Meeting Transcripts Meeting Proceedings[899]

304 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Friday, May 20, 1994 ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES (ACMUI) MEETING [OPEN SESSION] Holiday Inn 8120 Wisconsin Avenue Bethesda, Maryland UNITED STATES NUCLEAR REGULATORY COMMISSION 305 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 CHAIRMAN SIEGEL: meeting this morning. P R O C E E D I N G S (8:30 a.m.) I would like to reconvene the Before we begin with our formal agenda, Dr. Almond has a comment he wishes to make. DR. ALMOND: This is Almond. This is just to follow up on my statement and information of patients who die with this disease. I've just checked with my office. The notice from my Kentucky State Health Department Radiation Control clearly states that such patients who die must not be cremated because this is a U.S. Nuclear Regulatory Commission policy. have not gone beyond that but that is stated, and they would not come up with that without some input. This needs to be resolved because it is being suggested that this is a U.S. Nuclear Regulatory Commission's policy. CHAIRMAN SIEGEL: DR. QUILLEN: So noted. I checked with my I I'd like to comment. office, and my office said that they could not ever remember seeing such a policy. I happened to speak with another state last night which also could not remember having seen this as an NRC policy. DR. GLENN: I checked with our Office of State 306 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Programs this morning, and there has not been a communication from our Office of State Programs to the States. There is a letter going out stating what we know about the situation, but there has been no directive that I can identify any source that has said cremation should not be permitted. DR. MARCUS: the situation? What do you mean, what you know about Just denying that you put out a policy? I personally did not. I checked the DR. GLENN: Office of the Nuclear Regulatory Commission that has the responsibility. They have not. Okay. Region V -- Jack Horner was DR. MARCUS: telling people that it's a bad idea to cremate things, and I think that may be the origin of this whole thing. It may not be official, but he stopped somebody in Nevada from doing it. CHAIRMAN SIEGEL: Well, the information is out there It's not something now for people to act on as appropriate. this advisory committee needs to deal with. Our first item on agenda today is to review the bylaws -- the draft bylaws -- that have been prepared for this committee. You all will be aware that a staff requirements memorandum published about a year ago suggested to NMSS staff that it might be prudent for this advisory committee to add bylaws similar to the bylaws that are used by ACRS and ACNW. 307 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 us. The staff has subsequently developed draft bylaws for I've provided each of you with copies that I marked up last night that reflect comments that I received from Dennis Swanson, Peter Almond; substantial comments from Bob Quillen and generic comments from Dr. Marcus that I tried to address in a generic sort of way. I also, as you will see, have tried to make the document gender neutral. We can argue about whether a chairman should be a chair or chairperson, a chairwoman, or any term you prefer; whether "man" should be spelled with an "a" and a woman with a "y" and all of these other things, but I've made them gender neutral, and we can leave them that way. Now one important element of preparation of the bylaws relates to the fact as to what extent each of us loses our constitutional rights as citizens when we become special government employees and when we act as members of this committee. That might be a way of reframing the argument as I've heard it expressed. Consequently, Ms. Susan Fonner from the Office of General Counsel has agreed to come here this morning to present us with an overview of the Federal Advisory Committee Act, and we're going to do that first. However, I've been told that she's not been prepared to answer questions, that she'll take 308 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 on written questions that would be funneled through me and would then be prepared to have answers come back to us at a later time from the Office of General Counsel. I personally find that a little difficult to understand, but that's life in the big city. Because of that, Susan, I'm going to ask you to please do the following. Rather than give a long spiel about FACA and what it does and doesn't do, because of the fact we've all seen the act and understand its predominant features, what I would ask you to please focus your comments on is to what extent special government employees become bound by the rules of the agency for which they work and to what extent documents provided to this committee are under the control of the NRC rather than in the public domain. If you can try to restrict, you're certainly welcome to give us some general information, but in the interest of time I'd rather have you try to focus on those things. MS. FONNER: I'm sorry, Dr. Siegel, but I've come prepared to give remarks, and these are the remarks I'm prepared to give. I will touch lightly on the subjects that you have raised, but I'm really not prepared to go into them to any depth. The understanding, and I had conveyed this to the 309 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 staff that provides support to the committee, was that I was going to give an overview of the Federal Advisory Committee Act at this meeting, and that's all that I am prepared to do. We would be glad