more than one hundred parts per 16

million lead. In rough terms it was that kind of process. 17

MS. MILLAR: So for the jewelry industry where you 18

might use some stainless steel in children's watches, for 19

example, h igher end children's watches, the typical approach 20

would be to get a supplier assurance that the steel meets 21

the grade appropriate in the lead exemption so it doesn't 2274

have to be tested, because it is excluded from testing. So 1

that's on the lead side, but I think it's a similar issue. 2

MR. BUTTURINI: Yeah. We're talking about 3

phthalates now, and we've got plenty of time to talk about 4

leads later. 5

MR. GANDHI: If I may, I want to go back to the 6

previous questions about the bill of substance. The way 7

it's constructed is a lot of information from upstream 8

suppliers that moves up and it's aggregated in that former 9

bill, material bill of substance. So third

- party labs 10

normally do not create that bill of substance or verify in 11

any shape or form. 12

That would entail a massive assay type of work, 13

chemical assay type of work to create that bill of 14

substance. So it's just aggregating the information from 15

all the upstream suppliers to build that matrix of what 16

materials are and what substances, like additive s, pigments. 17

So he stabilizes a free list, classified those. Whatever 18

level of substances are added at what level, that's how it's 19

created. 20

MR. BABICH: I'm Michael Babich from CPSC, and I 21

just have a couple of questions. You have list of polymers 2275

t hat don't contain phthalates for various reasons, because 1

they're not compatible or won't mix with the polymer or they 2

adversely affect the properties. Is there any data that 3

would say, for example, that the phthalates can't mix with 4

polystyrene or some o ther polymer at 0 .1 percent. You know. 5

You're saying it's not mis ci ble, but could you say at that 6

low level, or is there a lower limit? There's got to be, 7

you know. Maybe it's a part per billion. I don't know, but 8

I'm wondering if there's any data lik e that. And for the 9

example of the polystyrene where phthalates would adversely 10

affect the properties, again, do you know is there a limit, 11

or maybe someone has data to that effect? 12

MR. KAUFMAN: Michael, I'll take a shot at trying 13

to answer that. Cl early, there is a limit. I don't know 14

that anybody has done any work to say that it's exactly this 15

number. The only thing I can offer is maybe some anecdotal 16

data from my time in the toy industry. It's always been an 17

article of faith that you never

-- a nd this goes back to the 18

days before phthalates were restricted. It was an article 19

of faith that you never put high impact polystyrene in 20

contact with flexible PVC. And the reason for that was that 21

just a small amount of phthalate migrating to the surfac e of 2276

that PVC would attack the high impact styrene and actually 1

would weld the two materials together. So it actually would 2

create a solvent bond between the two. So it doesn't take 3

much for you to degrade the properties of that material. 4

That's all I c an tell you. I can't give you a number. 5

MS. CAMPBELL: Are there any other audience 6

questions? We do have it open up here. It's okay to come 7

up. Any other questions from the staff? 8

MR. UHL: Hi. I'm Rick Uhl, also with CPSC. I 9

know you said , typically, recycled plastics aren't used in 10

your industries, but because we have to look at all the 11

scenarios that are out there, there is that possibility that 12

a recycled material could be used. And I was wondering if 13

you had recycled material, like a non

- PVC material

-- let's 14

say polyethylene or something like that. In the recycle 15

process could there be an accidental percentage of PVC 16

that's part of that recycle process? 17

Because, obviously, if you had some PVC with 18

banned phthalate in there that g ot mixed into the recycle 19

process, then you could have a theoretical non

- PVC, 20

typically safe plastic, that would then suddenly have an 21

unexpected, banned phthalate. And it may be at the 0.1 2277

percent level. So that's my question. And I'd like to say 1

if yo u don't have the answer to that question, that would be 2

the type of information we'd be looking to get, you know, 3

from technical experts in the field. Thank you. 4

MR. KAUFMAN: And I think the answer to that is we 5

don't have an answer that, again, what is the de minimis 6

level of PVC that could be tolerated as a contaminant. The 7

one thing I would say is that it's probably not much, and if 8

you consider that even if you mold in flexible PVC, 9

phthalate levels, if it's added as a plasticizer or 10

somewhere in the 40 to 50 percent range

-- or 30 to 50 11

percent range depending on what type of flexibility you're 12

looking for. 13

So when you talk about a small amount being mixed 14

into a stream at 30 to 40 percent, you're probably going to 15

be much lower than that tho usand part per million threshold. 16

But I, again, don't have experimental data that would say, 17

you know, you could tolerate one percent without noticing 18

it, typically because of the fact that it won't mix and the 19

processing temperatures are so much higher w ith other 20

materials than for PVC. 21

As Kyra mentioned, it degrades. It carbonizes, 2278

and you end up with black specks, and so you would know 1

right away

-- not to mention the fact your eyes would be 2

watering as you molded it because of the hydrochloric aci d 3

vapor. 4

MR. BUTTURINI: I have a question for Mr. Kaufman

. 5

B ecause he has the longest presentation , h e always has the 6

most number of questions. This is Randy Butturini from 7

CPSC. You're talking about

-- it's not a question. More 8

it's a here's how. There's that word again, the magic word. 9

He made the statement that "Thermoplastic polymers

-- you 10

know, PETE, PBT, PCT

-- are flexible, but despite their name 11

do not contain phthalates." And then you get to what would 12

be useful and interesting to us wo uld be to add "because 13

of," you know, reasons, A, B, C. 14

And when that's put together we can say "Oh, now I 15

understand what you're going about." Now I understand, and 16

maybe I can understand this at a high degree of assurance. 17

I need to ring a bell eve ry time we say one of these words. 18

MR. KAUFMAN: Okay. Let me take a stab at that 19

one. The name is very similar, and the reason is that they 20

are produced using terephthalic acid as a starting material. 21

So that is not an ortho

- phthalate. That is a t erephthalate. 2279

And I'm sure the staff can explain that when you have a 1

benzene ring, the materials can be attached at different 2

locations around the ring. So terephthalic acid is attached 3

at a different point on the benzene ring than ortho

4

phthalate acid, which is used to produce phthalates. And so 5

even though you have the term phthalate in that material, 6

that's what I was trying to point out. It does not contain 7

ortho

- phthalates. It starts from terephthalate. 8

MR. BUTTURINI: And then that gets to my second 9

statement, and these two are now going to overlap each 10

other. The one you say, "Some materials are plasticized

- 11

nylon 11, 12 and cellulosics ." "Some materials are 12

plasticized"

