OSHA: Proposed Standard For Indoor Air Quality: ETS Hearings, January 18, 1995
OSHA: Proposed Standard For Indoor Air Quality: ETS Hearings, January 18, 1995
UNITED STATES DEPARTMENT OF LABOR
OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION
PUBLIC HEARING
PROPOSED STANDARD FOR INDOOR AIR QUALITY
Wednesday, January 18, 1995
Department of Labor
Washington, D.C.
The above-entitled matter came on for hearing, pursuant to notice, at 9:35 a.m.
BEFORE: HONORABLE JOHN VITTONE
Administrative Law Judge
AGENDA
PAGE
R.J. Reynolds
Christopher R. E. Coggins
Michael W. Ogden
Paul R. Nelson
Stephen B. Sears
Michael W. Ogden
Christopher R. E. Coggins
Hoy R. Bohanon, Jr.
Questions:
Ms. Sherman 11588
Dr. Samet 11629
Ms. Sherman 11659
EXHIBITS
EXHIBIT NO. IDENTIFIED RECEIVED
NONE
P R O C E E D I N G S
9:35 a.m.
JUDGE VITTONE: Good morning. We resume our hearings this morning on the Occupational Safety and Health Administration's proposed rule on indoor air quality.
We had the direct presentation yesterday by the panel from the R.J. Reynolds Tobacco Company. We began questioning in a limited area by Ms. Sherman and we resume with Ms. Sherman and the OSHA panel this morning.
Ms. Sherman?
MS. SHERMAN: Good morning. How do you accommodate non-smokers at RJR?
DR. COGGINS: Ms. Sherman, we realized last night -- just before we answer any of your questions --
JUDGE VITTONE: Excuse me.
(Pause)
JUDGE VITTONE: Ladies and gentlemen with the cameras, it's the same procedure as yesterday, okay? I'd like the cameras to remain where they are. At 11:30, if you need to move the cameras to take a side shot, that would be fine, on either side. I don't want you up on the stage, though, okay?
I guess these two pillars right here on either side will be the furthest point that I would like for you to come, okay? But otherwise, between now and 11:30 and after you take the side shots, I want the cameras to remain where they are.
Thank you.
All right. I'm sorry. Now we will begin.
MS. SHERMAN: As you were saying?
DR. COGGINS: We realized last night we hadn't answered one of your questions and that was concerning leased buildings.
MS. SHERMAN: Yes.
DR. COGGINS: And Mr. Bohanon now has the answer for that question.
MS. SHERMAN: Good.
MR. BOHANON: What we were talking about with regard to leased buildings, I still don't have the numbers, but the specific question had to with what one does in leased buildings or how one assures indoor air quality as a tenant or occupant in a leased building.
MS. SHERMAN: Yes.
MR. BOHANON: I wanted to share with you some of my personal experience in being the tenant's representative or the building manager accountable for our tenants and occupants in leased space where there were multiple tenants within the space and we did not own the building.
In that case, again, what our practices were, and still would be, is that before we enter into any lease agreements we inspect the building, assess the quality of the HVAC system to assure that the owner has good maintenance practices. We certainly make sure that we define comfort levels within the terms of the lease. And in one case that I can think of where there was a large building that seemed to in fact not have any humidification at all, as a part of signing the lease we required that the building manager as a part of leasing the space provide an HVAC upgrade so to speak to provide humidification in the space so that we could maintain comfort levels in the coldest part of the winter when it gets very dry.
So I think that by showing a proactive interest during the lease process in the operational aspects of the building, which includes the HVAC system but also goes beyond that on other tenant service issues such as deliveries of packages and mail and cleaning frequency of both the office space and common areas, all of those operational factors, we take that into account in the lease negotiation process, and that's really our practice in how we do that.
The other thing I would like to just clarify, you're asking me about policies which implies we have some huge book of policies and in fact 10 or 15 years ago we did. We had several books that were massive and it was hard to keep up with what all those written policies were.
In streamlining our internal bureaucracy, much of that is gone and really we rely on good practice because practice is more flexible than policy. As an example I gave you yesterday, if someone has found some sort of an insect infestation in their office, it really doesn't behoove the building manager or the company to go in and say, well, such and such policy prevents me from taking care of this problem.
So relying on good practices and good judgment of people who have the accountability to provide building services and supervise the maintenance services with regard to the HVAC systems are really, I think, the keys to providing good indoor air quality as far as things relate specifically to the air.