to entertain questions you have in the Office of General Counsel if they are channeled through you and provided to us, but I am not prepared to discuss any particular subject in depth at this time. Hopefully, you can bear with me. If you feel that this is superfluous, then I will certainly understand, and you can go on with your next subject. CHAIRMAN SIEGEL: Okay. Why don't you proceed, and if it seems as though this is information that is not helping us, then we may just stop the discussion. I don't mean to be adversarial, but we're trying to resolve some issues that we need to deal with, and an overview may not help us. There are some specific problems, and I'm reasonably certain that those specific problems were transmitted by Mr. Camper when he met with OGC staff on Tuesday. MS. FONNER: I'm the OGC staff he met with, and also another attorney from OGC, and he did convey to me that there were concerns, but I conveyed to him the sentiments of the general counsel's office about what we are prepared to speak about at an open public meeting. 310 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 With that, stop me, if you like. CHAIRMAN SIEGEL: MS. FONNER: Continue. This is truly going to be an overview, but I'll try to make it as informative as I can. The Federal Advisory Committee Act, which is often referred to as FACA, was passed in 1972, after about 20 years of efforts on the part of the Congress to develop such legislation. It dictates procedure and not substance. In other words, it tells how an advisory committee is to be established, when an advisory committee must be established, procedurally, and what the procedures are that need to be followed. It never tell us what the nature of your substantive advice is required to be. The reasons for enactments of the act, which I think are important in interpreting it, was that there was a feeling in the Congress that, number one, there were too many advisory committees being used by the Executive Branch; and, number two, that the membership and advice was not readily available to the public and sometimes to other branches of the government. That concern, of course, related, in part, to possible conflict of interest; namely, individuals who were giving advice as members of advisory committees, might have 311 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 ago. some kind of a financial interest in the very matter they were advising about. Since its enactment in 1972, there have been some changes in the act, but not very many. If you are as familiar as Dr. Siegel says you are with the act, you'll probably notice it's not a marvelously well-drafted act. There are many gaps. Some of these are filled in my GSA regulations. GSA is the lead government agency. Government Services Administration. That's the They have a special office, the Committee Management Secretariat, which coordinates all of the agencies on the subject, and they've developed regulations which try to fill in at least a part of what was left out of the statute itself. NRC has regulations which were adopted a few years For the most part, they mirror the GSA regulations. Other administration of the act is through the agency committee management officer, and I don't know whether any of you know him or whether he's ever spoken to you. Hoyle, in the NRC, for a long time. That was John It's now Andy Bates. The role of the advisory committee management officer is to coordinate all of the advisory committees in the Agency and to help them when they need to prepare reports and matters of that nature. 312 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 There's also a designated federal officer. that's you, John, for this Committee. DR. GLENN: MS. FONNER: Correct. The designated federal officer has some There has to be one for every Right? I think very important responsibilities. advisory committee. committee meeting. He has to be present at each advisory He also has to approve the agenda of the advisory committee meeting. He is really there, in large part, to ensure that procedurally things go according to the statute and regulations. Of course, the Office of General Counsel has a We provide advice on many legal general advisory function. issues that arise under the FACA and its interpretation. As we said at the outset, please feel free to provide any questions you have about the act, the regulations, or their interpretation to your chairman, and he will, through the staff, provide them to my office, and we will respond. The salient features of the act are the definition of advisory committee, which is a group that is not made up of full time federal employees -- that's important, because a group made up only of full time federal employees does not fall under the act. It has to be established by statute or by an It can be established by the Executive Branch agency. 