PUBLIC WORKSHOP ON POTENTIAL HEALTH AND · PDF file02.03.2017 · i . state of california department of toxic substances control (dtsc) public workshop on potential health and safety

i

STATE OF CALIFORNIA

DEPARTMENT OF TOXIC SUBSTANCES CONTROL (DTSC)

PUBLIC WORKSHOP ON POTENTIAL HEALTH AND SAFETY IMPACTS OF CHEMICALS IN NAIL PRODUCTS

TRAINING ROOM 1, EAST/WEST

CAL/EPA HEADQUARTERS BUILDING

1001 I STREET

SACRAMENTO, CALIFORNIA

THURSDAY, MARCH 2, 2017

9:00 A.M. to 4:30 P.M. Reported by: Susan Palmer

CALIFORNIA REPORTING, LLC 229 NAPA STREET RODEO, CA 94572 510-313-0610

ii California Reporting, LLC

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APPEARANCES:

WORKSHOP PRESENTERS Barbara A. Lee, Director, DTSC André Algazi, Senior Environmental Scientist (Supervisory), DTSC Eric Sciullo, PhD, Staff Toxicologist, DTSC Diana Ceballos, PhD, Visiting Scientist, Harvard T.H. Chan School of Public Health Alexandra Scranton, MS, Director of Science and Research, Women’s Voices for the Earth Katherine Montgomery, Sr. Director, Corporate Regulatory Affairs Catherine A. Porter, JD, Policy Director, CA Healthy Nail Salon Collaborative Tom Myers, JD, EVP-Legal & General Counsel, The Personal Care Products Council Jill Ryder-Powder, PhD, DABT, Principal, Environmental Health Decisions Paula Johnson, PhD, MPH, Program Lead, California Department of Public Health Angela Perez, PhD, Supervising Health Scientist, Cardo ChemRisk Aja Frierson, Founder, Habit Cosmetics Jen Jackson, Toxics Reduction & Healthy Ecosystems Programs Manager, San Francisco Department of the Environment Meredith Williams, PhD, Deputy Director, Safer Products and Workplaces Program, DTSC

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APPEARANCES: DTSC STAFF PRESENT Marcia Rubin, Moderator, DTSC Andre Algazi, Senior Environmental Scientist (Supervisory), DTSC, Safer Consumer Products Program Christine Papagni, Senior Environmental Scientist (Specialist), DTSC, Safer Consumer Products Program Eric Sciullo, Staff Toxicologist, DTSC, Human and Ecological Risk Office Patrick Kerzic, Staff Toxicologist, DTSC, Human and Ecological Risk Office Efrem Neuwirth, Staff Toxicologist, DTSC, Human and Ecological Risk Office Dennis Guo, Research Scientist III, DTSC, Safer Consumer Products Program Diana Phelps, Hazardous Substances Engineer, DTSC, Safer Consumer Products Program Anne Cooper Doherty, Senior Environmental Scientist (Specialist), DTSC, Safer Consumer Products Program David Rist, Senior Environmental Scientist (Specialist), DTSC, Safer Consumer Products Program Julia “Ky” Gress, Environmental Scientist, DTSC, Safer Consumer Products Program James Joelson, Staff Services Manager I, DTSC, Safer Consumer Products Program Andrew King, Research Program Specialist II, DTSC, Safer Consumer Products Program PUBLIC PRESENT (In person) Catherine Porter, CA Healthy Nail Salon Recognition Program Katherine Montgomery, Coty Inc. Indira Balkissoon, AlterEcho Amy Le, California Safe Cosmetics Program Kathryn Cooke, San Mateo County Paula Johnson, SF Department of the Environment Tammy Ho Ting Leung, SF Department of the Environment Veena Singla, Natural Resources Defense Council (NRDC) Doug Schoon, Professional Beauty Association Mary Lennon, Côte LLC Kelly Chen, LeChat Nail Care Products Meg Haesloop, DTSC Brittani Orona, DTSC Susan Little, Environmental Working Group Angela Perez, Cardno ChemRisk Meg Haesloop, DTSC Newton Luu, LeChat Nail Care Products

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APPEARANCES: PUBLIC PRESENT (In person) (cont’d) Dennis Fitzpatrick, LeChat Nail Care Products Michael Megna, Backscratchers Salon Systems Inc. Jill Ryer-Powder, Environmental Health Decisions Lauren Hendrickson, San Mateo County Jen Jackson, San Francisco Dept. of the Environment Luda Kopelovich, Cardno ChemRisk Terri Edwards, Air Resources Board Jin Dang, Air Resources Board Debra Kloss, DPR Kathryn Alcantar, CEH/CHANGE PUBLIC PRESENT VIA WEBINAR: Simona Balan, DTSC Ann Blake, Environmental & Public Health Consulting Janet Blaschke, Intl Cosmetics & Regulatory Specialists, LLC Thomas Booze, DTSC Relly Briones, CA Dept. of Toxic Substances Control Paul Bryson, OPI Products Inc. Cathy Campbell, Health Canada Suzanne Davis, DTSC Aika Davis, ULI Karen DiBiasio, CalEPA/DTSC Katherine Donner, U.S. EPA Terri Edwards, Air Resources Board Neeraja Erraguntla, ACC Ariana Farina, Ariana Farina Consulting Holly Fraumeni, Platinum Advisors Michele Garcia, dtsc Lynn Goldman, DTSC Maureen Gorsen, Alston & Bird LLP Ewa Gorski, Ford Motor Company Soad Hakim, DTSC Suzanne Hartigan, IFRANA Nick Johnson, Charter Communications Jennifer Jose, L'Oreal Pinaki Joshi, Chanel INC. Megan Kalsman, SF Department of Environment Richard Krock, The Vinyl Institute Mandy Lee, Platinum Advisors Heather Lee, DTSC Mia Lei, SFPUC David Lennett, NRDC Jack Linard, Unilever

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APPEARANCES: PUBLIC PRESENT VIA WEBINAR (cont’d): Linda Loretz, Personal Care Products Council Leona MacKinnon, Health Canada Irina Malkina, CA Air Resources Board Kerry Morlock, Vermont Department of Health Sharen Muraoka Meltem Musa, CalEPA Lynn Nakayama Wong, DTSC Tuan Nguyen, State Compensation Insurance Fund Hung Nguyen, Energia Jessica Otto, g2 revolution Karl Palmer, DTSC John Quinn, DTSC Nicole Quinonez, Randlett Nelson Madden Leslie Riddle, Breast Cancer Action Nandi Robinson, Breast Cancer Fund Laura Rosenberger Haider, CEJC, Sierra Club, Fresnans Against Fracking Melissa Salinas, DTSC Annette Santamaria, Rimkus Consulting Group Jessica Schifano, OSHA Stephanie Seller, Boston Public Health Commission Derek Shendell, Rutgers School of Public Health Rona Silva, OEHHA Nancy Simcox, UW DEOHS Continuing Eduation Nivashni Veerasamy, DTSC James Votaw, Manatt Phelps & Phillips LLP Laura Walther, American Chemistry Council Dan Werner, Orly International Kimberly White Theresa Yi, Chanel Anna Young Xiaoying Zhou, DTSC jennifer hsieh Bill Jones, LACoFD Daphne Molin, DTSC Mitul Parikh, Revlon Jonathan Rivin Pankajkumar Sarda, Intertek David wawer, CPMA

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I n d e x

Page

1. Introduction 1 2. Welcome by Director Barbara A. Lee 3 3. Presentation by André Algazi 6

4. Presentation by Eric Sciullo, PhD 14 5. Questions & Comments 24 6. Presentation by Diana Ceballos, PhD 35 7. Questions & Comments 44 8. Presentation by Alexandra Scranton 50 9. Questions & Comments 63 10. Presentation by Katherine Montgomery 75 11. Questions & Comments 88 12. Presentation by Catherine Porter, JD 97 12. Questions & Comments 108 13. Presentation by Tom Myers, JD 117 14. Questions & Comments 132 15. Presentation by Jill Ryer-Powder, PhD 140 16. Questions & Comments 147 17. Presentation by Paula Johnson, PhD, MPH 158

18. Questions & Comments 163 19. Presentation by Angela Perez, PhD 173 20. Questions & Comments 185 21. Presentation by Aja Frierson 187 22. Questions & Comments 199

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I n d e x (cont’d)

23. Presentation by Jen Jackson 203 24. Questions & Comments 211

25. Closing remarks by Meredith Williams, PhD 222 26. Adjournment 224

27. Reporter’s Certificate 225 28. Transcriber’s Certificate 226

1 California Reporting, LLC

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WORKSHOP PRESENTATIONS AND DISCUSSION 1

MARCH 2, 2017 9:01 a.m. 2

MS. PAPAGNI: We’re going to go ahead and get 3

started, it’s 9 o’clock. Good morning, everyone. 4

I want to thank all of you for attending today, 5

both in person and via webinar. We have about seventy 6

people attending over the webinar today which is great. 7

Great attendance. 8

My name is Christine Papagni. Many of you have 9

communicated with me or some of my colleagues over the past 10

few weeks or months or participated in the webinar that we, 11

the Safer Consumer Products Program, hosted on 12

November 15th. The goal of today is essentially to continue 13

those conversations and we encourage you to share with us 14

and provide information. 15

Due to interest, we have a full day of speakers 16

and we’ve also allotted time after each presentation for 17

both questions of the speakers and comments to DTSC; so, 18

we’re encouraging you to share with us. And with that, I’d 19

like to introduce our moderator for the day, Marcia Rubin. 20

MS. RUBIN: Thanks, Christine. I’ll be moderating 21

the day and we have a lot of speakers. Thank you all for 22

taking the time to participate here with us today and on the 23

webinar. 24

I’m going to cover a few housekeeping points and 25


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ground rules before we get started. I want to ask the 1

speakers when you come up to speak, please go around the 2

sides, there’s a lot of technology here, we’re trying to 3

make sure that everyone gets to participate. 4

We also have a court reporter here. She’s 5

recording the day so that we can capture all of the great 6

speakers that we have and all of the comments and questions 7

that we get from people. 8

I’m going to ask you to silence any noise emitting 9

devices, smartphones, tablets, watches, anything that might 10

disrupt our workshop today. And limit your cross 11

conversation. Because we have people participating on the 12

webinar, we want to make sure that everyone gets heard and 13

so if you’ll keep the cross conversation limited. If you 14

need to have some, take it outside. 15

We also want to ask you to be brief in your 16

comments and questions. There’s a lot of information to be 17

shared and, there’s also going to be more opportunity for 18

dialog, so we’re going to follow our agenda very strictly 19

and try to make sure we get as much dialog as we can in 20

today. 21

For people joining us via webinar, I want to share 22

with you if you don’t see anything happening on the screen, 23

that’s a period where we’re going to be having question and 24

answers and dialogs so you can participate in that by typing 25


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in to your dialog box in the webinar and we’ll make sure we 1

try to get to as many questions or comments as we can. 2

The restrooms are upstairs and at the end of the 3

hall past the auditoriums; if you just go to the end of the 4

hall, they’re right there and you’ll see signs for that. 5

We are only using these two doors today for 6

entrances and exits so don’t use this door. In the event of 7

an emergency, our meeting point is going to be Cesar Chavez 8

Park and the cross streets for that are I and Tenth, it’s 9

directly diagonal to our building. 10

With that, we’re going to -- we have built-in 11

breaks on our agenda, but if you need to take a break, 12

please do so and try to be quiet as you can, so we can keep 13

the tone of the workshop going. 14

With that, I want to introduce our esteemed 15

director Barbara Lee. She’s here to welcome you today. 16

Thank you. 17

MS. LEE: Good morning, everyone. I hope you can 18

understand me. I’m coming off of a kind of an unfortunate 19

bug. All of you who are participating on the webinar are in 20

much better shape than the folks who have to share this 21

space with me, but I’m trying not to shake any hands or 22

cough on anyone, so bear with me. 23

I really appreciate the fact that so many of you 24

have turned out here in person to talk with us and also that 25


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you have participated via the webinar. This is a wonderful 1

opportunity for DTSC to gather information to expand our 2

understanding and to build the relationships that we need to 3

build in order for this to be a successful program. 4

Today is focused on nail salon products and what’s 5

in them and how they’re used and potential exposures to 6

them. You’re going to hear from a variety of different 7

perspectives on this and that’s the goal of our meeting 8

today. You have a wealth of talent in this room, you bring 9

a wealth of talent to this room. We have representatives 10

like Catherine Porter and Tom Myers who are here from the 11

Healthy Nail Salon Collaborative and also the Personal Care 12

Products Council. We also have some exciting presentations 13

including a webinar presentation from Diana Ceballos from 14

the Harvard School of Public Health. There is a broad scope 15

of information exchange that we’re hoping is going to 16

happen. And we want to hear all these unique perspectives. 17

We’re collecting information; we don’t have an 18

endpoint in mind yet. And that’s the beauty of this 19

program. It’s my personal feeling that our Safer Consumer 20

Products Program, Dr. Meredith Williams, Karl Palmer, and 21

all of the staff who work on it embrace this model of 22

collaborative working. And it makes the program 23

tremendously strong. I’m thrilled that I get to be here, at 24

least for part of it, and share this with you. Coming out 25


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of today we will probably have more questions than we have 1

going in to it now. That’s our goal, so please help us open 2

this topic up. Help us dive into it deeply. Share your 3

thoughts and ideas. Share your questions. You don’t have 4

to bring us answers, we’re looking for all the right 5

questions to ask so that we move forward with the most 6

comprehensive set of information that we can. 7

It’s also really important to me that our topic 8

today addresses an issue that is personally very important 9

to me which is environmental justice. Broadly, DTSC has 10

embraced environmental justice and our obligation to protect 11

all Californians regardless of their income status, their 12

ethnic background, or any of the other factors that makes 13

each and every one of us unique. 14

In this particular instance, the people who likely 15

bear the most significant exposure to these products are 16

largely immigrants. These are women, many of whom speak no 17

English. They come to us from Asian countries, they work in 18

shops where they are potentially exposed all day long and 19

have not always had the best recourse to have their concerns 20

heard and addressed. And this is an opportunity for all of 21

us to try to understand those concerns, to look at the tools 22

that we have to address those concerns, and to give them 23

protection that they deserve. And it isn’t clear to me yet 24

what shape that’s going to be. I don’t think the staff I 25


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have working on this issue know yet what shape that’s going 1

to take. But we do know the most critical first step is 2

listening and understanding and being receptive to an entire 3

range of opportunities that are out there for us to be 4

proactive and be protected. 5

Again, I am so happy that all of you are here, 6

that those of you who are participating via the webinar are 7

putting the time into this effort. We want to move forward 8

with as big of a tent as we can and with the best possible 9

information. Thank you for helping us to do that. 10

MS. RUBIN: Thanks, Barbara. 11

Our first two speakers of the day are -- are a 12

part of our DTSC team and we’re going ask you -- we’re going 13

to have an opportunity for questions and comments following 14

their presentations, but we’re going to ask you to hold your 15

comments until both of the presenters have finished. 16

First up we have André Algazi, he’s the lead for 17

the chemical product evaluation team here. And he’s going 18

to give you an overview of the Safer Consumer Products 19

Program and the nail products efforts that we’ve been 20

undergoing here. 21

MR. ALGAZI: Hi, good morning. Thank you all 22

again for being here. And welcome. 23

As Marcia just stated, what I’d like to do is sort 24

of provide a little bit of context for what we’re talking 25


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about today and today’s agenda. And I wanted to start by 1

reminding us of the regulatory framework for Safer Consumer 2

Products. Many of you will be familiar already and it would 3

just be sort of a reminder. For those of you who aren’t, 4

it’s a very brief introduction. 5

We’re working under the framework of the Safer 6

Consumer Products regulations, and there are four elements 7

of that framework. The first is Candidate Chemicals, and 8

the regulations themselves contain a compilation of 23 lists 9

of chemicals that have been identified based on either their 10

hazard traits, for example IARC carcinogens. And there’s 11

also a group of lists that are included because of their 12

chemicals that have been identified for exposure potential. 13

For example, the Biomonitoring California list of priority 14

chemicals. There are 23 lists, 15 of the hazard lists, 15

hazard trait chemicals, and 8 that are based on exposure 16

potential. 17

The second element of the regulatory framework is 18

Priority Products and that’s really where we are right now. 19

We’re in somewhat early stages of identifying our next 20

possible Priority Products. And I’ll talk a little bit more 21

about that element in a moment. 22

And then thirdly, once we’ve identified a Priority 23

Product and adopted regulations to list it formally as a 24

Priority Product, the manufacturers of that product are 25


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required to conduct an Alternatives Analysis in which they 1

identify potentially safer alternatives to using the 2

Chemical of Concern and sort of answer the question, is it 3

necessary to use this chemical or not. 4

And then, finally, the fourth element is the 5

regulatory response element, in which the regulations 6

provide a menu of options. And it really is dependent on the 7

Alternatives Analysis, what the alternatives identified 8

were, what the factors that were compared, and what the 9

outcome of the analysis is. As Director Lee said, we really 10

haven’t identified the products yet and even if once we do, 11

we won’t have a predetermined regulatory response in mind. 12

In this second of the four phases, we are working 13

under our three-year work plan and the regulations say that 14

every three years we adopt a work plan that identifies the 15

categories from which we will choose Priority Products 16

during that three-year cycle. 17

With the current work plan, we’re in year three of 18

the 2015 to 2017 Priority Product work plan. There are five 19

policy priorities that we used and we’ve identified seven 20

product categories in the work plan. And for each of those 21

product categories, we provide some example chemicals that 22

we identify. It is not an all-inclusive list of all the 23

Candidate Chemicals that might be in the product categories, 24

but some examples. 25


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The regulations provide the overarching criteria 1

for how we select a Priority Product -- the key 2

prioritization principles. And, they are, that whatever the 3

Priority Product is, there needs to be potential for 4

exposure to the Candidate Chemical in the product. And 5

secondly, there has to be potential for that exposure to 6

contribute to or cause significant or widespread adverse 7

impacts. That’s the overarching principle. 8

That’s a really brief overview of the regulatory 9

framework. Now I want to talk a little bit about why we are 10

talking about nail products today. And really our interest 11

in products in this category is not new, we’ve had a number 12

of activities around nail products, most recently in 2012, 13

and Dr. Sciullo will talk a little bit more about this. We 14

undertook an investigation in which we took some samples and 15

distributors in the Bay Area of products including ones 16

claiming to be free of certain chemicals and did some 17

analytical testing and found that a number of the products 18

claiming not to contain formaldehyde, toluene, or dibutyl 19

phthalate actually did sometimes contain one or more of 20

these chemicals. And we also, at that time, detected some 21

of the other chemicals that are now on our Candidate 22

Chemicals list in those products. 23

Currently, we have some new legislation that we’re 24

involved with which is Assembly Bill 2125, “The Healthy Nail 25


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Salon Recognition Program.” And this bill calls upon DTSC 1

to develop guidelines for local healthy nail salon 2

recognition programs that include things like best 3

practices, chemicals that they shouldn’t used if they want 4

to be certified, things like that. We have a January 1st, 5

2018 deadline to complete these guidelines. We’re also 6

going to be working with existing local healthy nail salon 7

recognition programs. And we’re also going to be working on 8

some outreach elements. 9

If you’re interested in that effort, it’s not 10

directly related to the Safer Consumer Products framework 11

but, because it affects the same set of products we’re 12

talking about today, I wanted to mention it. And there’s a 13

link to the actual legislation at the bottom of this slide. 14

There are a couple of other recent bills that were 15

also signed in 2016 related to nail salons having to do with 16

information availability to employees and language access. 17

These are the two bills, AB 2437 and 2025. And, again, I’ve 18

included links to those two. 19

I mentioned that our Priority Product work plan 20

has seven product categories which are shown on this slide. 21

And the nail products fall into this one, the beauty, 22

personal care, and hygiene products. It’s a subset of that 23

category. 24

And I also mentioned the five policy priorities. 25


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And at least four of those five policy priorities which we 1

used in selecting the categories in the work plan and that 2

we’re using as we look at personal care, beauty, and hygiene 3

products now have been met. Products where there’s clear 4

pathway to exposure to a Candidate Chemical which we’ve 5

found that there is for products in the nails category. 6

Products that contain chemicals which are found in indoor 7

air and dust and that’s also the case for this group of 8

products. Products containing chemicals detected in 9

biomonitoring studies is the third policy priority. And 10

products that have a potential to impact workers and 11

children. At least four of these policy priorities are met 12

by nail products. 13

The scope of our conversation today in our 14

presentations is the broad range of nail products including 15

ones for home use as well as salon. We’re seeking 16

information on what the chemicals are, their toxicity, and 17

their potential to expose people. We’re interested in 18

formulations, especially products that have claims of being 19

free of certain chemicals and what the alternative chemicals 20

might be. And we’re also interested in what initiatives 21

have been undertaken by industry manufacturers to improve 22

the safety of nail products. 23

We are looking for information on the use of these 24

potentially hazardous chemicals, what their functions are, 25


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how prevalent they are, what the safer alternatives or 1

potentially safer alternatives are either under development 2

or already in use. And as the director said, another major 3

goal today is to facilitate dialog among experts from all of 4

the different sectors that make up our group of 5

stakeholders. 6

We know that the landscape of nail products is 7

changing and has been over the last number of years, and 8

we’ve noted that a number of products are making claims of 9

being free of various chemicals, I mentioned the 3-free 10

earlier which were products purportedly free of dibutyl 11

phthalate, toluene, and formaldehyde. There are also now 12

products claiming to be free of 3, 4, 7, and 9 different 13

chemicals, and 10. And, again, Dr. Sciullo will give a 14

little more information about those. 15

Again, we’re interested in what’s being used to 16

replace these chemicals when they’re free of them. And are 17

they Candidate Chemicals and what do we know about their 18

safety relative to the chemicals that have been removed. 19

Again, in the four steps or the four elements of 20

the regulatory framework, we’re really in the second one 21

which is Priority Products. And we’re kind of ending our 22

public engagement phase, although it’s not over yet. We’re 23

actually going to be accepting information and comments 24

through the 17th of March. The deadline was February 28 and 25


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it’s been extended to the 17th of March so if you have 1

information or comments you’d like to share with us through 2

our Web portal CalSAFER, you still have a couple more weeks 3

to do that. 4

We started off this phase with our webinar on the 5

15th of November, and published our background document and 6

our stakeholder questions, so this has been ongoing for a 7

number of months. Based on the information that we get from 8

all of you and other venues, we will be refining our 9

research topics to look at this category through the lens of 10

those key prioritization principles, potential for exposure 11

and potential for exposure to contribute to or cause adverse 12

impact, and identifying products that might be potential 13

Priority Products. 14

Again, once we’ve made those kinds of 15

identifications, we would then embark on a rulemaking 16

process which is a public process. We are still early in 17

this second of the four stages of the process. 18

We do want to stay engaged with all of you and 19

this slide and the next one have some contact information. 20

If you’d like to follow our future public engagements, 21

announcements, things like that, you can subscribe to our e-22

list, there’s a link on this slide. We have a dedicated 23

Safer Consumer Products email box that can be used for 24

questions and inquiries, you can contact our Public 25


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Information Officer Ben Edokpayi. If you’re from the media 1

and you’d like to make an inquiry. You can contact me or 2

Christine Papagni with technical questions and Heather 3

Kessler if you’d like to request a meeting. 4

And, again, we’ve extended the deadline for 5

submitting information and comments through CalSAFER to 6

March 17th. And this slide also has a link to the CalSAFER 7

portal. 8

Again, I thank you for being here, for engaging 9

with us, for sharing your knowledge and expertise. I’ll 10

hand it back to Marcia. 11

MS. RUBIN: Now I’m going to cue up the next 12

presentation. The next speaker from DTSC is one of our 13

Ph.D. staff toxicologists. He is going to discuss in more 14

detail the potential health and safety impacts of chemicals 15

in nail products. And, with that, Dr. Eric Sciullo. 16

DR. SCIULLO: Thank you, Marcia. 17

Good morning. And welcome to this part of the 18

workshop entitled, “Potential Health and Safety Impacts of 19

Chemicals in Nail Products.” 20

I’d like to start with a little bit of an overview 21

in terms of how we’ve arrived at the place where we’re at 22

today and I’ll be going into these bullets with a little bit 23

more detail as we move forward in the talk. In 2012, DTSC 24

was involved in a sampling study of nail products looking at 25


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ingredient claims and seeing what exactly the constituents 1

turned out to be. Following after that, there were a number 2

of articles that came out that garnered national interest in 3

this topic, most notably one from the New York Times which 4

highlighted exposure concerns to workers to chemicals within 5

nail products. 6

In addition, in recent years, a number of healthy 7

nail programs have been established throughout the state of 8

California and multiple counties. And here we are, with 9

DTSC’s Safer Consumer Product initiative which has given us 10

the capability to evaluate chemicals across a wide variety 11

of categories in terms of potential hazards and exposure. 12

And as André just mentioned, a number of legislative bills 13

have recently passed in the state of California, most 14

notably AB 2125--“The Healthy Nail Salon Recognition 15

Program.” And finally, our stakeholder engagement efforts 16

which is where we’re at right now and we hope to have a nice 17

discussion here. 18

In 2012, DTSC underwent a nail product sampling 19

study. It was limited in scope to salon products from San 20

Francisco Bay area distributors and no retail products were 21

sampled. The samples were randomly collected and there were 22

25 samples taken. Approximately half, 12 of the 25 products 23

claimed to be free of at least one of the toxic trio 24

chemicals. And the toxic trio refers to formaldehyde, 25


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toluene, and dibutyl phthalate. And I’ll get into those 1

more soon. 2

Ten of the 12 products with toluene-free claims 3

contained toluene as high as almost 18 percent. Some 4

products claiming to be free of toxic trio had actually high 5

detections of dibutyl phthalate compared to products that 6

weren’t making any such claims. And, finally, triphenyl 7

phosphate was identified in some products as a chief 8

alternative plasticizer for dibutyl phthalate. 9

DTSC’s current efforts on nail products were 10

initiated by the 2015-2017 Priority Product work plan under 11

the general category of beauty, personal care, and hygiene. 12

We were able to evaluate chemicals in nail products and 13

quickly identified the obvious toxic trio formaldehyde, 14

dibutyl phthalate, and toluene. In addition, a number of 15

other Candidate Chemicals exist that may or may not be 16

within nail products and are potentially of interest and of 17

concern. 18

SWhy nail products? Well, there’s a wide variety 19

of chemicals and an incredible array of categories. And in 20

particular, we have concerns regarding salon workers and 21

also consumers. But nail salon workers in particular 22

because overwhelmingly a majority of salon workers are women 23

of color and reproductive age and they represent an 24

important niche market for Vietnamese immigrant workers. 25


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And as a result, they often have language barriers, limited 1

education on chemical exposure from products, limited use 2

and/or vulnerability of personal protective equipment, and 3

they often work in excess of 8-hour days and 40-hour 4

workweeks. In addition, pregnant women and children are 5

also of concern with regard to nail product. 6

The exposure potential of these chemicals varies 7

depending on the chemical and the product, but most products 8

contain volatile chemicals which have the potential to off-9

gas into indoor air and be a potential inhalation exposure 10

concern for humans. Also, these products can contain 11

chemicals that may be absorbed dermally across the skin. 12

Exposure is likely affected by poor ventilation or lack of 13

personal protective equipment, long workdays and weeks, 14

number of clients in a given day or week, weather 15

conditions, building properties, and there’s a wide range of 16

product types and categories; so, obviously, this will 17

influence exposure. 18

What types of products? Well, this list, 19

includes, but is not limited to, nail polish and coatings, 20

base adhesives, nail hardeners, nail conditioners, 21

artificial and gel nails, nail product thinners, nail polish 22

removers, and nail art. 23

Here is a summary table describing the toxic trio 24

of chemicals and triphenyl phosphate which was one of the 25


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chief alternative plasticizers for dibutyl phthalate that 1

was identified in our 2012 sampling study. And, I’m going 2

to go into these in more detail here, but I just put them up 3

here to get an overhead view. 4

I’d like to start with formaldehyde. Formaldehyde 5

is used as a preservative, an antimicrobial, and a nail 6

hardener in select products. The FDA has set a 7

concentration limit at 5 percent for nail hardeners. It’s a 8

human carcinogen, a respiratory toxicant, an eye irritant, 9

and can initiate dermal or allergic reactions in some 10

populations. 11

What is formaldehyde? Formaldehyde has a complex 12

history in terms of how it’s described and even the 13

terminology in the language. I think it’s worth kind of 14

going into what is formaldehyde exactly. 15

Formaldehyde is a gas, first, at room temperature. 16

And it’s highly reactive with water. When it reacts with 17

water, it forms methylene glycol. And methylene glycol has 18

distinct physical-chemical properties from formaldehyde; 19

however, the U.S. EPA, ATSDR, the FDA, and the Scientific 20

Committee on Consumer Safety treat them interchangeably with 21

respect to labeling, exposure, and hazard. Formalin is 22

another name you’ll see used to describe formaldehyde and 23

formaldehyde-type solutions. It’s an alternative name for a 24

percent solution of methylene glycol, and I think has its 25


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genesis within laboratory sciences. 1

There are also formaldehyde releasers and there 2

are also tosylamide formaldehyde resins which are related to 3

formaldehyde but they are also very distinct in their own 4

right. Again, their purpose is usually to release or 5

provide some sort of long-term preservative for product 6

stability. 7

I’ve created some questions of interest that I I 8

don’t really expect to be answered, but I hope that maybe 9

they’ll come up through the course of the day through 10

discussion, but these are some of the topics of interest 11

that we have. Hhow is formaldehyde added into nail products 12

and at what concentrations? Does free formaldehyde escape 13

from nail products into indoor air, and at what expected 14

concentrations? Does it escape from the product once the 15

solution as formalin or methylene glycol? 16

And, again, does it release from these 17

formaldehyde releasers or the tosylamide formaldehyde resins 18

into indoor air at what expected concentrations? And, 19

finally, to what extent is formaldehyde still being used in 20

nail products? What alternatives are currently being 21

considered or used or evaluated? 22

Next is toluene. Toluene is used as a solvent in 23

nail products for ease of application. It’s also often 24

added as a thinner to products at the nail salons at the 25


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time of consumer application. It’s a developmental 1

toxicant, a neurotoxicant, and it’s volatile with potential 2

human inhalation exposure. 3

Is toluene still used in nail products and at what 4

concentrations? How much thinner is added into these 5

products at the nail salons at the time of application? And 6

what ends up being a rough final toluene product 7

concentration? Are workers who add toluene-based solvents 8

at the salon being exposed to a higher dose of toluene than 9

anticipated? How are nail products formulated that result 10

in the need for a toluene-base thinner to be added at the 11

salon? 12

Next is dibutyl phthalate. And dibutyl phthalate 13

is used in nail polish as a plasticizer, typically in 14

concentrations at less than 10 percent and reduces cracking 15

by making the nail polish less brittle. It’s a reproductive 16

toxicant and a developmental toxicant with potential 17

endocrine disrupting action. It also has a cumulative 18

contribution with other phthalates in terms of their toxic 19

mode of action. Unlike the other two chemicals of the toxic 20

trio, dermal exposure is of more concern as opposed to 21

inhalation concern, and it’s been banned for use in 22

cosmetics in the European Union. 23

Is there any evidence that indicates human 24

exposure to dibutyl phthalate from nail care products? What 25


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plasticizer alternatives are being used for dibutyl 1

phthalate? Is triphenyl phosphate the preferred plasticizer 2

alternative? Or are others equally effective and in use? 3

Are there alternative assessments for nail polish 4

plasticizers available? 5

And, finally, I’ve also included a slide here for 6

triphenyl phosphate. Triphenyl phosphate is used also as a 7

plasticizer in nail products and is a common alternative to 8

dibutyl phthalate. It’s a potential endocrine disruptor and 9

a potential reproductive toxicant and dermal exposure is of 10

the most concern due to its readily absorption across the 11

skin. What is its frequency of use in nail products and are 12

they alternatives for triphenyl phosphate? 13

This table is put together based on some 14

reporting. The toxic trio viageneral consensus, is being 15

phased out of nail care products. However, according to the 16

Environmental Working Group’s Skin Deep database and the 17

California Department of Health Safe Cosmetics database, a 18

number of products, nail products, have been identified to 19

still contain these chemicals. We obviously are interested 20

in whether these chemicals are still being used in products? 21

What is the future trajectory for these chemicals in 22

products? How does the future look with respect to their 23

use and potential alternatives. I’ve also included a couple 24

of links here to these databases for your own interest. 25


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Here’s a list of additional Candidate Chemicals 1

believed to be present in nail products. It was compiled 2

from the California Department of Public Health Safe 3

Cosmetics database as known or suspected to cause cancer, 4

birth defects, or other reproductive harm as well as the 5

chemicals that were identified during DTSC’s 2012 sampling 6

study. It is not considered to be a comprehensive list of 7

chemicals detected in nail products. It’s simply a starting 8

point for our conversation regarding what types of chemicals 9

may be in nail products and if they pose any potential risk 10

or hazard or exposure potential to humans. 11

As a result, I’ve also included a bullet marked as 12

“others” to capture any potential chemicals or Candidate 13

Chemicals that may be in nail products but may not be 14

included in this initial list. Once again, I provided some 15

source link information. 16

Where is the market going, and what are the 17

regulatory trends with respect to nail products? Recently 18

there’s been an incredible public interest in safer 19

products. And California has engaged in voluntary healthy 20

nail salon programs throughout the state and through 21

multiple counties. In addition, Walmart has asked suppliers 22

to remove the toxic trio of chemicals from their supply 23

chain. And Target has just initiated a new chemical 24

strategy where they hope to have removal of phthalates and 25


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formaldehyde from products by 2020. 1

