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NATIONAL INSTITUTE FOR OCCUPATIONAL

SAFETY AND HEALTH 

(NIOSH)

+ + + + +

UPDATE OF NIOSH CARCINOGEN CLASSIFICATION 

AND TARGET RISK LEVEL POLICY FOR CHEMICAL 

HAZARDS IN THE WORKPLACE

+ + + + +

MONDAY

DECEMBER 16, 2013

+ + + + +

The meeting commenced in the 

Surface Transportation Board Hearing Room, 

Patriots Plaza One, 395 E Street, SW, 

Washington, D.C., at 9:00 a.m., Lauralynn 

McKernan, Deputy Director, Education and 

Information Division, NIOSH, presiding.

PRESENT FROM NIOSH

LAURALYNN McKERNAN, Deputy Director of the

Education and Information Division,

Chair

JOHN HOWARD, Director of NIOSH

T.J. LENTZ, Document Development Branch 

Chief

KATHLEEN MacMAHON, Associate Director for

Science of the Education and

Information Division

FAYE RICE, Policy Response Coordinator

PAUL SCHULTE, Director of the Education and

Information Division

CHRISTINE SOFGE, Risk Evaluation Branch 

Chief
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T-A-B-L-E O-F C-O-N-T-E-N-T-S

Introduction and Description of Meeting 

Procedures ................................. 4

Lauralynn McKernan, Sc.D.

Deputy Director, Education and

Information Division, NIOSH

Welcome and Overview ....................... 9

John Howard, M.D.

Director, NIOSH

Presentation on the Background and Key 

Points of the Draft NIOSH Carcinogen 

Classification Policy ...................... 11

Paul Schulte, Ph.D.

Director, Education and

Information Division, NIOSH

Questions/Answers of Clarification for the 

Previous Presentation ...................... 34

Audience/NIOSH Panelists

Public/Stakeholder Opportunity to provide 

Comment

Darius Sivin, International

Union, UAW

........................................... 50

Anna Mazzucco, National

Research Center for Women and 

Families

........................................... 59

James Melius, New York State

Laborers’ Health and Safety Trust 

Fund

........................................... 68

Lee Anderson, BlueGreen Alliance

........................................... 77
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Howard Marks, National

Asphalt Pavement

Association, declined.

T-A-B-L-E O-F C-O-N-T-E-N-T-S

(continued)

Public Opportunity to provide Comment 

Dana Loomis, International

Agency for Research on Cancer, 

Lyon, France

........................................... 89

Additional Questions/Answers of 

Clarification for the Speakers/Presentations

Audience/NIOSH Panelists 93

Concluding Comments ........................ 93

Lauralynn McKernan, Sc.D.

Deputy Director, Education and

Information Division, NIOSH
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P-R-O-C-E-E-D-I-N-G-S

(9:07 a.m.)

DR. McKERNAN: Good morning. 

Well, you know, it wouldn't be a public 

meeting without a few technical glitches 

first thing. So we've gotten all those out 

of our system and we should be good to go 

now.

So, good morning, and welcome to 

this public meeting to present and discuss 

the draft document entitled, “Update of the 

NIOSH Carcinogen Classification and Target 

Risk Level Policy for Chemical Hazards in 

the Workplace.”

My name is Lauralynn Taylor 

McKernan, I'm the Deputy Director of the 

Education and Information Division at the 

National Institute for Occupational Safety 

and Health. I will be chairing today's 

meeting.

You'll be hearing opening remarks 
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from Dr. John Howard, followed by a 

presentation by Dr. Paul Schulte, comments 

from a number of my NIOSH colleagues who 

were on the team that developed this 

document.

First, I have a number of matters 

of housekeeping. I've been informed this 

morning that this is a coffee-free room. So 

if you have coffee, please be extremely 

careful with it. This is a water room. You 

can have as much water as you want.

I'd also ask you to note where 

the exits are in this building. You can 

tell that you can either exit from the door 

from which we entered, or you can go out 

this exit door over here. We need to go 

through three double doors and then make a 

left to go onto Fourth Street.

From Fourth Street, we're going 

to go under an underpass and we're going to 

go to the baseball diamond, and we are all 

to meet on third base. And in case you 
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wanted to see that, I have a map up on top 

of the screen.

Restrooms are out the door and to 

the left from which you entered. If you 

have a cell phone, we ask that you mute it 

now. If you want to use your cell phone, 

I've been told that the only place that it 

works is on the corridor on the fourth 

floor. So if you go out this door and make 

a left, you'll see nice benches and chairs 

for your cell phone use.

Okay, we have individuals 

participating remotely via teleconference. 

We have muted their phone lines to prevent 

distractions from the presentations. We 

will unmute the telephone lines periodically 

to allow those participants to ask 

questions. And during the first break we 

will take roll call of those that are on the 

phone.

When NIOSH announced the 

availability of the document, it also 
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announced that stakeholder comments 

regarding the draft policy will be accepted 

until 5:00 p.m. Eastern Standard Time on 

February 13th, 2014. Written comments are 

requested to be submitted to the NIOSH 

docket as instructed in the Federal Register 

notice.

Today's public forum will be 

recorded and transcribed. Transcriptions 

will be made available within 30 days, in 

the NIOSH Docket Office and on the NIOSH 

Docket Website. Consequently, all 

discussions, presentations, and comments as 

a part of this meeting are considered to be 

in the public domain and will be documented 

as such.

Therefore, if you have a 

question, you are asked to step to a 

microphone. We have a walking microphone up 

here. And please identify yourself and your

affiliation. If you are on the phone and 

are calling in and make any comments, you 
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will also be asked to identify yourself and 

your affiliation.

This public meeting satisfies our 

Office of Management and Budget peer review 

requirements for a highly influential 

scientific assessment document. But we also 

see this as an opportunity to allow the 

authors of the document to present the 

salient technical points, but also to hear 

from our stakeholders and their 

perspectives.

Our overall goal is to provide a 

document that is scientifically sound, has 

relevance and utility, and is developed 

according to a rigorous, consistent, and 

transparent process.

Towards that end, I'd like to 

introduce the panel of my NIOSH colleagues 

who are also coauthors on this document: Dr. 

Paul Schulte, Director of the Education and

Information Division; Dr. Kathleen MacMahon, 

Associate Director of Science for EID; Dr. 
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T.J. Lentz, the Document Development Branch 

Chief; Ms. Faye Rice, the Policy Response 

Coordinator; and, shortly, Dr. Christine 

Whittaker Sofge, the Risk Evaluation Branch 

Chief, will be joining us.

According to the agenda, the 

first part of the morning will be dedicated 

to a technical presentation of the document 

followed by a question and answer session. 

Following the questions from our attendees 

in the room, we'll be asking those on the 

phone if they have any questions.

The second half of the morning 

will be an opportunity for stakeholders and 

members of the public, first who have signed 

up in advance, to give brief presentations 

and comments. You should know that 

stakeholder order was randomly assigned. 

Those presentations will, again, become part 

of the public record and be archived in the 

NIOSH docket.

If time allows, there will be 
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other opportunities following those 

presentations for other members of the 

public and for those present to provide 

comment. The meeting will adjourn no later 

than 4:00 p.m.

So, without further ado, I'd like 

to begin with our first speaker, Dr. John 

Howard, Director of the National Institute 

for Occupational Safety and Health.

DR. HOWARD: Thank you, 

Lauralynn. And thanks to everybody who came 

today. We really appreciate it. And to 

everybody on the phone. I hope that I can 

be heard on the phone, and if not, let us 

know and we'll try to amp up the volume.

This is a scientifically complex 

issue that we're facing. As you'll hear, 

NIOSH has been in the process of doing this 

sort of thing since 1975, actually, so it's 

nothing new.

We welcome, in fact we need, all 

comments. We need everyone participating, 
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because science policies aren't done every 

day and they last a long time and they 

affect a lot of people: workers, employers, 

and scientists also.

So please enjoy the meeting. 

Thank you again for those who are listening 

on the phone and those of you who are here 

for coming, taking time from your busy 

schedules to help us out. Thank you very 

much.

DR. McKERNAN: Thank you, Dr. 

Howard. I'd now like to invite Dr. Paul 

Schulte to the podium.

DR. SCHULTE: Thank you. 

Welcome, we're glad you're here. This is a 

process where NIOSH listens to the public 

and tries to get the best input it can to 

help finish out this document.

It's the NIOSH Carcinogen Policy, 

or more specifically, the “Update of NIOSH 

Carcinogen Classification and Target Risk 

Level Policy for Chemical Hazards in the 
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Workplace.” And I will give you an overview 

of what is in the document.

So, why are we doing an 

evaluation and an update of the cancer 

policy? Well, there have been new advances 

in risk modeling, biologic mode of action, 

and analytic methods over the last couple

decades that have driven us to think through 

what should be in our cancer policy.

Moreover, we've had some input 

from the public about some of the aspects of 

the current cancer policy, and I'll talk to 

you about them, that cause us to want to 

rethink the policy. And we want to use this 

opportunity to receive peer and public 

input.

And so there was an initial 

public meeting to get input, and then there 

is this comment process and period. So we 

look forward to that. And we hope by all 

these actions that we've increased the 

transparency of the process and that the 
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occupational safety and health community 

will be more familiar with how NIOSH makes 

decisions about occupational carcinogens.

