NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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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 Divisio n FAYE RICE, Policy Response Coordinator PAUL SCHULTE, Director of the Education and Information Division CHRISTINE SOFGE, Risk Evaluation Branch ChiefNEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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Introduction and Description of Meeting Procedures

................................ . 4

Laura lynn 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

................................ ........... 77NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### Howard Marks, National Asphalt Pavement Asso ciation, declined.

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Public Opportunity to provide Comment Dana Loomis, International Agency for Research on Cancer, Lyon, France

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

Additional Questions/Answers of Clarification for the Speakers/Prese ntations

Audience/NIOSH Panelists 93

Concluding Comments

........................ 93

Lauralynn McKernan, Sc.D. Deputy Director, Education and Information Division, NIOSHNEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### P

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- S 2



### (9:07 a.m.) 3



### DR. McKERNAN: Good morning. 4



### Well, you know, it wouldn't be a public 5



### meeting without a few technical glitches 6



### first thing. So we've gotten all those out 7



### of our system and we should be good to go 8



### now. 9



### So, good morning, and welcome to 10



### this public meeting to present and discuss 11



### the draft document entitled, “Update o f the 12



### NIOSH Carcinogen Classification and Target 13



### Risk Level Policy for Chemical Hazards in 14



### the Workplace.” 15



### My name is Lauralynn Taylor 16



### McKernan, I'm the Deputy Director of the 17



### Education and Information Division at the 18



### National Institute for Occupational Safety 19



### and Health. I will be chairing today's 20



### meeting. 21



### You'll be hearing opening remarks 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### from Dr. John Howard, followed by a 1



### presentation by Dr. Paul Schulte, comments 2



### from a number of my NIOSH colleagues who 3



### were on the team that developed this 4



### document

. 5



### First, I have a number of matters 6



### of housekeeping. I've been informed this 7



### morning that this is a coffee

- free room. So 8



### if you have coffee, please be extremely 9



### careful with it. This is a water room. You 10



### can have as much water as you want. 11



### I'd also ask you to note where 12



### the exits are in this building. You can 13



### tell that you can either exit from the door 14



### from which we entered, or you can go out 15



### this exit door over here. We need to go 16



### through three double doors and then make a 17



### left to go onto Fourth Street. 18



### From Fourth Street, we're going 19



### to go under an underpass and we're going to 20



### go to the baseball diamond, and we are all 21



### to meet on third base. And in case you 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### wanted to see that, I have a map up on top 1



### of the screen. 2



### Restrooms are out the door and to 3



### the left from which you entered. If you 4



### have a cell phone, we ask that you mute it 5



### now. If you want to use your cell phone, 6



### I've been told that the only place that it 7



### works is on the corridor on the fourth 8



### floor. So if you go out this door and ma ke 9



### a left, you'll see nice benches and chairs 10



### for your cell phone use. 11



### Okay, we have individuals 12



### participating remotely via teleconference. 13



### We have muted their phone lines to prevent 14



### distractions from the presentations. We 15



### will unmute the telephone lin es periodically 16



### to allow those participants to ask 17



### questions. And during the first break we 18



### will take roll call of those that are on the 19



### phone. 20



### When NIOSH announced the 21



### availability of the document, it also 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### announced that stakeholder comments 1



### regarding the draft policy will be accepted 2



### until 5:00 p.m. Eastern Standard Time on 3



### February 13th, 2014. Written comments are 4



### requested to be submitted to the NIOSH 5



### docket as instructed in the Federal Register 6



### notice. 7



### Today's public forum will be 8



### recorded and tr anscribed. Transcriptions 9



### will be made available within 30 days, in 10



### the NIOSH Docket Office and on the NIOSH 11



### Docket Website . Consequently, all 12



### discussions, presentations, and comments as 13



### a part of this meeting are considered to be 14



### in the public domain an d will be documented 15



### as such. 16



### Therefore, if you have a 17



### question, you are asked to step to a 18



### microphone. We have a walking microphone up 19



### here. And please identify yourself and you r 20



### affiliation. If you are on the phone and 21



### are calling in and make any co mments, you 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### will also be asked to identify yourself and 1



### your affiliation. 2



### This public meeting satisfies our 3



### Office of Management and Budget peer review 4



### requirements for a highly influential 5



### scientific assessment document. But we also 6



### see this as an oppo rtunity to allow the 7



### authors of the document to present the 8



### salient technical points, but also to hear 9



### from our stakeholders and their 10



### perspectives. 11



### Our overall goal is to provide a 12



### document that is scientifically sound, has 13



### relevance and utility, and is developed 14



### according to a rigorous, consistent, and 15



### transparent process. 16



### Towards that end, I'd like to 17



### introduce the panel of my NIOSH colleagues 18



### who are also coauthors on this document: Dr. 19



### Paul Schulte, Director of the Education and 20



### Information Divisio n; Dr. Kathleen MacMahon, 21



### Associate Director of Science for EID; Dr. 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### T.J. Lentz, the Document Development Branch 1



### Chief; Ms. Faye Rice, the Policy Response 2



### Coordinator; and, shortly, Dr. Christine 3



### Whittaker Sofge, the Risk Evaluation Branch 4



### Chief, will be j oining us. 5



### According to the agenda, the 6



### first part of the morning will be dedicated 7



### to a technical presentation of the document 8



### followed by a question and answer session. 9



### Following the questions from our attendees 10



### in the room, we'll be asking those on t he 11



### phone if they have any questions. 12



### The second half of the morning 13



### will be an opportunity for stakeholders and 14



### members of the public, first who have signed 15



### up in advance, to give brief presentations 16



### and comments. You should know that 17



### stakeholder order was randomly assigned. 18



### Those presentations will, again, become part 19



### of the public record and be archived in the 20



### NIOSH docket. 21



### If time allows, there will be 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### other opportunities following those 1



### presentations for other members of the 2



### public and for those p resent to provide 3



### comment. The meeting will adjourn no later 4



### than 4:00 p.m. 5



### So, without further ado, I'd like 6



### to begin with our first speaker, Dr. John 7



### Howard, Director of the National Institute 8



### for Occupational Safety and Health. 9



### DR. HOWARD: Thank y ou, 10



### Lauralynn. And thanks to everybody who came 11



### today. We really appreciate it. And to 12



### everybody on the phone. I hope that I can 13



### be heard on the phone, and if not, let us 14



### know and we'll try to amp up the volume. 15



### This is a scientifically complex 16



### issue that we're facing. As you'll hear, 17



### NIOSH has been in the process of doing this 18



### sort of thing since 1975, actually, so it's 19



### nothing new. 20



### We welcome, in fact we need, all 21



### comments. We need everyone participating, 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### because science policies aren't done eve ry 1



### day and they last a long time and they 2



### affect a lot of people : workers, employers, 3



### and scientists also. 4



### So please enjoy the meeting. 5



### Thank you again for those who are listening 6



### on the phone and those of you who are here 7



### for coming, taking time from y our busy 8



### schedules to help us out. Thank you very 9



### much. 10



### DR. McKERNAN: Thank you, Dr. 11



### Howard. I'd now like to invite Dr. Paul 12



### Schulte to the podium. 13



### DR. SCHULTE: Thank you. 14



### Welcome, we're glad you're here. This is a 15



### process where NIOSH listens to the public 16



### and tries to get the best input it can to 17



### help finish out this document. 18



### It's the NIOSH Carcinogen Policy, 19



### or more specifically, the “ Update of NIOSH 20



### Carcinogen Classification and Target Risk 21



### Level Policy for Chemical Hazards in the 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### Workplace. ” And I will give you an overview 1



### of what is in the document. 2



### So, why are we doing an 3



### evaluation and an update of the cancer 4



### policy? Well, there have been new advances 5



### in risk modeling, biologic mode of action, 6



### and analytic methods over the last couple 7



### decades that have driven us to think through 8



### what should be in our cancer policy. 9



### Moreover, we've had some input 10



### from the public about some of the aspects of 11



### the current cancer policy, and I'll talk to 12



### you about them, that cause us to want to 13



### rethink th e policy. And we want to use this 14



### opportunity to receive peer and public 15



### input. 16



### And so there was an initial 17



### public meeting to get input, and then there 18



### is this comment process and period. So we 19



### look forward to that. And we hope by all 20



### these actions th at we've increased the 21



### transparency of the process and that the 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### occupational safety and health community 1



### will be more familiar with how NIOSH makes 2



### decisions about occupational carcinogens. 3



### We will present this policy in a 4



### document we call “The Current I ntelligence 5



### Bulletin.” There are three elements in the 6



### policy. There's the carcinogen 7



### classification; there's a target risk level 8



### for carcinogen recommended exposure limits, 9



### or RELs; and there's a section addressing 10



### analytic feasibility and engineering 11



### a chievability. 12



### Let me give you a little bit of 13



### the history of the carcinogen classification 14



### as it's been practiced at NIOSH. Since 15



### 1978, we used the term “potential 16



### occupational carcinogen” as the highest 17



### designation for a substance. 18



### And there was some 19



### dissatisfaction with that term because it 20



### included well

- known carcinogens, such as 21



### asbestos, benzene, and cadmium. And, hence, 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### they were labeled as if we didn't know for 1



### sure that they were carcinogens. And so 2



### that was one of the main drivers for why we 3



### wanted to reconsider the policy. 4



### And so we requested public input 5



### in 2011. We had a kick

- off meeting. And 6



### then today we have this public meeting on 7



### the draft document. And it's currently on 8



### the Web for peer and public comment. We 9



### look forward to any comments that you would 10



### like to submit. 11



### So, first, the classification 12



### aspect of the policy. Historically, NIOSH 13



### classified the candidate substance going 14



### through an evaluation of all the scientific 15



### literature. To avoid duplication, and for 16



### more efficie nt use of government resources, 17



### the new policy utilizes classifications from 18



### well

- respected, authoritative organizations. 19



### So, we'll be using the National 20



### Toxicology Program, the Environmental 21



### Protection Agency, and the International 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### Agency for Research o n Cancer’s 1



### classification of chemicals. 2



### The role that NIOSH will play, 3



### then, is to assess the occupational 4



### relevance of those classifications and the 5



### evidence on which they were built. 6



### And then, to assist employers to 7



### follow the OSHA Hazard Communicati on 8



### Standard, NIOSH will assign a Globally 9



### Harmonized category for hazard 10



### communication. And I'll get in to that a 11



### little later. 12



### Let me just elaborate a little 13



### bit on the part of determining the 14



### occupational relevance of a carcinogen 15



### classification. For the most part, 16



### occupational relevance will be somewhat 17



### obvious because NIOSH would not be assessing 18



### the material if it didn't pertain to 19



### workers. 20



### But we wanted to further assess 21



### the extent to which there was worker 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### exposure and the applicability of the 1