-- excuse me

-- "nylon 11 and 12, and 13

cellulosics , but not with the r egulated phthalates." And 14

what I'd be interested in hearing about, and that's always 15

true "because of;" or, these are produced using 16

terephthalates always because of. You know, that sort of 17

thing that gets us towards the "will not" part. 18

So we can tr y to close that loop where we need to 19

work ourselves. What about this? Or what about this? And 20

is this even possible? No. It's not possible. That sort 21

of thing; that's the sort of information we're looking for. 2280

And a wonderful place to put that woul d be regulations

. gov, 1

docket CPSC

- 2011

- 0081, and you have until April 17th to do 2

that sort of thing. 3

DR. RECHT: Just following up on that, for 4

instance, with the PETE, which is the kind of plastic that's 5

used in like a two

- liter soda bottle, for instanc e. You 6

mentioned that the polyolefins float versus the PVCs sink. 7

PETE is also a dense plastic. And that's actually, you 8

know, in the recycling stream. The floating is used 9

somewhat to separate the different polymers, but it's 10

potentially, you know, a greater risk of contamination of 11

PVC into PETE. Just due to densities. 12

You know. You said phthalates aren't used in 13

PETE. But, again, is there a tolerance level for PVC and 14

PETE that's different than what you were saying in terms of 15

polyolefins' pro cessing temperatures? And even in the case 16

of polyolefins, is that true also for film products or only 17

for molded products? Are they processed at lower 18

temperatures for calendared films and things like that? If 19

you could provide us with some of that inf ormation, 20

especially the SPI, that might be helpful. 21

MR. KAUFMAN: And we can certainly get those data 2281

for you. A nd I think what's helpful is that in the case of 1

some of these materials, the number of manufacturers are 2

relatively small. For instance, Eastman produces a huge 3

percentage of the PETE; same for the cellulosic material. 4

So we can certainly go back to them and see if they have 5

some of these data. 6

DR. HATLELID: Well this should be quick. I just 7

wanted to clarify something that came up in a couple of 8

presentations. Sanjeev, you mentioned in the hardness, what 9

you were presenting in the hardness, you mentioned issue 10

with styrenics. And then we've talked about styrenics is 11

not typically being a phthal ate

- containing. So I just 12

wanted to clarify what you meant by that. Is it just with 13

the rigidity testing in styrenics or with the phthalate plus 14

rigidity testing, plus styrenics? 15

MR. GANDHI: Yeah. Earlier I had misspoken about 16

the styrenics as an example of that additional hardness 17

bein g effective, because then I corrected it. Other type of 18

elastom er ic materials where plasticizer may be used, and 19

then the Shore hardness as a proxy indicator may not be 20

valid. 21

MR. BUTTURINI: Could I ask Jacqueline to put Mr. 2282

Kaufman's phthalate present ation back up on the screen, 1

because I want to just pop between two pages and ask a 2

clarifying question? 3

[Slide.] 4

MR. BUTTURINI: My question is materials which do 5

not require certification testing

-- and here's the list of 6

materials and it continues on to page 12 and maybe beyond 7

that

-- okay

-- three pages worth. My question is really 8

pretty simple. If you could go back to page 9, these are 9

the materials that don't require certification testing, 10

you're saying "because of" the reasons and the ratio nales 11

given on page 9. It's that kind of connection? 12

MR. KAUFMAN: Well it's several things. First of 13

all, we know from the process that these materials are not 14

produced with phthalates. There's no feasible means for 15

phthalates to find their way into the process stream in 16

terms of producing the material. In addition, we also have 17

test data for those materials, in which I think some of 18

which we've provided already to staff on previous occasions. 19

And, third, we also have the bills of substance data of the 20

70,000 unique materials which have been evaluated based on 21

the bills of substance. So it's really you've got three 2283

branches of data, I guess, for lack of a better term. 1

MR. BUTTURINI: Okay. To follow up on the list on 2

page 11, while you were talki ng, you mentioned phthalates 3

are typically not utilized and they're typically not exposed 4

to phthalates. And my question is about the word "typical." 5

Do you mean typical as in never? Or typical as in most of 6

the time? Typical as in it would take a stra nge set of 7

circumstances to do something? How typical is typical? 8

MR. KAUFMAN: Good question. And, by the way, let 9

me reiterate that when I list these materials I'm talking 10

about molded or extruded parts where we're talking about 11

solid plastic parts. Some of these materials are used, as 12

mentioned earlier, in adhesives and in coatings. And those 13

are

-- I don't have any data on those. In fact, I would be 14

surprised if some of those materials did not contain 15

phthalates or potentially contain phthalates. So we're 16

talking about molded plastics here. 17

And to answer your question, "typically" was meant 18

to imply that if somebody could

-- I don't know why they 19

would, but somebody could intentionally add phthalates to 20

them, but there's certainly no reason t o do that. There's 21

no property that you would gain from doing that. Phthalates 2284

are fairly expensive materials. You wouldn't use them as a 1

filler. I mean there's no logical reason to do it and no 2

logical reason to find them there. 3

MR. BUTTURINI: Th at's great. And is this list 4

just for the resins made from these things, or is it after 5

they've been formed into component parts or children's 6

products? 7

MR. KAUFMAN: We're talking about the resins, and, 8

again, it's always possible, although unlikely, t hat 9

colorants, for instance, might contain small amounts of 10

phthalates. But if a manufacturer is using component part 11

testing and they can test the colorant, but not have to test 12

the natural resin, that still gains them in terms of testing 13

relief. 14

MR. BUTTURINI: I just have another clarifying 15

question. As long as we're here, if we could go to page 16, 16

the rational test BOM and BOS data, and the name and the 17

frequency are listed. These are evaluations of BOMs and 18

BOS ’ s? Is that what this is? 19

MR. K AUFMAN: That is correct. Sorry. Each of 20

those frequencies is the number of times that material was 21

evaluated based on a review of that bill of substance. And, 2285

again, you come up with something north of 600,000, total. 1

Now that represents multiple runs of some materials, because 2

there are only 70,000 unique materials that are represented 3

here. 4

DR. HATLELID: I just mentioned to Randy that he 5

just asked one of my questions. I'll ask you, maybe again, 6

and what I was thinking about in terms of practical and 7

implementation wise. And that had to do with when we're 8

talking about these individual plastic resins and then their 9

colorants and other things, you briefly mentioned there's 10

still opportunity for burden reduction there, even when the 11

finished compon ent or product is considerably more complex 12

than just the resin. 13

MR. KAUFMAN: Correct. 14

DR. HATLELID: Did you want to expand on that? 15

MR. KAUFMAN: Absolutely, Kris, and, you know, 16

clearly, even though the primary way that a phthalate is 17

going t o get into a part is it's used as a plasticizer; and, 18

typically, those use levels are pretty high as I mentioned, 19

you know, in the 30 to 50 percent range to get flexible PVC. 20

On the other hand, you know, there is an outside chance that 21

phthalates could be used as a carrier. 2286

Regulated phthalates could be used as a carrier in 1

things like colorants or heat stabilizers, or any of the 2

other additives. But I should qualify that statement. That 3

applies largely to PVC and allied materials, because those 4

phth alates are typically already in the formulation and are 5

miscible or compatible with PVC. In the case of 6

polyethylene it would be very unlikely to find it there, 7

again, because you're going to have a hard time getting it 8

to mix. You know. Even at fairly low levels, it's just not 9

going to solubilize in the material, even at high 10

temperatures. 11

MR. BUTTURINI: I have another question, and this 12

actually deals with scope of relief, the widest scope of 13

relief. What we have right now is the guidance document 14

from 2009, which is not a regulation. It's a guidance. And 15

my question would be there are materials expected not to 16

contain phthalates, and that could actually be a long list 17

of materials not expected to contain phthalates. 18

My question is if we menti on some things, or we 19

actually have a determination that here are some materials 20

that are not expected to contain phthalates

-- that nobody 21

expected to contain phthalates in the first place, such as 2287

titanium

-- how much would the scope of relief be on thin gs 1

that we don't expect? You know, and you could probably make 2

a reasonable case with a high degree of assurance it's not 3

to be an exotic material like natural gemstones and high 4

melting point metals, and things like this. Would there be 5

a scope of relie f? Do you observe people having to test 6

exotic materials, unfinished woods, for the presence of 7

phthalates? 8

MR. KAUFMAN: In some cases, yes, and here's why. 9

And I'm glad you brought that up, Randy, because what we're 10

looking for is relief in the for m of a regulation similar to 11

what was done with lead at 16 C.F.R. 1500.91. And the 12

reason for that is because very often retail customers are 13

not going to allow exclusion of testing unless they can 14

point to a regulation. Even the guidance document has no t 15

been enough for some retail customs. 16

In fact, just before this session, I actually 17

talked to a couple of retailers and said are you allowing 18

people to exclude materials based on the guidance document. 19

And they said, "Absolutely not. If it isn't a r egulation, 20

we're not going to allow it." 21

DR. RECHT: Just to follow up on that, you know, 2288

again that would be an area where some of you or your member 1

companies might have data that could help. You know, even 2

BASF, the phthalates will decompose or boil at these 3

temperatures and the processing temperatures of this metal 4

is higher than that. Or, you know, things along those lines 5

for that other range of products would still be very useful 6

to us. We've been talking mostly about plastics, but all 7

that same how and why information for other non

- plastic 8

products would be useful. 9

MS. MILLAR: So, again, while jewelry is not a 10

regulated product for phthalates and we have started to see 11

phthalates testing being required by the supply chain, the 12

information I have doesn't suggest that it's being required 13

for any metals, because metals are known not to contain

-- I 14

mean they wouldn't have phthalates. 15

We have also heard from some members that they 16

have been successful in talking to suppliers and to their 17

tes t laboratories about using Shore hardness as an 18

exclusion. So if you're talking about scope of relief, 19

categorically excluding rigid plastics, we think there's a 20

high degree of assurance based on the available data that 21

those products will not contain pht halates. And the reason 2289

I mention the steel exemption on the lead side is that to 1

the extent what we see, practically speaking, in the supply 2

chain, as we see supplier assurances that that product, that 3

is that product that it meets that exemption. So th e 4

supplier assurance, because you have false advertising and 5

warranty and other liability exposure, gives the supplier 6

the incentive to make sure that the product conforms with 7

that assurance. 8

So I think there are some ways that we could 9

practically ta lk about that would provide a high degree of 10

assurance that the component or the material would not 11

contain any of the prohibited phthalates, and there might be 12

a combination of techniques that we could talk about to 13

achieve the highest possible degree of assurance, because 14

that's what everybody wants. 15

MR. BUTTURINI: I'd like to follow with some 16

advice and then one other question on the long list of 17

materials that started on page 11. In terms of scope of 18

relief, Sheila Millar mentioned that rigid plas tics would 19

provide a wide scope of relief. If we could get, perhaps, a 20

comment even submitted saying here's a ranking order of 21

things that would provide wide scope to narrow scope; or, 2290

here's a group that would provide wide scope. So if you 1

have to do so mething on an individual level or if you have 2

to do something as a class, the greatest relief would come 3

from doing this first. Then turn your attention to the 4

second and the third, or however it might turn out. 5

That would be a useful thing for us to know. And 6

I have a question for Kyra Mumbauer on your second to last 7

slide. You recommended to publicly identify the many types 8

of plastic materials that are known not to contain the 9

restricted phthalates in excess of the specified limits. 10

There's more than one way to publicly identify that. And my 11

question is are you agreeing that a regulation similar to 12

1600 C.F.R. 1500.91 to lead would be the sort of public 13

thing you want; or, are you thinking of something else ? 14

MS. MUMBAUER: No. That's exactly r ight

-- 15

through a rulemaking process; and, part of the reason is 16

just to ensure that everyone pays attention and adheres to 17

that carefully. To the point about scope of relief that was 18

raised earlier, one of the challenges that our members face 19

is that eve n outside of the scope of regulated products, 20

these children's products and childcare articles, there are 21

instances where retailers and other customers will ask for 2291

testing of plastics that we discussed here today that would 1

not contain the restricted phth alates

-- just to be sure

-- 2

even though they're not trying to comply with the 3

Commission's regulation specific for children's products. 4

So we're talking an enormous amount of relief, if 5

an agency of the U.S. Government were to come out and make 6

public ly available this information about the classes of 7

materials that wouldn't contain these restricted phthalates. 8

So I agree with that from a legal perspective. A rule 9

provides the most specific assurance and comfort to the 10

supply chain about what does not need to be tested. But we 11

know that rulemakings take time. 12

And so to the extent more immediate relief in the 13

form of updated guidance or commentary from the Commission 14

could be provided, I think that could also be helpfully used 15

in the supply chain t o assist in reducing the cost of 16

unnecessary testing. Because those costs

-- I mean we 17

haven't quantified it for the jewelry industry because it's 18

a pretty new phenomenon for phthalates, but I think Al puts 19

some numbers up and those costs testing doesn't get cheaper 20

over time. Typically, it gets more expensive. 21

And so the net result will be some reduction in 2292

choice, some reduction, maybe, in the number of components 1

that you use because of that burden of testing. So, again, 2

I think we should be looki ng creatively at ultimately a role 3

which would provide the most assurance and relief, but other 4

techniques that could also provide useful signals to the 5

marketplace about the view of the Commission in areas where 6

there is a high degree of assurance that un necessary testing 7

can be avoided. 8

MS. CAMPBELL: Do we have any questions from the 9

audience? No? Any other questions from staff? 10

MR. BUTTURINI: I just have one more. One more 11

statement is that we're talking about providing a wide scope 12

of relief. And in the Federal Register Notice, one of the 13

questions we ask is what sort of things might have to be 14

done to assure the “ will not ” part in addition to the “ does 15

not ” part; will not be non

- compliant versus does not need to 16

be non

- compliant. 17

Now the re's that body of knowledge that we're 18

trying to put together again. You know. These materials do 19

not have the prohibited phthalates because of this. And 20

they will not have the prohibited phthalates because of 21

these other things, or they're unlikely in the future is 2293

always a little uncertain. They will not, with a high 1

degree of assurance, because of these factors, you know. 2

They're always subject to change in the future, but that 3

could be keep an eye out for this, and you will continue to 4

have “ will n ot. ” 5

That's sort of kind of path that we might be able 6

to take to come towards the determination with a high degree 7

of assurance. That would be very useful information, that 8

kind of process together or that kind of argument together. 9

MR. KAUFMAN: A nd I would say just to sort of 10

build on that a little bit, Randy, I think one of the 11

difficulties for industry and also for the staff is that 12

it's impossible to prove never. And so I think having that, 13

being able to build a case that says, look. It's not 14

introduced intentionally. There's no logical path for it to 15

get in there as a contaminant. 16

I mean to me that would qualify as a high degree 17

of assurance, because it's just not going to be there unless 18

someone intentionally sabotaged the process. And that's 19

very, very unlikely. In the case of these materials that 20

we're proposing, there really is no reason for phthalates to 21

be there. You don't gain anything by adding it; and, in 2294

fact, in virtually all of the cases, you lose something by 1

not being vig ilant about making sure it's not there. 2

MR. GANDHI: I'd just like to add a comment, 3

picking up on Sheila's comment about being creative. So 4

from the lab side, we are always looking for opportunities 5

to improve the testing process, making it quicker and 6

faster. And I would also say that as the time has 7

progressed, the cost of testing for phthalates has come down 8

tremendously. However, I just want to point out that we are 9

always looking for new technology that can be incorporated. 10

And I remember two y ears ago there was a panel 11

discussion here in this facility looking at some potential 12

hand

- held technology that may be on the horizon, and, 13

unfortunately, it hasn't progressed. You know. I remember 14

reaching out to some of those companies after that event ; 15

tried to learn more about it and how those opportunities can 16

be further explored through a Beta testing kind of state, 17

but, either, the technology hasn't matured on their end to 18

share with us what can be done to bring that technology to a 19

commercially vi able solution. 20

MR. COHEN: My name is Neal Cohen. I'm a CPSC 21

staff member. I'm going to just play the rube here, because 2295

I am. This discussion about Shore hardness and rigidity, is 1

this a standard spec in the industry? I mean I know that 2

stainless steel numbering, as Sheila had noted in the lead 3

determination, is a standard spec. Is this something that 4

SPI members already include in the resins when they're sold 5

at the substances level? Or is this another test that would 6

have to be performed by the end product manufacturer, 7

component part manufacturer after molding? In other words, 8

are you replacing one more expensive test for phthalates 9

with one less expensive test for Shore hardness? 10

MR. KAUFMAN: Yeah. In general, Neal , the cost of 11

testing for phthalates is fairly significant. The cost and 12

time to do Shore hardness is very, very quick. As I said, 13

it's just a penetrometer, a weighted penetrometer that gives 14

you a direct read

- out on a dial indicator as to what the 15

Shore hardness is of the ma terial. And to answer the other 16

half of your question, yes, it is a very common way of 17

specifying the hardness or softness of a material, at least 18

within the toy industry. 19

MR. BUTTURINI: I have a question. I just want to 20

emphasize something that Mr. Kaufman said. The lead 21

determinations that were done were done largely in part for 2296

things that can't contain lead greater than now 100 parts 1

per million. But, for manufactured materials, it's not 2

always

-- you can't always use the word “ can't ” as easily , 3

and that's why we intentional ly put in a high degree of 4

assurance, things like that, because we understand that 5

“ can't ” is pretty hard to do. And when you combine can't 6

and won't, that's even harder to show scientifically. 7

So that's why a high degre e of assurance is in 8

there. We know there is uncertainty. There is uncertainty 9

in process. There is uncertainty in product. There is 10

uncertainty in measurement, and there is certainly 11

uncertainty in the future, and we are trying to take that 12

into accou nt. 13

MR. KAUFMAN: And I guess the only thing I can say 14

in response is that at least in our view the likelihood of 15

phthalates being found in some of the materials that we're 16

proposing are probably lower than the likelihood of finding 17

lead in some of the excluded materials in 1500.91. 18

MS. CAMPBELL: Okay. If there are no more 19

questions, we can go ahead and break a little bit early for 20

lunch. Thank you. We are going to reconvene at 1:15 for 21

the panel on Lead and t he ASTM 8 Elements solubility. 2297

So en joy lunch. 1

If you haven't already gotten a copy, we do have 2

some handouts about lunch options that are in the vicinity. 3

[Lunch break.] 4

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2298

A F T E R N O O N S E S S I O N 1

MS. ADAIR : Good afternoon, everyone. We're going 2

to get star ted with our next session. I hope everybody had 3

a nice lunch and you're back and ready. 4

My name is Patty Adair and I'm with the Consumer 5

Products Safety Commission for Engineering Sciences. This 6

session will go very much like the one before, and I want ed 7

to add a few reminders

-- just housekeeping

-- before we get 8

started, and remind everybody that the workshop is being 9

webcast and taped. The presentations given will be posted 10

to SlideShare sometime early next week. I believe 11

Jacqueline will probably send out a link. 12

IV. LEAD AND ASTM 8 ELEMENTS 13

MS. ADAIR: So for this session, which is "Lead 14

and the ASTM 8 Elements," we are going to start with the 15

staff presentation and then follow that by presentations 16

from our panelists and statements. And then , again, just 17

like last time, we'll open the floor to questions and some 18

discussion. And the staff presentation will start with Kris 19

Hatlelid. 20

[Slide presentation.] 21

2299

DR. HATLELID: Good afternoon, everyone. So as 1

Patty just said, we're going to talk about lead and the 2

other elements in the F 963 Toy Standard, and a little bit of 3

background. We talked a little bit this morning. People 4

mentioned already that some years ago the Commission 5

determined a set of materials that do not exceed the current 6

100 per million lead content limit, and therefore not 7

subject to the third

- party testing. 8

And the citation here, 16 C.F.R. 1500.91

. A t the 9

same time, we put together some procedures/requirements for 10

lead content determinations, sort of a guidance to petiti ons 11

for stakeholders who would be interested in seeing other 12