313 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 President, of course. It's established for the purpose of giving recommendations or advice to the agency which establishes it. An advisory committee automatically terminates after two years, unless it's renewed. So every two years an advisory committee has to be renewed or it terminates unless there is a statute that provides to the contrary. When an advisory committee is established, the Agency has to send a charter to the GSA for their review and, with that, goes a letter explaining how the advisory committee is fairly balanced. Balance has always been an issue. A cross section of those affected, who are interested and qualified are supposed to be represented on any such committee. Since the early days of the Clinton Administration, the Office of Management and Budget has developed a significant role in the establishment of advisory committees. Not only do advisory committees now have to be approved through the GSA process, but also by OMB. That was because, at least in the early days of the Administration, there was concern that there were too many advisory committees in the government and they were costing the government too much money. As the Administration has become more knowledgeable 314 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 about the role of advisory committees, how important they are, and that they actually often save the government money, I think this attitude has somewhat softened. Nonetheless, we still Of course, that have to go through OMB for new Committees. doesn't affect this Committee, since you are not a new advisory committee. The salient features of the act, besides definition, which is very important, by the way, because, for example, the definition of advisory committees under the regulations has a series of exceptions. A meeting to exchange information, or an open meeting where you are simply getting individual views of outside parties, doesn't fall understand the act. Advisory committee members are usually government employees. That's the overall U.S. Government policy, and it's also the NRC policy. The consequence of that is that you are subject, as a government employee, even if it is a government employee who serves only a limited number of days per day to conflict of interest laws, and I think you get a talk periodically from a member of the general counsel's office on that subject. CHAIRMAN SIEGEL: might point out. MS. FONNER: Well, I'm glad to hear that. I will And quite an interesting talk, I 315 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 tell the attorney who gives it. I'm sure he'll be flattered. There are some other consequences besides being subject to the conflict of interest statutes and regulations. It also means that whether you are a government employee or a special government employee, you are subject to, in a broad sense, to the supervision of the agency. Once an advisory committee is established, there are procedures that must be followed in running the advisory committee. I mentioned already that the designated federal officer must also be present but, in addition to that, there are such niceties as: All meetings must be noticed. Of course, this meeting has been noticed, and I'm sure you are all aware of this. The notices usually have to be put into the Federal Register at least 15 days before the meeting. general rule. That's the In emergencies, you can have an exception. The meetings must be open to public attendance, as a general rule. It's necessary to provide enough space so members of the public can conveniently attend and to meet at a reasonable time, that members of the public are likely to be able to attend. There is some exception to this. By the way, before I forget. Members of the public 316 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 must be permitted to file a written statement on matters discussed at the meeting. This doesn't mean that the chairman is required to let them stand up and make an oral statement, but they must be permitted to provide a written statement on matters discussed at a meeting. There is a provision for closing meetings under the FACA, and the closure is permitted only under the same rules that a Sunshine Act meeting is permitted to be closed. know whether you are familiar with the Government in the Sunshine Act. It applies, for example, to -CHAIRMAN SIEGEL: MS. FONNER: Yes. I don't -- the Commissioners of the NRC. Whenever they meet, they are subject to the Government in the Sunshine Act. It was really intended to govern bodies that are collegial, that run a government agency, such as the Commissioners of the NRC. There are a number of exceptions to being required to hold open meetings that are listed in the Sunshine Act. For example, the most obvious, to protect classified information. If you are going to discuss classified information, you close the meeting. Also, to protect people's privacy; an unwarranted 317 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 invasion of personal privacy may be protected. Trade secrets may be protected. Under those circumstances, if you know that something like that is going to be, or is likely to be discussed, your designated federal official should proceed to try to get the meeting closed, and your notice of the meeting will then state that that portion is closed for this reason. Documents prepared for or by committees must be retained and made available to the public. So if a document is prepared for a Federal Advisory Committee, the statute says that all such documents for the life of the committee must be retained in a single place, where it will be made the public if the public asks. We have been called upon several times to interpret this provision, particularly with respect to what's a single place. Because we have some advisory committees, particularly available to the ACRS, that has been in business such a long time, that the volume of their documents has, by this time, far exceeded what they can hold in what are going to be their new offices shortly. After consulting with GSA, we have determined that all of the NRC is a single location. Very often, these documents go into the public document room as well. 318 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Title 5? There are some provisions for withholding documents. Not all documents, obviously, could be made public because it wouldn't make any