### evidence for occupational carcinogenicity. 2



### So is the mode of action appropriate for 3



### humans, if it was based on animal data? Are 4



### the routes of exposure appropriate for 5



### workers? And so those will be a major part 6



### in the process. 7



### And you can see that in t his 8



### slide. It's a little small here; you may be 9



### able to see it better on the monitors. 10



### And so let me walk through the 11



### slides a bit. The first box says, is 12



### occupational exposure to a chemical likely? 13



### If no, then we would go to a stop and have 14



### no furt her action regarding carcinogen 15



### classification. 16



### If yes, then we would ask the 17



### question, is the chemical classified by one 18



### of these agencies? And if the answer is no, 19



### then there are two options. We would end it 20



### in terms of carcinogen classification, but 21



### we might further assess it in terms of other 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### health effects. 1



### If yes, if there was other 2



### evidence of carcinogenicity but there was no 3



### classification, we would nominate it to NTP 4



### for classification. Or, in some cases, such 5



### as under specific time pressure s or 6



### otherwise, NIOSH would evaluate it itself 7



### using the Globally Harmonized System, GHS, 8



### criteria. 9



### Then going back to the left side, 10



### if indeed the chemical was classified by one 11



### of those agencies, NIOSH would evaluate the 12



### occupational relevance. And, i f yes, assign 13



### a GHS category, and report it as an 14



### occupational carcinogen. 15



### If no, NIOSH would report it as 16



### not anticipated to be an occupational 17



### carcinogen. We still would provide the 18



### underlying classification of the various 19



### agencies. 20



### And so we wanted to show you how 21



### the various classifications line up. And 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### this is the extent to which the 1



### classifications by the various agencies 2



### correspond with the Globally Harmonized 3



### System categories. 4



### Now, if you are familiar with the 5



### Hazard Communication Standard, it requires 6



### that employers, or manufacturers, actually 7



### classify a material. So NIOSH is just 8



### providing this as information to assist 9



### employers. 10



### So you can see for the most part, 11



### those materials known to be human 12



### carcinogens, or the highest category in each 13



### of the various classifications, crosswalk 14



### over to the GHS Category 1A. 15



### But then when you get to the NTP 16



### Reasonably Anticipated to be A Human 17



### Carcinogen, that straddles a couple 18



### categories: the GHS 1B and the Category 2. 19



### And the main driver there is in

-- I don't 20



### have a pointer that shows, but if you look 21



### under IARC Group 2B, the main driver there 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### is differentiation on the basis of the 1



### animal evidence. 2



### So under IARC 2B, the first box, 3



### if there is adequate animal evidence, that 4



### will then translate t o GHS Category 1. And 5



### if there is limited animal evidence, that 6



### will translate to GHS Category 2. 7



### While the GHS approach has 8



### different risk labeling, and that will need 9



### to be pursued by employers, NIOSH, for all 10



### intents and purposes, will treat all 11



### susp ected carcinogens, or known carcinogens, 12



### the same in terms of risk management 13



### procedures. So, if we're concerned about 14



### carcinogenicity, we will provide the same 15



### guidance across the board. 16



### So, this is how the system will 17



### report out. This is not the flow chart; 18



### this is the end product. And NIOSH will 19



### publish this in the Pocket Guide or other 20



### documents. 21



### So, this is an example for the 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### substance benzene. NIOSH would report it as 1



### a known, as a NIOSH occupational carcinogen, 2



### GHS Category 1A, known human carcinogen, 3



### based on NTP's Known to be Carcinogenic to 4



### Humans, EPA's Group A Human Carcinogen, and 5



### IARC's Group 1 Carcinogenic to Humans. 6



### So we believe that by doing this 7



### we will then provide NIOSH's summary 8



### recommendation based on all this 9



### information, the corresponding GHS category, 10



### and then all the nuanced information coming 11



### from the various authoritative organizations 12



### as shown there. 13



### Now here's another example. This 14



### is for heptachlor. Now, NTP doesn't have a 15



### classification for heptachlor. But the re 16



### are EPA and IARC classifications. So this 17



### would be reported out as a NIOSH 18



### occupational carcinogen, GHS carcinogen 19



### Category 1B Presumed Human Carcinogen, based 20



### on EPA's B2 Probable Human Carcinogen, 21



### Sufficient Data in Animals, and IARC's Group 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### 2B Possi bly Carcinogenic, Sufficient Data in 1



### Animals. 2



### So those are how we're going to 3



### report out the results of the process of 4



### classifying carcinogenic substances. 5



### Let's move on to the second 6



### element of the policy. And that involves 7



### risk levels and the conc ept of a target risk 8



### level. But this is by no means the center 9



### part of this policy. It's one tool to 10



### enable us to establish a REL. We need to 11



### have some cut point for establishing a REL. 12



### Prior to 1995, NIOSH did not have 13



### quantitative RELs and with carc inogens just 14



### said, “control it to the lowest feasible 15



### concentration.” This may seem like it's a 16



### highly protective bit of guidance, but 17



### indeed it was really left to be determined 18



### by employers. And employers had to evaluate 19



### the technical and economic optio ns. And, 20



### consequently, the exposures that could have 21



### occurred could be much higher than, say, 1 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### in 1,000. And so, indeed, the risk could 1



### be much higher than, say, 1 in 1,000. So, 2



### indeed, lowest feasible concentration had 3



### some limitations. 4



### So, in 1995 , NIOSH adopted a 5



### quantitative basis for RELs. And this is 6



### based on quantitative evaluation of risk 7



### using mathematical models to evaluate 8



### exposure response relationships. For the 9



### most part it involved animal data, though we 10



### prefer epidemiologic data, hum an data. But 11



### for the most part we have animal data. And 12



### that involves using mathematical models to 13



### extrapolate from animals to humans, and from 14



### high doses to low doses. 15



### And in this policy, in 1995, it 16



### was acknowledged that there would be risks, 17



### residua l risks, at a REL. So that the REL 18



### did leave a certain residual risk and the 19



### intent was that hopefully it would be 20



### relatively small. 21



### Inherent in establishing the REL 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### is the need to have some sort of target risk 1



### level, because that becomes the driver, or 2



### the cut point for which we start to consider 3



### where to have the REL. 4



### But the target risk level is only 5



### part of a broader context in which risk 6



### levels are considered. And that context is 7



### described in this slide. And so the key 8



### feature is that NIOSH affi rms the prevailing 9



### scientific knowledge that the only way to 10



### eliminate excess risk from carcinogens is to 11



### prevent exposure. 12



### And so NIOSH advocates using 13



### safer alternatives and to substitute non

14



### carcinogenic chemicals whenever feasible. 15



### Unfortunately, ho wever, removing all 16



### carcinogens in commerce is impractical. It 17



### won't be feasible to replace them all with 18



### alternatives, and so there is need for 19



### guidance on reducing carcinogen exposures. 20



### And NIOSH will develop this guidance, as I 21



### said, using quantitativ e risk assessment. 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### And when that risk assessment is 1



### conducted, NIOSH will communicate an array 2



### of lifetime cancer risks for exposures from 3



### 1 in 100, to 1 in a million. We believe 4



### that this information will be useful to 5



### employers and workers to take prev entative 6



### action. 7



### And so, in addition to the risk 8



### assessment, there is a heavy emphasis on 9



### risk communication. We will also identify 10



### within that array of risks a minimum level 11



### of protection. And this will be the 1 in 12



### 1,000 risk level as a nominal cut po int to 13



### help establish a REL. 14



### But throughout the policy and a 15



### strong position by NIOSH is the advocation 16



### to try to achieve exposures resulting in 17



### risks lower than 1 in 1,000. 18



### Now, what is the basis for this 1 19



### in 1,000 designation? Well, reflect up on 20



### th e U.S. Supreme Court's benzene decision, 21



### which characterized the range of risks 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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



### indicated that regulatory action should 2



### occur when there was significant risk. And 3



### they implied that 1 in 1,000 was a 4



### significant ri sk. So NIOSH will use that 5



### level because it better relates to OSHA's 6



### work in developing occupational exposure 7



### limits. And we will conduct the assessment 8



### of that using mathematical models. 9



### This is not the first time NIOSH 10



### has used the 1 in 1,000 risk le vel in 11



### interactions with OSHA or in putting out 12



### guidance. And so you can see going back to 13



### 1990 with the benzene PEL related to 14



### leukemia, in testimony to OSHA, NIOSH gave 15



### analysis of risks with recommendations 16



### focusing on the 1 in 1,000 risk level. 17



### Simi larly, in 1990, in testimony 18



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

- 19



### butadiene PEL. In 1995, this isn't cancer, 20



### but NIOSH used the 1 in 1,000 risk 21



### assessment in our criteria document to set 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### the coal dust REL. 1



### Similarly, in 1998, in 2



### collaboration wit h OSHA, we developed a 3



### journal article for cancer risk from diesel 4



### exhaust. In 2001 and 2002, we had two 5



### different journal articles related to using 6



### the 1 in 1,000 cut point for risk guidance, 7



### one for silicosis, and one for cancer. 8



### Then in 2007 NIOSH pu blished a 9



### journal article with a risk assessment that 10



### identified the 1 in 1,000 level for 11



### manganese - related neurobehavioral effects. 12



### In 2011, NIOSH as the first 13



### government agency in the world to develop a 14



### protective REL for workers exposed to 15



### nanoscale t itanium dioxide, used the 1 in 16



### 1,000 level as a cut point. That resulted 17



### in the lowest REL anywhere in the world. 18



### In 2013, to protect workers 19



### against lung cancer from exposure to 20



### hexavalent chromium, NIOSH used the 1 in 21



### 1,000 cut point as the basis for our REL. 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### And currently we're working on a 1



### REL for the flavorings, diacetyl

-- 2



### flavoring compounds

-- diacetyl and its 3



### substitute 2,3

- pentanedione to protect 4



### against respiratory dysfunction and 5



### bronchiolitis obliterans. And again the 6



### basis is the 1 in 1, 000 risk assessment. 7



### So, historically, in RELs that 8



### have been widely acknowledged around the 9



### world as being useful and protective, NIOSH 10



### has focused on the 1 in 1,000 cut point. 11



### There are additional protections afforded by 12



### the risk assessment and the re lated 13



### communication in the policy. 14



### For example, in our mathematical 15



### modeling we use a 45

- year working lifetime. 16



### Workers, then, who work less than 45 years 17



### will have less than the 1 in 1,000 risk. 18



### And not all workers work 45 years with the 19



### exposure to t hat same material. 20



### We also in our modeling treat 21



### exposure at the low dose as a linear 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### function. This is more or less a default 1