We will present this policy in a 

document we call “The Current Intelligence 

Bulletin.” There are three elements in the 

policy. There's the carcinogen 

classification; there's a target risk level 

for carcinogen recommended exposure limits, 

or RELs; and there's a section addressing 

analytic feasibility and engineering 

achievability.

Let me give you a little bit of 

the history of the carcinogen classification 

as it's been practiced at NIOSH. Since 

1978, we used the term “potential 

occupational carcinogen” as the highest 

designation for a substance.

And there was some

dissatisfaction with that term because it 

included well-known carcinogens, such as 

asbestos, benzene, and cadmium. And, hence, 
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they were labeled as if we didn't know for 

sure that they were carcinogens. And so 

that was one of the main drivers for why we

wanted to reconsider the policy.

And so we requested public input 

in 2011. We had a kick-off meeting. And 

then today we have this public meeting on 

the draft document. And it's currently on 

the Web for peer and public comment. We 

look forward to any comments that you would 

like to submit.

So, first, the classification 

aspect of the policy. Historically, NIOSH 

classified the candidate substance going 

through an evaluation of all the scientific 

literature. To avoid duplication, and for 

more efficient use of government resources, 

the new policy utilizes classifications from 

well-respected, authoritative organizations.

So, we'll be using the National 

Toxicology Program, the Environmental 

Protection Agency, and the International 
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Agency for Research on Cancer’s 

classification of chemicals.

The role that NIOSH will play, 

then, is to assess the occupational 

relevance of those classifications and the 

evidence on which they were built.

And then, to assist employers to 

follow the OSHA Hazard Communication 

Standard, NIOSH will assign a Globally 

Harmonized category for hazard 

communication. And I'll get in to that a 

little later.

Let me just elaborate a little 

bit on the part of determining the 

occupational relevance of a carcinogen 

classification. For the most part, 

occupational relevance will be somewhat 

obvious because NIOSH would not be assessing 

the material if it didn't pertain to 

workers.

But we wanted to further assess 

the extent to which there was worker 
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exposure and the applicability of the 

evidence for occupational carcinogenicity. 

So is the mode of action appropriate for 

humans, if it was based on animal data? Are 

the routes of exposure appropriate for 

workers? And so those will be a major part 

in the process.

And you can see that in this 

slide. It's a little small here; you may be 

able to see it better on the monitors. 

And so let me walk through the 

slides a bit. The first box says, is 

occupational exposure to a chemical likely? 

If no, then we would go to a stop and have 

no further action regarding carcinogen 

classification.

If yes, then we would ask the 

question, is the chemical classified by one 

of these agencies? And if the answer is no, 

then there are two options. We would end it 

in terms of carcinogen classification, but

we might further assess it in terms of other 
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health effects.

If yes, if there was other 

evidence of carcinogenicity but there was no 

classification, we would nominate it to NTP 

for classification. Or, in some cases, such 

as under specific time pressures or 

otherwise, NIOSH would evaluate it itself 

using the Globally Harmonized System, GHS, 

criteria.

Then going back to the left side, 

if indeed the chemical was classified by one 

of those agencies, NIOSH would evaluate the 

occupational relevance. And, if yes, assign 

a GHS category, and report it as an 

occupational carcinogen.

If no, NIOSH would report it as 

not anticipated to be an occupational 

carcinogen. We still would provide the 

underlying classification of the various 

agencies.

And so we wanted to show you how 

the various classifications line up. And 
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this is the extent to which the 

classifications by the various agencies 

correspond with the Globally Harmonized 

System categories.

Now, if you are familiar with the 

Hazard Communication Standard, it requires 

that employers, or manufacturers, actually 

classify a material. So NIOSH is just 

providing this as information to assist 

employers.

So you can see for the most part, 

those materials known to be human 

carcinogens, or the highest category in each 

of the various classifications, crosswalk 

over to the GHS Category 1A.

But then when you get to the NTP 

Reasonably Anticipated to be A Human 

Carcinogen, that straddles a couple 

categories: the GHS 1B and the Category 2. 

And the main driver there is in -- I don't 

have a pointer that shows, but if you look 

under IARC Group 2B, the main driver there 
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is differentiation on the basis of the 

animal evidence.

So under IARC 2B, the first box, 

if there is adequate animal evidence, that 

will then translate to GHS Category 1. And 

if there is limited animal evidence, that 

will translate to GHS Category 2.

While the GHS approach has 

different risk labeling, and that will need 

to be pursued by employers, NIOSH, for all 

intents and purposes, will treat all 

suspected carcinogens, or known carcinogens, 

the same in terms of risk management 

procedures. So, if we're concerned about 

carcinogenicity, we will provide the same 

guidance across the board.

So, this is how the system will 

report out. This is not the flow chart; 

this is the end product. And NIOSH will 

publish this in the Pocket Guide or other 

documents. 

So, this is an example for the 
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substance benzene. NIOSH would report it as 

a known, as a NIOSH occupational carcinogen, 

GHS Category 1A, known human carcinogen, 

based on NTP's Known to be Carcinogenic to 

Humans, EPA's Group A Human Carcinogen, and 

IARC's Group 1 Carcinogenic to Humans.

So we believe that by doing this 

we will then provide NIOSH's summary 

recommendation based on all this 

information, the corresponding GHS category, 

and then all the nuanced information coming 

from the various authoritative organizations 

as shown there.

Now here's another example. This 

is for heptachlor. Now, NTP doesn't have a 

classification for heptachlor. But there 

are EPA and IARC classifications. So this 

would be reported out as a NIOSH 

occupational carcinogen, GHS carcinogen 

Category 1B Presumed Human Carcinogen, based 

on EPA's B2 Probable Human Carcinogen, 

Sufficient Data in Animals, and IARC's Group 
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2B Possibly Carcinogenic, Sufficient Data in 

Animals. 

So those are how we're going to 

report out the results of the process of 

classifying carcinogenic substances.

Let's move on to the second 

element of the policy. And that involves 

risk levels and the concept of a target risk 

level. But this is by no means the center 

part of this policy. It's one tool to 

enable us to establish a REL. We need to 

have some cut point for establishing a REL.

Prior to 1995, NIOSH did not have 

quantitative RELs and with carcinogens just 

said, “control it to the lowest feasible 

concentration.” This may seem like it's a 

highly protective bit of guidance, but 

indeed it was really left to be determined 

by employers. And employers had to evaluate 

the technical and economic options. And, 

consequently, the exposures that could have 

occurred could be much higher than, say, 1 
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in 1,000. And so, indeed, the risk could 

be much higher than, say, 1 in 1,000. So, 

indeed, lowest feasible concentration had 

some limitations.

So, in 1995, NIOSH adopted a 

quantitative basis for RELs. And this is 

based on quantitative evaluation of risk 

using mathematical models to evaluate 

exposure response relationships. For the 

most part it involved animal data, though we 

prefer epidemiologic data, human data. But 

for the most part we have animal data. And 

that involves using mathematical models to 

extrapolate from animals to humans, and from 

high doses to low doses.

And in this policy, in 1995, it 

was acknowledged that there would be risks, 

residual risks, at a REL. So that the REL 

did leave a certain residual risk and the 

intent was that hopefully it would be 

relatively small.

Inherent in establishing the REL 
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is the need to have some sort of target risk 

level, because that becomes the driver, or

the cut point for which we start to consider 

where to have the REL.

But the target risk level is only 

part of a broader context in which risk 

levels are considered. And that context is 

described in this slide. And so the key 

feature is that NIOSH affirms the prevailing 

scientific knowledge that the only way to 

eliminate excess risk from carcinogens is to 

prevent exposure.

And so NIOSH advocates using 

safer alternatives and to substitute non

carcinogenic chemicals whenever feasible. 

Unfortunately, however, removing all 

carcinogens in commerce is impractical. It 

won't be feasible to replace them all with 

alternatives, and so there is need for 

guidance on reducing carcinogen exposures. 

And NIOSH will develop this guidance, as I 

said, using quantitative risk assessment.
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And when that risk assessment is 

conducted, NIOSH will communicate an array 

of lifetime cancer risks for exposures from 

1 in 100, to 1 in a million. We believe 

that this information will be useful to 

employers and workers to take preventative 

action.

And so, in addition to the risk 

assessment, there is a heavy emphasis on 

risk communication. We will also identify 

within that array of risks a minimum level 

of protection. And this will be the 1 in 

1,000 risk level as a nominal cut point to 

help establish a REL.

But throughout the policy and a 

strong position by NIOSH is the advocation 

to try to achieve exposures resulting in 

risks lower than 1 in 1,000.

Now, what is the basis for this 1 

in 1,000 designation? Well, reflect upon 

the U.S. Supreme Court's benzene decision, 

which characterized the range of risks 
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between 1 in 1,000 and 1 in a billion, and 

indicated that regulatory action should 

occur when there was significant risk. And 

they implied that 1 in 1,000 was a 

significant risk. So NIOSH will use that 

level because it better relates to OSHA's 

work in developing occupational exposure 

limits. And we will conduct the assessment 

of that using mathematical models.

This is not the first time NIOSH 

has used the 1 in 1,000 risk level in 

interactions with OSHA or in putting out 

guidance. And so you can see going back to 

1990 with the benzene PEL related to 

leukemia, in testimony to OSHA, NIOSH gave 

analysis of risks with recommendations 

focusing on the 1 in 1,000 risk level.