materials undergo the same sort of review. And that's at 16 13

C.F.R. 1500.89. As we talked about this morning with the 14

phthalates, we have a set of very similar questions to 15

discuss today and in the future. 16

For manufactured materials, we would be interested 17

in learning about the specific information and data that 18

staff should assess in considering a recommendation that the 19

materials production does not and will not result in lead 20

content above that limit. We are interested in the effect 21

of recycled materials, what could happen during recycling 22100

and introduction of recycled materials into manufactured 1

products, and the potential for contamination. 2

We are looking for what specific information and 3

data should be obtained to assure that continued production 4

of the materials for future manufacturer, regardless of its 5

origin, will continue to be compliant with the lead content 6

limits. And what other information should the staff 7

consider before po tentially making recommendations to the 8

Commission

. 9

B ecause we already have a list of lead determinations and a 10

procedure , w e wanted to ask about whether there might 11

potentially be changes that one might want to see to the 12

existing procedures, whether so mething should be clarified, 13

simplified, added to, and, again, that citation is 16 C.F.R. 14

1500.89. And we would be interested in more information 15

about some materials that intrinsically or inherently, sort 16

of versus manufactured products, but materials th at by their 17

nature do not contain lead above the current limit

. And is 18

that information available? As with the phthalates, we 19

would like to explore where we could make the most of our 20

potential activities in terms of burden reduction and cost 21

savings. 22101

So now we're going to switch to the ASTM heavy 1

elements. We're going to have some of the same sorts of 2

issues we want to explore, but a little bit of background. 3

The toy standard has in it, in addition to lead, so there 4

are 8 elements. One of them is l ead. It has its own 5

requirements. The other 7 are antimony, arsenic, barium, 6

cadmium, chromium, mercury and selenium. And I just wanted 7

to point out that the basis of that standard is solubility 8

of the chemical from the material or migration from the 9

ma terial ; that’s how the test is done. 10

And we're going to talk a little bit about 11

thinking about solubility of the elements from material as 12

well as content. The current version of the toy standard 13

has an optional test for content and that was under the 14

consideration that if a test is being conducted already for 15

lead content, the other elements could be included for only 16

a marginal increase in cost. So they tend to be amenable to 17

testing al l together. And because the lead test is for 18

content, the other test s would also be for content. 19

As we've talked about before with the other two 20

chemicals, what materials, by their nature, do not and will 21

not contain any of these elements above the solubility 22102

limits? I'll read that one again. In content, above t heir 1

solubility limits. So that goes to the optional test for 2

content. Content is not required. Content limits are not 3

required for these elements, but it can be the basis for a 4

test. So we can look at determinations based on content. 5

The second ques tion on this slide has to do with 6

the solubility. So how do we address thinking about 7

solubility? How do we know whether the chemical present in 8

a material or component part, or a product, will be below 9

the limits. It's the same sort of concept as the 10

d eterminations for phthalate content and lead content, but 11

we're talking about solubility in that case. 12

So, a related question. How can we think about solubility 13

limits and whether compliance with those limits can be 14

inferred from content? If we know s omething about content, 15

whether it's below the solubility limit or not, can we know 16

something about the potential solubility? And that needs to 17

consider the characteristics of the product. 18

We heard a little bit about this with phthalates 19

as well. It's not necessarily what's going on with the raw 20

material. It's the shape, the configuration once you make 21

the component of the product . And, again, what are the 22103

avenues to explore for the greatest cost reduction and 1

burden reduction in pursuing some of thes e questions? And, 2

a general question: What other information should we 3

consider before potentially making recommendations to the 4

Commission? 5

So Patty will be moderating this session, and she 6

will introduce each of our panel participants. I'll go 7

thr ough the list, the six of them, before I turn it back 8

over to Patty. 9

Nikki Brown from Penn State University; Bill 10

Perdue for the American Home Furnishings Alliance; Mark 11

Fellin from the Juvenile Products Manufacturer's 12

Association. We've met Al Kaufma n from the Toy Industry 13

Association; Hailey Mann from the American Plastic Toys; 14

and, we've also met Sanjeev Gandhi from SGS Consumer Testing 15

Services. 16

MS. ADAIR: Thank you, Kris, for that very 17

informative presentation. I'm going to invite Dr. Nikki 18

Brown from Penn State to come up and tell us a little bit. 19

Introduce yourself, your bio. 20

DR. BROWN: Good afternoon everybody. My name is 21

Nikki Brown. I'm here from Penn State. I'm in the 22104

Department of Ag and Biological Engineering, and my 1

expertise is wood, wood chemistry, wood adhesives. So Rick 2

asked me to come and comment about not just raw wood and the 3

exemption that it qualifies for, but also wood composites 4

and what kinds of heavy elements we might see in those 5

materials, coatings and paints. We'll talk a little bit 6

about recycled wood also. 7

So I don't have a formal presentation with slides. 8

I'd just like to offer some comments based on some 9

literature review and some discussion with some colleagues 10

in industry. So to begin with I'd like t o give credit to 11

some people who provided some information to me

-- Dr. World 12

Nieh and his colleague Alan Rudie at the USDA Forest 13

Service. My grad student Brett Diehl also provided some 14

time and energy searching some literature for me for today. 15

So than ks to them. 16

For raw wood, as you guys know, it qualifies for 17

an exemption, because all of these eight elements of 18

interest are considered trace compounds. The literature 19

that we were able to dig up on that supports that. When you 20

look at the ASTM F96 3, Table 1, the limits for each of 21

those, based on our literature search, we were well under 22105

the limits. So the exemption is supported. It's also 1

interesting to note that the highest levels of those 2

materials occur naturally. We find it in leaves, roots , 3

small branches and bark. And, of course, those are the 4

parts of the plant that are least likely to be found in 5

toys. 6

So even some of those elements that may have been 7

in the higher range or close to our limits might have been 8

found in plant tissue t hat would not be present in toys. 9

There is of course variation in species, so some of the 10

literature that we found also is most relevant to species 11

that we might use in pulp or paper, or other commercial 12

building materials, which again might not be consis tent with 13

what is found in toys. So just pointing out some of the 14

limitations of the information that's available in the 15

literature. 16

If we move on and think about wood composites, 17

since the '80s, there's been a big boom in composite 18

technologies, most ly because we can be more efficient with 19

how we use wood. We chip it up into small particles, and 20

then we glue it all together to make big products out of 21

perhaps lower quality wood elements. So the big question 22106

there is if wood is okay as it is, and it doesn't have heavy 1

metal levels that are a problem, well what happens when you 2

throw in some adhesives? 3

And adhesives are the main thing that we would 4

worry about. There's very little other additives to 5

composites that would be heavy metal based, perh aps some 6

waxes or things like that that would be more organic in 7

nature would be more typical. But the different resin 8

technologies that are used for composites include amino 9

resins, like urea formaldehyde, melamine formaldehyde, 10

isocyanate. 11

If you're looking at solid wood that has been 12

glued together, small, clear blocks of wood, that would be 13

polyvinyl acetate, primarily. And then there's also 14

phenolics, but again, some of these composite materials 15

would be very rarely found in wood. The particle b oard or 16

MDF that you might find in some toys or puzzles would 17

probably be an amino type resin, and they're

— talking with 18

one of the major U.S. suppliers , M omentive

— t hey indicated 19

that they don't use any catalysts or additives that would 20

include any of the eight heavy metals. 21

So something where there's a chain of custody or 22107

paperwork supporting what kinds of additives are provided to 1

a manufacturer could perhaps be a way to get around a 2

laborious or expensive testing process. For paints and 3

finishes, like adhesives, there's very little published 4

literature available. Most of this is kept in industry 5

knowledge, trade secrets. But, again, discussions with a 6

couple people

-- I was able to speak with a colleague at PPG 7

-- he indicated, again, very little of their current 8

technologies use any of those additives in their paints. 9

They would have used that, or they continue to use 10

some chromium

- based products for exterior steel applications 11

where they need incredible durability. Some of their 12

pigments may als o contain heavy metals that, again, for 13

interior type uses, the amount of these eight elements of 14

interest is extremely limited. So, again, the thought that 15

came to mind this morning as we were talking about this was 16

a very similar process that's been und ergoing for the wood 17

composites industry, relative to formaldehyde emissions, 18

where panel producers have had to demonstrate how much 19

formaldehyde is being released in their products. And, 20

again, there's third

- party testing that's required. 21

There's als o an extensive chain of custody and 22108

paperwork recordkeeping that's required; but exemptions are 1

possible for technologies that have no added formaldehyde. 2

So a very similar approach could work here where coatings or 3

paints, or resins that have no added el ements

-- antimony, 4

arsenic, lead

-- perhaps a recordkeeping method similar to 5

that Toxic Substances Control Act , Title 6, for 6

formaldehyde. Perhaps a similar approach could be viable. 7

The wood products industry responded really 8

favorably, actually, to this new EPA regulation after some 9

consideration. They realized that it was actually a boost 10

to their American competitiveness, relative to overseas 11

products that may be coming in. This way, by providing 12

certification and documentation to support their p roduct, 13

having very low formaldehyde emissions, that was an added 14

value for them. And so their product became more valuable, 15

so they were able to compete better with overseas 16

operations. 17

Finally, just a few comments on recycled wood 18

waste. This area is probably the one that we need more 19

information about. As I was searching through the 20

literature, there's a few articles in this area, but not 21

much. And the one that I focused on was from Sweden in 22109

2006. In Sweden there's a tremendous use of biomass and 1

biofuels for residential heat application. So they had a 2

tremendous interest in what happens when they use recycled 3

wood waste for that. 4

What kind of heavy metal considerations need to be 5

taken into effect? So they did a modeling approach based on 6

s ome published data, and the numbers that they came up with 7

put us right at the borderline of some of the acceptable 8

limits that are published in the ASTM standard table 1, 9

especially for arsenic. The arsenic level that they 10

reported for recycled wood wast e, the content was as high as 11

53 parts per million of arsenic. 12

Again, that was based on a lot of assumption. So 13

more literature is needed. More work is needed in that area 14

to document the levels of arsenic. Another one that was 15

close was chromium at 60 parts per million, and again based 16

on their assumptions. Probably those levels are coming from 17

CCA treated woods, which CCA was the most widely used wood 18

preservative from 1970 through 2004. In 2004 it was 19

voluntarily pulled because of concerns with arsenic 20

leaching. Just to give you an idea, CCA treated wood can 21

contain anywhere from 1500 to 3300 parts per million of 22110

arsenic. So containing or controlling or limiting, or 1

eliminating waste streams that contain CCA treated wood 2

would certainly be nece ssary in my opinion. 3

So that's just an overview of some information I 4

was able to find about wood, and these 8 heavy metals. 5

Thank you. 6

[Applause.] 7

MS. ADAIR: Thank you very much, Dr. Brown, for 8

sharing that with us. And I'd like to welcome Bill Perdue 9

from the American Home Furnishings Alliance. 10

MR. PERDUE: Patty, thank you, and good afternoon 11

everybody. I am Bill Perdue. I am vice president of 12

Regulatory Affairs for the American Home Furnishings 13

Alliance, and I have the distinction of bein g a fourth 14

generation furniture guy. So I've been in this industry all 15

my life and actually saw my great grandfather come through 16

this entire industry as well. At one time when I went to 17

work for American in Lawrenceville, Virginia, we had three 18

generati ons of my family working with one company. So I 19

have a pretty good background in this industry. 20

Let me tell you a little bit about the HFA. The 21

HFA is a trade association. We're the largest trade 22111

association for the home furnishings industry. We have 450 1

member companies. We do operate a very large domestic wood 2

furniture manufacturing footprint, as well as a 3

comprehensive and extensive global supply chain that does 4

provide a wide variety of home furnishings to the American 5

consumers. 6

Member compan ies basically provide approximately 7

300,000 manufacturing jobs throughout the United States, and 8

we represent a $35 billion segment of the industry. They 9

were around a long time. Our trade association's been in 10

existence for over a hundred years now. I want to focus, 11

really, on composite wood products. I've spoken to the 12

Commission and to staff sometimes about composite wood 13

products, and this is something that over the last several 14

years we've been testing. 15

Our products, especially youth furniture, with 16

relation to lead, mainly, 16 C.F.R. 1500.89, I think, is a 17

great platform to be able to make a determination not to 18

have to test composite wood products in our furniture. 19

Composite wood products in household furniture, as component 20

parts, do not con tain lead in amounts that exceed the 21

applicable lead levels specified by the CPSIA. Basically, 22112

these component parts should be exempt from the testing 1

requirement for total lead content that's imposed by Section 2

101(a). 3

A preponderance of our test sta tus since the 4

inception of the CPSIA clearly revealed the absence of lead. 5

The requirements to test are costly and very unnecessary to 6

our industry. Composite wood products primarily consist of 7

wood and glue, as you just heard from Dr. Brown. The 8

Commis sion has previously stated that wood will not exceed 9

the lead limits established by Section 101(a), and so wood 10

in and of itself is exempt. Lead is not intentionally or 11

inadvertently introduced into the manufacturing process. 12

Lead is not a routine or op tional additive that 13

contributes a positive characteristic to the finished 14

product. There's no reason for us to put lead in it. 15

There's no reason for us to have lead in our system. 16

There's no reason for lead to be in the resin systems. 17

There's no reaso n for lead to be present in these composite 18

wood products that we use as component parts for finished 19

goods. 20

Dr. Brown stated there are four major glue 21

suppliers to the wood products industry: Hexion, Arclin , 22113

Georgia Pacific and AXA. The primary resi n systems that are 1

employed currently within the United States and offshore 2

manufacturing are the more traditional or conventional urea 3

formaldehyde resin systems, do not add formaldehyde resin 4

systems and the ultra low e mitting formaldehyde resin 5

systems. All of these resin systems are under extreme 6

scrutiny by the state of California with their carb 7

regulation, and currently under the EPA proposed rule, again 8

bringing this type of scrutiny to the resin systems that we 9

currently use. 10

These resin syste ms are basically water, urea and 11

formaldehyde. There is wax in limited applications. These 12

wax are organic in nature, 40 percent solids, some in the 13

core glues we see from .5 to .75 percent in the entire make 14

up. Some have 1 percent for the face glues, and those would 15

be the glues that we use to actually put face veneer on top 16

of these composite wood products. 17

We do have an inherent challenge using wax in 18

composite woods as component parts of furniture, especially 19

youth furniture, and that's absorpti on and the adhesion of 20

finishes. A lot of times if we've got too much wax or waxes 21

found in the composite wood products, the finishing material 22114

just simply will not stick. It will bleed through the 1

veneer face, and we get what we call fisheyes in the 2

fin ishing room at that time. So it's an inherent problem 3

that we see. 4

The HFA a couple years ago, the outset of the 5

CPSI A , did do a study for lead in composite wood products 6

and component parts. We did contract with a CPSC certified, 7

third party lab, an d we had a broad sampling set. And when 8

I say broad, that included both domestically manufactured 9

composite wood products, as well as composite wood products 10

from offshore. And, again, to define composite wood 11

products, we were mainly looking at medium d ensity fiber 12

board and particle board. 13

Both have very similar characteristics, but the 14

fines in the MDF are that , they're fines, and they are part 15

of the manufacturing off fall of furniture as we bring our 16

component parts through the manufacturing proc ess. And then 17

in particle board, the particles are a little bigger, but 18

again they are comprised of the off fall that is generated 19

from the manufacturing of our component parts as we assemble 20

those component parts to make furniture. 21

Historically, the data that we've collected since 22115

the onset of CPSIA was verified by the study that we put 1

together. We had been testing since 2009 under Section 101 2

for composite wood products and lead. The testing really 3

was the result of our supply chain demands. We a s an 4

industry had great pressure put on us throughout the supply 5

chain from our customers asking us to test for lead and the 6

composite wood products. And, basically, this really has 7

generated a very sizeable repository of data point s

. 8

Regardless of wher e the composite wood product was 9

manufactured, the data and the result of the study were the 10

same. Our highest reading that we have, that we've seen to

11

date, is four parts per million. The majority of all of the 12

data points are non

- detect. When we start talking about the 13

manufacturing process and we start talking about recycled 14

products, and looking at how, if lead could be introduced in 15

the manufacturing process we use the quorum's "Life Cycle 16

Inventory Report" for MDF and particle board. 17

Basically, w hen you look at the process of 18

manufacturing these two composite product types, the 19

manufacturing process is very closed. It is very simple, 20

and it's linear in process. And it's highly automated. The 21

closed nature of the manufacturing process, in our op inion, 22116

does not permit any opportunity for the introduction of 1

lead. There is just no reason for it to be there, nor is 2

there an opportunity for it to be introduced in the process. 3

Basically, from the saw mill to the finished 4

product, and that's really from the log all the way down to 5

the piece of furniture that you have in your home, products 6

that include the process of wood chips fines that are the 7

off fall of furniture production will have a resin system 8

and wax . So really what they do is they take t he log. 9

We'll trim the log. We'll turn that into face veneer or 10

into some type of lumber wood that is used in the 11

manufacturing process. And then the other fines are 12

generated through the manufacturing process. This would run 13

these component parts thro ugh the manufacturing operation. 14

Those fines are collected, basically. Those wood 15

chips are collected. We store them. And then in a lot of 16

cases they are pneumatically transferred from the furniture 17

manufacturing facility, literally next door, to a plant that 18

makes the mat, as it's called, the particle board mat or the 19

MDF mat. In some cases we store these in siloes, and they 20

are then transported by truck to the composite wood product 21

manufacturer. Again, the system is very closed and very 22117

tight, a nd it does consist of basically wood chips and 1

fines

. 2

Some of those wood chips and fines would be 3

resinated , simply because of the fact that we're using 4

composite wood products in the manufacturing process. And 5

in order to make the mat, you have to us e the wood chips 6

with a resin system. That's how you get them to stick. And 7

so as we make those component parts, we will get some 8

resinated wood into our recycling stream. 9

Over the course of the last several years we've 10

collected quite a bit of data us ing CPSC

- CH

- E1002

- 08, and 11

also the ASTM 1479

- 99 method. One thing that came up here a 12

while back that I thought was really interesting, there was 13

an automotive glue. We were asked about an automotive glue, 14

and it was sort of one of these issues of what i f, what if 15

this glue were on the shelf. Could it be used? 16

We went back and we did a lot of research on that 17

glue; and, yes, there is an automotive glue that does use 18

lead in the catalyst to kick the reaction over. However, 19

that glue has to be used in an electrostatic water bath. I 20

think that if we're looking at reasonable determinations and 21

reasonable assumptions, you're not going to take a piece of 22118

wood furniture particle board and run it through an 1

electrostatic water dip bath in order to use a lea d catalyst 2

in a resin system. So that's the something that continues 3

to pop up, for whatever reason, and it's just impractical. 4

We don't use it in our manufacturing system. We never 5

would, and it would be impossible. 6

So with that, I will close my re marks and thank 7

the Commission, and thank the Commissioners for allowing us 8

the opportunity to speak. And, again, we are very focused. 9

What we are asking for is the determination for composite 10

wood products, fines testing, and in home furnishings and 11

you th furniture. Thank you very much. 12

[Applause.] 13

MS. ADAIR: Thank you so much, Bill. 14

We are going to welcome Mark Fellin from the 15