### assumption. Sometimes we have data to 2



### actually model it, but often we don't. 3



### And so in this slide, which shows 4



### risk by expos ure -- and this is at the low 5



### end of the dose response curve

-- we would 6



### assume, for modeling purposes, that the 7



### relationship is linear, that one unit of 8



### exposure relates to one unit of risk. 9



### But in fact, in many cases, and 10



### for some carcinogens, the risk will be 11



### sublinear. And so, again, the actual risk 12



### that we identify will overestimate the true 13



### risk. So, the true risk will be less than 1 14



### in 1,000, potentially, to workers. 15



### And then when we model, we make 16



### the result of the modeling as maximum 17



### likelih ood estimates of risk. And then they 18



### have confidence intervals to reflect the 19



### variability and uncertainty on either side 20



### of them. NIOSH will use the dotted line by 21



### the designation “95 percent lower confidence 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### limit” as the estimate that we actually use. 1



### So we won't use the maximum 2



### likelihood estimate of risk, per se, but 3



### rather the 95 percent lower confidence 4



### limit. That means that 95 percent of the 5



### estimates are between that dotted line and 6



### the solid line in the middle. 7



### And indeed, in some cases, tha t 8



### can be almost an order of magnitude lower 9



### than 1 in 1,000. And so, indeed, workers 10



### could be protected to close to 1 in 10,000 11



### in that regard, in some cases. 12



### Additionally, we continue to 13



### counsel that risk should be kept well below 14



### the REL because lower exposures lower the 15



### risk. We recommend alternatives whenever 16



### possible, and for these reasons the actual 17



### risk on which a REL is based, we believe, 18



### will be less than 1 in 1,000. 19



### Now, moving on to the third 20



### element of the policy. This is the element 21



### that deals with two issues: analytical 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### feasibility and engineering achievability. 1



### Now, in our history, going back at least to 2



### 1988, NIOSH stated that engineering control s 3



### should be used to control occupational 4



### exposures to the fullest extent feasible. 5



### Again , that issue of control to 6



### the level feasible, and this will be based 7



### on what levels can be feasibly achieved by 8



### engineering controls and managed by analytic 9



### techniques. So there are two issues here. 10



### There's the controllability and the 11



### measurability, if you will. 12



### And just by way of background, 13



### not all NIOSH RELs are health

- based. 14



### Historically, in many cases, the basis for 15



### the REL was not the health data but 16



### limitations of the analytical method. That 17



### we could not

-- the analytical capabilities 18



### were not in existence to allow us to measure 19



### down to the level that would be below the 20



### lowest observed effect. And so, in which 21



### case we had to default and set the limit at 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### the level of analytical feasibility. 1



### With regard to engineering 2



### achievability, while that was talked about 3



### in the 1995 policy, NIOSH hasn't routinely 4



### conducted analyses of the technical 5



### feasibility of achieving RELs. Nor was that 6



### ever defined in the policy. 7



### And so, from henceforth in this 8



### policy, NIOSH will no longer establish 9



### carcinogen RE Ls relying on the evaluation of 10



### engineering control achievability. That 11



### will not be a determinant in the evaluation 12



### process. 13



### But NIOSH will make an effort and 14



### provide in every REL document an overview of 15



### the effectiveness of engineering controls. 16



### Moreo ver, as we develop the RELs with the 17



### quantitative risk assessment, we also have 18



### to assess whether or not we can actually 19



### measure the chemical at the level that we 20



### would recommend. 21



### And so to help the public 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### appreciate the difference and to see more 1



### transp arently what the basis of a REL is, we 2



### will use these two designations. We will 3



### use health

- based RELs. And with a chemical, 4



### we will use the designation REL in the 5



### Pocket Guide or other documents i f it's 6



### health based. But if it's based on analytic 7



### feasib ility, we will use REL with the 8



### subscript AF. That will allow people to 9



### know which ones are based on an analytic 10



### limitation and which ones are health

- based. 11



### This is another slide that, 12



### without a pointer, it's hard to see. Let me 13



### walk you through it, bu t, essentially, if 14



### there is a 1 in 1,000 risk, we ask the 15



### question, is there a validated analytic 16



### method to measure the substance? 17



### If no, then we recommend research 18



### to develop a validated method. This can 19



### take many years, but at least it will fill a 20



### gap . 21



### In the interim, or if yes, if 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### there is a validated method, we ask the 1



### question, can the validated method detect 2



### the concentration that equates to a 1 in 3



### 1,000 risk? And indeed, if that does, we 4



### will provide recommendations to utilize a 5



### hierarchy of co ntrols and issue a 6



### recommended exposure limit. 7



### If not, we will adjust the REL to 8



### the analytical limit. And that would be the 9



### limit of quantitation, or the reliable 10



### quantitation limit. And for those RELs we 11



### will add the AF designation. 12



### So, those were the three elements 13



### of the NIOSH cancer policy. We're here 14



### today having this public meeting. We hope 15



### to receive all public comments by February 16



### 13th, 2014, and then receive all peer review 17



### comments by March 2014. That one month 18



### difference is because we w ant to avail the 19



### peer reviewers of all the comments of the 20



### public. 21



### So in addition to reviewing the 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### document, they will have, as input, the 1



### comments of the public. And we anticipate 2



### the completion of the final cancer policy 3



### sometime in 2014. 4



### I want to acknowledge the NIOSH 5



### intramural team that has worked on this 6



### document over the last two years. And we 7



### appreciate all their input. And draw your 8



### attention to the NIOSH carcinogen policy web 9



### page where you can get updates on this 10



### process. 11



### And so I thank you for your 12



### attention, and we look forward to your 13



### questions and comments. And I think right 14



### now we'll take clarifying questions. Then 15



### we'll get into the comments by individual 16



### members of the public. 17



### DR. McKERNAN: Thank you, Paul. 18



### We are going to t ake questions. We're first 19



### going to take questions in the room. After 20



### they have been completed, we'll then take 21



### questions from the phone line. I'd like to 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### remind everyone to please state your name 1



### and your affiliation. And we have a 2



### portable mic that w ill be rotating 3



### throughout the room. 4



### (Pause.) 5



### MS. CASANO: Hi, I'm Pat Casano, 6



### GE. And I apologize, I was a few minutes 7



### late. So, if you answered this question in 8



### your presentation, I'm sorry for the 9



### duplication. 10



### The classifications upon which 11



### you'r e proposing to rely

-- IARC, NTP, EPA

- 12



### - are of varying quality. In your process 13



### are you going to take that into account and 14



### provide an opportunity for people to comment 15



### on the quality of the assessments? Or are 16



### you going to take those classifications at 17



### face value? 18



### DR. SCHULTE: Whenever NIOSH 19



### develops a recommended exposure limit, the 20



### limit and the documentation will be open for 21



### public comment. And so there will be an 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### opportunity to comment on that. I would 1



### say, though, that we have viewed these thr ee 2



### agency reviews as of all sufficient quality 3



### to be part of our determination, and we 4



### don't intend to rethink their determination. 5



### So we will accept them at face 6



### value. We welcome comment about that, but 7



### unless there is some issue related to 8



### occupation al relevance, they are de facto 9



### the source of our classification. 10



### MR. SIVIN: Darius Sivin, UAW. 11



### Could NIOSH give an example, if not for a 12



### specific agent, for a hypothetical agent, of 13



### how it might find an agent found to be 14



### carcinogenic by these various agencies not 15



### occupationally relevant? 16



### DR. SCHULTE: Chris, you want to 17



### do that? 18



### DR. SOFGE: We expect that to be 19



### a very rare occurrence. And I'd love to 20



### just pull out a chemical and tell you, but 21



### it is a very rare thing that we would find 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### something no t occupationally relevant if 1



### it's been considered to be a carcinogen by 2



### one of these three agencies. Because just 3



### the fact that they're looking at it means 4



### there's probably exposure and it's probably 5



### relevant. 6



### What we put this in there for is 7



### those situ ations where you could imagine if 8



### there was a chemical that caused tumors if 9



### it was injected, and that's not a route of 10



### exposure you would ever have in an 11



### occupational setting. Or something like 12



### that. It gives us a way to deal with those 13



### kinds of chemica ls. 14



### (Pause.) 15



### MS. WISE: Can everybody hear me? 16



### DR. SCHULTE: Once you turn it on 17



### it takes a couple seconds before it 18



### activates, it seems. 19



### MS. WISE: Okay, so hopefully

-- 20



### there we go. Kimberly Wise, with the 21



### American Chemistry Council. You mentio ned 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### that there will be a peer review of the 1



### document. Is that going to be an open forum 2



### meeting? Or is it going to be like a letter 3



### peer review? I just want to know about how 4



### that peer review process will go and how the 5



### comments will be taken into consi deration in 6



### that peer review. 7



### DR. SCHULTE: The peer review is 8



### done by about six or eight peer reviewers 9



### who will review the document independently 10



### and provide a written report. There will be 11



### no attempt to achieve a consensus from the 12



### peer reviewers. K athleen, did I say that 13



### correctly? 14



### DR. MacMAHON: That is correct. 15



### What I would add to that is that the peer 16



### review s will be made publically available on 17



### the NIOSH website, and we also will document 18



### our responses to the peer review comments. 19



### DR. SCHUL TE: And that will all 20



### be in the public docket. 21



### MR. ELLIS: Thank you, hello. 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### Okay, Mark Ellis with the Industrial 1



### Minerals Association

- North America. I 2



### noticed that your model looks at a linear 3



### relationship in terms of carcinogenesis. 4



### Can you tell m e why you discounted the 5



### operation of any threshold that may operate? 6



### DR. SOFGE: Well, in practice, 7



### when you're doing risk modeling , thresholds 8



### are particularly difficult to locate using 9



### statistical models. So, part of it is a 10



### pragmatic point of view. 11



### That being said, we have had 12



### situations where if we know enough about the 13



### mechanism of action, or mode of action, to 14



### be confident that there is a nonlinear 15



### response, we have taken that into 16



### consideration when we have sufficient data 17



### to support that. 18



### So , even though, in general, we 19



### look at it from a linear point of view, 20



### that's in the situation where we don't have 21



### sufficient data to rule out a linear 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### response. 1



### MR. ELLIS: And that is spelled 2



### out in the policy? 3



### DR. SOFGE: The policy's the 4



### general sor t of thing. For individual 5



### chemicals, we always use the best data we 6



### have. I mean, and that is NIOSH's policy. 7



### MR. ELLIS: To be specific about 8



### it, does the policy

-- 9



### DR. SCHULTE: Use the microphone 10



### please. 11



### MR. ELLIS: Does the policy 12



### recognize a specific exemption for potential 13



### operation of a threshold based on mechanism 14



### of action? 15



### DR. SOFGE: Well, this policy 16



### isn't designed to really get into the 17



### specifics of how we do quantitative risk 18



### assessment and what data we're going into. 19



### But, in pract ice, like for titanium dioxide, 20



### for example, that's one chemical where we 21



### did have sufficient data that we thought 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### supported a sublinear dose response. 1