Similarly, in 1990, in testimony 

on the cadmium PEL, and in 1991 on the 1,3-

butadiene PEL. In 1995, this isn't cancer, 

but NIOSH used the 1 in 1,000 risk 

assessment in our criteria document to set 
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the coal dust REL.

Similarly, in 1998, in 

collaboration with OSHA, we developed a 

journal article for cancer risk from diesel 

exhaust. In 2001 and 2002, we had two 

different journal articles related to using 

the 1 in 1,000 cut point for risk guidance, 

one for silicosis, and one for cancer.

Then in 2007 NIOSH published a 

journal article with a risk assessment that 

identified the 1 in 1,000 level for 

manganese-related neurobehavioral effects.

In 2011, NIOSH as the first 

government agency in the world to develop a 

protective REL for workers exposed to 

nanoscale titanium dioxide, used the 1 in 

1,000 level as a cut point. That resulted 

in the lowest REL anywhere in the world.

In 2013, to protect workers 

against lung cancer from exposure to 

hexavalent chromium, NIOSH used the 1 in 

1,000 cut point as the basis for our REL.
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And currently we're working on a 

REL for the flavorings, diacetyl --

flavoring compounds -- diacetyl and its 

substitute 2,3-pentanedione to protect 

against respiratory dysfunction and 

bronchiolitis obliterans. And again the 

basis is the 1 in 1,000 risk assessment.

So, historically, in RELs that 

have been widely acknowledged around the 

world as being useful and protective, NIOSH 

has focused on the 1 in 1,000 cut point. 

There are additional protections afforded by 

the risk assessment and the related 

communication in the policy.

For example, in our mathematical 

modeling we use a 45-year working lifetime. 

Workers, then, who work less than 45 years 

will have less than the 1 in 1,000 risk. 

And not all workers work 45 years with the 

exposure to that same material.

We also in our modeling treat 

exposure at the low dose as a linear 
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function. This is more or less a default 

assumption. Sometimes we have data to 

actually model it, but often we don't.

And so in this slide, which shows 

risk by exposure -- and this is at the low 

end of the dose response curve -- we would 

assume, for modeling purposes, that the 

relationship is linear, that one unit of 

exposure relates to one unit of risk.

But in fact, in many cases, and 

for some carcinogens, the risk will be 

sublinear. And so, again, the actual risk 

that we identify will overestimate the true 

risk. So, the true risk will be less than 1 

in 1,000, potentially, to workers.

And then when we model, we make 

the result of the modeling as maximum 

likelihood estimates of risk. And then they 

have confidence intervals to reflect the 

variability and uncertainty on either side 

of them. NIOSH will use the dotted line by 

the designation “95 percent lower confidence 
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limit” as the estimate that we actually use.

So we won't use the maximum 

likelihood estimate of risk, per se, but 

rather the 95 percent lower confidence 

limit. That means that 95 percent of the 

estimates are between that dotted line and 

the solid line in the middle.

And indeed, in some cases, that 

can be almost an order of magnitude lower 

than 1 in 1,000. And so, indeed, workers 

could be protected to close to 1 in 10,000 

in that regard, in some cases.

Additionally, we continue to 

counsel that risk should be kept well below 

the REL because lower exposures lower the 

risk. We recommend alternatives whenever 

possible, and for these reasons the actual 

risk on which a REL is based, we believe, 

will be less than 1 in 1,000.

Now, moving on to the third 

element of the policy. This is the element 

that deals with two issues: analytical 
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feasibility and engineering achievability. 

Now, in our history, going back at least to 

1988, NIOSH stated that engineering controls

should be used to control occupational 

exposures to the fullest extent feasible.

Again, that issue of control to 

the level feasible, and this will be based 

on what levels can be feasibly achieved by 

engineering controls and managed by analytic 

techniques. So there are two issues here. 

There's the controllability and the 

measurability, if you will.

And just by way of background, 

not all NIOSH RELs are health-based. 

Historically, in many cases, the basis for 

the REL was not the health data but 

limitations of the analytical method. That 

we could not -- the analytical capabilities 

were not in existence to allow us to measure 

down to the level that would be below the 

lowest observed effect. And so, in which 

case we had to default and set the limit at 
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the level of analytical feasibility.

With regard to engineering 

achievability, while that was talked about 

in the 1995 policy, NIOSH hasn't routinely 

conducted analyses of the technical 

feasibility of achieving RELs. Nor was that 

ever defined in the policy.

And so, from henceforth in this 

policy, NIOSH will no longer establish 

carcinogen RELs relying on the evaluation of 

engineering control achievability. That 

will not be a determinant in the evaluation 

process.

But NIOSH will make an effort and 

provide in every REL document an overview of 

the effectiveness of engineering controls. 

Moreover, as we develop the RELs with the 

quantitative risk assessment, we also have 

to assess whether or not we can actually 

measure the chemical at the level that we 

would recommend.

And so to help the public 
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appreciate the difference and to see more 

transparently what the basis of a REL is, we 

will use these two designations. We will 

use health-based RELs. And with a chemical, 

we will use the designation REL in the 

Pocket Guide or other documents if it's 

health based. But if it's based on analytic 

feasibility, we will use REL with the 

subscript AF. That will allow people to 

know which ones are based on an analytic 

limitation and which ones are health-based.

This is another slide that, 

without a pointer, it's hard to see. Let me 

walk you through it, but, essentially, if 

there is a 1 in 1,000 risk, we ask the 

question, is there a validated analytic 

method to measure the substance?

If no, then we recommend research 

to develop a validated method. This can 

take many years, but at least it will fill a 

gap.

In the interim, or if yes, if 
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there is a validated method, we ask the 

question, can the validated method detect 

the concentration that equates to a 1 in 

1,000 risk? And indeed, if that does, we 

will provide recommendations to utilize a 

hierarchy of controls and issue a 

recommended exposure limit.

If not, we will adjust the REL to 

the analytical limit. And that would be the 

limit of quantitation, or the reliable 

quantitation limit. And for those RELs we 

will add the AF designation.

So, those were the three elements 

of the NIOSH cancer policy. We're here 

today having this public meeting. We hope 

to receive all public comments by February 

13th, 2014, and then receive all peer review 

comments by March 2014. That one month 

difference is because we want to avail the 

peer reviewers of all the comments of the 

public.

So in addition to reviewing the 
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document, they will have, as input, the 

comments of the public. And we anticipate 

the completion of the final cancer policy 

sometime in 2014.

I want to acknowledge the NIOSH 

intramural team that has worked on this 

document over the last two years. And we 

appreciate all their input. And draw your 

attention to the NIOSH carcinogen policy web 

page where you can get updates on this 

process.

And so I thank you for your 

attention, and we look forward to your 

questions and comments. And I think right 

now we'll take clarifying questions. Then 

we'll get into the comments by individual 

members of the public.

DR. McKERNAN: Thank you, Paul. 

We are going to take questions. We're first 

going to take questions in the room. After 

they have been completed, we'll then take 

questions from the phone line. I'd like to 
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remind everyone to please state your name 

and your affiliation. And we have a 

portable mic that will be rotating 

throughout the room.

(Pause.)

MS. CASANO: Hi, I'm Pat Casano, 

GE. And I apologize, I was a few minutes 

late. So, if you answered this question in 

your presentation, I'm sorry for the 

duplication.

The classifications upon which 

you're proposing to rely -- IARC, NTP, EPA -

- are of varying quality. In your process 

are you going to take that into account and 

provide an opportunity for people to comment 

on the quality of the assessments? Or are 

you going to take those classifications at

face value?

DR. SCHULTE: Whenever NIOSH 

develops a recommended exposure limit, the 

limit and the documentation will be open for 

public comment. And so there will be an 
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opportunity to comment on that. I would 

say, though, that we have viewed these three 

agency reviews as of all sufficient quality 

to be part of our determination, and we 

don't intend to rethink their determination.

So we will accept them at face 

value. We welcome comment about that, but 

unless there is some issue related to 

occupational relevance, they are de facto 

the source of our classification.

MR. SIVIN: Darius Sivin, UAW. 

Could NIOSH give an example, if not for a 

specific agent, for a hypothetical agent, of 

how it might find an agent found to be 

carcinogenic by these various agencies not 

occupationally relevant?

DR. SCHULTE: Chris, you want to 

do that?

DR. SOFGE: We expect that to be 

a very rare occurrence. And I'd love to 

just pull out a chemical and tell you, but 

it is a very rare thing that we would find 
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something not occupationally relevant if 

it's been considered to be a carcinogen by 

one of these three agencies. Because just 

the fact that they're looking at it means 

there's probably exposure and it's probably 

relevant.

What we put this in there for is 

those situations where you could imagine if 

there was a chemical that caused tumors if 

it was injected, and that's not a route of 

exposure you would ever have in an 

occupational setting. Or something like 

that. It gives us a way to deal with those 

kinds of chemicals.

(Pause.)

MS. WISE: Can everybody hear me?

DR. SCHULTE: Once you turn it on 

it takes a couple seconds before it 

activates, it seems.

