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DEPARTMENT OF HEALTH AND HUMAN SERVICES 

U.S. FOOD AND DRUG ADMINISTRATION 

CENTER FOR FOOD SAFETY AND APPLIED NUTRITION 

PUBLIC MEETING: COSMETIC MICROBIOLOGICAL SAFETY ISSUES 

WEDNESDAY, NOVEMBER 30, 2011 
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 CONTENTS

 PAGE

WELCOME AND OPENING REMARKS 5

Dr. Linda Katz, FDA 

FDA PERSPECTIVE 10

Dr. Patricia Hansen, FDA 

PUBLIC COMMENTS & QUESTIONS: 

 

Etan Yeshua 24 

Environmental Working Group 

Jay Ansell 37 

Personal Care Products Council 

Phil Geis 51

Geis Microbiological Quality 

David Steinberg 73 

Cosmetic Preservative Council 

Richard Whiting 102 

Exponent, Inc. 

CLOSING REMARKS 117 

Dr. Linda Katz, FDA 
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PROCEEDINGS 

 MR. GASPER: Good morning, everybody. Welcome 

to the meeting. I've just got a minute or two of 

housekeeping notes here. I'm John Gasper. I'm in the 

Office of Cosmetics and Colors. I will be the 

moderator. 

 So, first thing to note, this public meeting 

is being transcribed and the transcription will be 

posted on the FDA's website when completed. 

 A short reminder, during the question and 

answer sessions that we'll have after the presenters, 

please clearly state your name and your organization to 

make sure that they are captured for the transcripts. 

The restrooms, both of them, are to the right as you 

exit the ballroom. 

 Now, you should have all received a folder. 

And inside your folder you should find the agenda; you 

should find copies of both Dr. Katz's and Dr. Hansen's 

slide presentations; there's a copy of the Federal 

Register notice. And as noted on the agenda, January 

30th, 2012 is the deadline for submission of any 

written comments to the docket. And the docket's 
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address is listed there as well as in the Federal 

Register notice. We will be putting the slides to the 

docket later. And you also should have in the folder a 

list of attendees that have registered in advance. 

 Now, if anybody has any media or press contact 

questions, we do have somebody from our press office 

here, that's Miss Tamara Ward, she's standing in the 

back, waving, so if you have any question please 

contact her. 

 Now, for public comments, if there's anybody 

here who has not signed up to make a public comment 

today, and you would like to do so, please contact 

Juanita Yates. I believe she's still outside at the 

registration desk--oh, Juanita's right to your left 

here--or one of our staff members, by noon today, by 

the lunch break, and we can schedule you in. 

 If you need any -- have any more questions, or 

need some assistance, please talk to one of our 

personnel at the registration desk. Wendy Johnson is 

working outside; she should be able to answer any 

questions or help you. 

With that being said, I'd like to start the 
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meeting with Dr. Linda Katz, who is the director of the 

Office of Cosmetics and Colors. 

 DR. KATZ: Thank you, John. Good morning and 

welcome. I'm glad to see that we have such a great 

turnout today to talk about the cosmetic 

microbiological safety issues. And we look forward to 

hearing from all of you, either here today who are 

presenters, or through public comments. 

 During the brief time that I have this 

morning, what I'm going to do is just to give an 

overview and talk a little bit about FDA's mission, 

talk a little bit about FDA's oversight for our 

cosmetic safety with regard to our regulatory authority 

programs and tools, and then talk a bit about the 

purpose of today's meeting, which, all of you are 

aware, is why you are here. 

 Let me start off with talking about FDA's 

mission. This slide is very simple. And it's simple 

because really the mission itself is fairly simple, to 

protect and promote the public health. And we do this 

by looking at and focusing on cosmetic safety. 

FDA's authority for cosmetics is somewhat 
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limited. As probably all of you are aware, our 

authority is based on the Federal Food, Drug, and 

Cosmetic Act, and it states that cosmetics must not be 

adulterated or misbranded. 

 So what does this, basically, mean? It means 

that FDA's authority is post-market only. The law does 

not provide for FDA to have pre-market approval of 

cosmetics. Now, this is very different from drugs and 

devices in which an application will come into the 

agency for review and the agency will make a 

determination whether a product and ingredients are 

safe for use, as well as effective prior to marketing. 

For cosmetics, what we know about the products we learn 

after the products are out in the marketplace, in most 

cases. 

 So what is our responsibility at the FDA? 

Well, our responsibility is really to monitor safety 

and ensure the proper labeling of cosmetics. When a 

cosmetic gets marketed, industry has additional 

information and the responsibility to assure that 

products that are on the marketplace are safe. 

So what does this, basically, mean? It means 
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that the cosmetics must be safe when used as labeled 

and under the customary conditions for use. So, our 

main concern is for the safety and the appropriate 

labeling, so that consumers who are using these 

products can use them safely. 

 So how does FDA determine and monitor the 

safety of cosmetics? We do this really by information 

that comes to us. We do it by the monitoring of 

adverse events that come into the FDA. As all of you 

know, adverse event reporting for cosmetics is 

voluntary, so it's somewhat limited. But, by the same 

token, we look for trends. If there are certain trends 

that come through that suggest that there may be a 

safety issue, it sets off a flag for us to delve a 

little more fully. 

 We also look at the scientific research. We 

look at what's published in the literature. We look at 

any additional information that may become available to 

us, and here CIR is often a valuable source for 

additional information. 

 We will do inspections of cosmetic 

manufacturing facilities, particularly if we have 
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concern about a product or a concern about ingredients. 

We examine imported products, again for their safety. 

And we will take enforcement action against cosmetics 

that are adulterated and/or misbranded. The ability to 

do that is in our regulations. And we also have 

guidances and other public communications to help 

industry to manufacture safe cosmetics. 

 This again leads to important information and 

part of the reason for why we're here today. When we 

talk about microbiological safety, the FDA's 

information is somewhat limited. But we do give advice 

for things that we would like to see as you market and 

manufacture products. We have GMP guidelines that 

provide fairly general directions that are available on 

our website. Even though we all know that GMPs are not 

required for cosmetics, we hope that manufacturers do 

follow them because, again, this is one of our ways to 

assure that products are being manufactured safely. 

 We have a compliance program and general 

manuals that are also available, which will give 

general information to manufacturers as to what kinds 

of information we're looking at, Warning Letters that 
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may have been issued, and why Warning Letters have been 

issued. 

 And we also have the BAM, which is the 

Bacteriological Analytical Manual, which is a technical 

manual. In the BAM itself, one chapter is dedicated to 

cosmetics and cosmetic ingredients. And Dr. Patricia 

Hansen will talk a little bit more about that in just a 

few moments. 

 So that brings us really to the goal of this 

public meeting. We're here really to talk about 

microbiological safety of cosmetics and to link them 

directly to FDA's public health mission. We're really 

here to hear from you, to find out more information, 

and to get more opportunities for us to see where we 

need to potentially modify guidances, what additional 

information we might need to make available to all of 

you, both in industry and academia. We need to assure 

that any time we change any information that we 

publish, that there's a sound scientific basis. And 

that, really, this session itself is designated 

primarily as a listening session. Again, I need to 

emphasize, we want to hear from you. 
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 This slide section itself is just to let you 

know where you can find information about cosmetics and 

FDA's position about cosmetics and how we regulate 

them. On our home page we have multiple different 

listings. And we have question and answers to help to 

orient you about issues and questions that we get asked 

and what we think should be the answers. But again, 

the emphasis from this meeting will be to find out if 

any of our answers may potentially be incorrect because 

the science has changed. We need to know that. 

 So with that, I want to thank you and hope 

that this turns out to be a very productive meeting. 

And we look forward to hearing from you. Thank you. 

 MR. GASPER: Keith question: I need to make 

your slides larger. After we make this larger, Dr. 

Patricia Hansen will be giving you the FDA perspective. 

F5 didn't work. 

 DR. HANSEN: Okay. Little technical details. 

Good morning. It is really great to see so many of our 

stakeholders here this morning. And our office has 

really been looking forward to this day, the cosmetic 

program, and for those of you who are acquainted with 
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me, you know that personally I've really been looking 

forward to this day and to hearing from our 

stakeholders, your data, information, analysis, and 

perspective. 

 And I'm going to give, really, a brief, sort 

of overview and some context around FDA's perspective. 

I'm going to focus on safety and that will be a theme 

recurring. As Dr. Katz mentioned, safety really is our 

focus here--public health protection, and promotion of 

public health--and we're going to keep coming back to 

that. 

 We have a variety of current information 

sources, FDA sources, industry sources, others that 

address, in whole or in part, microbiological safety. 

I'm going to talk about those a little bit. I'm going 

to talk about our thoughts around updating and 

restructuring FDA information sources and getting to 

some of the themes that Dr. Katz mentioned. And also 

our information needs in this broad area and areas, 

excuse me, for stakeholder input, because we really 

want to hear from you. Again, you have valuable 

insight, information, and perspective and we need to 
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exchange that. 

 So microbiological safety and quality -- these 

are fundamental concepts and we believe they're 

important to all stakeholders. We also believe that 

stakeholder input into FDA's work and information 

sources is critical. We need current science. We need 

insight into current manufacturing and testing 

practices, suggestions about areas, future areas of 

research are also of interest, stakeholder needs and 

concerns, and other considerations. 

 Turning to the topic of information sources, 

there are various sources. FDA is one, industry 

importantly is another, standard setting organizations 

are again a source additionally of information relevant 

to microbiological safety. And there are other 

sources. Different sources emphasize different aspects 

of microbiological safety and/or quality. 

 FDA's information sources, Dr. Katz mentioned 

a couple of them, I'll go on a little bit more in 

depth. We have a cosmetic compliance program, which 

she mentioned, last updated in 2010 (and these 

documents are on a regular revision schedule). We have 
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the Cosmetic Good Manufacturing Practice Guidelines and 

Inspection Checklist, last updated in 2008, currently 

under revision now. 

 We have the Bacteriological Analytical Manual, 

familiar to many people in the audience, and Chapter 

23, "Microbiological Methods for Cosmetics." This 

chapter has not been updated in some time. It was last 

updated in 2001. 

 Then we have consumer sources. Consumer 

updates is one vehicle we use and one of particular 

pertinence here is the one that addresses using eye 

cosmetics safely. And we're interested in hearing from 

all of our stakeholders too on information sources and 

topics that might be helpful for consumers. 

 There are industry information sources. There 

are the CTFA Microbiology Guidelines, 2007 update, CTFA

Quality Assurance Guidelines, also 2007. And there are 

other information sources and guidelines out there, and 

many of you active in the field and in the industry 

will be well familiar with those. And my intent is not 

to give an exhaustive list but merely to highlight some 

of the critical ones. 
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 Standard setting organizations are another 

source of information and guidelines. I'm highlighting 

ISO here, most prominent, in my view, but there are 

other bodies out there. There is the ISO Technical 

Committee 217 Work Group Six product, Cosmetic Good 

Manufacturing Practice, and I'll be taking up this 

particular information source in a little more detail 

later on in the presentation. 

 There is a draft International Standard, ISO, 

Evaluation of the Anti-microbial Protection of a 

Cosmetic Product. And that was out and last discussed 

at this year's meeting in March. Also at that meeting--

the 17th meeting of Working Group 1--a proposal was 

sent to the ISO advisory group for discussion. And that 

was to develop an international standard identifying 

objectionable microorganisms and setting microbial 

limits for cosmetics, considering current safety and 

quality standards. And I highlight this one to 

emphasize that these topics are of importance across 

the international scene. And there is some confluence 

of interest and priority, I think, across the group of 

stakeholders: Government, industry, consumers. 
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 As many of you are aware, we are updating and 

restructuring FDA information sources and typically 

many documents do undergo periodic updating. 

 We need to align related FDA documents. This 

is very important: that we try to keep them, if they 

can't be absolutely synchronized, consistent and 

aligned. We don't need one pointing off to the right 

and one to the left. And so there's always that effort 

to keep things aligned. 

 We want our information sources to be up to 

date in terms of science and technology. And that is 

sometimes a real challenge in rapidly developing areas. 

And we really, again, want to hear from our 

stakeholders, particularly on science and technology. 

 In any library of information sources, you 

know, you pick one up off the shelf and when you're 

trying to use it things emerge. Things you thought 

were crystal clear are maybe not so crystal clear. So 

we need to clarify confusing or ambiguous areas and 

that is part of this effort that the agency is 

continually engaged in, in updating and restructuring 

its information sources. 
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 We believe it desirable to align with 

international standards to the greatest extent possible 

within the existing legal framework, important 

parameter there, and without compromising safety, 

another critical parameter. 

 And we need to consider new information 

sources that may be needed. And here I'm harkening 

back again to Dr. Katz's remarks where we've been 

considering, given that some of our information sources 

are very general, there's a need to update. Do we need 

to develop new information sources, new guidelines, new 

consumer updates? What kinds of topics and what kinds 

of formats will be most useful? 

 So I'll talk about a few of the things that 

we're doing right now. You heard me speak about the 

compliance program, that that was last updated in 2010. 

And in that effort we removed a lot of obsolete 

material, clarified sections that had been found to be 

confusing or ambiguous to the users, and in general, 

really pulled it up to date. 

 We are presently engaged in revising the 

Cosmetic GMP Guidelines and Inspection Checklist. 
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Again, we are removing obsolete or extraneous 

information, clarifying ambiguous areas. We are also 

considering incorporating elements from the 

corresponding ISO guideline that I mentioned to the 

extent that's possible -- very important. And this 

document is very well developed, and it is in 

clearance. We do not have a date certain for its 

issuance. I will note that, but it's well along in the 

clearance process and we anticipate it issuing, 

hopefully, soon. 