### So, in practice, that's what we 2



### do. This policy doesn't go that far in to 3



### prescribe the specific risk assessment 4



### practices, like which model to use. 5



### DR. SCHULTE: It does, however, 6



### specify that we will use the best data 7



### available. So if there are data that would 8



### allow modeling for a sublinear relationship, 9



### that would be included in that. And indeed, 10



### a s Chris said, we did that in the risk 11



### assessment for titanium dioxide. 12



### DR. McKERNAN: We're now going to 13



### switch over to any questions that are on the 14



### telephone line. 15



### AUTOMATED PHONE MESSAGE: The 16



### conference is now in talk mode. 17



### DR. McKERNAN: I remin d those 18



### that are on teleconference to please state 19



### your name and also your affiliation. 20



### MR. MIRER: Hi, this is Frank 21



### Mirer and I'm a peer reviewer. The sound is 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### really bad, you can't hear any of the 1



### audience comments, and it's kind of shaky 2



### half the ti me from the NIOSH participants. 3



### That's just a point of personal privilege. 4



### I don't have a technical question at this 5



### time. 6



### DR. McKERNAN: Okay, thank you. 7



### DR. SCHULTE: We'll try to speak 8



### up for the folks on the phone. 9



### MS. JACOBS: This is Molly 10



### J acobs from the University of Massachusetts

11



### Lowell. And I have a question regarding the 12



### chemical classification piece of things, and 13



### wondering if NIOSH will include more agents, 14



### in quotation there, rather than just 15



### chemicals. 16



### I'm thinking of ionizing 17



### rad iation and/or radio frequencies, and 18



### potentially in the future issues around 19



### mixtures rather than single chemicals. Can 20



### you speak to whether those type of agents 21



### will be inclusive of NIOSH's review of 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### occupational carcinogens? 1



### DR. SCHULTE: Yes. They w ill 2



### not. This is the NIOSH chemical carcinogen 3



### classification policy. Subsequently, once 4



### we get this done, then we are going to move 5



### to physical agents. So any physical agents, 6



### such as ionizing radiation, won't be 7



### addressed in this, but we expect to add ress 8



### them subsequently. 9



### With regard to chemical mixtures, 10



### we don't specifically single out an approach 11



### for them in this policy, but we have a 12



### review of the literature on chemical 13



### mixtures which we hope to publish in the 14



### near future, where we don't think at this 15



### time we're ready to have a particular policy 16



### on it. We don't think the science is 17



### evolved enough. 18



### But we are interested in 19



### following the science on mixtures and 20



### particularly on cumulative risk assessments. 21



### And we hope to at least review that 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### li terature in the future. 1



### DR. McKERNAN: Do we have any 2



### further questions on the phone line? 3



### MR. HERRICK: Yes, this is Bob 4



### Herrick, Harvard School of Public Health. I 5



### just have one question. It's kind of a 6



### hypothetical, but let me just pose it to you 7



### anyway. How would NIOSH approach a compound 8



### that is turning up evidence in the 9



### scientific literature as being a carcinogen, 10



### but none of those three entities that you 11



### mentioned have acted on it yet? How would 12



### NIOSH proceed? 13



### DR. SCHULTE: Thank you, yes. 14



### There is a point in the flow chart of Figure 15



### 1, the third box down which says, is there 16



### other evidence of carcinogenicity? And if 17



### the three agencies have not classified the 18



### substance but there is other evidence of 19



### carcinogenicity, NIOSH has two options in 20



### that case. 21



### We can nominate it to NTP to 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### classify it, or if there's a need to move 1



### with more dispatch, we can evaluate it 2



### ourselves using the Globally Harmonized 3



### System of labeling and classification 4



### criteria. 5



### So, that's how we would deal with 6



### those. So, there would be a way to take 7



### something that has not been addressed by one 8



### of the three authoritative agencies. 9



### MR. HERRICK: Thank you. 10



### DR. McKERNAN: Is there another 11



### question from the phone line? Do we have 12



### any further questions in the room? 13



### MR. MIRER: Yeah, actually, I do 14



### have another question. This is Frank Mirer. 15



### DR. McKERNAN: Go ahead. 16



### MR. MIRER: Is it NIOSH's 17



### intention to present an array of risk rate 18



### estimates for the chemical, and exposure 19



### levels associated with various risk ra tes? 20



### DR. SCHULTE: Yes, in part. When 21



### we do the risk assessment we will 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### communicate an array of risks, from 1 in 100 1



### to 1 in a million. And so that will be part 2



### of the report

- out of the risk assessment in 3



### the REL developing document. So, in that 4



### sense , we will identify what the risks are. 5



### For the 1 in 1,000 risk, 6



### certainly we will show the concentration REL 7



### that relates to that. I don't know if we 8



### had planned on doing it for the other risks 9



### from 1 in 100 to 1 in a million. 10



### We weren't going to repo rt an 11



### exposure that corresponded, or were we? 12



### Okay, we are. Yes, I stand corrected. We 13



### are going to do that, Frank. We will array 14



### the risks from 1 in 100 to 1 in a million. 15



### And we will also report the corresponding 16



### exposure level that relates to those

. 17



### MR. MIRER: One other question. 18



### Is it NIOSH's intention to go back through 19



### the RELs and through existing chemicals and 20



### classify them according to this new system? 21



### DR. SCHULTE: Yes, we have 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### already started on thinking about a 1



### retrospective applicati on of this policy to 2



### the previously classified NIOSH substances. 3



### It's a little more complicated than one 4



### might think. And we can't really move 5



### ahead on it until we get the policy 6



### finalized. So, once this policy is 7



### finalized, yes, we do intend to try to apply 8



### it retrospectively. 9



### DR. SOFGE: And I want to clarify 10



### that that's the chemical carcinogen piece, 11



### not developing new RELs for everything. 12



### DR. SCHULTE: That's correct, 13



### just the classification. 14



### DR. McKERNAN: We have another 15



### question in the room . We're going to do 16



### that now. 17



### DR. SCHULTE: Yeah, that's a good 18



### idea. 19



### MS. CASANO: Pat Casano, GE. 20



### Just to clarify, when you talk about you 21



### know , risk of 1 in 100, or 1 in 1,000, 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### you're really talking about excess cancer 1



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

-- 2



### you're not saying that you have a 1 in 100 3



### chance of developing cancer from this 4



### particular exposure? Is that correct? 5



### DR. SCHULTE: Yeah, let me repeat 6



### the question. The question was, when we 7



### talk about risk levels, like 1 in 100, or 1 8



### i n 1,000, we're really talking about excess 9



### risk levels. And indeed you're exactly 10



### correct. And that's the way it's specified 11



### in the policy. 12



### DR. McKERNAN: Do we have any 13



### further questions on the

-- oh, we have some 14



### more in the room. Okay. 15



### MR. ERKKIL A: Hello. Brian 16



### Erkkila from the FDA. I was wondering if 17



### you could comment on the AF designation and 18



### how you would approach it if there's a large 19



### difference between the health

- based and the 20



### analytical, how big a difference is 21



### acceptable. 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### DR. SCHULTE: Well, I think if 1



### the limitation on the analytic method was 2



### so great that the risks were much greater 3



### than 1 in 1,000, that that level

-- or just 4



### greater than within the range of 1 in 1,000 5



### and 1 in 10,000 we would have to treat that 6



### on a case - by

- case basi s. 7



### Clearly, we would say to have 8



### exposures at the level you can measure 9



### wouldn't be appropriate. And we'd probably 10



### put more emphasis on calling for substitutes 11



### or alternatives in that case, or engineering 12



### controls that were essentially leading to 13



### zero, or very low exposures. But that would 14



### have to be more on a case

- by

- case basis. 15



### DR. McKERNAN: We would also put 16



### additional energy into trying to create an 17



### analytical method that would be able to 18



### measure to a lower level. And we have a 19



### very talented gro up of scientists at DART 20



### that have that analytical expertise. 21



### MR. HELMES: This is Tucker 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### Helmes from SOCMA, Society of Chemical 1



### Manufacturers and Affiliates. What’s the 2



### dynamics between NIOSH and NTP, for example? 3



### Specifically what I mean, you know, N TP 4



### accepts nominations for its annual report on 5



### carcinogens. Does NIOSH make nominations to 6



### NTP for that because of a concern about an 7



### occupational exposure? Or does NIOSH wait 8



### and see what the NTP publishes in its report 9



### on carcinogens, and then evaluat e whether 10



### there is an occupational relevance? 11



### DR. SCHULTE: For those on the 12



### phone, the question dealt with the 13



### relationship between NIOSH and NTP. 14



### NIOSH is a founding member of the 15



### National Toxicology Program and continues to 16



### have a seat on the boar d that governs it. 17



### NIOSH also has the capability of making 18



### nominations to NTP and in some cases we do 19



### that. And NIOSH also utilizes the 20



### information in the report on carcinogens 21



### after that's put out. So all of those are 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### possibilities. But we are a membe r of the 1



### NTP and participate in deliberations of it. 2



### MR. ELLIS: Mark Ellis with the 3



### Industrial Minerals Association again. When 4



### you talked about analytic feasibility, are 5



### we talking about the limits of detection, or 6



### are talking about limits of quantifi cation? 7



### And are there confidence intervals on either 8



### side of that? 9



### DR. McKERNAN: I'll take that 10



### one. So, when we develop a REL, we'll 11



### typically use a validated NIOSH method or a 12



### validated OSHA method. If it's a NIOSH 13



### method, we're going to be using L OQ, limit 14



### of quantification. But our colleagues at 15



### OSHA don't use LOQ, they actually use an 16



### RQL, a reliable quantification level. So, 17



### depending on the analytical method that we 18



### use, we use those two terms. 19



### (Pause.) 20



### MR. SIVIN: Darius Sivin of UAW 21



### aga in. Could you tell us what criteria 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### NIOSH will use to determine whether a data 1