MS. WISE: Okay, so hopefully --

there we go. Kimberly Wise, with the 

American Chemistry Council. You mentioned 
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that there will be a peer review of the 

document. Is that going to be an open forum 

meeting? Or is it going to be like a letter 

peer review? I just want to know about how 

that peer review process will go and how the 

comments will be taken into consideration in 

that peer review.

DR. SCHULTE: The peer review is 

done by about six or eight peer reviewers 

who will review the document independently 

and provide a written report. There will be 

no attempt to achieve a consensus from the 

peer reviewers. Kathleen, did I say that 

correctly?

DR. MacMAHON: That is correct. 

What I would add to that is that the peer 

reviews will be made publically available on 

the NIOSH website, and we also will document 

our responses to the peer review comments.

DR. SCHULTE: And that will all 

be in the public docket. 

MR. ELLIS: Thank you, hello. 
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Okay, Mark Ellis with the Industrial 

Minerals Association-North America. I 

noticed that your model looks at a linear 

relationship in terms of carcinogenesis. 

Can you tell me why you discounted the 

operation of any threshold that may operate?

DR. SOFGE: Well, in practice, 

when you're doing risk modeling, thresholds 

are particularly difficult to locate using 

statistical models. So, part of it is a 

pragmatic point of view.

That being said, we have had 

situations where if we know enough about the 

mechanism of action, or mode of action, to 

be confident that there is a nonlinear 

response, we have taken that into 

consideration when we have sufficient data 

to support that.

So, even though, in general, we 

look at it from a linear point of view, 

that's in the situation where we don't have

sufficient data to rule out a linear 
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response.

MR. ELLIS: And that is spelled 

out in the policy?

DR. SOFGE: The policy's the 

general sort of thing. For individual 

chemicals, we always use the best data we 

have. I mean, and that is NIOSH's policy.

MR. ELLIS: To be specific about 

it, does the policy --

DR. SCHULTE: Use the microphone 

please.

MR. ELLIS: Does the policy 

recognize a specific exemption for potential 

operation of a threshold based on mechanism 

of action?

DR. SOFGE: Well, this policy 

isn't designed to really get into the 

specifics of how we do quantitative risk 

assessment and what data we're going into. 

But, in practice, like for titanium dioxide, 

for example, that's one chemical where we 

did have sufficient data that we thought 
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supported a sublinear dose response.

So, in practice, that's what we 

do. This policy doesn't go that far in to 

prescribe the specific risk assessment 

practices, like which model to use.

DR. SCHULTE: It does, however, 

specify that we will use the best data 

available. So if there are data that would 

allow modeling for a sublinear relationship, 

that would be included in that. And indeed, 

as Chris said, we did that in the risk 

assessment for titanium dioxide.

DR. McKERNAN: We're now going to 

switch over to any questions that are on the 

telephone line.

AUTOMATED PHONE MESSAGE: The 

conference is now in talk mode.

DR. McKERNAN: I remind those 

that are on teleconference to please state 

your name and also your affiliation.

MR. MIRER: Hi, this is Frank 

Mirer and I'm a peer reviewer. The sound is 
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really bad, you can't hear any of the 

audience comments, and it's kind of shaky 

half the time from the NIOSH participants. 

That's just a point of personal privilege. 

I don't have a technical question at this 

time.

DR. McKERNAN: Okay, thank you.

DR. SCHULTE: We'll try to speak 

up for the folks on the phone.

MS. JACOBS: This is Molly 

Jacobs from the University of Massachusetts

Lowell. And I have a question regarding the 

chemical classification piece of things, and 

wondering if NIOSH will include more agents, 

in quotation there, rather than just 

chemicals.

I'm thinking of ionizing 

radiation and/or radio frequencies, and 

potentially in the future issues around 

mixtures rather than single chemicals. Can 

you speak to whether those type of agents 

will be inclusive of NIOSH's review of 
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occupational carcinogens?

DR. SCHULTE: Yes. They will 

not. This is the NIOSH chemical carcinogen 

classification policy. Subsequently, once 

we get this done, then we are going to move 

to physical agents. So any physical agents, 

such as ionizing radiation, won't be 

addressed in this, but we expect to address 

them subsequently.

With regard to chemical mixtures, 

we don't specifically single out an approach 

for them in this policy, but we have a 

review of the literature on chemical 

mixtures which we hope to publish in the 

near future, where we don't think at this 

time we're ready to have a particular policy 

on it. We don't think the science is 

evolved enough.

But we are interested in 

following the science on mixtures and 

particularly on cumulative risk assessments. 

And we hope to at least review that 
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literature in the future.

DR. McKERNAN: Do we have any 

further questions on the phone line?

MR. HERRICK: Yes, this is Bob 

Herrick, Harvard School of Public Health. I 

just have one question. It's kind of a 

hypothetical, but let me just pose it to you 

anyway. How would NIOSH approach a compound 

that is turning up evidence in the 

scientific literature as being a carcinogen, 

but none of those three entities that you 

mentioned have acted on it yet? How would 

NIOSH proceed?

DR. SCHULTE: Thank you, yes. 

There is a point in the flow chart of Figure 

1, the third box down which says, is there 

other evidence of carcinogenicity? And if 

the three agencies have not classified the 

substance but there is other evidence of 

carcinogenicity, NIOSH has two options in 

that case.

We can nominate it to NTP to 
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classify it, or if there's a need to move 

with more dispatch, we can evaluate it 

ourselves using the Globally Harmonized 

System of labeling and classification 

criteria.

So, that's how we would deal with 

those. So, there would be a way to take 

something that has not been addressed by one 

of the three authoritative agencies.

MR. HERRICK: Thank you.

DR. McKERNAN: Is there another 

question from the phone line? Do we have 

any further questions in the room?

MR. MIRER: Yeah, actually, I do 

have another question. This is Frank Mirer.

DR. McKERNAN: Go ahead.

MR. MIRER: Is it NIOSH's 

intention to present an array of risk rate 

estimates for the chemical, and exposure 

levels associated with various risk rates?

DR. SCHULTE: Yes, in part. When 

we do the risk assessment we will 
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communicate an array of risks, from 1 in 100 

to 1 in a million. And so that will be part 

of the report-out of the risk assessment in 

the REL developing document. So, in that 

sense, we will identify what the risks are.

For the 1 in 1,000 risk, 

certainly we will show the concentration REL 

that relates to that. I don't know if we 

had planned on doing it for the other risks 

from 1 in 100 to 1 in a million.

We weren't going to report an 

exposure that corresponded, or were we? 

Okay, we are. Yes, I stand corrected. We 

are going to do that, Frank. We will array 

the risks from 1 in 100 to 1 in a million. 

And we will also report the corresponding 

exposure level that relates to those.

MR. MIRER: One other question. 

Is it NIOSH's intention to go back through 

the RELs and through existing chemicals and 

classify them according to this new system?

DR. SCHULTE: Yes, we have 
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already started on thinking about a 

retrospective application of this policy to 

the previously classified NIOSH substances. 

It's a little more complicated than one 

might think. And we can't really move 

ahead on it until we get the policy 

finalized. So, once this policy is 

finalized, yes, we do intend to try to apply 

it retrospectively.

DR. SOFGE: And I want to clarify 

that that's the chemical carcinogen piece, 

not developing new RELs for everything.

DR. SCHULTE: That's correct, 

just the classification.

DR. McKERNAN: We have another 

question in the room. We're going to do 

that now.

DR. SCHULTE: Yeah, that's a good 

idea.

MS. CASANO: Pat Casano, GE. 

Just to clarify, when you talk about you 

know , risk of 1 in 100, or 1 in 1,000, 
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you're really talking about excess cancer 

risk, correct? So, it's not as though --

you're not saying that you have a 1 in 100 

chance of developing cancer from this 

particular exposure? Is that correct?

DR. SCHULTE: Yeah, let me repeat 

the question. The question was, when we 

talk about risk levels, like 1 in 100, or 1 

in 1,000, we're really talking about excess 

risk levels. And indeed you're exactly 

correct. And that's the way it's specified 

in the policy.

DR. McKERNAN: Do we have any 

further questions on the -- oh, we have some 

more in the room. Okay.

MR. ERKKILA: Hello. Brian 

Erkkila from the FDA. I was wondering if 

you could comment on the AF designation and 

how you would approach it if there's a large 

difference between the health-based and the 

analytical, how big a difference is 

acceptable.
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DR. SCHULTE: Well, I think if 

the limitation on the analytic method was 

so great that the risks were much greater 

than 1 in 1,000, that that level -- or just 

greater than within the range of 1 in 1,000 

and 1 in 10,000 we would have to treat that 

on a case-by-case basis.

Clearly, we would say to have 

exposures at the level you can measure 

wouldn't be appropriate. And we'd probably 

put more emphasis on calling for substitutes 

or alternatives in that case, or engineering 

controls that were essentially leading to 

zero, or very low exposures. But that would 

have to be more on a case-by-case basis.

DR. McKERNAN: We would also put 

additional energy into trying to create an 

analytical method that would be able to 

measure to a lower level. And we have a 

very talented group of scientists at DART 

that have that analytical expertise.

MR. HELMES: This is Tucker 
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Helmes from SOCMA, Society of Chemical 

Manufacturers and Affiliates. What’s the 

dynamics between NIOSH and NTP, for example? 