MS. SHERMAN: By the way, do you know whether R.J. Reynolds is participating in this building air quality alliance program that's being sponsored by the U.S. Environmental Protection Agency?
MR. BOHANON: I believe that at this point in time we are not participating in that project with the EPA. In fact, at this point in time our relationship with the EPA is not at its best. We are in litigation with them.
MS. SHERMAN: So that's why you're not?
MR. BOHANON: I would think -- basically, we have a disagreement. As I understand, some of the qualifiers in that program are things that we disagree with, specifically with relationship to environmental tobacco smoke.
MS. SHERMAN: How do you accommodate non-smokers at Reynolds?
DR. COGGINS: Hoy?
MR. BOHANON: Our policy is that smokers and non-smokers both need to be accommodated and smokers and non-smokers need to deal with each other's wishes. And that's really enforced on an individual-by-individual basis. It's up to individuals to work out what their practices are within various work areas.
Now, I would point out that with proper ventilation of our workspaces we have very low levels of any indoor contaminants, including anything that might come from environmental tobacco smoke, so there really doesn't exist that situation of the smoke filled office or smoke filled conference room.
MS. SHERMAN: Do you happen to know how many of your employees smoke and how many don't smoke?
MR. BOHANON: No, I don't happen to know that in total. We did report on a survey, in fact, the experiment that we ran on the one floor of the building and I can look up the number. I believe there was something around 30 percent smokers on that one floor of that building.
MS. SHERMAN: Well, do you have any reason to believe that that's representative of the company workforce?
MR. BOHANON: No, I don't. It's just a single sample of one occupational segment of our workforce and would not, I don't think, represent the whole workforce.
MS. SHERMAN: So you don't keep track of smokers versus non-smokers in terms of your health insurance or anything else?
MR. BOHANON: I don't know the answer to that. I don't know why we would but I don't know.
MS. SHERMAN: If you do have this data, I would like for you to submit it as a post-hearing comment.
Do you keep any data on employee absenteeism?
DR. COGGINS: I'm sure we do. That's probably out of our domain as scientists.
Does anybody know anything about absenteeism?
I don't think we do.
JUDGE VITTONE: Could we have maybe a little bit more specific question?
MS. SHERMAN: Okay. What I was going to ask them is if they keep data on employee absenteeism and if there is a difference in absenteeism between your smoking employees and your non-smoking employees.
If you have such information, I would like for it to be submitted as a post-hearing comment.
DR. COGGINS: There are a number of papers on the rates of absenteeism in smokers and non-smokers. I don't think we have any data on that but the paper I am particularly thinking of has examined this and, of course, smokers and non-smokers are different in many facets other than just the fact that they smoke. So just taking the rate of absenteeism in the two groups and saying, ah, there's a difference and it's due to smoking, was examined in the paper and I don't have it with me but I can certainly find it.
MS. SHERMAN: Well, if you wish to submit that paper also but I am asking more for the experience of your company.
DR. COGGINS: Okay.
MR. BOHANON: Again, I don't believe that we count smokers and non-smokers in our workforce. I think in general we believe that's an individual's business as to whether or not they're a smoker.
MS. SHERMAN: Do you make available your product to your employees at a discount?
DR. COGGINS: I've never seen any. I don't know if anybody else has. We certainly don't get free cigarettes.
MR. BOHANON: The answer is no, I don't believe that we do. I believe it's the retail price.
DR. COGGINS: Dr. Ogden?
DR. OGDEN: Well, first of all, to reiterate, cigarettes are not distributed to the employees. There is a souvenir store that I'm aware of that does sell cigarettes in addition to other souvenir items and I believe there is a very minimal discount on everything in that store and that does include cigarettes. But it's a minimal discount.
MS. SHERMAN: That's just at your headquarters building?
DR. OGDEN: I don't believe there is one at the headquarters building. I believe it's associated with the factory.
MS. SHERMAN: You do conduct your own research and you also contract out research?
DR. COGGINS: The work we've described today, yesterday, of course, is all of our own research and occasionally we do contract other research out. Yes. But the work that, for example, I described, it was all done in-house and I was the principal investigator. The other guys here, the work that they presented yesterday was their own work. Yes.
MS. SHERMAN: And you also contract out research?
DR. COGGINS: Yes. On occasion, we contract out research, too.
MS. SHERMAN: What types of research project would you contract out instead of doing in-house?