 We're also revising Chapter 23 of the BAM. 

We're seeking greater alignment with more recently 

updated chapters. The BAM, in the main, focuses on 

foods and has chapters that are microorganism specific. 

Some of these chapters are more up to date in terms of 

methodology, so we are looking closely to, again, to 

align the cosmetics chapter, which is broader, to align 

with those chapters where it is needed, that are more 

specific to microorganisms and food products. And so, 

that's one thing that we're trying to achieve. 

 We're seeking greater clarity in some of the 

sections of that chapter, especially regarding follow-
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up on ambiguous results. We're removing extraneous 

non-technical material to have a tighter, more focused 

chapter. 

 And we see opportunities here, in periodic 

revision, to incorporate newer methodologies, perhaps 

as screening tools. And, if you recall from the 

Federal Register notice, we are particularly interested 

in hearing from our stakeholders on testing methods of 

all kinds. 

 And again, we're considering the possible 

development of new information sources. Should we be 

developing guidance to industry on cosmetic 

microbiological safety? What specific topics are most 

in need of addressing? We're really hoping to hear 

from you. What kind of formats will be most useful? 

Again, we're trying to keep these information sources 

current and there are a variety of different ways, 

formats, that would lend themselves, we believe, more 

easily to that. But we want to hear from you. 

 We're considering developing additional 

resources for consumers on cosmetic microbiological 

safety. We don't have an awful lot. Up there I gave 
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the one example of using eye cosmetics safely; that is 

the main one that we have. And we're looking for other 

topics that stakeholders believe are important to 

address, topics important to consumers, and what kinds 

of formats and presentation would be most useful for 

our stakeholders. 

 So, I've mentioned repeatedly that there are 

areas where information and input are needed. And I'll 

amplify some of those highlighted in the Federal 

Register notice. And I'm going to go through those and 

amplify a little bit on some of them here. 

 A number of things group under Product 

Manufacturing and Controls. We're very, very 

interested in hearing from stakeholders on 

microbiological testing of cosmetics, types of 

preservative systems, and methods for preservative 

efficacy testing, product and packaging characteristics 

that affect microbial growth as well as other factors. 

 We have a number of people here who have 

signed up to give presentations. We're hoping to have 

a great deal of technical information in this and other 

areas, and are hoping that people will also take full 
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advantage of the opportunity to submit written material 

to the docket. 

 We are very, very, interested in hearing from 

you on these factors I've outlined and other factors 

that you, from your perspective, believe are important 

to that broad umbrella topic of microbiological safety. 

 Some group under microbiological risk 

assessment. Here I want to emphasize that that's human 

health risk assessment. We're interested in the 

identity and prevalence in cosmetics of microorganisms 

that pose specific health risks, the question of frank 

pathogens, opportunistic pathogens, non-pathogens, and 

that whole continuum. And we're, again, interested in 

data and information, analysis and perspective. There 

are emerging pathogens. There are antibiotic resistant 

strains. All of these factors, we believe will be 

useful to hear from stakeholders and to consider as we 

move forward. Routes of exposure to microorganisms and 

the corresponding effective doses -- very important. 

 Particular sub-populations that may be at 

greater risk, we're very interested in this area and 

other considerations relevant to human health risk 
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assessment with microbial considerations. 

 We are also very interested in hearing about 

adverse events. You heard a little bit from Dr. Katz 

on the adverse event reporting system that FDA has. We 

have limited information. It's a passive system. And 

common to all passive systems, we believe there's 

significant underreporting; there's an awareness issue. 

We believe that consumers generally are not very aware 

of FDA's system for reporting cosmetic adverse events. 

So we are engaged, actually, in a separate effort to 

promote greater awareness amongst consumers and health 

professionals. 

 But we are very interested in hearing from 

you, our stakeholders, on topics relevant to this broad 

umbrella. The occurrence of adverse events in 

different product types, the occurrence of adverse 

events associated specifically with microbial 

contamination and other aspects of adverse events, 

including reporting and monitoring systems. 

 And this list, that I have been going through 

and that was enumerated in the Federal Register notice,

is really not meant to be all inclusive. There are, we 
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believe, an abundance of other considerations that may 

be relevant to microbiological safety of cosmetics and 

protection of consumers. And we want to hear from you. 

 So again, to reemphasize, you know, we are 

really seeking to hear from you: Your data, your 

information, your scientific analysis, your perspective 

in the areas that I've outlined. And to recap them: 

the identity and prevalence of microorganisms, 

including antibiotic resistant strains, pathogens, 

frank or opportunistic non-pathogens; microbiological 

testing; preservative systems and preservative efficacy 

testing; product and packaging characteristics that may 

impact routes of exposure to microorganisms associated 

with cosmetics and infective doses; subpopulations who 

may be at greater risk; and the adverse event reporting 

topics that I just mentioned. 

 We also want to hear from you beyond those 

topics of what other topics you believe would be useful 

to stakeholders, useful to industry, useful to 

consumers, useful in the academic sense. And what 

types of formats and vehicles would be most practical, 

most useable, and helpful. And we need to hear from 
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you on that. 

 So, there are multiple opportunities for 

stakeholder involvement. That is a point I really want 

to emphasize. We're here today with really an early 

input kind of workshop, to gather from you, again, 

data, information, analysis, and perspective to help 

inform, really, our plan for moving forward. Setting 

some priorities around that, what topics do we need to 

address? What are most important? Should we proceed 

to formal guidance? That would be an area where there 

are further opportunities for stakeholder input and 

involvement built into the process. 

 But I hope that you realize, by our comments 

today, we really want to hear from you and want to 

offer as many opportunities for input and involvement 

as possible. We believe it will really strengthen the 

effort and ensure the very best and most useful of 

products in terms of information sources. 

 Today is a huge opportunity in this regard. 

And again, I'm really just so happy to see so many 

people here, to see the folks who have lined themselves 

up to present, very good. I hope that people who have 
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additional information to offer will sign up at 

lunchtime, as our moderator mentioned, to take their 

few minutes at the microphone. 

 Following up on this meeting there is a docket 

open, and a 60-day comment period. And I really want 

to encourage all of our stakeholders, whether they are 

formally presenting here today or not, to submit 

written material to the docket. 

 Information on the docket is contained in the 

folders that you have at the meeting. But it's here 

again for reference, up on the screen. And these 

comments, we're looking for them by January 30th in the 

coming year. 

 And more of just how to get hold of us. If 

you've got questions and information outside that 

docket process that you want to propose. And with 

that, I think I will close. Thank you. 

 MR. GASPER: Okay. Our first presenter is Mr. 

Etan Yeshua, from Environmental Working Group. 

 MR. YESHUA: Good morning. I don't have any 

slides for you all, so hopefully I'm enough to capture 
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your attention for the next 20 minutes. 

 Thanks for providing EWG the opportunity to 

comment on the issue of cosmetic microbiological 

safety. My name is Etan Yeshua, I'm the 2011 Stabile 

Law Fellow at the Environmental Working Group, where my 

work focuses on the regulation of cosmetic products. 

 EWG is a non-profit research and advocacy 

organization based in Washington, D.C. and Oakland, 

California. Our mission is to use the power of public 

information to protect public health and the 

environment. We appreciate FDA's interest in and 

commitment to ensuring the safety of cosmetics or 

personal care products. 

The average consumer uses nearly ten different 

personal care products every day. That means there are 

ten opportunities daily for a microbiologically 

contaminated cosmetic product to spread infection to an 

unknowing consumer. Moreover, the 126 unique 

ingredients that the average person applies to his or 

her skin every day contain preservatives, chemicals 

that may often be toxic, and present hazardous health 

risks. 
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 The federal government does not require the 

vast majority of these products to undergo health 

studies or pre-market testing. The information gap 

makes it all the more alarming then, in that young 

children, who are of course more susceptible to 

microbial and toxic contamination, are exposed to 61 

unique cosmetic ingredients in a handful of different 

products every day. 

 Given the lack of regulatory authority 

provided FDA under the Federal Food, Drug, and 

Cosmetics Act, FDA guidance for industry would be one 

of the most effective ways to ensure cosmetic products 

to ensure that consumers are protected from microbial 

contamination. 

 EWG supports the agency's efforts to promote 

safe industry practices, especially given the narrow 

confines of FDA statutory authority. As a consumer 

advocacy group, and as a founding member of the 

Campaign for Safe Cosmetics, EWG has long backed the 

call for effective and efficient cosmetic safety 

regulation with sound scientific research. 

To that end, EWG recommends that FDA develop 
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guidance for industry on the best methods for 

protecting consumers from both microbial contamination 

and exposures to harmful chemical preservatives to 

ensure the following: 

 That cosmetic products do not pose undo risks to 

consumers from microbial contamination. 

That cosmetic products are formulated and their 

packages designed to minimize the risk of microbial 

contamination without toxic chemical preservatives. 

 That cosmetic products are safe for consumers, 

especially vulnerable populations, including pregnant 

women and young children, taking into account all 

sources of exposure, because health risks are not only 

from exposure to a single product but also the 

aggregated effects of repeated exposures. 

 And finally, that cosmetic products are 

labeled accurately, with expiration dates and 

information about the presence of all preservatives and 

chemicals, including those like formaldehyde that are 

often released into the product by the chemical 

breakdown of other ingredients. 

In working to achieve these goals, our own 
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research has highlighted two specific areas of concern 

with regard to cosmetic preservation as well as a 

number of additional areas where further research is 

needed. 

 Since 2004, EWG's Skin Deep Database has 

provided consumers with a free, publically accessible, 

on-line tool with hazard profiles of almost 70,000 

cosmetic products, and more than 8,000 cosmetic 

ingredients. 

 Our researchers continually compile and 

analyze information from more than 60 toxicity and 

regulatory databases to generate safety ratings for 

what has become the world's largest personal care 

products safety guide accessed every month by over one 

million people. 

 With eight years' worth of data, our Skin Deep 

Database serves as the basis for our research and 

policy conclusions about cosmetic product risk and 

regulation. The data we have amassed has revealed 

hidden health risks, spurred regulatory action, and led 

to changes in product formulation. The data also 

highlight the need for FDA guidance with regard to 
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preservation of cosmetic products. 

 Many products on the market contain 

preservatives that may be hazardous to human health; 

some may be over-preserved, while others may contain 

too little preservative ingredient to be effective. 

Still others, alarmingly, appear to contain no 

preservative at all. Information we have suggests that 

there's a gap in industry knowledge, or at least use of 

cosmetic preservation best practices. A gap, which we 

believe, FDA guidance would be well suited for. 

 Two topics stand out, first, a growing trend 

of products that do not protect against microbiological 

contamination. In evaluating the need for cosmetic 

preservative guidance, FDA should consider products 

that are unpreserved or under-preserved. Our database 

lists 943 such water-based products that do not contain 

any of the 1,159 preservatives we track. Products with 

high water content are of course especially susceptible 

to contamination. Shampoos, conditioners, lotions, 

liquid soaps, creams, and the like merit specific 

attention because their high water content increases 

the need for proper preservation, be it a chemical 
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agent, package design or product labeling. 

 Second, products with potentially toxic 

preservatives. Some 3,579 products in our database are 

preserved with one or more of 22 different 

preservatives for which there's evidence of toxicity 

and risk to human health, including the health of 

children and developing fetuses. The personal care 

products should not threaten consumers with infection 

from preventable microbial contamination. Neither 

should they force consumers to choose between microbial 

contamination and contamination due to harmful 

preservatives. 

 While FDA should guide industry toward antipathogenic and better preserved products, the agency 

should simultaneously promote safer, less toxic methods 

of preservation. Personal care products ought to be 

manufactured and used safely with minimal risk of 

microbial contamination, but without trading one risk 

for another. 

 For example, parabens are frequently used as 

preservatives in personal care products that contain a 

significant amount of water. Of the 40,000 currently 
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marketed products in our database, more than 12,000 

include as an ingredient at least one of four parabens. 

Their widespread use is troubling because of evidence 

demonstrating that parabens may disrupt the hormone 

system. 

 Moreover, in a recent study traces of five 

different parabens were found in the breast cancer 

tumors of 19 out of 20 women examined. And other lab 

studies in the last decade have also linked parabens to 

cancer and to reproductive health problems. 

 Formaldehyde also prevents bacterial growth, 

but is a known human carcinogen and a proven immune 

system intoxicant. A 2011 investigation by the 

Campaign for Safe Cosmetics found quaternium-15, a 

formaldehyde-releasing preservative, in baby shampoo 

sold in the United States. The same product sold by 

the same company in several European countries contains 

another preservative instead of the formaldehydereleasing agent. 

 The manufacturer's use of a safer preservative 

in its overseas products suggests that a safer 

formulation is indeed possible, and yet American babies 
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are exposed to this carcinogenic intoxicant. Even the 

industry-driven Cosmetic Ingredient Review Panel this 

year declared formaldehyde an unsafe ingredient in 

certain hair products. The carcinogenic chemical is a 

distinct ingredient in at least seven currently 

marketed products; 11,000 others contain formaldehydereleasing ingredients such as quaternium-15 and DMDM 

hydantoin. 

 In light of these dangers associated with both 

under-preservation and preservation through the use of 

hazardous chemicals, more research is needed to 

determine the risks and benefits of different 

preservation systems. Where toxic chemicals can be 

reduced or replaced with product reformulations or 

careful package design, for example, they should be. 