Juvenile Products Manufacturers Association. Mark? 16

MR. FELLIN: Thank you for giving me the 17

opportunity to speak he re today on behalf of the Juvenile 18

Products Manufacturers Association. I appreciate the 19

Commission taking the time to review this. On behalf of the 20

entire industry, we certainly do appreciate it. A little 21

bit of history about JPMA: JPMA represents 95 p ercent of 22119

the pre

- natal industry and we have rough ly 250 members. 1

I loved when Al spoke earlier, when he said that 2

industry is not seeking any relief regarding compliance, but 3

only relief from testing, which does not advance safety. I 4

think when we co nsider JP products, I love to tell people 5

that we have a great story. We're the only industry that 6

has affected every single person in this room on a personal 7

level. Everyone here at some point has used one of our 8

products

-- not something that our manuf acturers take very 9

personally. And we hold that to the highest regard in terms 10

of safety. 11

There are a couple of things that I want to 12

address in my comments, and I know Al is going to go through 13

kind of a lot more of the materials for exemptions that we 14

share. One thing I want to address in particular

-- and 15

Sheila mentioned this earlier when she said the smaller the 16

industry, the more the cost; and the smaller the production, 17

the cost is still the same. With the JP industry, that 18

hasn't been the cas e. 19

Since 2007 'til now, the industry as a whole has 20

absorbed all the cost of testing. We haven't put it back on 21

the consumers. I think that's something important to note. 22120

For instance, the average cost of a travel system is roughly 1

about $219. So w hen we were talking about the different 2

types of materials, I know Al is going to talk about, for 3

their average product it's $9. When you translate, that's 4

$219 for our products, a significant cost. So I think 5

that's something to be kind of aware of. 6

Now, when Kris talked earlier, she said one of the 7

things that they're trying to look at is changes to existing 8

procedures. And I want to get this right here. So 16 9

C.F.R. 1500.89 was crafted prior to the CPSIA amendment, 10

which provided that CPSC may gr ant exemptions for products 11

if lead is required, because it is not practicable or not 12

technologically feasible to manufacture the product by 13

removing the excessive lead or by making that lead 14

inaccessible. The product, or any of its components, is not 15

lik ely to be placed in the mouth or ingested, and the 16

exception will have no measurable adverse effect on public 17

health or safety, taking into account normal and perceivable 18

reasonable use and abuse. 19

I know that the main portion of this isn't focused 20

on t he idea of accessibility, but I think it's important to 21

note, particularly as it relates to the cost of some testing 22121

for juvenile products. Back when Congress developed Public 1

Law 112

- 28, they exempted certain products that they knew 2

had a certain amount of component parts. For example, 3

bicycles and ATVs were exempted as well as books, because of 4

the lead content. 5

JPMA is very similar in some of our products. For 6

instance, for a play yard, when considering the rivets, 7

tubes, caps, protective componen ts, wheels, corner knuckles 8

and many other components of play can cost

-- that's cost in 9

testing

-- cost well over $2,000 in test costs, just for 10

lead and substrates. So I think it's really important to 11

note, kind of, as we're going through this discussio n and 12

you're trying to look at ways in which to reduce the burden, 13

that you're looking at where things are actually accessible, 14

and knowing that you have the authority to kind of look at 15

that in greater detail. 16

So that's kind of the brief overview that I wanted 17

to give, and I'm happy to answer any questions on the 18

presentation. So, thanks once again for having me. 19

[Applause.] 20

MS. ADAIR: Thank you so much, Mark. 21

We're going to get a presentation up for Al, here. 22122

[Slide presentation.] 1

MR. KAUFMA N: Hi, for those of you who weren't 2

here this morning, and I suspect that almost everybody was. 3

I'm Al Kaufman. I'm the senior vice president of Technical 4

Affairs for the Toy Industry Association. Since most of you 5

were here this morning, I'm going to speed through some of 6

this. 7

So, first of all, you don't need to hear again 8

about the Toy Industry Association. But, again, just to 9

reemphasize, and it's something that Mark spoke about, we're 10

not looking for any relief regarding compliance. You know 11

w e believe that it's in everyone's interest that the product 12

be compliant. What we do want some relief on is testing 13

that tells us something we already know, and is essentially 14

dollars that are being diverted from more productive 15

pursuits that could be u sed to focus on other areas of 16

safety. 17

We're going to present some proposals and 18

rationales. And, again, since I wrote this before I had the 19

conversation with the staff, definition of accessible, 20

again, same argument as with phthalates. In other word s, 21

the current definition of accessibility was primarily 22123

developed for sharp edges and sharp points, where touching 1

it is clearly an issue. On the other hand, for heavy 2

metals, oral ingestion is usually the issue, and so simply 3

because you can touch somet hing doesn't render it an 4

exposure risk. We're also going to talk about screening 5

materials based on rigidity and a proposal to test or 6

exclude materials based on composition. So we're to talk a 7

little bit about that. 8

The second proposal that we had beyond the 9

accessibility was ASTM's F 963 currently contains a de 10

minimis level. In other words, if you have a toy material 11

that is less than 10 milligrams in mass, the standard 12

doesn't require testing. And so what we would like to see 13

is at least some in vestigation into the idea of adopting 14

that 10 milligram de minimis level for the lead requirements 15

in both surface coatings and in substrates. 16

We currently don't have the data, but we are 17

collecting them. The one thing that we did have, the staff 18

did so me excellent work a couple of years ago and determined 19

that a lead exposure of less than 2.2 micrograms per day

-- 20

and that's an exposure level, not a content level

-- would 21

not result in a measurable increase in blood lead level, 22124

which is the gold standar d that H.R. 2715 put in place. But 1

it used an assumption of 50 percent absorption of any 2

ingested lead. And what we are finding from our ASTM 3

soluble testing is that absorption may be much less than 50 4

percent. In fact, it may be much less than one perc ent. So 5

we are still collecting data and we'll be proposing

-- 6

making a final proposal

-- at a future date. 7

And proposal number 3 is to exclude some materials 8

from lead and heavy elements testing based on their 9

composition. And we're talking here

-- I want to be clear. 10

We're talking here about natural or neat resins. We don't 11

have the confidence that all colorants

-- for instance, once 12

the y’re added to the material

-- wouldn't create a potential 13

issue. What we are talking about, those manufacturers w ho 14

are using component part testing who currently are testing 15

the resin. They're testing the colorant. They're testing 16

any other additives that they might be putting into the mix. 17

So we'd at least like to give them the relief on 18

the materials, the res ins themselves that contain nothing 19

else except the plastic that they don't contain lead or 20

heavy elements. And then composite wood, for the reasons 21

that you've heard, I won't go into all the details, since 22125

it's been covered very adequately by some of my fellow 1

panelists. Composite wood is unlikely to contain 2

significant lead or heavy metals. And then, again, we're 3

still collecting data and we'll make a final proposal at a 4

future date. 5

The materials for which data gaps exist, P V C, 6

while most P V C supp liers have switched, there were heat 7

stabilizers that were based on lead or cadmium or barium. 8

Most of the P V C suppliers for the children's market have 9

switched. Most of the stabilizers these days are based on 10

calcium or zinc, or a combination. The same for 11

polyvinylidene chloride and chlorinated PVC, neither of 12

which is used commonly in toys. 13

PVDC, occasionally you'll see it in things like 14

doll hair. But chlorinated PVC is almost never used. And 15

then thermoplastic polyesters, PETE, we're still colle cting 16

data. We have a concern about the fact that antimony tri

17

oxide is sometimes used as a catalyst in producing that 18

material. Now, while we're not using it in the soluble 19

test, we want to make sure that we've got the data before we 20

make that proposal to the Commission. 21

Again, why some materials don't require a 22126

certification testing, most plastic materials that we've 1

listed are, again, they use petroleum or natural gases of 2

feed stock, which typically don't contain high levels of the 3

regulated metal s. Polylactic acid, again, coming out of 4

cornstarch, unlikely that the heavy metals would find their 5

way in there. And then, again, resin producers tightly 6

control the extraneous materials to make sure that they're 7

producing the quality that's necessary, particularly when 8

you are reacting these materials and you're polymerizing 9

them. 10

Keep in mind that in many cases the polymerization 11

process is using a platinum or palladium catalyst. So 12

particularly for the case of lead, that would tend to poison 13

the catalyst. So for that reason alone, you would want to 14

be very, very careful about making sure you don't have any 15

lead in the process. And then, again, composite wood 16

contains only trace levels due to wood, itself, and it's 17

already exempted from lead tes ting by 16 C.F.R. 1500.91. 18

Our experience is most of the resin systems used in 19

manufactured wood are as you've heard urea formaldehyde or 20

melamine formaldehyde based. 21

So formaldehyde is an issue, both from the 22127

standpoint of the CARB ATCM and the pendi ng EPA regulations. 1

But we're certainly not seeing heavy metals there. So, by 2

test, it's been absent. And, again, materials which should 3

not

-- and again we're talking about natural resin, no 4

colorant, just the resin as it comes out of the bag. 5

There's a list of materials here which we'd like to propose 6

to be exempt. 7

Testing for lead and heavy elements, in some cases 8

for years, and Hailey's going to talk about this in a 9

minute. She's a manufacturer based here in the U.S., and 10

she's done extensive t esting. We're just not finding these 11

things. They're not in many plastic materials. They're not 12

in composite or manufactured wood materials. And these data 13

in combination with knowledge of the material and the 14

process, we believe, give us adequate assu rance that you're 15

not going to find these trace metals in these materials. 16

And I'd like to directly answer one of Kris's 17

questions, which is can we make some assumptions about 18

solubility of materials based on how much is there in terms 19

of total amount. And I would say other than to say that the 20

soluble amount is going to be no greater than the total 21

amount, I don't know that we can say anything. And the 22128

issue is that it depends so much on the matrix in which it's 1

distributed; and, it depends so much on the individual 2

species that we're dealing with. 3

For instance, a good example is barium sulfate is 4

very commonly used as a paint pigment. It's very commonly 5

used as a plastic pigment. It's used on paper; however, 6

it's virtually insoluble. And so, in fact, it's used in 7

medical contrast studies. They feed you a barium malt so 8

they can get a better X

- ray view and it passes through the 9

system without being absorbed. On the other hand, other 10

barium salts might be very different in terms of their 11

solubili ty. So I don't think we can come to any 12

conclusions, or at least not based on the data we have. 13

Accessibility in summary, accessibility 14

determinations we think we should better reflect the hazard 15

than they do today; and certain materials, we think, ma y 16

require continued testing, and we're continuing to gather 17

data. We think other materials should be exempt, based on 18

their composition. And, again, we're not seeking relief 19

from compliance. We're seeking relief from what we think is 20

unwarranted testing that doesn't get us anywhere. And I 21

guess that brings me to a question I have for the staff, and 22129

I'll kind of kick it off here. 1

When we talk about a high degree of assurance, 2

what level of assurance are we looking for? And maybe we 3

can talk about th at as we field questions. Thank you. 4

[Applause.] 5

MS. ADAIR: Thank you so much, Al. 6

I'm going to welcome Hailey Mann from American 7

Plastic Toys. 8

[Slide presentation.] 9

MS. MANN: Hi, everybody. I'm Hailey Mann. I'm 10

responsible for quality, en gineering, product safety and 11

compliance for American Plastic Toys. Again, I'd like to 12

thank the Commission and the staff for the opportunity to 13

participate on the panel today, and I just want to give a 14

brief history of American Plastic Toys. 15

We are a d omestic manufacture of injection molded 16

plastic toys. The company was founded in 1962 and has 17

operated continuously for over 50 years. Our corporate 18

headquarters are located in Walled Lake, Michigan. We 19

currently have five buildings with over a million square 20

feet of assembly, manufacturing and storage space, and all 21

of our products are produced and shipped from either our 22130

Michigan facilities or our Olive Branch, Mississippi 1

facility. 2

We're a vertically integrated manufacturer. We 3

take in raw plasti c and colorants, and mold and assemble the 4

finished product. We have over 50 injection molding 5

machines, corporate wide, and they vary in sizes from 150 6

tons up to 946 tons . And we have just over 300 employees. 7

We do have the most comprehensive product line of injection 8

molded toys in the United States. We currently have 9

approximately 125 items in our product line. I brought a 10

little example. They range from a small sand shape, which 11

retails for about a dollar, to a large plastic playhouse 12

that retail s for over a hundred dollars. 13

What I'm here to talk about today is to present 14

data for two materials used in our manufacturing process: 15

natural, unpigmented polypropylene and polyethylene resins. 16

These two materials will not contain any of the eight 17

elements at detectable levels. I have a data packet that 18

contains results I've compiled over the last 15 months. I 19

have tested 105 different lots of natural resin that total 20

represent 20 million pounds of polypropylene and 21

polyethylene. I'd like to high light in every case the test 22131

results for the 8 ASTM elements, and these resins confirm 1

these plastics are not just compliant, but the element 2

content is so low or non

- existent as to be undetectable. 3

Here is one example of the supporting test results 4

in cluded in my data packet. I've highlighted the results 5

section, showing that all 8 elements are below detectable 6

levels. The test results demonstrate a high degree of 7

assurance that these two materials, polypropylene and 8

polyethylene, will not have any o f the 8 elements at 9

detectible levels. The technical considerations, as Al 10

already pointed out that polyethylene and polypropylene are 11

produced from petroleum or natural gas, which do not contain 12

appreciable amounts of the regulated metals. These gases 13

a re polymerized in a reactor in a closed process, which 14

eliminates contamination opportunities. 15

The resin producers are careful to control the 16

presence of trade metals, as they will interfere with the 17

ability to obtain desired properties in the finished 18

plastics. Polypropylene and polyethylene, natural raw 19

resin, should be excluded by regulation based on the test 20

data submitted. We, as a manufacturer, know what goes into 21

our products. Excluding polypropylene and polyethylene 22132

resin will produce an annu al savings of $30,000 for American 1

Plastic Toys. This is a significant percentage of our 2

overall testing expenditure. We're considered to be a small 3

manufacturer, and a $30,000 savings annually can be put 4

towards new product development or hiring manufac turing 5

employees. 6

Resin manufacturing is a technical and controlled 7

process. Resin is tested and certified throughout the 8

public manufacturing process, and we received material 9

certificates with each shipment of raw, natural resin. 10

Manufacturing, safe quality and fun products is our top 11

priority as an industry. Having quality systems placed 12

throughout our manufacturing process for periodic testing 13

and inspection gives us assurance that our products are 14

compliant. 15

Eliminating the need to test materi als that do not 16

have detectable levels of the 8 elements is a great way to 17

reduce third

- party testing costs without compromising safety 18

and compliance. That's all I have today. 19

[Applause.] 20

MS. ADAIR: Hailey, thank you so much. That's 21

very good infor mation. 22133

MS. MANN: Thank you. 1

MS. ADAIR: Again, welcome Dr. Sanjeev Gandhi to 2

the podium. 3

DR. GANDHI: Hi. I'm Sanjeev Gandhi, deputy VP 4

and technical director for SGS, North America. I want to 5

thank again the Commission, the Commissioners, for the 6

opportunity to be here. For this afternoon's session, I did 7

not have any prepared slides to show. I just wanted to make 8

a few comments. And, given some of the assertions that were 9

made by previous panelists, I just want to echo my 10

concurrence with s ome of the conclusions that they have 11

drawn, especially with respect to lead in case of natural 12

wood and as well as composite wood materials. 13

So, and even some of the glue systems that we have 14

looked at, they have consistently shown now to be either 15

sh owing no detectable level of lead, or very, very low 16

level, and maybe lower than thresholds that are in the 17

standard. So I just want to also provide a clarification to 18

the requirement

-- I think, Nikki, you mentioned

-- about 19

certain low formaldehyde, ure a formaldehyde resin systems 20

are non

- urea formaldehyde based resin systems that are 21

grandfathered in under the CARB scheme, which is also part 22134

of the basis for the EPA's regulation, although they have 1

not yet come into effect. 2

So those certifications, based on the usage of the 3

low formaldehyde level, are non

- formaldehyde based resin 4

systems. Those are subject to a certification scheme, which 5

is through a traceability requirement, but there is also a 6

validation step that is built into it through a data packet 7

that the manufacturer has to provide, that indeed the resin 8

system used is off that type. And that data packet is in 9

the form of testing that is done, either in

- house, because 10

that's acceptable, or through a third

- party. So I just 11

wanted to issue that clarification, that certification for 12

the traceability of the formaldehyde resin system or non

13

formaldehyde

- based resin system to be grandfathered in, 14

there is a requirement of validation built into the 15

regulation, as well. 16

Thank you. That's all I wanted to say for now. I 17

will take questions as we proceed further. Thank you. 18

[Applause.] 19

MS. ADAIR: Thank you to all the panelists, and 20

this is the time to ask questions. As we did before, if you 21

have a question, if we have questions from the a udience, you 22135

need to come up to the lectern, speak into the microphone. 1

State your name first and then your question, and as well 2

for the panelists and staff. You want to make sure you use 3

the microphone so we get everything on the webcast and for 4

the tr anscript. So I'll ask first from the audience, does 5

anyone have a

-- would like to start us off with a question. 6

Great. State your name. 7

DISCUSSION 8

MR. UHL: I think everybody knows me. I'm Rick 9

Uhl with CPSC. I'm just going to start off with a re al 10

simple question. Then I'll go sit down until I think of 11

another one. 12

Hailey, I'm curious with the resins that you test, 13

if you can divulge it. I'm interested in the sources of 14

those resins. You know. Is it a lot of different 15

manufacturers? Is i t overseas? Domestic? You know. If 16

you can give that information, I'd be interested to hear it. 17

Thank you. 18

MS. MANN: Sure. So with each test report that I 19

submitted, I put in the material certificate from the person 20

that we purchased the material f rom. We do purchase from 21

distributors. So that material, essentially, could come in 22136

from overseas, or it could have been manufactured 1

domestically. So we really don't know. I can say 100 2

percent, unless the distributor were to give me a definitive 3

answ er for where they purchased the plastic. However, like 4

I said, I did submit the material certificate coming from 5

the distributor based on what they're told the material is 6

to be from whoever they purchase the material from. 7

DR. RECHT: I have a questi on, I guess, maybe for 8

Nikki, but for all of

-- well at least maybe the right half 9

of the table that had the wood experience

-- on my right, 10

that is. I'm wondering. I know some woods can be 11

composited with plastics. There's decking. I have trim on 12

my h ouse with PVC and wood composited together. Are there 13

terms of art to distinguish that from MDF and particle board 14

and plywood? But also, are there instances where plywood or 15

MDF, or some things that as you would define them might 16

somewhere in the world be pigmented or have polymer 17

additives as well as the glue systems? 18

DR. BROWN: I can take a stab at that, and anybody 19

else, feel free to jump in. So some of the decking 20

materials certainly are pigmented. You can see different 21

options that are availa ble, you know, when you go to a home 22137

supply company. And it's certainly plausible to have 1

different chemistries that have been done or that are 2

applied to wood particles, or actually the resin itself can 3

be modified slightly with anhydride functionality t o improve 4

the coupling between the wood particles and the plastic. 5

So those would be my two comments that, yes, 6

pigmentation is possible. And then, secondly, there are 7

some functionalities, but those typically would not

-- the 8

pigments may contain som e of these elements of concern, but 9

the functionality coupling chemistries that I'm aware of are 10

anhydride based and don't contain any heavy metals. 11

MR. PERDUE: Joel, just to answer your question 12

from the furniture industry's perspective, we do not use 13

that blended product in component parts for finished goods. 14

So we don't use that. That's not typical of what we do, nor 15

would we find that in any of our product offerings. It's 16

strictly

-- it's going to be wood

- based; and, again, as I 17

indicated in my pr esentation, the system is pretty closed. 18

So we're not recycling plastics in our process to make these 19

wood mats that we turn into MDF and particle board that are 20

used as component parts for furniture. 21

MR. KAUFMAN: Yeah. If I could add something, I 22138