DR. COGGINS: I can only speak for my area so I will and then I'll ask the other guys if they have any comments. We've contracted out a number of toxicology studies to contract research laboratories, the main reason being for some confirmation of the results that we have performed. We may want to get a second lab's opinion.
Other reasons are sometimes that we have such a workload in our in-house facilities that we can't get it all done and so we use an external facility.
MR. GROSSMAN: Let me clarify the question, if I may, Ms. Sherman. You're referring to research dealing with ETS, certainly not research dealing with, say, new product development or anything else.
MS. SHERMAN: That's correct.
How do you select the contractor when you feel it's necessary to contract out a project, to replicate your results or to explore something you don't have time to?
DR. COGGINS: As far as I know, we haven't, and I didn't realize that Mr. Grossman was going to make the point, we haven't as far as I know contracted out any ETS work but I can answer it in a very generic sense of how I would select a laboratory. It would be on the basis of their expertise, their published record and knowledge of the individual scientists.
JUDGE VITTONE: Excuse me a second. I think the question was related to ETS. Is that correct?
MS. SHERMAN: Yes, it was.
JUDGE VITTONE: While I appreciate you're trying to be as complete as possible, I don't want to get into extended answers or extended questioning on subjects that really are not part of the proceeding.
MS. SHERMAN: You also make contributions or fund the CIAR, do you not?
DR. COGGINS: I don't know too much about the Center for Indoor Air Research. I understand that they are a grant-giving body and I understand that we donate funds to that body. Other than that, I don't know too much about them.
Can anybody else on the panel comment on that?
DR. OGDEN: No, I would just concur with that. I do believe Reynolds is a sponsor, which means they do contribute, but as to details of the amount, I couldn't speak to that.
MS. SHERMAN: Well, I guess -- and perhaps nobody on this panel can answer it, I am interested in how contributions are made to the CIAR. Are they made on the basis of a specific project that gets supported or is it a yearly grant? And who in the company has anything to do with that?
DR. COGGINS: I think my answer to both those questions is I don't know.
DR. OGDEN: Yes. I'm not sure that I know any details about that either.
MS. SHERMAN: Well, R.J. Reynolds has a very large research budget, judging from the number of laboratories and everything that you have. When -- I don't know if you would call it a grant or just money is given to another agency such as CIAR, I guess in a post-hearing comment I would like to know who makes these decisions and what criteria is used and the percent of the research budget that gets parcelled out in this manner.
MR. GROSSMAN: Is that going to affect the question of whether there is substantial evidence on the record that ETS presents a significant risk of material impairment of health?
MS. SHERMAN: Well, I think what it does, Mr. Grossman, is it suggests how research is carried out by your company and the relationship with the research projects. When the company does a research project, of course, they control it. If they ask a contractor to do it, they perhaps control it. If they give a grant, maybe they do and maybe they don't.
MR. GROSSMAN: The panel has testified that to their knowledge Reynolds has not contracted out ETS work.
MS. SHERMAN: And my next question was what about work done by the CIAR, do they fund it. And the answer, I believe, was that they know that some funds are given to CIAR and I'm trying to explore how this happens.
MR. GROSSMAN: I don't see the relevance of your request but we'll take it under advisement.
JUDGE VITTONE: Can you provide a statement of what your relationship with this organization is? I think that's essentially what she's asking for.
DR. COGGINS: I can give you my answer and that is that --
JUDGE VITTONE: Do you know?
DR. COGGINS: The answer is that R.J. Reynolds provides some funds to the Center for Indoor Air Research. I'm not sure if it's done on an annual basis, on a project basis. There are many other companies, I think, that are involved. That's all I know.
MS. SHERMAN: Do you know if R.J. Reynolds has representatives on the board of CIAR?
DR. COGGINS: Again, I don't know.
MS. SHERMAN: I believe Mr. Ogden helped participate in the Oak Ridge study, did you not?
DR. COGGINS: That's Dr. Ogden.
MS. SHERMAN: Dr. Ogden.
DR. OGDEN: I did. That's correct.
In answer to your previous question, which board are you talking about? The board of directors or the science advisory board?
MS. SHERMAN: The board of directors.
DR. OGDEN: Yes. I believe that there is at least one representative from R.J. Reynolds on the board of directors.
MS. SHERMAN: And who is that?
DR. OGDEN: I believe Dr. Green is on the board of directors.
MS. SHERMAN: And what is his position in the Reynolds company?