### set is adequate to justify a deviation from 2



### a linear model, and whether, at least in the 3



### case of each individual agent, those 4



### decisions will be subject to public comment? 5



### DR. SCHULTE: Chris, would you 6



### handle this? Let me just repeat for the 7



### phone people. The question was: what 8



### criteria will NIOSH use to deviate from the 9



### assumption of a linear model at low doses to 10



### make its analysis? 11



### DR. SOFGE: Yeah, that will be 12



### done on a case - by

- case basis. And all of 13



### our documents always involve opportunity for 14



### public comment and peer review. So there 15



### would definitely be opportunities for input 16



### on those decisions. 17



### Now, as far as we don't have a 18



### set of criteria, it really depends on what 19



### the mode of action is, how much confidence 20



### we have in that mode of action. 21



### DR. SCHULTE: But, clearly, as we 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### did in the titanium dioxide report, upon 1



### using the data to model a sublinear 2



### relationship, we subjected that whole 3



### analysis to a sensitivity analysis. And 4



### that was put in the report and made 5



### available for public comment. 6



### DR. McKERNAN: Do we have any 7



### further questions in the room? If not, I'm 8



### going to switch back to our colleagues that 9



### are on the telephone and ask them if they 10



### have any fur ther questions? 11



### (No response.) 12



### Okay. Then we'll go ahead and 13



### shift gears. For our colleagues on the 14



### telephone I wanted to apologize that your 15



### audio experience is not everything that we 16



### hoped it would be. I am comforted by the 17



### fact that we are taking a whole transcript 18



### of what's going on in the room. And that 19



### transcript will be posted on the NIOSH 20



### Docket within 30 days. 21



### Additionally, I wanted to remind 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### you that the presentations made today will 1



### also be posted on the NIOSH Docket Website

. 2



### So I apol ogize that your experience is not 3



### 100 percent. But I hope that those two 4



### additional items will make today, at least 5



### post

- today, more meaningful. 6



### Okay, so we're going to shift 7



### gears now and we're going to have some of 8



### our stakeholders make some comments. Again, 9



### these were people that signed up in advance. 10



### If there is anyone else that would like to 11



### make formal comments today, please let us 12



### know. We did put all the stakeholder names 13



### into a hat and randomly selected them. 14



### And our first speaker today is 15



### going to be Darius Sivin from the 16



### International Union UAW. I'd like to invite 17



### him up to the podium, please. 18



### (Pause.) 19



### MR. SIVIN: Good morning. Thank 20



### you for the opportunity to comment on 21



### NIOSH's draft carcinogen policy. The 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### International Union UAW di d submit comments 1



### at the 2011 public meeting. And I recently 2



### had an occasion to revisit them in the 3



### D ocket online. And I noticed that a crucial 4



### page was missing. 5



### And that was the page where we 6



### specifically stated our opposition to the 7



### use of the 1 in 1 ,000 risk level. Now, I 8



### assume that this was an accident. It 9



### appears, looking at what's online, that our 10



### document was printed off email and then re

11



### scanned and uploaded, and in the process of 12



### re - scanning, a page was missing. 13



### But since we did submit tho se 14



### comments on time, I will be a happy to 15



### resubmit them so that NIOSH can correct the 16



### D ocket. 17



### DR. McKERNAN: We'd be happy to 18



### correct the D ocket, and we apologize if an 19



### error was made. Those have been on the 20



### D ocket from 30 days since the last public 21



### mee ting, but we would be happy to correct 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### that for you. 1



### MR. SIVIN: Thank you. I would 2



### like to commend NIOSH, first, for bringing 3



### its carcinogen policy in line with IARC, 4



### EPA, and NTP, and GHS. And, secondly, for 5



### having adopted a policy of strongly 6



### advoca ting safer alternatives. 7



### On that second point, I would 8



### like to recommend that each criteria 9



### document for a carcinogen indicate that the 10



### REL is only properly used after safer 11



### alternatives have been sought. And that it 12



### would be an improper use of the REL to not 13



### start at the top of the hierarchy of 14



### controls and go directly to engineering 15



### controls or administrative controls rather 16



### than looking for safer alternatives first. 17



### I do have grave concerns about 18



### the use of the 1 in 1,000 risk level. First 19



### of all, I would like to disagree slightly 20



### with Dr. Schulte about his interpretation of 21



### the benzene case. 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### In the first place, that number 1



### appeared in a non

- binding footnote to what 2



### was in fact a plurality and not a majority 3



### decision. And the 1 in 1,000 number co mes 4



### from the Solicitor of Labor’s interpretation 5



### of that non

- binding footnote. 6



### And so I think it should hardly 7



### form the basis of a policy of recommended 8



### exposure limits from a scientific 9



### organization in the U.S. Public Health 10



### Service. In fact, I think i t would be 11



### outrageous for any entity in the U.S. Public 12



### Health Service to issue a recommendation 13



### which, if followed, would result in a 14



### thousand fatal cancer cases per million 15



### workers exposed. 16



### If there are legal or 17



### administrative reasons for which NIOSH n eeds 18



### to provide the information, for example for 19



### OSHA's use, since OSHA is subject to the 20



### Solicitor of Labor, NIOSH should provide 21



### that information in that array of risks that 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### you talked about, but not describe that as 1



### the recommended exposure limit. 2



### Sci entifically, I think it's not 3



### necessary to have a particular target risk 4



### level at all. In part because of the great 5



### uncertainty in determining what level of 6



### exposure is associated with a particular 7



### risk, as described in the Silver Book, 8



### called Science and Decisions: Advancing Risk 9



### Assessment. 10



### I would commend the use of 11



### sensitivity analysis as in the titanium 12



### dioxide documents. And I would suggest 13



### that, in all RELs, when saying that such and 14



### such dose is associated with such and such a 15



### risk, that NIOSH p ublish not only the array 16



### of recommendations, and not only indicate 17



### that it's a lower confidence interval, but 18



### also always publish an analysis of the 19



### sensitivity of the models to assumptions and 20



### indicate under different assumptions what 21



### those risk levels w ould be. 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### In particular, for example, if 1



### NIOSH were to go to a sublinear model for 2



### any particular REL, I would strongly 3



### recommend that you indicate in the criteria 4



### documents what the exposure level would be 5



### if you used the linear model. And clearly 6



### descr ibe the assumptions of the data set 7



### that justified not doing so. 8



### So, I also think that it is very 9



### important that NIOSH indicate in its policy 10



### and its criteria documents that people have 11



### the same right to protection at work that 12



### they do in other activitie s. That there is 13



### no principal justification for setting 14



### exposure limits for workers that provide 15



### less protection than the 1 in a million 16



### lifetime risk in the general population. 17



### So, that I can imagine justifying a 18



### particular REL on the grounds that the 19



### r obustness of the data set doesn't permit 20



### going down that low. 21



### I certainly think, as I said, 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### that for all carcinogens, NIOSH should 1



### indicate very strongly that the REL is not 2



### properly followed, and, as I say, in each 3



### criteria document and I think in the N IOSH 4



### Pocket Guide, that you're not properly 5



### following the REL if you haven't looked for 6



### safer alternatives first. 7



### Yeah, those are

-- oh, I would 8



### also like to add a comment on analytical 9



### feasibility, which is my concern is that 10



### obviously criteria document s can become 11



### outdated either due to advances in the 12



### science telling us what the risk is, or the 13



### analytical feasibility. 14



### But I think they'll become 15



### outdated faster if we have analytic 16



### feasibility RELs and not just health

- based 17



### RELs, because if we set it a t a health basis 18



### and then analytical feasibility improves, 19



### then we can have

-- that same REL will still 20



### be applicable and now we can measure to it. 21



### Whereas if we set it at 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### analytical feasibility and there's an 1



### advance in analytical feasibility, the REL 2



### w ill become outdated much faster and also it 3



### will be less protective. 4



### And so thank you very much for 5



### the opportunity to comment on the policy. I 6



### appreciate it. 7



### DR. McKERNAN: I'm actually going 8



### to allow the panel to see if they've any 9



### clarification q uestions that you'd like to 10



### ask? We don't. Thank you. 11



### Going to move on to our next 12



### speaker, who is Anna Mazzucco from the 13



### National Cancer Center for Women and 14



### Families. 15



### DR. MAZZUCCO: Hi, thank you very 16



### much for allowing me the opportunity to 17



### speak today. My name is Dr. Anna Mazzucco 18



### and I represent the National Research Center 19



### for Women and Families and our Cancer 20



### Prevention and Treatment Funds. 21



### After completing my Ph.D. in cell 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### and developmental biology, I also conducted 1



### research at the Natio nal Cancer Institute 2



### and I bring those perspectives today. I 3



### speak as a cancer biologist who's concerned 4



### that these regulations still lag behind the 5



### state of the science and fall short of their 6



### goal of protecting Americans from cancer as 7



### they work. 8



### In 2 013 alone, more than half a 9



### million Americans will die from cancer. And 10



### a 2003 joint report from the NCI and the 11



### National Institute for Environmental Health 12



### Sciences stated that exposure to a wide 13



### variety of natural and man

- made substances 14



### in the environm ent accounts for at least 15



### two

- thirds of all the cases of cancer in the 16



### United States. 17



### Yet after reviewing the current 18



### state of regulatory policy and research, the 19



### President’s Cancer Panel reported in 2010 20



### that environmental health, including cancer 21



### risk, has been largely excluded from overall 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### national policy on protecting and improving 1



### the health of Americans. 2



### When decades

- known carcinogens 3



### such as asbestos and radon are still present 4



### at either unsafe or unknown levels in 5



### American workplaces, how can th e public have 6



### confidence that our regulations can handle 7



### new and complex occupational hazards arising 8



### every day? 9



### The National Institutes of Health 10



### also estimated the total cost of cancer in 11



### 2008 at $201.5 billion in both direct health 12



### care costs and the indirect cost of lost 13



### productivity due to premature deaths. 14



### Another recent study estimated 15



### that cancer is responsible for 20 percent of 16



### all healthcare spending in the U.S., and 17



### that disability days cost $7.5 billion in 18



### lost productivity each year. And t hese 19



### numbers cannot attempt to capture the human 20



### value of lives lost. 21



### Although we appreciate the 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### adoption of a classification system by 1