Specifically what I mean, you know, NTP 

accepts nominations for its annual report on 

carcinogens. Does NIOSH make nominations to 

NTP for that because of a concern about an 

occupational exposure? Or does NIOSH wait 

and see what the NTP publishes in its report 

on carcinogens, and then evaluate whether 

there is an occupational relevance?

DR. SCHULTE: For those on the 

phone, the question dealt with the 

relationship between NIOSH and NTP. 

NIOSH is a founding member of the 

National Toxicology Program and continues to 

have a seat on the board that governs it. 

NIOSH also has the capability of making 

nominations to NTP and in some cases we do 

that. And NIOSH also utilizes the 

information in the report on carcinogens 

after that's put out. So all of those are
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possibilities. But we are a member of the 

NTP and participate in deliberations of it.

MR. ELLIS: Mark Ellis with the 

Industrial Minerals Association again. When 

you talked about analytic feasibility, are 

we talking about the limits of detection, or 

are talking about limits of quantification? 

And are there confidence intervals on either 

side of that?

DR. McKERNAN: I'll take that 

one. So, when we develop a REL, we'll 

typically use a validated NIOSH method or a 

validated OSHA method. If it's a NIOSH 

method, we're going to be using LOQ, limit 

of quantification. But our colleagues at 

OSHA don't use LOQ, they actually use an 

RQL, a reliable quantification level. So, 

depending on the analytical method that we 

use, we use those two terms.

(Pause.)

MR. SIVIN: Darius Sivin of UAW 

again. Could you tell us what criteria 
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NIOSH will use to determine whether a data 

set is adequate to justify a deviation from 

a linear model, and whether, at least in the 

case of each individual agent, those 

decisions will be subject to public comment?

DR. SCHULTE: Chris, would you 

handle this? Let me just repeat for the 

phone people. The question was: what 

criteria will NIOSH use to deviate from the 

assumption of a linear model at low doses to 

make its analysis?

DR. SOFGE: Yeah, that will be 

done on a case-by-case basis. And all of 

our documents always involve opportunity for 

public comment and peer review. So there 

would definitely be opportunities for input 

on those decisions.

Now, as far as we don't have a 

set of criteria, it really depends on what 

the mode of action is, how much confidence 

we have in that mode of action.

DR. SCHULTE: But, clearly, as we 
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did in the titanium dioxide report, upon 

using the data to model a sublinear 

relationship, we subjected that whole 

analysis to a sensitivity analysis. And 

that was put in the report and made 

available for public comment.

DR. McKERNAN: Do we have any 

further questions in the room? If not, I'm 

going to switch back to our colleagues that 

are on the telephone and ask them if they 

have any further questions?

(No response.)

Okay. Then we'll go ahead and 

shift gears. For our colleagues on the 

telephone I wanted to apologize that your 

audio experience is not everything that we 

hoped it would be. I am comforted by the 

fact that we are taking a whole transcript 

of what's going on in the room. And that 

transcript will be posted on the NIOSH 

Docket within 30 days.

Additionally, I wanted to remind 
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you that the presentations made today will 

also be posted on the NIOSH Docket Website. 

So I apologize that your experience is not 

100 percent. But I hope that those two 

additional items will make today, at least 

post-today, more meaningful.

Okay, so we're going to shift 

gears now and we're going to have some of 

our stakeholders make some comments. Again, 

these were people that signed up in advance. 

If there is anyone else that would like to 

make formal comments today, please let us 

know. We did put all the stakeholder names 

into a hat and randomly selected them.

And our first speaker today is 

going to be Darius Sivin from the 

International Union UAW. I'd like to invite 

him up to the podium, please.

(Pause.)

MR. SIVIN: Good morning. Thank 

you for the opportunity to comment on 

NIOSH's draft carcinogen policy. The 
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International Union UAW did submit comments 

at the 2011 public meeting. And I recently 

had an occasion to revisit them in the 

Docket online. And I noticed that a crucial 

page was missing.

And that was the page where we 

specifically stated our opposition to the 

use of the 1 in 1,000 risk level. Now, I 

assume that this was an accident. It 

appears, looking at what's online, that our 

document was printed off email and then re

scanned and uploaded, and in the process of 

re-scanning, a page was missing.

But since we did submit those 

comments on time, I will be a happy to 

resubmit them so that NIOSH can correct the 

Docket.

DR. McKERNAN: We'd be happy to 

correct the Docket, and we apologize if an 

error was made. Those have been on the 

Docket from 30 days since the last public 

meeting, but we would be happy to correct 
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that for you.

MR. SIVIN: Thank you. I would 

like to commend NIOSH, first, for bringing 

its carcinogen policy in line with IARC, 

EPA, and NTP, and GHS. And, secondly, for 

having adopted a policy of strongly 

advocating safer alternatives.

On that second point, I would 

like to recommend that each criteria 

document for a carcinogen indicate that the 

REL is only properly used after safer 

alternatives have been sought. And that it 

would be an improper use of the REL to not 

start at the top of the hierarchy of 

controls and go directly to engineering 

controls or administrative controls rather 

than looking for safer alternatives first.

I do have grave concerns about 

the use of the 1 in 1,000 risk level. First 

of all, I would like to disagree slightly 

with Dr. Schulte about his interpretation of 

the benzene case.
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In the first place, that number 

appeared in a non-binding footnote to what 

was in fact a plurality and not a majority 

decision. And the 1 in 1,000 number comes 

from the Solicitor of Labor’s interpretation 

of that non-binding footnote.

And so I think it should hardly 

form the basis of a policy of recommended 

exposure limits from a scientific 

organization in the U.S. Public Health 

Service. In fact, I think it would be 

outrageous for any entity in the U.S. Public 

Health Service to issue a recommendation 

which, if followed, would result in a 

thousand fatal cancer cases per million 

workers exposed.

If there are legal or 

administrative reasons for which NIOSH needs 

to provide the information, for example for 

OSHA's use, since OSHA is subject to the 

Solicitor of Labor, NIOSH should provide 

that information in that array of risks that 
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you talked about, but not describe that as 

the recommended exposure limit.

Scientifically, I think it's not 

necessary to have a particular target risk 

level at all. In part because of the great 

uncertainty in determining what level of 

exposure is associated with a particular 

risk, as described in the Silver Book, 

called Science and Decisions: Advancing Risk 

Assessment.

I would commend the use of 

sensitivity analysis as in the titanium 

dioxide documents. And I would suggest 

that, in all RELs, when saying that such and 

such dose is associated with such and such a 

risk, that NIOSH publish not only the array 

of recommendations, and not only indicate 

that it's a lower confidence interval, but 

also always publish an analysis of the 

sensitivity of the models to assumptions and 

indicate under different assumptions what 

those risk levels would be.
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In particular, for example, if 

NIOSH were to go to a sublinear model for 

any particular REL, I would strongly 

recommend that you indicate in the criteria 

documents what the exposure level would be 

if you used the linear model. And clearly 

describe the assumptions of the data set 

that justified not doing so.

So, I also think that it is very 

important that NIOSH indicate in its policy 

and its criteria documents that people have 

the same right to protection at work that 

they do in other activities. That there is 

no principal justification for setting 

exposure limits for workers that provide 

less protection than the 1 in a million 

lifetime risk in the general population. 

So, that I can imagine justifying a 

particular REL on the grounds that the 

robustness of the data set doesn't permit 

going down that low.

I certainly think, as I said, 
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that for all carcinogens, NIOSH should 

indicate very strongly that the REL is not 

properly followed, and, as I say, in each 

criteria document and I think in the NIOSH 

Pocket Guide, that you're not properly 

following the REL if you haven't looked for 

safer alternatives first.

Yeah, those are -- oh, I would 

also like to add a comment on analytical 

feasibility, which is my concern is that 

obviously criteria documents can become 

outdated either due to advances in the 

science telling us what the risk is, or the 

analytical feasibility.

But I think they'll become 

outdated faster if we have analytic 

feasibility RELs and not just health-based 

RELs, because if we set it at a health basis 

and then analytical feasibility improves, 

then we can have -- that same REL will still 

be applicable and now we can measure to it.

Whereas if we set it at 
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analytical feasibility and there's an 

advance in analytical feasibility, the REL 

will become outdated much faster and also it 

will be less protective. 

And so thank you very much for 

the opportunity to comment on the policy. I 

appreciate it.

DR. McKERNAN: I'm actually going 

to allow the panel to see if they've any 

clarification questions that you'd like to 

ask? We don't. Thank you. 

Going to move on to our next 

speaker, who is Anna Mazzucco from the 

National Cancer Center for Women and 

Families.

DR. MAZZUCCO: Hi, thank you very 

much for allowing me the opportunity to 

speak today. My name is Dr. Anna Mazzucco 

and I represent the National Research Center 

for Women and Families and our Cancer 

Prevention and Treatment Funds. 

After completing my Ph.D. in cell 
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and developmental biology, I also conducted 

research at the National Cancer Institute 

and I bring those perspectives today. I 

speak as a cancer biologist who's concerned 

that these regulations still lag behind the 

state of the science and fall short of their 

goal of protecting Americans from cancer as 

they work.

In 2013 alone, more than half a 

million Americans will die from cancer. And 

a 2003 joint report from the NCI and the 

National Institute for Environmental Health 

Sciences stated that exposure to a wide 

variety of natural and man-made substances 

in the environment accounts for at least 

two-thirds of all the cases of cancer in the 

United States.