DR. OGDEN: I believe his job title is Principal Scientist.
MS. SHERMAN: Do you work for him?
DR. OGDEN: No.
MS. SHERMAN: Okay. What other people from Reynolds helped participate in the Oak Ridge study?
DR. COGGINS: Mike, I think you're the expert on this one.
Dr. Ogden?
DR. OGDEN: Are you asking me for a list of names?
MS. SHERMAN: Yes. And their positions. Are they all people who work for you?
DR. OGDEN: No. Gosh. There are many people because we had a multi-disciplinary team.
MR. GROSSMAN: Excuse me one moment.
(Pause)
MR. GROSSMAN: I don't see any reason for providing a list of employees. And, in fact, let me reiterate something that I said at the beginning of this.
On the first day of these hearings, I asked your panel, Ms. Sherman, who wrote the NPR, who wrote the sections of the NPR, which members of the OSHA staff wrote which sections of the NPR so they could be questioned, and you refused even to give that.
Now, we'll take under advisement your request for the employees of Reynolds who participated in some way or another in the Oak Ridge project. We won't be giving those names now but I would like to know from your agency who is responsible for which portion of the NPR so that we in any --
JUDGE VITTONE: Mr. Grossman, you can make that -- this is not the time to raise that.
MR. GROSSMAN: In any event, we'll take advisement that request.
JUDGE VITTONE: You've made your point.
DR. OGDEN: What I can do, Ms. Sherman, is I am familiar with all of our involvement and I believe I can adequately address any questions you have about any particular piece of that involvement as to what we did without getting into who did what. And I would be happy, to the extent of my knowledge, to represent the nature of the science, the quality of the science and to the extent I'm able answer your questions directly on those issues.
MS. SHERMAN: Okay. Did the marketing firm that was involved in the study, I don't remember their names, perhaps you do?
DR. OGDEN: Yes. Bellomy Research.
MS. SHERMAN: Did Reynolds suggest Bellomy Research as a participant in the study?
DR. COGGINS: Yes, please, Mike.
DR. OGDEN: Our history or my particular research history with Bellomy Research predates the study done by the Oak Ridge National Laboratory. When this particular project was conceived, we already had a relationship, a research relationship, with Bellomy Research in conducting exposure monitoring studies. In fact, since 1991, we've conducted studies. The studies that I've testified to here on the record, we have conducted with the assistance of Bellomy Research.
So when the Oak Ridge project came, we suggested Bellomy Research as one agency that we had worked with. We knew that they were competent. We knew that they had relevant experience and we knew that they could do a good job.
So to that extent, yes, we provided the name of Bellomy Research as somebody we could attest to could do the quality and the quantity of the job that was being asked.
MS. SHERMAN: And they were hired on your recommendation?
DR. COGGINS: Didn't we work that out with -- CIAR was the overall sponsor of the work, isn't that right, Dr. Ogden?
DR. OGDEN: Yes. The Center for Indoor Air Research sponsored the project. Oak Ridge National Laboratory principal investigators, as he testified some weeks ago, had final authority as to who participated and who did not participate and that included the participation of Bellomy Research.
DR. NELSON: If I could add to that --
DR. COGGINS: Dr. Nelson.
DR. NELSON: When Dr. Roger Jenkins testified, he made some statement to the extent that he also approved and agreed with the use of Bellomy Research.
DR. COGGINS: Thank you, Dr. Nelson.
MS. SHERMAN: Your lab, then, went out and assisted the principal investigator in taking the samples?
MR. GROSSMAN: I'm not sure I understand when you say "your lab". What are you referring to?
MS. SHERMAN: I believe that R.J. Reynolds did the analytical work in the Oak Ridge study and I believe it was Dr. Ogden's lab that did this analytical work. Am I incorrect?
DR. COGGINS: Is that right, Dr. Ogden?
DR. OGDEN: My lab and another lab. Yes.
MS. SHERMAN: Which other lab?
DR. OGDEN: Part of the analysis, the air quality monitoring, the exposure markers, were done in my laboratory. The cotinine determination in saliva is done in a biological chemistry area of research and development.
MS. SHERMAN: Within the Reynolds company?
DR. OGDEN: Yes. Within Reynolds Research & Development.
DR. COGGINS: So we measured nicotine and cotinine in saliva --
DR. OGDEN: Yes. Let me be specific. We measured only cotinine in saliva. That was done in a biological chemical research unit. Then in our particular group, my particular group, we measured all of the other airborne markers of environmental tobacco smoke.