 In addition, EWG suggests that FDA consider 

the following areas of investigation before issuing 

guidance on cosmetic microbiological safety. First is 

a comparative analysis of domestic and foreign markets. 

The European Union enforces more stringent regulations 

than the United States does with regard to cosmetic 

ingredient and product safety. Whereas FDA has banned 
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or restricted only a handful of ingredients, the 

European Union's 2003 Cosmetics Directive banned 1,100 

chemicals from use in cosmetic products. 

 The more restrictive bans do not necessarily 

equate to smarter regulation and safer products. FDA 

should not ignore the data amassed and lessons learned 

from years of policy development by the European Union. 

Indeed, it was a comparative analysis by the Campaign 

for Safe Cosmetics that led to the discovery that a 

safer formulation was being used in foreign baby 

shampoos than in the same product marketed in the U.S. 

 Because manufacturers are faced with more 

stringent regulations in the European market, they may, 

and in at least one case most certainly have, already 

demonstrated an ability to reformulate their products 

to be safer while maintaining profitability. 

 The second area for further investigation is 

product labeling. Legible product labeling, including 

ingredient lists and expiration dates may be an 

effective means of encouraging safe use and timely 

disposal of personal care products. Whether seeking 

safer ingredients or avoiding known allergens, a 
34

consumer should have access to information about the 

contents of their cosmetic products. And yet, a 2007 

study found that, quote, "Forty-six percent of the 

study's participants had difficulties reading the 

labels of personal care products mainly because of the 

small font size and the long chemical names." 

 Indeed, FDA regulations currently allow for 

font sizes on ingredient labels to be as small as 1/32 

of an inch. FDA ought to reconsider this regulation in 

light of its guidance that font size and style be, 

quote, "easily readable." 

 Manufacturers should be encouraged to include 

expiration dates on cosmetic products. Currently in 

the U.S. personal care products are not required to 

carry an expiration date. Consumers may not know when 

to dispose of their products. Cosmetics, especially 

those with high-water content and those that come in 

direct contact with the user's body run an increased 

risk of contamination if not disposed of before the 

product becomes contaminated. 

 Cosmetic products should be no less safe than 

foods and drugs, which are required to carry expiration 
35

dates and which often contain the same preservatives 

used in cosmetics. 

 Comparative analysis would be useful here as 

well. The European Union recently introduced "best 

used before date" and "period after opening" labeling. 

Moreover, products with expiration dates may be able to 

contain safer preservatives because the shelf life of 

the product may be shorter than those of cosmetics 

lacking expiration dates. Of course, the contaminating 

effects on the environment of disposed cosmetic 

products should be considered as well. 

 Finally, concentration disparities. Studies 

of cosmetic products in the European market have 

revealed a great variation in preservative 

concentration among the investigated products. Though 

this variation may be attributable to variations in 

formula and to various combinations of different 

preservatives in a single product, it may also indicate 

that some products are over preserved while others 

under-preserved. 

 FDA should consider the disparities, if any, 

in cosmetic preservative concentrations in the United 
36

States and provide industry with guidance regarding 

product design, formulation, testing and labeling, as 

well as the use of preservatives that would provide a 

reasonable certainty of no harm for vulnerable 

populations exposed to cosmetic products. 

 Given the many aspects of cosmetic safety for 

which more research is needed, EWG believes FDA 

guidance and analysis could go a long way to promote 

the safety of personal care products. EWG looks 

forward to working with FDA to address these issues and 

to ensure that personal care products are formulated, 

manufactured, labeled, and used so as to prevent 

contamination by both microbiological pathogens and 

toxic preservatives. Thanks. 

 MR. GASPER: Okay. We have scheduled ten 

minutes for any questions for Mr. Yeshua. And if you 

would, we have two people with hand-held mics. If you 

would just raise your hand, and as I stated earlier 

please state your name and your organization clearly, 

so it can be accurately caught in the transcript. 

 Is there anyone who has any questions? Okay. 

I guess we don't. Last call. 
37

 All right. Well, I believe we're scheduled 

for a twenty minute break now. So, I guess since it's 

just about quarter to, if we can reconvene at 10:05, 

all right. Okay. I'll see you here in 20 minutes. 

 (Recess) 

 MR. GASPER: Our next presenter is Jay Ansell 

from the Personal Care Products Council. 

 DR. ANSELL: Good morning, all. My name's Jay 

Ansell and I'm currently Vice President of Cosmetic 

Programs at the Personal Care Products Council, where 

I'm responsible for providing technical support for the 

council staff and various committees addressing the 

science and regulation of personal care products. 

 I previously led product safety and regulatory 

affairs at raw material suppliers and a finished 

products company. My academic training is as a 

chemist, completing my Ph.D. at the State University of 

New York at Binghamton, and I was first certified as a 

Diplomat by the American Board of Toxicology in 1986. 

 Based in Washington, D.C., the Council, 

formerly CTFA, is the leading national trade 

association representing the $250 billion global 
38

cosmetic and personal care products industry. Founded 

in 1894, the Council's more than 600 member companies 

manufacture, distribute, and supply the vast majority 

of finished personal care products marketed in the 

United States. 

 As such, we are most pleased to be able to 

provide these remarks and participate in today's public 

meeting on the microbiological safety of cosmetics. In 

addition to myself, Phil Geis and Richard Whiting will 

be speaking later. And of course, we will be filing 

additional detailed written comments by the January 

30th deadline. 

 The U.S. cosmetic industry and the Council 

have a long history of working cooperatively with FDA 

in assuring the safety and quality of cosmetic 

products. In 1974, then Commissioner Alexander Schmidt 

said I know of no industry which has better -- a better 

record of voluntary accomplishments. Again, in 1980, 

Acting Deputy Commissioner Novitch cited Commissioner 

Schmidt, adding, what was true in 1974 is, if anything, 

more true today. We take pride in that history and 

strive to maintain that record of accomplishment. 
39

Indeed, in the area of microbiology we've been working 

for more than 40 years developing, publishing, and 

updating microbiological guidelines for the industry. 

 Now, we know that in the '60s and '70s studies 

of topical drugs and cosmetic products in Europe and 

the United States raised concern about the 

microbiological quality of these products. Further, as 

the agency considered contaminated products with--

products contaminated with gram negative organisms to 

present a moderate to serious health hazard, any 

contaminated product would be considered adulterated 

within the meaning of the Food, Drug, and Cosmetic Act. 

 Findings from those studies were as concerning 

to the cosmetic manufacturers, and industry took 

action. In 1969 the then CTFA organized the 

microbiological committee and began publishing 

technical guidelines in CTFA's cosmetic journal. By 

1973 the value and number of these guidelines had grown 

to the point that an independent volume was published 

to assist companies in establishing and maintaining a 

microbiological quality assurance program. 

Between 1972 and 1975, CTFA undertook a 
40

comprehensive national survey of the microbiological 

quality of cosmetics and published those findings in 

1977. Of particular note, the survey found that of the 

3,967 products tested, 97.7 percent were free of 

measurable microorganisms, and 99.6 percent were within 

the recommended microbiological limits. 

 In 1975, FDA conducted its own survey. And 

the findings of this and later surveys, in addition to 

the information from inspections of cosmetic 

manufacturers, led FDA to conclude that the 

contamination of cosmetics entering the market was no 

longer a major regulatory issue. 

 Thus, the main concern voiced by the agency 

then became the adequacy of product preservation, 

especially in the hands of the consumer. Industry 

agrees. And preservation of cosmetics is indeed an 

important consideration, and in fact, the original 1973 

microbiological guidelines contain substantial 

information addressing the preservation and protection 

of cosmetic formulations. 

 Now, it should be noted that the state of 

science is not static. And so, the guidelines undergo 
41

continual review and updating as new information 

becomes available. New guidelines are routinely added, 

while the existing guidelines are updated and revised 

to reflect the most current science. For example, 

guidelines specifically for aqueous eye area products 

were added in 1975, and included methods for testing 

water-based cosmetics, toiletries, and eye area 

cosmetics. 

 As another example, the 1993 edition included 

guidelines for the microbiological assessment of 

product quality after use, intended to assist 

manufacturers in assessing the microbiological quality 

of the products during use by consumers. 

In fact, the ability of in-use tests to 

corroborate preservation efficacy test results has been 

the subject of several published studies. Most 

recently, the 2007 edition included new chapters on the 

determination of preservation efficacy in non-woven 

substrates. Methods for preservation of atypical 

products, rapid method preservation testing of watermiscible personal care products, and seven additional 

chapters underwent significant revisions. 
42

 Finally, as part of our long history of 

action, we should also mention the Council's 

participation, at the agency's request, in the 

development of a preservation efficacy test 

specifically for cosmetics. Through AOAC, a method was 

tested collaboratively in a study involving 19 

laboratories, with the results being published in the 

2001 Journal of the AOAC International. Today this 

method is still the only validated challenge test 

available. 

 Today the Council's microbiological guidelines 

are an important tool to assist manufacturers in 

establishing microbiological quality assurance programs 

and controls, to assure product quality, and consumer 

safety. Based on modern quality management techniques, 

including quality system approaches, the guidelines 

address assessing personnel qualifications, the 

microbiological evaluation of the physical environment 

including the plant, grounds, equipment, cleaning and 

sanitation, procedures for sampling, testing, assessing 

water quality, lab practices for method validation, 

documentation, and assessing the adequacy of product 
43

preservation, including products after use. 

 The Council is also active in the development 

in international advancement of best biological 

practices through active participation in the ISO 

Technical Committee 217 we heard about earlier. The 

U.S. Technical Advisory Group representing the American 

National Standards Institute is chaired and 

administered by the Council and currently has 22 

experts, including experts from FDA participating. 

 The U.S. experts, along with experts from 57 

other national delegations have written nine 

international standards in the area of microbiology 

since 2005. These address general directions for 

microbiological examinations, methods for detection of 

aerobic mesophilic bacteria, E. coli, Pseudomonas 

aeruginosa, Staph aureus, Candida albicans, and a 

method for the enumeration of mold and yeast. 

 Of particular note, the experts have also 

published guidelines for risk assessment of 

microbiologically low risk products and established a 

standard for cosmetic good manufacturing practices that 

has now been adopted or referenced by authorities 
44

worldwide. These include the U.S. FDA, the European 

Commission, Japan's Ministry of Health, Labour and 

Welfare, and Health Canada. Additionally, we are 

working currently on new standards for the evaluation 

of anti-microbial protection of a cosmetic product, 

microbiological limits, and preparing a technical 

report to assist in conducting microbiological risk 

assessment. 

 Now, those of you who are familiar with ISO 

know that the core mission of ISO is international 

harmonization to facilitate trade, allowing everyone to 

compete on an equal footing, everywhere. However, as a 

participant, I can say that the experts also firmly 

believe that advancing best practices through the 

standards, and with their adoption by the 160 members 

of ISO, including both advanced and developing 

countries, also has a direct impact on improving human 

health and safety. 

 Now, earlier I mentioned that the current 

Council guidelines rely on modern concepts of quality 

management and that our means to control the microbial 

content of a cosmetic begins during the earliest stages 
45

of product development. Carl Brooke of FDA, in his 

1971 paper, reminds us that man lives in equilibrium 

with a wide spectrum of microorganisms. Therefore, 

cosmetics are not required to be sterile, nor do they 

need to be. He then goes to describe those aspects 

that are common to cosmetic products of high 

microbiological quality. Highlighting three main 

criteria, specifically microflora, if present, are not 

harmful to the consumer or the product. They are 

processed with quality materials under sanitary 

conditions and products can tolerate microbial insult 

introduced by the consumer. 

 With that in mind, the microbiological 

research scientist will set microbiological limits 

based on consideration of the product's intended use, 

including application area and target populations. 

They will then develop an effective preservation and 

protection system, taking into account the raw 

materials used, the manufacturing procedures, 

information gained from the preservation of other 

products, the types of packaging, shelf life, and 

anticipated storage and shipping conditions. 
46

 Ultimately, with this information, we have a 

product preservation system designed to assure not only 

the product is adequately preserved to assure the 

quality at the point of purchase, but also ensure that 

the microbes introduced during normal and customary use 

of the product will not adversely affect quality and 

safety of the product. 

 With that said, I believe we can say with 

confidence that current industry practices assure that 

cosmetics are safe. However, as confident as we may 

be, a critical component of any quality system is postmarket surveillance. 

 To that end, cosmetic manufacturers have in 

place robust systems for post-market surveillance. 

Here companies put in place systems where consumer 

calls are monitored, tracked, sorted into 

subcategories, like those formulation related, 

compliments on the effectiveness, packaging, or health, 

and conduct investigations initiated where appropriate. 

 These data show a very low incident rate, 

overall, consisting primarily of reports associated 

with irritation or sensitization. Indeed, those 
47

attributed to microbiological affects are even lower. 

As examples, in 1971 and 1972, the FDA, at the request 

of CTFA, did establish voluntary programs for facility 

registration, filing of formulation information, and 

filing of cosmetic product experience reports. While 

the programs were discontinued in 1996, I should add 

parenthetically that the voluntary cosmetic reporting 

program has recently been reinvigorated with the 

completion of an on-line filing system. 