In addition, there are a number of products 2

designated as “free,” such as the 3-free, 5-free, 7-free, 3

and 9-free nail products. These products do not reportedly 4

contain the toxic trio and other potential Candidate 5

Chemicals or other potential chemicals of interest. And 6

I’ve adapted this table from Dr. Ceballos’ poster 7

presentation on the types of chemicals that are in these 8

nail products marketed or advertised as free. And I’m sure 9

she’ll talk about this in more detail, but I think the real 10

purpose here of this slide is to indicate DTSC’s interest in 11

alternatives. What types of chemicals are being used in 12

place of these ten here that are looking to be replaced in 13

terms of 10-free marketing or 3-free marketing? What types 14

of other options exist? What benefits do they offer and 15

what obstacles exist? 16

In summary, DTSC is seeking input from 17

stakeholders and moving forward on chemicals in nail 18

products due to the hazard traits associated with the toxic 19

trio and the awareness that there are other Candidate 20

Chemicals in nail products, the potential exposure and 21

adverse impacts to workers and consumers in California, 22

especially to pregnant women and children, and the 23

associated nail salon worker safety legislation. 24

Thank you so much for your attention and I’ll hand 25


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it back to Marcia. 1

MS. RUBIN: Okay. Thank you. 2

We have about 20 minutes now to take questions or 3

comments on the presentations that you’ve just heard. We’ll 4

start with people here in the room and then move to people 5

participating remotely. 6

MS. PORTER: I really appreciated that 7

presentation, Eric, and I’m wondering, are slide 8

presentations going to be available? Because there were a 9

lot of great slides in there that I know that we at the 10

Collaborative would love to have available to us. 11

MS. RUBIN: I’m just going to repeat the question 12

for the benefit of the people participating online. Her 13

question was: Will the slide shows be available? 14

MS. PAPAGNI: Yes, all the slides will be posted 15

on the DTSC website after the workshop. 16

And, if each person could say your name and your 17

organization before you state a question or comment,that 18

would help us. 19

MS. PORTER: Okay. 20

MS. PAPAGNI: Especially for our court reporter. 21

MS. PORTER: If I could have a quick follow-up 22

question. This is Catherine Porter with the California 23

Healthy Nail Salon Collaborative. 24

On the one slide with the “Xs,” the grid of the 3-25


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free, 4-free, 5-free, there were some squares that were 1

green, what did the green squares mean? 2

DR. SCIULLO: I didn’t go into it as much because 3

I have a sense that Dr. Ceballos is going to talk about it 4

more, but the purpose of that was to show that once you get 5

past 3-free and 5-free, there’s not a real standardization 6

in terms of what those ingredients are. So in some 7

products, 7-free is different from 7-free that you may see 8

in another product and those chemicals may swap. That’s 9

what the color coding was trying to show in that case. 10

MS. PORTER: I see. Thank you. 11

MS. RUBIN: Okay. In the back, please. 12

DR. PEREZ: I’m Angie Perez, I’m with Cardno 13

ChemRisk, and I just had a quick question about your 14

Candidate Chemicals. I know we talked about this a little 15

bit in the November meeting, but I noticed that, for 16

example, retinyl palmitate which is Vitamin A1 supplement. 17

I’m just curious, are you planning to pare those down a 18

little bit more or is this the final list? 19

DR. SCIULLO: No, I wouldn’t say this is final. 20

It’s quite the opposite; it’s just an initial starting 21

point. The Candidate Chemical list that I showed up there, 22

it was a simple, compilation of source information. We 23

haven’t made any informed decisions around those chemicals, 24

we haven’t done any paring down yet, but those kinds of 25


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actions and decisions will be taken as we move forward, 1

depending on the input and the research that we gather. 2

DR. PEREZ: Okay. 3

MR. ALGAZI: I’ll add something to that. 4

The Candidate Chemical list was -- this is André 5

Algazi for those of you on the Web. 6

The Candidate Chemicals list is incorporating 7

external lists that were generated by various authoritative 8

bodies; some of them are governmental or international 9

organizations. Depending on how you count them, there are 10

several thousand chemicals included on that list. Some of 11

them are part of groups, some of them are listed 12

individually on one or more of the constituent lists that 13

make it up. This list was drawn from the compiled lists of 14

Candidate Chemicals that is posted on the website. I think 15

Eric is just listing them to say these are things that 16

appear on the list for whatever reason that have been 17

detected or that we’ve had information suggesting are in or 18

have been in nail products. 19

Whether or not all of these are of particular 20

interest, we haven’t made that determination. But the 21

Candidate Chemicals list is what it is and there are several 22

thousand chemicals on it. 23

MS. RUBIN: For people listening in, her question 24

was whether the list that Eric showed earlier in his 25


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presentation, is the final determination. 1

Angie, did you have a follow-up question? 2

DR. PEREZ: I did. 3

MS. RUBIN: Okay. 4

DR. PEREZ: Unless somebody else has one. 5

I was just curious, a couple of these chemicals, 6

like carbon black and titanium dioxide, are you going to be 7

distinguishing in any way between nano scale and non-nano 8

scale? 9

MR. ALGAZI: We haven’t made any decisions about 10

whether or how we will focus on those chemicals or whether 11

we’ll focus on nano versus larger, it’s really just here’s 12

some things that we’ve found, information we found, in nail 13

products. If we should be focused on nano scale, then that 14

would be good information. 15

DR. SCIULLO: I would say that if those things end 16

up becoming significant and on our radar for further work, 17

then those types of issues and questions will likely arise. 18

MS. RUBIN: All right. For those people listening 19

in, her question was about whether we would distinguish 20

between nano scale and non-nano scale chemicals when it 21

comes to the Priority Products. 22

I saw your hand go up on this side. 23

MS. MONTGOMERY: Katherine Montgomery from Coty. 24

You mentioned a lot about hazard, but you discuss 25


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a lot about risk. When you’re looking from a safety 1

assessment standpoint, you need to weigh hazard versus risk, 2

so how is that being taken into consideration during their 3

review of Candidate Chemicals? 4

MS. RUBIN: For those of you listening in online, 5

her question was about hazard versus risk and how we take 6

that into consideration. 7

MR. ALGAZI: This is Andre again. And the 8

framework of our Safer Consumer Products regulation is not a 9

risk assessment framework. It’s looking at the hazard and 10

the potential for exposure and the potential for adverse 11

impacts. We don’t have a system whereby we calculate the 12

risk posed by an exposure and then determine whether it’s 13

above or below some threshold, there’s not an algorithm for 14

determining an acceptable versus unacceptable risk, that’s 15

just a different sort of paradigm that we’re working in. 16

But we do definitely have those criteria that I 17

showed my slide which there has to be potential for exposure 18

and potential for the exposure to contribute to or cause 19

significant or widespread adverse impacts. 20

It’s a more narrative approach, but if there’s no 21

adverse impacts, then we wouldn’t choose to focus on that 22

particular chemical-product combination. 23

DR. SCUILLO: And one thing to add, if there are 24

risk assessments done on particular chemicals or products or 25


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exposure scenarios available, obviously we’ll be considering 1

those as part of our evaluation. 2

MS. MONTGOMERY: So, for example, almost all of 3

your Candidate Chemicals have been safety assessed by 4

outside agencies. 5

DR. SCIULLO: Right. And those types of 6

assessments will be part of our evaluation. 7

MS. MONTGOMERY: Okay. Thank you. 8

MS. RUBIN: Yes. 9

DR. POWDER: So I have a question for Doctor -- 10

MS. RUBIN: State your identification. 11

DR. POWDER: Oh, I’m sorry. Jill Powder from 12

Environmental Health Decisions. 13

I have a question for Dr. Algazi. Is that right? 14

MR. ALGAZI: It’s mister, but yeah. 15

DR. POWDER: Mister. Okay. 16

MR. ALGAZI: But thank you. 17

DR. POWDER: At least I errored in the right 18

direction. 19

You had mentioned something regarding program 20

guidelines for cities and counties. And I was wondering 21

what the logistics of that would be. Would that be 22

something that a CUPA would get and then they would be 23

responsible for implementing those programs in local nail 24

salons or what is that about? 25


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MR. ALGAZI: Under this legislation, AB 2125, 1

we’re directed to develop guidance and collaborate with 2

Department of Public Health and somebody else and -- 3

DR. SCIULLO: BBC and OSHA. 4

MR. ALGAZI: Yeah. And OSHA. Barbering and 5

cosmetology. We’re supposed to collaborate with some other 6

agencies, with local agencies that already have a program, 7

so that the overarching goal is to have more standard 8

definition of what it means to be a healthy nail salon, to 9

have some understood standards. It’s not an enforcement-10

related program; it’s a program where the salons would seek 11

recognition. I don’t think the CUPAs are directly involved 12

in this -- implementing this legislation. 13

DR. POWDER: I see. So, the salons would seek 14

recognition as part of this program and they would get some 15

kind of a seal, so consumers could see this is a healthy 16

salon -- 17

MR. ALGAZI: Right. 18

DR. POWDER: -- is that the goal? 19

MR. ALGAZI: Yes, and the consumers would have 20

some understanding of what it means when they see that 21

because there would be some sort of criteria that have been 22

defined. 23

DR. POWDER: Great. 24

MS. RUBIN: Did you want to -- Catherine, did you 25


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want to add anything to it? 1

MS. PORTER: Yes, this is Catherine Porter with 2

the California Healthy Nail Salon Collaborative. 3

The Collaborative, along with some of our county 4

and agency partners, some of whom are here, have been 5

developing these programs over the last five or seven years, 6

and they’re local voluntary programs that are implemented by 7

local entities by cities and counties or cities or counties. 8

And they run basically like green business programs do. You 9

have to meet certain criteria and then you’re recognized and 10

then you can use that for marketing reasons. 11

Those have been in existence already and the 12

involvement of DTSC is going to hopefully give it an extra 13

boost and some additional sets of eyes to look at the 14

guidelines and to help with notifying and telling consumers 15

about these programs. 16

DR. POWDER: Where would one start to see if their 17

city or county has something like this going on? 18

MS. PORTER: Well, there are City and County of 19

San Francisco, San Mateo County, Santa Clara County, Alameda 20

County, and the City of Santa Monica, those are the existing 21

programs. 22

DR. POWDER: Oh, okay. 23

MR. ALGAZI: Part of what we will be doing is some 24

outreach and education. Once we’ve carried out what we’re 25


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supposed to do under this bill, there will be more 1

information available on our website. 2

DR. WILLIAMS: Over the course of the next year, 3

you’ll start to see the information about how municipalities 4

can get involved, but we’re just in the very early days of 5

mapping out the plan for implementing. 6

MS. RUBIN: Angie. 7

DR. PEREZ: Oh, sorry. 8

MS. RUBIN: It’s okay. 9

DR. PEREZ: Angie Perez, Cardno ChemRisk. 10

I was curious about that plan, because one of the 11

things that I have noticed is that there’s a severe lack of 12

any kind of consistent epidemiology data that would suggest 13

that nail salon workers are at increased risk. Is part of 14

this plan to also include some sort of biomonitoring or is 15

there any kind of disease reporting pathway for these 16

workers? 17

MS. RUBIN: So her question was: Are 18

epidemiological studies and biomonitoring being considered 19

for our plan going forward. 20

DR. WILLIAMS: This is Meredith Williams and there 21

were no provisions for that in the law and no resources 22

provided for being able to conduct that. I think it would 23

be fantastic to be able to do that but we just don’t have 24

the resources. 25


(510) 313-0610

Catherine, am I right? 1

MS. PORTER: There has been one small follow-up 2

study to the program in San Francisco, and it did show that 3

healthy nail salons did have lower amounts of I believe 4

toluene in the air. And there also have been biomonitoring 5

studies of nail salon workers that do show an increased 6

level of dibutyl phthalate via biomonitoring programs. 7

There is already some evidence of exposure and there’s 8

evidence of harm from those chemicals. 9

DR. PEREZ: Evidence from those chemicals as they 10

relate to nail products or for those chemicals as they 11

relate to animal studies? 12

MS. PORTER: There has been no, as far as I know, 13

probably the kind of study you’re looking for. We’d love it 14

if someone would finance a study like that. Maybe industry 15

could help us with that. 16

MS. RUBIN: Okay. Do we have any more questions 17

or comments from anyone in the room? 18

Okay. Via webinar? 19

MR. JOELSON: No questions at this time. 20

MR. RUBIN: Okay. In that case, we’re going to 21

take our break a little bit early. We’ve scheduled a break 22

until 10:15. We will start promptly with our next 23

presentation at 10:15, so please be back in the room with 24

enough time to get going and settle down. 25


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MR. ALGAZI: Thanks. 1

MS. RUBIN: Thank you. 2

[Whereupon a recess was taken at 9:53 a.m.] 3

[Whereupon the workshop resumed at 10:16 a.m.] 4

MS. RUBIN: I’d like to introduce our next 5

presenter, who’s presenting remotely. It’s Diana Ceballos. 6

She’s a Ph.D. She’s a visiting scientist at the Harvard 7

T.H. Chan School of Public Health. And her presentation is 8

called, “Evaluating Product Labels and Ingredient 9

Composition of Nail Polishes to Inform Safer Alternatives.” 10

Please give your attention to Diana Ceballos. 11

DR. CEBALLOS: Hello, everyone. Can you see my 12

screen? 13

MS. PAPAGNI: Not yet, Diana. 14

MS. RUBIN: And if you could speak up, Diana, that 15

would help us a lot. Thanks. 16

DR. CEBALLOS: Can you hear me better? 17

MS. RUBIN: Yes. 18

MS. PAPAGNI: We can hear you better. We’re having 19

a technical issue on our end, so if you could just wait one 20

moment, we’ll let you know when your slides are up. 21

DR. CEBALLOS: Sure. 22

MS. RUBIN: Can everyone hear back there? 23

I’m also going to take this opportunity to ask 24

you, all of the speakers, to ask you to wait for me to 25


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repeat any questions that you receive so that the people 1

online can hear them. And, also, when you’re presenting, 2

try to speak up as much as you can. And if you’re 3

presenting from this room, please stand close to the podium 4

so that your presentation will be heard by everyone 5

participating remotely. 6

I think in just one second we’ll have your screen 7

up, Diana. 8

MR. JOELSON: There we go. 9

MS. RUBIN: Okay, so we’re ready for you, Diana. 10

Thank you for your patience everybody. 11

DR. CEBALLOS: Good afternoon. Do you hear me 12

okay? 13

MS. RUBIN: Yes. 14

DR. CEBALLOS: Great. Thank you for the 15

invitation to your webinar. I would like to acknowledge my 16

coauthors Anna Young, Joseph Allen, and Thomas Webster. And 17

I would like to make a brief introduction of the nail salon 18

industry and its chemical hazards, very briefly, about 19

current studies and some preliminary results presented by 20

Anna Young, our graduate student here, and a little bit of 21

our future studies in mind. 22

As you all know, the nail salon industry has had a 23

booming in the last decade. It is estimated that it’s a $9 24

billion industry and it has at least 130,000 nail salons in 25


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the United States with 400,000 licensed nail salon 1

technicians. And there’s a revolution of nail procedures, 2

polishes, nail art, and brands that have been evolving, 3

including finishes that last much longer. And getting nails 4

done has become a staple of the youth culture. And what we 5

commonly knew as solid colors and French manicures have even 6

evolved into unique pieces of art on nails and a lot of 7

different options for colors. 8

The industry has workers that are vulnerable for 9

different reasons. First, they work in small businesses that 10

often have less resources and information on health and 11

safety. Most of the workers are female and young which 12

makes them vulnerable for reproductive health issues. 13

Majority are immigrants which create multicultural and 14

multilingual workplaces that also present challenges for 15

health and safety. Some of the workers have low education 16

and the licenses require limited training, not always 17

including health and safety. And they’re exposed to complex 18

chemical mixtures. 19

With little control including inappropriate use of 20

personal protective equipment, including surgical masks 21

which are not considered respirators like in the photo, 22

unfortunately, no gloves, even when policy has changed like 23

in New York, and little ventilation. 24

As most of you know, the New York Times did a 25


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series of articles exposing some of the hazards in the 1

workplace at least in the New York area and they highlighted 2

cases of women suffering reproductive health, cancer, lung 3

disease, nosebleeds, and skin conditions. But what was most 4

important of these articles was the acknowledgement of the 5

little health studies that have been done for this industry. 6

Even though there’s been just a few studies 7

because some of them have only approach cosmetology as a 8

whole and there’s only a few that do manicurists. Some of 9

the health concerns that happen most of the nail salon work 10

included skin irritations, respiratory conditions, headache, 11

neurological problems, and maternal complications. However, 12

more longitudinal studies are needed that have a strong 13

exposure of some of components to be able to understand 14

better how to prevent these problems from happening. 15

Some of the chemicals that are in these workplaces 16

include volatile organic compounds like solvent in the nail 17

polish removers and glues. Some of them include toluene, 18

acetone, formaldehyde that are toxic. Studies have assessed 19

exposure to volatile organic compounds and levels are often 20

below occupational exposure limits emitted by the strong 21

odors often caused by the alkaline. For example, toluene 22

mean air concentration is only 84 ppb, so they’re well 23

beyond regulation. However county health concerns then 24

start playing a role in these work populations. 25


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Exposure to volatile organic compounds is informed 1

because they can be a measure of ventilation in these 2

salons. For example, in a study in the Boston area, it 3

shows a level of total VOCs is associated with lower 4

ventilation. We’ve also known that most salons are usually 5

above the ASHRAE minimum ventilation requirements of 8600 6

ppm carbon dioxide. 7

Other chemical hazards include semivolatile 8

organic compounds. It’s specifically plasticizers in the 9

nail polish that include phthalates and other plasticizers 10

like triphenyl phosphate. 11

And few studies have assessed these exposures. 12

The conclusion on exposures to SVOCs from the few studies is 13

that definitely there is a workplace component to these 14

exposures; partly, because they’ve been clear, that air 15

concentrations of some of the solvent measures occurred in 16

nail salons compared to other indoor environments were 17

higher in salon workers compared to other workers and the 18

general population. And metabolites in urine increased 19

throughout the work shift. However, some of the solvents 20

are no longer added to the nail polish and this is why it’s 21

important to have more positive data before if starting 22

larger studies that include these exposure assessment 23

measurements. 24

For the plasticizers, one concern is potential 25


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dermal contact exposure and these have been highly neglected 1

in the literature, but there’s enough evidence that urine 2

metabolites in the urine decrease if workers use gloves or 3

for example if you are self-apply nail polish when you’re 4

using gloves, it decreases your exposure. 5

Another chemical concern is metal contaminants 6

which often comes from pigments in color like in red colors 7

and it may include some heavy metals that are also concerns 8

with reproductive and other health hazards. But there’s 9

definitely an increase in metallic and shimmer finishes that 10

could be increasing the levels of metal contaminants. Since 11

that has not been looked at, this is one of the key 12

questions that we’re asking in our studies. 13

In general, our studies are trying to understand 14

the exposures of chemicals that may affect reproductive 15

health, including VOCs, SVOCs, and metal contaminants, 16

understand how these metal chemicals get into our bodies, 17

both through inhalation and dermal absorption, and 18

understand sources of these chemicals. And today we’re going 19

to present some preliminary data on understanding sources of 20

the chemicals. 21

MS. YOUNG: In our conversations with nail salon 22

workers, we’ve learned that they state confusion about the 23

chemical ingredients in nail polish and how to choose safe 24

brands. We wanted to research the full ingredient 25


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compositions of various nail polishes as well as their 1

product labels to better understand the chemicals that 2

workers and consumers are exposed to. 3

We identified 20 commonly used nail polish brands 4

based on market statistics and visits to nail salons in 5

Boston. For each brand, we located Safety Data Sheets which 6

are chemical hazard information sheets required in nail 7

salons by the Occupational Safety and Health Administration. 8

We found that few salons listed these data sheets. Although 9

some manufacturers voluntarily provide a complete list of 10

ingredients, most only disclosed a handful of ingredients 11

that comprise more than one percent of the product, or more 12

than 0.1 percent. 13

A handful of the SDSs we looked at did not 14

disclose some ingredients in the composition section because 15

there are trade secret claims, as you can see in this 16

example on the bottom left. However, trade secrets have to 17

be well supported since they are not specifically claimed. 18

Finally, the SDSs were very difficult to track 19

down and frequently required us to contact manufacturers 20

directly. These three challenges can significantly limit 21

nail salon workers’ access to chemical hazard information. 22

We also tracked down consumer product ingredient 23

lists which are required by FDA for products marketed on a 24

retail basis to consumers, but not for products 25


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professionally used in nail salons. These ingredient labels 1

often provide much more comprehensive information. The 2

label on the bottom right lists the same product as the SDS 3

example but lists many more chemicals, demonstrating where 4

SDSs lack. 5

In our research of 20 brands, we found over 200 6

unique ingredients in nail polishes which make safety 7

evaluations difficult. There are also a couple of 8

limitations to these lists. Companies can list colorants 9

without providing specifics and can also list fragrance as 10

an ingredient, their trade secret concern. The plasticizer 11

dibutyl phthalate is one such ingredient that can qualify as 12

fragrance. 13

The good news is that companies have been 14

proactive about removing certain ingredients of concern. 15

We’ve seen many 3-free nail polish products emerge in the 16

last decade which are free of the toxic trio dibutyl 17

phthalate, toluene, and formaldehyde. As more ingredients 18

are found to have toxicity concerns, some companies have 19

transitioned to 5-free and even up to 10-free. 20

Because of the wide variety of product labels and 21

confusion about their definitions, we put together this 22

table. On the top are the product labels, from 3-free to 23

10-free. On the left are nail polish ingredients. And then 24

“X” indicates that the label reports the product to exclude 25


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that ingredient. You can visually see how the labels have 1

evolved over time, continually removing more ingredients. 2

3-free removes the toxic trio, 4-free also removes cancer, 3

5-free removes formaldehyde resin. 4

As new labels have emerged more rapidly, the 5

label definitions become less clear. The 7-free and 9-free 6

labels are defined differently by some companies. The 6-7

free nail polish has excluded nitrocellulose but none of the 8

later labels do. And although all exclude dibutyl 9

phthalate, only two labels exclude phthalates in general. 10

Some labels also address other types of 11

ingredients such as trace amount contaminations, fragrances, 12

and animal ingredients. These labels are important steps to 13

reducing nail polish toxicity, but they are not consistently 14

defined and the implications of each label for health are 15

not listed, making decisions by nail salon owners, workers, 16

and consumers difficult. Advertisements about “safe”, “non-17

toxic”, or “natural” nail polish can also potentially 18

provide false reassurances. 19

One concern about evolving labels that will be 20

important to address is regrettable substitution of 21

ingredients. Although none of our research products 22

disclose dibutyl phthalate, one of the toxic trio, 13 of the 23

20 disclose triphenyl phosphate, an alternative plasticizer. 24

Although there’s limited data about TPHP, it has been linked 25


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to endocrine disruption, reproductive and developmental 1

concerns, and skin sensitization. A few brands are now 2

reporting to be free of TPHP, as you may have seen in the 3

table, so we need to work to ensure the ingredient 4

substitutes are safe. 5

Another challenge with labels is quality. The 6

Department of Toxic Substances Control tested nail polishes 7

and found out the majority of 3-free or toluene-free nail 8

polishes did contain one of those ingredients, and often 9

even in higher concentrations. For example, in our table 10

here, you can see that median dibutyl phthalate 11

concentrations are higher for those with 3-free claims 12

compared to those without. For example, 76,000 ppm for 3-13

free polishes compared to 24,000 ppm. And similarly for 14

toluene. 15

We are currently conducting a couple of pilot 16

projects to determine exposure by nail salon worker space. 17

We are analyzing nail polish samples for plasticizers and 18

heavy metals which we will compare with SDS and label 19

information. We are also measuring solvents exposures 20

through blood, breath, and air samples. Plasticizer 21

exposures through urine, skin wipes, and air samples. And 22

heavy metals exposure through toenail samples and surface 23

wipes. 24

We hope these pilot projects inform future studies 25


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to assess the effectiveness of intervention to nail salons 1

to health effects of exposures in the importance of workers, 2

training, and outreach. We look forward to continued 3

efforts by industry, government, academia, and advocacy 4

groups to build on current progress on approving the 5

chemical safety of nail products. 6

Thank you. We’d like to acknowledge our sources 7

of funding and support. And we’ll have time for questions. 8

MS. RUBIN: We’ll take questions from anyone in 9

the room. Again, please let me repeat the question before 10

you answer it. Sir. 11

MR. SCHOON: Yes. My name’s Doug Schoon with the 12

Professional Beauty Association. I may have misunderstood 13

but it seemed like the insinuation was because a Safety Data 14

Sheet doesn’t contain all the ingredients on the ingredient 15

label, that Safety Data Sheet was missing information. And 16

I just want to make it clear that the Safety Data Sheet 17

doesn’t always contain all of the ingredients on the label. 18

Water would be a good example of what you won’t necessarily 19

see on the Safety Data Sheet even though it would be on an 20

ingredient list. 21

MS. RUBIN: Okay. So his comment -- it was a 22

comment? 23

MR. SCHOON: It’s more of a comment. 24

MS. RUBIN: Okay. His comment was about the Safety 25


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Data Sheet may not necessarily contain all of the data that 1

is on the label. 2

MR. SCHOON: And it would still be correct. 3

MS. RUBIN: But it would still be accurate. 4

DR. CEBALLOS: Correct. 5

MS. RUBIN: Okay. 6

DR. CEBALLOS: Yeah. 7


DR. CEBALLOS: We agree. Thank you for the 9

comment. 10

MR. SCHOON: I thought I just misunderstood. 11

MS. RUBIN: Okay. And it was also clarification. 12

Thank you. 13

All right. Yes? 14

Oh, also, can I make a note. If you’re sitting in 15

this U-shape area, it’s hit or miss with whether people can 16

hear you or not, so please speak up. Thank you. 17

DR. POWDER: Jill Powder with Environmental Health 18

Decisions. You were talking about some pilot studies being 19

done with regard to exposure. Who are those pilot studies 20

being done on and how are you getting volunteers or people 21

to be a part of those pilot studies? 22

MS. RUBIN: Jill’s question is about pilot studies 23

and the details of them. Where do the people come from that 24

participate in the pilot studies. And -- is that it? 25


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DR. POWDER: That’s pretty much it. 1

MS. RUBIN: That’s pretty much it. Okay. Thanks. 2

DR. CEBALLOS: Hi, this is Diana. We have three 3

ongoing pilot studies that are basically funding this, you 4

know, a main study. And we basically have ten nail salon 5

workers from the Boston area and we’re just recruiting 6

volunteers through our network. And we’re working with the 7

Massachusetts Healthy Cosmetology Committee, a stakeholder 8

group in this area to sort of help us promote this study. 9

Anna is doing more work and specifically with metals so that 10

may end up recruiting another ten. They are workers, so we 11

go to their nail salon for one day. 12

MS. RUBIN: Okay. I believe Karl has a comment or 13

question. 14

MR. PALMER: Yes. Thank you for your 15

presentation. This is Karl Palmer from DTSC. 16

My question is on the table that shows the various 17

3-, 5-, 7-, 9-, 10-free categories, my assumption is that 18

all of those chemicals serve some functional use in the 19

product. So my question is, have you gone the next step to 20

create a table which then sort of fills in comparing 21

ingredients from these products of what you assume might be 22

the specific chemicals which take the place of those 23

constituents which are not there? This is to get to the 24

question of, well, if you’re not using something, maybe 25


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that’s great, but what are you using instead for that same 1

function and do we have any assessment of those hazard 2

traits and potential challenges? 3

MS. RUBIN: Karl’s question was about the product 4

label table that Diana showed, and if there has been further 5

research determining what the substitutions for these 6

chemicals might be. 7

MS. YOUNG: Hi, this is Anna here. So we’ve been 8

putting together a database of the 20 nail polishes we 9

researched, it includes all the ingredients that are in each 10

of those products, and our research products include some of 11

the new safer alternatives. We’re trying to identify some 12

substitute plasticizers and other ingredients. 13

We’ve identified some plasticizers that seem to be 14

growing in popularity such as acetyl tributyl citrate and 15

some others, but we don’t have complete information on that 16

right now. But that’s a great point. Thank you. 17

MS. RUBIN: Yes. 18

MS. GRESS: This is Ky Gress from the Safer 19

Consumer Products Program. I was just curious if you’re 20

looking at any products that are specifically marketed to 21

children. 22

MS. RUBIN: Ky’s question was if you are looking 23

for any products specifically related to children. 24

MS. YOUNG: There are a couple of products. We’ve 25


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seen some labels saying safe for children or safe for 1

pregnant women. Although we haven’t found those to be 2

common, it is important to evaluate the implications of 3

those labels and what they mean for health. 4

MS. RUBIN: Thanks. Yes. 5

MS. BALKISSOON: Indira Balkissoon of AlterEcho. 6

I have a question about NMP. Are you seeing 7

anything in the nail polish removers, has that been showing 8

up at all? 9

MS. RUBIN: Her question was about NMP, and if 10

it’s been found in nail polish removers or elsewhere. 11

DR. CEBALLOS: Right now we have focused on the 12

preliminary data, and what we were showing is exclusive for 13

nail polish and we haven’t looked at removers. But actually 14

every time we’ve been to the nail salons which we visited, 15

six by now, they actually use pure acetone, almost 16

exclusively. Originally I was going to be more focused on 17

analysis of commercial removers, but my work is really with 18

the workers. So far, it’s not really a need and it may be 19

more for a project that focuses on consumers. But I’ll just 20

have to finish the rest of my nail salon visits to make that 21

determination. 22

MS. RUBIN: Okay. Thank you. 23

Any other questions or comments in the room? 24

Yes. 25


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MR. JOELSON: We have a question from the web. 1

MS. RUBIN: Oh. Okay. 2

MR. JOELSON: Mr. David Lennett asks, what is the 3

timeframe for completing the exposure studies, particularly 4

for the solvents exposures study? 5

MS. RUBIN: His question is about the timeframe 6

for completion of the solvent exposure study. 7

DR. CEBALLOS: Our ideal date is in April but with 8

another conflict in scheduling, it may be more like May. 9

But thankfully with solvent data usually we see the data 10

much quicker. I’m really hoping that that would move much 11

smoother in terms of publication and future grants. 12

The plasticizers lab analysis are more complex and 13

laboratories usually take much longer than that. Even if we 14

finish in the field soon, it would likely be more like next 15

year by the time we have things done. 16

MS. RUBIN: Great. Thank you. 17

Any other questions from our remote participants? 18

MR. JOELSON: No more questions. 19

MR. RUBIN: Okay. Anyone else in the room have a 20

question or comment? 21

Okay. Thank you so much. 22

We’re going to move to our next presenter, 23

Alexandra Scranton. She is also participating remotely. 24

She’s the Director of Science and Research for Women’s 25


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Voices for the Earth. And her presentation is, “The 1