sense. Classified documents, obviously, aren't going to be released to the public. The rules under which documents may be withheld are contained in what we call the FOIA -- the Freedom of Information Act. You can, of course, as individuals, always try to use the FOIA to get a document, but the FOIA sometimes permits the Agency to withhold. CHAIRMAN SIEGEL: Susan, would that be Section 552 of Is that where FOIA is contained? MS. FONNER: That's right. Okay. The It is ChairMAN SIEGEL: MS. FONNER: The FOIA has many exceptions. Agency generally doesn't have to use a FOIA exception. within the discretion of the Agency, in most instances, as to whether it will release a document or not. However, there are all kind of tests that have evolved through court cases as to whether a document may be withheld or not. The exceptions in the FOIA are very similar to the exceptions in the Sunshine Act. Nevertheless, whenever there is a question about the closing of a meeting or withholding of a document, we have to always keep in mind when we make a 319 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 differ. determination both of these statutes. There is one very important way in which the two As you may be aware, a deliberative document is generally withholdable under the FOIA, but there is no deliberation closure under the Sunshine Act. that differs. There are also a couple of others, but that's probably the most important. The reason there isn't a That's one area deliberative exception under the Sunshine Act is pretty obvious. That's because the Sunshine Act was passed in order to open meetings. Some of the exceptions that you could have under the FOIA, I've already mentioned: classified information, protect privacy information, protect trade secrets -- those are the same under both statutes. deliberative documents. withheld. Once the Agency makes the decision to withhold, of course, all of the employees of the Agency are bound by that ruling. Another requirement of the FACA is that detailed Minutes, or a transcript, has to be maintained of every meeting that fulls under the Act. I see that you have a transcript Under the FOIA, you can withhold Attorney-client documents may be 320 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 made. I don't know whether you also do Minutes or not. CHAIRMAN SIEGEL: MS. FONNER: Yes. These are certified by the chairman. The usual procedure, in most advisory committees is to circulate them also to members. Those are really the highlights of the Federal Advisory Committee Act. I've told you about the functions of You know about the Minutes. the designated federal officer. Subcommittee meetings sometimes can fall under the FACA, sometimes not. If there is a meeting of two or more advisory committee members, only for the purpose of gathering information or conducting research for the parent advisory committee, the subcommittee meeting does not have to follow all of the procedures. Those two or more members don't have to They can even analyze relevant follow all of the procedures. issues and facts. However, if they develop a position -- if this group develops a position -- you have to remember that it has to be fully deliberated upon by the full committee or, in retrospect, that subcommittee or subgroup meeting, will become subject to the FACA, will require all of the procedural elements. At a meeting -MR. CAMPER: Susan, a question? The documents that 321 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 MS. FONNER: Right. may be withheld, deliberative documents, classified, trade secrets, attorney-client, et cetera, is there any specify language that must be put in those documents when it's provided to members of the committee? I mean, obviously, for example, attorney-client privilege would be identified as attorney-client. Certain things would be identified as not being subject to release until the Commissioner approves it. MS. FONNER: The statute itself does not state what specific language must be used to identify them, but obviously you've got to identify them to the people who they are circulated to. For example, in the NRC when a document contains proprietary information, at least all of those I've seen, there's usually, when I receive them, a yellow sheet on top, saying proprietary information. understand what that means. MR. CAMPER: No, that's clear. I'm looking for Your employee is supposed to something that links it to the fact that it is a document that is subject to being withheld under FOIA consideration. There is no specific language, other than the obvious identification. 322 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 MR. CAMPER: MS. FONNER: Right. But in your notice to the public about the meeting, if you're going to close a portion of the meeting, there is supposed to be an identification of why you're closing. MR. CAMPER: MS. FONNER: Correct. Sure. So what we require, at least I have required it, is that there be a citation to the provision that allows for the closing under the Sunshine Act. I think it's a good idea to do the same thing with documents, so that you clearly identify where the provision is under which you are withholding. are in order. When there is a document that there's a question about whether it's permissible to withhold it under the FOIA, we have FOIA experts. I am not a FOIA expert. I know the FOIA I think a few words, then, like attorney-client from years of working in the government, but we have people who spend most of their time looking at documents and deciding whether they're withholdable or not. So when you have a document, if there's any issue about whether it may be withheld from the public, it should be forwarded to my office, and we will have a FOIA expert look at it and make a determination as to whether it's withholdable. 