wou ld say that I'm assuming what you're talking about is 1

something like Trex decking. That is not, you know, by 2

definition, a composite wood product. It's really a plastic 3

product that's been loaded with wood fibers to give it the 4

appearance of wood; but, i t's really high density 5

polyethylene. It's a molded plastic product. So when we're 6

talking about wood here and when we say composite wood, 7

we're talking about something that's a hundred percent wood, 8

basically glued together into a whole. 9

And I would say that, certainly, if there is any 10

pigmentation, if there are any coatings, those would be 11

outside the scope of what we're looking for. We're talking 12

about just the composite wood itself: Masonite, particle 13

board. What are some of the others

-- plywo od, et cetera, 14

MDF, so. 15

DR. BROWN: If I could clarify, that's a great 16

point. So typical resin loadings and traditional wood 17

composites are up to 10, 12 percent resin cont ent . The 18

plastic decking components are an entirely different class 19

of

-- we call them composites, academically, but they're 20

not. They're traditional wood

- based composite; they're a 21

plastic that's heavily filled with wood particles. And, in 22139

that case, it may be much higher loadings of

-- it would be 1

certainly much, much higher loadin gs of plastic that's 2

filled with wood particle. So a very good point, Al. 3

MR. PERDUE: And I think we need to keep that 4

distinction that we're talking about two, different product 5

categories and product types. What we're typically using is 6

wood, not pl astic. And if there is a clear definition that 7

defines those type of products that are used, yes, but 8

they're not typically

-- to use Randy's term, they are never 9

used in the wood furniture industry to a high degree of 10

assurance. 11

DR. HATLELID: I'd like to ask a question that 12

maybe we're not going to get the answer to directly. But, 13

so, I heard some technical information from Nikki and Bill, 14

and everybody else, and in general terms, the formaldehyde 15

resins and the other types of things. And I'm wonderi ng if 16

there are written resources that detail the chemistries of 17

these, including catalysis steps, the catalysts used. I 18

mean I guess I realize some things are going to be 19

proprietary at some point, but, so that we can understand. 20

To hear that a product is just glue and resin kind of makes 21

us go, okay, we don't know what those things are. So if 22140

there are written, detailed descriptions of some of those 1

common chemistries, that would, I think, fill in our 2

knowledge gaps on what really goes on. 3

MR. PERDUE : Kris, that's a great point, and yes. 4

I'm sure. Absent in this panel discussion are the resin 5

suppliers and the resin manufacturers, and I'm sure that 6

they can provide that type of information to us about how 7

the resins are constructed and put together , and just 8

exactly what makes those resins up and why lead wouldn't be 9

part of a catalyst system that would be used, again, 10

typically in wood furniture. So, yeah. I believe we could 11

get that information to you. 12

MR. KAUFMAN: Yeah. And absolutely, we 'll see if 13

we can get you some information; but, in general, what's 14

going on is you're putting precursors in between layers of 15

wood, and you're using heat or steam to essentially drive an 16

irreversible reaction. It's a thermoset plastic. So you're 17

really in the same way that you're using a urea formaldehyde 18

resin to glue these together, it would be very similar to, 19

let's say, a melamine ball once you've driven that thermoset 20

process forward. 21

DR. BROWN: There's also information, the 22141

published literatur e about the mechanism of formaldehyde 1

based resins that I can provide. There's been textbooks on 2

wood adhesives technology. So the information is also in 3

the technical literature. But, primarily, the catalysis 4

mechanism for the formaldehyde based resins is PH driven, so 5

it's either acidic

- cure or base

- cure, depending on the type 6

of resin that you're looking at. So, again, it's not a 7

traditional

-- metal

- base catalysis is not used in the 8

formaldehyde systems, and isocyanate currently is frequently 9

not ca talyzed at this point, although they're trying to push 10

the speeds for iso. So it may be in the future catalyzed. 11

MR. PERDUE: And just to speak to the di

12

isocyanate issue, typically, again in our industry we don't 13

use di

- isocyanate. Typically, it's ver y slow as Dr. Brown 14

pointed out. So it's something that we don't use quite a 15

bit. So

-- 16

DR. RECHT: Just on the topic of the references in 17

addition to providing the academic references that you just 18

mentioned, which would be very helpful, you mentioned at the 19

start of your talk that you had found some sources of 20

information about the 8 elements in natural wood

-- not 21

composite. If you could share those references with us as 22142

well, that would be most helpful. 1

MR. BUTTURINI: And I want to emphasize tha t Bill 2

said exactly the right thing, and not for the first time. 3

Let me point that out. He said exactly the right thing, 4

that with composite woods, the wood's been taken care of 5

with regards to lead content. And what the Commission is 6

interested in know ing is about the resins. And the magic 7

word here is because there won't be lead or there won't be 8

other elements in resin, because of this or because of that. 9

And there's this knowledge available about all the 10

manufacturers of resins that are used in man ufactured woods 11

-- and I'd back up one step

-- and that manufactured woods 12

use resins that could be called adhesives, and phthalates 13

are sometimes used in adhesives. 14

And if there's a way to make that loop close, that 15

the prohibited phthalates can't be used, won't be used for 16

reasons, A, B, C in manufactured woods, then that would open 17

up a possibility for making a determinat ion for toys, for 18

example, that are made with manufactured woods being 19

compliant with the phthalates limits. 20

Mr. P e rdue : Say, Randy, you bring up a good 21

point. And one of the notes that I made, specifically about 22143

phthalates when we were talking about this before the 1

session, was looking at the resin systems and trying to 2

determine within that system what phthalates are present a nd 3

why. Yes, it is an adhesive, it's in the family of 4

adhesives. So, typically, the assumption would be that 5

there is some, I guess, congener of a phthalate present 6

within the resin system. But that's something we'd have to 7

take a very hard look at to d etermine what's actually there. 8

But, again, the focus of what we're talking about 9

today is lead and a determination for lead for composite 10

wood products. And I want to make that very clear, that 11

what we're asking for, while the phthalate is an ancillary 12

issue that needs to be addressed

-- and I understand that

-- 13

the focus right now is on a determination for composite wood 14

products and lead, and not have to test for lead. 15

MR. KAUFMAN: Yeah. And the only thing I would 16

add to that is you're absolutel y right, Randy, that 17

phthalates are occasionally used in adhesives; but, 18

typically, they're either hot melt or polyvinyl acetate

19

based adhesives. The types of thermoset resins we're 20

talking about here do not contain phthalates; and, in fact, 21

if you look a t the data that I presented, we have 4800 cases 22144

of where we've tested wood products and not found 1

phthalates, any of the restricted phthalates. 2

DR. BROWN: Yeah. I'd just like to echo that. 3

When you think about the chemistry and what we're trying to 4

accomplish when we make composites from wood, there's just 5

no need to add a plasticizer. Wood, itself, the mechanical 6

properties give you what you need, so there's no need to 7

soften. So, again, why would you add cost, add a 8

contaminant to the system? So the traditional resin 9

chemistries used in composites are not going to contain 10

phthalates, but the polyvinyl acetates and the ethylene 11

vinyl acetate systems for hot melt or for solid wood 12

components glued together could and do contain phthalates. 13

MR. PER DUE: And, just, if I may follow up on 14

that, that's a process of the manufacturing process. And so 15

when we're making the mat and we're making a composite wood 16

product, typically MDF or particle board, we're not using a 17

PDA type resin system when we make t he mat, because we're 18

using heat and steam in order to kick that over. And so 19

those, typically, are not phthalates, typically are not 20

found in that resin system for making the mat. So it really 21

is a function of the process, and I think that needs to be 22145

a lso distinguished in this conversation. 1

MS. ADAIR: Questions from the audience? 2

MR. UHL: Yes, it's me again, Rick Uhl, CPSC. 3

Kris alluded to this earlier. But when we think about the 4

ASTM F963 and the 8 elements in terms of solubility, and we 5

sta rt thinking about determinations, there's two roads that 6

we can look at. One is if the content of any of those 7

elements or all those elements is less than the solubility 8

limit, then you're in, right, if you can prove that the 9

content is always lower than the solubility requirement. 10

Then there's the second option, which is, okay, 11

the amount or the content might exceed the solubility limit, 12

but it will never extract in the hydrochloric acid test 13

method. We've talked about wood and we've talked about 14

plast ics. I'm curious. Are there any other materials that 15

come to mind as we're having this discussion beyond wood and 16

resins? Thank you. 17

MR. KAUFMAN: That's a good question, Rick. I 18

would say certainly you could apply at least the solubility 19

question to coatings, surface coatings and potentially to 20

adhesives and other materials. The issue is that if you're 21

simply testing the product without knowing what went into 22146

it, it would be very difficult to do that, because you don't 1

know exactly what species or e xactly what matrix you're 2

dealing with. 3

If, for instance, you are the manufacturer and you 4

know that you've put in a certain amount of a very specific 5

species of lead, let's say, just for sake of argument, it 6

would be relatively easy to use textbook da ta to determine 7

what the likely solubility is of that material. Lead's not 8

a good example there, because you've got a total limit 9

anyway, but, let's say, chromium. So, you know, if you for 10

some reason had intentionally had chromium, and you knew 11

what chr omium species you were dealing with, you could 12

potentially do that, but, you would have to know what that 13

material was. And a good example would be, you know, let's 14

say

-- well, barium sulfate is the example that keeps coming 15

to mind. I mean you could lo ad barium sulfate in there all 16

day, and it's never going to be soluble. On the other hand, 17

you might very well put another barium salt in there that's 18

much more soluble, and you would have to be very careful and 19

then know exactly what you're putting in th ere. 20

MS. ADAIR: More questions from staff or from the 21

audience? Okay, Randy. 22147

MR. BUTTURINI: I just want to make sense. Randy 1

Butturini, CPSC. I just want to make clear what I'm hearing 2

so I understand it. So it's sort of a question. Then I 3

hav e another question, which is more difficult to answer. 4

When you're talking about resins, plastic resins, natural

-- 5

well natural plastic resins, right, before the colorants, 6

before the processing. What you're saying is

-- and this is 7

what I'm asking abou t. 8

Is what you're saying because these things are 9

made in a very pure fashion, there's very little chance that 10

extraneous materials

-- some of which could be lead, some of 11

which could be the 8 elements

-- are very unlikely to 12

appear? And that sounds v ery interesting. We'd be 13

interested in knowing about all the other ways to make and 14

all the other people making these types of resins. Because 15

if everyone uses a pure process, for example, if there's so 16

much market competition that anybody that does some thing in 17

an uncontrolled fashion has difficulty getting customers, 18

something. You know, something, again, to answer the 19

question because, or to say always. It's always this way 20

for these reasons

-- you know

-- A, B, C, and it's going to 21

be that way for e veryone, because of these reasons. 22148

The reasons could be, you know, economic , process 1

control, volume. You can't make it poorly and get very 2

much. I mean whatever it turns out to be, that's the kind 3

of information we're interested in. 4

MR. KAUFMAN: This is Al Kaufman again. That sort 5

of brings us back to my initial question, which was if the 6

bar that we have to get over is always to have a high degree 7

of assurance, that's going to be very difficult. I think we 8

can certainly get it to the point wh ere you say it's highly 9

unlikely, in fact, very highly unlikely; but, I don't think 10

we can ever prove never. 11

MR. BUTTURINI: You're right, Al, that a high 12

degree of assurance does not mean never. And it 13

intentionally does not mean certainly, you know. There's 14

certainty, and then there's a high degree of assurance, and 15

there's a difference between those two, because we know that 16

some information is just not obtainable in one sense. That 17

would be one question I could pose, if we're talking about 18

gettin g this sort of information to make a determination. 19

What can't we get? And that would be interesting to know, 20

because if we can't get it, then let's stop asking for it, 21

that sort of thing that can go on. But in 16 C.F.R. 1107 is 22149

the definition of a high degree of assurance. 1

MS. MANN: And I just would like to state that 2

besides the way that the natural resin is manufactured, the 3

data speaks for itself. I mean I've compiled that data over 4

the last 15 months, and every, single test result that came 5

back was not detected for almost 20 million pounds of resin. 6

And that's just to us that, you know, purchase 20 million 7

pounds of resin over the last 15 months, and we're a small 8

company. And that type of impact, for me, shows that I am 9

testing something that 's unnecessary from our standpoint and 10

doesn't improve safety of the product. 11

MR. KAUFMAN: Well, and also when we're talking 12

about plastics, polymerization processes, keep in mind

-- 13

and I talked about it a little bit in my presentation

-- not 14

only is there no reason to put it in there, but there is a 15

very strong incentive for the manufacturer to keep it out of 16

there, because, as I said, some of those trace elements can 17

poison the catalyst and keep the polymerization process from 18

going forward. And yo u just end up with this mess in the 19

bottom of the reactor that you have to go in and chip out 20

with an air gun. So, I mean there's a very strong incentive 21

to keep that process going. 22150

DR. RECHT: I have a question for Sanjeev. You 1

showed some data in t he phthalates presentation about 2

different kinds of materials and where you found phthalates. 3

I wonder, again, getting back to the idea of are there some 4

other materials, even beyond the wood and the plastic resins 5

-- where you have data about the 8 eleme nts collectively 6

never extracting out above the levels

-- because the matrix 7

of the material doesn't let them out, even when they're 8

there, or because they're the level that they're present and 9

that kind of a thing. 10

DR. GANDHI: Thank you. One of the reasons that I 11

did not have that data to share with the audience today is 12

that the data that I'm in the process of examining right now 13

and further analyzing, you know, is yet not granular enough 14

for me to say between the different type of materials

-- you 15

know

-- if at a sub

- grouping level, what are the high risk, 16

low risk, medium risk. So that kind of granularity is not 17

there. You know, composite wood is bisulfate category, and 18

therefore I was happy to make a categorical announcement, if 19

you will, based on our examination of that data. You know. 20

We don't see a phenol rate associated with lead. 21

Now, going to the other elements, that is 22151

something I still need to look at. We have recently 1

undertaken a study at SGS looking with expansion of, well, 2

for U.S.'s 8 heavy metals, for Europe we have 19 heavy 3

metals. And so we end up processing and analyzing a large 4

set of data that takes into account different types of 5

substrates for all those 19 different heavy metals. 6

So, like I said, I'm still not far enough in my 7

analysis to present that finding with the Commission. There 8

are still some questions I have that I haven't answered for 9

myself, and I need the assistance of my team overseas. So 10

that's why I did not feel comfortable bringing that to the 11

tabl e here, but I'll be happy to share that in the future. 12

DR. RECHT: Thank you. 13

DR. GANDHI: We are, you know, looking for the 14

kind of data I brought last time. So I didn't feel 15

comfortable I had that high degree of assurance that I could 16

speak to tha t data. 17

MR. KAUFMAN: And, excuse me a second, if I could 18

just add onto that. I would say that certainly, at this 19

point, from our viewpoint, we have enough data based on test 20

data, base d on what we know about process, based on all of 21

the work that Haile y has done that, certainly, at least 22152

polyolefins could be put in an exempt category. And we 1

believe that that list will get a lot longer, but we're 2

still gathering data. 3

DR. RECHT: In that case, are you referring to the 4

resins, again, as opposed to the colored, finished product? 5

MR. KAUFMAN: Yes, absolutely. In other words, as 6

I said, we don't have the confidence that you will, for all 7

colorants. We know a lot of them don't contain these 8

materials; but, we can't say with certainty that all of them 9

don't. 10

DR. HATLELID: I'd like to follow up a little bit 11

on the resins issue. So tell me if it's the case when one 12

makes an order for its natural resins that you have to 13

specify things like the low metal kind, or that doesn't 14

exist. You're shaking yo ur head. And to follow

- up on that, 15

is the situation with these products or these materials now 16

any different now that we have requirements for some of 17

these elements, at least for the children's products, to 10 18

years ago? Or is there a differen ce in manu facturing or the 19

supplies? 20

MR. KAUFMAN: That's a couple of questions, 21

actually. And I'll start with the second one first, which 22153

is yeah, there have been changes made with respect to some 1

materials, as I mentioned, PVC. It used to be reasonably 2

commo n to run into PVC with lead or cadmium stabilizers. We 3

almost never see that anymore. As I said, almost 4

everybody's gone to calcium zinc. For other materials, they 5

typically didn't contain them to start with, and so there 6

haven't been any changes. And that's one of our issues is 7

we're testing repetitively to find out something that we 8

know was never there and still isn't there. Does that 9

answer your question? 10

MS. ADAIR: More questions? Questions from the 11

audience? Randy. 12

MR. BUTTURINI: I'll a sk my second question now, 13

and this is both for, let's say, the plastic resins and the 14

manufactured woods. We have a procedure, 1500.89, 16 C.F.R. 15

1500.89, to request a determination for lead. Have you ever 16

considered using that procedure to make a reque st for 17

manufactured woods? Did something get into the way, you 18

know, to keep you from doing that? Was there some part of 19

it that you didn't think you could do? Or is there anything 20

intrinsic in that that kept you from following through with 21

actually mak ing a request using that procedure? 22154

MR. PERDUE: Randy, yes. The answer to that 1

question, we did consider making a determination with 2

composite wood products. As a matter of fact, we were 3

working with the Composite Panel Association to do so, very 4

earl y on. We sent in a letter. CPA sent in a letter, and 5

basically it was rejected at that time. We came back and 6

started talking to staff about, okay, what do we need to do ? 7

How do we make this determination? What do you require from 8

us? We were given a pretty detailed laundry list. 9

We went away, put that laundry list together, sat 10

down with staff again. And, Randy, with all due respect you 11

have a great staff and I really enjoy working with all of 12

them. But it seemed as if we were just chasing a gh ost in 13

the dark, and we never could get to this level of assurance. 14

You know. Where did we stop trying to figure out is this 15

there, are you assured, is there certainty ? And we just 16

backed away. We got to the point where we were putting a 17

lot of time an d effort and resource in developing this 18

determination, and just simply felt we could never get to 19

the end point. 20

MR. KAUFMAN: And just to add to that, correct me 21

if I'm wrong, but my understanding of the procedure in 22155

1500.89 is something which is int ended to provide an 1

exemption on a very narrow basis. In fact, one example that 2

comes to mind is aluminum castings in a ride

- on toy, so that 3

what we're looking for is broader or more general 4

exemptions. We're not looking to have a specific grade of 5

polye thylene exempted. We're looking for all polyethylene 6

to be exempted. 7

DR. HATLELID: So I want to clarify that. There 8

are two types of issues we're dealing with for the lead 9

requirements, and one of them is the determinations

-- 10

things that do not con tain the lead and then don't undergo 11

the third

- party testing. That's the procedures at .89. 12

There used to be procedures at .90, and those have been 13

withdrawn. 14

That had to do with statutory exception process, 15

which changed in 2011 for things that do con tain lead, such 16

as the cast aluminum in that petition. So the 1500.89 is 17

for the things that we have already for lead, like natural, 18

untreated wood that we're talking about. Or, as you're 19

talking about, the olefins that are intrinsically not lead 20

contain ing. So there is that existing system, and it's to 21

do exactly what we're talking about right now for lead. 22156

MR. KAUFMAN: Actually, as you were speaking, 1

Kris, I realized I hadn't answered one of your earlier 2

questions, if you'll permit me. You were a sking about 3

whether you needed to specify low metal content when you 4

ordered. Typically, plastics are not made to order. 5

Usually, you go to a resin supplier and they have a list of 6

standard grades that you can choose from and usually select 7

that grade ba sed on the properties that you're looking for. 8

Does it have the tensile strength I need for this 9

application? Does it have the impact strength? Does it 10

have the melt flow index? Can I mold it in my equipment? 11

Those sorts of things; and, in general, t hose specification 12

for trace metals are the same across all of those grades. 13

In other words, they're trying to keep those at absolute 14

minimum levels, so. 15

MS. ADAIR: Do we have any additional questions? 16

We're getting towards the end of the session. We've got a 17

few more minutes, though. If you've got questions, ask 18

them. Ask away. 19

MR. BUTTURINI: I just want to make another 20

clarification. Public Law 112