### NIOSH, we are concerned that this report 2



### still represents a more reactive rather than 3



### proactive approach to regulation . It 4



### maintains a historical risk threshold which 5



### may no longer be appropriate. And it still 6



### places burdens on workers rather than on the 7



### industry. 8



### We have five areas of concern 9



### that we want to emphasize. And I'll just 10



### briefly state them and just give a few 11



### details. 12



### Number one. Safe exposure limits 13



### must be based on actual, not theoretical, 14



### workplace exposures. Real

- life workplace 15



### chemical use involves multiple agents and 16



### complex exposures. This report does not 17



### give any concrete statements on how to 18



### address the true chemical milieu to which 19



### workers are exposed, and there is no 20



### scientific reason to limit our safety 21



### analyses to single agents. 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### If the goal is to prevent 1



### chemical hazard exposure in the workplace, 2



### then we must start with the workplace, no t a 3



### theoretical framework which likely applies 4



### to very few real life situations. 5



### And I know that this issue 6



### already came up on questions on the phone, 7



### and so we look forward to the work from 8



### NIOSH on addressing more complex chemical 9



### situations. 10



### Accepta ble occupational risk 11



### assessments should be based on up

- to

- date, 12



### circumspect and truly representative 13



### information. As we discussed also already, 14



### NIOSH uses a lifetime excess cancer risk of 15



### 1 in 1,000 as the minimal acceptable 16



### regulatory threshold, while stating that 17



### controlling exposure to lower concentrations 18



### is always warranted. We appreciate that, 19



### especially the statement that an excess risk 20



### of 1 in 1,000 is one or more orders of 21



### magnitude higher than what the United States 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### permits for the general pub lic. 1



### And this is justified in this 2



### report by two arguments which we already 3



### heard a little bit of this morning. The 4



### first being the historic benzene decision, 5



### which we also think was used more in a 6



### rhetorical example. But the second also 7



### being that this justification has been used 8



### historically because workers represent a 9



### very small subset of the population, and 10



### higher exposures for small numbers of people 11



### may be considered acceptable if they are 12



### comparable to the overall risks of that 13



### employment itself. 14



### But we think, in this particular 15



### case, actually even at that time and 16



### certainly now, many occupations have lower 17



### than 1 in 1,000 risk. And so we think that 18



### that should also be recognized. 19



### There is also increasing evidence 20



### that occupational carcinogens spread into 21



### the greater environment. For example, TCE, 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### an industrial solvent, is now present in as 1



### much as one

- third of the U.S. water supply. 2



### And so we think that distinguishing between 3



### occupational versus overall environmental 4



### exposures is very diffic ult. Especially 5



### given that the EPA 1 in a million target 6



### threshold is what they prefer for the 7



### largest number of people possible, and 8



### that's a 1,000 times lower than the NIOSH 9



### threshold. 10



### And the bottom line is that there 11



### is no scientific basis for these 12



### differential safety standards, and we now 13



### know that occupational and environmental 14



### exposures can become difficult to 15



### distinguish. And for that reason, it would 16



### be better for the workplace, and the general 17



### public, more comparable protections. 18



### And I'm ju st going to stop here 19



### because I'm worried I'm going to go over 20



### time. But we also just wanted to mention 21



### that a safe exposure level based on 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### technical feasibility rather than safety 1



### does place workers at risk. NIOSH plans to 2



### use the recommended exposure li mit to the 3



### highest detectable dose, the reliable 4



### quantitation limit, as we heard this 5



### morning. 6



### But this would directly place 7



### workers in potentially unsafe conditions, 8



### and they would also be powerless either to 9



### detect or remove the agent to guarantee safe 10



### levels. 11



### If we really want to guarantee 12



### absolute safety to workers in that 13



### situation, the better thing to do would 14



### actually be ban these chemicals until a more 15



### safe and sensitive detection method is 16



### developed. And such a policy really would 17



### protect work ers while also creating an 18



### incentive for industry to develop more 19



### sensitive diagnostic capabilities or find 20



### safer alternatives. 21



### And, lastly, I just wanted to say 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### that sensitive subpopulations need to be 1



### addressed in more detail. For example, we 2



### know tha t birth defects, childhood cancer, 3



### and adult cancers can all caused by in utero 4



### exposures. And this report doesn't provide 5



### any really specific details on how sensitive 6



### subpopulations would actually be protected. 7



### And just as the NIOSH risk 8



### threshold, you know, is intended to protect 9



### all workers, we really need to make sure 10



### that everybody is included in that. 11



### So just to end, we urge you to 12



### consider these changes and use every 13



### resource at your disposal to ensure that our 14



### national policies regarding occupa tional 15



### carcinogens meet their goal of protecting 16



### Americans at work. This will ensure a 17



### healthy society, a thriving economy, and 18



### also safeguard our environment for the 19



### future. Thank you. 20



### DR. McKERNAN: Does our panel 21



### have any questions? I have a questi on for 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### you. I just want to clarify. So are you 1



### recommending that NIOSH not consider 2



### analytical feasibility when establishing a 3



### REL for a carcinogen? 4



### DR. MAZZUCCO: I mean, I 5



### understand, you know, the practical 6



### limitations, and I think, you know, I thin k 7



### it gets to the question that was asked 8



### earlier about kind of if the difference 9



### between the analytically feasible limit and 10



### the REL, you know, how much of a difference 11



### would be acceptable between those two 12



### numbers, would be kind of the really salient 13



### poin t just to make sure that in those 14



### situations the risk isn't, you know, in 15



### greater excess of the 1 in 1,000 threshold. 16



### DR. McKERNAN: Thank you. Okay, 17



### we're going to rotate to our next speaker, 18



### who is James Melius from the New York State 19



### Laborers’ Health and Safety Trust Fund. 20



### (Pause.) 21



### DR. MELIUS: Okay. Good morning 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### everybody. And, again, first of all, thank 1



### NIOSH for holding this meeting and giving us 2



### the chance to come back and talk to you 3



### again. I actually did read the transcript 4



### from the last time, which was two years ago. 5



### I do admit, I read it on Friday, so, I 6



### haven't checked my comments but that

-- a 7



### couple things. 8



### One, first of all, I think, first 9



### of all I'd like to thank you for some 10



### significant improvements in what was 11



### discussed, at lea st, two years ago in this 12



### document. I think the new, more detailed, 13



### more layered classification system is good. 14



### And I think the approach to sort of 15



### compatibility or conversion with NTP, EPA, 16



### and IARC are good. 17



### I mean, the science is advanced 18



### enough now that certainly these kinds of, 19



### you know, multi

- level classification 20



### policies make much better use of the 21



### scientific data and certainly are much more 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### -- better in terms of communicating what is 1



### known about a carcinogen or a potential 2



### carcinogen without goi ng into, you know, a 3



### complete 500 page criteria document or 4



### whatever. 5



### So I think that is useful and I 6



### think also the approach to conversion to the 7



### GHS is also very reasonable. 8



### One area I'd like to point out, 9



### and again I don't think it's a change to 10



### th is document, but I think it is an area 11



### that may require at least some more mention 12



### in the document is it's very clear that 13



### we're relying, or are going to have to rely 14



### more and more, on mechanistic data in terms 15



### of classifying chemicals as carcinogens or 16



### po tential carcinogens, whatever. 17



### Our understanding of the 18



### development of cancer, its progression, is 19



### greatly increased. I think we're recognizing 20



### more mechanisms, and I think we're also 21



### doing fewer epidemiological studies, having 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### more difficulty getting th ose done for many 1



### materials that are used in the work place. 2



### And similarly animal bioassay and 3



### the other kinds of information we used to 4



### rely on heavily in these classification 5



### systems are much less available than they 6



### used to be. Therefore, we're looki ng for 7



### substitutes for that. It's a complicated 8



### evolving area and I think that needs to at 9



### least be acknowledged in this. And I know 10



### you are well aware of it and well

- versed in 11



### it, but I think in terms of developing some 12



### consistency and development of pr oper 13



### classification systems, this needs to be 14



### brought into the system. Much as you're 15



### doing in terms of background documents on 16



### risk assessment and so forth. 17



### It's obviously, I think, much too 18



### detailed to be part of this document. I'm 19



### not sure that anyb ody really has come up 20



### with a good global approach to this, but 21



### since it tends to be very substance 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### specific, or at least within classes of 1



### materials, but I think it is important. I 2



### think it's worth mentioning in more detail 3



### in this document. 4



### I'd also have a number of other 5



### sort of recommendations I'll put in writing 6



### at this time. I think, Paul, I'd like to 7



### thank you and your staff. Your presentation 8



### today actually clarified a number of areas 9



### that I think warrant a little bit more 10



### emphasis in the doc ument itself. They sort 11



### of get lost in the detail, and I think it 12



### would be very helpful to do that. 13



### The one area I remain very 14



### disturbed about is the target risk 15



### assessment level. I think that is not, and 16



### should not, be NIOSH policy, the 1 in 1,000 17



### exc ess risk. It is not what, I don't think, 18



### Congress intended when it set up the agency. 19



### And as I can quote from Page 31 20



### in your own document, was requesting NIOSH 21



### develop exposure levels at which no employee 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### will suffer impaired health, or functional 1



### capa cities, or diminished life expectancy as 2



### a result of his work experience. 3



### And I think 1 in 1,000 clearly 4



### violates that. And I think something

-- I 5



### don't think that NIOSH should be bound by a 6



### feasibility determination that's been made 7



### by OSHA as part of a regulatory process 8



### involving economic and other feasibility 9



### determinations as part of setting a level. 10



### So I think that has to go. 11



### I guess we're all

-- I think your 12



### overall policy of sort of no safe level, or 13



### very reduced as much as is feasible, or as 14



### possible, is much better. I do think that 15



### it needs to be implemented in some way for 16



### the greater occupational health community in 17



### terms of a recommended, an REL, recommended 18



### exposure level, and do that. 19



### I don't think that 1 in 1,000 is 20



### adequate. I thin k a lower level is much 21



### more appropriate for that and it would drive 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### exposures down and provide a much more 1



### healthful workplace for workers. And better 2



### guidance for people that are overseeing 3



### these workplaces. 4



### I also would agree with Darius's 5



### comment. I don't think analytic feasibility 6



### should be directly tied to the REL. I think 7



### if you're going to

-- it's fine to make the 8



### determination, as Darius mentioned, those 9



### analytic feasibility tends to change over 10



### time. And even change from workplace to 11



### workpla ce depending on background 12



### contamination, the nature of the work 13



### process. 14



### So I think having a dual 15



### notation, one being a recommended health 16



### based exposure limit, is intended by the 17



### Occupational Safety and Health Act for NIOSH 18



### to recommend. 19



### And, secondl y, to list with that 20



### a feasibility limit based on the analytic 21



### feasibility, based on the current methods 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### that would change. That would provide 1