 However, certain data from FDA's product 

experience reports from the period of operation are 

available. A summary from the first six bi-annual 

reporting periods, from 1974 to 1976, showed an 

estimated 125 companies participating, with an 

estimated distribution of 9.75 billion units. With 

that, FDA reported an incident rate of 2.03 experiences 

per million units sold. Even given FDA's estimate that 

this may represent only 30 to 40 percent of cosmetic 

sales, it would still only represent five to seven 

unconfirmed experiences reported for every million 

units sold. This would give an incident rate of five 

ten-thousandths of a percent. 
48

 Today, more focused on eye area reports, a 

request for reported adverse events to FDA’s CFSAN 

Adverse Event Database showed ten reports in the period 

2004 to 2011. While comparison of the same eight-year 

sales period wasn't available, sales figures for the 

six-year period, 2005 to 2010, showed 2.7 billion eye 

makeup units sold during that period. From that, we 

see less than one reported adverse reaction for every 

270 million units sold, or an incident rate of three 

ten millionths of a percent. 

 Now, while we do understand that incidents 

based comparisons of cosmetic and drugs are difficult, 

I think it is instructive to have some comparison. 

During the seven-year period, 2004 to 2010, the FDA's 

Adverse Event Reporting System for drugs and 

therapeutic drugs received 3.7 million reports. 

Similarly, the Center for Veterinary Medicine has an 

adverse drug experience system for domestic drug 

experiences that have been determined to be at least 

possibly drug related. The cumulative summary report 

for the period 1987 to 2011 exceeded 2,000 pages. 

Now, while my comments have demonstrated that 
49

the industry's quality programs are delivering safe 

cosmetics to consumers, I thought it might be useful to 

see how the microbial limits set by other international 

authorities compare. Perhaps not surprisingly, as the 

standards are science based, the U.S. recommendations 

are entirely consistent with worldwide standards. ISO 

TC-217 has just begun a program of work on new 

microbial standards that began with a comprehensive 

survey of objectionable organisms and microbiological 

limits. 

 The report included individual nations and 

community of nations that encompassed 71 separate 

nations. In brief, the report found that the limits 

recommended by the industry association on this slide 

are the same or lower than those set for baby and eye 

area products, with the single exception of Algeria, 

which had set a limit of 50 CFU for eye products. 

 The same net results may be found in 

identification of objectionable organisms. The 

organisms selected here are entirely consistent among 

all the authorities with minor deviations like the 

inclusion of a sulfito-reductor Clostridium in Algeria 
50

and in talc products in the Miracor countries, as well 

as the addition of salmonella in Mexico and Chile. 

 With that said, industry does have a long 

history of effective cooperation with FDA in assuring 

that cosmetics are safe and we are committed to 

continuing this cooperative approach. To the extent 

that FDA believes additional guidance is needed, we are 

ready to participate in developing that guidance. 

 Consistent with the guidance that applies to 

modern quality management techniques, including 

implementation of quality systems approaches to all 

aspects of cosmetic production, and quality assurance 

that encourages implementation of risk-based approaches 

that focus industry and the agency's attention on 

critical areas, ensures that the regulatory review, 

compliance, and inspection policies are based on state 

of the art science, and enhances the consistency and 

coordination of FDA's cosmetic quality regulatory 

programs, in part, by further integrating and enhancing 

quality systems approaches into the agency's business 

processes and regulatory policies concerning review and 

inspection activities. 
51

 In conclusion, the industry practices do 

assure that cosmetic products are safe and meet 

consumer's quality expectations. We do this by using 

the best science and implementing the best quality 

management practices from start to finish. Industry 

practice had been proven effective with any type of 

adverse events being extremely rare and almost 

exclusively due to irritation and sensitization. 

 And finally, the industry is committed to 

continuous improvement and expects to continue to work 

cooperatively with FDA, ensuring world class 

performance in our industry. So with that, we'll open 

the floor for questions. 

 MR. GASPER: Any questions at all? We have 

time set aside for this. 

 DR. ANSELL: Thank you. 

 MR. GASPER: Okay. Our next speaker is Phil 

Geis from Geis Microbiological Quality. 

 DR. GEIS: Well, thank you. And thank the FDA 

for this opportunity to speak. I've been asked by the 

Council to speak to the scientific aspects of cosmetic 

micro quality. 
52

 But, let me first introduce myself, I'm Phil 

Geis. I am -- was trained initially as a medical 

microbiologist. After my undergraduate career at the 

University of Texas, I entered the Army, where I was 

trained as a medical microbiologist, my last assignment 

being establishment of a full microbiological 

capability for the Army's 45th Field Hospital. After 

the Army, I returned to the University of Texas, earned 

a Ph.D. in microbiology mycology, and then joined the 

Procter & Gamble company, where I spent the next 30 

years studying microbiology, applied microbiology, 

especially in the context of cosmetics. 

 I retired about three months ago and formed 

this consulting group you see here in affiliation with 

the Advanced Testing Laboratory, and I'm an adjunct 

professor at the University of Florida, where I'll be 

teaching courses in microbiology, starting in the first 

of the year. 

 I've had the pleasure to be part of a dynamic 

industry, an industry that started to do its science in 

various focused manners. It wasn't one that discussed 

esoteric scientific principles; it was one that was 
53

focused on applied micro. Basically, just a few 

subjects: Preservation, preservative testing, 

detection of microorganisms, detection of -- 

establishment of good manufacturing procedures, and 

understanding how consumers use and may have used our 

products in protecting against that. 

 The publication record goes back over 50 years 

for this industry. And if you look at it, it's 

somewhat surprising as to the detail that these guys 

went to. As Jay said, in the late '60s early '70s, 

agency concerns as well as industry concerns of 

contamination led us to form committees, and the PCPC, 

which was at that time the CTFA, was the organization 

that governed these committees. It brought the 

scientists together to combine their knowledge with the 

idea of forming some guidelines that would guide this 

industry to provide good quality products for consumers 

and lower the consumer risk for micro contamination. 

 The risk assessments in this context that led 

us to guidelines and compendial protocols and methods 

are the ones Jay mentioned. And these are very 

effective means, and they have brought us decades of 
54

success. 

 The last method that Jay mentioned was in the 

AOAC. This is a preservative test method and if you 

examine this method, you'll see that we go well beyond 

what is traditionally true for drugs. He showed the 

four bacteria there, the Staph, the E. coli, the 

Candida albicans, Aspergillus. You examine this 

method, you'll see that there's a wide range of 

bacteria against which we try to control contamination. 

 Not only do we do guidelines and methods, but 

we also establish a greater level of capacity in our 

own colleagues. The PCPC committee has mentoring 

opportunities where the older folks, like myself, would 

mentor young microbiologists that are just entering 

this rather arcane field of cosmetic microbiology. We 

do training. We've conducted webinars, workshops, and 

scientific sessions to communicate what we understand 

about cosmetic microbiology. And we've enjoyed the 

FDA, who has joined us at these training sessions, to 

bring their understanding of policy and their 

understanding of the science so our young folks coming 

up will understand what the agency thinks. 
55

 Jay mentioned global harmonization. This is 

very important because I believe this industry in the 

United States is probably the most advanced in terms of 

quality in the world. And certainly our major 

companies, Procter & Gamble, Unilever, Johnson & 

Johnson, Estée Lauder and Avon, we manufacture around 

the world to the same quality standards that we make 

here in the U.S. 

 And by virtue of that passive presence outside 

the United States, we have established some additional 

knowledge in terms of what establishes quality. And 

now we are actively pursuing ISO harmonization to meet 

these same quality standards. 

 So I believe, as Jay said, we've established a 

superior quality record, not only just in the U.S., but 

one that both actively and passively influences the 

entire world. We've done this by understanding the 

entire scope of product quality. 

 And I hope this cartoon is not too goofy for 

you to see. What I try to portray here is this is not 

a matter of just preservation or testing products. 

Those things build -- attempt to build quality into the 
56

product. What we've done here is attempt to control 

the whole scope of product quality from the first raw 

material to the last consumer use. Our industry has 

set up protocols, dynamic protocols, that change with 

the changing nature of our bacteria, changing nature of 

our products, that address each of these items from the 

vagaries of raw materials to the processes by which we 

combine these raw materials to make our finished 

product, to how the consumer will use it and how that 

product may be abused by the -- even the reasonable 

consumer. 

 The product left in the car to freeze in the 

winter, or to be baked in the summer in El Paso. The 

human bathroom where there's all sorts of mold floating 

around in a mildewed bathroom. We understand these 

elements and we've developed protocols to address 

these. And these are the things we teach each other as 

we go forward. 

 Let me go through the various aspects. The 

first one is product design. When our formulation 

chemists and our engineers first figure a product, they 

think of a consumer benefit that will delight our 
57

consumers. The microbiologist is, at the same time, 

formulating a quality design that's consistent with his 

commitment to quality. Try and understand how they can 

make this product and give it to consumers so one, it's 

clean when they get it, and two, they won't contaminate 

it during use, during a long period of use, because 

again, this is years' worth of stability we build into 

our products. 

 It starts with the raw material qualification. 

When a raw material is identified, we go to that raw 

material supplier and determine how they will give us a 

high quality raw material consistently, batch after 

batch after batch. We don't take what they give us. 

It has to meet our standards. And to be successful in 

business we have to look at consistency of that supply. 

Often times, this means we have to go to this supplier 

or that supplier. But in order to establish the robust 

supply system we have, that is necessary for our 

product design microbiology. 

 Of course, there's preservation. And we have 

a small number of preservatives. You heard early today 

there are a bunch of preservatives. There aren't a 
58

bunch of preservatives. We've lost preservatives. We 

have virtually a handful of preservatives left that are 

safe and effective, including parabens and formaldehyde 

releasers. 

 We use these to establish preservation in 

pilot plant batches, lab batches, and we demonstrate it 

in our manufacturing as well. And it's not just 

preservative capacity immediately, it's chronic 

preservative capacity that through the life of this 

product, the consumer's going to be protected. 

 That preservative system and that product 

quality also affects packaging. Packaging and the 

implements we use to apply the makeup to the face, 

apply the wipe to the hands, the various elements of 

delivery. 

 We do anticipate reasonable consumer use. We 

do this early in the process and indeed, if the 

consumer, in our early in-use testing, contaminates the 

product, we reformulate or repackage. We don't accept 

any level of contamination. 

 And finally, this is a part of the risk 

assessment. The overall risk assessment goes beyond 
59

that--I'll tell you about that in a second--but this is 

the first step of our risk assessment. 

 The next aspect is in manufacturing, quality 

assurance, and quality control. I showed you that 

diagram that from beginning to end; we control the 

process by which we make products and make them clean, 

make them safe for consumer use. But it goes, again, to 

the design. Our construction and design of our 

manufacturing equipment is done in a manner that brings 

us a high level of hygiene, a high level of capability 

of removing and eliminating microorganisms. 

 It starts with raw material control. We've 

established by this time a reliable source of raw 

materials. That doesn't mean we stop testing. Our 

affirmative risk assessment says we had to establish 

quality upfront. We test to confirm that quality. 

Good manufacturing practices are, as mentioned before, 

are consistent across our industry. 

 We also borrow from other industries. HACCP, 

which is Hazard Analysis and Critical Control Point, is 

a concept adopted from the food industry. And here 

this concept identifies those areas in the making, in 
60

that diagram I showed you, perhaps a pump, perhaps a 

heat exchanger where there's greater risk, we 

identified those and control the risk at that point. 

Environmental monitoring, which is something from the 

drug industry. We evaluate the bugs that may be 

appearing in our product stream, or adjacent to our 

product stream that can contaminate the product during 

making. 

 And finally, our QC testing, finished product 

testing. And all this is validated, validated to show 

that we can recover bacteria if they're there. Our 

finished product testing is well below the standards 

Jay mentioned. Those are governing standards. In a 

practical effect, the greatest percentage of product we 

make has no detectable microorganisms in our testing. 

Again, it's the product of an affirmative risk 

assessment. We built quality in. We expect to see 

nothing and we see nothing in our finished product. 

 The products are not sterile, and indeed, if 

we wanted to guarantee sterility it would have a major 

effect, and be unnecessary and not be worth it to 

consumers. But most of our products have less -- have 
61

significantly less than one microorganism per gram. 

 In fact, we do most of our release testing in 

this industry by virtue of rapid methods. These rapid 

methods are go, no go. Detect, no detect. And they're 

very sensitive, down to less than one per gram. 

Economically we could not sustain these rapid methods 

if we had multiple things that had any presence of 

microorganisms. So by and large, we have no microbes 

detectable in our products. 

 Consumer safety: Jay mentioned some of the 

protocols developed to understand consumer use and 

anticipate consumer contamination of our products. We 

are very well aware of this. And to do this, we 

establish stability of preservation through the various 

vagaries of consumer use and practices. In-use testing 

is a very common element. In the late '80s Procter & 

Gamble published a landmark study where we calibrated 

the level of preservation versus the level of consumer 

contamination. Of course, the objective was zero, zero 

consumer contamination. And that became the standard 

by which Procter & Gamble pursued preservation for 

cosmetics, in addition to safety and other elements, to 
62

have zero contamination in the hands of the consumer, 

the reasonable consumer. 

 We continue to monitor, though; this is a 

dynamic industry. It's a scientific effort; we monitor 

the globe in terms of microbiology, the recalls of the 

European RAPEX Index, the recalls in Australia, China, 

Japan, Canada, to see how these products that are 

recalled failed. What made them fail? What was the 

nature of the microorganism that grew up in these 

products that substantiated the recall? And why did it 

happen? And we modify our protocols and address these 

in our own practices. 

 We look carefully at consumer comments and 

adverse reports. As Jay said, these are very rare. 