MS. SHERMAN: How many laboratories do you have at Reynolds?
DR. COGGINS: A lab, is it four foot by four foot or a great long building? That would be a difficult question to answer.
MS. SHERMAN: Okay. Are your laboratories organized along the lines of who is in control of the laboratory or what the subject matter of the laboratory is?
DR. COGGINS: The labs are in a constant state of change. Facilities move, management changes. Within the Research & Development Department, which is, of course, the only --
MS. SHERMAN: The Research & Development Department is the only department that has laboratories, is that true?
MR. GROSSMAN: I don't even know what you mean by the term laboratories, Ms. Sherman. Are you referring to buildings in which scientists do work?
MS. SHERMAN: And experiments. Yes.
DR. COGGINS: For example, Mr. Bohanon here is not part of Research & Development and yet he has laboratories.
MS. SHERMAN: Okay. So you're part of the engineering department, Mr. Bohanon?
MR. BOHANON: I'm a part of the Environmental Department. We have a laboratory where we analyze water samples as a part of our environmental activities.
MS. SHERMAN: In the Research and Development Department, do most of the laboratories in the company come under the Research & Development Department?
MR. GROSSMAN: Once again, I don't understand how organizational structure at Reynolds is of any relevance to this proceeding, Your Honor.
MS. SHERMAN: I'm trying to understand how the research is done and what research and organization you have to do it so I can better direct my questions.
JUDGE VITTONE: Are your questions more related as opposed to laboratories in buildings as opposed to -- not laboratories in buildings but questions of laboratories on subject matter or subject line, particular areas of science?
MS. SHERMAN: Yes.
JUDGE VITTONE: Okay. Does that help answer your question?
DR. COGGINS: I wouldn't know how to count them. There are so many peripheral parts. For example, Dr. Ogden mentioned that one lab was doing some analyses of salivary cotinine. That may well have been a very small fraction of their overall work but as part of Dr. Ogden's study, it was a large part. There are many, many labs that could be participating in a major or minor way and for me to give you an answer of (a) how many labs there are and (b) how much of their work, if any, is related to environmental tobacco smoke, I really couldn't do it.
MS. SHERMAN: Well, could you submit to the record the organizational structure of R.J. Reynolds' Department of Research and Development?
MR. GROSSMAN: Once again, we'll take this under advisement but I really think it ill behooves this agency that refused to allow its own scientists to testify to the NPR that they wrote to ask for organizational structure of people who have come here to testify in this proceeding and give information as we did for a full day yesterday of a scientific nature that might be useful to the agency in deciding whether to proceed with the regulation.
MS. SHERMAN: What is the mission of the R.J. Reynolds deBethizy lab?
DR. COGGINS: Don't know what the R.J. Reynolds deBethizy lab is. I know a Dr. deBethizy.
MS. SHERMAN: What does he do in his laboratory?
MR. GROSSMAN: Once again, first of all, I don't know if this relates to proprietary research that Dr. deBethizy may do or to non-proprietary research. I would direct the witnesses not to answer any question that relates to the development of new product or other proprietary information. And I don't know what this has to do --
JUDGE VITTONE: If the question relates to product development or something of that nature, you can object to the question. But if he knows who --
What's his name?
MS. SHERMAN: deBethizy.
JUDGE VITTONE: If you know who Dr. deBethizy is, if you can answer the question, I'm going to ask that you do so, please, Dr. Coggins.
DR. COGGINS: I know Dr. deBethizy. He is in charge of a large group within R&D. When I say large, I think it's in excess of a hundred people. I have no idea what the vast majority of those people do. I know a couple of the individuals, even some of them are on this panel. To say what does his lab do is a very, very large question. I can't tell you the entirety of it.
MS. SHERMAN: Well, okay. We have some submissions from Dr. Doolittle.
DR. COGGINS: Right.
MS. SHERMAN: Does he work for Dr. deBethizy or does he have a separate area of expertise?
DR. COGGINS: As I said earlier, the management structure changes continually in R&D. I think Dr. Doolittle does report to Dr. deBethizy, yes.
MS. SHERMAN: Do you know the mission of Dr. Doolittle's laboratory? I assume he has one.
DR. COGGINS: In terms of a formal mission, like a formal policy that Mr. Bohanon was saying? I'm not sure if he does.
MS. SHERMAN: The type of research that he does in the laboratory.