### guidance for people, not only as to what 2



### would be feasible in terms of measuring in 3



### the workplace for industrial hygiene 4



### purposes, but also would tell people sort of 5



### how much residual risk there may be based on 6



### what is feasible to analyze at this point in 7



### time. 8



### But I think that whole section 9



### needs to be really rethought and revamped 10



### before this policy goes forward . I 11



### understand your concerns, however I don't 12



### think that the precedent that's been made in 13



### terms of recommendations to OSHA and so 14



### forth, I think, are in a different context. 15



### And I think that the 1 in 1,000 16



### is not an appropriate targeted risk level 17



### for NIOSH to be making. So, I thank you for 18



### your time. 19



### DR. McKERNAN: Can we please have 20



### any questions from the panel ? 21



### DR. SCHULTE: Yes, thank you, 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### Jim, that was very helpful. I wanted to 1



### probe a little bit on the idea of the 2



### analytic feasibility. If y ou can't measure 3



### it, you really don't know what you have. 4



### So, it doesn't matter if we say some other 5



### level; if you can't measure that level you 6



### don't really know what's going on in the 7



### workplace. So, it's not really clear what's 8



### happening there. 9



### DR. ME LIUS: Yes, but often 10



### analytic feasibility is based on what can be 11



### routinely measured. And there may very well 12



### be techniques that are non

- routine and maybe 13



### not practical for everyday use, but allow 14



### measurements within the work place and do 15



### that. 16



### And a g reat example is asbestos, 17



### where phase contrast microscopy allowed one 18



### level of measurement, and electron 19



### microscopy could go to a much lower level. 20



### Now, all this may be substance specific. 21



### But I think that having sort of 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### the dual designations, first of all, one for 1



### an REL, second for what currently can be 2



### measured based on an analytic feasibility, 3



### routine analytic feasibility, I think would 4



### convey the same information, but recognizing 5



### there may be some level of residual risk 6



### that will not be able to be r outinely 7



### measured in the work place. 8



### I don't think it's an easy answer 9



### to it, but I think that's the best 10



### compromise. 11



### DR. SCHULTE: Well, thank you, we 12



### appreciate your comments. 13



### DR. SOFGE: I have a question 14



### about

-- 15



### DR. McKERNAN: Is your mic on? 16



### DR. SOFGE: Is that better? I 17



### have a question about you don't like 1 in 18



### 1,000 risk. So, do you have a 19



### recommendation for where you think we should 20



### go with what would be an acceptable risk 21



### level in your mind? 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### DR. MELIUS: Well, I think for a 1



### number, e ither 1 in a million, or 1 in 2



### 100,000. One in a million is preferable, but 3



### ties in more with other government policy 4



### and so forth. 5



### DR. SOFGE: Thank you. 6



### DR. McKERNAN: Thank you. We're 7



### now going to shift to our next presenter, 8



### who is Lee Anderson fro m the BlueGreen 9



### Alliance. 10



### MR. ANDERSON: Thank you very 11



### much. I think I might be too tall for your 12



### microphone but I'll give it a try. Thank 13



### you, good morning. I'm vertically 14



### challenged in a different way, but thank you 15



### and good morning. I appreciate the 16



### opportunity to give comments here today. 17



### Dr. Schulte, first of all, I 18



### wanted to say a couple things about a couple 19



### comments that you made that I thought were 20



### very positive this morning. You said that, 21



### whatever standard you're going to use, that 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### it w ill be NIOSH's aim to keep the risk 1



### lower than the stated standard, which is to 2



### the good. 3



### And that you would promote 4



### alternatives, safer alternatives, also to 5



### the good. It's actually something that our 6



### organization, the BlueGreen Alliance, has 7



### spoken on at great length. And we have an 8



### entire report on this on our website. 9



### The whole point being that the 10



### research and development needed to create 11



### safer alternatives is also a job creator. 12



### And I wouldn't be doing my job as a member 13



### of the BlueGreen Allian ce if I didn't bring 14



### up jobs. So those are very positive comments 15



### and I appreciate them. 16



### And I also was struck by your 17



### comment that the information that you'll be 18



### providing will set out the entire spectrum 19



### of risk, from 1 in 100 to 1 in a million. 20



### So yo u won't just be providing a single data 21



### point, 1 in 1,000. 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### That's great, that makes a lot of 1



### sense and gives a lot of data on which to 2



### base implementation decisions. So, also to 3



### the positive. 4



### But I wanted to talk about that 5



### risk level, the 1 in 1,000 risk level that 6



### we've heard other folks talk about this 7



### morning, because it is a primary point of 8



### concern for my organization as well. 9



### It is a little intimidating to be 10



### in the room with so many people who have 11



### doctor in front of their names. I'm just a 12



### simple country lawyer. But for that reason, 13



### you know, I wanted to talk about the old 14



### benzene case that all this is based off of. 15



### It struck me on the Metro as I 16



### was riding in today that more than two 17



### decades have passed since I first read that 18



### case as a first year tort student, which I 19



### find humbling. 20



### And I think I had memorized the 21



### phrase, significant risk, at the time. 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### Wrote it in a blue book and promptly forgot 1



### it. But then this came up in my career 2



### professionally, representing trade unions 3



### and work ers, and working on toxic tort cases 4



### to see the real world affect that the lack 5



### of appropriate chemical regulations can have 6



### on people. In my particular case, the 7



### context was asbestos and silica. 8



### And now here I am again 20 years 9



### later trying to find out what do we mean 10



### when we say, “significant risk?” 11



### Significant how? Who decides what's 12



### significant to whom? 13



### Well, since we are basing all 14



### this on this on the old decision, I thought, 15



### well, what did Justice Stevens, who wrote 16



### the opinion, actually say ab out it? I don't 17



### want to put words in the man's mouth, so I 18



### just brought it here. And I thought I would 19



### just read it. 20



### In the famous language that we 21



### all know, he says, "It is the Agency's 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### responsibility to determine, in the first 1



### instance, what it consi ders to be a 2



### significant risk." 3



### It is NIOSH's job. You decide 4



### what is significant risk. It has, "an 5



### obligation to find that a significant risk 6



### is present before it can characterize a 7



### place of employment as unsafe." And, by the 8



### way, risking error shoul d be done on the 9



### side of overprotection rather than 10



### underprotection. 11



### Why is that important? Because 12



### who's deciding what is or is not 13



### significant? That's your job. Even went so 14



### far as to say expressly, we, the Supreme 15



### Court, are not making that decisio n today. 16



### Again, I'll just read the language because 17



### Justice Stevens is a way smarter guy than I 18



### am. 19



### He says, “Nor do we express any 20



### opinion on the more difficult question of 21



### what factual determinations would warrant a 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### conclusion that significant risks a re 1



### present.” He expressly says they are not 2



### deciding that. They are not saying, the 3



### Supreme Court, they are not saying that 1 in 4



### 1,000 is the tip

- over point. That is not 5



### the cut point, which is a term I heard 6



### earlier this morning. 7



### It's somewhere in th at interval 8



### between 1 and a 1,000 and 1 in a billion. 9



### Where is that tip

- over point, however? 10



### That's for you to decide. If you say it's 1 11



### in 10,000, 1 in 100,000, 1 in a million, 12



### then it's the court's job just to evaluate 13



### whether the method by which you came up with 14



### that number was appropriate. 15



### Now, you can imagine the argument 16



### in the Supreme Court when one of the 17



### justices says, now, where did you get this 1 18



### in 1,000 standard? And the lawyer replies, 19



### well, we got it from you. What? That is 20



### not what t he benzene case said. They did 21



### not say we are giving you a standard to 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### follow. 1



### It even came up, I noticed it, it 2



### was even in the concurring opinion written 3



### by Justice Burger. He says the Secretary's 4



### factual finding of risk must be quantified 5



### sufficien tly to enable the Secretary to 6



### characterize it as significant in an 7



### understandable way. Precisely what this 8



### means is difficult to say. 9



### I should say it is. Twenty years 10



### later we're still not entirely clear what 11



### significant risk means. So I understand t he 12



### balancing that has to be done here because 13



### you have an obligation to OSHA, and I 14



### understand that OSHA has adopted that. But 15



### that presumes on the front end that OSHA's 16



### decision was correct. 17



### The discussion and battle over 18



### whether OSHA should be using t hat standard 19



### is for another day and another forum. Our 20



### question here is, should NIOSH be 21



### legitimizing and enshrining that decision? 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### That, what I would call, a bad decision, 1 1



### in 1,000. 2



### Now that's why I appreciate your 3



### comments, Dr. Schulte, when you sa y, we will 4



### push for greater protection. We will push 5



### for alternatives. That's great. 6



### But in the real world we all know 7



### there will be people who say, I've met the 1 8



### in 1,000 standard, now leave me alone. 9



### Maybe you have some way for doing 1 in 10



### 10,000, but I'm not going to do it. I don't 11



### have to, because that's not what it says. 12



### They're interested in what does 13



### it say in the regulation. Doing otherwise I 14



### think i t’ s simply advocating the Agency's 15



### responsibility over to the Supreme Court, 16



### which is not w hat is supposed to happen. 17



### Two, and I'll finish this point 18



### with an abswer to relate to the question 19



### that was asked, what should the number be? 20



### And it ties into some of these basic issues 21



### of fairness that we've heard other 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### commenters talk about 1



### If we'r e going to say, in this 2



### context it's 1 in a million, over here it's 3



### 1 in 100,000, over here it's 1 in 10,000, at 4



### a bare minimum it needs to be lined up with 5



### these other policy decisions. 6



### One in a million, what's wrong 7



### with 1 in a million? I don't know i f 1 in a 8



### million is perfect. But that is at least 9



### the sort of policy considerations upon which 10



### this decision is to be made. That's the 11



### phrase that Justice Stevens used. 12



### He said deciding that number is 13



### supposed to be a policy consideration. And 14



### the age ncies are where the policy comes 15



### from. So if you say, look, EPA has set it 16



### at a 1 in million standard in these contexts 17



### for all these number of years, why is that 18



### not perfectly valid? Why is that not, in 19



### fact, more valid than relying on the Supreme 20



### Court Justices, who do not set policy? So 21



### there's that. 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### It was also

-- I

-- one final 1



### comment on that, I noticed that in your 2



### actual document you say, "Keeping risk 3



### within 1 and 1,000 is the minimum level of 4



### protection. Controlling exposure to lower 5



### concentr ations is warranted because of 6



### excess risk of 1 in 1,000 is one or more 7



### orders of magnitude higher than what the 8



### U.S. permits for the general public." 9



### But what is not stated, there's 10



### not another sentence that says why this 11



### different level of risk should be acceptable 12



### in the workplace, when it is not acceptable 13



### for soccer moms shopping at Target. I take 14



### the point, but I don't know the why. Why is 15



### it different? 16



### It cannot be that we're saying a 17



### condition of your employment is that you 18



### accept a 1,000 time s greater risk of cancer 19



### because you took this job. That cannot be. 20



### It's just, you know, representing 21



### trade unions, as I did for a long time, and 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### working with folks on the shop floor, what 1