Potential Hazards of Undisclosed Fragrance Chemical Exposure 2

in Nail Salons.” 3

So we’ll be moving the presentation control over 4

to her in just a minute. 5

Alexandra, are you on the line? 6

MS. SCRANTON: Yes. 7

MS. RUBIN: Okay. 8

MS. SCRANTON: Can you hear me? 9

MS. RUBIN: Yes, we can hear you. Just give me a 10

second to make sure that your presentation is cued up, okay? 11

MS. SCRANTON: Sure. 12

MS. RUBIN: Okay. We’re ready to go. Thank you 13

so much. 14

MS. SCRANTON: Okay. Terrific. Thank you so much 15

for letting me present. Again, I’m Alexandra Scranton, 16

Director of Science and Research for Women’s Voices for the 17

Earth. 18

For those of you who may be unfamiliar with my 19

organization, we are a women’s environmental health advocacy 20

organization that works to amplify women’s voices to 21

eliminate toxic chemicals that impact our health and 22

community. 23

We’ve been researching and working on the issues 24

of hazards to nail salon workers for over a decade and been 25


(510) 313-0610

particularly focused on hazards of fragrance for the last 1

several years. My presentation is on fragrance in nail 2

salons. 3

The first obvious question is: where are we seeing 4

fragrance in a nail salon? I think traditionally when we 5

think of hazards in a nail salon, we think of products like 6

nail polishes, top coats, acrylic nails, polish removers, 7

solvents, that kind of thing. These products while 8

occasionally are scented, novelty nail polish that smells 9

like strawberries, most of these are not scented. Where 10

you’re finding fragrances is in the pre-manicure and pre-11

pedicure application. It’s the lotion that gets rubbed on 12

your hands or on your feet. It’s the massage oils that get 13

used when you’re soaking your feet or your nails. Those 14

products have fragrance in them. They’re often advertised 15

as kind of aromatherapy, these products are technically 16

applied to your feet or your hands but it scents the whole 17

room and adds to this kind of spa experience. 18

These are the products that are used virtually on 19

every client that a nail salon worker works on so these 20

exposures are repeated numerous times per day, regardless of 21

the other service a customer is getting. And of course, as 22

has been discussed by other speakers, this work is 23

predominantly done without gloves, so there is significant 24

exposure to the nail salon worker. 25


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In addition, because there are so many other 1

odorous products associated with nail salon work, air 2

fresheners are commonly used throughout beauty salons in 3

effort to mask the odors of other products like acetone. 4

The fragrance is pumped into the air in salons. Similarly, 5

cleanliness and sanitation are real priorities and certainly 6

requirements in nail salons. The vast majority of cleaning 7

products and disinfectants used in salons are going to have 8

the light scent of something to try to make them more 9

pleasurable. These are also ongoing exposures throughout 10

the day as well. 11

Now when we talk about chemical exposures from 12

fragrance, keep in mind that fragrance doesn’t have to be 13

one simple chemical composition. Any one fragrance can be 14

made up of over a hundred individual fragrance chemicals. 15

And, unfortunately, due to long history of tradition in the 16

fragrance industry, these ingredients are generally not 17

disclosed. 18

Decades ago when this was first written into laws, 19

and as you see here where ingredients are required to be 20

disclosed, fragrance was allowed to be disclosed simply as 21

the word fragrance. And this tradition of a special 22

nondisclosure status for the fragrance industry has 23

continued unfortunately well past its usefulness, and I’ll 24

talk a little bit about that later. 25


(510) 313-0610

While we’re hampered by this kind of lack of 1

disclosure, we don’t have specific information about what’s 2

in an individual fragrance. What we do know about fragrance 3

comes largely from a list of ingredients voluntarily 4

disclosed by the International Fragrance Association, IFRA, 5

on their website, it contains just under 3,000 ingredients 6

currently used in fragrance. And I’ll call this list, the 7

IFRA list. 8

And from this list we can really learn something 9

about potential hazards that may be present in fragrance. 10

Specifically, when we look at the list, and perhaps most 11

relevant to the DTSC, there are 54 fragrance chemicals I was 12

able to identify on the IFRA list that are also on the 13

California Candidate Chemicals list. These are chemicals of 14

interest to the DTSC, for honestly a number of reasons. Any 15

of these 54 chemicals could be present and undisclosed in 16

any fragrance product; we just don’t know which product or 17

which chemical. 18

I decided not to create a slide for you with the 19

full list of 54 Candidate Chemical names, too hard to read, 20

but that full list is available on our website link below. 21

A few of the highlights of the kind of ingredients 22

you can find in fragrance, which are things like styrene, 23

parabens, pyridine, cresols, xylenes, phthalates, 24

nonylphenol, etc., 30 or 40 other chemicals. It's a 25


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significant list of chemicals with a host of potential 1

hazards including cancer and endocrine disruption, 2

environmental effects and more. 3

To give you another idea of the kind of chemicals 4

that can be present in fragrance, we also did an analysis 5

looking at the Globally Harmonized System, the GHS 6

classification for fragrance chemicals. These are kind of 7

the indications of how chemicals should be flagged or 8

classified on their Safety Data Sheets. 9

There are 190 fragrance chemicals that have been 10

assigned the signal word danger. Due to their 11

characteristics, over a third of fragrance chemicals have 12

been assigned the word warning. There are 44 that need a 13

skull and cross bones for acute toxicity, 97 require the 14

pictogram for being a hazard to human health. 15

This gives you some idea of the extent of 16

potential hazard in fragrances. These are the kind of 17

chemicals that we generally want to be aware of, they’re on 18

SDS sheets and we want to be aware of our exposure to them. 19

If you would like to see the list of these, you know, 20

chemicals, they’re also available on our website, it’s that 21

similar link from before, womensvoices.org/fragrance-22

ingredients. You can get all the lists and about ten others 23

will be cross-referenced the IFRA list with various other 24

lists, authoritative lists of chemicals and concerns. 25


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Given that there are a number of potentially 1

harmful chemicals in fragrance, it begs the question of what 2

harm those fragrance exposures cause. The literature is 3

somewhat limited, but there certainly is some. And there 4

are studies documenting harm to human health from fragrance. 5

By far, the most comprehensive data comes from the 6

dermatology literature. This has established about 2 to 11 7

percent of the general population has skin allergies to 8

fragrance. This translates to tens of millions of people 9

globally. Other well-documented effects of fragrance 10

exposure include eye, nose, and throat irritation. There 11

are quite a few studies on fragrance-induced headaches, 12

particularly migraines, in the literature. Fragrance 13

exposure can exacerbate respiratory disease such as asthma 14

and COPD. There are studies on longer term chronic effects, 15

cancers, reproductive effects. The research has never been 16

done looking at fragrance exposures. 17

There are some lists of well-documented case 18

studies on symptoms like immune system effects, neurological 19

effects, and certainly anaphylaxis happens on occasion. And 20

through all of this data, a very common thread is that women 21

are significantly more affected than men to exposures to 22

fragrance. This is best documented in the dermatology 23

literature; the ratio is about three to one women to men who 24

had skin allergies as to fragrance. Given that the nail 25


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salon worker population, and certainly their clientele, are 1

predominantly women is a distinctive very relevant factor. 2

Now what do we know about the impacts of fragrance 3

exposure to nail salon workers? I’d love to tell you there 4

are studies on this. I could find exactly none that have 5

looked at nail salon workers’ exposures to fragrance. I 6

don't think there are very many, if there are any, 7

fragrance-free nail salons that could be controlled for a 8

study like this. 9

What we can, however, learn from is the 10

epidemiological data that’s out there of salon workers that 11

does exist. And that gives us a better idea of the 12

conditions that disproportionally effect nail salon workers, 13

and so this is undefined a number of conditions that affect 14

nail salon workers. All the citations for these claims, 15

they’re all in a report called “Beauty and its Beast” which 16

is on our website, at that link where you can find the 17

descriptions of the studies and the links there. 18

The conditions that nail salon workers are facing 19

at higher rates officially than other occupational groups, 20

things like skin conditions and irritations and rashes, 21

occupational asthma to nasal throat irritation symptoms. 22

There have been a few studies measuring decreased lung 23

function in nail salon workers over the course of the day, 24

increased risk of miscarriage and low birth weight babies, 25


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headaches, dizziness, neurological symptoms. And then there 1

were two studies particularly on immune disorders such as 2

lupus and primary biliary cirrhosis which were significantly 3

higher in nail salon workers. 4

In most cases, the researchers of these studies 5

were unable to draw conclusions about specific chemical 6

exposures in these conditions, but in most studies the 7

researchers did hypothesize the chemical exposures in the 8

salon were contributing major contributing factors. 9

From this information, we know that these effects 10

are caused by fragrance exposure, however I can’t rule it 11

out, it’s certainly a possibility of to say a contributing 12

factor. In any case, this is important and relevant 13

information to our discussions today. And certainly poses a 14

valid cause for concern about the impacts of fragrance and 15

the need for more investigation. 16

What do we need to know about fragrance in nail 17

salon products in order to move forward and better protect 18

the health of nail salon workers and their clients? Quite 19

simply, we need disclosure of fragrance ingredients so that 20

we actually know what we’re dealing with. I think the State 21

of California especially should be asking for disclosure of 22

any fragrance ingredients that are on that Candidate 23

Chemicals list. We need to know how commonly these 24

chemicals are used in fragrance in what kinds of product. 25


(510) 313-0610

Ideally, we would like to see product-specific 1

disclosure of fragrance ingredients. And, I know this 2

sounds like a big challenge for some manufacturers who 3

aren’t used to it, there’s potential interim step that’s not 4

as good, asking for fragrance palates, this is just a master 5

list of chemicals a particular manufacturer uses in their 6

fragrance. It’s not nearly as helpful. It can identify 7

problem products but potentially could rule out Candidate 8

Chemicals from further investigation. 9

And one major reason that asking for this kind of 10

disclosure appears to be a challenge is what I mentioned 11

before, this long tradition of granting the fragrance 12

industry special nondisclosure status. And this was 13

originally instated over a half century ago into law. And, 14

at the time, it really made a lot of sense. Fragrance 15

formulas were very, very top secret stuff. Giving away a 16

list of ingredients would make it a lot easier to pirate a 17

fragrance or create a counter threat. But you fast forward 18

to today’s technology and recreating a fragrance from a 19

simple laundry list of chemicals is by far the hardest and 20

most labor intensive way to try and steal a formula. 21

Today with gas chromatography-mass spectrometry, 22

they really changed the game entirely. You can now plug a 23

sample of your fragrance into your GC-MS, have it loaded 24

with the fragrance GC-MS database, which is available from 25


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several vendors, and you have your fragrance formula names 1

of specific chemicals and the percentages on a printout I 2

mean practically in real time. This is how counterfeiting 3

is done today. 4

I think it’s really worth being very clear here 5

that a simple list of fragrance ingredients really no longer 6

meets the definition of trade secret. I’ve got the 7

definition here from the Uniform Trade Secrets Act; 8

paraphrasing, but it’s basically trade secrets are 9

information that derives economic value from not being 10

generally known or readily ascertainable through appropriate 11

means by other persons who might obtain economic value. 12

In this case, fragrance ingredients are clearly 13

readily ascertainable through appropriate means like GS-MS 14

by competitors when they are seeking this information for 15

nefarious purposes. 16

In a report on trade secrets in the fragrance 17

industry written by the National Fragrance Association, it 18

does clearly admit that the relatively cheap availability 19

and analytical technologies like gas chromatography-mass 20

spectrometry now allow for very detailed analysis of 21

fragrance. Using these latest techniques to support an 22

experienced perfumer, a competitor can rapidly bring close 23

approximations of the original to the market without having 24

to cover substantial R&D investment of the innovator. 25


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These compositions of these fragrances are not 1

secrets anymore, they are certainly vulnerable. Having said 2

that, I strongly recommend the report in the link there. 3

There’s a lot of influential property that still exists in 4

the fragrance industry from having ingredients extracted, 5

how you combine those. There’s all kinds of interesting 6

chemistry that’s going on that is certainly top secret and 7

really worth holding on to as trade secret. But 8

compositions of fragrances, the list of ingredients, they’re 9

just not secrets anymore. 10

And I do understand that this is a really hard 11

habit to break. There are so many laws where the fragrance 12

exception exists. I think industry first and regulators and 13

even activists are just used to giving fragrance industry a 14

pass on this kind of disclosure, for so-called trade secrets 15

reason, but we really have to get past this outdated way of 16

thinking. It’s unfortunately keeping us in the dark from 17

potential harms from fragrance, and it’s really preventing 18

efforts to improve public health from these exposures. 19

The other issue I’d like to address briefly is 20

this kind of rationale for backing the lack of disclosure 21

which is this idea that fragrance and its safety is very 22

well documented in the research. The reality is, there’s no 23

kind of external moderating of safety assessment of 24

fragrance ingredients. The safety of fragrance ingredients 25


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are almost exclusively conducted by internal mechanisms 1

within the fragrance industry itself. There is an inherent 2

conflict of interest when an industry self-regulates for 3

safety. 4

This slide just briefly describes the basic 5

outline of the fragrance industry safety program. It does 6

involve publishing peer reviewed safety assessments of 7

fragrance ingredients. These are based on validation and 8

review and evaluation by an independent expert panel. They 9

have made a database of these studies that are used to draw 10

these conclusions. 11

And then IFRA does issue standards that determine 12

allowable levels of fragrance ingredients to be used in 13

products for fragrance ingredients that could pose harm. 14

And, currently, there are roughly about 200 chemicals that 15

IFRA has issued standards for restricting or banning their 16

use. 17

And this sounds great; there’s a lot of good 18

things to this program. The problem is that the safety 19

program isn’t actually comprehensive for all fragrance 20

ingredients. I was taking a look through the 54 fragrance 21

ingredients on the Candidate Chemicals list of those, just 22

three are restricted in use by IFRA. So the vast majority, 23

styrene, phthalates, nonylphenol, etc., can all be used in 24

fragrance in unrestricted concentrations. 25


(510) 313-0610

And that’s really a concern. There is also a lack 1

of these cumulative safety assessments of certain chemicals. 2

A lot of these have been done, they’ve been published, you 3

can find them in the literature, but they haven’t been done 4

for all fragrance ingredients. There’s no easy compilation 5

of all the safety assessments. None of the 54 fragrance 6

chemicals on the Candidate Chemicals list has been reviewed 7

by fragrance industry at least anytime recently that I’ve 8

been able to find. I’ve never been able to find safety 9

review of styrene. There are no published reviews of 10

phthalates by the fragrance industry. There are a lot of 11

holes in the safety program, particularly respect the 12

certain chemicals of concern. 13

And if you want more information about this, we 14

have another report on our website called “Unpacking the 15

Fragrance Industry” which is kind of a critical analysis of 16

the industry safety program. 17

To summarize, we understand that fragrance is 18

commonly found in nail salon products in pre-manicure, pre-19

pedicure products. The nail salon is certainly a heavily 20

fragranced workplace to work in. Fragrance exposure to nail 21

salon workers is associated with virtually every client 22

regardless of the sort of that’s requested. Fragrance 23

exposure has been documented to harm human health. There 24

are certainly chemicals of concern, including 54 chemicals 25


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on the Candidate Chemicals list. And the lack of disclosure 1

of fragrance ingredients has really hampered our ability to 2

investigate these hazards and really to investigate these 3

exposures to specific fragrance ingredients. 4

In conclusion, fragrances really can pose 5

potential hazards to nail salon workers, and we believe it 6

deserves greater scrutiny and attention. 7

Thank you very much. 8

MS. RUBIN: All right. Thank you. 9

We’ll take questions from our participants in the 10

room first, or comments. Anybody? 11

Yes. 12

MS. BALKISSOON: Mine may be negative, but the 13

annex -- 14

DR. WILLIAMS: Could you identify yourself again. 15

MS. BALKISSOON: I’m Indira Balkissoon from 16

AlterEcho and I work on EU cosmetic assessments. And in the 17

European Union, there’s 26 allergens, fragrance allergens 18

that are required to be labeled. So I don’t know if I agree 19

with that statement that they’re not included on the labels. 20

MS. RUBIN: Okay. So her -- 21

MS. BALKISSOON: I don’t know if that’s a comment 22

or a question. 23

MS. RUBIN: Okay. Her comment was that there are 24

26 -- 25


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MS. BALKISSOON: Yeah, 26. 1

MS. RUBIN: -- fragrance allergens listed on EU -- 2

MS. BALKISSOON: Pardon? 3

MS. RUBIN: Listed on EU labels? 4

MS. BALKISSOON: Yeah, the EU required -- 5

MS. RUBIN: So theirs required. 6

MS. BALKISSOON: -- (indiscernible) is required to 7

be listed on the label. 8

MS. RUBIN: In EU, 26 fragrance allergens required 9

to be listed on labels. 10

MS. BALKISSOON: By the EU. 11

MS. RUBIN: But not in the United States. 12

MS. BALKISSOON: Well -- 13

UNKNOWN SPEAKER: Most labels are globally 14

compliant so they would include the EU allergens. 15

MS. RUBIN: So another follow-up comment to that 16

was that most labels in the United States are globally 17

compliant and they would include that list of the 26 18

allergens. 19

Yes. 20

MR. SCHOON: Doug Schoon, Professional Beauty 21

Association. 22

MS. RUBIN: One second, Doug. 23

Did you want to respond to that at all? 24

MS. SCRANTON: Sure. All of the 26 EU fragrance 25


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allergens which is a great thing for the EU customers. You 1

do sometimes see those EU allergens here in the U.S. There 2

are certain companies, globally, who require that. I 3

wouldn’t say it’s the norm yet in the U.S. We have a lot of 4

products out there that would just say fragrance and won’t 5

have any of the allergens listed. But some do. 6

MS. RUBIN: Okay. 7


Association. 9

Another concern or comment I’ll make is that 10

another thing that has to be considered is that many of 11

these fragrances are complex mixtures of tiny amounts of 50 12

or 60 different ingredients sometimes. To be able to put 50 13

or 60 difference ingredients onto an ingredient label is a 14

huge challenge for probably any manufacturer. 15

MS. RUBIN: His comment was about the number of 16

ingredients that may have to be disclosed on an ingredient 17

label. As you mentioned before, some of the fragrances are 18

composed of numerous different chemicals and there could be 19

over 50 that might have to be listed. So that would pose a 20

challenge. 21

MS. SCRANTON: Sure. We certainly look at that 22

there are a lot of way around this or, people looking at 23

whether or not fragrances could be just found online where 24

of course there’s unlimited space for disclosing 25


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ingredients. 1

It’s to some degree a label design challenge. In 2

Canada, for example, every label for consumer product is in 3

both English and French. Every label in Canada has twice as 4

much text as it does it the U.S. And they figured out how 5

to do that. Given, those kind of dynamics, and certainly in 6

Europe there’s multiple languages often on the same label. 7

When it comes to that, there’s only room to add in the most 8

of the ingredients that are necessary. 9

MS. RUBIN: Yes. 10

MS. MONTGOMERY: This is Katherine Montgomery from 11

COTY. 12

You showed several SDSs regarding fragrance 13

ingredients that would have the exploding chest symbol or 14

hazard symbol. That’s for fragrance at 100 percent. And 15

for nail polishes, or body lotions for that matter, 16

fragrances are very rarely used above five percent so if 17

you’re going to look at an SDS and determine hazard by that, 18

you have to put it as a grain of salt; it’s not used at a 19

hundred percent. If you were to pick up an SDS for an 20

alcohol, it would have the exact same hazards on them. I 21

mean, we all have alcohol in our houses, we use it on daily 22

uses, it’s not really considered a dangerous material. You 23

really need to think about what the actual exposure to the 24

consumer is when looking at an SDS. 25


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MS. RUBIN: Her comment was about the slide that 1

you had with the SDS label and the levels of exposure people 2

would have to any of the fragrances or chemicals. Tthe 3

exposure is a hundred percent for it to be dangerous and 4

rarely are these chemicals used at that level in nail polish 5

or lotion; they’re usually closer to five percent. 6

Did I capture that accurately? 7

MS. MONTGOMERY: Yes. 8

MR. RUBIN: Okay. 9

MS. SCRANTON: Yeah, thank you. That’s a 10

really good point and a really good comment. 11

I think what we have seen particularly with the 12

new SDSs that have come out for the latest hazard 13

communication standard is that we have seen some examples of 14

products that are now starting to disclose some of those 15

fragrance ingredients that have never been disclosed before, 16

particularly chemicals that are carcinogens or the ones 17

where there’s so much lower thresholds for reporting on an 18

SDS. We are starting to see some of that -- some of that 19

disclosure come around. 20

It’s certainly not standard. I think companies 21

are still getting used to having to do the SDSs; they’re 22

very much not used to disclosing fragrances. But there are 23

companies who look at their formulas and are like, okay, 24

we’re over the thresholds, we need to be, we need to be 25


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disclosing this. 1

We think often of fragrance that well, one just 2

smells nice, it must be harmless. There can be some rather 3

serious chemicals that are in there. And we certainly know 4

very low level of fragrance can really affect a person a 5

great deal. There are biological effects that can happen at 6

very low concentrations, seen all the time in the 7

literature. Even a low concentration can have an effect. 8

MS. RUBIN: We’re going to -- you had a question, 9

right? You raised your hand earlier. So we’re going to -- 10

MS. KOPELOVICH: Luda Kopelovich, Cardno ChemRisk. 11

MS. RUBIN: Okay. I’m sorry, could you speak up. 12

MS. KOPELOVICH: Luda Kopelovich, Cardno ChemRisk. 13

MS. RUBIN: Luda Kopelovich. And then we’ll go 14

over to you. 15

MS. KOPELOVICH: My question was a lot of these 16

fragrances are very commonly found in a lot of other 17

consumer products not just nail polish. So when you’re 18

looking at health risks to nail salon workers, I’m curious 19

to see how you are going to pick in terms of the hazard 20

coming from nail products versus fragrances that are 21

probably found in other consumer products; they’re also used 22

by other people, maybe outside of work. 23

MS. RUBIN: Her comment -- is this a question for 24

DTSC or for our presenter? 25


(510) 313-0610

MS. KOPELOVICH: To the presenter. 1

MS. RUBIN: Presenter? Okay. 2

Her comment was that a lot of these fragrances 3

might be found in other products that the nail salon workers 4

use outside of the salon. How would we determine their use 5

of these products outside of their work environment and 6

their personal environment? 7

Is that accurate? 8

MS. KOPELOVICH: Sure. 9

MS. RUBIN: Okay. 10

MS. SCRANTON. I think that’s a really good point. 11

If you’re measuring levels of these chemicals in the air, 12

then they certainly could be volatilizing off of a person 13

who is wearing a fragrance. If we get disclosure of what 14

chemicals are in the products we’re actually using rather 15

than doing it from air testing, then that will tell us what 16

additional exposures they, in fact, have in addition to 17

whatever they’re exposing themselves to if they choose to be 18

someone who wears fragrance. 19

I think it’s just more information, it would be 20

very difficult from air testing to be able to distinguish 21

the two, but if we had information from the manufacturer, we 22

would certainly be able to tell what comes from the products 23

that they’re using every day. 24

MS. RUBIN: Does that answer your question? 25


(510) 313-0610

MS. KOPELOVICH: Kind of. 1

MS. RUBIN: Did you -- 2

DR. PEREZ: I mean, Luda read my mind. This is 3

Angie Perez from Cardno ChemRisk. 4

Luda read my mind, had a similar question about 5

how exactly is this specific to the nail industry? If I 6

plug in an air freshener in my house and it’s my choice to 7

use sprays or whatever, I mean it’s everywhere. It’s just a 8

little unclear a why the nail salon worker cohort is the 9

focus 10

MS. RUBIN: Her question was a follow-up to the 11

previous question. Why would the nail salon workers be of 12

particular interest when it comes to the fragrances? For 13

example, air fresheners. What would the difference be if 14

one person plugged one in an air freshener at their house 15

that periodically emits fragrance as opposed to exposure to 16

a nail salon worker? 17

MS. SCANTON: Sure. Another really good question. 18

I think there is really data the speaker before me talked 19

about the ASHRAE standards for ventilation in nail salons. 20

And from that particular study, I think it was in Boston 21

that showed that the vast majority of nail salons do not 22

have adequate ventilation based on the levels of C02 in the 23

air. An air freshener added to that sort of environment 24

where there isn’t good ventilation, where there are already 25


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high levels of the VOCs in the air, could make a bigger 1

difference than what’s in your house if you’ve got windows 2

open and you are coming and going and that kind of thing. 3

It’s true, the air freshener is –not adding any 4

more harm in a nail salon that it is in your house. I think 5

there’s also problems with air fresheners in homes but it’s 6

the concentration overall. Fragrance is coming from so many 7

different potential places in a nail salon that it certainly 8

seems deserving of greater investigation as to what the 9

exposures are to the people who work there. 10

MR. ALGAZI: Well, I think Angie’s point might 11

have been about given the ubiquity of fragrance, chemicals 12

in all kinds of products, why focus on nail products. 13

Is that it? Yeah. 14

MS. SCRANTON: Oh, sure. And I think, again, it’s 15

coming back to the nail salon and certainly this is true of 16

hair salons as well, but actually we’re talking about nail 17

salons today, it is a heavily fragranced workplace. I mean, 18

that there’s greater concentration than you might find in 19

your average office setting. Where there can be air 20

fresheners and our concern with people wearing fragrances, 21

but these are women applying fragrance lotion to their hands 22

and the hands of their clients eight, ten times a day. All 23

right. There’s a tremendous fragrance exposure to nail 24

salon workers given the work they do and the products that 25


(510) 313-0610

they’re using. 1

DR. PEREZ: One may argue, though, that you’ve 2

also have a significantly higher rate of hand washing which 3

has been shown to clear products on their hands, too. So I 4

I’d like to see data for that. 5

MS. RUBIN: And so Angie mentioned that also in 6

these environments, there is a higher rate of hand washing 7

by the workers and she would like to see data for your 8

conclusions. 9

MS. SCRANTON: Oh, okay. I’m certainly happy to 10

provide that. With hand washing, a lot of soap is 11

fragranced too. There’s, exposure there as well. 12

The point of my presentation is that there’s a lot 13

that we don’t know about what’s in fragrance, but there are 14

a number of chemicals we’re really concerned about that 15

could be in fragrance that these women are being exposed to, 16

and I think we need more information. And we need more 17

investigation to see if fragrances are, in fact, causing 18

these health effects that we’re seeing in these workers. 19

MS. RUBIN: We have another question on this side 20

of the room and then we’ll come back over here. 21

MS. LITTLE: Thank you. 22

This is Susan Little with the Environmental 23

Working Group. 24

And I just had a question in line with concerns 25


(510) 313-0610

about the lack of data, and whether or not the manufacturers 1

of the products have been able to demonstrate that in that 2

kind of a work setting that their products are actually safe 3

to workers. 4

MS. RUBIN: Her question was about worker safety 5

and manufacturers being able to -– 6

MS. LITTLE: Demonstrate -– 7

MS. RUBIN: -- to demonstrate -– 8

MS. LITTLE: Yeah. 9

MS. RUBIN: -- the safety of their products in 10

that setting with the lack of availability of data. 11

MS. LITTLE: If there are any studies to that 12

effect or if the industry, the nail salons, have been able 13

to demonstrate that the fragrances in their workplace do not 14

harm their workers? 15

MS. RUBIN: Did you get that? 16

MS. SCRANTON: I did, yes. 17

MS. RUBIN: Okay. 18

MS. SCRANTON: Thank you. And, thank you, Susan, 19

for the question. 20

I have not seen any studies looking at the safety 21

of fragrance or fragrance products in the nail salon. That 22

specific angle of research just hasn’t been done as far as 23

I’m concerned. I think there are likely research that 24

manufacturers have done looking at things like skin 25


(510) 313-0610

irritation from lotions. I think they do that all the time 1

and make sure that their customers are not immediately going 2

to break out in a rash, or like most of them aren’t. But I 3

don’t know, I’ve never seen studies by those manufacturers 4

looking specifically at the occupational setting and the 5

multiple, multiple use of these chemicals. I’d love to see 6

it among that research; I don’t think it’s published if it’s 7

done internally. But it’s not something I’ve been able to 8

find. 9

MS. RUBIN: We only have time for one more comment 10

and we’re going to take it from – 11

MS. PORTER: Catherine Porter with the California 12

Healthy Nail Salon Collaborative. 13

Just a quick comment about what a nail salon 14

worker’s exposed to at work and what she may be exposed to 15

elsewhere. I think there may be a host of chemicals that 16

nail salon workers are exposed to both at work and at home. 17

I will be talking about some of those chemicals. 18

But I don’t think that should be reason for those 19

chemicals not to be targeted in the nail salon working 20

environment. If we can start whittling away at some of the 21

exposures of any worker, any individual, I think it behooves 22

an agency to do that. 23

MS. RUBIN: Did everyone get that? Alexandra? 24

MS. SCRANTON: Thanks, Catherine. 25


(510) 313-0610

MS. RUBIN: Okay. 1

MS. SCRANTON: Thanks, Catherine, that was a great 2

point. 3

MS. RUBIN: Thank you for your presentation. 4

We’re going to move on to our next presenter who 5

is here with us. 6

We have Katherine Montgomery, the Senior Director 7

for Corporate Regulatory Affairs with Coty, Inc. And let me 8

just get her presentation set up for you. It is, “An 9

Industry Leader’s Perspective on the Regulation of Nail 10

Products and their Ingredients.” 11

MS. MONTGOMERY: Good morning, good afternoon, for 12

everyone that’s on the phone that’s not on the West Coast. 13

My name is Katherine Montgomery, I’m from Coty. And I 14

wanted to first start by thanking DTSC’s Safer Consumer 15

Products Program for inviting me to speak to you guys on the 16

industry’s behalf or from an industry’s perspective. 17

We’ll go from a little bit more general to more 18

specific on all nail products from what’s in the nail 19

products to the chemicals, how they’re manufactured, and of 20

course the focus on safety. In order to frame exactly what 21

I’m going to go over, I wanted to give you a background on 22

exactly who Coty is. We currently don’t manufacture 23

anything under our actual name. But I wanted to give you an 24

idea that we have over 70 brands ranging in luxury 25


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fragrances, color cosmetics, professional hair color, and 1

luxury skin care. We’re sold in 130 plus countries. We 2

have over 20,000 employees, and we have roughly $9 billion 3

in revenue. 4

As a little bit more exciting way at looking at 5

it, these are some ideas of our brands. You’ll see listed 6

OPI Nail – OPI, Incorporated and also Sally Hansen which are 7

two of the major nail product companies out there in the 8

U.S. You’ll also see a lot of our fragrances like Bottega 9

Veneta, Miu Miu, Marc Jacobs, and some of our color 10

cosmetics such as Cover Girl and Rimmel. 11

Given that we’re talking specifically about nail 12

products, I wanted to give you some background on OPI 13

Products which is located here in California, in Southern 14

California and North Hollywood. They sell primarily to 15

distributors who sell to salons so they do professional nail 16

products. They are members of several industry trade 17

associations including the Nail Manufacturers Council and 18

the Professional Beauty Association and the Personal Care 19

Products Council. OPI, since it started in 1981, has been 20

working very hard to provide knowledge and education to 21

salon professionals. OPI was acquired by Coty in December 22

of 2010. 23

I know that we’ve talked a lot about nail products 24

today. So this might be a little bit of an overview, but I 25


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wanted to make sure that everyone was on the same level. So 1

this is just a little bit of nail product 101. Please get 2

your books out, but you can take some notes on this in case 3

you needed some idea on nails. 4

Solvent nail enamels are what you think of when 5

you think of nail polishes. Everything that you see out 6

there, a lot of them are solvents. They come up with four 7

different parts, you have a solvent, a film former, the 8

plasticizer, and the pigment. This is what you see out 9

there the most. There’s a large range of brands from large 10

companies to small companies. And the solvents are the 11

major component of the product and it’s used to dissolve the 12

polymers and suspend any of the added pigments until 13

application. And those pigments are what everyone goes 14

after so those are the colors and the effects that you are 15

going to see on the nail. 16

The new product categories are the UV-cured nails. 17

I don’t know how many people have seen all the ads recently, 18

but these are things that last longer than seven days on the 19

nail. They don’t start with a solvent, they actually start 20

with monomers. And they use the UV or LED lamp to photo 21

initiate the monomers, that allows them to link and it 22

creates more solid film on your nails. And that polymer 23

network holds the color and shimmer particles in place. It 24

creates a very hard film on your nails and it lasts, in most 25


(510) 313-0610

cases, up to two weeks. 1

The kind of the older version of these long-2

lasting nail products are the acrylics. They’re still out 3

there in a professional setting, but you don’t see them as 4

often anymore. Those are generally made up of two separate 5

portions. There’s the liquid portion and then there’s the 6

powder portion of the system. 7

In the liquid portion, a catalyst interacts with 8

the benzoyl peroxide that you’re going to find in the powder 9

portion to create the needed energy to create the polymers 10

that creates the base of the nail. 11

And then in the powder, the polymer is usually 12

either a poly ethyl methacrylate (or poly methyl 13

methacrylate) or a blend of the two, along with the benzoyl 14

peroxide to create the overall look. And then, of course, 15

you have those pigments that we discussed earlier, the 16

titanium dioxide, mica, and the D&C and FD&C approved 17

pigments which we’ll get into later. 18

The other major category I wanted to discuss 19

briefly are bonders and pre-primers. You’ll see these 20

primarily also in salon nails. The bonders help bond the 21

monomers better to the nail so that you have a longer 22

lasting nail finish. And you also have pre-primers that 23

help make the nail surface more alkaline before priming. 24

Now that we all have a general level setting of 25


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what nail products are, I wanted to go into a deeper dive on 1

the chemicals in nail products. This is somewhat very 2

similar to Eric’s presentation earlier. As we discussed, 3

there’s a variety of solvents, plasticizers, film formers, 4

and colorants that are found in nail products. And, as 5

we’ll all hear, there’s additional scrutiny on some of those 6

products. We’re going to go into a little bit more detail 7

on dibutyl phthalate, toluene, formaldehyde, triphenyl 8

phosphate, and a variety of colorants. 9

The first, dibutyl phthalate, otherwise known as 10

DBP, was used in nail polish, top coats, and base coats. It 11

is a plasticizer. We’ve heard that today already. Safety 12

concerns, estrogenic effects when used at high dosages. 13

However, a study done showed that in order for the human to 14

get the right level for it to be toxic, we would have to 15

ingest five bottles of nail polish every day. So it might 16

be toxic at a hundred percent, we’re not using it at that 17

level. The EU cosmetic directive, or EU cosmetic 18

regulation, banned the use of the dibutyl phthalate in 2005 19

in nail polish use. However, quickly following the EU 20

Scientific Committee on Consumer Safety, or the SCCS, 21

published a report demonstrating the safety of the 22

ingredient. The ban was not overturned; however, the safety 23

study’s still out there. You should know that Coty 24

reformulated out of dibutyl phthalate in 2008, along with 25


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most of the major nail manufacturers out there. 1