Yet after reviewing the current 

state of regulatory policy and research, the 

President’s Cancer Panel reported in 2010 

that environmental health, including cancer 

risk, has been largely excluded from overall 
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national policy on protecting and improving 

the health of Americans.

When decades-known carcinogens 

such as asbestos and radon are still present 

at either unsafe or unknown levels in 

American workplaces, how can the public have 

confidence that our regulations can handle 

new and complex occupational hazards arising 

every day?

The National Institutes of Health 

also estimated the total cost of cancer in 

2008 at $201.5 billion in both direct health 

care costs and the indirect cost of lost 

productivity due to premature deaths.

Another recent study estimated 

that cancer is responsible for 20 percent of 

all healthcare spending in the U.S., and 

that disability days cost $7.5 billion in 

lost productivity each year. And these 

numbers cannot attempt to capture the human 

value of lives lost.

Although we appreciate the 
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adoption of a classification system by 

NIOSH, we are concerned that this report 

still represents a more reactive rather than 

proactive approach to regulation. It 

maintains a historical risk threshold which 

may no longer be appropriate. And it still 

places burdens on workers rather than on the 

industry.

We have five areas of concern 

that we want to emphasize. And I'll just 

briefly state them and just give a few 

details.

Number one. Safe exposure limits 

must be based on actual, not theoretical, 

workplace exposures. Real-life workplace 

chemical use involves multiple agents and 

complex exposures. This report does not 

give any concrete statements on how to 

address the true chemical milieu to which 

workers are exposed, and there is no 

scientific reason to limit our safety 

analyses to single agents.
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If the goal is to prevent 

chemical hazard exposure in the workplace, 

then we must start with the workplace, not a 

theoretical framework which likely applies 

to very few real life situations.

And I know that this issue 

already came up on questions on the phone, 

and so we look forward to the work from 

NIOSH on addressing more complex chemical 

situations.

Acceptable occupational risk 

assessments should be based on up-to-date, 

circumspect and truly representative 

information. As we discussed also already, 

NIOSH uses a lifetime excess cancer risk of 

1 in 1,000 as the minimal acceptable 

regulatory threshold, while stating that 

controlling exposure to lower concentrations 

is always warranted. We appreciate that, 

especially the statement that an excess risk 

of 1 in 1,000 is one or more orders of 

magnitude higher than what the United States 
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permits for the general public.

And this is justified in this 

report by two arguments which we already 

heard a little bit of this morning. The 

first being the historic benzene decision, 

which we also think was used more in a 

rhetorical example. But the second also 

being that this justification has been used 

historically because workers represent a 

very small subset of the population, and 

higher exposures for small numbers of people 

may be considered acceptable if they are 

comparable to the overall risks of that 

employment itself.

But we think, in this particular 

case, actually even at that time and 

certainly now, many occupations have lower 

than 1 in 1,000 risk. And so we think that 

that should also be recognized.

There is also increasing evidence 

that occupational carcinogens spread into 

the greater environment. For example, TCE, 
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an industrial solvent, is now present in as 

much as one-third of the U.S. water supply. 

And so we think that distinguishing between 

occupational versus overall environmental 

exposures is very difficult. Especially 

given that the EPA 1 in a million target 

threshold is what they prefer for the 

largest number of people possible, and 

that's a 1,000 times lower than the NIOSH 

threshold.

And the bottom line is that there 

is no scientific basis for these

differential safety standards, and we now 

know that occupational and environmental 

exposures can become difficult to 

distinguish. And for that reason, it would 

be better for the workplace, and the general 

public, more comparable protections.

And I'm just going to stop here 

because I'm worried I'm going to go over 

time. But we also just wanted to mention 

that a safe exposure level based on 
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technical feasibility rather than safety 

does place workers at risk. NIOSH plans to 

use the recommended exposure limit to the 

highest detectable dose, the reliable 

quantitation limit, as we heard this 

morning.

But this would directly place 

workers in potentially unsafe conditions, 

and they would also be powerless either to 

detect or remove the agent to guarantee safe

levels.

If we really want to guarantee 

absolute safety to workers in that 

situation, the better thing to do would 

actually be ban these chemicals until a more 

safe and sensitive detection method is 

developed. And such a policy really would 

protect workers while also creating an 

incentive for industry to develop more 

sensitive diagnostic capabilities or find 

safer alternatives.

And, lastly, I just wanted to say 
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that sensitive subpopulations need to be 

addressed in more detail. For example, we 

know that birth defects, childhood cancer, 

and adult cancers can all caused by in utero 

exposures. And this report doesn't provide 

any really specific details on how sensitive 

subpopulations would actually be protected.

And just as the NIOSH risk 

threshold, you know, is intended to protect 

all workers, we really need to make sure 

that everybody is included in that.

So just to end, we urge you to 

consider these changes and use every 

resource at your disposal to ensure that our 

national policies regarding occupational 

carcinogens meet their goal of protecting 

Americans at work. This will ensure a 

healthy society, a thriving economy, and 

also safeguard our environment for the 

future. Thank you.

DR. McKERNAN: Does our panel 

have any questions? I have a question for 
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you. I just want to clarify. So are you 

recommending that NIOSH not consider 

analytical feasibility when establishing a 

REL for a carcinogen?

DR. MAZZUCCO: I mean, I 

understand, you know, the practical 

limitations, and I think, you know, I think 

it gets to the question that was asked 

earlier about kind of if the difference 

between the analytically feasible limit and 

the REL, you know, how much of a difference 

would be acceptable between those two 

numbers, would be kind of the really salient 

point just to make sure that in those 

situations the risk isn't, you know, in 

greater excess of the 1 in 1,000 threshold.

DR. McKERNAN: Thank you. Okay, 

we're going to rotate to our next speaker, 

who is James Melius from the New York State 

Laborers’ Health and Safety Trust Fund.

(Pause.)

DR. MELIUS: Okay. Good morning 
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everybody. And, again, first of all, thank 

NIOSH for holding this meeting and giving us 

the chance to come back and talk to you 

again. I actually did read the transcript 

from the last time, which was two years ago. 

I do admit, I read it on Friday, so, I 

haven't checked my comments but that -- a 

couple things.

One, first of all, I think, first 

of all I'd like to thank you for some 

significant improvements in what was 

discussed, at least, two years ago in this 

document. I think the new, more detailed, 

more layered classification system is good. 

And I think the approach to sort of 

compatibility or conversion with NTP, EPA, 

and IARC are good.

I mean, the science is advanced 

enough now that certainly these kinds of, 

you know, multi-level classification 

policies make much better use of the 

scientific data and certainly are much more 
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-- better in terms of communicating what is 

known about a carcinogen or a potential 

carcinogen without going into, you know, a 

complete 500 page criteria document or 

whatever.

So I think that is useful and I 

think also the approach to conversion to the 

GHS is also very reasonable.

One area I'd like to point out, 

and again I don't think it's a change to 

this document, but I think it is an area 

that may require at least some more mention 

in the document is it's very clear that 

we're relying, or are going to have to rely 

more and more, on mechanistic data in terms 

of classifying chemicals as carcinogens or 

potential carcinogens, whatever.

Our understanding of the 

development of cancer, its progression, is 

greatly increased. I think we're recognizing 

more mechanisms, and I think we're also 

doing fewer epidemiological studies, having 
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more difficulty getting those done for many 

materials that are used in the work place.

And similarly animal bioassay and 

the other kinds of information we used to 

rely on heavily in these classification 

systems are much less available than they 

used to be. Therefore, we're looking for 

substitutes for that. It's a complicated 

evolving area and I think that needs to at 

least be acknowledged in this. And I know 

you are well aware of it and well-versed in 

it, but I think in terms of developing some 

consistency and development of proper 

classification systems, this needs to be 

brought into the system. Much as you're 

doing in terms of background documents on 

risk assessment and so forth.

It's obviously, I think, much too 

detailed to be part of this document. I'm 

not sure that anybody really has come up 

with a good global approach to this, but 

since it tends to be very substance 
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specific, or at least within classes of 

materials, but I think it is important. I 

think it's worth mentioning in more detail 

in this document. 

I'd also have a number of other 

sort of recommendations I'll put in writing 

at this time. I think, Paul, I'd like to 

thank you and your staff. Your presentation 

today actually clarified a number of areas 

that I think warrant a little bit more 

emphasis in the document itself. They sort 

of get lost in the detail, and I think it 

would be very helpful to do that.

The one area I remain very 

disturbed about is the target risk 

assessment level. I think that is not, and 

should not, be NIOSH policy, the 1 in 1,000 

excess risk. It is not what, I don't think, 

Congress intended when it set up the agency.

And as I can quote from Page 31 

in your own document, was requesting NIOSH 

develop exposure levels at which no employee 
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will suffer impaired health, or functional 

capacities, or diminished life expectancy as 

a result of his work experience.

And I think 1 in 1,000 clearly 

violates that. And I think something -- I 

don't think that NIOSH should be bound by a 

feasibility determination that's been made 

by OSHA as part of a regulatory process 

involving economic and other feasibility 

determinations as part of setting a level. 

So I think that has to go.

I guess we're all -- I think your 

overall policy of sort of no safe level, or 

very reduced as much as is feasible, or as 

possible, is much better. I do think that 

it needs to be implemented in some way for 

the greater occupational health community in 

terms of a recommended, an REL, recommended 

exposure level, and do that.