- 28 established another method 21

to establish an alternative lead limit for something, and 22157

that w as the petition submitted for the ride

- on toy parts. 1

So there are two ways to do this. One is a determination 2

that lead is not there; the other is a determination of an 3

alternative lead limit. So we're dealing with we have a 4

couple of balls being thrown up in the air at this point. 5

MR. KAUFMAN: Can I ask a question? How many have 6

actually been granted at this point? 7

DR. RECHT: One. 8

MR. KAUFMAN: Yeah. So that would sort of speak 9

to the difficulty of going that route. 10

DR. HATLELID: Well that was for the things that 11

do have the lead, and the other route, it's

-- 12

[Microphone off.] 13

MS. ADAIR: Randy, do you have another question or 14

a statement? 15

MR. BUTTURINI: Yeah. I just want to make one 16

thing clear when we're talking about determi nations. Test 17

data is a wonderful thing, and test data might be considered 18

necessary. But there's a chance that the test data won't be 19

sufficient to make a determination. I keep waiving my arms 20

and saying, you know, test data

-- and Al has mentioned thi s 21

in both of his presentations. Again, he said exactly the 22158

right thing. The test data, plus the knowledge about this, 1

plus these conditions over here, plus the high incentives, 2

plus the other sorts of things, that makes a body of 3

knowledge that together could be considered as a whole to 4

develop a high degree of assurance that does not and will 5

not be non

- compliant, can be achieved. So, a pile of test 6

data is a very interesting thing. 7

And of course the first question we'll ask is, 8

this is great, what does this tell you about the things that 9

haven't been tested ? And it's the parts on either side of 10

that that can extend the knowledge of the data information 11

inside the test reports outside of that into the wider world 12

of all the suppliers of this, all th e users of this, all the 13

chemical processes that do these sorts of things. And with 14

that body of knowledge, then perhaps we can do something on 15

that order. 16

MR. MULLAN: Gib Mullan, CPSC. I wanted to follow 17

up on that point, Randy, because another que stion that comes 18

up a lot is when we get a bunch of data, it might be very 19

informative, but it would be more informative if it would be 20

accompanied by comments that help us understand is this all 21

the data you had. Is this all the data for a period of 22159

time ? Did you have any data that you didn't provide or that 1

wasn't available? There are suspicious questions that can 2

arise, and no matter how comfortable you are with the 3

submitter of the data, it really helps to characterize the 4

submission of the data. 5

So, for example, Hailey, you described the data 6

that you had, the test that you had done. And it sounded to 7

me like from your description you had done tests on every 8

batch you had received from every source for 18 months. 9

If that is a universe of dat a from lots of 10

different sources, and without any particular specifications 11

trying to deal with the content of that, that's more 12

meaningful to me, because it's a universe of data. Whereas, 13

in some of the datasets that we received, they're just like 14

whatev er the person who's setting the data can get, and that 15

might be only the good test results

-- not to put too fine a 16

point on that. So it's very helpful if you can characterize 17

the data that you submit, and I think that fits with the 18

theme here, too. Than k you. 19

MS. MANN: In the packet of data that I did 20

submit, I did put a cover sheet in there explaining a little 21

bit about the process for polymerization of the material. 22160

Like I said, there was a material search showing who the 1

distributor was of the mat erial. So you can see the range 2

of material, and I only picked 15 months, ranging from two 3

weeks ago for the past 15 months, because I didn't know how 4

much data to bring. But I'm here. If you have any 5

questions or you need more data from more suppliers, again, 6

we only use polyethylene and polypropylene copolymers in our 7

process. So that's the data I had and that's what's 8

important to me as a company, because that will have the 9

greatest impact to reduce our third

- party testing. 10

MR. M U LLA N : So an exa mple, what I'm talking 11

about, Hailey, is you just mentioned you selected 15 months. 12

MS. MANN: No, that's everything. 13

MR. M U LLA N : Okay. Well that's where I'm trying 14

to get to is try to characterize, you know, that's 15

everything, so that there's no con cern that you in any way 16

cherry

- picked the data. That's the point that I'm trying to 17

get out. Thank you. 18

MS. ADAIR: More questions, Neal? 19

MR. COHEN: This is Neal Cohen, CPSC. This is 20

kind of a general question related to Dr. Brown. You 21

mentione d some of the studies that you found in Sweden and 22161

the rationale or the reason that there was an interest in 1

Sweden in doing that testing. Is there

-- besides this 2

group here

-- and many of us know each other for many years 3

of these sorts of things. Is t here an interest elsewhere in 4

your academic community in these sorts of questions? And, 5

if so, why and by whom? 6

DR. BROWN: By "these sorts of questions," do you 7

mean heavy metal content in wood? 8

MR. COHEN: Yeah, and solubility. 9

DR. BROWN: And s olubility

-- good question. From 10

a fundamental point of view, I think there's always people 11

interested in knowing more about how tree physiology

-- 12

phytoremediation issues, for example

-- lead to fundamental 13

changes in the material. But I would say it's probably a 14

pretty small community. You know. It would be more 15

relevant to practical groups like this. So I don't know if 16

people

-- other examples where those would be of tremendous 17

interest. 18

MR. COHEN: Right. So, I guess, as you just said, 19

sort of

- - and it's a sort of applied scientific context

-- 20

there's a limited audience for it. You do

-- I think you 21

indicated you do research. And, if so, I'm not familiar 22162

with anything that you do. 1

DR. BROWN: Okay. 2

MR. COHEN: But, um

-- you know. 3

[Laugh ter.] 4

DR. BROWN: Not many people are. 5

MR. COHEN: Well, and I think that's the point, 6

like not many people are, and we're very pleased to have you 7

here and bring your perspective here. 8

DR. BROWN: Sure. 9

MR. COHEN: So it's like what do you do, who funds 10

what you do, who has an interest in funding what you do. 11

DR. BROWN: Okay. 12

MR. COHEN: Do people move in and out of your 13

position from industry to academia? Or what does an 14

academic like yourself do and why, I guess. I think that 15

would be in teresting. 16

DR. BROWN: Yeah. 17

MR. COHEN: I don't know if anyone else does, but 18

if you would. 19

DR. BROWN: Sure. I'd be happy to comment on 20

that. That was a lot of questions, but wood research used 21

to be heavily funded by the USDA. There's been dr astic 22163

funding cuts for our field, and wood is becoming grouped now 1

with many more materials. So, for example, I was in a wood 2

products unit at Penn State. Now, we've changed our focus 3

to bio renewable systems. So we're not just focusing on 4

wood. We're thinking about other bio

- renewable materials 5

and plastics. So the field, generally, is experiencing that 6

change, and it's largely due to funding shifts from the 7

government. 8

We still do have to compete for funds from USDA, 9

Department of Energy related to Bioenergy. To a very 10

limited extent NSF funds our work, but a lot of the interest 11

now is moving into bioenergy co

- products to make the bio

12

renewable platform viable, so developing different 13

chemistries or materials from cellulosic compounds to green 14

co mposites, how to make adhesives or coatings more 15

environmentally friendly for wood and wood

- based composites. 16

These are the kinds of things that are more of interest to 17

our community. 18

MR. COHEN: Thank you. And this is going to be my 19

last thought abo ut it. But to those sorts of questions, the 20

Swedish study was certainly focused on environmental impact 21

upon humans through bio

- renewables, basically. And we're 22164

talking to some degree about recycled content here, and 1

other stuff about virgin or feed stoc k. But, so within that 2

bio

- renewable sphere, is there sort of like an EPA sort of 3

emphasis on heavy metals or other human

-- 4

DR. BROWN: Yeah. That's a good question. So, in 5

general, the impact of regulation has drastically changed in 6

the last five y ears, especially focusing on the wood and 7

wood utilization industry. For being a renewable producer, 8

it's kind of been somewhat shocking. You know, the CARB 9

rule, big, big changes; and, again, that's becoming 10

nationalized through the EPA Toxic Substances Control Act

. 11

So there've been a lot of interests on greening of adhesives 12

chemistry. 13

How do we develop resins that are less toxic

-- I 14

guess would be the right word. But on the other extent, 15

yes, people are interested in issues like burning wood. Y ou 16

know. What do you do with all the CCA

- treated wood that's 17

going to be disposed of? I mean it's been 40

- 50 years. You 18

look at all the houses in America that have decks, you know, 19

built from 1970 to 2004. What are we going to do with all 20

that wood tha t has all that chromium and arsenic in it? You 21

know, big problems. So that's one thing

-- remediation of 22165

those types of materials. 1

EPA is looking at particulate emissions, or is 2

going to be soon, from boilers. So even people who are 3

trying to burn o r recycle residue furnished from their mill, 4

what kind of particulates are coming off. And then from dry 5

kilns, there's increasing concerns now about methanol 6

concentrations coming out off of dry kilns. So for wood 7

being such a natural, renewable, sustai nable material, you 8

know, I think it's a great material. There's just tons of 9

challenges now that professionals are having to think about 10

and deal with. So I think that helps. 11

DR. RECHT: I have another question for Nikki that 12

reminded me. You spoke about the recycled woods in the 13

biofuel example. Bill mentioned that his processes are very 14

closed, that they make the board right next to their 15

furniture facility. They take the waste from there and 16

recycle it into the boards. That's not the only way that 17

composite boards are made. I'm sure there are manufacturers 18

making composite wood elsewhere. And I wonder to what , if 19

any , extent are recycled wood products used. You know, 20

maybe not in the furniture industry, but by and large, just 21

commercial M D F board maker or particle board maker? 22166

DR. BROWN: I'm glad you brought that up, Joel, 1

because when Bill made the comments about reuse within the 2

manufacturing plan, I just wanted to say, yeah, absolutely. 3

The comment that I made about Sweden was dealing more with 4

reclaiming municipal solid wastes, so materials that were 5

coming out of renovation, sort of things like that, entering 6

municipal solid waste and reclaiming those. 7

That's an entirely different challenge than 8

reusing what might be inside a clos ed, manufacturing 9

facility. So I guess the in between, then, is what you were 10

getting at Joel with. What about a plant makes MDF and then 11

they ship it to somebody else off

- site? And then what do 12

they do with the waste that might be generated? 13

DR. RE CHT: Right. As an example, I used to work 14

in the paper industry, so it's different, but not that 15

different. And we made paper and we shipped it to whoever 16

was going to print or make packaging from the paper. And, 17

mostly, we made virgin paper, but we ma de paper with 18

recycled content as well; and, in that case, we bought post 19

consumer waste from the market and made paper from it. Is 20

there some analogy to that in making wood with post consumer 21

waste, composite wood products? 22167

DR. BROWN: Yeah. So feel free to comment, but in 1

my experience, when it's resinated and compressed into 2

composite, there's very limited options for reuse. So it's 3

typically burned, boiler recover, if possible, if the 4

chemistry allows that. Solid wood waste, however, from saw 5

mi lls, can have a plethora of uses, like animal bedding, all 6

kinds of use for particle board feed stock and other areas, 7

as well as boiler feed. So I'll defer to others to comment. 8

MR. PERDUE: Just a couple points to clarify

-- 9

and splitting hairs here

- - but we don't burn. We combust. 10

This is a fuel stream. 11

[Laughter.] 12

MR. PERDUE: It is not a waste, because it's not 13

discarded under RCRA , so it is therefore a fuel. So we need 14

to make sure what our terminology is here, because that's 15

very importa nt. And back to just looking at resonated off

16

fall, which is what we're doing in our system, is taking a 17

mat where we're using a resin system, a glue, to take wood 18

particles that have been generated in the manufacturing 19

process. We lay them in a mat. We put glue on them. We 20

press them and use heat. We create particle board and MDF. 21

One of the things that you need to understand is 22168

there are two, very distinct mat standards that EPA has put 1

together that regulate not only the drying of this wood, but 2

t he particle board and plywood mat really deals with sort of 3

those intrinsic and internal emission requirements for the 4

manufacture of a MDF, particle board and drying of lumber, 5

and then the boiler mat. And what's really important about 6

this

-- to underst and about resonated wood

-- is that the 7

non

- hazardous solid waste rule, which is attached to the 8

boiler rule, where we use, basically, some of the off

- fall 9

that we do not then turn into particle board, MDF board. We 10

use it as a boiler fuel. It's a feed s tock. 11

Resinated wood is considered a fuel and not a 12

waste. So it's really important to understand those 13

distinctions. So we're not typically using post

- consumer 14

materials, such as creosote

- treated railroad ties of that 15

nature in what we're doing. Ba sically, what we're doing, it 16

really is a system where we're making this board. Is there 17

some wood that is post

- consumer or that's purchased, like 18

you did in the paper industry, that's added to the stock? 19

Yes, it is, but that's a very controlled, natural wood 20

fiber. It's not this post

- consumer, building construction, 21

railroad ties type of wood that's added into the mix. 22169

DR. RECHT: Just to follow up on that, because, 1

again, that's getting closer

-- right at the end of that

-- 2

to what I was getting at . I didn't mean to bring into your 3

boiler operation, because I understand that fully well, too. 4

But in the case

-- again, just a board producer of MF board 5

or particle board could, for instance. And is there any

-- 6

you know, we talked about the CCA trea ted wood, the existing 7

stock in my back yard and many others of CCA wood. Is there 8

any way that that could find its way into a recycling stream 9

and to a manufacturer ground up and be used as a small 10

component or at what fraction with virgin wood to make a 11

composite wood product? 12

MR. PERDUE: Just to speak to the industry, my 13

industry, very little; basically, what we're doing is using 14

wood or resonated wood would off fall from the process from 15

the system. And that's kind of traded around between these 16

co mpanies that are making the mat for an MDF or for particle 17

board. You know. You use the words would or could or 18

possibly, again. You know, would or could or possibly, of 19

course. However, typically, going back to Randy's 20

discussion about defining "typic ally" within our industry, 21

we don't do that. So I can state with some certainty that 22170

we're not bringing in this type of post consumer wood into 1

what we're doing within our processes within our industry. 2

MR. KAUFMAN: And remember that that CCA treated 3

wood is visually differentiable, very easily. It's that 4

greenish color, because of the copper, and I just wanted to 5

clarify, Joel. Was your question specifically about 6

resonated, for instance, a composite wood products? Or was 7

it about the Trex decking as well? 8

DR. RECHT: No. No, I meant for the composite 9

wood products. You know. Is there a marketplace for post

10

consumer, recycle content, composite wood products, like 11

there's a market for people look to buy 10 percent recycled 12

content paper as mark er, 50 percent recycled content paper. 13

There's various levels as a post

- consumer recycle content. 14

Again, not within the furnishings industry, but there are a 15

couple of big companies like a Georgia Pacific or a 16

Louisiana Pacific that makes lots of wood pr oducts. 17

I don't know, you know, what they make. But as 18

well as overseas, are there companies that make building 19

materials that are composite wood building materials that 20

use post

- consumer waste? 21

MR. KAUFMAN: And I guess the answer would be not 22171

to my knowledge. I couldn't swear that nobody's doing it, 1

but I'm not aware of a market for it, not aware of a demand 2

for it. And, frankly, if you think about the raw material 3

for those composite wood products, someone who is an 4

integrated wood supplier wo uld certainly have enough 5

generated from their own operations that they wouldn't need 6

to look for post

- consumer material. 7

DR. BROWN: I'd just say I agree with that. I'm 8

not aware of any operations that are using vast quantities 9

of that, and it's certai nly not going to be the bigger 10

manufacturers who are going to be doing that. I think a lot 11

of concern could come up from the mom and pop shop that just 12

is eking it out. And they find something laying on the side 13

of the road and they want to

-- the Amish, you know, mill 14

wants to turn it into a product and sell it. 15

And those are the kinds of operations personally 16

that I'm more concerned about. I know that the big players 17

in the industry are. They know the technology. They know 18

what they're dealing wi th. They know how to make product 19

and what not to make product out of. So that would be my 20

comment. 21

MR. PERDUE: Joel, I think you hit the nail on the 22172

head. Is there a market for it and is there a demand for 1

it? To my knowledge, based on what I know about my 2

industry, no. There isn't, so. 3

DR. GANDHI: I just want to mention as a side 4

comment to that, I don't know about the wood industry, but 5

for carpet for recycling, there's an incentive based on some 6

state legislations and some are already in pl ace. But some 7

of them are in proposal stage that are trying to put that 8

kind of marketplace infrastructure, if you will, for 9

enhancing the recycling of carpets, and that kind of model 10

that you're talking about. But I don't know anything that 11

currently ex ists with respect to wood. 12

MS. ADAIR: Another question from the audience? 13

DR. BROWN: I'd just like to make a comment while 14

he's coming up. We talked a lot about CCA here today, and 15

the pull on that was voluntary. So I just didn't want 16

anybody to get the idea that that's a necessarily awful 17

thing, that if you have it you need to get rid of it. 18

There's a lot of contradictory literature about leaching of 19

arsenic out of that material, and a lot of the scientific 20

data suggests there's not a problem. So I just wanted to 21

make that point. It was a voluntary pull by industry to 22173

remove CCA as a wood treatment compound, because the 1

scientific literature was contradictory. 2

MR. LEONARD: Hi. Chris Leonard, Modern Testing 3

Services. As of late, we've bee n receiving in our 4

laboratory a number of samples that have been submitted by 5

Native American manufacturers. And my question is for Dr. 6

Brown. You had mentioned that leaves, roots, branches, 7

bark, typically have the highest, natural occurring levels 8

of h eavy metals. So it's a three

- part question. So you 9

also mentioned that this does vary by species of wood. 10

Can you give us an example of what types of 11

species from a high to a low range, where we may find those 12

types of heavy metals? And do any of th ose species that the 13

levels exceed the limits under F963

- 11? And, the third part 14

is due to its rise in popularity

-- and I don't know if this 15

falls outside of this scope of your expertise

-- has there 16

been any evaluation, or is there any evaluations under going 17

for bamboo? Thank you. 18

DR. BROWN: Let's see if I can remember the three 19

questions. The first one, the listing of species with the 20

heavy metals listed for each one, no. I cannot give you 21

that, simply because I'm certainly happy to provide

-- I c an 22174

give this to Rick, actually, and you can post it to the web 1

or whatever. I'd be happy to provide the data that I 2

uncovered in preparation for today, which does list some 3

species and some studies; but, there certainly is not 4

extensive information availa ble by metal type. 5

What there is available, though, in pretty decent 6

detail, is ash contents for various species. So that it's 7

kind of a grouping then of all the metals that you might 8

find in a tree species. And the most common ones that 9

contribute t o ash and trees are calcium, phosphorous, 10

potassium and magnesium. Those are the four big ones, the 11

things that we've been talking about today. These 8 things 12

are traced ash constituents, but, anyway, that gives you an 13

idea. 14

Tropical species typicall y have about double the 15

amount of ash content than what we see in temperate 16

deciduous species. So that data is available. Let's see. 17

The next question was bamboo. I did not look, though. I'm 18

not aware of data from bamboo. The reason that the tropical 19

species had much higher ash contents is that they tend to 20

have much more silica, which is taken from the soil in 21

tropical regions. And so I might expect that similar for 22175

bamboo, you might see more silica content as part of the 1

ash. And I know that other perennial grass is actually like 2

rice have high silica and silicate content. But, again, I'm 3

not aware of heavy metal content in bamboo. 4

Was there another question in there, or is that 5

good? That's good. Okay. Thank you. 6

MS. ADAIR: We are actuall y a little bit over 7

time. I didn't want to cut anybody off, but we have one 8

more. 9

MR. BUTTURINI: I just have a statement to make, 10

similar to phthalates. The Commission is interested in 11

which materials would provide the widest scope of relief? 12

We spen t a lot of time talking about wood and a lot of time 13

talking about plastic resins. If that's true, then you 14

should go to www.regulations.gov/docket/CPSC

- 2011

- 0081, and 15

submit a comment before April 17th ends. 16

MS. ADAIR: Thank you so much. Thanks to all the 17

panelists. That was a really good discussion. 18

We are going to break and do we want to come back 19

at 3:15 to stay on schedule. So that's 10 minutes. 20

[Recess.] 21

// 22176

V. DISCUSSION 1

MR. COHEN: Okay. Good afternoon. My name again 2

is Neal Cohen. I'm the Small Business Ombudsman at the 3

Consumer Products Safety Commission. I'm not part of this 4

team, but they did ask me to moderate this final discussion 5

session today at 3:15 in the afternoon. Thank you very much 6

for that distinct honor

-- 7

[Lau ghter.] 8

MS. CAMPBELL: Yeah. We appreciate it. 9

MR. COHEN:

-- trying to keep everyone awake at 10

this point. But, no. It's been a very interesting 11

discussion today, and hopefully scientific and technical 12

enough that we will be able to bring it back. And with the 13

submissions to regulations

. gov by April 17th be able to come 14

up with some pathways forward from here. 15

So today, this final discussion is a bit more 16

broad in nature. I don't think I would be insulting any of 17

my panelists by saying they are not necessarily technicians 18

in the scientific form of the word, but they're very well 19

versed in the law, the regulations governing this area, and 20

have their own perspectives on it. 21

Randy and the whole team today have been asking 22177

this question, repeatedl y, of the various panelists: “ how ?” 1

Right? You've made an assertion, but how are you backing 2

that up with data? “ Why ?” , “ because ?” , to get us to the 3

result. And I think that's very much a question that to the 4

extent the panel can address, I would so u rge you to address 5

that within the confines of this discussion, which is just 6

today on possible determinations. Right? 7

We understand that there are other avenues out 8

there, potential, so

- called third

- party testing burden 9

relief, but that's not sort of what's on the agenda today. 10

One thing that I think this panel is particularly well

11

suited to speak to is not so much of how, why and because, 12

but which. Which one of these items that are up for 13

discussion that are in front of the staff for consideration 14

do you in your experience or expertise believe provide a 15

pathway forward, or believe provide the greatest potential 16

and scope of relief which is discussed in the Federal 17

Register notice; and, why do you believe that. 18

So I'm going to just turn it over. I don't think 19

anyone has any prepared slides today. The four panelists, 20

they are Ami Gadhia from Consumers Union; Randall Hertzler 21

from the Handmade Toy Alliance; Rebecca Mond from the Toy 22178

Industry Association; and Rachel Weintraub from the Consumer 1

Fed eration of America. And they're going to speak, just in 2

the order up there, and, I think, be seated or standing, 3

which ever you prefer. Thank you. 4

MS. GADHIA: Hi. Good afternoon. I'm Ami Gadhia 5

with Consumers Union. We are the policy and advocacy 6

D ivision of Consumer Reports. I thought I'd come up from 7

behind that podium, since a lot of you probably couldn't 8

see. So I am coming to this. First of all, I want to thank 9

the Commission very much for holding this workshop and for 10

allowing me to speak, and just give some thoughts. 11

My comments will be very much a general frame

- up 12

from the consumer perspective. As Neal mentioned, there was 13

a lot of technical expertise that was given today, and I 14

found that very, very interesting and good to know. So ju st 15

some thoughts that I would offer generally that we would 16

urge the Commission to keep in mind as it moves forward on 17

this particular rulemaking, if that's what it is, and 18

proposal. 19

You know, as everybody in this room well knows, 20

third

- party testing w as one of the key components of the 21

CPSIA. Consumers, I think, prior to the CPSIA passing, just 22179

sort of assumed that somebody was testing all toys and 1

children's products for safety and other hazards before they 2

hit the market. And, sometimes, that was t he case, and 3

sometimes it wasn't. So that expectation is, I think, what 4

comes to bear, brings us to this point. 5

There's also the perspective that we believe that 6

a level playing field on safety keeps manufacturers from 7

competing on safety and from off ering products at a lower 8

price, because they've not taken the same safety steps that 9

other, more scrupulous manufacturers have taken. At the 10

same time, we do recognize that certain third

- party test 11

requirements may impose high, and at times, even a 12

prohi bitive cost on manufacturers who produce only very 13

small batches of a certain type of product, and whose gross 14

revenue from the sale of the product is small. 15

So while we're not opposed to exploring 16

alternative testing requirements for very small batch 17

manufacturers, we feel very strongly that every product 18

intended for children must meet mandatory safety standards 19

and must be safe. Parents

-- this is again coming from the 20

consumer perspective. Parents buying toys and other 21

products intended for their children expect them to be safe 22180

and to meet applicable standards, whether they're buying the 1

product at a large box store, at toy fair, small toy fair, 2

what have you. 3

We also urge the Commission to ensure that very 4

small batch manufacturers who receive these exemptions, or 5

this is less so a comment for, I think, some of the 6

categorical exemptions that have been discussed today. But 7

to the extent that there are particular exemptions that are 8

targeted at very small manufacturers to give them relief 9

that there's registration with the Commission as to which 10

companies those are, because if there is a problem, it's 11

important for the Commission to be able to then follow

- up 12

with those companies and trace the particle back to the 13

appropriate manufacturer. And, in general, I think what's 14

going to be very helpful to the Commission and to giving 15

consumers assurances and piece of mind is knowing that any 16

exemptions or determinations that are made are empirically 17

backed

- up, that there is solid data to say that this i s 18

something that is clearly not going to pose a hazard, 19

whether it's not intrinsically in the product or it's not 20

going to find its way into that product. Consumers need 21

those assurances, that that kind of determination has been 22181

independently made based o n scientific data, and that's 1

documented. 2

I think the Commission is asking all the right 3

questions to get at all these concerns. Dr. Recht, you 4

asked a very good question this morning about the Dollar 5

Store example. In my mind, it was a Dollar Store example. 6

You were talking about the concerns about products being 7

made off

- spec and ending up in a pool of products that are 8

maybe sold to low income consumers. That's something that 9

we're very concerned about, that products don't somehow then 10

end up in a separate pool and end up being sold at a dollar 11

store. So that's how I shorthanded it in my brain

. 12

So I think the other concern

-- the last point 13

that I would just make

-- is there's been discussion of the 14

terms "always" and "never" in that kind of a thing. And, 15

again, a very general concern we'd have is that if you are 16

across the board making a determination about a particular 17

product or a particular ingredient, is there no mechanism to 18

go back and check and make sure that those hazards are no 19

long er in those products , should processes change , s hould 20

ingredients change , raw materials , s hould the type of resin 21

in the composite wood change? Do you have to at some point 22182

come back and revisit that? 1

So we would strongly urge that there be some sort 2

of mechanism to require both the regulated entities and the 3

Commission to come back to that analysis. So it's not that 4

a product is just never checked back up on again and then a 5

problem emerges down the line. So those are my sort of 6

general thoughts, a nd would welcome questions. 7

[Applause.] 8

MR. COHEN: Thanks, and we will take questions at 9

the end from staff and audience members. Randy? 10

MR. HERTZLER: Thank you, Neal, and I too want to 11

thank the CPSC for providing this opportunity again for us 12

to provide input. 13

The Handmade Toy Alliance is a group of small and 14

microbusinesses that formed in 2009 after the CPSIA law was 15

passed in 2008. We really represent the bottom end of the 16

children's product market, when it comes to revenue figures, 17

size o f the businesses and those sorts of things. But the 18

Handmade Toy Alliance is made up of 800 small and 19

microbusinesses. The lion's share, or I believe 95 percent 20

of the Handmade Toy Alliance members, have fewer than 10 21

employees. And the majority of them have no employees at 22183

all, are just sole proprietors. This issue has been 1

important to the Handmade Toy Alliance, of course, for some 2

time, because we represent the group of people who find it 3

the hardest to be able to comply, simply because you do the 4

ma th of a third

- party test, and you amortize it over 50 or 5

even 20 items. And you come up with a big number, and that 6

makes it difficult to sell your product. 7

So when Public Law 112

- 28 was passed, there was a 8

provision for a small batch exemption to pro vide relief from 9

third

- party testing for these particular

-- this group of 10

people. The small batch exemption has not turned out to be 11

the primary method of compliance; and, in fact, the small 12

batch exemption does not exempt the business from 13

compliance, b ut simply the third

- party test. And I can say 14

with a high degree of assurance that the members of the 15

Handmade Toy Alliance are a very conscientious group, and 16

they want to be able to comply. And a primary method of 17

compliance has become determinations, because when we 18

determine that wood does not have lead, I can be a small 19

batch manufacturer, and then that exempts me from testing my 20

wood. But the determination means that I comply and that I 21

know that I comply. And that's important. 22184

So today we're certainly welcome to accept your 1

questions and see how this particular process affects the 2

Handmade Toy Alliance, and I'll certainly welcome your 3

questions. Thank you. 4

[Applause.] 5

MS. MOND: Hello. My name is Rebecca Mond, and 6

I'm director of Federal Government Affairs at the Toy 7

Industry Association. First of all, I want to thank the 8

CPSC staff, as well as the CPSC leadership in the audience 9

for taking the time to hold this workshop and engage with 10

the technical experts on materials determination. This has 11

been quite the chemistry for a lot of us here. 12

We appreciate the Commission's efforts over the 13

years to listen to and to integrate many of the regulated 14

community's comments, as well as the other stakeholders' 15

comments and suggestions into the t esting regulations. We 16

look forward to continuing to work with the Commission to 17

further improve the testing and certification requirements 18

in a manner that effectively ensures compliance without 19

unduly burdening the regulated community. 20

As the CPSC loo ks at reducing third

- party testing 21

burdens, we understand that this process requires a 22185

significant amount of data and requires time. And it 1

doesn't end with this workshop, nor are comment requests 2

enough. We need continued dialog with the CPSC staff to 3

u nderstand what data the agency has, what data does the 4

agency need, and what data can we provide the agency so that 5

the CPSC can issue meaningful relief from unnecessary 6

testing, and not just by acting on these material 7

determinations, but the other CPSC s taff recommendations as 8

well as some of the recommendations that were brought forth 9

today. 10

While waiting for CPSC action, many companies, 11

particularly SMEs, are conducting testing that does not 12

improve the safety of the product, nor does it give the 13

comp any greater assurance that a product complies with the 14

phthalate or heavy metal standards. I agree with my 15

panelist's point, here, that testing is a key component of 16

the CPSIA, provided that the testing advances safety and it 17

gives a company greater assur ance of compliance. 18

The Toy Industry Association has a high degree of 19

confidence that the materials discussed today do not and 20

will not contain the regulated phthalates and heavy metal. 21

Continuing to require costly testing is not advancing 22186

safety, but is, instead, an expensive way to prove something 1

that manufacturers and resin suppliers already know; that 2

there is a high degree of assurance that these materials 3

will always comply with CPSIA limits. Thank you. 4

[Applause.] 5

MS. WEINTRAUB: The las t speaker on the last panel 6

of a day

- long workshop like this is a challenge. And it 7

looks like even the ink filling in my name also was probably 8

the last one to be printed, because it looks rather tired. 9

But I am not tired, and I am incredibly glad to be here 10

today. 11

I am Rachel Weintraub, legislative director and 12

senior counsel with Consumer Federation of America. 13

Consumer Federation of America is a non

- profit organization 14

made up of other non

- profit organizations, now are 15

approximately 250. And we were founded in 1969 to protect 16

the public interest through research , advocacy and 17

education. 18

First, I'd like to thank the CPSC Chairman Adler, 19

Commissioners Robinson and Buerkle. Thank you so much for 20

your leadership on this issue, and thank you so muc h to the 21

CPSC staff. I mean I really think the way that this session 22187

was organized and structured. And the questions that you 1

asked throughout the day are exactly the type of questions 2

that we've been thinking about, and exactly the type of 3

questions tha t we'd hope you'd ask to figure out the best 4

way to move forward on these issues. 5

As Ami said, the third

- party testing provision s of 6

the CPSIA were very important provisions, and really 7

represented a paradigm shift for many in the product safety 8

market place. And while CFA and others certainly do not want 9

companies to have to test things unnecessarily

-- and we 10

support efforts to reduce testing cost, but safety can't be 11

compromised, and compliance can't be compromised. And I 12

think that's something that has been reiterated today, 13

numerous times, by all participants really. And that's a 14

very important aspect here that safety itself and compliance 15

itself can't be compromised. 16

So I think, you know, the questions that Randy and 17

Joel and Kris and Jacquelin e

-- and especially the way Randy 18

put it, I think we're all going to remember sort of the why 19

and the because, I think, are exactly the essence of where 20

things should be focused so we don't compromise safety and 21

we don't compromise compliance. So any chan ges made to 22188

reduce the testing burdens can't weaken, not only the 1

testing provisions, but any of the product safety standards, 2

and can't weaken any public health protections. 3

Just a few things, and some of these were 4

mentioned today. And I think that af ter listening today, I 5

think people generally agree that supplier declarations 6

alone are not sufficient evidence; that while mechanisms to 7

ensure that the supply chain is monitored carefully, that 8

alone is not sufficient evidence to support that a product 9

does not contain prohibited ingredients. I mean 10

determinations made ultimately within this framework will 11

impact both the most scrupulous manufacturers, as well as 12

the least scrupulous. So all of these decisions need to be 13

made, knowing that there's a wi de variety of manufacturers 14

of supply chain protections, and that these determinations, 15

like all rules, impact the entire marketplace and not just 16

those that are the most rigorous. 17

While certain chemicals are not naturally 18

occurring, like phthalates, i t doesn't mean that they're not 19

ubiquitous; and, phthalates are certainly an example of 20

something that are used in many different products for many 21

different purposes. So, clear evidence is necessary to 22189

provide its absence, and I think today we certainly talked a 1

lot about plastics and hard plastics. But what we didn't 2

talk about were places where phthalates may be in consumer 3

products in other contexts, such as fragrances. 4

And I know that in my home over the years, my 5

daughters in particular have had dolls, for example, that 6

smell like particular berries; and, they have plush toys 7

that when you push them in a certain way, a puff of vanilla 8

scented air is exuded. And while I'm not a chemist, I do 9

work with a number of chemists in different capacities, and 10

I know that there are phthalates in fragrances. So how does 11

that work in this context, and when there are fragrances in 12

children's products, for example? 13

And, not to mention there are certainly children's 14

cosmetics, children's nail polish, childr en's perfume and 15

cosmetics which, while FDA has jurisdiction, it is a 16

children's product. So these are broader issues to 17

consider, because the use of phthalates, again, while not in 18

our environment necessarily naturally, is it in our 19

environment extensive ly? And I think that it's also 20

important, and I think it's clear from this discussion, that 21

those seeking the determinations bear the burden of proof. 22190

They bear the responsibility to answer the “ why ” 1

and to answer the “ because. ” And I also think that C PSC 2

should be clear about what evidence is required and is 3

sufficient to exempt third

- party testing from a particular 4

type of product while preserving compliance with the 5

provisions of the CPSIA. So I think as we move forward, 6

answering these questions, i t's also very useful and 7

important for CPSC to be as clear as possible. 8

Well, thank you all very much, and I'm happy to 9

take questions as well. 10

[Applause.] 11

MR. COHEN: Thank you, Rachel. So, I guess just 12

to start of the discussion

-- it seems like Joel would like 13

to say something. Please, go ahead. 14

DR. RECHT: Just real quickly, I just want to make 15

clear that I didn't say anything about the Dollar Store in 16

particular. I know Ami didn't mean that I did, but

-- 17

MS. GADHIA: Yes. My words, not Joel's. 18

DR. RECHT:

-- low cost, low quality, but not any 19

particular venue. 20

MS. GADHIA: Duly noted. 21

MR. COHEN: And, while we're on disclaimers, I 22191

want to remind you about the one at 9 a.m. this morning. 1

The views of participants, of course, do not represent those 2

of CPSC staff. Thanks. 3

Turning first to sort of representatives from the 4

business stakeholder community on the panel, I guess I 5

broached the first question before. Which of the 6

determinations or categories of determinations that we s poke 7

about do you see as providing the greatest cost savings to 8

your particular area and why? And why would they be useful 9

to you? 10

MR. HERTZLER: For the members of the Handmade Toy 11

Alliance, I think that the manufactured woods determination 12

and the h eavy metals

-- those two are certainly the most 13

important. As you might imagine, plastic is not a primary 14

ingredient in a handmade children's article with the 15

exception of, perhaps, like buttons or some things like that 16

that might be used. But, primarily , it's the wood 17

determinations and the natural material determinations. 18

It's basically extending the lead determinations to the 19

heavy metals, as well. 20

MR. COHEN: Thank you. 21

MS. MOND: I think that based on what we've heard 22192

from our members, the pht halate testing is very expensive, 1

and so that has been where we've been focused and where we 2

believe that determination would provide the most benefit 3

for industry. And to echo my colleague's points earlier 4

today that focusing on hard plastics might be th e easiest 5

route; not only from the CPSC resource perspective, but then 6

also would provide the greatest benefit for the toy 7

industry. 8

MS. WEINTRAUB: I know you didn't ask me this 9

question

-- 10

MR. COHEN: Go ahead. 11

MS. WEINTRAUB: But I'm going to answ er, if I may. 12

I would say I think the CPSC should be guided by where they 13

have the best evidence, and where they answer the “ why ” and 14

the “ because. ” And where it's chemically

-- you know

-- 15

impossible is a difficult term, but chemically wouldn't be 16

possib le. Or I really think that the decision should be 17

guided by where the clearest, most robust evidence is in 18

this phase. 19

MR. COHEN: There was some discussion in the 20

earlier panels about the distinction between resins, 21

pigments, paints. And I wouldn't say it was like it was a 22193

new idea, but the idea that a determination solely for the 1

virgin resin itself, untreated, without colorant, would be 2

of significant utility, certainly, I guess to

-- based on 3

your priorities for the TIA, Rebecca

-- the large toy 4

s egment, the large toy manufacturers. 5

What have you seen so far in your experience in 6

the component part market today? Because inherent in that 7

distinction is the idea that the component market would 8

flourish and be able to distinguish between the resi ns and 9

the colorants, et cetera. Have you seen any evidence of 10

that to

- date? Is there nascent activity in that area? 11

Would this invigorate that? 12

MS. MOND: What we've seen in the component part 13

market is that the toy industry isn't a significant buyer of 14

these resins. And so, as a result, the toy industry ends up 15

taking on a lot of these third

- party testing costs. And the 16

resin suppliers, they know what's in their materials. They 17

supply the supplier declarations. They do their own in

18

house testings , but they aren't willing to incur the third

19

party testing costs. So as a result, separate companies who 20

are buying resin from perhaps the same resin manufacturers 21

all have to do their own third

- party testing. And so there 22194

would still be a benefit for th e toy industry, even if it's 1

just the raw resin and not going to the colorants, because 2

they wouldn't have to do that testing on just that resin. 3

MR. COHEN: And have there been any efforts or 4

movement towards

-- I mean how has the component part rule 5

pr ovided the relief that it was sort of promised that it 6

might provide to

- date? And do you think this could help 7

that? 8

MS. MOND: It has provided some relief, 9

definitely. This will certainly provide additional relief. 10

MR. COHEN: Okay. 11

MS. MANN: T his is Hailey Mann from American 12

Plastic Toys. From a component part testing standpoint that 13

has provided tremendous relief for us, because if I produce 14

a toy that has three or four different colors across four or 15

five different items, then I don't have t o test that for 16

each end unit. For example, we have a hundred colors in our 17

litany of colorant that we use, and I can test it now in the 18

liquid form, annually, because it's purchased from one 19

vendor. So, and it uses the same formulation. So I'm able 20

to use that component part testing ruling. 21

I brought orange as an example. So I'm able to 22195

test this orange, annually, and then I could color every 1

single different skew number I had orange, and it's covered 2

by that test result. So for us from the compon ent part 3

testing standpoint, breaking up the two and testing the raw 4

resin separately, and the colorant, has given us great 5

relief from our testing cost. 6

MR. COHEN: And, please feel free to ask more 7

questions. On these comments regarding would there be a 8

mechanism to change any of the determination, should things 9

change in the future, I guess what I heard there on the end 10

-- and I guess this kind of both goes to both Ami and Randy 11

Hertzler

-- is if hypothetically there was evidence to 12

provide the Commis sion with a high degree of assurance to 13

provide a determination on something like manufactured wood 14

products. What I think I hear you saying is you would want 15

the specificity of that analysis to be reflected in the 16

regulation, such that it's the manufactu red wood based on 17

resins using a urea formaldehyde resin system, or something 18

to that nature. 19

MS. GADHIA: Yes, correct, that determination 20

being a specific determination so that it applies to a 21

specific set of ingredients, essentially. And it goes ba ck 22196

to Rachel's point about the evidentiary basis for the 1

determinations. If that information is available, it should 2

be

-- each determination needs to be specific and backed up 3

by specific evidence so that there is assurance amongst 4

consumers that that pa rticular part has been tested, has 5

been backed up by data, and that determination is made, not 6

in a blanket way that might raise concerns down the line for 7

CPSC from a compliance or enforcement perspective. 8

MR. COHEN: And that would be, obviously, wel comed 9

by your members. Do you think they would be able to locate 10

on the vendor market materials delineated in that way? 11

MR. HERTZLER: Yeah. That's basically where I 12

would go with this question is if that's the case, it is the 13

determination is create d on an individual basis for certain 14

combinations of adhesives and that sort of thing. Then that 15

needs to be able to be identified in the market, obviously, 16

or it doesn't do us any good. You know. You go to home 17

depot and you buy three

- eighth

- inch plywo od to make your 18

wooden puzzles. You need to be able to tell that that 19

three

- inch plywood has the correct adhesive in it so that 20

you can use it and take advantage of the determination. 21

MR. KAUFMAN: Hi. Al Kaufman with the Toy 22197

Industry Association. A ctually, it's not a question. I 1

just had one clarification. 2

Rachel, you'd mentioned phthalates in fragrances. 3

The phthalates that are in fragrances are not plasticizers. 4

They're solvents, and so it's overwhelmingly di

5

ethylphthalate and di

- methylphtha late. So it's sort of 6

irrelevant to this. They're not regulated under CPSIA. 7

MS. WEINTRAUB: It would be great, I think, for 8

there to be evidence provided that supports that. So that 9

consumers know, consumers would understand. I mean if there 10

are d ifferent phthalates used, then that's important to 11

know. 12

MR. COHEN: Rachel, in your comments you discussed 13

sort of CPSC should be very clear as to what evidence is 14

required, and that the sort of business takeover should bear 15

the burden of proof in meeti ng that evidentiary requirement. 16

The discussion today has used the word "high degree of 17

assurance" a great deal, which is also the terminology, as 18

Randy pointed out, that's in 16 C.F.R. 1107. And, as Randy 19

pointed out, inherent in that is the recognition that 20

nothing could ever be 100 percent certainty. There's no 21

certainty, but there is a high degree of assurance. I guess 22198

in your comments is that consistent with the sort of 1

evidence that you'd be looking for from your perspective and 2

from Ami's perspec tive? 3

MS. WEINTRAUB: Yeah, I would say yes. I mean I 4

think, you know, there needs to be the best scientific 5

evidence provided that supports the underlying statement 6

that particular ingredients, heavy metals, phthalates, would 7

not be in other particular materials. I mean certainty I 8

think is not the goal; but within the framework of the 9

regulation, I think that all fits together nicely in this. 10

That's, I think, the way to move forward, but I 11

think there needs to be clarity in looking over

-- there's 12

actually quite a body of information of different documents 13

that entities have submitted over time. And there seems to 14

be some ambiguity about what type of information is 15

sufficient to make these determinations, and whether 16

supplier declarations are suffi cient. And it just seems 17

like, you know, I think this is the direction the Commission 18

is clearly going in after today's meeting. But it seems 19

like more clarity within that statutory paradigm would be 20

helpful. 21

MS. GADHIA: I would just add that I think Gibb 22199

raised a good point earlier when he was talking to the panel 1

that Hailey was on about assurances to the Commission that 2

there is no cherry

- picking of data. And I think the same 3

assurances need to be communicated to consumers as well. 4

There needs to be a public disclosure, a public explanation, 5

some transparency to know that there wasn't that kind of 6

cherry

- picking. It's independent, reliable data. 7

MS. WEINTRAUB: And I would just also add that 8

convening, I think, today, there were great experts wh o are 9

here; but also, looking further at other metallurgists, 10

other chemists who have expertise in these issues who may 11

not be connected to a particular industry. I know that's 12

hard in this context, but figuring out who the best, 13

independent scientists ar e in the particular field to get 14

the best evidence so that these determinations are made in a 15

way that safety and compliance are not compromised. 16

MS. MOND: One quick point is something I think 17

was very important to include in the lead determinations w as 18

a provision saying that regardless of any testing 19

exemptions, the underlying product must comply with the lead 20

content standard. And, certainly, the toy industry would 21

expect to have that provision included in any determinations 22200

for phthalates or heavy metal standards. So going back to 1

the example of the fragrance

-- regardless of the fragrance 2

-- the toy must comply with the CPSIA phthalate limits, and 3

that's also regardless of a testing determination or a 4

testing exemption that that toy would need to comply with 5

the phthalate limits. 6

MR. COHEN: Right. And, Rachel, to your point, I 7

mean I think CPSC staff today really did try really hard. I 8

think it was evident today and to try to locate folks who 9

were sort of outside the usual suspects that peo ple in CPSC 10

were. Dr. Brown from Penn State

-- her expertise was 11

welcome. And that sort of was kind of the underlying point 12

to my earlier question to Dr. Brown is what do you do, who 13

do you do it for, who funds you. Why is no one interested? 14

What is yo ur source of funding? Because we typically are an 15

applied research agency. 16

We have scientists here, but they apply their 17

technical and scientific expertise to consumer products. 18

And even though research is part of our mission here and 19

today is part o f reaching that mission, we don't necessarily 20

-- we're not like NIH or the National Science Foundation. 21

We don't award grants. And so trying to locate, A, who 22201

these people are, B, get them to come here on their own 1

dime, and 3, without really promise of funding, how do we, 2

collectively, as a stakeholder group

-- not just the 3

business stakeholders, not the consumer stakeholders, not 4

just the government stakeholders

-- how do you find and 5

bring that set of expertise to answer these "because" 6

questions and p rovide that high degree of assurance ? And I 7

think it's an ongoing question, today. I hope you agree it 8

was a positive first step in that direction. Are there any 9

questions from the audience? 10

Sheila, did you have a question? 11

MS. WEINTRAUB: And I w ould just agree with you. 12

I mean I think the speakers here

-- and maybe I didn't say 13

it clearly enough. I think they were a great example of 14

experts, and I found the presentation on wood to be really, 15

really interesting and insightful. And I think we al l 16

learned a lot about chemistry, as Rebecca mentioned, and 17

other issues. So I think that the Commission really did 18

take a very big step and continuing step in doing that 19

today. 20

MS. MILLAR: Sheila Millar, Keller & Heckman, 21

representing the Fashion Jew elry and Accessories Trade 22202

Association. I wanted to thank the Commissioners and the 1

staff again for putting together the workshop, and I didn't 2

want the day to end without asking a process question. 3

Hopefully you'll maybe address it in the closing commen ts, 4

but we're all here for the same reason. We want to assure 5

compliance, and we want to reduce testing burdens with a 6

high degree of assurance that products will comply. 7

So at Regulations dot gov, we'll all be sending in 8

our comments very soon. But then, I guess, two questions. 9

What happens after that? I mean what do you expect the 10

timeframe to be? Do you expect to convene other stakeholder 11

discussions of this sort? That's question number two. I 12

mean question number one. And then question numbe r two, 13

there were some things clearly out of scope for the day, but 14

there were some points mentioned or alluded to during the 15

day that could also help reduce the cost of third

- party 16

testing. So is there any expectation that you will be 17

looking at a second path to evaluate some of those points to 18

also address cost of testing in that way. Thank you. 19

MR. BUTTURINI: In terms of timeframe, the 20

operating plan for 2014 for the CPSC states that we'll 21

conduct additional research. This is part of our additional 22203

research, and that the staff will begin a rulemaking 1

process, words to that effect. And it says, "begin," which 2

implies not end by the end of the fiscal year. At least 3

that's what it means to me, but I can answer your question 4

explicitly about the timef rame. I don't know. 5

[Laughter.] 6

MR. BUTTURINI: It will take us processing this 7

data, the first timeframe is two weeks, because we wait two 8

weeks until the comment period closes and we get all of that 9

information in. Then we're going to sit down and sort of 10

try to figure out what it means. So the timeframe was where 11

I started on it. The operating plan is a certain amount of 12

staff hours assigned to this sort of thing. The budget 13

process of CPSC seems continuous in my opinion, but it does 14

have dates on it. 15

In terms of your other question about looking at a 16

second path or other burden reduction possibilities that are 17

not determinations, the briefing package sent to the 18

Commission on the request for comments had a long list of 19

items that could be pur sued, basic research looks into one 20

thing. Determinations was one of these things. Looking at 21

manufactured wood was another thing, and the Commission 22204

chose to look at these particular things right now. They 1

still have the list, and they can choose it an y other time 2

to staff and fund other activities related to burden 3

reduction, using items on that list or using something that 4

we may learn here. You know. This is something that you 5

want to do now with determination; but, it gave us an idea 6

about somethi ng else, and we can always propose that and see 7

if the Commission wants to take that up. So doing this 8

doesn't mean we don't do anything else in that way. 9

MR. COHEN: Thanks, Randy. And, again, I mean we 10

do want to encourage the written comments, bec ause, as we 11

all know, that's really where the rubber meets the road in 12

these activities. We need to see data. We need to see, 13

hopefully, peer reviewed literature if it's available, 14

citations to the literature. If companies have information 15

that they wan t to share with us, we'd like to see that 16

information. 17

If there's confidential business information, 18

there may be provisions and ways to get that to us to 19

protect that, but you can contact one of the staff and we 20

can speak to that offline. Rick Uhl ha s a question, but I 21

also meant to acknowledge Rick who did a lot of the legwork 22205

in calling and trying to get experts from outside here 1

today. So we do appreciate everyone's work on the team. 2

And, Rick, you did a lot of the groundwork on that. 3

Do you ha ve a question for the panel? 4

MR. HERTZLER: And this is related to the 5

timeframe issue. The CPSIA law was passed in August of 2008 6

and the 1500.91 determinations on lead was issued in August 7

of 2009. So within the span of one year, we had this ruling 8

a nd determination on lead. The process that we're in now 9

started with Public Law 112

- 28, and I believe the first 10

request for information was in November of 2011. And staff 11

came up with their first document, the consideration of 12

opportunities to reduce tes ting burdens, something like 13

that, I think was in 2012. 14

And we've gone through this iteration of comment 15

and that sort of thing now for a number of years. So I'm 16

just curious how the lead determination was able to be 17

started and finished in the span o f less than a year, but 18

that this process is dragging on for multiple years. 19

[Laughter.] 20

MR. BUTTURINI: Neal owes me one for this. 21

The lead determinations, if you look at the 22206

materials in there, they're in the category more of "can't," 1

and “ can't ” i s much easier than “ won't. ” Lead can't be a 2

natural gemstone. Lead can't be in titanium, things like 3

this. So that was sort of an easier thing to do. That's 4

one explanation. I wasn't intimately involved with that. 5

Now we're dealing with man

- made chem icals and you can do 6

anything you want to to manmade chemicals. We're trying to 7

figure out, rather than “ can't, ” how do we do this with a 8

high degree of assurance. 9

You know. Again, we ring the bell every time that 10

sort of phrase is done. So we have a tougher technical 11

challenge to deal with in this and we have a wider range of 12

things. Lead is one element that is naturally occurring and 13

it shows up in many products. 14

When you're getting to phthalates, phthalates is a 15

man

- made chemical done a diffe rent way; but, as I found out, 16

worldwide production of phthalates is greater than worldwide 17

production of lead, so it actually has the opportunity to 18

show up in more places than lead shows up in. So part of 19

this is a technical challenge that we have to de al with. 20

MR. HERTZLER: So it seems like, and I think you 21

allude to the fact, that there's probably some low

- hanging 22207

fruit here that perhaps could be fast

- tracked. For 1

instance, natural unfinished wood can't have chromium and 2

antimony, and whatever. I mean maybe that's possible. 3

Maybe we can say the same thing for bamboo. Maybe we can 4

say the same thing for cotton fibers. It just seems like 5

there's a pathway forward on some of these things that could 6

be accomplished with little effort, that low hangi ng fruit. 7

MR. COHEN: Right. And we'll take that comment 8

sort of in response in the nature of the FR , which is where 9

is the biggest bang for the buck. And so we appreciate that 10

comment. 11

Rick, did you have a question? 12

MR. UHL: Rick Uhl again with CPSC, my question 13

was for Randy. I was just curious about the process that 14

they use at the Handmade Toy Alliance, if they have, like, 15

for example, a natural wood product that they're making and 16

then the paint it. Okay. So if you're exempt on the 17

natural wood, but then you put the paint on, how do they 18

handle the paint aspect? Do the paint manufacturers provide 19

the third

- party testing for you, or do they have to go 20

through that expenditure themselves to do that? Do they co

21

op and try to test a single lo t, or what's the process? 22208

Thank you. 1

MR. HERTZLER: Generally, paint would not be a 2

component, but more typically a surface coating like 3

beeswax, vegetable dyes, those items that show up in the 4

determination lists, like beeswax is probably the primary 5

w ood coating that would be used. There would be some use of 6

the component part rule along with the small batch exemption 7

and determinations, and sort of this conglomerate of a path 8

to compliance as well. 9

MR. COHEN: Okay. And with that Jacqueline is 10

goi ng to come up in a moment. I just want to thank the 11

panel. I know it was a long day and I appreciate everyone 12

for everyone's attention and the panel, and all the panels 13

today, for trying to do their best to stay within the lines 14

of the Federal Register t hat we discussed. 15

There were a couple of off break

- outs, but we did 16

our best to keep everyone on

- point and I appreciate 17

everyone's best efforts to control themselves and cooperate 18

with us. So thank you to this panel, and I'll turn it back 19

to Jacquelin e. 20

[Applause.] 21

// 22209

VII. CLOSING REMARKS 1

MS. CAMPBELL: Thank you Neal and thank all of 2

you. Thank our panelists and the audience, and our audience 3

out in webcast land. 4

You know, I know we've said this so many times 5

that we've gotten some laughs, bu t we take this very 6

seriously. Our public comments, we use them to guide us and 7

inform us. And so we really, really do want you to get your 8

comments in to us. Again, the deadline for submission is 9

April 17th. And hopefully now we've given you more 10

info rmation about some of the things that we're looking for. 11

The idea that data alone doesn't tell us the whole 12

story or just information about one specific company or one 13

specific industry doesn't give us the whole story. So we 14

want you to be mindful of th at when you're sending things 15

in, and if you know what your limitations are, you can tell 16

us that. Like I only know this information, so the things 17

that are unknown, acknowledging those things are very 18

helpful to us too, because then we know where else to look. 19

So, with that, again, I want to thank all of you 20

for being here and for participating in this discussion. 21

And, with that, I think we'll close it. I do want to make 22210

one note. As I did mention earlier and I think that it was 1

reiterated a couple of times, we'll be putting the panelists 2

presentation and the staff presentation on SlideShare. And 3

for those of you who registered, I will be sending out a 4

link for both where the webcast will be located, after the 5

fact, and also where those slides can be found. 6

Again, thank you very much, and I hope you guys 7

have a great day. 8

[Applause.] 9

[The workshop adjourned at 4:07 p.m.] 10

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