Toluene, another one of the toxic trio was used in 2

nail polish, base coats, and top coats. It is a solvent. 3

Again, at high exposure levels, it can present a cancer and 4

a reproductive system risk. A study done by the State of 5

California showed that that at the average toluene exposure 6

levels, an average work technician would have only received 7

1/200th of the OSHA safe exposure level. So again, the risk 8

is really not there. 9

Regulation against toluene, there really hasn’t 10

ever been set regulations against toluene; however, the 11

consumers are very vocal about what they’re looking for. 12

Therefore, Coty voluntarily ceased the use of toluene in 13

2012. Again, you will not see toluene in most major nail 14

polishes or manufacturers. 15

The next one, formaldehyde. Formaldehyde is used 16

in nail hardeners, as we heard this morning. It acts as a 17

cross linking agent that stiffens the nail, fingernail 18

protein. It’s linked to a rare nasopharyngeal cancer when 19

large amounts of formaldehyde gas are inhaled in industrial 20

settings. The OSHA 8-hour workday standard for formaldehyde 21

exposure is .75 parts per million, almost 200 times higher 22

than the highest level in the OSHA study which is .0038 23

parts per million. This is why a risk is a really important 24

aspect to the risk hazard safety assessment. 25


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U.S. and Health Canada both allow up to 5 percent 1

of formaldehyde in nail hardeners. And the European 2

Commission, again the European Commission Scientific 3

Committee for Consumer Studies, the SCCS, so they say up 2.2 4

percent of free formaldehyde can be used to safely 5

strengthen nails. Coty only uses formaldehyde in nail 6

hardeners, and it is never used in any other uses. 7

One of the last ones I want to discuss is 8

triphenyl phosphate, which several people have mentioned 9

today is a plasticizer. It has been linked in one or more 10

studies to endocrine destruction. However, the World Health 11

Organization has identified triphenyl phosphate as low 12

toxicity in short-term studies. It is not mutagenic, it 13

does not cause delayed neuropathy or neurotoxic changes. 14

Also, triphenyl phosphate does not meet the criteria for 15

persistent, bioaccumulative and toxic (PBT) or very 16

persistent and very bioaccumulative (vPvB) substance, per 17

the UK Environmental Agency. And OECD has identified the 18

material as a low hazard. 19

Overall, there are no regulations against 20

triphenyl phosphate in the cosmetic industry. Additionally, 21

the U.S. FDA allows triphenyl phosphate as an indirect food 22

additive when it comes to food. 23

I wanted to give everyone a little bit of 24

background on colorants. So all colorants used in U.S. 25


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cosmetics must be approved by the FDA. There are two 1

classifications of colorants. There are those that are 2

exempt from certification and those that require 3

certification by the FDA. Those exempt from certification 4

are the ones that you see with the names of iron oxides, 5

ultramarines, ferricyanide, and titanium dioxide. 6

So the FDA, you can go to their website, maintains 7

a positive list of these colorants and their permissible 8

uses. Some of them can only be used in the eye area, some 9

can only be used on nails. They’re all on the FDA website. 10

The second classification are the batch certified 11

FDA colorants. For a manufacturer of a colorant, they have 12

to provide a sample of the batch to the FDA who then does a 13

test on it to ensure purity and that heavy metals are within 14

the requirements. This is done on every single batch and 15

the manufacturer of the finished goods actually gets a copy 16

of the certificate and it’s contained in their records. Not 17

only are the FDA very specifically looking at colorants, the 18

actual manufacturer of the product is looking at them as 19

well. 20

For example, as we’ve mentioned, the industry is 21

extremely global. So not only are we selling our products 22

in the U.S., we’re selling them in Japan, we’re selling them 23

in the EU. Therefore we ensure that our products meet the 24

industry standards set forth by the EU Cosmetic Regulation 25


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as well as the Japanese Administrative Health. There’s also 1

an additional level of this so it’s great that so many 2

different countries have regulations, but Coty also has 3

internal standards as many other cosmetic companies do. We 4

have very strict purity and heavy metal content that must be 5

followed for every single material that goes into our 6

product as well as the finished good. 7

Manufacturing and quality control is the next 8

section. Nail lacquer formulas as really unique. They are 9

not like a body lotion, they’re a little bit more difficult 10

to make. In most cases, you go to specialized third-party 11

manufacturers to create the bulk. But it’s not as if we 12

just go the manufacturers and say, make this formula, give 13

them the formula and we’re going to market it. Before 14

anything actually gets awarded to a third-party 15

manufacturer, a company is going to send them their own 16

quality control and make sure that a whole audit is done; so 17

that they’re meeting all of their requirements. We only 18

manufacture using manufacturers who are GMP compliant. Many 19

of them are also FTA OTC certified facilities and ISO 20

22716:2007 certified. We ensure quality from numerous 21

different standpoints. Not only do we ensure quality from 22

the actual manufacturing standpoint, when the bulk of the 23

finished good then comes back into the Coty facility, we do 24

our own set of quality controls. Through SOP following, we 25


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ensure that the product evaluation and the quality assurance 1

standards are met. Nothing goes on the market without all 2

of these standards being met from both the raw materials to 3

the finished good. 4

Today we’ve talked a lot about safety which is 5

extremely important to Coty and to anyone that sells a 6

product in the U.S. The FDA requires that you are able to 7

substantiate the safety of your product prior to putting it 8

on the sale, prior to putting it on the market. The EU took 9

it one step further and requires the creation of something 10

called the product information package or PIP, it goes 11

through numerous different names. This was passed through 12

the European Cosmetic Product Regulation 1223/2009 and it 13

was -– became operational in July of 2013. 14

What this is, is that it’s a very thick packet of 15

every single thing that has to do with the product. You 16

have your quantitative formula, your qualitative formula, 17

the manufacturer instructions, your product specifications, 18

your bulks specifications, your actual packaging 19

information, your SDSs, your raw materials specifications, 20

and then a huge portion of the packet is the safety 21

assessment. It goes through every aspect of that product 22

and its exposure and its end use. They follow the SCC 23

guidance document when it comes to exposure, and only people 24

who can actually make the safety assessments are board 25


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certified toxicologists or people who have diplomas similar 1

to it. You have to take a course in Brussels that goes 2

through all of us, it’s not easy course from what I’ve told. 3

I have not taken it. 4

But what I can tell you is that all of this 5

documentation has to be compiled and signed off on prior to 6

the product even going on the market. So this is a 7

requirement for the EU. It’s also a requirement for many 8

other salon locations in the world including the Asian 9

countries which is Southeast Asia. 10

Coty ensures that before anything goes on the 11

market, a complete safety assessment is done. Also the PIP 12

needs to be ready to go. Because if EU regulatory comes to 13

us, we have less than 72 hours to provide it to them. 14

That’s a really short amount of time to compile all of this 15

information so we make sure that it’s already compiled prior 16

to sale. 17

We talked about how you’re substantiating your 18

safety assessments. We do internal studies and we also rely 19

on external information. Prior to sale, every single one of 20

our products are tested. And I believe that this is pretty 21

similar to any other company within our industry. Some of 22

these example typical tests are repeated result patch tests 23

on nail enamel. We’ve had one study or at least one study 24

that had 110 test subjects, the total of nine different 25


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applications. In-use safety evaluations with dermatologists 1

signing off on nail polish. There were 16 test subjects and 2

a total of 8 applications. We’ve also done the in-use 3

safety evaluation of the gel manicure systems with 34 4

subjects who participated in a six-week study. Nothing goes 5

on the market without very strict safety review. 6

Finally, we also leverage independent studies from 7

both U.S.-based companies and external. There’s the 8

California Salon Formaldehyde-Toluene Safety Study that we 9

rely on, the SCC opinion on the safety of the use of 10

formaldehyde in nail hardeners, and the Cosmetic Ingredient 11

Review Board which has reviewed a large percentage of the 12

products that we use. 13

I only have five minutes left so I’m going to try 14

to get through this. As I said in the beginning, OPI in our 15

industry has worked very closely with the Professional 16

Beauty Association and the Nail Manufacturers Association to 17

communicate to salons. We heard earlier that SDSs are 18

sometimes found for salons. I can tell you that for OPI, we 19

have a database that if you’re a professional nail salon or 20

if you are a distributor of our product, you log on, you can 21

get every single SDS that you want. Many of them are 22

translated in other languages including Vietnamese. 23

Additionally, on the PBA and NMC websites, there 24

are 18 different guidance documents coauthored by OPI 25


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employees that communicate to salon owners. This goes 1

through ergonomic basics, cleaning, disinfecting procedures, 2

steps to minimize inhalation and skin exposure. I know the 3

slides are going to be posted but in the annex of this, I go 4

through every single one of them and what their topics are. 5

Amazingly enough, all of these are translated into Korean, 6

Russian, Spanish and Vietnamese. We know it’s a very ethnic 7

population who is actually doing the applications; they all 8

need to have access to this information. 9

The EPA has also released a guidance document in 10

March of 2017. Sorry, in March of 2007, protecting the 11

health of nail salon workers. Topics include best shop 12

practices, gloves, masks, respirators, and liquid methyl 13

methacrylate monomer fact sheet. 14

Very quickly, microtrends in nail products. 15

Consumers drive our industry, obviously, so right now the 16

current solvent-based formula technology provides a manicure 17

that suits the consumer needs. We have found in our studies 18

that the alternative technologies do not meet the 19

performance or the needs of the consumer in the solvent-20

based technology. Therefore, they’re not reproducible and 21

not a good alternative on the market. An example of these 22

are the water-based nail colors, and I believe the group 23

from Harvard had shown that many of those who come out as 24

saying that they’re safer or green might be providing a 25


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misconception out there to the market. 1

In conclusion, the global cosmetic industry is 2

subject to national and international rules that regulate 3

and govern the safety and efficacy of our products. While 4

specific requirements may vary from country to country, 5

product safety and regulation compliance is essential. No 6

products should be going on the market if there’s a safety 7

concern. Many of the ingredient concerns discussed today 8

have been proven to be false or unfounded by international 9

bodies. 10

Coty, along with other multinational companies, 11

work with industry to publish guides in a variety of 12

languages to ensure worker safety. 13

Thank you. 14

MS. RUBIN: Thank you. At this time, we’re going 15

to take any questions or comments that we have for 16

Katherine. We’ll start with folks in the room and Doug had 17

your hand up first, so we’ll start with you. 18


Association. Excuse me, as I cough through. 20

We talked in last section about IFRA. Under this 21

science-based organization, there’s a tremendous amount of 22

research into fragrance ingredients. And the purpose of 23

that research is so they can make recommendations to 24

manufacturers about the safe levels of fragrances. I know 25


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you’re not a formulator, but can you tell us if Coty adheres 1

to the IFRA guidelines when they decide how much fragrance 2

to put in the products? 3

MS. MONTGOMERY: Yes, everything that we 4

manufacture meets IFRA standards. You actually in most 5

countries cannot even sell in those countries without 6

providing an IFRA certification. We rely on the fragrance 7

houses whose trained toxicologists only look at fragrance 8

ingredients. And they help us determine what the best level 9

is dependent on the IFRA standards. Every single thing that 10

we manufacture goes by the IFRA standards. 11

MR. SCHOON: Thank you. 12

MS. RUBIN: So for folks on the phone, his 13

question –- 14

MS. MONTGOMERY: Sorry. 15

MS. RUBIN: -- was about IFRA standards. 16

It’s okay if you want to repeat it, I don’t mind. 17

MS. MONTGOMERY: Okay. Sorry. 18

MS. RUBIN: Go ahead and repeat if you don’t mind 19

his response. 20

MS. MONTGOMERY: Yeah, of course. 21

MS. RUBIN: Okay, great. 22

MS. MONTGOMERY: The question was specifically 23

about whether or not we follow IFRA standards because IFRA 24

does a large amount of studies on safety of fragrance 25


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ingredients. 1

MS. RUBIN: Our next question will be over here. 2

MS. PORTER: I’m Catherine Porter with the 3

California Healthy Nail Salon Collaborative and I have a 4

sort of a two-part question. One is, I see the third bullet 5

down on your conclusions, I’d be interested in seeing the 6

studies that you’re alluding to there that prove things 7

discussed here today are false or unfounded. Will you be 8

posting that along with your presentation? 9

MS. MONTGOMERY: The question is regarding my 10

statement that many ingredient concerns discussed today have 11

been proven to be false, unfounded by international bodies. 12

And to answer your first question, the presentation will be 13

posted. 14

To go back, I provided the references associated 15

with the studies that I cited when it came to ingredient 16

safety. From a cosmetic standpoint, we always take risk 17

into consideration when doing safety assessments. 18

Therefore, in the formaldehyde study by the European 19

Scientific Committee on Consumer Safety which is a publicly 20

available study -- I’m more than happy to send it to you, if 21

you would like -- showed through numerous different studies 22

that formaldehyde was safe up to 2.2 percent. And it also 23

has pointed out that formaldehyde is naturally occurring in 24

foods and formed in mammals, including humans, and it’s not 25


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a problem from a human safety perspective. Also, for 1

dibutyl phthalate, again the SCC report is out there, it’s 2

publicly available and it shows that there’s a safety of the 3

ingredient even after the ban. 4

MS. RUBIN: Okay. And -- 5

MS. PORTER: Can I just follow up? 6

MS. RUBIN: You have a follow up? 7

MS. PORTER: Maybe you can talk a little bit more 8

about you’ve mentioned showing safety, proving safety, 9

certifying safety. And I’m curious if that safety speaks to 10

chronic effects such as cancer, reproductive harm, 11

respiratory problems, asthma, neurological problems, things 12

like that. 13

MS. MONTGOMERY: I’m not a toxicologist. Oh, the 14

question is whether or not we’re looking at repeated 15

exposure. I’ll admit that I’m not a toxicologist, I’m in 16

regulatory. However, I do not that the SCC and other 17

certified bodies do look at repeated exposure. I can 18

definitely look into that and provide more information. 19

MS. PORTER: Well, repeated exposure with the 20

result of being chronic illness like cancer -- 21

MS. MONTGOMERY: Yes. 22

MS. PORTER: -- reproductive harm. 23

MS. MONTGOMERY : I under -– I do know -– 24

MS. PORTER: Etc. 25


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MS. MONTGOMERY: -- the SCC does look into that, 1

but again, as not a toxicologist, I don’t feel it’s right 2

for me to comment. 3

MS. RUBIN: We had another question up front and 4

then we’re going to go this side and then back over to 5

Angie. 6

MS. ALCANTAR: This is Kathryn Alcantar, with the 7

Center for Environmental Health and the CHANGE Coalition. I 8

have a question similar but maybe slightly different to 9

Catherine’s which is for the safety studies that you 10

referred to that have been done, are those just for 11

consumers of the product or are they also for workers? 12

And then, does it also include, as seeing now more 13

children using nail products in particular, have those 14

studies also been considered, exposure to children and their 15

unique vulnerabilities? 16

And then finally, have those studies also included 17

aspects of multiple, you mentioned repeated exposure, but as 18

was shared earlier, it’s also from multiple contaminants, 19

right? Multiple chemicals. I’m wondering if your health 20

and safety studies that have been done prior to going to 21

market also look at mixtures, if you will, of various 22

products being used in the workplace and on consumers. 23

MS. MONTGOMERY: One of the first questions was 24

whether or not we test our products and investigate the 25


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safety on children. None of the Coty products from our 1

entire category are to be sold to children. It is part of 2

what we do; so, we’ve not looked at the safety of children. 3

It’s actually not ethically sound to test on children as 4

within our testing methods. 5

Another one of the questions was whether or not we 6

investigate the safety from a safety worker perspective. 7

During application and also during the creation of the 8

instructions, the safety of the workers are considered and 9

that’s why safety guidance documents and the safety 10

instructions are written to that prospective. We have sales 11

associates who go out to the salons and demonstrate how the 12

how the products should be applied safely. 13

In terms of repeated exposure, again, that’s a 14

great question and something I’m going to have to look back 15

at. 16

MS. PORTER: Can I just ask a follow-up question 17

which is, is there a way to ensure that children aren’t 18

using the products that you create that aren’t supposed to 19

be sold to them? Are there manufacturers looking into that? 20

MS. MONTGOMERY: From my perspective, they’re not 21

looking into that. But, to be honest, there’s really no way 22

to control anyone from using a product; so, that’s part of a 23

double-edged sword. You could ask if anything could be used 24

by a child. I don’t think that’s necessarily a fair 25


(510) 313-0610

question. 1

MS. RUBIN: We’re going to go to this side first 2

and we’ll try to get around to all of your questions, but we 3

only have five minutes left so let’s all try to be as 4

concise as we can. Thank you. 5

MS. LITTLE: Just to reiterate concern about 6

making sure if the studies were pertaining specifically to 7

the worker population, but you said that as manufacturers, 8

you do give guidance as to how the workers are supposed to 9

be using the products. 10

MS. MONTGOMERY: Uh-huh. 11

MS. LITTLE: Do you have any follow-up data as to 12

whether or not they actually use the product that way? And 13

if they don’t, then what are they exposures? What are they 14

exposed -– 15

MS. MONTGOMERY: The question is whether or not we 16

have follow-up data to show whether or not the salons are 17

using the products correctly. I don’t have that in front of 18

me right now. I can tell you that we do have a consumer 19

affairs hotline where we do get questions from consumers, we 20

provide additional guidance. Also OPI and Coty don’t own 21

the salons. We can provide guidance, but we can’t 22

necessarily dictate exactly how they operate. 23

MS. LITTLE: And then, do you have follow-up data 24

if those guidelines aren’t being complied with? What are 25


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the effects? What is the potential risk to the workers 1

without the complying to guidelines, from just the regular 2

exposure? 3

MS. MONTGOMERY: I don’t have that information. 4

MS. RUBIN: We’re going to take a question from 5

this gentleman, then we’re going to go back over here and 6

try to get you in as well. 7

MR. KING: Andrew King with DTSC. 8

I have a two-part question. The first is you 9

mentioned reformulation. I’m just curious, in the industry, 10

how frequently it happens, where with a typical product, how 11

frequently is reformulation of the ingredients for the same 12

product? That’s the first question. 13

And the second is, with your third-party 14

manufacturers, if you can you tell us a little more about 15

the quality control. Are you literally testing to make sure 16

the ingredients they said they’re putting in it is going in 17

there? Is that part of the testing? 18

MS. MONTGOMERY: The first question is regarding 19

reformulation, how often it occurs. Reformulation occurs 20

for a variety of reasons. Very rarely is it a safety 21

reason. It wouldn’t be on there. A lot of the time it’s 22

change in regulations, it’s for a cost savings, it’s the 23

fact that a raw material supplier has stopped actually 24

selling the raw material. I would like to say that it 25


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doesn’t happen that often, because it’s a huge undertaking. 1

It’s usually not only changing the product, you have to make 2

sure that it’s performing as well as your previous product 3

so that you’re not losing consumers. And, also, you’re 4

changing all of your labeling which is not an easy feat to 5

do when you have such a large product line. 6

Reformulations are very driven by numerous 7

different functions. Again, very rarely is it a safety 8

concern. When it comes to the quality controls, what I can 9

tell you is I know it’s not publicly available information 10

but we did have one of our third-party manufacturers, on our 11

behalf, submit confidential information on their quality and 12

manufacturing processes to DTSC. I don’t remember who that 13

went to. I think it might have been you. 14

MS. PAPAGNI: Right. We haven’t received it yet. 15

MS. MONTGOMERY: I can follow up with them as well 16

if it’s still not there. But we do test to ensure the 17

ingredients that are supposed to be there are there. And 18

also that’s part of the GMP certification. If you’re 19

stating that you are GMP compliant, you should be following 20

your own rules at the same time. 21

MS. RUBIN: We’re going to have to stop there. 22

Thank you so much. 23

MS. MONTGOMERY: You’re welcome. 24

MS. RUBIN: We’re going to take a break for lunch 25


(510) 313-0610

and we’re going to come back at 1 o’clock. We’re going to 1

start at 1 o’clock, so if you could come back a few minutes 2

before, get settled in, we have some more great speakers 3

lined up for you today. 4

Thank you for your participation, thank you to our 5

presenters. And we’ll see you back here at 1. 6

(Off the record 11:50 a.m.) 7

(On the record 1:00 p.m.) 8

MS. RUBIN: We're going to dive back in and I'm 9

going to start cuing up our next presentation. I want to 10

introduce now Catherine Porter, the Policy Director of the 11

California Healthy Nail Salon Collaborative. Her 12

presentation is titled, The Chemical World of Nail Salon 13

Work, Practice, Processes and Toxic Products. 14

We're just going to take a couple minutes. A lot 15

of people are filing back into the room. For those of you 16

online, Catherine will be giving her presentation shortly. 17

(Pause) 18

MS. RUBIN: If we could have everybody settled and 19

give our full attention to Catherine, we're going to start 20

now. Thanks very much. 21

MS. PORTER: Good afternoon, everyone. Hope 22

everyone had a good lunch and is not too relaxed, so that we 23

can all pay attention during the second half. I'm Catherine 24

Porter. I'm the Policy Director for the California Healthy 25


(510) 313-0610

Nail Salon Collaborative, and today I'm talking about The 1

Chemical World of Nail Salon Work, Practices, Processes and 2

Toxic Products. 3

At some point I'm going to give you a really 4

bird's eye view of what a process in a nail salon looks 5

like. The California Healthy Nail Salon Collaborative was 6

formed in 2005, composed of public health and environmental 7

advocates, nail salon workers and owners, community-based 8

groups and allies in government agencies. 9

Our mission is to protect and improve the health 10

and safety and rights of the nail salon community. We do 11

our work to benefit working women like the one whose quote 12

we see here. The woman whose quote we see here started out 13

as a nail salon worker for a few years, and then has been 14

owning her own nail salon for several, and she is a 15

Vietnamese immigrant. 16

Mmost nail salon workers and owners, at least in 17

California, are Vietnamese immigrants. Most are women. 18

Many are of reproductive age, and language can be a barrier 19

to accessing information about state and federal labor and 20

occupational health laws and regulations designed to protect 21

their rights and safety. 22

Nail salon workers may work as many as six days a 23

week, eight or 10 hours a day. While many of the acute 24

symptoms, such as headaches, dizziness, rashes, respiratory 25


(510) 313-0610

problems, watery eyes and watery nose experienced by nail 1

salon workers is well-documented, nail salon professionals 2

are concerned are potential chronic harms, including those 3

related to the reproductive system. 4

Nail salon workers are calling California 5

Occupational Health Hazard hotlines in significant numbers 6

to make pregnancy-related inquiries. Some technicians say 7

they plan to quit their jobs when pregnant to avoid toxic 8

exposures. And there is reason for concern. 9

Although there is not a tremendous amount of 10

research on the issues, we do know that chemicals are 11

getting into nail salon workers' bodies and that many of 12

those chemicals can be harmful. As an example, phthalate 13

levels in the body have been found to be higher in nail 14

salon workers relative to the general population. 15

And as far as harm, studies have shown a positive 16

association between phthalate exposure levels and adverse 17

reproductive outcomes such as pre-term birth. And just 18

recently, I believe last week, the EU decided to recognize 19

dibutyl phthalate and three other phthalates as endocrine-20

disrupting chemicals for humans under the EU's REACH 21

regulation. 22

A 2014 study found that manicurists in California 23

are at greater risk of pregnancy complications such as 24

placenta previa, as well as diabetes, gestational diabetes, 25


(510) 313-0610

premature rupture of the membranes, low birth weight and 1

small for gestational age, compared with the general 2

population for all races combined. 3

And while studies that quantified toxic exposure 4

in nail salons are wanting, chemicals of concern have been 5

detected by air monitoring in salons. Every day nail salon 6

workers and owners are served up toxic cocktails of 7

potentially harmful ingredients. 8

Here, for example, are the various products used 9

in a pedicure with traditional polish, and this is an 10

example of a pedicure I personally just went through. The 11

technician was a woman of Vietnamese descent. She spoke a 12

little English and we were able to have a conversation. 13

She came to the United States as a refugee from 14

Vietnam, stopping on the way in the Philippines in a refugee 15

camp before she came to the United States. She got into the 16

nail salon work because she could be trained for it. 17

English language wasn't essential. For many women in the 18

Vietnamese community nail salon work is their route to some 19

sort of economic security. 20

First, there's polish thinner, which may be used 21

if a polish is too thick to spread. And thinners often have 22

toluene or methyl ethyl ketone, both of which are neuro and 23

developmental toxicants among other health concerns, and 24

both are on the DTSC Candidate Chemical list. 25


(510) 313-0610

And I'm going to be mentioning that list quite a 1

few times, and so to avoid tongue-tying myself with 2

Candidate Chemical list, I'm just going to say CC list. So 3

everyone knows now what I'm going to be talking about. Then 4

after the polish is thinned, polish remover may have to be 5

applied if there's nail polish already on the toes. 6

And polish remover often contains significant 7

amounts of acetone. Although an alternative may be with 8

ethyl or butyl acetate may be better as far as human health 9

impacts, both are prohibited from polish by the Air 10

Resources Board's Consumer Product VOC limit. Acetone, on 11

the other hand, is an exception to that regulation. 12

Then after the nail polish is removed, cuticle 13

remover or softener is applied to work on the cuticles. A 14

2012 safety data sheet for cuticle remover listed, among 15

other chemicals, methyl ethyl butyl propyl parabens, which 16

may be reproductive toxicants and endocrine disrupters, 17

they're also on the DTSC CC list and are priority chemicals 18

for California Biomonitoring Program. 19

And this product also contained fragrance, and we 20

heard a presentation about potential impacts of fragrance 21

earlier, and we also heard that they are not required to be 22

disclosed. The product just contained the general listing 23

of fragrance, and who knows how many components and how 24

dangerous those components are. 25


(510) 313-0610

Then after the cuticle remover or softener, 1

cuticle oil or a scrub product is often used, and they often 2

contain fragrance, and quite a strong fragrance, I might 3

add. And then comes sort of the main event, which is the 4

base coat, the color coat and the top coat. 5

And the ingredients for those products are pretty 6

similar, if not identical. In fact, I believe Creative Nail 7

Design makes a safety data sheet that is supposed to reflect 8

ingredients in base coats, top coats, and nail lacquer. 9

Some of the ingredients in base coat, top coat, 10

and nail lacquer include solvents, and that makes the polish 11

spreadable. And examples of solvents in nail salon products 12

are toluene, which is a reproductive toxicant, and isopropyl 13

alcohol. 14

Resins have the function of reducing brittleness 15

and improving adhesion and create a more durable polish. An 16

example of a resin is tosylamide formaldehyde resin. That 17

may be a skin allergen for some, and one study showed that 18

the higher the tosylamide formaldehyde resin levels in 19

polish, the higher the formaldehyde level in that polish 20

also. 21

Plasticizers are added for flexibility and reduce 22

brittleness. Examples of plasticizers, which you've heard 23

of today, are dibutyl phthalate, which is a reproductive and 24

development toxicant; we've also heard about triphenyl 25


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phosphate, which is a suspected endocrine disrupter, and a 1

recent Duke University study showed that TPP can be absorbed 2

through the nail or skin of customers. 3

And rounding off the content of polishes, there 4

are pigments which can contain harmful metals. And then 5

after the coat is applied to speed up the drying process a 6

nail dry aerosol is often applied which contains t-butyl 7

alcohol and butane, both of which are DTSC Candidate 8

Chemicals. 9

Then after the customer steps away from the 10

pedicure booth, the nail salon worker or owner has to scrub 11

the tub, and they have to use a hospital grade disinfectant. 12

They have to do that after each client and they have to do 13

that at the end of the day, according to state agency rules. 14

And then they have to do it once a week. They 15

have to fill the tub with this hospital grade disinfectant 16

and leave the disinfectant in the tub for six hours in order 17

to comply with Board of Barbering and Cosmetology Rules. 18

All during that time there are exposures to not only the 19

nail salon worker, but any customer that's in a salon. 20

That's just a pedicure service using traditional 21

polishes. There are also artificial or acrylic nail 22

services, which for many nail salons are really the bread 23

and butter of their businesses. Artificial nail systems 24

grew out of dental technology used for bridges and crowns. 25


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Many major nail product companies started in 1

dental products before branching out to cosmetics. OPI, for 2

instance, originally stood for Odontorium Products, Inc. 3

There are basically two types of artificial nail services. 4

The term "acrylic" usually refers to liquid and powder 5

mixes, which are combined by the nail technician into a 6

dough and shaped onto the nail with a brush and then air 7

dried. 8

Gel nails, the newest product, are painted on from 9

a container of already mixed dough. Now, gel nail services 10

avoid the nail technicians having to mix the powder and the 11

liquid monomer and the consequential exposure. However, gel 12

nails require multiple rounds of exposure to UV or LED 13

light, and LED light also contains UV light, to cure or dry 14

the artificial nail covering. 15

And this is especially concerning as UV rays are 16

carcinogenic. Plus, we have no idea what synergistic effect 17

there may be when UV light and these chemicals come 18

together. Sometimes, the gel products are touted as a safer 19

alternative to acrylic nails, but we have concerns about 20

both, since both gel and acrylic nails contain 21

methacrylates. 22

Methyl methacrylate or MMA, is irritating to the 23

skin, eyes and mucous membranes in humans, an allergic 24

response to dermal exposure may develop and there are 25


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respiratory effects, such as occupational asthma. 1

Respiratory symptoms observed following acute exposures 2

include chest tightness, coughing, wheezing and reduced peak 3

flow. 4

Neurological symptoms such as headache, lethargy 5

and lightheadedness have also been reported in humans 6

following acute exposure to MMA. And MMA monomer is 7

prohibited from use in California nail salons by the State 8

Licensing Agency, but it's prohibited due to the harm that 9

resulted several years ago to the nail beds of customers, 10

not because of any potential harm to the nail salon workers. 11

EMA, or ethyl methacrylate, is often used as a 12

substitute, but EMA raises similar concerns as far as 13

allergic contact dermatitis and occupational asthma, but to 14

date there is little, if any, study as far as we know 15

regarding the relative safety of MMA versus EMA, or the many 16

other methacrylates, and as time goes on one is being 17

replaced or substituted out for another. 18

And another problematic chemical in artificial 19

nail products is the carcinogen N, N-Dimethyl-p-toluidine, 20

which is also on the DTSC Candidate Chemical list. It's 21

used as an accelerator in the curing of methyl methacrylate 22

monomers and is a substance of concern for workers and 23

consumers, as exposure routes include not only inhalation, 24

but also possibly through skin absorption. 25


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The backdrop to this not so jolly chemical 1

cocktail party at nail salons is that industrial chemicals 2

in cosmetic products are largely un- or under-regulated in 3

the U.S. Of the 10,000 chemicals used in personal care 4

products, including nail care products, only 10 percent have 5

been assessed for safety. 6

When it comes to cosmetic products the federal FDA 7

law prohibits the marketing of adulterated and mis-branded 8

cosmetics in interstate commerce. Adulterated signifies 9

whether it contains a poisonous or a deleterious substance, 10

and it's usually connected with more acute reactions. 11

Currently, there's no requirement that the FDA 12

assess the safety of cosmetics products before they go on 13

the market. There's no mandatory recall authority for the 14

FDA if a product is unsafe, and fragrance components do not 15

have to be disclosed, as you heard earlier. 16

And due to a large loophole in the labeling laws, 17

manufacturers of professionally used cosmetics do not have 18

to list the ingredients on the labels. And on the state 19

level there's the Sherman Food Drug and Cosmetic Law that 20

pretty much tracks the federal law, the Safe Cosmetics Act 21

and Program -- someone will be talking about that program 22

later today -- and then Cal OSHA law, which sets exposure 23

limits for many chemicals. 24

And it was referred to today as sort of a 25


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touchstone to show that a chemical is safe if it's below Cal 1