But when we have these, we follow these up, especially 

if they have anything that indicates microbiology, a 

bad smell, a bad color. If a consumer complains about 

this, we follow these things up. And this is 

consistent across our industry. 

 So let me give you an overview. I believe the 

cosmetic industry in the U.S. is a global leader. And 

I think that overall, the world has, frankly, 
63

benefitted from the practices developed since the 1960s 

and 1970s by the PCPC groups. And it's very important 

you understand that because over-regulating this area 

is going to have a significant effect, and I'll discuss 

that in a second. 

 We have established and applied best 

practices. And these things have been copied around 

the world. And I believe these things will appear in 

the ISO guidelines. Through the many decades, we've 

established a very good record of safety. 

 And we have cooperated with the FDA. As I 

said, we welcome the FDA at our training sessions. And 

we're happy to be here today. We thank the FDA for 

giving us the opportunity to talk. 

 But all this quality, all this success is a 

product of affirmative risk assessment. I need to 

emphasize that. We don't test products, and see if it 

has bacteria, and throw that batch away if it does, and 

hope the next batch is good. We expect every batch to 

have no detectable microorganisms. Every consumer use 

has to be successful and can be safe because we built 

quality in from the very start. We've validated this 
64

with data, with our testing data in the laboratory, 

with our consumer data, with monitoring stuff on the 

market. And we have decades of quality in this 

context. 

 As we go forward, I know the FDA will consider 

a number of standards here. And one of those standards 

-- and one of those considerations has to be safe and 

effective preservation; that includes parabens and 

formaldehyde releasers. We have very few preservatives 

to use. And clearly, failures in preservative -- 

failures in preservation have globally, outside the 

U.S. been shown to be very significant for consumer 

health. 

As the agency considers other organisms, other 

microbes, especially the objectionable microbes, we 

have to carefully consider the risk assessment behind 

that. It's important to establish a technical 

justification and tap the industry's knowledge and 

experience in terms of risk assessment. Our current 

affirmative risk assessment means if there's a 

microorganism identified, we have to work against that. 

Mitigate it. Drive it out of our system. 
65

 And some of the bugs proposed so far have us 

concerned because those would drive us towards sterile 

products. And cosmetics do not need to be sterile. It 

does not serve the consumer at all to have them 

sterile. It will stifle the innovation and certainly 

limit consumer choice if they are required to be 

sterile. 

 I think it's important as we go forward, and I 

know the FDA's interested in this, and I welcome other 

groups as well, even the EWG, to cooperate with us on 

this risk assessment, because this is a relatively rare 

group. There is no school of cosmetic microbiology; 

there's no academic exercise here. This is learned. 

It's an arcane arts and science. And very few people 

know that. There's probably 20 people in this country 

that are experts at it. But they're all with companies 

that control major shares of the market. And they all 

are at the PCPC teaching new microbiologists how to do 

it. 

 I appeal to the agencies to continue this risk 

assessment with us and allow us to provide our 

experience and expertise as goes forward. 
66

 Again, thank you for this opportunity. I'm 

happy to take any questions. Scott? 

 MR. SUTTON: Phil, thanks. You've mentioned 

risk assessment at least five or six times. We're 

about three-eighths of the way through today's session 

and no one has yet commented on the current topic of 

bacillus cereus and risk assessment and where exactly 

is this going. Are we more concerned with hazard 

avoidance or in risk assessment? Thanks. 

 DR. GEIS: Certainly from my perspective, I'm 

more interested in risk assessment but maybe my 

colleagues from the FDA would like to answer that 

question. 

 MR. SUTTON: Yeah. I'm sorry. Just if I can 

interject? I've been asked to give my name and 

affiliation. My name is Scott Sutton. I'm the 

principal consultant with Microbiology Network. Thank 

you. 

 DR. GEIS: Let me make a shot at it first then 

Dave you can talk. I think the risk assessment is the 

important element. Not risk elimination. Risk 

elimination, especially in the context of B. cereus, 
67

which for those of you that don't know, is a very 

common dust-born microorganism. 

 You mentioned B. cereus, and that, in some 

context, is a very serious pathogen, but it is also a 

very common dust-born organism. This room is full of 

B. cereus. So it's important that we do a risk 

assessment, because we can't eliminate B. cereus in 

this room. 

 The microorganisms in our -- as I said, in our 

cosmetic products are such a low concentration that 

whatever is in there is dwarfed by whatever you see on 

the skin when you apply it, by your face, by whatever 

intimate body surface you put it on. So that's why the 

risk assessment, I think, is the -- has to be the 

paradigm we use. 

 John, would -- you got a comment? 

 MR. GASPER: No. 

 DR. GEIS: Okay. Did that answer your 

question, Scott? 

 MR. SUTTON: Yes. Thank you. 

 DR. GEIS: Yes? 

DR. KATZ: Actually, I have a question, and it 
68

relates somewhat similarly, I guess, to the risk 

assessment question. When you're doing a risk 

assessment, which microorganisms are you looking at to 

assure that you've considered all concerns, because 

that wasn’t explained in terms of your talk itself. 

 DR. GEIS: Yeah. I think the -- if you were 

to look at the AOAC documents you would see that. But 

in addition to the ones that Jay mentioned, Staph 

aureus, E. coli, Candida albicans, there's a wide 

range, especially, of Gram negative bacteria, 

Burkholderia cepacia, Serratia marcescens, 

Enterobacters, that we are very concerned with. And 

our preservative testing is designed to show that these 

bacteria, indeed, will not be present in our products. 

I can definitely get back to you with that list, but it 

is in the AOAC document. 

 DR. KATZ: Thank you. 

 DR. HANSEN: I guess I've got a question. 

 DR. GEIS: Yes? 

 DR. HANSEN: Again, on that risk assessment, 

which is admittedly a broad umbrella -- 

DR. GEIS: Yeah. 
69

 DR. HANSEN: -- many facets coming under 

that. We haven't heard from anyone yet on vulnerable 

sub-populations. Or, I guess, another area of interest 

would be products marketed for use in particular 

settings, a related topic. I know I've used the 

example before of products that are marketed for use in 

an institutional setting, particularly, say, a hospital 

or a nursing home. And what factors our stakeholders 

would look at in doing a risk assessment and what sorts 

of guidance they believe would be appropriate toward 

that end of protecting consumers in those particular 

settings and situations. 

 DR. GEIS. Yeah. I think it is an important 

consideration. Indeed one of the speakers to address 

this group shortly will talk about risk assessment. 

But one of the goals and understandings from our 

industry is that we have virtually nothing detectable 

in our products. That doesn't mean there's nothing 

there. But indeed, the practitioner, the people 

responsible for those institutions, those conditions, 

whether they're an isolation ward or a nursing home, 

have to consider what products are appropriate for 
70

that. Is that what you were thinking, Dr. Hansen? 

 DR. HANSEN: Well, you've answered partially 

and you've promised that somebody else is -- 

 DR. GEIS: I promise. I promise. 

 DR. HANSEN: -- is going to address, you know, 

in a little bit more detail, which is fair enough, fair 

enough. Thank you. 

 DR. GEIS: Thank you. If there's no more -- 

oh, there is another question. 

 MR. VAN NESS: John Van Ness, Chemaid 

Laboratories. I just want to ask one more time, you 

were saying that the parabens and the formaldehyde 

releasers -- 

 DR. GEIS: Yes. 

 MR. VAN NESS: --you're contending that they 

are safe? 

 DR. GEIS: They are safe. I believe that the 

data are clear on that. And clearly, the concerns 

there dwarf in comparison to the consequences of 

contaminated products. We have very few preservatives 

to use. If you get rid of preservatives, if you limit 

their use because of concerns that don't have a lot of 
71

foundation, we are putting our consumer at risk, 

clearly. 

 I'll defer for a second to an example in Saudi 

Arabia where a knock-off of a baby shampoo was not 

preserved appropriately, was not made appropriately to 

the right standards, clearly, had Serratia marcescens 

in it and resulted in the death of four or five babies 

in a hospital. The consequences are not so obvious, 

but when they are -- when they do happen, they are 

profound. 

 MR. VAN NESS: So in saying that, you had 

stated also that the practices and the things that have 

been studied by you and the PCPC, are used worldwide, 

and are the basis for a lot of the things. So would it 

be contrary to what the representatives of the EWG 

said? In other words, is the EU, are they so much more 

robust than what we're doing? Or -- 

 DR. GEIS: We market the same products around 

the world. There's no difference. We get the same 

quality standards, the same efficacy standards are 

marketed around the world by all these companies, by 

Procter & Gamble, Estée Lauder, Avon. There's no 
72

difference. We don't consider any population to be 

less deserving of protection. 

 MS. TALLENT: Hi, I'm Sandra Tallent from the 

FDA. You mentioned that you had rapid methods to 

detect one CFU per gram. Can you elaborate on your 

methods? 

 DR. GEIS: Sure. These are based on 

enrichment, enrichment of a quantity of product in a 

large vessel, in a large volume of broth. So, per -- 

so whatever volume of product is put in there, whether 

it's one gram of product or ten grams of product, 

anything viable in there will grow. So anything that 

grows in there, we'll say this product doesn't meet our 

standards. 

 And by virtue of our testing, by virtue of 

testing to that level -- and then we validate it, 

indeed to be -- to show that we can detect at that 

level -- by releasing by this method we have very 

vanishing levels of microorganisms at any level in our 

products. Is that what you were thinking? Okay. 

Well, thank you very much. 

MR. GASPER: All right. Since we're running a 
73

bit ahead of schedule, which is good, we'd like to 

have our next presenter, David Steinberg, up. And he's 

from the Cosmetic Preservative Council. 

 MR. STEINBERG: I have to change my speech, 

good morning, instead of good afternoon. Thank you 

very much for giving me this opportunity to speak. 

Just a little brief background, I got involved in the 

cosmetic industry in the '60s, that's why I have white 

hair, and been involved in the area of preservation 

shortly thereafter. In the early '80s I started 

teaching the chemistry of cosmetics in graduate school. 

I've lectured throughout the world. One of my 

specialties has been preservatives, I've invented 

preservatives; I've worked in this area for many years. 

 In 1995 I left the wonderful confines of 

industry and started consulting on my own. I was one 

of those people who voluntarily did this. And I'm here 

to talk on behalf of the Cosmetic Preservative Council. 

Now many of you have never heard of this and that's 

because we don't make a lot of publicity and we don't 

make a lot of noise. But we got together in 2006, the 

major producers of preservatives for cosmetics in the 
74

world, to basically discuss about mutual problems and 

advocate the use of preservatives and to defend the use 

of preservatives. 

 We generally conduct most of our information 

through email. We do try to meet maybe once a year at 

the Supplier's Day of the Society of Cosmetic Chemists. 

Our current members include Dow, which also includes 

its acquisition of Rohm & Haas, Ashland, who purchased 

ISP and Sutton Laboratories, Clariant who had purchased 

Nipa Laboratories, Lonza, who also has now purchased 

Arch Chemical, Ueno Fine Chemicals from Japan, Sharon 

Laboratories from Israel, Schuelke & Mayr from Germany 

and Jeen. There are a couple of companies who 

sometimes attend meetings but haven't officially 

joined. 

 A couple comments, and these are very broad 

things, which everyone should be aware of, that 

preservation is the prevention of microbial -- or 

retardation of microbial contamination of our products 

from the time they are manufactured and the time they 

are used up by the consumer. We add chemical 

preservatives to a formulation to retard and prevent 
75

this growth from consumer contamination. Preservatives 

are not a replacement for GMPs. 

 Regulations of preservatives vary throughout 

the world. In the United States the FDA does not 

preapprove preservatives, the FDA has the authority to 

prohibit preservatives, and they have prohibited some 

preservatives and we do not use these and have not used 

these. In fact, when I mention some of them when I 

teach the course, people say, "What is it? I've never 

even heard of it." We haven't used these in 50 years. 

 The European Union, on the other hand, has a 

preapproval list, currently under the Cosmetic 

Directive. It is called Annex-6 under the new cosmetic 

regulations which go into effect in 2013 this has been 

changed to Annex-5. Japan also preapproves 

preservatives and they break preservatives down by 

whether they are being applied for leave on, rinse off, 

general use or products that come in contact with 

mucous membranes. 

 As I said before, we add preservatives to 

products that have been produced under GMPs that are 

clean, so that they prevent contamination by consumers 
76

under normal and foreseeable use. Now, previous 

speakers have talked about packaging, and let's 

understand some of the issues that cosmetic 

microbiologists and cosmetic manufacturers and people 

who manufacture preservatives understood full well. 

 Let's take a facial cream and package it in a 

typical jar with a nice wide mouth on it. And the 

consumer uses this by putting her absolutely sterile 

fingers into the jar and smearing the cream on to their 

face. If that product is not adequately preserved, it 

will grow and the problem is that we don't see 

bacteria. We might see mold, but we won't see 

bacteria. 

 Take the exact same product and instead of 

putting it into a wide mouth jar, put it into a tube 

with a very narrow orifice where the consumer can't 

stick her dirty fingers into, we have a totally 

different preservative issue and a totally different 

manufacturing and safety issues that you have to deal 

with. 

 Now, we have pretty much agreed in the world 

to establish the efficacy of preservatives by a 
77

preservative efficacy test. And this is a simple test 

that basically we use and we'll talk about in a couple 

seconds. What did the FDA say about the adequacy of 

preservation? And again I'll date myself, because this 

goes back to the '60s and '70s, it went up until the 

'90s, the FDA had a cosmetic handbook. And I guess 

Stan Milstein and myself who still have original 

copies, I don't know whether anyone else does. I still 

have mine, I still use it very regularly. 