I don't think that 1 in 1,000 is 

adequate. I think a lower level is much 

more appropriate for that and it would drive 
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exposures down and provide a much more 

healthful workplace for workers. And better 

guidance for people that are overseeing 

these workplaces.

I also would agree with Darius's 

comment. I don't think analytic feasibility 

should be directly tied to the REL. I think 

if you're going to -- it's fine to make the 

determination, as Darius mentioned, those 

analytic feasibility tends to change over 

time. And even change from workplace to 

workplace depending on background 

contamination, the nature of the work 

process.

So I think having a dual 

notation, one being a recommended health 

based exposure limit, is intended by the 

Occupational Safety and Health Act for NIOSH 

to recommend.

And, secondly, to list with that 

a feasibility limit based on the analytic 

feasibility, based on the current methods 
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that would change. That would provide 

guidance for people, not only as to what 

would be feasible in terms of measuring in 

the workplace for industrial hygiene 

purposes, but also would tell people sort of 

how much residual risk there may be based on 

what is feasible to analyze at this point in 

time.

But I think that whole section 

needs to be really rethought and revamped 

before this policy goes forward. I 

understand your concerns, however I don't 

think that the precedent that's been made in 

terms of recommendations to OSHA and so 

forth, I think, are in a different context.

And I think that the 1 in 1,000 

is not an appropriate targeted risk level 

for NIOSH to be making. So, I thank you for 

your time.

DR. McKERNAN: Can we please have 

any questions from the panel?

DR. SCHULTE: Yes, thank you, 
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Jim, that was very helpful. I wanted to 

probe a little bit on the idea of the 

analytic feasibility. If you can't measure 

it, you really don't know what you have. 

So, it doesn't matter if we say some other 

level; if you can't measure that level you 

don't really know what's going on in the 

workplace. So, it's not really clear what's 

happening there.

DR. MELIUS: Yes, but often 

analytic feasibility is based on what can be 

routinely measured. And there may very well 

be techniques that are non-routine and maybe 

not practical for everyday use, but allow 

measurements within the work place and do 

that.

And a great example is asbestos, 

where phase contrast microscopy allowed one 

level of measurement, and electron 

microscopy could go to a much lower level. 

Now, all this may be substance specific.

But I think that having sort of 
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the dual designations, first of all, one for 

an REL, second for what currently can be 

measured based on an analytic feasibility, 

routine analytic feasibility, I think would 

convey the same information, but recognizing 

there may be some level of residual risk 

that will not be able to be routinely 

measured in the work place.

I don't think it's an easy answer 

to it, but I think that's the best 

compromise.

DR. SCHULTE: Well, thank you, we 

appreciate your comments.

DR. SOFGE: I have a question 

about --

DR. McKERNAN: Is your mic on?

DR. SOFGE: Is that better? I 

have a question about you don't like 1 in 

1,000 risk. So, do you have a 

recommendation for where you think we should 

go with what would be an acceptable risk 

level in your mind?
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DR. MELIUS: Well, I think for a 

number, either 1 in a million, or 1 in 

100,000. One in a million is preferable, but 

ties in more with other government policy 

and so forth.

DR. SOFGE: Thank you.

DR. McKERNAN: Thank you. We're 

now going to shift to our next presenter, 

who is Lee Anderson from the BlueGreen 

Alliance.

MR. ANDERSON: Thank you very 

much. I think I might be too tall for your 

microphone but I'll give it a try. Thank 

you, good morning. I'm vertically 

challenged in a different way, but thank you 

and good morning. I appreciate the 

opportunity to give comments here today.

Dr. Schulte, first of all, I 

wanted to say a couple things about a couple 

comments that you made that I thought were 

very positive this morning. You said that, 

whatever standard you're going to use, that 
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it will be NIOSH's aim to keep the risk 

lower than the stated standard, which is to 

the good.

And that you would promote 

alternatives, safer alternatives, also to 

the good. It's actually something that our 

organization, the BlueGreen Alliance, has 

spoken on at great length. And we have an 

entire report on this on our website.

The whole point being that the 

research and development needed to create 

safer alternatives is also a job creator. 

And I wouldn't be doing my job as a member 

of the BlueGreen Alliance if I didn't bring 

up jobs. So those are very positive comments 

and I appreciate them.

And I also was struck by your 

comment that the information that you'll be 

providing will set out the entire spectrum 

of risk, from 1 in 100 to 1 in a million. 

So you won't just be providing a single data 

point, 1 in 1,000.
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That's great, that makes a lot of 

sense and gives a lot of data on which to 

base implementation decisions. So, also to 

the positive.

But I wanted to talk about that 

risk level, the 1 in 1,000 risk level that 

we've heard other folks talk about this 

morning, because it is a primary point of 

concern for my organization as well.

It is a little intimidating to be 

in the room with so many people who have 

doctor in front of their names. I'm just a 

simple country lawyer. But for that reason, 

you know, I wanted to talk about the old 

benzene case that all this is based off of.

It struck me on the Metro as I 

was riding in today that more than two 

decades have passed since I first read that 

case as a first year tort student, which I 

find humbling.

And I think I had memorized the 

phrase, significant risk, at the time. 
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Wrote it in a blue book and promptly forgot 

it. But then this came up in my career 

professionally, representing trade unions 

and workers, and working on toxic tort cases 

to see the real world affect that the lack 

of appropriate chemical regulations can have 

on people. In my particular case, the 

context was asbestos and silica.

And now here I am again 20 years 

later trying to find out what do we mean 

when we say, “significant risk?” 

Significant how? Who decides what's 

significant to whom?

Well, since we are basing all 

this on this on the old decision, I thought, 

well, what did Justice Stevens, who wrote 

the opinion, actually say about it? I don't 

want to put words in the man's mouth, so I 

just brought it here. And I thought I would 

just read it.

In the famous language that we 

all know, he says, "It is the Agency's 
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responsibility to determine, in the first 

instance, what it considers to be a 

significant risk."

It is NIOSH's job. You decide 

what is significant risk. It has, "an 

obligation to find that a significant risk 

is present before it can characterize a 

place of employment as unsafe." And, by the 

way, risking error should be done on the 

side of overprotection rather than 

underprotection.

Why is that important? Because 

who's deciding what is or is not 

significant? That's your job. Even went so 

far as to say expressly, we, the Supreme 

Court, are not making that decision today. 

Again, I'll just read the language because 

Justice Stevens is a way smarter guy than I 

am.

He says, “Nor do we express any 

opinion on the more difficult question of 

what factual determinations would warrant a 
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conclusion that significant risks are 

present.” He expressly says they are not 

deciding that. They are not saying, the 

Supreme Court, they are not saying that 1 in 

1,000 is the tip-over point. That is not 

the cut point, which is a term I heard 

earlier this morning.

It's somewhere in that interval 

between 1 and a 1,000 and 1 in a billion. 

Where is that tip-over point, however? 

That's for you to decide. If you say it's 1 

in 10,000, 1 in 100,000, 1 in a million, 

then it's the court's job just to evaluate 

whether the method by which you came up with 

that number was appropriate.

Now, you can imagine the argument 

in the Supreme Court when one of the 

justices says, now, where did you get this 1 

in 1,000 standard? And the lawyer replies, 

well, we got it from you. What? That is 

not what the benzene case said. They did 

not say we are giving you a standard to 
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follow.

It even came up, I noticed it, it 

was even in the concurring opinion written 

by Justice Burger. He says the Secretary's 

factual finding of risk must be quantified 

sufficiently to enable the Secretary to 

characterize it as significant in an 

understandable way. Precisely what this 

means is difficult to say.

I should say it is. Twenty years 

later we're still not entirely clear what 

significant risk means. So I understand the 

balancing that has to be done here because 

you have an obligation to OSHA, and I 

understand that OSHA has adopted that. But 

that presumes on the front end that OSHA's 

decision was correct.

The discussion and battle over 

whether OSHA should be using that standard 

is for another day and another forum. Our 

question here is, should NIOSH be 

legitimizing and enshrining that decision? 
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That, what I would call, a bad decision, 1 

in 1,000.

Now that's why I appreciate your 

comments, Dr. Schulte, when you say, we will 

push for greater protection. We will push 

for alternatives. That's great.

But in the real world we all know 

there will be people who say, I've met the 1 

in 1,000 standard, now leave me alone. 

Maybe you have some way for doing 1 in 

10,000, but I'm not going to do it. I don't 

have to, because that's not what it says.

They're interested in what does 

it say in the regulation. Doing otherwise I 

think it’s simply advocating the Agency's 

responsibility over to the Supreme Court, 

which is not what is supposed to happen.

Two, and I'll finish this point 

with an abswer to relate to the question 

that was asked, what should the number be? 

And it ties into some of these basic issues 

of fairness that we've heard other 
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commenters talk about

If we're going to say, in this 

context it's 1 in a million, over here it's 

1 in 100,000, over here it's 1 in 10,000, at 

a bare minimum it needs to be lined up with 

these other policy decisions.

One in a million, what's wrong 

with 1 in a million? I don't know if 1 in a 

million is perfect. But that is at least 

the sort of policy considerations upon which 

this decision is to be made. That's the 

phrase that Justice Stevens used.