OSHA limits. However, Cal OSHA limits and OSHA limits are 2

woefully out of date. In fact, if you go to the OSHA 3

website you'll see that the agency itself says that these 4

exposure limits are out of date. 5

And many of the exposure limits with OSHA or with 6

Cal OSHA are not based on chronic harm. They're based on 7

acute harm. So you've heard something about healthy nail 8

salon recognition programs. The Collaborative started 9

advocating for those about five, six years ago. 10

Now, there are five cities and counties in 11

California and about 130, 140 nail salons total that are 12

trying to use less toxic products, and this dovetails very 13

nicely with AB 2125, where DTSC is going to be involved in 14

this effort, and then this program with DTSC to try to find 15

safer alternatives. 16

And we know that nail salon workers and owners 17

want safer products. We've done surveys of consumers and of 18

healthy nail salons. They say they're willing to pay more 19

for healthier products. Nail salon owners say their 20

business goes up. So safer products, as hopefully this 21

process will result in, is a win/win for everyone. 22

To close, the Collaborative and our Research 23

Advisory Committee and our various scientific and policy 24

partners really believe that ultimately, DTSC, assuming it 25


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does pursue nail products, look at chemicals as a group, as 1

groups of chemicals and not as individual chemicals. 2

Some of the groups that DTSC might target would 3

include plasticizers, methyl methacrylates, resins, 4

solvents, phthalates, and fragrances. The Collaborative 5

believes it's better to be safe than sorry when it comes to 6

health of women workers, especially the most vulnerable, 7

like nail and other salon working professionals. And we're 8

hoping that you all here today and DTSC agree with us on 9

that. Thank you. 10

MS. RUBIN: Thank you, Catherine. At this time 11

we're going to take questions and comments to Catherine's 12

presentation. If you'd like, I can repeat the question or -13

- 14

MS. PORTER: Sure. 15

MS. RUBIN: Okay. So I'll repeat the question 16

asked or comment for those on the line, and we will have 10 17

minutes now. So does anyone have any comments or questions 18

in the room? Yes. 19

DR. SINGLA: Thank you for the presentation. You 20

mentioned a -- 21

MS. RUBIN: Could you -- oh, sorry. Can you 22

identify yourself and your affiliation? 23

DR. SINGLA: Veena Singla, with the Natural 24

Resources Defense Council. Thank you for the presentation. 25


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You mentioned a number of different chemicals of concern in 1

these salon products. Could you speak a little bit about -- 2

what do you know about the placental health effects of 3

exposure to these many different chemicals at once, and what 4

are some of those concerns? 5

MS. RUBIN: Her question was about the health 6

effects to potential exposure or to exposure -- 7

DR. SINGLA: Of many different chemicals. 8

MS. RUBIN: -- to exposure of a combination of all 9

these different chemicals. 10

MS. PORTER: We don't know much, if anything. 11

That's a great issue and it's an issue I think that's come 12

up here today. These chemicals generally are looked at as 13

individual chemicals and not as chemicals that may be 14

interacting with other chemicals. 15

I mentioned the issue of UV light interacting with 16

chemicals on nails. That's an issue that has not been 17

looked at. And then, of course, just your hodge-podge, your 18

cocktail of chemicals and how they interact or react with 19

others has not been looked at, as far as we know, although 20

there was much reference to studies or certifications that 21

show safety of products. 22

Again, we'd love to see those studies and we'd 23

love to see if any of those studies look at chemicals in 24

conjunction with other chemical exposures. 25


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MS. RUBIN: Okay. On this side. 1

MS. POWDER: Jill Powder, Environmental Health 2

Decisions. This is more of a comment than a question. I 3

would imagine the only way to address that question would be 4

through some kind of epidemiological study where they're 5

actually looking at, here's the concentrations of chemicals 6

x, y, z, a, b, c, d in the air at the nail salon, and here 7

are the potential health effects of the workers there that 8

are exposed eight hours a day, five days a week. 9

I mean, short of that, I can't think of any other 10

way to find an answer to that question. 11

MS. RUBIN: Her comment was a response to the 12

first question asked, and it was a recommendation for an 13

epidemiological study based on nail salon workers and the 14

chemicals they interact with. 15

MS. POWDER: And actual air concentrations. 16

MS. RUBIN: And actual air -- and indoor air, 17

sampling. 18

MS. POWDER: And exposure scenarios. 19

MS. RUBIN: And exposure scenarios. 20

DR. SINGLA: And could I just add one more comment 21

to that? 22

MS. RUBIN: Yeah. 23

DR. SINGLA: This is Veena Singla again, with the 24

NRDC. Thank you for the comment. I agree that this is 25


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certainly an area for more research, but I think the studies 1

that we do have on a number of these chemicals together do 2

indicate cause for concern. 3

For example, let me think about VOCs and total VOC 4

content. There is definitely evidence that total VOC 5

exposure can be attributed to respiratory irritation. With 6

the phthalates, as well, there's definitely concern for a 7

cumulative exposure to multiple phthalates that act together 8

to impact the same health end point. 9

MS. RUBIN: Her comment was on exposure to 10

multiple chemicals and the knowledge that we do have. There 11

are studies that show exposure to multiple chemicals, like 12

different types of phthalates and VOCs, can in fact help. 13

Is that accurate? 14

DR. SINGLA: Yes. 15

MS. RUBIN: Okay. Good. Just making sure. I 16

believe you were next. 17

MS. LITTLE: Yeah. Catherine, at the beginning of 18

your presentation, you talked about some studies that had 19

been done with regard to the effects or the health concerns 20

among nail workers. How close did those studies match 21

something that she's talking about? 22

MS. RUBIN: Okay. 23

MS. LITTLE: I guess my question is, can you talk 24

more about the studies that you all have done with regard to 25


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the nail salon population in terms of the overall health 1

effects, as we would assume they would all be exposed to 2

this cocktail of chemicals. 3

MS. RUBIN: So again, that's Susan Little. 4

MS. LITTLE: Susan Little, with the Environmental 5

Working Group. 6

MS. RUBIN: Okay. And your question was? 7

MS. LITTLE: Was to explain more about those 8

studies that she brought up in the beginning, and how they 9

illustrated the effects of the chemicals that the salon 10

workers were exposed to. 11

MS. RUBIN: She's looking for a more in-depth 12

explanation of the studies referenced earlier in your 13

presentation on how the chemicals affected -- 14

MS. LITTLE: Affected salon -- 15

MS. RUBIN: -- the workers. 16

MS. LITTLE: Yeah. 17

MS. PORTER: I believe it was the study that 18

looked at the large world of cosmetologists and nail salon 19

technicians licensed through the BBC throughout California. 20

It wasn't individual nail salons looking at individual air 21

levels at individual nail salons. 22

It was just a study that looked at whether 23

reproductive concerns are prevalent in the nail salon and 24

cosmetology world, and how prevalent are they compared to 25


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the general population. And it determined that there are 1

several types of negative reproductive outcomes that are 2

more prevalent among nail salon workers. 3

And in fact, specifically among Vietnamese nail 4

salon workers there was information. I believe that was 5

small for gestational age, was something that was unique, 6

even to Vietnamese nail salon workers. 7

MS. RUBIN: Okay. Angie. 8

MS. PEREZ: This is Angie Perez, Cardio ChemRisk. 9

I have a couple questions. The first is: are you exploring 10

any sources of funding for biomonitoring through this 11

program? 12

MS. RUBIN: Her question for Catherine was, are 13

you exploring any sources of funding for biomonitoring for 14

this program? 15

MS. PEREZ: It just seems like such a perfect 16

setup for it. 17

MS. PORTER: Well, this program, meaning the 18

Healthy Nail Salon Program? 19

MS. PEREZ: Um-hum. 20

MS. PORTER: We are not. There have been 21

biomonitoring studies, though, that did show high levels of 22

various chemicals. It's not as if that hasn't been done. 23

Our organization is a small nonprofit and we depend on 24

foundation funding. 25


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And so I'm sure if there were any manufacturers 1

that would be willing to donate some money for us or for the 2

state to do a biomonitoring study that would be great. 3

There is a biomonitoring program in California. So I'm sure 4

that program could also use some funding, also. 5

MS. RUBIN: And did you have a follow-up question 6

to that or was that -- 7

MS. PEREZ: I do, but it was unclear. 8

MS. RUBIN: Okay. Okay. Yes, Ky. 9

MS. GRESS: Ky Gress, from Safer Consumer 10

Products. I have a question. Would it be feasible for your 11

organization to collaborate with a college of public health 12

to do large-scale surveys in nail salons through California 13

to try to get some of this epidemiological data, fill in the 14

gaps? Would it even be feasible for your organization to 15

collaborate on that level? 16

MS. RUBIN: So the question was about 17

collaboration with colleges or other organizations to -- 18

MS. GRESS: Collect data. 19

MS. RUBIN: Collect data. 20

MS. GRESS: Go into those salons. 21

MS. RUBIN: And -- 22

MS. GRESS: Collect health, potential health 23

effect data. 24

MS. RUBIN: And organize a biomonitoring -- 25


(510) 313-0610

MS. GRESS: No, not biomonitoring. 1

MS. RUBIN: Oh, it's not -- epidemiological. 2

MS. GRESS: Just literally surveying potential -- 3

MS. RUBIN: Okay. So a literal survey by colleges 4

or other organizations of -- 5

MS. GRESS: I'm just -- no. Really. It just 6

seems like it would -- might be a fit, your organization, 7

your staff, a college of public health and your 8

organizational and staff going into the salons, facilitating 9

the gathering of survey data to help fill in some of these 10

gaps. 11

MS. PORTER: Right. I can answer that. I think I 12

mentioned we've done one set of informal surveys or what I 13

characterize as informal, with our Healthy Nail Salon 14

Program, nail salons, and elicited andreceived some 15

information through that. 16

The nail salon community, like many small worker 17

communities or immigrant communities, have their sets of 18

unique characters that make the process of surveying 19

different and more time-intensive and requiring more in 20

relationship-building and outreach with our bilingual staff 21

than, say, if a community was all English-speaking, U.S. 22

born. 23

I'm sure if an agency or a foundation was 24

interested in providing us money and providing us more staff 25


(510) 313-0610

to be able to do that sort of bilingual, cultural, sensitive 1

outreach on a large scale, maybe in conjunction with DTSC 2

and its AB 2125 Program, I'm sure we wouldn't turn away from 3

that. But that's a significant amount of resources that we 4

would require to participate in that. 5

MS. RUBIN: We've got time for one more, and okay, 6

Angie. All right. 7

MS. PEREZ: I just had one follow-up question 8

about one of the endpoints that you mentioned, placenta 9

previa. Whereas, you mentioned that that was a potential 10

adverse health outcome as a result of exposure, do you know 11

if that study controlled for genetic or population-based 12

risk factors? Because it's my understanding that Asian 13

women generally have higher rates of placenta previa than 14

their white counterparts. 15

MS. PORTER: I -- 16

MS. GRESS: So -- we got to repeat the question. 17

MS. RUBIN: Sorry. We're going to repeat it. 18

MS. PORTER: Oh, I can repeat the question. 19

MS. RUBIN: Okay. 20

MS. PORTER: The question was about asking for a 21

few more details about the study that looked at the nail 22

salon community, nail salon technicians and their higher 23

levels of negative reproductive outcomes, including placenta 24

previa, and specifically, placenta previa. 25


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I don't remember offhand. I actually have a copy 1

of the study with me. I'd be glad to -- I'm not sure I'd be 2

glad to give it to you, just because I like to hold onto my 3

hard copies of things. 4

MS. PEREZ: You can just tell me -- 5

MS. PORTER: But if I got your email I'd be glad 6

to send you that study and you could take a closer look at 7

it, yeah. 8

MS. PEREZ: Okay. 9

MS. RUBIN: Okay. So thank you very much. Thank 10

you, Catherine. 11

MS. PORTER: Thank you. 12

MS. RUBIN: We're going to move on to our next 13

presentation. Our next presenter is Tom Myers, EVP-Legal 14

and General Counsel for the Personal Care Products Council. 15

His presentation is about The Safety Behind Ingredients in 16

Nail Products. 17

MR. MYERS: Good afternoon, everyone. Thank you 18

for being here. Thank you to DTSC for inviting me to do 19

this, Christine, too, although probably reluctantly agreeing 20

to let me up here. I think that it's really important and 21

very helpful to have these conversations and these types of 22

workshops where we kind of come together and talk about 23

these things. 24

Especially because of the diversity of opinion in 25


(510) 313-0610

the room, there is certainly a tendency for people to hear 1

from an industry representative or an NGO and to not listen 2

to what the other person is saying. So I really do try to 3

listen to all the different presentations, and I hope you do 4

the same, as well, so that we can facilitate good 5

conversations going forward. 6

My name is Tom Myers. I'm with the Personal Care 7

Products Council. I'm their general counsel. We are a 8

national trade association for the cosmetics industry. 9

We've been around since -- a long time -- since the 19th 10

century, and we have had a multiple number of name changes 11

over the years. 12

For the last 10 years we've been known as the 13

Personal Care Products Council. We have about 600 member 14

companies. A majority of them are manufacturers, cosmetics 15

finished-food manufacturers, although we do also have 16

suppliers, as well. We have a number, like many trades 17

associations, for those of you who -- well, most of you are 18

probably familiar with them, but they have a variety of 19

different departments. 20

Science is probably our largest one, Legal and 21

Regulatory Government Affairs, etc. And we try to get out 22

there and be the voice of the cosmetics industry. 23

A couple of things I want to talk about today and that 24

is the following. The first is the myth that cosmetics are 25


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not regulated. Cosmetics are not pre-approved, which may be 1

why this narrative seems to continue and to be, and is kind 2

of accepted, widely accepted narrative in the public, but 3

that's absolutely not true. 4

They are regulated. They're regulated different 5

than, say, a drug, also regulated by the FDA, which of 6

course does have pre-approval. Cosmetics do not, but that 7

does not mean that they are not regulated. So if you take 8

away anything today, hopefully, that's it. 9

These are the three pillars that I want to talk 10

about, and when I said that they were reluctant to let me up 11

here, it wasn't because I'm a lawyer or this is an open mic 12

or the fact that I'm not a scientist. It's really because I 13

wasn't sure, since I wasn't talking specifically to some of 14

the questions that were going to be presented in this 15

background document. I said I really want to provide some 16

more context, and maybe some additional points of reference 17

that people can refer to when they're seeking information on 18

some of this stuff. And so that's why they said, okay, 19

fine, you can come up and speak. 20

Let me talk first, a little bit about the 21

government. I'll only do a little bit about that, since we 22

have heard from the last speaker on that and some other 23

folks. I also want to talk about some third-party 24

assessments that are done, and then some of the things that 25


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the industry is doing beyond what you heard today from the 1

representative Coty, who got up here and talked about what 2

the industry does and how they test for safety before 3

anything goes to market, what are some of the other things 4

that are out there that we can also look at. 5

Briefly, what does the law say? You heard a 6

little bit about this. The cosmetics products and their 7

ingredients have to be safe. Before they get out there you 8

have to be able to substantiate their safety. It's like a 9

post-surveillance system. 10

Why is that different? Why are they regulated 11

different than drugs? Well, FDA has come out and said, 12

“you're the safest product category that we regulate. We 13

basically have bigger fish to fry and so we don't worry as 14

much about cosmetics.” 15

So they have a post-surveillance, post-marketing 16

effort in place, which is how they regulate things. 17

Companies, of course, are legally responsible for their 18

products. You heard a little bit about the Food, Drug and 19

Cosmetics Act. 20

What it says is that it can't be adulterated. It 21

can't be misbranded. I also want to mention briefly, it's 22

not on the slide, but the Fair Packaging and Labeling Act, 23

that's one of the laws that's out there that says that you 24

can use the word "fragrance," for example. 25


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And I will say, I heard the discussion earlier 1

about the fragrance issue, and in a quick plug for IFRA, 2

another trade association out there, I think that they 3

really struggled with how to reconcile the right to know for 4

consumers with their trade secret information. 5

You have intellectual property law and this right 6

to know kind of bumping up against each other; so, they're 7

trying to find this balance. And so they released a 8

palette; here's the stuff that's in it. They don't give the 9

concentrations. 10

And I heard the comment that it's not trade 11

secret. It's not like the formula to Coke. Well, it is 12

like the formula to Coke. It is very important to these 13

fragrance houses. That is, the value is in the fact that it 14

is secret. 15

Fifty years of intellectual property law supports 16

that. I think they have struggled with the issue. They're 17

certainly aware of it and they have tried to find a way to 18

address that. I just wanted to put that out there as well. 19

Last slide on the government's authority, but this 20

is with FDA. What can they do? They do all kinds of 21

inspections, they issue warning letters, voluntary recalls. 22

Voluntary recalls are, in effect, mandatory recalls for the 23

industry. 24

If the FDA is going to say, we want you to recall 25


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something, they're not going to say no. They're going to do 1

it. They're going to get out there and do it. I will also 2

say there is federal legislation that has been trying to get 3

passed to modernize the Food, Drug and Cosmetic Acts, 4

specifically with regard to cosmetics. 5

Senator Feinstein, in fact, Feinstein-Collins 6

Bill, which has been around. They've been doing this for 7

seven or eight years now, trying to get something together 8

and the industry has been there saying, we support mandatory 9

reporting. We support mandatory recalls; we support all 10

this kind of stuff. 11

There are a lot of things that, while it's 12

voluntary now, the industry is behind having mandatory, as 13

well, GMPs, etc. Other things, they can have restraining 14

orders, they can seize products, criminal prosecution, if 15

there's criminal negligence or intentional acts. 16

Imports, also, I think the most common reason that 17

things get stopped at the border coming in from other 18

countries is usually because they're making a drug claim on 19

a cosmetic, that's a no-no, or it has an unapproved color 20

additive. 21

You've heard again today from a couple of folks 22

that color additives are pre-approved. You can look them up 23

in the CFR, Title 21 of the CFR. They list them all out 24

there. Those have to be pre-approved, and then, of course, 25


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the drug claims are things where if you're saying something 1

like, my cosmetic will cure cellulite or something, or 2

mitigate wrinkles, you can't say that. 3

You can say it will reduce the appearance of 4

wrinkles or something along those lines, a more cosmetic-5

type claims. There are lot of issues with regard to making 6

drug claims on cosmetics. That's another reason that 7

they're stopped, not because they're not safe necessarily. 8

The Adverse Event Reporting, this has been in the 9

news a lot lately. CFSAN, the Adverse Event Reporting 10

System, CFSAN, is the Center for Food Safety and Applied 11

Nutrition under which the Office of Cosmetics and Colors 12

falls at FDA. 13

CFSAN's the umbrella and cosmetics and colors 14

reports up to it. They have an Adverse Event Reporting 15

System. That information it has to do with foods, dietary 16

supplements, cosmetics. You can go and now it's all 17

publicly available, publicly searchable, and you can look 18

for instances where there have been complaints about certain 19

products, etc., etc. 20

It comes from consumers, healthcare professionals, 21

industry representatives. Anybody else that wants to file a 22

complaint can do so. A couple of quick stats. Looking back 23

at the last 13 years there have been 4,300 unique reports on 24

cosmetics, which results in about 340 reports a year. 25


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That includes 1,200 reports on one single product 1

where there was a very well publicized incident regarding a 2

shampoo. About 70 percent of these are non-serious, like a 3

rash or an allergic reaction of some type. I found this 4

stat, which I liked, was 122 billion units of cosmetics were 5

sold in 2010, which equates to 0.004 reports per million 6

units out there. 7

And then if you compare that to the same thing on 8

drugs in 2014, for example, 823,813 adverse event reports; 9

340 reports versus 800,000something , quite a difference. 10

You can see why FDA has said it's such a safe category. 11

And the take away of that is that adverse events 12

with personal care products are actually extremely rare. I 13

get that the Adverse Event Reporting System, it is not 14

perfect. It needs to be addressed and updated, and again, 15

they're attempting to do that in the federal legislation, 16

but it's a useful barometer for these kind of things, so. 17

And the bottom line, of course, is that our 18

present practices that we're doing, both inside industry and 19

outside, are proven to work. Okay. So third-party 20

confirmation. I don't know. Maybe everyone knows. Maybe 21

this is just a refresher. But the Cosmetics Ingredient 22

Review is a third-party group that is out there that looks 23

at all the cosmetics ingredients or has been looking at 24

cosmetics ingredients and publishing safety data or safety 25


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reports based on the data they find. 1

This group, Cosmetics Ingredient Review, and their 2

website is not up there. So it's a secret. No. It's 3

actually, I don't know why it's not there. I must have 4

forgotten it; cir-safety.org is the website. So how did it 5

get started? 6

Well, industry back in the early '70s decided that 7

they needed some type of mechanism in place, went to the FDA 8

and said, hey, we really think this is a great idea. We 9

think you should assess the safety of all the cosmetics and 10

they said, we have neither the time, the inclination nor the 11

resources to do that, you go do it, which they turned around 12

and did. 13

In 1976 industry funded the CIR. They did it with 14

the support of FDA and the Consumer Federation of America. 15

They tried to make it as completely independent as possible, 16

knowing that it would be knocked as some industry hack 17

organization, right? 18

Again, talking about the narratives that are out 19

there; yes, it is industry-funded, but it is truly set up as 20

independently as possible. All of the meetings are open. 21

All of the reports are public and published. 22

There is notice and comment. Anybody can comment. 23

Anybody can submit comments on this. This is the expert 24

panel that actually does it: Wilma Bergfeld, who is the 25


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Chair of the CIR, from the Cleveland Clinic, there are 1

dermatologists, toxicologists, pathologists, and chemists. 2

You can see all the different academic 3

institutions from which they come, not from industries. 4

And, then, the non-voting liaison. They represent the 5

consumers, which is Rachel Weintraub, Linda Katz. Dr. Katz 6

is the director of the Office of Cosmetics and Colors at 7

FDA, and Dr. Beth Jonas, representing industries. You have 8

those kind of three legs. 9

They don't get to vote, but they're at every 10

meeting and they can represent and talk and do some things 11

like that. So how does it work? Well, they set the 12

priorities. They go through a process of setting 13

priorities, which chemicals they're going to look at. 14

Frequency of use tends to be the surrogate for 15

exposure. They also see if there's -- sometimes you'll see 16

a lot of news reports or things -- red flags that pop up and 17

they say, okay, there may be a specific concern. They take 18

that into consideration when they're looking at these and 19

setting priorities. 20

Then they go out and they canvass all the 21

scientific literature that they can find, both published and 22

unpublished. People can submit unpublished data, as well. 23

Then they solicit comments. They do their findings, et 24

cetera, et cetera. It's this whole -- as I said, it's this 25


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very inclusive process, very open process. 1

And then they have a public discussion and of 2

course make a decision, and then all of the results get 3

published. They're not only available on the CIR website, 4

but they -- all the final reports at least get published in 5

the International Journal of Toxicology. So they can all be 6

found there, as well. 7

Right now they've looked at about 4,800 cosmetics 8

ingredients and each one of those ingredients, as it says up 9

there, there can be hundreds of studies for each ingredient. 10

If you have data that you want them to consider when they 11

are setting their priorities, when they are looking at these 12

chemicals, I strongly encourage you to participate and be 13

part of this. 14

That's the whole point of it, is to take in as 15

much information as possible when they're coming to their 16

conclusions. And their conclusions are usually one of four. 17

It's safe. It's unsafe for using cosmetics. It's safe with 18

certain qualifications to it or there's insufficient data to 19

come to a decision. So those are the four kinds of things 20

that they can conclude. 21

Okay. Moving onto another one, INCI. I suspect 22

many people probably know that. If you're here and you know 23

cosmetics, you know what INCI is: the International 24

Nomenclature of Cosmetics Ingredients; too much of a 25


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mouthful, so it's shortened to INCI. 1

There is a committee that it's -- looks at -- you 2

can make applications. You can apply for this whole naming 3

process for an ingredient. And the reason that they have 4

this up there is so that they have uniform, systematic 5

names, not just in the United States on labels and for 6

labeling purposes, but internationally, as well. 7

It is recognized around the world, INCI names are 8

used on labels and in regulations. It's actually 9

referenced. We have a dictionary. It says up there, the 10

International Cosmetics Ingredient Dictionary and Handbook. 11

That dictionary is published and has been every year for 12

decades now, and it's pretty voluminous. 13

And it is like a Merriam Webster's on steroids. 14

It's enormous. It's got a lot of information, as you'll see 15

in a moment, and a useful resource, and it is. So, what is 16

it? It's a technical compendium. It's got a lot of 17

different information. 18

It's not just the genus and species and all that 19

kind of information about the naming convention, but it goes 20

through what the uses are,, who participates in this INCI 21

Committee. It's different trade associations, international 22

groups, all looking to come together and it's completely 23

science-based. 24

And the purpose, of course, is to have a single 25


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reference for the name of that cosmetics and it's very 1

important to be talking about -- to make sure everybody's 2

using the same language when you're talking about something, 3

right. 4

And I was trying to think of a good example of 5

that on the way over today, and here's what I came up with. 6

I was on a family vacation in Florida and we were driving 7

the car and we were going through this town. My wife says, 8

oh, we're in Kissimmee, Florida. I said, no, it's 9

Kissimmee, Florida. And she said, no, it's Kissimmee, 10

Florida, and I said, no, it's Kissimmee, Florida. 11

And so we're kind of going back and forth. Then, 12

the kids in the back seat start getting into it. No. No. 13

It's Kissamay [sic], and I'm like, oh, God. This is going 14

on and on. I said, all right, I've had it. So I pull off 15

the road and I pull into this parking lot and I said, I'm 16

going to settle this once and for all. 17

And I went inside to the first establishment I 18

could find and I walked up to this poor young lady and I 19

said, can you please tell me very slowly, very succinctly, 20

where am I? And she looks at me and she goes, Burger King. 21

(Laughter) 22

MR. MYERS: And I said, okay. Words are 23

important; words are important. It's important that you're 24

talking about the same thing, right? So what is INCI not? 25


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It is not an endorsement of an ingredient's safety. That is 1

not what it's there for. 2

As I said, it's strictly a naming convention. It 3

is not a pre-approved list of ingredients for any country. 4

It's always the responsibility of the finished goods 5

manufacturer to substantiate safety and to comply with the 6

regulations. 7

These are the key takeaways for the INCI. It is a 8

uniform ingredient labeling and the names promote a common 9

understanding of cosmetic composition. The last point there 10

is important, as well, consumer health benefit so that you 11

can recognize ingredients. 12

For example, if you're over in Europe or something 13

you can look at the same -- if you know you're allergic to a 14

particular ingredient, you can find it, you know, et cetera, 15

et cetera. It's useful. It's useful for that purpose, as 16

well, literally a health benefit. 17

And then the final source that might be of use to 18

folks, in addition to the CIR and the SCCS -- I didn't 19

mention that. I know some other folks did. The SCCS is 20

very similar to CIR, very similar to RIFM, Research 21

Institute for Fragrance Materials, all of them doing their 22

own studies, all of them doing safety studies. 23

SCC does look at sensitive sub-populations and CMR 24

information, as well. That's part of it. 25


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cosmeticsinfo.org. This is another website. It's not just 1

scientific information on ingredients, but also what's most 2

commonly used in cosmetics. 3

It's really kind of two-parted. It's got a safety 4

information page, so it's useful from that front, as well as 5

an ingredient database. It tends to be a little more user 6

friendly for consumers because it's not total geek speak. 7

It's dialed back a little bit so they can understand it and 8

it sets out how cosmetics are regulated and so forth. 9

There's really a lot of really useful information 10

on this site. I did get the website up there, of course, 11

because that's what we call it. It's not very creative. 12

We'll have to come up with a better name, I suppose, but for 13

now, cosmeticsinfo.org. And it includes CIR summaries and 14

other things like that. So there are other things that are 15

out there. 16

My conclusions. Cosmetics are regulated. 17

Cosmetics are safe. We believe that they are safe. I hope 18

that you do, too. Industry responsibility with FDA 19

oversight and third-party reviews has proven to be an 20

effective type -- to be very effective. 21

We see this in the limited number of adverse event 22

reports. Yes, I know that it's not a perfect system, as I 23

said before, but it's the one we have and hopefully it will 24

be improved. And consumer safety -- I know a lot of times 25


(510) 313-0610

people say, well, it's industry, they're going to take the 1

lowest common denominator and they don't care about, the 2

consumers. They only care about their money and so forth. 3

Well, that's like saying, NGOs only care about 4

raising money and scaring people. That's not true either. 5

We need to have better discussions about this. But the 6

number one priority, of course, is the consumers, and we 7

wouldn't have them very long as consumers or customers if we 8

were harming them. We are very cautious about that. And 9

that's it. Thank you. 10

MS. RUBIN: We've got about looks like eight 11

minutes to take any comments or questions to Tom's 12

presentation. Susan. 13

MS. LITTLE: Sure. Just in terms of the 14

industry's industry initiatives, are they planning to look 15

into the issue of chronic effects of the products, versus 16

just adverse? 17

MR. MYERS: The chronic effects -- 18

MS. RUBIN: Will you repeat the question for the 19

people on the line? 20

MR. MYERS: Oh, do you want -- or do you want me 21

to? 22

MS. RUBIN: It's up to you. 23

MR. MYERS: Do the industry initiatives look at 24

chronic effects -- 25


(510) 313-0610

MS. LITTLE: Relative to the long-term 1

application. 2

MR. MYERS: Well, certainly. If there are reports 3

in the published literature that look at that, then that is 4

considered by CIR as part of their assessment. I mean, to 5

that extent, does that answer your question? 6

MS. LITTLE: Just to the extent that it's actually 7

reported, again. You don't look proactively at the 8

potential long-term effects? 9

MR. MYERS: No, not proactively if it's not in the 10

published literature. I think RIFM is different. I think 11

RIFM actually has -- that's the Research Institute for 12

Fragrance Materials -- they actually have scientists and 13

actually conduct studies, as well, rather than just looking 14

at the existing literature base. 15

MS. RUBIN: I'm not sure who was first. In the 16

back? Oh. 17

DR. SINGLA: Veena Singla, with Natural Resources 18

Defense Council. Thank you for a very informative 19

presentation. I've looked at the CIR reviews before. 20

They're very useful. My question is actually about CIR. 21

You mentioned that they can make different findings. 22

If CIR finds that an ingredient or use is unsafe, 23

then what's the process for removing that used ingredient 24

and how is that insured? 25


(510) 313-0610

MR. MYERS: They don't have a -- it's not an 1

enforcement -- there's no enforcement mechanism for CIR. 2

MS. RUBIN: Can you repeat the question before you 3

answer it? 4

MR. MYERS: Oh, yeah. Sorry. I always forget 5

that. 6

MS. RUBIN: That's okay. That's okay. 7

MR. MYERS: The question was, is there, with 8

regard to CIR, is there some type of enforcement mechanism? 9

If they find an ingredient unsafe, for example, how do they 10

go about making sure that it gets off the market and out of 11

products? They don't. 12

There's not an enforcement mechanism, but when 13

they make these findings, industry is very in tune and takes 14

them very seriously. And therefore, if there is an -- I 15

don't know any company, if there is an unsafe finding for a 16

cosmetic that that industry, or there is a company that is 17

still using that chemical as a result. 18

DR. SINGLA: Sorry. Just a quick follow-up to 19

that. 20

MR. MYERS: Sure. 21

DR. SINGLA: Just I guess my concern is exactly on 22

that point, because I know CIR did make a finding in 2011 23

about formaldehyde in hair straightening products, and far 24

as we can tell there are still products with that ingredient 25


(510) 313-0610

on the market. MR. MYERS: I'm not saying 1

everybody's listening to us. I'm just saying -- 2

DR. SINGLA: No. I think -- 3

MR. MYERS: -- yeah. 4

DR. SINGLA: -- that's definitely a concern as far 5

as the unsafe findings, and then ensuring that those 6

products are actually not on the market anymore. 7

MS. RUBIN: Catherine, you were next. 8

MS. PORTER: Yeah. The process of safety 9

substantiation that you mentioned, manufacturers have to do 10

in order to be on the market. I'm wondering if you can 11

describe what's entailed with manufacturers determining 12

safety of a product. 13

MR. MYERS: My guess is that it varies somewhat by 14

the manufacturer. You may have to talk to a manufacturer 15

for that one. 16

MS. RUBIN: Her question was about how -- 17

MR. MYERS: Oh, God. I keep forgetting that. 18

MS. RUBIN: It's all right. I got you. Her 19

question is about how manufacturers determine the safety of 20

products. 21

MS. PORTER: Yes. 22

MS. RUBIN: Yes. 23

MR. MYERS: And that would be that manufacturers 24

have their own -- I don't know. There may be a manufacturer 25


(510) 313-0610

in the house. I don't know. I won't put her on the spot, 1

but I think that they all look at it in different ways. Is 2

that accurate, Katherine? 3

MS. MONTGOMERY: Yeah. And I kind of touched upon 4

our safety assessment process in the presentation this 5

morning. 6

MS. RUBIN: All of the slide shows will be posted 7

on our website, and we just had a comment from Katherine 8

Montgomery and she was mentioning that the processes that 9

they undergo as a manufacturer were mentioned earlier in her 10

presentation. So you'll be able to refer back to that. 11

MR. MYERS: The steps they take for safety 12

substantiation, right? 13

MS. RUBIN: Yes. We're going to go to Angie next, 14

and then -- 15

DR. PEREZ: I had a question about the CIR. The 16

data, is there industry data within -- that's utilized 17

within CIR also, or is it fairly -- 18

MR. MYERS: Sure. Whoever's got -- well, they'll 19

look at the -- all the available published literature out 20

there on a chemical, regardless of whether it's industry 21

funded or otherwise. So yes, there can be -- and there 22

could be unpublished data, as well. A company may come and 23

say here's some unpublished data, as well, that you can 24

consider. 25


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DR. PEREZ: Is that pretty common, that industry 1