 And it says there -- and it says that 

cosmetics and topical pharmaceuticals need not be 

sterile. And the reason for that is they're not 

applied to sterile surfaces. We have bacteria growing 

on our skin all the time, so applying a sterile product 

to a non-sterile surface really doesn't seem to make 

too much sense. 

 However, they say that our products cannot be 

contaminated with pathogenic microorganisms, bugs that 

can cause disease and illness. And further, that the 

other levels of microorganisms must be low, without 

really a definition of what that means. 

Finally, the most important thing, which I 
78

find which continues today is that cosmetics and their 

raw materials must be manufactured and stored under 

conditions that basically prevent adulteration, 

especially microbial contamination. And some of the 

most common types of contaminations that I am called 

upon to look at are products that are manufactured 

under clean operations, have adequate preservatives but 

are stored in such a way as they become contaminated. 

 The last one I was involved with was a company 

who made a bulk lotion, put it into a tote bin and left 

the tote bin sitting around for four days, uncovered. 

Naturally it became contaminated and naturally the 

product had to be destroyed. When management found out 

about it, they were rather upset, because their 

instructions were anything that is manufactured has to 

be filled immediately, not stored. 

 The European Union defines pathogens as three, 

Pseudomonas aeruginosa, Staph aureus and Candida 

albicans. Let me say one thing right now, which people 

who have taken my courses, have heard my lectures, for 

years and years and years I've said I've never been 

able to get C. albicans to grow in a cosmetic. I had 
79

tremendous numbers of cosmetics that failed challenge 

testing for C. albicans, but I just never could get C. 

albicans to grow. 

 I always thought it was because cosmetics were 

hostile to C. albicans, but actually there is a real 

valid scientific reason and this came out in 

publication by a colleague of mine about 10, 12 years 

ago in a very obscure pharmaceutical journal. And 

basically what it said was that C. albicans need a 

very, very narrow range of water activity. Now water 

activity has been mentioned before. Water activity is 

not the amount of water present, water activity is the 

amount of water that's available for microbial growth. 

 And C. albicans needs a water activity of 

between .88 and about .91 and we just don't manufacture 

cosmetics in that water activity range, which is why 

we've never seen contamination. 

 Finally, about five years ago I was called 

into an account that had a contamination of C. 

albicans, it was actually growing, it was thriving 

there. We ran water activity, .9. 

What does the FDA recommend? That each batch, 
80

which is not self-preserving, should be tested for 

microbial contamination before it is released. We're 

going to talk a little bit more about that. And 

finally, that each batch, especially each cosmetic 

batch that is intended for eye area cosmetics, during 

their development, we check for adequacy of 

preservation under normal and reasonable foreseeable 

consumer conditions of use. 

 Challenge tests, we've already said a couple 

words. It's a short term test to see whether our 

product will withstand the contaminations that 

consumers do to our products. 

 This works very well for typical cosmetics, 

and you've heard that statement before. Let me say 

that typical cosmetics are products which have water as 

the solvent, water is the continuous phase. Challenge 

testing does not work well for atypical cosmetics and 

atypical cosmetics are products that do not contain 

water or do not have very high levels of water or water 

is not the continuous phase. For example, a water and 

oil emulsion. When we go and run a typical challenge 

test on a water and oil emulsion, we invert the 
81

emulsion, so that water is the continuous phase. And 

when we try to do a standard test like this, all we 

have to do is formulate to pass the test, as opposed to 

adequately preserve it. 

 Now PCPC's micro committee has spent 

significant amount of time and effort to come up with 

ways in which we can adequately really understand 

atypical cosmetics and how they need or do they need to 

be preserved and how we test them and the information 

is available, just contact PCPC and they'll be glad to 

get you the information that we've developed. 

 Jay had talked about general microbial limits, 

Jay used a simple ten to the third, I'm using a 

thousand, that's ten to the third colony forming units 

per milliliter, eye and baby products in the absence of 

pathogens. Many years ago Don Orth and myself 

coauthored a paper which was sort of like a contest 

between the two of us as to whether this was 

appropriate. And we both agreed on one thing, that 

these tests are appropriate on one important condition, 

that if you turn up with a positive number of colony 

forming units, you define what happens to it 24 or 48 
82

or 72 hours later. 

 So, if you turn up with a count of let's say 

50 CFUs, you are taking a snapshot at one moment of 

time. Come back 24 hours later and see what numbers 

you have. Could it be too numerous to count? Then you 

have a product that's inadequately preserved and should 

not be shipped. Has it died off so we can't detect it? 

Or is it stasis, meaning it's staying the same? 

 And this is what we concluded. The most 

common test for this plate count is USP-61, I won't go 

into details to it, just that this seems to have been 

adopted as the universal standard. When we talk about 

preservatives, I have written several books on this, 

and please save your money, the third edition is coming 

out next year. Please buy it. I define preservatives 

by their chemical structures. And I'm going to go 

through them very briefly here. We have a lot of acids 

that are used, they're principally active against 

fungi. Many of the acidic preservatives are also 

allowed in foods, these would include things like 

benzoic acid and sorbic acid. 

Aromatic alcohols are mostly active against 
83

bacteria, these are extremely common, we'll talk about 

them in a few minutes. And methylol groups are often 

referred to formaldehyde donors or formaldehyde 

releasers, they're mostly active against bacteria. 

 When we put a halogen group onto most 

molecules, they tend to become very strongly antifungal, so most of our strong anti-fungal bacteria 

agents happen to have a halogen group on them. 

 We have a whole classification of two actual 

used preservatives which are based on isothiazolinone 

chemistry, and because of the way they're produced, 

we'll talk about that in a second, they are active 

against both fungi and bacteria. 

 There are some preservatives which are 

quaternium compounds, they're mostly active against 

bacteria. We tend not to use them very frequently in 

cosmetics, they have more important uses in terms of 

disinfectants. 

 And finally, one of the more important groups 

that's growing in popularity are the 1,2-diols which 

are mostly effective against bacteria. 

Preservatives that tend to be active against 
84

bacteria generally are not active against fungi. 

Preservatives that are active against fungi tend to not 

be active against bacteria. So, we combine them, we 

put them together to give us a broader coverage, so we 

take care of all microorganisms. 

 The following are the most popular 

preservatives used in the United States, as of my last 

publication, which was two years ago. Back in the 

early '70s, the FDA issued a publication on the 

frequency of use of preservatives, this was updated 

from the voluntary cosmetics registration base. When I 

started consulting in the mid-90's I was asked to take 

over this project and about every three years I updated 

this list. I want to thank Don Havery for his support 

in getting me the information. 

 The last time -- well, I published last year, 

but three years before that I also obtained the exact 

same information from Health Canada. Now, the 

difference between Health Canada and the United States 

is Health Canada has mandatory registration of cosmetic 

formulations. So, the numbers there actually represent 

what is in Canada, where what we have in the United 
85

States are voluntary. And guess what, they're the 

exact same order. We use the exact same preservatives 

whether we force people to register or we don't, we get 

the same information. 

 And the trends also track the same. Most 

popular preservative continues to be methylparaben and 

number two is propylparaben. Both of them happen to be 

universally permitted in foods, not very frequently 

used, but universally permitted in foods. They also 

are permitted in ingestible and injectable drugs. 

Phenoxyethanol is a very popular preservative, it's 

also a solvent, followed by butylparaben, ethylparaben, 

we'll talk a little bit more about that and 

isobutylparaben, in a couple minutes. 

 MCI/MI are just my abbreviations for 

methylchloroisothiazolinone and methylisothiazolinone. 

This is a mixture, but it's not really a mixture, it's 

produced this way, a three to one ratio of the 

methylchloro to the methyliso. It was introduced to 

the cosmetic industry in Europe in the '70s, in the 

United States around 1981, 1982. It is the most 

popular preservative for shampoos and rinse off 
86

cosmetics. It is also the most powerful preservative. 

We typically use this in the total of ten to fifteen 

parts per million range. 

 This is followed by DMDM hydantoin, one of the 

N-methanol groups, followed by imidazolidinyl urea, 

another N-methanol group. Finally, benzyl alcohol 

rounds off the top ten. Benzyl alcohol could be 

questioned, because besides being a preservative, 

benzyl alcohol is a fragrance component and it's a 

solvent, so we don't know how it's functioning. In 

fact, I've always wondered, the European Union permits 

benzyl alcohol as a preservative up to one percent, and 

they permit it up to 100 percent as a solvent. And 

I've always wondered, when I'm making a formulation, 

does the benzyl alcohol know what's doing in the 

formulation? Do I ask it or does it tell me? Good 

question. 

 Caprylyl glycol, growing in popularity. One 

(1),2-diol, diazolidinyl urea one of the N-methanol 

groups. Sorbic acid, a food grade preservative, 

strongly anti-fungi. Benzoic acid, another food grade 

preservative. Finally, number 15, chlorphenesin, we'll 
87

talk about that a little later. Halogenated group, it 

gives it anti-fungi properties. 

 Sixteen, dehydroacetic acid, another product 

that's also allowed in foods, but it's rather obscure. 

I believe the only food application that was approved 

was for yellow squash. I haven't quite figured out why 

yellow squash needs to be preserved. 

 Number 17, IPBC, I again abbreviated this so 

it would fit on the slide, Iodopropynyl butylcarbamate, 

very strong anti-fungi preservative. Number 18, 

ethylhexylglycerin which is used more as a solvent. 

Number 19, pentylene glycol, another 1,2-diol and 

finally, rounding out the top 20 is quaternium-15. 

 If I look at the next 80 preservatives and add 

them together, the number of uses doesn't equal where 

we are with the last one on the list. So, although we 

might have a hundred different preservatives, we're 

basically using only about 15 to 20. Our list is very, 

very narrow. 

 We use combination products, we call them 

cocktails. Okay, why? First, it gives us broader 

activity. Second, it gives us an easier way to 
88

incorporate the methylchloroisothiazolinone, 

methylisothiazolinone. Can you imagine weighing out 

ten parts per million of a powder accurately? Well, 

maybe the plant can do it, because you're making a big 

batch, but I know in the lab, when I worked in the lab, 

if I could measure out a tenth of a percent it was a 

miracle. Ten parts per million, never would get it in 

correctly. But it's sold in solution so that it's 

easier to incorporate and it's easier to weigh in the 

lab. And finally, that was why we dilute it. 

 Okay. The most popular mixtures, now I have 

this in an order for a reason. This is a chronological 

order, the first combination which really became 

popular was the methylchloroisothiazolinone, 

methylisothiazolinone, around 1981, 1982, for rinse off 

products. It is manufactured at a three to one ratio. 

Can they make it pure? Yes. Do they? No, there's no 

reason for it. Recently, five years ago, they 

introduced just the methylisothiazolinone, very 

strongly antibacterial, needs an anti-fungal agent, a 

number of combinations. 

Okay. The second one was one which I was 
89

deeply involved, I invented it was the combination of 

the diazolidinyl urea with parabens predissolved in 

propylene glycol. The big reason it achieved 

popularity, it was easy to use, you just dumped it in, 

instead of worrying about how to dissolve things. This 

was promptly followed by the parabens dissolved in 

phenoxyethanol. 

 And if you look at the first slide in which I 

had the different preservatives, the combination of 

parabens and phenoxyethanol is why you see methyl, 

ethyl, propyl, butyl and isobutyl. That was what was 

in this combination and it attests to the popularity 

of, again, a liquid which is much easier to corporate 

into formulations. 

 The latest one has been the use of caprylyl 

glycol and because of its limited solubility it is 

usually offered in combination with phenoxyethanol as a 

solvent. 

 With one exception, all of the preservatives 

in that top 20 list have been reviewed and re-reviewed 

for safety by the Cosmetic Ingredient Review. The only 

preservative on that list which has not been reviewed 
90

yet by the Cosmetic Ingredient Review is chlorphenesin 

and in two weeks I will be back in Washington when we 

will have the first review of chlorphenesin. 

 So, all of our preservatives are being 

reviewed or have been reviewed by independent people, 

people who have no connection to cosmetic companies or 

anything else, they're only interested in reviewing the 

safety of these products. 

 They've also been reviewed and re-reviewed by 

the European independent group of safety assessors 

called the SCCS, the Scientific Committee on Consumer 

Safety. 

 Many of these preservatives we have been using 

safely for 90 years. Parabens were introduced in 

1920's, and used safely since then. 

 The biggest problem and the biggest injuries 

and biggest concerns of safety of preservatives has 

always been sensitization. Preservatives function to 

kill bugs. When we apply too high a level or very high 

levels we can cause sensitization or reaction to the 

human skin. A lot of the industrial preservatives are 

not used in cosmetics because of this reason. The 
91

preservatives that are used in cosmetics are tested 

constantly for sensitization and most of the time when 

we have reports of sensitization they usually occur 

because people have higher levels than what are needed. 

 All cosmetic companies, that I'm aware of, 

test their finished formulations for sensitization. 

Yes, I can know a preservative that's very sensitizing 

and I can formulate it so it's not sensitizing. If I 

can't, I won't use it. 

 What's happened in our marketplace? Since the 

late '70s the consumers have been inundated by 

advertising and selling of consumer products, and I'm 

not just talking about cosmetics, I'm talking about 

foods, I'm talking about other consumer products, for 

what they do not contain. I remember one time, 

probably about 15 years ago, going to the supermarket 

and there was a little stand and a woman was selling 

frozen boil-in-bags of soup. And she was telling 

everyone, "Please try it. It's preservative free." 