### invariably got them wound up and wanting to 2



### file a grievance or do an organizing 3



### campaign, was a basic sense of unfairness. 4



### I am being treated differently than that 5



### person over there. It's just human nature. 6



### And when you say 1 in a million 7



### over here, and 1 in 1,000 over here, it's 8



### glaringly unfair. I know why it's 9



### happening, I know why it's being proposed. 10



### I'm not characterizing, but there is an 11



### appearance there, a perception that can be, 12



### that can grow up in workers’ minds to say, 13



### look, you're valuing my life less than you 14



### are valuing those lives over there by 15



### for cing me to accept this greater risk. 16



### And then the last thing I wanted 17



### to touch on was this question of analytic 18



### feasibility. Again, I'm not an engineer, 19



### I'm not a scientist, I don't want to talk 20



### about it from that aspect. But I do want to 21



### point out som e unfortunate legal history 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### that played out in regard to asbestos and 1



### the old TSCA regime. 2



### An over reliance on this cost 3



### benefit analysis way of thinking is what 4



### broke National Chemical regulation. It's 5



### why TSCA does not regulate asbestos. 6



### Asbestos is unregulated because of an over

7



### reliance on cost benefit. 8



### Am I saying there should be zero 9



### cost benefit analysis? No. I recognize 10



### it's a balancing act. But you have to be 11



### very careful about that. And you can see it 12



### even now in the proposed fix to TSCA that's 13



### circulating up on the Hill right now. 14



### It contains what I think is the 15



### same type of cost benefit language that is 16



### going to be a trap door down the road, if 17



### that actually should become law. 18



### You know, there's other folks 19



### here who can talk about th e science and the 20



### engineering controls much more articulately 21



### than I. I'm just pointing out as a matter 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### of the unfortunate legal history, what can 1



### happen when you place too much reliance on 2



### cost benefit analysis to say, look, be very 3



### careful with that or you'll end up not being 4



### able to regulate it at all. 5



### With that, I think I will close. 6



### I'll be happy to answer any questions you 7



### may have. 8



### DR. McKERNAN: Do we have any 9



### questions from the panel? No. Thank you. 10



### Okay, our last scheduled presenter is Ho ward 11



### Marks from the National Asphalt Pavement 12



### Association. 13



### MR. MARKS: I’m going to decline 14



### at this time. 15



### DR. McKERNAN: You're going to 16



### decline at this time? Okay. Okay, great. 17



### Is there anyone else in the room that would 18



### like to make public comment s at this time? 19



### (No response.) 20



### Okay, Paul, do you want to make 21



### any additional comments at this time? 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### DR. SCHULTE: We're very grateful 1



### for all the comments. Certainly they were 2



### thoughtful comments and we will take them 3



### under consideration, sincere consideration. 4



### And hopefully they will be able to improve 5



### the policy and we look forward to any 6



### written submissions that you might want to 7



### make. And also those of the peer reviewers. 8



### DR. McKERNAN: We wanted to give 9



### one more opportunity for the folks on the 10



### phone to make any comments if they wanted 11



### to. 12



### AUTOMATED PHONE MESSAGE: The 13



### conference is now in talk mode. 14



### DR. McKERNAN: Okay, go ahead, 15



### sir. 16



### MR. LOOMIS: So, I am Dana Loomis 17



### from the International Agency for Research 18



### on Cancer in Lyon, Fr ance. And

-- 19



### DR. SCHULTE: Dana, try speaking 20



### up. 21



### MR. LOOMIS:

-- information as 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### part of the process that they've described. 1



### I would just briefly like to comment on the 2



### proposed policy. I appreciate a chance to 3



### do this. In general, I think the prop osed 4



### policy is very reasonable and consistent 5



### with current scientific understanding. 6



### And given the large number of 7



### substances that are used in industry and 8



### commerce, it's very important, I think, to 9



### have a scientifically robust and efficient 10



### way of ident ifying carcinogens. And the 11



### proposed policy accomplishes this, in part 12



### by drawing on existing evaluations from this 13



### agency and U.S. EPA and NTP. 14



### NIOSH has asked some specific 15



### technical questions that I wanted to comment 16



### on, and I'll submit written comm ents that go 17



### into more detail here, but one particular 18



### issue is that NIOSH has asked about the 19



### classification of IARC group 2B agents. 20



### And what I want to point out is 21



### that the proposed process actually neglects 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### one group of IARC 2B agents, and those are 1



### ones that have inadequate evidence in 2



### animals, but limited evidence in humans. We 3



### assign those to group 2B. 4



### It looks like NIOSH would not 5



### classify those to any GHS category. And I 6



### would suggest that these be approached the 7



### same as the other IARC 2B age nts with less 8



### than sufficient evidence in humans, and 9



### assign these also to GHS Category 2. 10



### The rationale for that is that 11



### even though the animal evidence is weaker 12



### than some other IARC 2B agents that would be 13



### assigned to Category 2, human evidence is 14



### str onger. And stronger human evidence 15



### should in essence compensate for the 16



### relatively weak animal evidence. 17



### Again, I'll describe this in more 18



### detail in written comments which I'll submit 19



### later. But that would be one 20



### recommendation. 21



### Just two other commen ts very 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### briefly. In the description of the 1



### evaluation process that we do for the IARC 2



### monographs, I think it would be useful to 3



### note that, like the EPA evaluations, these 4



### are also based on the weight of the 5



### evidence. 6



### Now, we have some documents that 7



### tal k about strength of evidence, but it's 8



### noted in those documents that that wording 9



### is employed for historical continuity. 10



### We acknowledge that the 11



### preferences in terminology have evolved 12



### quite a bit over in the last few decades 13



### since we've been making thes e evaluations 14



### and that now people see

-- or at least some 15



### people see a dichotomy between strength and 16



### weight. 17



### So, I'd suggest adding those 18



### words, “strength of evidence,” to the 19



### description of the IARC monograph process. 20



### And finally, although IARC does 21



### not conduct quantitative risk assessments or 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

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### make recommendations about exposure levels, 1



### we do support the notion that any such 2



### recommendations should be based on the 3



### science and not on other considerations. 4



### Well, that's all. Thank you very 5



### much for th e opportunity to speak. 6



### DR. McKERNAN: Thank you. Do we 7



### have any further questions from the panel 8



### for our speaker? No questions here. Thank 9



### you. Do we have any other speakers on the 10



### phone line that would like to make comments? 11



### (No response.) 12



### Anyo ne left in the room that 13



### would like an opportunity? 14



### (No response.) 15



### Okay. Did you want to make any 16



### additional comments? I have some ending 17



### ones. 18



### DR. SCHULTE: No, just again to 19



### say thank you to everyone for attending. 20



### There was a comment? 21



### MR. SIVIN: Yes, please. 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

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### DR. McKERNAN: Please hold on and 1



### wait for the microphone, sir. 2



### DR. SCHULTE: Okay. 3



### MR. SIVIN: Does NIOSH intend to 4



### make use of IRIS risk assessments in any 5



### part of its recommended exposure limit 6



### process? Either for carcinogens or for non

7



### carcinogens? 8



### DR. SCHULTE: The question was: 9



### does NIOSH intend to make use of EPA's IRIS 10



### risk assessments in any part of its process? 11



### We have been looking at them. Chris, do you 12



### want to talk about that? 13



### DR. SOFGE: Yeah, we've been 14



### looking into trying to do that sort of 15



### thing. It's not as easy as it seems like it 16



### should be, and that's one of the things we'd 17



### really like to get to that point where, you 18



### know, we shouldn't have three, four agencies 19



### looking at the same chemicals. And so, yes. 20



### That is

-- we're working on that. 21



### DR. SCHULTE: Okay, so, seeing no 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

- 4433 WASHINGTON, D.C. 20005

- 3701 www.nealrgross.com 

### other hands, once again thank you all for 1



### your input. Please send us your comments. 2



### We look forward to receiving them and we 3



### will be responding to them in the NIOSH 4



### D ocket. 5



### DR. McKE RNAN: Okay, so just a 6



### few concluding comments. I want to express 7



### my gratitude for all of you attending, both 8



### on the telephone and in person. 9



### I did get some emails that our 10



### sound quality did improve on the telephone 11



### in the lat t er part of the meeting, so I'm 12



### happy to hear that. 13



### I want to encourage everyone to 14



### consider submitting comments. And remind 15



### everyone that there are two methods to 16



### submit written comments. 17



### They can be submitted through the 18



### federal e

- rulemaking portal, which is 19



### regulations.gov. And you need to follow the 20



### instructions on that W ebsite. Be sure to 21



### reference the agency name and docket number, 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234

- 4433 WASHINGTON, D.C. 20005

- 3701 www.nealrgross.com 

### which is CDC

- 2013

- 0023. 1



### You can also mail your formal 2



### comments to the NIOSH D ocket O ffice. And 3



### that address is the Robert A. Taft 4



### Laborato ries, 4676 Columbia Parkway, Mail 5



### Stop C

- 35, Cincinnati, Ohio, 45226. All of 6



### these details are in the Federal Register 7



### notice and also at the NIOSH topic site 8



### which shows the cancer policy. 9



### Unfortunately, we have an error 10



### on of the slides that was show n today with 11



### the correct W ebsite. I wanted to give that 12



### address to everyone. And that is: www.cdc. 13



### gov/NIOSH/topics/cancer/policy.html. And we 14



### will be putting that up momentarily, so if 15



### you wanted to write that down, you could. 16



### Given the input that we 've 17



### received today, after you submit your 18



### comments, I would like to recommend that you 19



### actually go back and double check. There 20



### are humans involved in this process, so just 21



### double check that all the pages were 22NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A VE., N.W. (202) 234

- 4433 WASHINGTON, D.C. 20005

- 3701 www.nealrgross.com 

### submitted and posted. 1



### Thank you so much fo r your 2



### attendance today and have a wonderful day. 3



### (Whereupon, the meeting in the 4



### above

- entitled matter was concluded at 10:51 5



### a.m.) 6

7

8

9