would submit data to CIR? 2

MR. MYERS: Yes. It happens, sure. 3

MS. RUBIN: We're going to take our next two 4

questions from people who are participating remotely, and 5

James is going to read them. 6

MR. JOELSON: Okay. The first question is from 7

Simona Balan. Does the CIR produce new data on the 8

cosmetics ingredients they assess? If not, how do they deal 9

with data gaps? 10

MR. MYERS: They will make a finding, if there is 11

insufficient data they can make that finding, but if there 12

are data gaps after the initial review they'll put that out 13

in their call for additional comments and say, we need 14

additional information in these areas, hoping to get 15

additional input from other entities and organizations. 16

MR. JOELSON: And the second question is from Alex 17

Scranton. The claim is that adverse reaction reports are 18

rare, only 4,000 in the last 13 years. It was recently 19

reported that WEN Cosmetics received 21,000 adverse event 20

reports on their products alone in the last four years. 21

Isn't it likely other companies have also received 22

adverse event reports that have not been officially 23

reported? 24

MR. MYERS: Thanks for the question Ms. Scranton. 25


(510) 313-0610

The question was about the WEN shampoo. Is it likely that 1

since they didn't report that others didn't report? Yes, it 2

is possible. As I said, it is not a mandatory system. 3

That is something that we hope to make it through 4

federal legislation or otherwise, and we would like to see. 5

And in that case that is a classic example of how the system 6

doesn't always reflect what's going on. There were 1,200 or 7

so reports that came in regarding WEN products, complaints 8

from consumers and so forth, and in fact the company had 9

actually received thousands more that it did not report into 10

the adverse event report system. 11

The system is not perfect. That was the subject 12

of a congressional hearing as a matter of fact, and 13

discussed at that time. And so that actually helped to make 14

the case for Senator Feinstein's legislation or federal 15

legislation, I should say. 16

MS. RUBIN: Okay. Thanks very much. 17

MR. MYERS: Okay. 18

MS. RUBIN: One more? Okay. 19

MS. ALCANTAR: This is Kathryn Alcantar, with the 20

Center for Environmental Health and CHANGE Coalition. On 21

this -- it's a follow-up question on the reporting issue. I 22

know that part of the reason we're all convening here today 23

is to discuss the particular vulnerabilities on nail 24

products, both for consumers and workers. 25


(510) 313-0610

And so one thing I just -- that was more of a 1

question or a comment, but I'm curious, how those sort of 2

reporting systems address for the fact that, at least for 3

the workers, many of them are, as we've heard today, 4

immigrants, non-English speaking folks who may not have the 5

understanding of how agencies work and when to report or 6

even just the agency to do that, right, because of where 7

they're coming from and the different attitudes towards the 8

government. 9

I'm wondering if any of the systems address 10

something like that, because it could be that there is 11

significant under-reporting happening because of that. 12

MS. RUBIN: Her comment was on barriers to 13

reporting, based on language and knowledge of reporting 14

systems. 15

MR. MYERS: And it's a well-made point, and I 16

think that, certainly, they tried to address it, for 17

example, with putting SDSs in Vietnamese or different 18

languages and trying to get information out to the workers, 19

for example. 20

But it is. It's an obstacle to reporting and it 21

is not a perfect system, but it is the one we have, so. 22

It's a well-made comment. 23

MS. RUBIN: Thanks very much. At this time I'm 24

going to introduce our next speaker, Jill Ryer-Powder. 25


(510) 313-0610

She's a Ph.D., she's the Principal at Environmental Health 1

Decisions. Her presentation is going to be an Overview of 2

Products Present at Nail Salons, Chemicals in the Products 3

and Potential Exposures and Health Effects. 4

DR. RYER-POWDER: Good afternoon. First, I want 5

to thank DTSC for allowing me to come and speak here, and 6

then second, I kind of want to apologize in advance. My 7

talk is more of an overview. I was picturing going first 8

and giving everybody the broad picture. 9

If some of this sounds repetitive, again, I 10

apologize, but hopefully, you have learned and you will re-11

learn. And I might in between interject some basic, how do 12

you assess health hazard information, because I haven't 13

heard about that yet, and maybe a little bit of risk 14

assessment or hazard assessment 101 might be helpful to the 15

audience. 16

That being said, my presentation is an overview of 17

the products present at nail salons, chemicals in the 18

products and the potential exposures and health effects. An 19

overview of what I'm going to be talking about is, first, a 20

statement of the chemical exposure and health-related issues 21

in nail salons. 22

I'll talk about an overview of the chemicals used 23

in nail salons. I'll discuss the potential routes for 24

exposure in nail salons and present potential health effects 25


(510) 313-0610

from exposure to the chemicals. First, a statement of the 1

issues, and this is what I came up with. 2

In my practice, I do human health risk assessment. 3

I look at the potential for health effects from exposures to 4

chemicals. I combine both the information about inherent 5

toxicity of chemicals and the exposures to come up with what 6

is the actual risk. 7

From my perspective, a statement of the issues is 8

there are a wide variety of chemicals that are found in nail 9

salon products. It's really hard to establish a definitive 10

list of the products. Many of the products are volatile 11

organic chemicals that readily evaporate and could be 12

present in indoor air of nail salons. 13

There are studies of health outcome to nail salon 14

workers which show associations with respiratory, 15

musculoskeletal and neuropsychological symptoms. There's 16

other reported health effects that include irritation of the 17

eyes, nose, throat, skin and headaches. 18

I wasn't able to come up with any definitive 19

studies regarding reproductive outcomes among nail salon 20

workers with regards to epidemiological studies like I was 21

asking about where they have actual, here's the 22

concentrations in the nail salons and here's the outcomes 23

regarding reproductive system effect. 24

Correct me if I'm wrong, but I was not able to 25


(510) 313-0610

come up with any. Why is it so difficult to come up with 1

just a list of the chemicals? There's approximately 100 2

chemicals potentially found in nail salon products, and I 3

got that from a citation from New Ecology. 4

A single nail polish can contain dozens of 5

chemical constituents. We've heard that before. It's hard 6

to establish a list of ingredients because, first, the 7

ingredients vary between products and as we saw, there's a 8

bunch of different products. 9

It's influenced by the character, such as the 10

polish color, the texture, the drying time. We saw that 11

there's metallic nail polishes, which would contain metals; 12

whereas, some other polishes would not contain metals. The 13

ingredients that are common now or in the past may not be 14

used in the future. 15

For example, the gel polishes are all the rage 16

now, and so you know, in the future we may not be using 17

other nail polishes that you paint on one time and call it a 18

day. And then chemicals not currently in use may become 19

common again in the future. So again, hard to establish a 20

definitive list and go off that one list to do future work. 21

The most common categories of products currently 22

reported in nail salons are solvents, thinners, glues, nail 23

polish removers, nail polishes, nail hardeners, artificial 24

nails, and disinfectants. The potential routes of exposure 25


(510) 313-0610

to workers and customers, and again, this is where I'm using 1

my artistic license to diverge from what I originally had 2

planned. In order to really understand what the potential 3

for the risk or the health effect of a chemical, we need to 4

understand the inherent toxicity of the chemical, and we 5

also need to understand the exposure situation. How long is 6

a person exposed? How frequently are they exposed, hours 7

per day, days per year? What is the concentration in the 8

air to which they were exposed? And this again, this is 9

going to depend on their HVAC system, the ventilation, how 10

close the worker or the consumer might be in contact with 11

the actual product. So as a risk assessor, we need to 12

figure out what are the potential routes of exposure. Let 13

me talk a little bit about those. 14

First, there's inhalation and that's the breathing 15

of chemicals that might volatilize from products or 16

particulates that come off of products. There's the 17

inhalation of volatile chemicals that are in product removal 18

and product application. 19

And then the next one, that should be a big 20

bullet, but there's the inhalation of particulates during 21

removal and application of acrylic product. Those of you 22

that might get your nails done or have seen people getting 23

their nails done, when they're removing acrylics they have 24

this machine that grinds along the nails and you get puffs 25


(510) 313-0610

of acrylic and whatnot, acrylic and maybe residual polish 1

coming off into the air, and you have the nail salon workers 2

wearing those surgical masks that are obviously not 3

protecting against these particulates. 4

Volatiles and particulates are real important in 5

the exposure aspect regarding inhalation. There's the 6

dermal contact, and that's the actual contact with the 7

chemicals for the workers, and the application of the 8

products for the customers. 9

There's contact with removers, polishes, gels, 10

acrylics and glues, and then somebody briefly discussed, 11

there's the UV light from the gel-setting equipment. So I 12

don't really know that that has been looked at, but 13

basically, again, for those of you that might not have 14

gotten their nails done, if they put on the gel product, the 15

customer sticks their hand inside a UV lamp for three 16

minutes at a time while they do the other hand, and then 17

they keep switching. 18

For the consumer doing that every two weeks for 10 19

minutes each time, when you add it all up that could add up 20

to some significant exposure from UV light. And then 21

there's incidental ingestion, the hand-to-mouth contact. I 22

love that picture. That was so perfect for that hand-to-23

mouth contact. 24

And just getting -- and this is, again, basic risk 25


(510) 313-0610

assessment where people get chemicals on their hands. They 1

pick up their cup of coffee, drink their coffee and then 2

touch their mouth. And they can have incidental ingestion 3

from that, and any kind of hand to mouth contact, eating a 4

sandwich or eating a cookie or whatnot where they have 5

chemicals on their hands. Then there's accidental splashing. 6

If you look at the bottom, doing the toes there, there's 7

some accidental splashing that goes on where you could get 8

some incidental ingestion of these chemicals. I'm not going 9

to go through these in painstaking detail. 10

My understanding is my slides will be available on 11

the website, but I've come up with a list in those different 12

categories of products that I described before that look at, 13

what is the chemical, what might be a short-term effect, for 14

example, headache, dizziness, nausea, irritation, and what 15

might be a long-term effect. 16

If you're exposed to them chronically, like a 17

worker might be, what might a chronic effect be? And again, 18

I want to qualify that these are for individual chemicals. 19

We're not really sure what happens when you get the mixtures 20

of chemicals, but these are well-documented effects of each 21

chemical. 22

For the solvents, thinners, glues, nail polish 23

removers there's chemicals such as acetone, butyl acetate, 24

isopropyl acetate, methyl ethyl ketone and toluene. For the 25


(510) 313-0610

nail polishes, there's been benzene detected in nail polish, 1

dibutyl phthalate, butyl acetate, diethylhexyl phthalate. 2

For the nail hardeners, here are the chemicals 3

associated with the nail hardeners. And then the 4

disinfectants, which somebody discussed at the end, where 5

the worker's required to clean out the pedicure tub each 6

time. Those disinfectants obviously also contain chemicals 7

and those chemicals can have potential health effects. 8

I put together a slide of a summary of the common 9

effects so I wouldn't have to read through each effect. In 10

the short term, there's irritation of the eyes, nose, 11

throat, skin and respiratory tract; reversible central 12

nervous system effects such as headaches, dizziness and 13

drowsiness, difficulty breathing, and methemoglobinemia, 14

which is difficulty in carrying oxygen to the tissues. 15

And then for the long-term effects there's skin 16

sensitization, adverse effects on the liver and kidney. 17

There's a risk of certain cancers, potential reproductive 18

system effects and potential effects on the developing 19

fetus. For some final comments, some types of chemicals 20

found in nail salon products are associated with adverse 21

health effects at certain exposure levels. 22

And again, we need to qualify what those levels 23

might be and what the mixture of chemicals might be and the 24

levels of those mixtures of chemicals. Nail salon workers 25


(510) 313-0610

and clients may be at risk for such adverse health effects. 1

To assess the potential for adverse health effects, it's 2

necessary to understand the dose to which the worker or the 3

clients may be exposed. 4

And then measures to decrease exposure, including 5

ventilation, gloves, alternative chemicals, will decrease 6

the potential for health risk. And I had a couple of 7

thoughts when I was sitting there listening, and as a 8

consultant I'm always interested in what can you do right 9

now, without even having a full understanding of what's 10

going on. 11

And I was thinking maybe as part of the training, 12

these people have -- they have to get a license, obviously, 13

to work at a nail salon, and I'm wondering if it could be 14

part of the training, a personal protective section on, 15

here's how you can protect yourself against inhalation of 16

particulates, here's the reason why you need to wear gloves, 17

and if you decrease the exposure then you're going to 18

consequently decrease the health effects. 19

I am going to close with that. Hopefully, you got 20

something out of my talk and it wasn't all repetition, and 21

I'm glad to take any kind of questions. 22

MS. RUBIN: Doug. 23


Association. I very much enjoyed your presentation. 25


(510) 313-0610

DR. RYER-POWDER: Oh, thank you. 1

MR. SCHOON: Thank you for that. I totally agree 2

with your assessment about the training. I think training 3

is critical to solving these issues. I heard several times 4

people say that UV hasn't been studied, UV lights haven't 5

been studied. 6

And there are actually two very good studies done 7

on that, one by Dr. Robert Slater and John Daly (phonetic), 8

who are world leading photo biologists who study these 9

lamps; another one out of Brown University. If anyone wants 10

references to these articles, I'd be happy to share them 11

with you, because the news is very good. 12

They found these lamps are far safer than people 13

imagine, largely because of the limited ranges of UV that 14

are used. They're UVA to visible. They cut out even the 15

low end of the UV range and focused just on the ones nearest 16

to the visible range. 17

And I wanted to ask two questions after I made 18

those comments. What do you think about, rather than using 19

the doctor's type surgical mask, using an N95 dust mask, for 20

inhalation of dust? And, I wanted to find out what you 21

think would be a good alternative to doing epidemiology that 22

doesn't involve self-assessments? Because, as we all know, 23

self-assessments can be notoriously inaccurate, and I think 24

we need to get some better information than simply asking 25


(510) 313-0610

people. What do you think, without correlating it with 1

other types of information? 2

DR. RYER-POWDER: Okay. The first question again 3

was an industrial hygiene-related question, and I'm not an 4

industrial hygienist, but I think it's a really good idea if 5

we -- let me first repeat the question. 6

And, for the court reporter, and to get this on 7

record. First of all, he liked my talk. So that was good. 8

(Laughter) 9

MR. SCHOON: Very much. 10

DR. RYER-POWDER: Very much. And the gentleman 11

was talking about, I had mentioned exposures from the UV 12

light during the gel acrylic manicure, and he was talking 13

about that there's actual studies that have been done by two 14

separate groups showing that the health effects from those 15

exposures are not as bad as we might think, due to the 16

limited UV range to which people are exposed. 17

MR. SCHOON: In addition to light. 18

DR. RYER-POWDER: And then he asked me, first, if 19

I thought that as an alternative to the surgical masks that 20

we see the nail workers wearing, if a particular kind of 21

mask would be more helpful to prevent the particular 22

exposure? 23

MR. SCHOON: Correct. 24

DR. RYER-POWDER: Is that right? And I responded, 25


(510) 313-0610

I'm not an industrial hygienist. So I can't really answer 1

that question, but I would think as a part of the training 2

aspect, that would be yes, these are the types of masks you 3

would wear for those applications. 4

And then I am wondering from the woman who was 5

from Coty, do you know when they do the safety assessments, 6

is part of those safety assessments personal protective 7

equipment and how to prevent exposures? 8

MS. MONTGOMERY: They're looking at the actual 9

finished goods, if they have recommendations on how it 10

should be applied or if there should be certain additional 11

steps taken from the personal protection, if they would make 12

reference to that. But it's not something that we generally 13

always reference. 14

DR. RYER-POWDER: What was the next question, 15

please? 16

MR. SCHOON: It was about how we can improve the 17

value of self-assessments, because relying simply on self-18

assessments I think could be very misleading and has misled 19

people in the past. 20

DR. RYER-POWDER: That's a tough one. The only 21

thing I can think of off the top of my head would be if 22

someone were to go into the community to the doctors of the 23

women, of that specific population and somehow get 24

permission to talk to the doctors and say, what kind of 25


(510) 313-0610

health effects are you seeing from these types of workers, 1

because they would have actual medical records and see, we 2

see respiratory infections this often, we see miscarriages 3

or whatnot. 4

So that's the only thing I can think of with 5

regard to that. And then the other -- well, the other part 6

of that if is -- I would think if you get the workers 7

interested enough, not to the point where you're scaring 8

them, that you might get better information from them 9

instead of just, here's a survey, fill it out. 10

MS. RUBIN: So Angie was next and then Veena. 11

DR. PEREZ: Oh. I was just adding a follow-up 12

question with respect to the N95 masks. Has anybody ever 13

done a study characterizing the particle size distribution 14

for dust or particulate emanating during a process, because 15

I don't know if I've ever seen that, because that would 16

really dictate what type of protection we would want. 17

DR. PEREZ: Does anybody know. This is to the 18

group, I guess. 19

MR. SCHOON: I have done studies, but they've not 20

been published. But I do agree, I think that's something 21

that should be looked at. 22

DR. PEREZ: So N95 mask -- 23

MR. SCHOON: N95 masks are arguably highly 24

effective. I think one no one would say they're 25


(510) 313-0610

ineffective, but some would be concerned that if they're not 1

properly fitted that they might not get very good 2

protection. It goes back to training. 3

DR. RYER-POWDER: The question, and the answer to 4

the question in summary, was with regards to the N95 mask is 5

there data out there to show what the sizes of the particles 6

are, such that that type of mask would actually protect 7

against inhalation of those particles. 8

And the answer was, there's some data out there, 9

but not really a huge amount. Is that -- 10

MR. SCHOON: I think that's fair to say. 11

DR. RYER-POWDER: Yeah. 12

MS. RUBIN: We're going to go to Veena and then 13

Catherine and then -- did you have a comment or? And then 14

Catherine. 15

DR. SINGLA: Thank you. Veena Singla, with the 16

Natural Resources Defense Council. Thank you for a very 17

informative presentation. I had kind of a comment which 18

leads into my question. The discussion of the N95 masks is 19

interesting, and it just made me think about my time in the 20

lab as a grad student and when I had to wear one of those 21

while I was working and how uncomfortable it was after just 22

an hour or two. 23

I just feel like realistically, on the grounds 24

that it would be difficult to wear all day, I just couldn't 25


(510) 313-0610

imagine doing it. And that would lead me to my next 1

question which -- I appreciated how you explained thinking 2

about risk, there's inherent hazard and there's exposure. 3

And we've talked a bit about the exposure component. I 4

wondered if you could discuss more the thinking on hazard 5

reduction. And, as I understand it, in the occupational 6

hierarchy of controls, the exposure control is the last 7

thing you want to do and you want to think more towards the 8

inherent hazard. I wondered if you could speak to that. 9

DR. RYER-POWDER: I'm not sure if I agree with the 10

exposure is the last level of control. Because the way I 11

look at it is, first of all, I think this industry is here 12

to stay. I think women are going to get their nails done 13

and people are going to work in nail salons. 14

The toxicity of the chemicals that are used, the 15

nature of the beast, the toxicity, it is what it is. You 16

can't really change that unless people can find alternative 17

products that are going to give the same quality. It's my 18

opinion that your best defense is decreasing the exposure, 19

and looking at ways to do so. 20

With regards to the mask and the acrylics, these 21

workers aren't doing the acrylics and the grinding all day. 22

That's limited to a six-minute deal for each customer. [The 23

dust mask] that's not such a bad alternative. 24

In looking at ventilation, in looking at masks, and looking 25


(510) 313-0610

at gloves, I think exposure reduction is our best bet for 1

reducing the potential for health risks. 2

MS. RUBIN: We're going to go to Catherine, 3

please. 4

MS. PORTER: Yes. Just speaking to the issue of 5

personal protective equipment, which we, at the 6

Collaborative, think that as much as possible should be done 7

to protect oneself, but I just want to echo some of the 8

things that Veena was referring to with the N95 masks. 9

We've also had experience that they're ill-10

fitting, and it's not because they're not properly trained. 11

It's because they're ill-fitting, and many of these women 12

are very small and maybe these masks don't fit properly. 13

And then what we've seen happen is that the dust actually 14

collects inside the mask. 15

And so the particulate is trapped. So there's 16

that side and that problem with ill-fitting masks. 17

Similarly, the gloves, we encourage people to wear gloves, 18

on one hand; on the other hand, there is self-consciousness 19

around gloves because the fear is that the message to the 20

client is that, you are unsanitary, and because you are 21

unsanitary I'm have to wear gloves. 22

Now, maybe some of us think, well that's dumb, why 23

would anyone think that? But, that concern is there. So, 24

on one hand, personal protective equipment would be helpful, 25


(510) 313-0610

but it's more complicated and it's not as a result of 1

insufficient training or that nail salon workers aren't 2

trying to do the right thing. 3

MS. RUBIN: Did you want to respond, Jill? 4

DR. RYER-POWDER: Not really. 5

MS. RUBIN: Okay. So -- 6

(Laughter) 7

MS. PORTER: Thank you. 8

MS. RUBIN: Okay. 9

MS. PORTER: I think we're in -- 10

MS. RUBIN: Just for people on the phone, her 11

comments were about the challenges of personal protective 12

equipment and some of the misconceptions that people may 13

have when they encounter workers using this equipment. It's 14

not just training that's a challenge in this circumstance. 15

MS. PORTER: Right. 16

MS. RUBIN: Okay. We're going to go to Patrick 17

next. 18

MS. PORTER: Thank you. Well done. 19


DR. KERZIC: This is Patrick Kerzic with DTSC. We 21

heard Tom Myers talk about the CIR safety assessment process 22

by which they use frequency of use as a surrogate for 23

exposure. My question for you is do you think you could 24

perform a credible health assessment or risk assessment 25


(510) 313-0610

using frequency of use as your exposure method, or do you 1

require something more quantitative? 2

DR. RYER-POWDER: The question is, in order to try 3

and understand the potential for health effects, the CIR 4

use a frequency of use parameter in their safety 5

assessments. Would that be enough for someone like me to 6

come in and do a type of risk assessment to assess the 7

potential for health effects from exposure to these 8

products? Is that right? 9

DR. KERZIC: Yes. 10

DR. RYER-POWDER: I think, and another risk 11

assessor might disagree with me, I think without 12

epidemiological data it's a good place to start. Because 13

frequency of use is going to say using the product 500 times 14

a year, and then you could make professional judgments as to 15

time of use and sort of come up with an exposure parameter 16

that way, and then come up with your answer regarding 17

potential for cancer risk. 18

In answer to your question I think it could be 19

done. It might be crude and it might have limitations, but 20

I think it's better than nothing. 21

MS. RUBIN: And Susan was next. 22

MS. LITTLE: Just to clarify. It's my 23

understanding that the program has -- this is the Consumer 24

Products Safety Program -- has a more of a hazard focus from 25


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the standpoint of looking at the hazard potential of 1

chemicals and then looking at solutions based on that. And 2

that's correct, right? Can you speak to that, Meredith? 3

DR. WILLIAMS: We have two criteria in the 4

regulations. The first criteria is that we show that there 5

is a potential for exposure to the Candidate Chemical in the 6

product, and the second is that that exposure had the 7

potential to contribute to or cause significant or 8

widespread adverse impacts. It's not strictly risk. It's 9

not strictly hazard. It's somewhere in between. 10

MS. LITTLE: Somewhere in between. So, a hazard 11

is definitely a focus of part of the review and the 12

decision-making? 13

DR. WILLIAMS: Right. And, if I could add one 14

more thing? 15

MS. LITTLE: Yeah. 16

DR. WILLIAMS: Which is, we do consider the 17

hierarchy of controls. We fundamentally believe that if you 18

can eliminate the hazard you're going to be better off, if 19

possible. 20

MS. LITTLE: Can you speak to that? I mean, you 21

basically have said that you don't believe eliminating the 22

hazard is the right approach, but instead eliminating the 23

risk is the approach. Is that right? 24

DR. RYER-POWDER: I don't think she's saying that; 25


(510) 313-0610

that's their focus to eliminate the hazard. I think we're 1

on the same page. I think we're both saying that you need 2

to look at the hazard and the exposure, but my opinion is 3

that you can't change the inherent toxicity of the chemical. 4

DR. WILLIAMS: The purpose of the green chemistry 5

law is to spur innovation. And so ultimately, if by taking 6

an action we can actually initiate the search for safer 7

alternatives, we've been successful. 8

DR. RYER-POWDER: Right. And again, I think 9

that's consistent with what I'm saying. If you cannot 10

decrease the exposure to the point where you take away, the 11

potential for harm from the hazard, then that's incentive to 12

come up with an alternative. 13

MS. RUBIN: We're going to have to stop there and 14

move on to our next presenter. 15

DR. RYER-POWDER: Thank you. 16

MS. RUBIN: Thank you so much, Jill. Our next 17

presenter is Paula Johnson, Ph.D. and MPH. She's the 18

Program Lead for the California Department of Public Health. 19

Her presentation is called California State Cosmetics 20

Program Focus on Nail Products. 21

DR. JOHNSON: Good afternoon, everyone. Thanks 22

for having me here today. We're almost to the afternoon 23

break, so hang in there with me. I want to take this 24

opportunity to introduce the program and give a brief update 25


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on what we're working on that's relevant to today's workshop 1

on nail products. 2

The California Safe Cosmetics Act established the 3

Safe Cosmetics Program at the State Department of Public 4

Health, and it's based on right-to-know, and cosmetics 5

companies are required to report products with ingredients 6

that are known or suspected carcinogens or developmental or 7

reproductive toxicants, as determined by authoritative 8

bodies. 9

Similar to DTSC's Candidate Chemicals list -- they 10

have 23 lists -- we actually only reference five different 11

lists. The Act takes a precautionary approach, not risk-12

based, and this means that it concerns whether or not a 13

certain chemical is present in the product rather than the 14

amount or how a person may be exposed. 15

And the intent of the Safe Cosmetics Act was to 16

encourage substitution with less hazardous alternatives. 17

And then also, the Department of Public Health has 18

additional authority to collect additional information that 19

is not subject to the routine reporting by companies. 20

Routine reporting is done by cosmetics companies 21

themselves via our online system, and this is a screen shot 22

of our public searchable database. The data is reported by 23

companies is and then the product and ingredient information 24

is available on our public searchable database. 25


(510) 313-0610

You can type in, for example, a type of product 1

like nail polish or you can type in a particular brand you 2

might be interested in to see if it shows up on our database 3

for those hazardous ingredients that are reportable, or you 4

can put in a chemical name and learn more about that 5

chemical. 6

And, if you would like to learn more about what's 7

been reported to our program, we just published a report, 8

the first report of the program that summarizes this data 9

that was reported to the program since reporting began in 10

2009. And this report is now posted online and I've 11

provided the link within this presentation, and which should 12

be available to you after this workshop. Additionally, if 13

you talk to me today, I'd be happy to email the link to you 14

directly. 15

I wanted to just provide a snapshot of what's 16

currently in our database for nail products. Nail products 17

is the second largest category in our database, second to 18

makeup. And these numbers on the screen now represent 19

products that are presumably actively marketed. Products 20

that have been reported to be discontinued are not counted 21

in this table. There were a number of products that 22

contained dibutyl phthalate, but were later marked as 23

discontinued. I just wanted to mention that. 24

I also noted that the number of products 25


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containing toluene and formaldehyde haven't changed; none of 1

them have been reported to be discontinued. So as you can 2

see here, there are a few products that are still showing up 3

for toluene, formaldehyde, and DBP, along with these other 4

chemicals. I just wanted to mention those because we've 5

been talking today about the toxic trio chemicals. 6

We do rely on companies to accurately report their 7

products and to subsequently make changes accordingly. One 8

of the limitations of the database is that if a company 9

edits the product report online, for example, to remove a 10

certain chemical, we don't see what replaced that chemical 11

unless that new chemical is also reportable by the law. 12

And then likewise, in the marketplace when certain 13

ingredients are phased out, for example the toxic trio 14

chemicals, we don't always know what is replacing them. So 15

due to limitations in routine reporting and because there's 16

plenty of interesting topics to study, we've initiated a 17

data call-in to some nail product companies to more deeply 18

examine various types of formulations of nail products. 19

And this includes looking at product labels, of 20

course, and safety day sheets, but also, detailed 21

formulations, which we are obligated to keep confidential at 22

the Health Department. And so something that is of interest 23

is to compare regular or traditional nail polish 24

formulations with the newer gel polishes, and these gels are 25


(510) 313-0610

marketed as improvements for a variety of reasons, mostly 1

performance reasons, but they're also considered to be 2

odorless or less smelly. 3

And we want to look at this more deeply and 4

determine if the low odor or low solvent, lower VOCs, 5

volatile organic compound gels are of less concern, or they 6

have other concerns associated with them. And we do realize 7

that it's important to consider companion products, in other 8

words, products that are used together, for example, primers 9

that are used in conjunction with gel polishes. 10

And so, I'm working with the Health Department's 11

Indoor Air Quality Laboratory and we've just begun this 12

endeavor. Unfortunately, I don't have quantitative results 13

to share, but I can share our plans and where we are in the 14

process right now. One aspect of this project is to measure 15

emissions from products, which is relevant to nail salon 16

workers, in particular, who have potentially high inhalation 17

exposures to nail products. But we'll keep in mind that 18

volatile emissions are only one exposure route. And we plan 19

to start with nail polish comparisons, but also look at 20

acrylic and gel artificial nail systems. 21

As you can imagine, studying nail products is very 22

complicated. There's a lot of different types. There's a 23

lot of different formulations. And so far we've compiled 24

about 120 unique formulations, which have 222 unique 25


(510) 313-0610

chemicals. If you exclude the colorants, which are subject 1

to some regulation or approval at FDA, that leaves 153 2

different, unique ingredients. And so right now, we're 3

still compiling these ingredients and we're sorting through 4

them and we're trying to make some sense of it and 5

categorize the ingredients for different product types and 6

look at some commonalities among the types of products. For 7

example, some ingredients can be common between both 8

traditional and gel formulations, such as plasticizers. I 9

want to emphasize that we've really just started this effort 10

and it's going to rely on some cooperation from 11

manufacturers of nail products, and we really appreciate the 12

cooperation that we're receiving so far in a lot of 13

companies being forthcoming with their formulations, knowing 14

that we have to keep those confidential. 15

Suggestions are definitely welcome at this stage, 16

such as existing data or important considerations in this 17

study. And that's my contact information for you if you 18

want to provide any help with this. That's all I have. 19

Questions. 20

MS. RUBIN: Thanks, Paula. We’ve got about 21

ten minutes before our next break. We’re going to 22

take any questions or comments for Paula. 23

Catherine. 24

MS. PORTER: I just wanted to confirm, 25


(510) 313-0610

Paula, so you said that your database shows 153 1

different chemicals in nail products on your 2

database, so all those are reproductive or 3

developmental toxicants or carcinogens. Did I 4

understand that correctly? 5

DR. JOHNSON: No, no. 6

MS. PORTER: Oh, okay. 7

DR. JOHNSON: That’s a separate thing. 8

MS. PORTER: Oh. Sorry. 9

DR. JOHNSON: So Catherine’s question was: 10

when I had mentioned that there are 153 unique 11

chemicals in the nail product formulations that we’re 12

looking at, if those are the ones that are on our 13

database of routine reporting for carcinogenic or 14

reproductive and developmental toxicants, and that’s 15

not true, those are two separate things. 16

The 153 are other chemicals; that’s using 17

our ability to do studies outside of just what’s 18

reportable in the routine database. 19

MS. PORTER: Okay. 20

MS. RUBIN: Veena was next. 21

DR. SINGLA: Veena Singla. Thank you for a 22

great presentation, and I thought it was really 23

interesting that you’re doing a data call-in of 24

companies and getting information. I feel like that 25


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might be really useful to DTSC if they’re thinking 1