MR. GROSSMAN: Dr. Doolittle had a submission that indicated the nature of the work he was doing.
MS. SHERMAN: Dr. Doolittle had a submission that was perhaps one aspect of the work he was doing. We have many papers in the docket.
MR. GROSSMAN: You want to know about things that an individual employee of Reynolds does other than relating to the ETS matter here?
MS. SHERMAN: No. Dr. Doolittle has submitted many papers to the docket on different areas.
Correct, Mr. Coggins?
DR. COGGINS: Yes, that's right. I have them in front of me. For example, his comments on the genotoxicity of environmental tobacco smoke.
MS. SHERMAN: Correct. Does he do research in this and other areas?
DR. COGGINS: Clearly, otherwise he wouldn't be able to written the comments and delineated the research results that I presented some of yesterday. For example, the DNA adduct data that I presented yesterday came directly from Dr. Doolittle's laboratory. We work together.
MS. SHERMAN: Does he work for you or do you work for him?
DR. COGGINS: Neither.
MS. SHERMAN: You are colleagues in the same department?
DR. COGGINS: He, like myself, are both board certified toxicologists so we tend to have informal communications, yes
MS. SHERMAN: When somebody, let's take you, Dr. Coggins, since you're here, when you have a research project, how do you go about getting the project approved?
DR. COGGINS: Certainly. I can give you a very good example of how we got our research approved on environmental tobacco smoke because we have the full papers that are in the docket. I can describe if you wish exactly how we got that project underway.
MS. SHERMAN: Did somebody ask you to do the research or did you decide that the research was useful and you went to somebody for approval?
MR. GROSSMAN: Ms. Sherman, I believe you cut off the witness when he was about to describe the process.
JUDGE VITTONE: Well, I think she was following up with the question. He made an offer, she's following up with the question.
DR. COGGINS: Okay. Let me give you, then, the example of how we initiated our biological research on ETS.
The work was originally initiated as a result of conversations between myself, Dr. Doolittle and Dr. Lee. Dr. Lee and I had reviewed published work on animal studies with environmental tobacco smoke and we felt that these studies were of very poor scientific quality for the reasons I gave yesterday. Many of the studies used the wrong test material, mainstream smoke, and most of them used the wrong concentrations. They used massive concentrations of the wrong material.
Dr. Lee and I decided to put forward a research protocol whereby we would develop a method for exposing animals to aged and diluted sidestream smoke such that we could perform toxicological evaluations.
Dr. Lee and I worked along with other colleagues in the inhalation department, Drs. Mosberg and Ayers and a large number of multi-disciplinary meetings were held between the scientists. We then came out with a plan of action of how we would want to build a facility and we then took that plan, the construction of the inhalation laboratory that I described yesterday in my slides, and said to management this is what we want to build.
MS. SHERMAN: And this would be the head of the research department that you would send this to or is there some funding board or how does this work?
DR. COGGINS: I can't recollect the exact detail. It wasn't anything like as high as the head of R&D. I believe it went to our then department head and we said, look, to build this will take us X dollars and Y days, can we go ahead. We were given that permission, built the facility and then tested it out, did a number of runs under different experimental conditions. And then went back and said, okay, we're now ready to do some animal work, having proven the facilities work.
MS. SHERMAN: And which Dr. Lee is this?
DR. COGGINS: Dr. Chin Lee, who is the co-author on the 90-day paper.
MS. SHERMAN: And --
DR. COGGINS: I hadn't quite finished.
MS. SHERMAN: I'm sorry. I didn't mean to interrupt you.
DR. COGGINS: So once we said that we could perform biological studies, we wrote a research protocol and said that we wanted to do the kind of studies that are described and that we have published and we decided to embark on the 14-day study that we performed originally.
We then looked at the results of that and said, well, yes, that's very interesting but we would really like to see a little bit longer term exposure and then we wanted to add on the extra endpoints that I described to you yesterday. Again we went to management and they just said go ahead.
MS. SHERMAN: Is this a formal process? Is this all done in writing in terms of proposals?
DR. COGGINS: We have a formal position for the definition of an experimental protocol. This is largely required in the area of animal use. We have a number of internal committees that we have to ensure that we do not break any of the principles of animal experimentation, so we have a formal protocol that is approved by, for example, pathologists, veterinarians and, indeed, we have a group called Institutional Animal Care and Use Committee and they reviewed the procedures that we