Now, for someone who is deeply interested in 

preservatives, this always arouses my curiosity. 

So, I took some of the soup and I tasted it 
92

and I said, "Yum, you're right. I don't taste any 

preservatives." I tasted it again, I said, "You know, 

I don't taste any automobile tires in here either." I 

tasted it again, I said, "Hey, boy, I don't taste any 

dynamite. Why don't you say they're dynamite free?" 

And the woman says, "Look, I'm just hired to say this." 

 What was the implication? There was something 

wrong with preservatives. And I told her, I said, 

"Your issue is you're selling a frozen product, that is 

how it's preserved. And if you put a preservative in a 

frozen product someone is wasting someone's time and 

effort." 

 The FDA took action in the '70s against a 

company who advertised their vegetable oil was 

cholesterol free. Well, there was never ever 

cholesterol in vegetable oil, cholesterol comes from 

animal fats, not vegetable fats. 

 In the early '90s, not far from here, I 

attended a meeting of what we called Anti-microbial 2, 

which was one of the monographs from the Division of 

Drug Evaluation and Research. And they had made the 

announcement that they were going to divide Anti-
93

microbial 2 into what we commonly call now healthcare 

antiseptics and first aid antiseptics. 

 But the speaker made the comment that one of 

the things he was disturbed about was the use of 

alcohol in mouthwashes. And he wanted to put the 

percent alcohol into mouthwashes on the label. And I 

spoke to him privately and I said that this will only 

have the effect of demonizing alcohol and the function 

of alcohol in mouthwash is the preservative. The 

removal of this will cause companies to advertise and 

market alcohol free mouth rinses. 

 Well, back when he said this, the only time 

you ever saw an alcohol free mouthwash was the little 

bottles you were given when you went into the hospital. 

I remember my wife getting one when she gave birth to 

our son. Now it's a mass marketed consumer item. If 

you look at the FDA's voluntary recall of contaminated 

products, the most common one that you see are alcohol 

free mouthwashes. But that's a GMP problem, correct? 

Because it's manufactured under conditions in which it 

was contaminated. Well, let's ignore that. Let's 

assume we make it properly under good GMP and it's not 
94

contaminated. How do consumers use mouthwash (gulping 

sound). Do you think that bottle is now not 

contaminated? 

 Marketing quickly picked up on this and 

suddenly everything was free of whatever we could sell 

product for. Preservatives became a prime target, 

whether it be paraben-free, formaldehyde-free, 

triclosan-free. These organizations are constantly 

attacking preservatives. So what do we do? Marketing 

turns to the microbiologist and said, "I don't want you 

to formulate with these." Well, if you look at our 

list of characters of what we can use, we start using 

them at higher levels. 

 I go back to the '60s when potassium sorbate 

and sorbic acid were one of the most common anti-fungal 

agents used in cosmetics. And the number of 

sensitizations to sorbic acid was high, they were one 

of the highest that was reported from the constant 

dermatology group. We almost discontinued using sorbic 

acid, even though it's natural and it's food grade, 

it's not so great on your skin. 

Well, what's happening now, we're back to 
95

using it because parabens were our big anti-fungal 

preservative and you want to be paraben-free you need 

an anti-fungal agent. And you want it to be halogenfree. I expect to see probably higher levels as we 

have to use higher levels of sorbic acid. 

 The organizations basically talk about several 

things. If it's natural it's safe. I have no concept 

or no idea why consumers believe this. If it's 

natural, it's safe. Arsenic is natural, cyanide is 

natural. Next thing, if it's chemical it's toxic. I 

hate to tell everyone, but everything's a chemical. 

 I was at a meeting and someone used the term 

chemical free and I said, "Chemical free is a damn good 

vacuum. What are you talking about?" "Oh, I mean 

natural." "What do you mean natural? They're 

chemicals also." 

 Industry doesn't care about safety. You just 

heard two speakers talk about how much time and efforts 

are spent to justify the safety. I have a question for 

everyone in the audience, how many of you buy unsafe 

cosmetics? Oh, where's my market then? Adam Smith's 

Invisible Hand, if you took economics, the marketplace 
96

says cosmetics have to be safe because people won't buy 

them and companies can't sell them. 

 One of the other comments here, government is 

paid off by industry. The pharmaceutical industry 

spends a fortune in fees to the FDA to approve new 

drugs. They're called user fees. Congress mandates 

them. The law is up for review. Should we eliminate 

user fees for drugs? We approved -- the FDA approved 

more new drugs in 2011 than they did for the past two 

or three years combined. Why? Because they have user 

fees and have resources without having to raise taxes 

to pay for it. 

 If the first attacks against you on a 

preservative don't work there’s another one, but keep 

attacking it and finally everyone will believe that 

whatever you're attacking is true and is bad. Canada 

addressed this. Advertising Standards Canada in 

cooperation with Health Canada considered all of these 

free claims to be inherently false and misleading. So, 

if you want to claim your product is hydrogen cyanide 

free, that is a false and misleading claim. 

They did say there are times when it's 
97

important to the consumer to know that the product 

doesn't contain something, for example, if you're a 

diabetic and your food contains sugar, you should know 

that it contains sugar. 

 So they set up some rules and regulations as 

to when you can make this claim. The first thing is 

the product has to have been sold with this in it. So, 

your product had to have been registered, had been on 

the market in Canada and then you have to notify the 

government that you're removing the ingredient. We're 

taking the parabens out of our creams and lotions. You 

must then also submit an outside laboratory analysis 

showing that the new formulation contains no detectible 

paraben, none. If our detection limit is one part per 

quadrillion, then that's what we have to find absent. 

 At this point you're allowed to make a 

paraben-free claim for one year. And at the end of one 

year, not only are you no longer allowed to make the 

claim, you must go to the store and remove all products 

which make this claim. What's happened in Canada? You 

don't see free claims anymore. What you do see is 

saying the product has not been formulated with 
98

hydrogen cyanide or it contains no hydrogen cyanide, or 

we do not have hydrogen cyanide in the product. 

However, these all have to be true and provable. 

 In 2008 I was asked to speak on what was going 

on with the different preservatives and I said every 

single one of them is under attack. Most of the 

attacks are silly, most of them are not based on 

science whatsoever. We have the science that says they 

are safe. The Cosmetic Ingredient Review has said they 

were safe. The European SCCS said they were safe. 

Cosmetic companies would not use them if they weren't 

safe. 

 Are there going to be new preservatives, the 

answer to that question is no. I'll go back to 1960, a 

new preservative was developed, the company who 

invented it took it to a major user and said, "What 

safety data do you need for us to sell this 

preservative to you?" And they said, "Well, we want 

you to do an LD-50," feed this to rats until you've 

killed half of them. "We want you to do a rabbit eye 

irritation test to be sure it doesn't irritate the 

eyes." And finally, "We want you to do a skin 
99

irritation sensitization on guinea pigs." Total cost 

was about $2,000. 

 Same company, in the '80s, that I worked for, 

when they came out with my brand new cocktail that I 

invented, even though every single ingredient in the 

cocktail had been safety tested for ages, it cost us 

over $100,000. And that was in 1980, that was 30-some 

years ago. 

 The latest one that was approved took five 

years to get approval in Europe, five years to get 

approval in Japan. The costs were in the seven to 

eight figure range. That's just cosmetic safety, now 

we have to deal with environmental issues like REACH 

and the DSL list in Canada and NICNAS in Australia. 

It's too expensive, our market's not that big. It's 

not that big. 

 So, what's happening? We're seeing more and 

more non-preservatives offered to the marketplace. 

What's a non-preservative? It's a product that's not 

on the European approval list. The glass is half full 

or the glass is half empty. If it's a preservative, 

the glass is half full. If it's not a preservative, 
100

the glass is half empty. It's an emulsifier, it's a 

skin conditioning agent, it's whatever else you want to 

call it. And that makes our products self-preserving. 

 Let's go back to the FDA's comments. 

Cosmetics that are not inherently self-preserving need 

to be tested and challenge tested, et cetera. They're 

in conflict with each other. 

 One of the things that marketing asks, "Well, 

give us something that's natural, that will selfpreserve our products." Well, what happens is if you 

ask for it there will be people who give it to you. 

 Just like dietary supplements, which claim 

drug activity but are dietary supplements and the FDA 

constantly is recalling these because they contain real 

drugs that are not disclosed. Just about every 

botanical extract that I have looked at has had one of 

those top 20 preservatives in them. 

 Caveat emptor, let the buyer beware. So what 

can we do? The manufacturers of cosmetic 

preservatives, we believe in a strong FDA. We believe 

in strong public relations. We believe that the public 

has to know that their products that we are selling are 
101

safe and that they're safe for the consumer to use, 

that we have excellent safety standards and that we 

have had this evaluated, not by ourselves, but by 

independent scientists who have no vested interest in 

this. 

 The history has supported that the cosmetics 

are sold are safe and that the preservatives that we 

use today are safe. 

 And I thank you. I'll be glad to take any 

questions. 

 MR. GASPER: We're going to take a break for 

lunch but first a few little housekeeping notes. In 

addition to the hotel restaurant on this level, there 

are a number of places on the mall level serving 

sandwiches, salads, et cetera. 

 Another reminder, if you have not signed up 

yet to make public comments, but would like to do so, 

please see Juanita Yates before going to lunch. That 

was something I mentioned in the morning. 

 And if any of you drove in today and are 

parked in the hotel parking garage, please see Juanita 

before going to lunch. 
102

 I guess with that we'll break for lunch till 

one o'clock. Thank you very much. 

 (Lunch break) 

 MR. GASPER: Thank you all for coming back. 

Next up we have Dr. Richard Whiting from Exponent. 

 MR. WHITING: Thank you. I'm Richard Whiting. 

I'm a microbiologist and a microbial risk assessor. 

Prior to joining Exponent I spent a career with the 

U.S. Department of Agriculture and with the FDA. 

 Exponent has conducted microbial risk 

assessments in food products and we are just in the 

process of collaborating with the Personal Care 

Products Council in the cosmetic area, in microbial 

risk assessment. 

 We noted in the Federal Register Notice for 

this meeting, that FDA noted a variety of factors 

affecting microbial safety and requested information on 

organisms that posed specific health hazards and 

requested stakeholder input in the development of 

guidance. 

 So, what I'd like to do in this presentation 

is discuss the microbial risk assessment process 
103

itself, look on it as a necessary procedure to develop 

guidance and that this should be done in collaboration 

with industry and consumer stakeholders. And I noticed 

on Dr. Hansen's slide this morning that she had one on 

risk assessment and I think actually we're very much on 

the same page with this and I hope this will prove to 

be the case. 

 As someone who has done a lot of microbial 

risk assessments, I've noticed the word is used a lot, 

it's been kicked around here today on many 

presentations, but I also have seen that people do not 

really have a good understand of exactly what is 

involved with microbial risk assessments and what it's 

all about. So, that's what I would like to present 

today, is looking at microbial risk assessment as a 

process to help you come up with guidance. 

 My objectives here, briefly, are to describe 

the risk analysis process and I'll present sort of a 

hypothetical case to help describe that. To present 

risk assessment as a tool for making informed decisions 

in evaluating potential hazards and to describe the 

risk assessment process as a foundation in developing 
104

guidance, by providing structure, transparency, 

objectivity and as a basis for good risk 

communications. 

 Now risk analysis is the broader picture here. 

And again, it's a tool here to make a systematic 

evaluation of the relative scientific knowledge to help 

the risk managers make an informed decision. And there 

are three basic activities within this. The risk 

management, within the context of this meeting, would 

be FDA and making decisions on what guidance they would 

put out. The risk assessment is the scientific 

gathering of information and data and evaluation of 

that. And then risk communication refers to the 

necessary actions of collecting information from 

various stakeholders, it could be from the industry, 

could be from the public, for doing the risk 

assessment, but also getting this information back out 

again afterwards. 

 The classic structure of a risk assessment has 

four different components. Called first the hazard 

identification, which describes what the purpose of the 

risk assessment is, which bacteria, which products, 
105

which people are concerned and the subject of the risk 

assessment. The exposure assessment then is determined 

how many bacteria are actually exposed to the consumer, 

what are the numbers what are the frequencies of 

exposure. And it's important to realize, of course, 

this is to the consumer, not necessarily at the end of 

manufacture or some other time when regulatory control 

might be applied. The hazard characterization or as 

they sometimes call it the dose response, looks at the 

organism itself and asks what the potential for illness 

of that organism or the virulence of that organism. 

 The risk characterization part then brings 

these last two together and looks at a specific product 

with its contamination, the exposure to the consumer 

and the risk characterization from the organisms, says 

what is the risk of this product to the consumers. 

 And again, the overall purpose of this is to, 

you know, inform the risk managers for the decision. 

The risk assessment does not actually determine or 

calculate the safety. It provides information to the 

risk managers that they can make their decision. 

Now the risk managers would then commission a 
106

risk assessment, because they have some issue that they 

need scientific information to help them make a 

decision on. And the risk assessment, therefore, is 

tailored specifically for each situation, each one is 

unique. And there are several different forms or 

levels that it can take. The first here is a risk 

profile, which is really quite similar to what you 

might think of as a white paper. 