about chemicals in nail products. Will you be able 2

to share some of that information with them? 3

DR. JOHNSON: Well, not really, because as I 4

said, at the Health Department we are obligated to 5

keep the formulations that are shared with us by 6

companies confidential. The results of any study 7

that might include aggregated data that doesn’t 8

identify specific companies is definitely something 9

that is a potential to share. 10

MS. RUBIN: For those of you on the phone 11

who might not have heard the question, it was about 12

whether CDPH might be able to share the information 13

they’re gathering from manufacturing companies with 14

DTSC. 15

Doug. 16

MR. SCHOON: Doug Schoon. Not being a 17

manufacturer, I’ve never had to fill out your form, 18

so I was curious when I saw your reports of 19

crystalline silica, which to my knowledge is not used 20

in our industry, amorphous silica is used. I’m 21

wondering were both asked and some reported 22

crystalline and some were amorphous and could that 23

have just been an error these people might not have 24

understood? 25


(510) 313-0610

DR. JOHNSON: I think your question is 1

whether or not that we required reporting of both 2

crystalline and amorphous silica? 3

MR. SCHOON: Correct, because it specified 4

crystalline silica. 5

DR. JOHNSON: I think it does. Let me just 6

go back to that slide, but I think that it’s listed 7

here, crystalline, yeah, airborne particles of 8

respirable size. 9

MR. SCHOON: To my knowledge our industry 10

focuses and uses exclusively amorphous. I could be 11

wrong, but that was just my understanding. 12

DR. JOHNSON: So your understand is -- 13

MR. SCHOON: Our industry focuses on using 14

amorphous silica, not the crystalline form, so that’s 15

why I was a bit surprised to see that. 16

DR. JOHNSON: You were surprised to see 17

crystalline silica show up in our database. 18

MR. SCHOON: Yes. 19

DR. JOHNSON: I don’t really have an answer 20

for why that would be showing up in our database 21

because our data is reported by companies, so you 22

could be right, that it was a misunderstanding of 23

what is required to be reported. 24

MS. RUBIN: We’re going to go to Ephrem and 25


(510) 313-0610

then to -- 1

MS. MONTGOMERY: I was just going to 2

clarify. 3

MS. RUBIN: Okay. 4

MS. MONTGOMERY: If I remember correctly, 5

you enter by CAS number. So if the CAS number is 6

slightly off or the raw material supplier provided 7

you the wrong CAS number, it’s very easy to get the 8

wrong material to come up. And if someone’s not 9

paying attention, it’s very quickly easily to be, oh, 10

I’m using the wrong code. If I remember correctly, 11

you enter it by CAS number and not by raw material. 12

DR. JOHNSON: Yes, we do have CAS number 13

entries. 14

MS. RUBIN: Katherine from Coty was 15

clarifying the reporting errors that could take place 16

when companies make reports to CDPH, so it could very 17

easily just by human error get entered incorrectly, 18

so that might be it. 19

DR. JOHNSON: And thanks for those comments, 20

because that’s something I always try to emphasize 21

when I’m talking about our program is that we really 22

can’t take responsibility for the data that’s 23

reported to our program because it is company self-24

entry. 25


(510) 313-0610

MS. RUBIN: We’re going to go to Ephrem. 1

DR. NEUWIRTH: This is Efrem Neuwirth. That 2

was actually the same subject matter that I had 3

intended to comment on was the first one when I saw 4

that there were seven things listed there. 5

And I just wanted to additionally point out, 6

since it was already addressed, was the airborne 7

particles of respirable size, that would be the area 8

of concern for silica but you wouldn’t necessarily 9

know, whoever’s using probably wouldn’t know that 10

that’s how we would classify the problematic 11

crystalline silica. 12

The only study that I saw which tried to 13

measure in a real world situation couldn’t measure at 14

the detection on this, which was from NIOSH. I think 15

it was a NIOSH-run study, and I think it was for the 16

OSHA limits on silica in air, but there’s detection 17

sensitivity issues, identifying the crystalline 18

silica is pretty limited. You can’t get the 19

detection level down to NIOSH thresholds; you can 20

only get down to the OSHA standards thresholds. 21

I wanted to ask you more about the initial 22

studies that you’re doing. Are they on a process 23

where somebody’s applying the product to the nail in 24

a way that somebody would in a nail salon or is it 25


(510) 313-0610

just on the raw material; what sort of studies are 1

you doing? 2

DR. JOHNSON: We’re starting off just within 3

environmental chambers, small micro chambers. Sort 4

of like a simulation, but we haven’t gotten as far as 5

being able to simulate an entire process. These are 6

all the chemicals for the products that you would use 7

for this entire process, like a gel nail application. 8

Right now we’re just we’re looking at individual 9

products, but that is our intention. 10

DR. NEUWIRTH: I would follow up 11

(inaudible). 12

DR. JOHNSON: Yeah, and if you have any 13

suggestions, this is the time. 14

DR. NEUWIRTH: Maybe I know some people at 15

universities that may be interested in doing some 16

work also. 17

DR. JOHNSON: Yeah. Well, we could use 18

help. Thank you. 19

MS. RUBIN: For those of you on the phone, 20

Efrem’s question was about the emissions studies that 21

they’re undergoing. 22

DR. JOHNSON: Just starting. 23

MS. RUBIN: They just begun. 24

Were there any more questions in the room? 25


(510) 313-0610

Susan. 1

MS. LITTLE: Just a comment that it would be 2

really helpful to get a copy of that study, or if you 3

have any reiterations of it as you go along, it would 4

be very helpful to see that. 5

DR. JOHNSON: Absolutely. 6

MS. RUBIN: How can people get copies of 7

your study as it progresses, and will you be 8

updating? 9

DR. JOHNSON: Well, it’s probably not going 10

to be a state report, and, if it’s published, it 11

would be in a peer review journal. We don’t have 12

dissemination plans yet, we’re still in the initial 13

stages, but I would imagine we would publish it and 14

let our stakeholders know that it’s out there. 15

MS. LITTLE: (Inaudible) right now? 16

DR. JOHNSON: You’re talking about the -- 17

MS. LITTLE: The study, the specific report 18

that you’re talking about. 19

DR. JOHNSON: So if you’re referring to I 20

said that we have this report? 21

MS. LITTLE: The one that you have right 22

there. 23

DR. JOHNSON: This is the report that we 24

just published online that summarizes all of the data 25


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that’s been reported by companies to our program, and 1

that is now available online at this link. 2

MS. RUBIN: Any more questions before we 3

take a break? Yes. 4

DR. SCIULLO: Yes. Eric Sciullo, DTSC. You 5

mentioned that your list operates off of five 6

authoritative lists as opposed to our 23, I believe. 7

Are they listed in this report? I don't remember 8

seeing them listed. What are the five sources? 9

DR. JOHNSON: Yes. And so again, this 10

report that’s on the screen now, it’s just published 11

online so you may not have seen it yet, but it does 12

detail what those sources are. 13

DR. SCIULLO: Okay. 14

DR. JOHNSON: And I believe my associate Amy 15

is here, maybe you can help me answer this. But I 16

think that we have that also as a regular posting up 17

on our database, which I admit is not organized very 18

well. 19

DR. SCIULLO: No, that’s all right. 20

DR. JOHNSON: It’s a typical government 21

database, but the sources are Proposition 65, IARC, 22

National Toxicology Program report on Carcinogens, 23

and also their OHAT, Office of Health Assessment and 24

Translation Reproductive Toxicant List, and the fifth 25


(510) 313-0610

is U.S. EPA’s carcinogen list. 1

DR. SCIULLO: And a second part. Obviously 2

there are requirements involved in industry having to 3

deliver this information to you, right? I believe it 4

has to have over a million dollars in sales, right, 5

as part of it? 6

Do you have any idea of what percentage of 7

the industry at large would you say is contributing 8

to your report? I mean, is it 40 percent of the 9

cosmetic industry that fits within that category of 10

compulsory reporting? 11

DR. JOHNSON: The question is: if we have a 12

sense of what percentage of the industry is actually 13

reporting to us, right? And you also mentioned that 14

we do have that, a million dollar annual sales as a 15

bar to reach in order to have to be reporting to us. 16

It’s a good question and we don’t know how 17

to assess that really, and if anyone has any 18

information or suggestions of how to assess that. 19

But we have been asked that before, how many 20

companies are reporting that should be reporting. I 21

mean, we know how many companies are reporting, 500 22

or so, but we don’t know what the universe of 23

cosmetics really is, there’s no comprehensive list. 24

The FDA has a voluntary list, but then 25


(510) 313-0610

again, it’s not really that helpful to compare who’s 1

reporting to us those companies to their voluntary 2

list because there’s no indication of whether those 3

companies on FDA’s voluntary reporting system are 4

using chemicals that would be reportable to us, so we 5

really have not assessed that. That’s a good 6

question. 7

MS. RUBIN: Thank you so much, Paula. 8

DR. JOHNSON: Thank you. 9

MS. RUBIN: We’re going to take a break and 10

I’ll ask to you return a minute or two before 3, this 11

is a quick break, so try to be back on time. We have 12

three speakers left. 13

(Off the record 2:53 pm to 2:59 pm) 14

MS. RUBIN: We’re running a little bit late, 15

so I’m going to ask you all to take your seats at 16

this time. Thank you. Thanks for hanging in there. 17

We’re going to get started with our next 18

presenter, Angie Perez. She’s a PhD, the supervising 19

scientist at Cardo ChemRisk, and her presentation is 20

The Screening Level Human Health Risk Assessment of 21

Toluene Dibutyl Phthalate in Nail Lacquers. 22

DR. PEREZ: Thank you very much, and thank 23

you to the DTSC for hosting us in this very 24

informative and fun public forum. 25


(510) 313-0610

I’m Angie Perez. I am a consultant at Cardo 1

ChemRisk, been there for about eight years. 2

Just a little bit about me. 3

I have a PhD in toxicology. I do some 4

testifying and then also consulting toxicology work. 5

I’m a mom and also a foster parent licensed in 6

California. 7

Today I’m going to talk about a study that 8

we published a couple years ago with my co-author 9

Luda Kopelovich, who you’ve heard speak today also. 10

We utilized the data that was published by the Cal 11

EPA, in their 2012 report. We took that data through 12

a screening level risk assessment, human health risk 13

assessment, because we wanted to know: with these 14

bulk concentrations is there a way that we could 15

potentially try to estimate risk without having air 16

concentrations, without having actual measured data 17

in humans, as a preliminary first pass type of 18

assessment. And, in full disclosure, this study was 19

funded entirely by Cardo ChemRisk. 20

I’m going to skip over there because we’re 21

heard about them ad nauseum today. The study focuses 22

on toluene. The important point to remember here, 23

and you’ll see it again later, toluene has a maximum 24

allowable dose level that’s listed under Proposition 25


(510) 313-0610

65, and that dose level, that’s for reproductive or 1

developmental effects, and that dose level is 7,000 2

micrograms per day. 3

Similarly, dibutyl phthalate, or DBP as its 4

referred to in this presentation, it also has an MADL 5

set at 8.7 micrograms per day. 6

And we’ll talk about how these MADLs are 7

used in the screening level risk assessment and some 8

pitfalls of using an MADL in this type of analysis. 9

This is the information that was recorded in 10

the 2012 report by the Cal EPA. They had three 11

objectives: to verify the legitimacy of the toxic 12

trio related products claims; number two, to 13

determine a baseline concentration of these 14

chemicals; and then also to explore the trends of 15

possible ingredient substitution. 16

Here’s a brief overview of what the sample 17

breakdown looked like. Predominantly, it was nail 18

lacquer, the actual color, nail color polish. There 19

were some base coats, thinners, some art. In total, 20

there were 25 total products sampled. They 21

represented 15 manufacturers. They had approximately 22

92 percent detection frequency for toluene, and they 23

had 40 percent detection frequency for dibutyl 24

phthalate. 25


(510) 313-0610

They also categorized these samples by “free 1

of” claims which we’ve heard a lot about today so I 2

won’t go into it, but the majority of samples had no 3

claims at all but there were some who had claimed 4

either two free or one free. 5

Here’s a general breakdown of the frequency 6

distribution of the concentrations in these products 7

that the Cal EPA measured. You can see that the 8

majority of the products were less than 50,000 9

milligrams per kilogram toluene. In fact, the median 10

was around 6,600 part per million. We did see a 11

maximum value of 190,000 part per million. 12

Now, some of the risks of the “free of” 13

labeling are shown here, and we’ve talked about these 14

already. For example, two products that claimed to 15

be three-free actually had about 17 percent toluene 16

in there. Another one had about 7 percent toluene. 17

There were two non-detects in the study. 18

There were five with trace concentrations, or less 19

than one percent, and there were five that contained 20

toluene at greater than one percent. 21

Now, one thing that should be pointed out 22

here for the study is that we were not able to 23

ascertain the detection limits for all of the 24

samples. Those were not listed in the study. We did 25


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contact the Cal EPA on various occasions and were not 1

able to, and we also contacted the lab that Cal EPA 2

used, and were not able to acquire those detection 3

limits. And, as such, this screening level risk 4

assessment only includes detected samples. We 5

already assumed an overestimation because we only 6

included detectable samples because that value wasn’t 7

listed. 8

In our study objectives we did utilize this 9

Cal EPA data and the objectives were to quantify 10

toluene and DBP exposures from normal use of nail 11

products, and we did this for three different 12

scenarios: 13

For consumers. The first consumer is 14

somebody who goes into a salon, sits down and has a 15

manicure. A home user, who was someone whom we 16

assumed went into their bathroom -- we actually 17

quantified the area into a small space -- they were 18

in their bathroom painting their nails. And then, 19

for a nail technician who conducted 16 manicures per 20

day, so one manicure every 30 minutes. And then we 21

took this through a screening level risk assessment. 22

To estimate our human health exposures we 23

utilized the AIHA model, it’s called IH MOD, and what 24

IH MOD is is essentially a model that you can use, 25


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it’s listed on the EPA’s guidance list for available 1

models to estimate inhalation exposures, and one of 2

the things that it does is it measures, you can 3

estimate a near field and a far field. What a near 4

field is: if you hold your arms out imagine a sphere 5

around your head with you just holding your arms out. 6

And a far field is the size of the room minus your 7

near field bubble, that’s how you calculate a far 8

field. 9

What we were trying to get at is, if I’m 10

getting my nails done, I’m also experiencing the same 11

exposures that Eric and Christine and André might be 12

experiencing also. We summed up all of those 13

different exposures this way. 14

And then for the well-mixed room model, we 15

assumed that this was only consumer use and then we 16

assumed this was a pretty small test, like we’ve 17

said. 18

For dermal exposure we utilized again the 19

AIHA model SkinPerm. SkinPerm is used by the 20

equivalent of the French Food and Drug 21

Administration, ANTES, so they utilize and publish 22

reports using the SkinPerm model, so it’s something 23

that is widely available and used. Essentially it 24

uses some quantitative structural activity 25


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relationship methodology to estimate a skin 1

permeability specific to each chemical. 2

We did this for both DBP and toluene, and 3

the results are as follows. 4

Just to give a brief overview of our 5

exposure too. If you are a salon patron, we assume 6

that you have one manicure a day. That’s a lot. I 7

mean, nobody’s going to get a manicure every day. 8

And that’s important because of some earlier comments 9

about the CIR database where we were talking about 10

frequency. 11

With proper frequency information you can 12

actually calculate a more realistic exposure 13

scenario. And not only is that important to get a 14

more accurate representation, but it also can, in 15

this case, be important for Prop 65 claims because -- 16

and I wish Tom was here because he probably knows 17

more about it. But, the Beechnut decision was one 18

that happened about two years ago where consumers of 19

fruit juice that had detectable lead were concerned 20

about exceeding the MADL for lead under Proposition 21

65. And because Beechnut Corporation had really 22

reliable data on the frequency of consumption of 23

their product, they were actually able to average 24

that exposure out over every seven days. They knew 25


(510) 313-0610

that people on average drink one of their drinks or 1

had one of their products every seven days, and so 2

with that information they were able to average that 3

exposure out. 4

Versus me saying I’m assuming your exposure 5

is X because you get one manicure every day, and 6

that’s important, that’s pretty important. 7

We assumed it took 30 minutes for you to 8

finish your manicure, and we also assumed you had 9

three other patrons in the salon with you. 10

For the home user we assumed you also had 11

one manicure a day and that your manicure lasted 60 12

minutes. And then we also assumed that you were far 13

more sloppy with your application -- which I don't 14

know about for you but for me that’s absolutely true 15

-- so with your application we assumed a larger 16

surface area. We assumed that you actually spread 17

fingernail polish on the total surface of about three 18

tips of each finger, so it’s a gross overestimation. 19

For the nail technician worker, we assumed 20

you did 16 manicures each day, each was 30 minutes in 21

duration, and that there were three other technicians 22

working in the salon with you. 23

The results of the study are as follows. 24

I’m showing toluene estimated air 25


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concentrations using the IH MOD for the near field 1

and far field, and the two zone model represents the 2

cumulative near field/far field. If I add my 3

exposure and then I add all three of yours together, 4

that’s what that value represents for the two zone 5

model. 6

And what I’m showing here is that the 7

majority of the samples were far below the OSHA PEL, 8

so it’s not showing, in this case, to be a risk for 9

workers using this exposure scenario. And it’s also 10

below the Cal OSHA PEL of 10 ppm. 11

What we did see, though, was an exceedance 12

of the U.S. EPA reference concentration, and that’s a 13

concentration you can have every day all day long 14

without having an increased risk of disease or 15

adverse effect. We did see some exceedances with the 16

RFC only for the maximum concentrations. 17

Similar results for the well-mixed model. 18

That’s where you go into your bathroom and you paint 19

your own nails. Majority of the samples were less 20

than the U.S. EPA reference concentration but there 21

were a few that exceeded. 22

Now, if we think about cumulative toluene 23

exposure, this is taking into account not only 24

inhalation but dermal exposures to toluene also, what 25


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we see is for a technician, we exceed the Proposition 1

65 MADL of 7,000 micrograms per day; in fact, by 2

quite a bit. 3

We don’t see any exceedances with the 4

patron, but we see an exceedance of the maximum value 5

with the home user. 6

Now, I want to preface these results by 7

saying that this is assuming you’re getting a 8

manicure every single day, so this is an 9

overestimation. So for this day you would exceed 10

under these parameters, but if it’s only once every 11

certain amount of time a home user probably wouldn’t 12

exceed. 13

So DBP, dibutyl phthalate for dermal 14

exposure, this is again using the AIHA model for 15

SkiPerm. We again saw exceedances in all scenarios. 16

I also want to preface this by saying that, 17

just for fun, there was one limit of detection that 18

the lab provided us; they said it was their average 19

limit of detection, but since we didn’t have it for 20

all the individual samples we didn’t use it. But, if 21

you run the limit of detection, which I think was 22

4,700 ppm through that lab, you actually exceed the 23

MADL if you back calculate. 24

So, therein, is the issue with using MADL 25


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and comparing against MADLs, because the 1

concentration that would need to be present of DBP 2

that would need to be present in a lacquer would have 3

to be below 6 ppm, so that’s 700 times less than the 4

lowest detection limit reported by the lab that the 5

EPA used. 6

We all understand that MADLs have a 7

thousand-fold uncertainty factor. And my point in my 8

discussion in this room today, too, is how relevant 9

is this as a benchmark to compare against in terms of 10

really getting at human health risk, trying to 11

understand human health risk. 12

To conclude, we agree that product labels 13

may not accurately represent true content. We only 14

saw only the polish with the maximum toluene 15

concentration resulted in exceedance of the MADL for 16

technicians and for home users. 17

And then we typically, just to put a number 18

on it, only polishes with toluene concentrations 19

greater than about 13 percent exceeded the RFC, the 20

reference concentration in our scenarios. 21

The MADL for DBP was exceeded in every 22

scenario, even in those below detection limit; so, 23

clearly there is a disconnect between the detection 24

limits and the MADL for DBP. And then, also 25


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exceedances of an MADL don’t necessarily indicate 1

risk, particularly in this scenario. 2

I put this on here. I’m so glad we were 3

talking about ventilation too because I was trolling 4

the internet and found this really cool ventilation 5

device, and I was hoping that one of the industry 6

representatives might speak to it. 7

But as Veena pointed out, it is 8

uncomfortable. I’ve worn facemasks, I’ve worn a 9

PAPR, I’ve worn full Tyvex, the whole nine yards, and 10

they’re really uncomfortable and hot and I wouldn’t 11

want to go to a nail salon and see somebody in full 12

face gear. I’m hoping that with innovation they’ll 13

find different solutions. 14

It’s difficult to see here but it looks like 15

a vacuum cleaner hose that’s hooked up right next to 16

the nail station and then it sucks it all out so you 17

hopefully will minimize any exposures, especially to 18

some of the particulates. 19

Ventilation is variable. That’s one thing 20

that was difficult to control in this study. We 21

assumed one air exchange per hour per the EPA 22

Exposure Factors Handbook. 23

We also know that dermal exposures, in this 24

case, are likely overestimated. We assumed one per 25


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day. We assumed you were very messy and terrible at 1

painting your fingernails, which may actually be 2

reflective of a child. 3

We also didn’t take into account a 4

cumulative dose, you’re getting a manicure and 5

pedicure. And we also didn’t account for any other 6

types of nail treatment services, any acrylics, gels. 7

I mean, the sky is the limit on research in this 8

area, truly. 9

We also didn’t account for loss of toluene. 10

Toluene potentially will volatilize and you may see a 11

decrease of toluene in a bottle over time. 12

There’s a lot of unanswered questions with 13

this type of data. And I’d love to answer any 14

questions. 15

MS. RUBIN: Thanks, Angie. 16

We’re going to take any comments or 17

questions right now from our participants in the 18

room. Does anyone have a question or comment? 19

Patrick. 20

DR. KERZIC: This is Patrick Kerzic with 21

DTSC. Thank you for making that talk, it was very 22

nice. 23

There are methods by which you make 24

extrapolations from types of exposure assessments to 25


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determine bioavailable dose and, maybe you can find 1

an internal concentration that’s estimated. Have you 2

gone down that road? And, if you have, how does that 3

relate to some of the things that I’ve been seeing 4

with NHANES data and BiomonitoringCalifornia? 5

DR. PEREZ: The question was about 6

extrapolating from these types of exposure 7

assessments to determine what would be the 8

bioavailable dose, I’m assuming, and then how you 9

compare that bioavailable dose to, for example,NHANES 10

data, some of the biomonitoring, like urinary 11

metabolates or California Biomonitoring data. 12

No, we haven’t, but that’s a really 13

interesting question. 14

I will say that the SkinPerm model is 15

actually measuring what would be considered a 16

bioavailable dose. It’s assuming full permeability 17

through epidermis and dermis, and so we considered 18

that. And they have some language in their 19

guidelines about how to interpret, but it would be 20

considered at least an internalized dose or what we 21

consider to be bioavailable. 22

Does that answer your question? 23

DR. KERZIC: Yes. 24

MS. RUBIN: André? 25


(510) 313-0610

MR. ALGAZI: Angie, thanks for the good 1

talk. André Algazi again. 2

You mentioned the loss of toluene, which 3

made me think about the addition of neat toluene back 4

into the products. Did you use that in your scenario 5

at all or just assumed that the products were as they 6

are formulated? 7

DR. PEREZ: I’ve never even heard of that 8

before today. So that was news to me that that even 9

happened. 10

MS. RUBIN: Anybody else? Anyone on our 11

webinar? 12

MR. JOELSON: No. 13

MS. RUBIN: Thanks. 14

At this time, we’re going to move to our 15

next presenter, who is participating remotely. Our 16

next presenter is Aja Frierson, founder of Habit 17

Cosmetics, and her presentation is about Exploring 18

the Gap Between Performance and Safety. 19

MS. FRIERSON: Hi everyone. It’s been great 20

listening to some of the speakers today and I just 21

want to say thank you for inviting me and to the DTSC 22

for letting me participate. 23

MS. RUBIN: We’re ready when you are. 24

MS. FRIERSON: To give you an overview, My 25


(510) 313-0610

goal for this presentation is to address some of the 1

questions that Dr. Sciullo raised in his presentation 2

last year on the toxicity of certain chemicals in 3

nail polish. I’m also hoping to provide a 4

manufacturer’s perspective to explain why they use 5

some of the chemicals they do, and to explore how we 6

can make nail polish safer, yet still have it perform 7

the way consumers expect. 8

To be clear I am at the helm of a brand that 9

produces nail polish, but I’m not a chemist or a 10

manufacturer myself. I came into the beauty industry 11

as a consumer that wasn’t seeing the kind of products 12

I wanted available in the marketplace, so I designed 13

a product and sourced manufacturers to make it. So 14

this presentation is based on conversations I’ve had 15

with my manufacturers as well as roughly six years of 16

experience being active in the beauty industry. 17

I’d like to give you a bit of a background 18

on why I started Habit. 19

Basically I went through a period 20

[interference] I was obsessed with nail polish and 21

began painting nails all the time. [interference] 22

DR. WILLIAMS: Aja, you’re breaking up a 23

bit, and so could you back up a little? 24

MS. FIERSON: Sure, I’m sorry about that. 25


(510) 313-0610

So I just wanted to give you some background 1

no how I started Habit. Can you hear me clearly now? 2

So anyway, I just wanted to give you a 3

little background about how I started Habit. 4

Basically, in 2011 I was painting my nails 5

all the time, so they started peeling because nail 6

polish is very drying, and so I started looking for a 7

strengthening polish to solve that problem. All I 8

was seeing on the market were formaldehyde-based 9

strengtheners, and I didn’t want to use formaldehyde-10

based strengtheners. 11

I try to limit my exposure to carcinogens if 12

I can help it, so I sought out alternative 13

strengtheners in the plant world, and I found that 14

myrrh extract strengthens nails and it’s also 15

antiinflammatory, antifungal, and antibacterial. 16

To summarize, I saw a gap in the marketplace 17

for a nail polish with natural strengthening 18

properties and I began development on Habit in 2011. 19

In June of 2015, after two years of development, I 20

launched the brand. 21

I try to make Habit as toxin free as 22

possible, so to that end we work with a manufacturer 23

in California that makes Habit free of toluene, 24

formaldehyde, formaldehyde resin, camphor, triphenyul 25


(510) 313-0610

phosphate, dibutyl phthalate, xylene, and parabens. 1

We are also launching three new products 2

later this year and two of those products are almost 3

completely organic. And the reason why I mention 4

that is because creating them has taught me some 5

interesting new things about formulation in the 6

beauty industry that I will talk about later. 7

Now I’d like to talk about some of the 8

chemicals that can be found in nail polish, and I 9

can’t tell you to what extent these chemicals are 10

still used by the industry as a whole, but I can give 11

you the perspective of my nail polish manufacturer. 12

That being said, Habit’s manufacturer has 13

been in business since 1993 and they’re the largest 14

nail polish manufacturer in the United States, so I 15

think their answers are a good indication of where 16

the industry is at. 17

They discontinued the use of formaldehyde in 18

all of their nail polishes with the exception of one 19

nail product they sell, which is a nail hardener, and 20

they continue to use formaldehyde in that product 21

because they say it’s, without a doubt, the most 22

effective nail hardener. The fact that they continue 23

to sell that product just tells me that there’s still 24

a market for it. 25


(510) 313-0610

Toluene is a solvent they stopped using 1

roughly 14 years ago. 2

Dibutyl phthalate was removed in 2004. 3

Triphenyl phosphate was removed in 2012; 4

concerns over that have been a more recent 5

development. 6

UV absorber Benzophenone was replaced with 7

Benzophenone-1, which is made from benzene, a 8

different molecule. 9

They still use silica primarily to suspend 10

glitter in glitter polishes but also to reduce gloss 11

in matte nail polish. 12

And they use titanium dioxide as a colorant. 13

It’s also widely used in cosmetics in general and 14

personal care products like toothpaste, paint, 15

plastics, and paper. 16

Moving on, I’d like to talk about some of 17

the alternatives available to the Candidate Chemicals 18

that I just mentioned. 19

Speaking for plasticizers like triphenyl 20

phosphate and dibutyl phthalate, the good news is 21

that there are literally hundreds of alternatives 22

that can replace them. But TPP was actually 23

initially adapted as a replacement for dibutyl 24

phthalate so the alternatives aren’t always better. 25


(510) 313-0610

Also replacements for DBP and TPP are more expensive. 1

The same is true for the replacements to 2

toluene, and manufacturers, of course, pass these 3

higher costs on to brands, who pass those on to the 4

consumer. 5

When toluene and formaldehyde resin were 6

removed, adhesion, gloss, and polish hardness 7

suffered, so isobutylphenoxy epoxy resin was added to 8

regain those properties, but that ingredient is now 9

on an EU banned and restricted fragrances list for 10

being an immune system toxicant. 11

Benzophenone-1 may be an endocrine disruptor 12

according to several studies done in the 2000’s. And 13

there are other UV absorbers that can be used in its 14

place, but it is unknown whether these alternatives 15

are safer and they’re definitely more expensive. 16

Silica also can be replaced with 17

Stearalkonium Hectorite; however, silica is clear 18

whereas Stearalkonium Hectorite gives polish a muddy 19

brown tint. 20

And as far as there being different 21

formulations for salons versus those sold by large 22

and small retailers and luxury stores, that was a 23

question that was asked last year. Manufacturers 24

sell the same base formulas to everyone. Of course, 25


(510) 313-0610

there’s always the option to customize your formula, 1

which is what we did. 2

Another nail polish brand that I know has a 3

custom formula is the polish sold by Christian Dior, 4

and I know this because my manufacturer did fillings 5

for them. In that case, Dior delivered pre-made 6

polish and printed bottles to my manufacturer, and 7

all my manufacturer did in that case was machine-8

filled the bottles for them. 9

The drawback to customization from a brand 10

perspective is that is it usually comes with higher 11

material and labor costs and higher order minimums, 12

so because of that, my opinion is, you’re more likely 13

to get customer formulas with higher priced nail 14

polishes like Habit and like the nail polish sold by 15

Dior. 16

Today we’ve been talking primarily brands 17

sold in nail salons, and from what I understand, 18

salon brands were the brands that the DTSC tested in 19

2012. Unless nail salons specifically market 20

themselves as being low toxicity or “eco-friendly” or 21

if they are marketing themselves as a luxury type of 22

salon, then they’re likely buying the cheapest nail 23

polish possible because most nail salons make 24

business doing the most volume they can at any cost. 25


(510) 313-0610

I would say that the brand whose bread and butter is 1

selling low cost nail polishes to salons are more 2

likely to use cheaper chemicals to keep their costs 3

down, and toxic chemicals tend to be cheaper. 4

Also, if you’re a brand that wants to have 5

the lowest cost possible, China can make almost 6

everything cheaper than U.S. manufacturers can. Some 7

of these brands may be making their polishes in 8

China, and the problem I see with that is, unless 9

you’re familiar with how China regulates its 10

cosmetics industry and you’re confident that your 11

manufacturer is following those regulations and 12

you’re happy with what those regulations are, then 13

you don’t really know what you’re getting. 14

There are standards and regulatory agencies 15

that exist to guide manufacturers in formulating 16

their nail polish, which some people addressed 17

earlier today, and here’s a list of some of them. 18

You can look at that in depth when this presentation 19

is posted. 20

I can’t say if any of the rules are enforced 21

or if they’re simply guidelines that my manufacturer 22

is expected to abide by, but I can say that my 23

manufacturer claims to follow the good manufacturing 24

practices that are set forth by the FDA as well as 25


(510) 313-0610

good laboratory practices set forth by the FDA and EU 1

Council directives. 2

To close, I would say that the DTSC might 3

consider adding isobutylphenoxy epoxy resin to the 4

Candidate Chemicals list. There’s not a lot of 5

information available on it but it is listed on an EU 6

banned and restricted fragrances list as an immune 7

system toxicant or allergen. 8

I also suggest adding formaldehyde resin to 9

the list, as it can be derived from formaldehyde. 10

Also, I know the DTSC is concerned about 11

titanium dioxide as well as some D&C colors, which I 12

saw several of those listed in the Candidate 13

Chemicals database, but I think it’s going to be very 14

difficult to try and eliminate those colorants from 15

cosmetics. 16

Color is one of the main reasons that people 17

buy makeup and there are only so many colors and 18

textures that you can get with micas, iron oxides, 19

and animal-derived ingredients, if you’re using 20

those, like carmine and pearl. There are 21

alternatives in natural pigments and those can be 22

made, for example, from cabbage, beets, and turmeric, 23

but they can be expensive. One quote I got from a 24

manufacturer for $1,300 per color and that’s a 25


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minimum order, or per pigment powder, I should say. 1