He said deciding that number is 

supposed to be a policy consideration. And 

the agencies are where the policy comes 

from. So if you say, look, EPA has set it 

at a 1 in million standard in these contexts 

for all these number of years, why is that 

not perfectly valid? Why is that not, in 

fact, more valid than relying on the Supreme 

Court Justices, who do not set policy? So 

there's that.
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It was also -- I -- one final 

comment on that, I noticed that in your 

actual document you say, "Keeping risk 

within 1 and 1,000 is the minimum level of 

protection. Controlling exposure to lower 

concentrations is warranted because of 

excess risk of 1 in 1,000 is one or more 

orders of magnitude higher than what the 

U.S. permits for the general public."

But what is not stated, there's 

not another sentence that says why this 

different level of risk should be acceptable 

in the workplace, when it is not acceptable 

for soccer moms shopping at Target. I take 

the point, but I don't know the why. Why is 

it different?

It cannot be that we're saying a 

condition of your employment is that you 

accept a 1,000 times greater risk of cancer 

because you took this job. That cannot be.

It's just, you know, representing 

trade unions, as I did for a long time, and 
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working with folks on the shop floor, what 

invariably got them wound up and wanting to 

file a grievance or do an organizing 

campaign, was a basic sense of unfairness. 

I am being treated differently than that 

person over there. It's just human nature.

And when you say 1 in a million 

over here, and 1 in 1,000 over here, it's 

glaringly unfair. I know why it's

happening, I know why it's being proposed. 

I'm not characterizing, but there is an 

appearance there, a perception that can be, 

that can grow up in workers’ minds to say, 

look, you're valuing my life less than you 

are valuing those lives over there by 

forcing me to accept this greater risk.

And then the last thing I wanted 

to touch on was this question of analytic 

feasibility. Again, I'm not an engineer, 

I'm not a scientist, I don't want to talk 

about it from that aspect. But I do want to 

point out some unfortunate legal history 
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that played out in regard to asbestos and 

the old TSCA regime.

An over reliance on this cost 

benefit analysis way of thinking is what 

broke National Chemical regulation. It's 

why TSCA does not regulate asbestos. 

Asbestos is unregulated because of an over

reliance on cost benefit.

Am I saying there should be zero 

cost benefit analysis? No. I recognize 

it's a balancing act. But you have to be 

very careful about that. And you can see it 

even now in the proposed fix to TSCA that's 

circulating up on the Hill right now.

It contains what I think is the 

same type of cost benefit language that is 

going to be a trap door down the road, if 

that actually should become law.

You know, there's other folks 

here who can talk about the science and the 

engineering controls much more articulately 

than I. I'm just pointing out as a matter 
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of the unfortunate legal history, what can 

happen when you place too much reliance on 

cost benefit analysis to say, look, be very 

careful with that or you'll end up not being 

able to regulate it at all.

With that, I think I will close. 

I'll be happy to answer any questions you 

may have.

DR. McKERNAN: Do we have any 

questions from the panel? No. Thank you. 

Okay, our last scheduled presenter is Howard 

Marks from the National Asphalt Pavement 

Association.

MR. MARKS: I’m going to decline 

at this time.

DR. McKERNAN: You're going to 

decline at this time? Okay. Okay, great. 

Is there anyone else in the room that would 

like to make public comments at this time? 

(No response.)

Okay, Paul, do you want to make 

any additional comments at this time?
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DR. SCHULTE: We're very grateful 

for all the comments. Certainly they were 

thoughtful comments and we will take them 

under consideration, sincere consideration. 

And hopefully they will be able to improve 

the policy and we look forward to any 

written submissions that you might want to 

make. And also those of the peer reviewers.

DR. McKERNAN: We wanted to give 

one more opportunity for the folks on the 

phone to make any comments if they wanted 

to.

AUTOMATED PHONE MESSAGE: The 

conference is now in talk mode.

DR. McKERNAN: Okay, go ahead, 

sir.

MR. LOOMIS: So, I am Dana Loomis 

from the International Agency for Research 

on Cancer in Lyon, France. And --

DR. SCHULTE: Dana, try speaking 

up.

MR. LOOMIS: -- information as 
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part of the process that they've described. 

I would just briefly like to comment on the 

proposed policy. I appreciate a chance to 

do this. In general, I think the proposed 

policy is very reasonable and consistent 

with current scientific understanding.

And given the large number of 

substances that are used in industry and 

commerce, it's very important, I think, to 

have a scientifically robust and efficient 

way of identifying carcinogens. And the 

proposed policy accomplishes this, in part 

by drawing on existing evaluations from this 

agency and U.S. EPA and NTP.

NIOSH has asked some specific 

technical questions that I wanted to comment 

on, and I'll submit written comments that go 

into more detail here, but one particular 

issue is that NIOSH has asked about the 

classification of IARC group 2B agents.

And what I want to point out is 

that the proposed process actually neglects 
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one group of IARC 2B agents, and those are 

ones that have inadequate evidence in 

animals, but limited evidence in humans. We 

assign those to group 2B.

It looks like NIOSH would not 

classify those to any GHS category. And I 

would suggest that these be approached the 

same as the other IARC 2B agents with less 

than sufficient evidence in humans, and 

assign these also to GHS Category 2.

The rationale for that is that 

even though the animal evidence is weaker 

than some other IARC 2B agents that would be 

assigned to Category 2, human evidence is 

stronger. And stronger human evidence 

should in essence compensate for the 

relatively weak animal evidence.

Again, I'll describe this in more 

detail in written comments which I'll submit 

later. But that would be one 

recommendation.

Just two other comments very 
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briefly. In the description of the 

evaluation process that we do for the IARC 

monographs, I think it would be useful to 

note that, like the EPA evaluations, these 

are also based on the weight of the 

evidence.

Now, we have some documents that 

talk about strength of evidence, but it's 

noted in those documents that that wording 

is employed for historical continuity.

We acknowledge that the 

preferences in terminology have evolved 

quite a bit over in the last few decades 

since we've been making these evaluations 

and that now people see -- or at least some 

people see a dichotomy between strength and 

weight.

So, I'd suggest adding those 

words, “strength of evidence,” to the 

description of the IARC monograph process.

And finally, although IARC does 

not conduct quantitative risk assessments or 
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make recommendations about exposure levels, 

we do support the notion that any such 

recommendations should be based on the 

science and not on other considerations. 

Well, that's all. Thank you very 

much for the opportunity to speak.

DR. McKERNAN: Thank you. Do we 

have any further questions from the panel 

for our speaker? No questions here. Thank 

you. Do we have any other speakers on the 

phone line that would like to make comments?

(No response.)

Anyone left in the room that 

would like an opportunity? 

(No response.)

Okay. Did you want to make any 

additional comments? I have some ending 

ones.

DR. SCHULTE: No, just again to 

say thank you to everyone for attending.

There was a comment?

MR. SIVIN: Yes, please.
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DR. McKERNAN: Please hold on and 

wait for the microphone, sir.

DR. SCHULTE: Okay.

MR. SIVIN: Does NIOSH intend to 

make use of IRIS risk assessments in any 

part of its recommended exposure limit 

process? Either for carcinogens or for non

carcinogens?

DR. SCHULTE: The question was: 

does NIOSH intend to make use of EPA's IRIS 

risk assessments in any part of its process? 

We have been looking at them. Chris, do you 

want to talk about that?

DR. SOFGE: Yeah, we've been 

looking into trying to do that sort of 

thing. It's not as easy as it seems like it 

should be, and that's one of the things we'd 

really like to get to that point where, you 

know, we shouldn't have three, four agencies 

looking at the same chemicals. And so, yes. 

That is -- we're working on that.

DR. SCHULTE: Okay, so, seeing no 
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other hands, once again thank you all for 

your input. Please send us your comments. 

We look forward to receiving them and we 

will be responding to them in the NIOSH 

Docket.

DR. McKERNAN: Okay, so just a 

few concluding comments. I want to express 

my gratitude for all of you attending, both 

on the telephone and in person.

I did get some emails that our 

sound quality did improve on the telephone 

in the latter part of the meeting, so I'm 

happy to hear that.

I want to encourage everyone to 

consider submitting comments. And remind 

everyone that there are two methods to 

submit written comments.

They can be submitted through the 

federal e-rulemaking portal, which is 

regulations.gov. And you need to follow the 

instructions on that Website. Be sure to 

reference the agency name and docket number, 
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which is CDC-2013-0023.

You can also mail your formal 

comments to the NIOSH Docket Office. And 

that address is the Robert A. Taft 

Laboratories, 4676 Columbia Parkway, Mail 

Stop C-35, Cincinnati, Ohio, 45226. All of 

these details are in the Federal Register 

notice and also at the NIOSH topic site 

which shows the cancer policy.

Unfortunately, we have an error 

on of the slides that was shown today with 

the correct Website. I wanted to give that 

address to everyone. And that is: www.cdc. 

gov/NIOSH/topics/cancer/policy.html. And we 

will be putting that up momentarily, so if 

you wanted to write that down, you could.

Given the input that we've 

received today, after you submit your 

comments, I would like to recommend that you 

actually go back and double check. There 

are humans involved in this process, so just 

double check that all the pages were 
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submitted and posted.

Thank you so much for your 

attendance today and have a wonderful day.

(Whereupon, the meeting in the 

above-entitled matter was concluded at 10:51 

a.m.)