 If you're interested in comparing two products 

or two treatments, you might want to do a risk ranking, 

determine whether one was greater or lesser than the 

other. If you don't have a lot of quantitative 

information you might move into what we call a 

qualitative risk assessment where the frequency might 

be considered high, medium and low or frequent, rare, 

something like this. 

 And the finally, a fully quantitative risk 

assessment where you have numerical values for levels 

and various other parameters and I'll show you an 

example later. 

 Obviously as you go down towards the 

quantitative risk assessment, there's a need for more 
107

data, better quality data in order to make the 

calculations. It also means that the quantitative risk 

assessment will be probably more time consuming and 

expensive to conduct. But again, what you do will 

depend on partly the information that's available but 

also what is necessary to provide the information that 

the risk managers need to make their decision. 

 It's important, in the risk management 

process, that the risk managers define very 

specifically what the particular issue or question is 

that they want guidance on. And some of the things I 

threw out here that might be of concern to the risk 

managers: Which particular products, what specific 

products do you want a risk assessment on or perhaps 

products that have certain types of applications, what 

particular microorganisms are you interested in, are 

you interested in the numbers of the bacteria or the 

numbers that might be above or below a certain level. 

You might want a basis on virulence factors, not all 

strains of a certain bacteria are equally virulent. 

And then finally, you may have a risk assessment for 

different users. You might be interested in all people 
108

or you might be just interested in children, for 

example. 

 For an example, today I've put together just 

an outline of a hypothetical risk assessment here. 

Looking at sort of the question of what is the 

likelihood that a facial product could cause an eye 

infection and how often and why will the product exceed 

the specific criteria that leads to that. 

 In the hazard identification section, you can 

see some of the things that you will be looking for 

information on. And I might just add, as a side thing 

here, I've put the word pathogen up there, but that's a 

very general term that I'm using it today, it's really 

the organism that you are concerned with that may have 

a public health impact. And in fact, it may turn out 

that the risk assessment shows that it does not have a 

public health impact. 

 So, again, you're looking at contamination 

levels, where is it coming from, what does the pathogen 

do in the particular product. Will it grow? Is it 

inactivated? And then, what's the epidemiology? What 

does the pathogen do when it is used by the consumer? 
109

 A typical step here is to develop a flowchart. 

In this case we've got our ingredients, one of which 

may be contaminated with our organism of concern. We 

have our bulk processing, processing, packaging, which 

is another opportunity for contamination. Then there's 

distribution and consumer storage, and again, it's very 

important in a process like that to consider what the 

consumer is doing with the product. 

 And then finally, on the right side, the risk 

assessor's -- risk managers may ask for different 

outputs. They may ask what's the likelihood of illness 

per serving or per use, or how frequently does the 

contamination exceed a certain level. And that can be 

looked on as an individual basis or if you have a 

population, what are the total numbers for a 

population. 

 So, this is our flowchart then that we are 

going to populate with data which we need for each step 

of the process. And what occasionally will happen here 

is that you do not have good data for a particular step 

and in this case, if it proves to be a very critical 

step in the process, this is now a research need that 
110

you need to go out and collect data, then come back and 

do the risk assessment. 

 Just very briefly here, some of the types of 

data that you would use in populating this risk 

assessment. What's the thermal inactivation of spores? 

In this case you've got D-values time for one log of 

inactivation. What do you know about growth? Is it 

inhibited by water activities below a certain level? 

What about the inhibitors that are added to the 

product, are they effective? 

 During the storage period of the product, 

what's the organism doing? Does it decline at a 

certain rate? 

 Consumer use, here's examples of some of the 

information that you would need. How long does the 

consumer store the product? Is it used daily or less 

frequently? How much is applied? If, in this case, a 

concern about the eye, what's the likelihood that some 

of this could get into the eye and how much, if that 

happens? 

 Looking at the dose response part of it, 

here's some of the factors. Are we talking about a 
111

competent or susceptible population? Do we have 

simultaneously an injury to the eye at the time we're 

concerned about it or not? And if there are say 

certain standards, like 100 CFUs, are we above or below 

that at the time of exposure? 

 So just to kind of summarize all of this back 

up here. The risk assessment here is really your only 

way to really take a complex process like this, with a 

lot of different steps, a lot of different factors, and 

try to put it all together to see how those steps 

actually affect your public health outcomes that you're 

concerned with. 

 In a case like this you could say, which one 

of these locations of contamination would be the most 

important? Or, is a processing step sufficiently 

severe to have the desired public health? Or, what is 

the organism doing during the storage period and how 

does that affect the public health? 

 So, to just summarize this, quick look at 

this. What we're using the risk assessment process 

here is to try to develop effective guidance. And in 

order to do that you need to have this full risk 
112

assessment process. The risk assessment provides, you 

know, a structured and transparent way of collecting 

all the data that everybody can see and evaluate and it 

can show how this complex process interacts and what 

particular parts of this process are particularly 

important. 

 And then finally, the risk assessment process 

provides a mechanism for stakeholder involvement and 

it's also a very effective way, when it's done, to 

communicate the results back to the various 

stakeholders. 

 So, you know, as FDA goes forward in 

developing guidance I certainly encourage them to use 

this risk assessment approach to its fullest advantage. 

So, with that I'd like to thank you and I'll be happy 

to answer any questions. 

 MR. SCHNITTGER: My name is Steve Schnittger, 

I'm a microbiologist, part of the PCPC Micro Committee. 

I work for Estee Lauder. My question to you, or I 

guess my observation is that your risk assessment 

scheme can really be broken down into two parts. The 

risk of the product itself to support microbial growth, 
113

which we use preservatives in our products to make sure

that there is no possibility that those bugs could grow 

to high levels. And then there's also the risk to the 

consumer, of that bug potentially becoming a concern or 

developing into an adverse reaction to the consumer. 

 And but what your -- the way your scheme is 

laid out there, it looks at, like you'll look at the 

overall picture as far as the overall risk assessment 

of that product plus bacteria, in the same light. 

 And I think what we've tried to do in the 

industry is really look at what the potential or what 

the risk is of a certain product type to support 

microbial growth and that's why we add preservatives, 

that's why we look at packaging. And that's done just 

pretty much on a daily basis with every product that we 

make. 

 So, as I think that this scheme can be used 

for the FDA or for whomever to look at the different 

types of organisms of concern, this is something that 

is done on a daily basis by each of our companies. So, 

it's nothing new, but it does help in overall look at 

the different types of bacteria and those of concern. 
114

 MR. WHITING: Several comments. Yes, first of 

all, the risk assessment process is not new. What I 

think is new with this is we are becoming much more 

quantitative about all the calculations, before it was 

a little more of a subjective process. 

 And, in your example you're looking at part of 

the whole process and then you've made certain 

judgments on other parts of it. You know, you look at 

what's the contamination level, you're kind of 

assuming, okay, that's perhaps at certain levels. 

 MR. SCHNITTGER: But -- 

 MR. WHITING: Is that true or not? And this 

is just a way of getting all of the information 

together and on the table. 

 MR. SCHNITTGER: My only concern is, again, we 

set these limits and Phil and Jay talked about the 

limits that we use for the industry, and as long as 

those limits are set and that the products that are 

sold within those limits, then that chance of an 

adverse reaction of that product to the consumer really 

is minimal. Because we're not putting out products 

that exceed that limit of 100 CFU or 1,000 CFU. And we 
115

know, based on those specifications, that those 

products are safe. 

 MR. WHITING: Well, in this case the risk 

assessment should back that up. And by going through 

this process now you've put out, on the table, all of 

your data and all of your reasoning to support the 

conclusion that you have. 

 MR. SUTTON: Scott Sutton, Microbiology 

Network. One of the aspects that we've found really 

useful over the past few years in looking and 

investigating issues is CAPA, corrective and preventive 

action plans. And usually you start with a problem and 

you identify a root cause for this problem, you 

identify a fix for the root cause and then you 

demonstrate the fix was effective. 

 I guess my question is more of one for the 

industry and FDA as a whole. What's the problem we're 

correcting here? Is there a serious issue with 

microbiological safety of cosmetics. Thank you. 

 MR. WHITING: I'm not sure I'm quite following 

your question. You say you found the problem, 

corrected it and -- 
116

 MR. SUTTON: What's the problem with testing? 

 MR. WHITING: The problem with testing? 

 (Speaking off the microphone) 

 MR. WHITING: You're not on here. 

 MR. SUTTON: We're addressing the general 

topic of microbiological safety of cosmetics, which 

infers that there's a problem with microbiological 

safety of cosmetics. And I'm just asking, what is that 

problem? 

 MR. WHITING: Well, I think I would put it 

back to FDA here for calling the meeting. I'm talking 

about the process, not specifically any particular 

organism or product. I'm trying to talk about the 

general process, the general way you would approach 

developing guidance and developing standards. 

 DR. KRAEMER: Axel Kraemer from Schwan. Maybe 

I'm going to rephrase your question. Somehow industry 

and FDA lost, how to put it, the mutual understanding 

of what is a microorganism which is objectionable. And 

I'm wondering how we are getting back to mutual 

understanding which microorganisms which are to be 

considered as objectionable microorganisms. And that's 
117

basically a comment or a question to your direction. 

 DR. HANSEN: This is Pat Hansen, Office of 

Cosmetics and Colors. That's one of the purposes of us 

holding this public meeting – is to gather information, 

to share information. We are really looking for, as I 

said before, is data, information, analysis, and 

perspective to help inform our approach to these 

issues. 

 And I guess I would say also that, in part in 

response to Scott Sutton's question, that we're really 

on a preventive perspective here. Preventive 

perspective, and that's in large part what guidance is 

intended for, is to put out, as industry's own 

guidelines do, best practices, and points to consider 

in taking a preventive approach. And I think that 

informs FDA's approach across the vast range of 

products that we regulate, and cosmetics is one of 

them. This is not a different approach that we're 

taking. 

 MR. GASPER: Okay. Now we're going to move on 

to our closing remarks with Dr. Linda Katz. 

DR. KATZ: Thank you. And actually my closing 
118

remarks are fairly brief. I'm posting a slide that I 

posted earlier this morning for the goals of this 

public meeting. And as Pat Hansen said, the purpose of 

this meeting is for us to gain information from you, 

from others who are concerned, and interested parties. 

 As we went through the history and even 

listening to the history that was presented to us by 

industry, a lot of the guidances and recommendations 

that we've used are old. We've revised some of the 

information that we've received, but others are 

probably in need of being revised. Part of the reason 

is that science changes. Hopefully this isn't a static 

process but one that's an active process, where we can 

constantly gain new information - a wealth of 

information that all of you can provide to us. So as we 

look at the guidances that we have on our website, both 

from GMPs and from our BAM chapter, this is probably 

the right time to go back and see what needs to be 

changed. 

 It doesn't necessarily imply, from the 

questions that have been asked, that we have to change 

anything. But if science has changed and if we have 
119

moved forward, now is the time to do make changes. 

 Some of the information that we have and some 

of the information that we rely upon, is close to ten 

years old. Some is less than that, but again, it's 

time for us to gain information, to look at the science 

once again to make the determination, whether our 

guidances are current, and if they are up to date. 

 So, basically, the bottom line is that as 

we've listened to today's presentations, we know that 

there probably is other information that all of you may 

have. We hope that you'll be able to share that with us 

in the form of written comments that will go to the 

docket, so we can go back and look to see if we need to 

revise anything, or if our current guidances and 

practices are appropriate, so that we make the 

determination if modifications are needed. 

 So, the basic bottom line is, we want to hear 

from you. We've heard from some of you earlier today, 

but we'd like to hear, hopefully from all of you or 

from all of you who have any interest in this area, and 

to provide us with written information, comments to the 

docket. 
120

 As John mentioned, all comments need to be 

submitted by January 30th. And so that way, as soon as 

the information becomes available after the docket's 

closed, the comment period closes, we'll go back and 

we'll reassess and make a determination as to what we 

need to do and how we can go forward. 

 With that being said, it may be that we may 

need another meeting; it may be that we don't. The 

information that we receive will make that 

determination. But I do want to thank all of you for 

coming. 

 And I will turn over to John, so John can go 

through our final information and some of the logistics 

that need to be taken care before the meeting closes. 

Thank you again for coming and sharing with us. 

 MR. GASPER: Okay, I've just got three simple 

things here, since we're obviously moving up the break. 

Feel free to enjoy the refreshments we have provided 

for you outside. 

 We have gotten a few questions about receiving 

a copy of the slides from the presenters today. If you 

want a copy, give either like I say your card or your 
121

contact information to either Juanita Yates or Wendy 

Johnson or Shirley Turpin outside, or other FDA staff, 

and we can get you a copy of the slides. 

 I mentioned about the refreshments. We do 

have this space till five o'clock this evening, so if 

anybody -- you want to stay, possibly have some short 

discussions, whatever, the space is available to you 

till five o'clock today. 

 That's basically all I have to say. Thank you 

again. 

(End of Meeting) 
122

CERTIFICATE OF NOTARY PUBLIC 

I, Natalia Thomas, the officer before whom the 

foregoing meeting was taken, do hereby certify that the 

proceedings were taken by me in audio recording and 

thereafter reduced to typewriting under my supervision; 

that said transcription is a true record of the 

proceedings; that I am neither counsel for, related to, 

nor employed by any of the parties to the action in 

which this was taken; and, further, that I am not a 

relative or employee of any counsel or attorney 

employed by the parties hereto, nor financially or 

otherwise interested in the outcome of this action. 

_______________________________ 

Natasha Thomas 

Notary Public in and for 

 The District of Columbia