Also, these natural pigments have a very 2

high plate count specification, which means that the 3

amount of colony forming microorganisms per gram of 4

powder is very high. For reference, natural pigments 5

contain about 50,000 colony forming units per gram of 6

powder whereas iron oxides contain about 100 colony 7

forming units per gram. This means that if you use 8

these colorants your products might spoil before you 9

can sell them. 10

The manufacturer I spoke to about these 11

natural pigments believes that some cosmetic 12

companies get around this problem by irradiating the 13

pigments, and that’s safe. All of us have probably 14

eaten irradiated food at some point, but extra 15

processes add to costs. 16

Something else to consider is that the color 17

itself in these pigments is not very stable and can 18

fade quickly when exposed to light. 19

I know from personal experience there is, 20

based on what you found during your 2012 21

investigation of nail products, sometimes products 22

are advertised as being free of certain chemicals 23

when they’re not, and that’s why I mentioned earlier 24

that I’m developing new products because during the 25


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development phases I made new discoveries. 1

So, to tell you how things work when you’re 2

developing new products, you do something called 3

trend shopping, which is basically you’re trying to 4

get good ideas from your competitors and see what 5

they’re offering. 6

Though I really like the formula that one 7

company offers, and part of what I like about it is 8

that it was supposedly free of FD&C colors. This 9

company’s packaging listed only iron oxides and micas 10

as colorants, and I’m doing my best to avoid using 11

FD&C colors in my new products. So, I bought one of 12

their products and sent it to my manufacturer to 13

reference. 14

Well, my manufacturer did some research on 15

this company and found an ingredient listed on their 16

website for the same product that I sent her, but 17

this ingredient list showed FD&C colors as being a 18

part of the formula. If an average consumer 19

purchases this company’s product from a store, like I 20

did, but doesn’t check the ingredient list on the 21

company’s website, they would think they’re getting a 22

product free of artificial colorants. 23

It seems like this was just a mistake in 24

this case because at least this company had a correct 25


(510) 313-0610

ingredient list posted somewhere, but I do believe 1

there is some intentional obscuring of the truth 2

going on when it comes to ingredients. 3

And I don't know if it happens at the brand 4

level or at the manufacturer level, but speaking 5

specifically of FD&C colorants again, there are 6

several companies who advertise their products as 7

being free of artificial colorants and yet they sell 8

really bright colors. 9

Well, there’s something I’ve discovered 10

through attempting to make new products without FD&C 11

colors, and that is it’s impossible to produce really 12

vibrant colors without artificial colorants. 13

There’s one company out there that claims to 14

color everything with fruit pigments, and my lab has 15

told me there’s no way they’re being transparent 16

about what’s in their makeup. But at the company I’m 17

speaking of they have their own lab and the founder 18

is a chemist. Who really knows what’s going on at 19

that company? 20

Ultimately, I think the burden of removing 21

harmful chemicals from nail polish falls on the 22

brands selling these products and on the 23

manufacturers making them. I think, for change to 24

occur, brands have to care about their product 25


(510) 313-0610

ingredients and they need to work with reputable 1

manufacturers that care about ingredients also. 2

But I think there is still a lot of research 3

that needs to be done to find alternative chemicals 4

that are non-toxic but still perform well and are not 5

prohibitively expensive. 6

Does anybody have any questions? 7

MS. RUBIN: Thanks, Aja. 8

We have a few minutes to take any questions 9

or comments. Please speak up. We only have a couple 10

of microphones that go through to the people joining 11

us remotely. 12

Doug. 13

MR. SCHOON: Yeah, Doug Schoon. Unless I 14

misunderstood, it sounds like you’re advocating for 15

cosmetic companies to use unapproved FDA colorants. 16

MS. FRIERSON: I’m sorry, could you repeat 17

that? 18

MS. RUBIN: I’m going to repeat the question 19

for you and everybody else participating remotely. 20

He is asking you to clarify whether you are 21

advocating for manufacturers to use colorants that 22

are not FDA approved. 23

MS. FRIERSON: Oh. I just think it’s an 24

alternative that can be explored and something to 25


(510) 313-0610

look for in the future. 1

I’m sorry if I was a little misleading. 2

When I was speaking in the presentation about 3

attempting to not use FD&C colors, I would still be 4

using iron oxides and micas and that was for non-nail 5

polish products but I brought that in as an example 6

of how I feel companies aren’t totally transparent 7

with their ingredients sometimes. 8

MR. SCHOON: So she does agree that all 9

colorants need to be FDA approved. 10

MS. RUBIN: Yes. He’s asking if you agree 11

that all colorants should be FDA approved. 12

MS. FRIERSON: Yes, I think they have to be. 13

MR. SCHOON: The other question I had was I 14

noticed that you have paraben free, which parabens 15

are preservers for water based systems and there are 16

very few water based nail polishes, so I was 17

wondering if you found a lot of paraben-containing 18

nail polishes? 19

MS. RUBIN: (Repeats question.) 20

MS. FRIERSON: You know, I’m not sure about 21

that. I just know that it’s something that our 22

customers were concerned with having it free of 23

paraben, so it’s something that I thought to 24

advertise. 25


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MR. SCHOON: But if nobody else uses 1

parabens in their nail polishes and you say paraben-2

free, isn’t that semi-deceptive at least? 3


MS. FRIERSON: I think there are polishes 5

that use parabens. I can’t say any off the top of my 6

head. 7

MS. RUBIN: Okay. Anyone else? 8

MR. JOELSON: David Lennett asked do you 9

have other phthalates in your products besides DBP? 10

MS. FRIERSON: Yes, we do. There are 11

ingredients posted on our website in each product or 12

in each color. Yeah, so we do use some phthalates 13

but not DBP. 14

MR. JOELSON: That’s it. 15

MS. RUBIN: Anybody else? Yes. 16

MS. ALCANTAR: This is Kathryn Alcantar with 17

CEH. You mentioned that you had the list of 18

ingredients on your website. Does your company offer 19

the full ingredient list on your website? 20

MS. FRIERSON: Yes, it’s on the website. 21

Basically, if you pull up any individual nail polish 22

product, the ingredients list is listed there for 23

each color. 24

MS. ALCANTAR: And so my follow-up question 25


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would be, have you found that to be a challenge for 1

the advancement of your company, is that an economic 2

problem for you to be transparent about the 3

ingredients? 4


MS. FRIERSON: I would say we’re occupying a 6

space in “green” or the “natural” beauty industry for 7

trying to be as natural and non-toxic as possible, 8

and I think in that sector they really value 9

transparency. We do get comments from people that 10

are picking apart the ingredients list and say, well, 11

I read on EWG’s SkinDeep database that this certain 12

ingredient is of concern, why do you guys put it in 13

or can you take it out? And so I’ll talk with my 14

manufacturer about whether we can take certain 15

ingredients out. 16

But I think that the problem is you want to 17

take as many toxic ingredients out as possible but at 18

the same time you have to produce a nail polish that 19

will meet the performance standards that people 20

expect of a traditional nail polish. 21

You have these alcohol-based nail polishes 22

and water-based nail polishes, but I don’t see those 23

overtaking traditional nail polish because they don’t 24

really perform like you would expect nail polish to 25


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do. You can’t put your hands in warm water or the 1

nail polish will come off. And you don’t have the 2

same type of colors. 3

MS. RUBIN: Okay, thanks Aja. Any other 4

questions? 5

MR. JOELSON: No more on the web. 6

MS. RUBIN: Okay. Our last presenter for 7

the day is Jen Jackson. Jen is the Toxics Reduction 8

and Healthy Ecosystem Project Manager of the San 9

Francisco Department for the Environment, and her 10

presentation is San Francisco Department of 11

Environment’s Nail Product Database Research Update. 12

MS. JACKSON: Jen Jackson. Thanks so much 13

to all at DTSC for having us here. I’m with the San 14

Francisco Department of the Environment. I oversee 15

the toxic reduction program, which has lots of 16

different programs, one of which, it’s my pleasure to 17

oversee, is the healthy nail salon program. 18

As you heard from Catherine Porter earlier, 19

we’re one of the five counties that has a healthy 20

nail salon program, and we were the first city to 21

start implementing one. 22

Within the Department of the Environment, we 23

have the luxury of working with the precautionary 24

principal ordinance, so that basically charges us 25


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with not necessarily needing to have all of the 1

scientific data at our fingertips to decide to take 2

action if there’s a potential for harm. 3

We decided in 2012, as we were hearing from 4

the Asian Health Services, which is an organization 5

in Oakland, that there were a number of cases of 6

people having various problems, and so we thought, 7

you know what, we probably could take action. We 8

might be able to help people get ventilation units in 9

their salons. We may be able to help them find 10

alternative products that don’t have the toxic trio. 11

So we began the program. 12

And our program, just for ground truthing, 13

we have about 250 salons in San Francisco. As 14

someone mentioned earlier, it’s a very robust sector. 15

We are a 49 square mile city with 250 salons, so we 16

have a lot of salons. In our program, we have about 17

40 salons that are healthy nail salons. 18

I say that because there’s been a lot of 19

discussion about training and letting people know 20

about all of the various things like gloves and 21

ventilation, and this is a community that needs 22

serious hand holding. There are language barriers, 23

as we’ve heard. We need to go in every year at least 24

to make sure that the ventilation units themselves 25


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have had their filters checked. These women are 1

working day in and day out with people’s hands and 2

feet, and it’s often a second thought, it’s not their 3

first thought to be checking some of these things. 4

So we have to go in a lot, and that means 5

that our one full-time employee who was supposed to 6

present today and is sick, she is spending a lot of 7

time just making sure that those that are in our 8

program are able to comply and complete the criteria 9

within the program. 10

As we’ve already heard, the chemicals that 11

are in a lot of these products, there are so many 12

products and these are just the polishes. We know 13

that there are gel products, there’s the solvents, 14

the thinners, the removers, the strengtheners, all of 15

those things, and a lot of these use chemicals that 16

are used in them are industrial chemicals, so we work 17

with our Department of Public Health in San Francisco 18

who employs industrial hygienists, and they came to 19

us saying we’re really concerned people are using 20

chemicals in nail salons that are being used in auto 21

body part painting facilities. These are the same 22

kinds of things that we see in industry, and they 23

have no personal protective equipment. What can you 24

all do? 25


(510) 313-0610

This is a real fact that they’re exposed to 1

chemicals that folks in other industries, where 2

they’re wearing protective equipment, are exposed to. 3

And then, of course, employee health. These 4

are real people who are trying to make a living and 5

we are concerned about their health. 6

Back in 2011 when we were approached by 7

Asian Health Services and the Nail Salon 8

Collaborative, we decided that the precautionary 9

principal also asks you to look at what science 10

exists, so we undertook a database project where we 11

took a look at all of the ingredients that we put in 12

various different products in salons to identify what 13

would be the worst chemicals that would be in these 14

salons, and so that’s really where the toxic trio for 15

us was. We solidified the science, we understood 16

that those were the ones we were most concerned 17

about, so that ended up becoming part of our 18

criteria, so when a salon becomes a healthy nail 19

salon they have to eliminate the use of dibutyl 20

phthalate, toluene and formaldehyde in their 21

products. 22

A lot has changed in the last five years, so 23

what we are doing now is relooking at that 24

information. As you’ve heard, there’s been a lot of 25


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changes. 1

We are seeing the advent of gel nail 2

polishes really taking over. Traditional nail polish 3

is definitely still used, but gel has really taken 4

off. 5

And interestingly, we’re finding that, at 6

least in our healthy nail salons they are actually 7

trying to move out of the acrylic nails, the 8

artificial nails, I should say. That’s a good thing 9

that the education that we’re providing them that 10

they’re exposed to a lot more chemicals when they do 11

artificial nails, that’s encouraging them to move out 12

of that service. But the gel nails are really scary 13

to us; we’re really concerned about them. 14

We decided to do, in collaboration with a 15

number of organizations whom you’ve already heard 16

from today, so Paula from California Department of 17

Public Health, Virginia St. Jean from our Department 18

of Public Health in San Francisco, and Catherine 19

Porter from Healthy Nail Salon Collaborative, and we 20

have assembled a lot of SDSs for products from 2011 21

to today to see what is in these products. 22

As you know, and as we’ve already heard, 23

there are a lot of problems with SDSs. They do not 24

necessarily list all the ingredients nor are they 25


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supposed to, but we’re just working with what people 1

are disclosing as the problem chemicals in their 2

products. 3

With traditional polishes, we basically 4

assembled quite a number of 95 traditional nail 5

products from 40 brands for a total of 1,042 6

ingredients that were disclosed on SDSs, so we put 7

all of those into a big Excel spreadsheet to see what 8

rose to the top. 9

So, 97 percent of products contained butyl 10

acetate, 96 percent contained ethyl acetate, and you 11

can read the rest yourselves. This isn’t necessarily 12

any kind of smoking gun, but when we compared it 13

against the toxic trio they didn’t really show up 14

very much, which is great, so there’s a lot less use 15

of the toxic trio. 16

But triphenyul phosphate is actually pretty 17

high, so 32 percent of the products that we surveyed 18

-- again, these are just products that we found in 19

salons that we were working with and also in supply 20

shops -- so 32 percent contained triphenyul 21

phosphate. 22

And then these are the other Candidate 23

Chemicals that are the 20 that were listed in the 24

preparatory documents for this meeting. We 25


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understand that there’s some 3,000 candidate 1

chemicals and we would like eventually to compare our 2

list with that full 3,000. 3

But a note on chemistry, as others have 4

said, CAS numbers are not consistent. One SDS may 5

say one number for a chemical and it’s another number 6

in a different SDS, and then comparing that to the 7

CAS number that’s in the Candidate Chemicals list 8

could be a completely different number. I’m really 9

excited about the website that the gentleman that 10

spoke earlier talked about INCI because we’re going 11

to have to take a look and see if we can try to 12

compare some of these chemicals, but it’s really 13

challenging. It’s tedious work as well. 14

With the gel polishes, these were the top 15

ten ingredients that we found, and we had 47 gel 16

products, 15 brands, and 771 ingredients that were 17

reported on the SDSs. Again, that doesn’t include 18

all the ingredients, it’s just what’s reported on the 19

SDSs as potential a hazard. 20

So, 47 percent contained hydroxy ethyl 21

methacrylate and 45 percent hydroxycylohexyl phenyl 22

ketone. And again, we compared that against the 23

Candidate Chemicals list and titanium dioxide was the 24

highest but triphenyl phosphate was in quite a few 25


(510) 313-0610

products. 1

The other thing that we found really 2

challenging, again because of nomenclature in 3

chemicals, there are quite a few acrylates that we 4

found in gel polishes, and so we’re not chemists and 5

so we’re not sure how to compare those and so we’d 6

love to work with DTSC to try to see if there’s some 7

way to compare that with your Candidate Chemicals 8

list to try to group things that we’re not quite sure 9

how to do that. 10

For the future, the next step is to take a 11

look at the artificial nail products, and currently 12

we have 33, 13 brands and 121 ingredients from SDSs 13

and we’re hoping to get more SDSs. As someone said 14

earlier, a lot of this is going to supply stores, 15

asking them for an SDS, asking a nail salon if they 16

have the SDSs on hand, or calling manufacturers or 17

looking at their websites, so it’s hard for us to get 18

all this information, so those in the industry that 19

are here, we’d love to get your information, that 20

would be great. 21

And we also are hopeful that in this process 22

that for DTSC and everyone in the room that folks can 23

really think about that this is not that we have to 24

have a full stack of studies that show harm. If we 25


(510) 313-0610

can move out of problem chemicals like toluene, 1

dibutyl phthalate, and formaldehyde, like we already 2

have, and other problem chemicals that we’re now 3

finding in these polishes and find safer 4

alternatives, why not? Why shouldn’t we do that? It 5

seems like it just makes sense. 6

So with that, I’ll take questions. And if I 7

can’t answer a question because my staff person who 8

implements this program and is our subject matter 9

expert isn’t here, I can always follow up with her 10

and answer those questions. 11

MS. RUBIN: Let’s start with Cathy. 12

MS. PORTER: Yeah, kind of a comment just to 13

add a little more context to this ingredients review. 14

This was started, and I think Jen mentioned 15

this, to take a look at what chemicals were in 16

products now in healthy nail salons. In healthy nail 17

salons they can’t use products that have toluene, 18

dibutyl phthalate, or formaldehyde, so the question 19

for us was what is replacing those three chemicals? 20

I don’t think we can look at this survey of 21

ingredients to tell the larger story of how pervasive 22

the toxic trio is in the whole world of nail salon 23

products, in cheaper nail salon products and in 24

retail products, because these salons by definition 25


(510) 313-0610

should not have any products with the toxic trio. I 1

just wanted to make sure that people got that kind of 2

contextual setting. 3

MS. JACKSON: That’s a good point. 4

We did go into some supply stores but most 5

of the SDSs are for products that are in our healthy 6

nail salons, so we were trying to see what the 7

replacement chemicals might be. 8

MS. RUBIN: Doug? 9

MR. SCHOON: Doug Schoon. I thought your 10

final comment was interesting, that if we don’t have 11

studies to show harm, why not remove the ingredient 12

anyway, and I think there are a lot of reasons for 13

that. 14

I think that if we don’t know that there’s 15

harm and we don’t have reason to believe that the 16

ingredient should be removed, then I think we should 17

question whether or not it should be removed. 18

And I was very pleased today to hear the 19

DTSC is not just going to take a hazard list approach 20

or just the risk based approach. They’re going to 21

combine the two and look at them. Because I think 22

that we want to move carefully, not jump out of the 23

frying pan into the fire, as I’m sure everyone 24

agrees, but I think we really need to rely on studies 25


(510) 313-0610

to determine which ingredients ought to be replaced 1

and which ones we ought to study more. 2

MS. JACKSON: Do you want to repeat that? 3

MS. RUBIN: I’ll do my best to summarize it. 4

Doug was commenting on the last point that 5

Jen made in her presentation about even if we don’t 6

have significant data showing harm from particular 7

chemicals, why not remove them if it’s possible. And 8

he wanted to share that he thought studies were 9

necessary to determine if there is harm before 10

removing a chemical, and remarked on our plans for 11

determining which chemicals will be considered. 12

MR. SCHOON: Well, modify that. I’ll just 13

say I think we need studies as well. It shouldn’t be 14

just because it’s on a list it should be removed. I 15

think it’s a combination of things we look at. 16

MS. RUBIN: Remarking on we should be 17

looking at a combination of things, doing studies, 18

not just removing a chemical because it’s on a list 19

of potential Candidate Chemicals. 20

MR. SCHOON: Right. 21

MS. JACKSON: I think I would agree in some 22

ways. Titanium dioxide, unless it’s in a powder 23

form, we’re not really concerned about that probably, 24

but I think that there’s enough data for many of the 25


(510) 313-0610

things on the Candidate Chemicals list that if there 1

is a safer alternative, why not, let’s move in that 2

direction as soon as we can and prevent harm from the 3

very beginning. 4

And, just a note about the ventilation 5

units, they cost about $1,500 for a salon to 6

purchase, which doesn’t sound like much perhaps to 7

anyone in this room, but salons make very, very small 8

margins. For them to get a ventilation unit is 9

pretty expensive and it’s a one-time outlay of cash 10

they may not have, so that’s a really big barrier to 11

increasing the mix of fresh air into their salons. 12

We also encourage to open doors, which is really easy 13

in San Francisco most of the year, but in a lot of 14

other places that’s just not possible. 15

In New York and other communities, they’re 16

starting to require a whole HVAC system. But again, 17

if a salon is approaching a landlord and saying I 18

want to put a salon here and I may have to go get 19

this HVAC system, they may not be able to set up 20

shop. 21

We are trying to remove some of those 22

barriers through our program. We’re working with the 23

Healthy Nail Salon Collaborative to offer micro loans 24

so that they can pay that off over a three year term, 25


(510) 313-0610

I believe it is. 1

And then when we started our program we 2

actually offered free to the salons so they could get 3

going and sort of prove the concept that it would be 4

helpful. 5

MR. SCHOON: You’ll be very happy to know 6

that I know this company where the price of their 7

units have dropped down to around $800, because I do 8

agree with your earlier statement. I think 9

alternatives like this are in many ways better than a 10

huge HVAC system that might not work for a mobile 11

technician, someone moving from place to place. 12

So again, I think we should look at a wide 13

range of alternatives, and I think that’s in the 14

spirit with what the DTSC is looking for, is 15

innovation, and fortunately there are ventilation 16

companies out there who are innovative. 17

MS. JACKSON: And I would love it if a salon 18

is purchasing something with really toxic chemicals 19

that they got a free unit along with it. 20

MS. RUBIN: That’s just a follow-up 21

discussion on the ventilation units that Jen 22

mentioned and just looking at different ideas and 23

trying to come up with solutions, realistic practical 24

solutions to ensure the safety of nail salon workers 25


(510) 313-0610

and people who visit them. 1

All right. We’re going to hit Veena next 2

and then you, Patrick. 3

DR. SINGLA: Veena Singla with NRDC. Thank 4

you for an interesting presentation, and I think 5

following up on your comment about really thinking 6

about moving to less hazardous chemicals, I think 7

another benefit of that is to avoid this kind of 8

cycle of substitutions which I think we’ve seen 9

throughout some of the various presentations and the 10

previous one, you know, in 2002 this one was removed, 11

2005 that one was removed, 2012 the next one was 12

removed. 13

I think really giving consideration to the 14

health and safety characteristics of a chemical 15

before you use it as a replacement and trying to go 16

to a safer alternative has a lot of benefits. It’s 17

more of a comment. 18

MS. RUBIN: (Repeats comment.) 19

MS. JACKSON: And if I can add, I think the 20

alternatives assessment process is where we’re 21

heading. Hopefully we do find things that won’t be 22

regrettable substitutes for things but much better. 23

MS. RUBIN: Patrick. 24

DR. KERZIC: Patrick Kerzic from DTSC. 25


(510) 313-0610

Regarding the ventilation units, I know with 1

other parts of our program, we offer mitigation 2

measures for contaminated sites that sometimes flat 3

out don’t work. Do you know of any efforts to 4

empirically determine the efficacy of these units? 5

MS. JACKSON: Yes. The State of Washington, 6

I think it’s King County, they have a healthy nail 7

salon program also and they conducted some studies to 8

see if it improved. For toluene, I believe it did. 9

I could get you that information. 10

DR. KERZIC: Are you doing those results as 11

well? 12

MS. JACKSON: We haven’t done that. It’s 13

something we could potentially do. We don’t have a 14

lot of funding for the program, but potentially and 15

maybe in collaboration with others who already have 16

personal meters or things like that, we’d be happy to 17

work with you on that. 18

MR. SCHOON: The Swedish government actually 19

has very good requirements for ventilation in salons, 20

and they have test methods that they specify must be 21

used, so I would recommend looking at what they’re 22

doing. They’ve really made some great headway in 23

salons in Sweden. 24

MS. JACKSON: I think for us when we started 25


(510) 313-0610

this program we did a lot of stakeholder meetings 1

with people in the industry, people who were working 2

in salons, salon owners, and loud and clear we heard 3

that, “Please, please, this is our bread and butter. 4

Don’t put us out of business. Don’t go telling 5

people not to have their nails done.” And so okay, 6

yes, we hear you. 7

And so what we really had to do was figure 8

out practical solutions that weren’t going to be so 9

cost prohibitive. And so again, requiring a whole 10

change out of an HVAC system, working with someone’s 11

landlord, that kind of thing, it’s really, really 12

difficult. And the way that’s being handled in other 13

communities is that it’s only for new construction. 14

For us in San Francisco, we have a building 15

stock of 100 or more years, and so it’s really 16

challenging in a really densely packed city to do 17

that kind of renovation. 18

But if there were a new salon -- and 19

actually, we have a couple new salons who have come 20

into the program who from the very beginning before 21

they even really started construction of their salon, 22

they worked with us to figure out what kind of system 23

to put in place, so it can work. 24

MR. SCHOON: The risk that you run is that 25


(510) 313-0610

people just won’t start new salons. We’re seeing 1

this in New York now. It costs too much money. The 2

State of New York doesn’t allow for ventilation 3

systems like this, which I think was a big mistake on 4

the State of New York’s part. 5

MS. RUBIN: Paula? 6

DR. JOHNSON: I wanted to mention that the 7

other side of the argument that if there’s no data 8

showing harm then why discontinue using certain 9

chemicals. 10

The other side of that, if there’s no data 11

showing safety, why expose thousands of people to 12

that exposure? 13

MS. RUBIN: Are there any other comments or 14

questions in the room? Go ahead. 15

MS. ALCANTAR: Kathryn Alcantar from CEH. I 16

have a question, maybe more directed to DTSC, which 17

is: I really appreciate the opportunity to have 18

various stakeholders come and present and really 19

learn more about the industry and how it operates. 20

From our perspective, one of the things we 21

appreciate about the program is that it’s very 22

different than other programs because of this focus 23

on hazard. And so, I have to say that a lot of the 24

conversation around personal protective equipment and 25


(510) 313-0610

reducing risk, of course we want to reduce that risk, 1

but putting that burden on low wage immigrant 2

communities with limited English speaking proficiency 3

is very problematic. I would just want to encourage 4

DTSC to utilize in full effect its authority to focus 5

more on hazard necessarily not having to do risk 6

assessment. 7

Those lists have been vetted by 8

authoritative bodies, so this concept of well, let’s 9

study it further, the point of the program is to 10

prevent that from happening and really look for 11

alternatives, so I just want to make sure I got that 12

in. 13

And then the second piece is, I’m not an 14

expert on the nail product manufacturing process, but 15

the presentations and conversations today I think 16

rightly so have focused on the health hazards for 17

workers and consumers directly. 18

But the other element of the Safer Consumer 19

Products Program is the attempt to look at a 20

product’s hazard throughout its life cycle. I’m 21

curious if the Department has reached out to 22

manufacturers to better understand, for example, what 23

worker exposure might be in the manufacturing of 24

these products. 25


(510) 313-0610

And then, conversely on the other side, from 1

manufacturer all the way to disposal, how are they 2

being disposed? 3

One of the people said hand washing is much 4

more common. If you’re hand washing down these 5

products, how much of that is getting into the water 6

stream? 7

And also, having learned from the 8

pharmaceutical industry in terms of things being 9

washed down the drain, how are people disposing of 10

this? I have to say I’ve accumulated bottles of nail 11

polish throughout my life, and thus far, I’m not 12

quite sure what to do with. Do people just throw it 13

away? What does that mean? How is it getting into 14

our environment? So we haven’t talked about any of 15

those today, and I just want to call that out and see 16

if there could be further discussions to that end. 17

MS. JACKSON: Could I just add to that? 18

MS. RUBIN: Of course. 19

MS. JACKSON: We have seen, especially on 20

the disposal side, a lot of problems: acetone being 21

poured down drains which, of course, is probably not 22

very good for plumbing. All sorts of things being 23

disposed of improperly, and of course in our program 24

we train folks on what they need to do for proper 25


(510) 313-0610

disposal; take it to household hazardous waste 1

facility, which in our community small businesses can 2

use. That’s not true everywhere. And, of course, 3

all of the salons that are not in our program have 4

not necessarily received that training. 5

I don’t believe that it’s part of the BBC’s 6

training. It would be great if that were true, but 7

it’s a really big problem. 8

And to your other point, if we can try to 9

eliminate some of these toxics in the products in the 10

first place then we don’t have to deal with the 11

disposal issues. 12

I used to work in the wastewater industry 13

for many years and a way is down drains and in the 14

garbage and then you never think about it again until 15

it ends up in your groundwater. It’s a really 16

terrible problem, so nothing really ever goes away. 17

MS. RUBIN: Thanks Jen. 18

Do we have any more questions or comments 19

from anyone in the room? No one online? 20

I want to thank you all and introduce Dr. 21

Meredith Williams, our Deputy Director of the Safer 22

Products and Workplaces Program. 23

DR. WILLIAMS: Thank you. Thank you for 24

doing such a great job today and thanks to the entire 25


(510) 313-0610

team for giving everybody this opportunity to really 1

share the information with us. 2

I am very heartened by the discussion today, 3

just because we invite a discussion and you never 4

know if anybody’s going to show up and really give 5

you meaningful information, and I know that we 6

learned a lot today and we do consider this 7

fundamental to our decision making process. 8

This is a new program. It is a new 9

paradigm. You saw that today. I’m heartened by the 10

level of understanding of how these regulations work, 11

but I still think we have more to do to talk about 12

where we are in that spectrum between hazard and risk 13

and how we make our decisions. We’ll continue to 14

provide as much transparency about those things as 15

the program evolves. 16

I often say that we’ll be successful not if 17

we just name a bunch of products, but if companies 18

start to think the way that we think. So, if 19

manufacturers start to think about “what’s worth it” 20

in terms of their product formulations, we think 21

we’ll be getting somewhere. 22

I think today we got some indications that 23

people are wrestling with these issues. They’re 24

willing to be in conversation with us. We have very 25


(510) 313-0610

knowledgeable people from the NGO community who are 1

plugged in and we’re very grateful for that, and I 2

think that puts us in a good position to continue to 3

move this topic along, along with our other topics, 4

and get to the point where we can make decisions 5

about what we want to do in this space, if we want to 6

do anything. 7

Thank you all for your attention. It was a 8

long day but it did seem to me to move along at a 9

great clip in terms of just having the variety of 10

speakers and covering a lot of ground. We hope that 11

you will stay engaged and continue to reach out to 12

us. 13

There is contact information on the agenda 14

for everything from media inquiries to the technical 15

information. 16

There’s still time to comment through 17

CalSAFER. Please use CalSAFER, our online tool for 18

comments, and please be in touch. 19

Thank you. 20

MS. RUBIN: Thanks, everyone. 21

(Adjourned at 4:19 pm) 22

23

24

REPORTER’S CERTIFICATE


(510) 313-0610

I do hereby certify that the testimony in the foregoing

hearing was taken at the time and place therein stated;

that the testimony of said witnesses were reported by me, a

certified electronic court reporter and a disinterested

person, and was under my supervision thereafter transcribed

into typewriting.

And I further certify that I am not of counsel or

attorney for either or any of the parties to said hearing

nor in any way interested in the outcome of the cause named

in said caption.

IN WITNESS WHEREOF, I have hereunto set my hand this

20th day of March, 2017.

Susan Palmer

Certified Reporter CERT 00124


(510) 313-0610

TRANSCRIBER'S CERTIFICATE

I do hereby certify that the testimony in the

foregoing hearing was taken at the time and place

therein stated; that the testimony of said

witnesses were transcribed by me, a certified

transcriber.

And I further certify that I am not of

counsel or attorney for either or any of the

parties to said hearing nor in any way

interested in the outcome of the cause named

in said caption.

IN WITNESS WHEREOF, I have hereunto set my

hand this 20th day of March, 2017.

Jill Jacoby Certified Transcriber AAERT No. CERT**D-633

Documents

PUBLIC WORKSHOP ON POTENTIAL HEALTH AND · PDF file02.03.2017 · i . state of california department of toxic substances control (dtsc) public workshop on potential health and safety