323 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Once the FOIA expert determines that a document is withholdable, then the Agency working through the responsible official, determines whether they want to withhold it. If that decision is that it should be withheld, then every one, A, is subject to that decision; B, the document should only go then to people who have a need to know. That's what I've come prepared to tell you about. time is up. My I thank you very much, and I would appreciate it if you would provide any of your questions to Dr. Siegel, or if you want to call me, my name is Susan Fonner -- F-o-n-n-e-r. My number is 504-1634. Thank you. CHAIRMAN SIEGEL: Don't run away yet. We're not I'm in One White Flint. going to drill you, but you actually did a very good job of addressing the issues that were of concern to us, so despite my adversarial introduction, you've addressed a lot of our questions. You have provided, I think, at least me and I think John and Larry, with a useful tool, which are documents that really, in fact, are non-releasable under FOIA can simply be identified as such with an appropriate FOIA regulation citation to show why that particular document is non-releasable. Carol. She may not be willing to take your question, but why don't you just tell me -- 324 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 MS. FONNER: DR. MARCUS: Let me repeat to you -I'm not giving her a question. I'm going to be talking to you, and you will funnel it to the Office of General Counsel throughout whatever maze the federal ability you can find. CHAIRMAN SIEGEL: DR. MARCUS: Go ahead. I First of all, I want to thank you. think you've clarified a lot of the legal construct that I think needed to come out. I have a couple of questions, Barry, that I would like you to ask or the Committee to consider asking Dr. Siegel to ask -- whatever. One has to do with attorney-client privilege. my understanding that attorney-client information may be withheld to protect the client. However, it should not apply It is to the protection of federal lawyers who have responded to federal employees about public matters. That is, almost everything the Office of General Counsel at the NRC does is requested of it by members of the Nuclear Regulatory Commission, and I don't think that the intent of the law is to protect them from public disclosure of their thinking. So I think we need some clarification of when 325 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 attorney-client privilege holds. CHAIRMAN SIEGEL: Susan, attorney-client privilege is determined by the client; isn't that correct, rather than by the lawyer? MS. FONNER: Well, the lawyer tells the client if the attorney-client privilege can be used. CHAIRMAN SIEGEL: MS. FONNER: Right. If the lawyer says the attorney-client may be used, then the client determines whether it's going to be used, like all of the other exceptions to openness under the FOIA. CHAIRMAN SIEGEL: An exception, a problem, Carol, is that in a federal agency the attorneys work for the agency and their actions in deciding that a document is privileged can be viewed as a Witness/Counsel confer of the agency, and it is, I think, an open question. I've also discussed this with some lawyers, as to whether or not staff can independently, staff in another branch of the agency, can independently decide, that a document can be released if the Office of General Counsel has said it's a privileged document. Ultimately, the decision rests with the Commissioners as to whether the privilege is to be exercised or not, is the way I understand it. 326 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 though. DR. MARCUS: Okay. I have one other question. Please. expert. I agree with you that trying to work with this advisory committee in an open fashion is very important and one shouldn't hide behind attorney-client privilege, but it's not our decision to make, it's the Commission's decision to make. MS. FONNER: Let me just interject here. Please. CHAIRMAN SIEGEL: MS. FONNER: As I said earlier, I'm not a FOIA I think it's a very good question, and I think if you want to pursue this further, if your chairman decides that he, working with the staff, is going to submit this to us, I will look into it and have a FOIA expert write something on it. I can tell you that, in general, a government attorney's client is the whole agency. I think that, while issues have arisen about whether actions of individuals within the agency are considered actions of the agency, generally speaking, an agency is a client. That would encompass actions by all people who work for the agency but, beyond that, I'm really not prepared to give you an analysis of that. CHAIRMAN SIEGEL: That's, actually, a good answer, CHAIRMAN SIEGEL: DR. MARCUS: It's basically, what precise material, 327 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 supplied to the ACMUI members, is not available to the public? Other than names of patients of preliminary documents related to a patient case, particular physicians' names when reviewing training and experience, matters of personal privacy and private sector proprietary information, I know of no material that would not be publicly available. Matters of national security have not been brought to the attention of the ACMUI during my tenure. Such material would also be unavailable to the public if it should, in the future, be made available. I would like to read from FACA, describing that material that is public information. 3(b) of FACA: Subject to Section 552 of Title 5, U.S. Code, the records -CHAIRMAN SIEGEL: Carol, I'm going to stop you. You Going to paragraph 10, just read the key phrase: Subject to Section 552 of Title 5, U.S. Code, and those are the things that need not be in the public domain under FOIA, and -DR. MARCUS: What things have gone to us -She gave us the list. CHAIRMAN SIEGEL: DR. MARCUS: Yes. CHAIRMAN SIEGEL: She gave us the list. 328 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 MS. FONNER: I didn't give you an exhaustive list. I have a copy of the There were other things in the list, too. FOIA with me, and if you really want me to, I'll get the statute out and I'll read it to you, but I don't think we have time for that. CHAIRMAN SIEGEL: Right. The key item on the list, Carol, and the two key items that there has been concern about, are attorney-client work product, and we've just heard at least a partial answer about that. The second item relates to deliberative documents as opposed to deliberative procedures or proceedings. We can choose to get further definition of that if we wish, but she's just told us that deliberative documents are, in fact -- the agency can make a decision to withhold those under FOIA. If FOIA allows that, then we're bound by it if that's the Agency's decision. MS. FONNER: That's an Agency deliberative document. Correct. I understand that. CHAIRMAN SIEGEL: MS. FONNER: Then you have the tension between that and the Sunshine Act, and we don't want to go into that now. CHAIRMAN SIEGEL: MS. FONNER: (Pause.) Right. Basically, what you said is correct. 329 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 MS. FONNER: All right. Thank you very much. I appreciate it. CHAIRMAN SIEGEL: Thank you, Susan. Did you understand, Carol? DR. MARCUS: deliberative -CHAIRMAN SIEGEL: DR. MARCUS: Yes. Let's consider it asked. I think we'll ask the question. I need a definition for what a CHAIRMAN SIEGEL: DR. MARCUS: Because all pre-decisional information could be thought upon as being deliberative, and therefore nobody can know anything until the final rule comes out, and it's obviously silly. CHAIRMAN SIEGEL: No. The law doesn't allow that. I think where we're walking a fine line here, we're walking a line between wanting to have a lot of information so we can make intelligent decisions and we can be well informed, and we can provide good advice and wanting to be able to release that information widely to our colleagues and cohorts so that we can get their advice and use their advice in making our input as broadly based as possible. We are told that there are some restrictions on our abilities to release some documents. Now, the Agency has a simple way of dealing with this 330 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 if we choose to push this too hard, which is just to give us nothing, in which case our ability to function as an advisory committee will be impaired. If those documents can be withheld under FOIA and, therefore, restrictive to people who need to know, they can make the decision that we don't need to know, in which case we won't see the documents, and we will seek a result in terms of our ability to do the job. Push it as hard as you want, but you run the risk of pushing it even to our disadvantage. DR. MARCUS: Here's a question for you. Sure. CHAIRMAN SIEGEL: DR. MARCUS: If, as part of a public meeting, documents that we have reviewed are discussed in that public meeting; are those documents that we have used in our deliberation for the public meeting still not available to the public? CHAIRMAN SIEGEL: DR. MARCUS: that the NRC. I don't know the answer to that. I would appreciate it if you would ask I can understand whether perhaps some preliminary documents that we use might be considered restricted and deliberative, but at the point where there is a public meeting, it may change its status. CHAIRMAN SIEGEL: We can pose that as a specific 331 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 question. Okay. Bob? Working under a state open records act, DR. QUILLEN: which is the same sort of thing as the FOIA, I've had some experience in this. The only question I have is there is some point in the federal process where a document does not become deliberative anymore, where it goes into an open records situation. CHAIRMAN SIEGEL: My personal sense is that the problems we're dealing with here are relatively few and that the process is, in fact, reasonably open. a giant problem. You obviously have been troubled by it, Carol, but I'm not sure how troubled I am by it. I think we've been I don't see this as getting the information we need to provide reasonable advice most of the time. What do the rest of you think? Or have you all been troubled by receiving documents that you were told were "Eyes Only"? Joan? MS. McKEOWN: No. I really don't have any trouble at all, because I think it's very important that we get what they're really thinking when we're trying to make a decision. If we say, well, everything we say is going to be only going to be FOIA upon request, by tomorrow afternoon, because that's 332 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 when the meetings are, I think we're going to lose the credibility of the information that we get from people, because they're not going to be able to trust that what they say is going to stay in this group. CHAIRMAN SIEGEL: Yes. I think the Agency has a responsibility not to abuse its FOIA privileges, but we have a responsibility to live by the agency's decisions. There may well be appeal mechanisms under FOIA that would allow a government employee to work through some mechanism. I haven't got a clue if there is, but to work through some mechanism to claim that a document should not be excluded from release or not be made available to the public, just about every other law, as an appeal mechanism, why not this one. Bob. DR. QUILLEN: My only concern is that such documents be appropriately flagged, so I know what is privileged and what is not privileged. CHAIRMAN SIEGEL: Correct. I agree. I think that is a key thing now; and ideally flagged with the specific section of the regulations that relate to FOIA so that we can, chapter and verse, know why a document is being held back, and that's fine. 333 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 subject. CHAIRMAN SIEGEL: MR. CAMPER: Sure. Okay. MR. CAMPER: Just a comment before we leave the I think what's interesting about this discussion is that over the last four to five years, this Committee has undergone a substantial evolution in terms of the level and degree of advice that are advised to our agency. If I go back in history and look back 6, 7, 8 years ago, this committee primarily focused upon technical issues. It certainly wasn't a body, at that time, that dealt with as many policy issues as early in the process as you do today. This Committee has asked the staff to bring it issues sooner in the process. We've been doing that. I think what's happened now is we're at a point where there are certain key questions that need to be answered, so that on one hand, as Dr. Siegel has said, the staff can provide to this committee certain documents that are sensitive, if you will, for lack of a better term, so that it will facilitate the advice you can give to the staff, and, at the same time, be certain that we're doing this in concert with FOIA restrictions and other applicable laws. I really think the discussion, while there are some 334 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 concerns, particularly with Dr. Marcus, I do think that these discussions and these questions that will go forward now to OGC is another step in that evolution process. Frankly, I think it's positive, and we will seek some answers to some of these questions that you have raised. CHAIRMAN SIEGEL: Okay. Let's move forward. We need to essentially do a mark up of the bylaws. I've provided you with a copy that has your comments, plus my own, incorporated in it. I have here a copy of a mark up made I wish I by Susan Fonner that, unfortunately, I just got. would have had it last night, because if I would have had it last night, then these comments, most of which are terrific, would have been in here. In fact, she is recommending deletion of even more things than I did, that I think we may find troublesome. may be able to just zoom right through this. I think we've got to do this on a paragraph by paragraph basis. We'll look at the paragraph that's there. We I'll tell you what Susan Fonner recommends in that paragraph, as distinct from what I recommend, then we can decide whether to move forward. My sense is -- and, John and Larry, tell me if you agree -- that the way we're putting these bylaws together, they 335 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 won't really be finalized until the next meeting, at which point we can say that these are finalized, but then we can't really adopt them until one meeting after that because we're not going to get a final version today. DR. GLENN: That's certainly consistent with the way they've been drafted, and they will have to be reviewed and approved by the NRC management. CHAIRMAN SIEGEL: Right. I understand. Good. Paragraph 1 of the Preamble, I have no comment, and Susan Fonner had no comment. (No response.) CHAIRMAN SIEGEL: let's just zoom through it. Paragraph 2, as edited, I can just tell you that Susan Fonner says that she suggested the following wording in terms of it providing objective and independent advice to the Commission. Instead of saying: as requested by the Director of IMNS, of the NMSS, says: To the Commission through the Office of Nuclear Material Safety and Safeguards. describes the working relationship. Does anybody object to my making that change? (No response.) It more accurately This is going to be boring, but Anybody? 336 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Bylaws. CHAIRMAN SIEGEL: somewhere in the Bylaws. MR. CAMPER: Line item. For right now, go to the last There should be a line item sentence. CHAIRMAN SIEGEL: DR. MARCUS: That's now just going to say -- Could you just read it? Yes. I'll read you the first CHAIRMAN SIEGEL: It now says: These Bylaws have as their purpose fulfillment of the Committee's responsibility to provide objective and independent advice to the Commission, through the Office of Nuclear Material Safety and Safeguards. That's exactly the way we operate. All right. The only other thing that Susan had was that she suggested that the last sentence about internal conflicts regarding the interpretation of the Bylaws actually should be within the Bylaws rather than the Preamble. I also am not certain we need the sentence, to be quite honest with you. Is anybody paying enough attention to see what I'm talking about here? MR. CAMPER: Yes, there should be a line item in the CHAIRMAN SIEGEL: sentence of the Preamble; delete the word "internal," and just 337 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 say: any conflicts regarding interpretation of these Bylaws shall be decided by a majority vote of the current membership of the Committee. Just make note that that sentence is going to get moved somewhere into the operational portion of the bylaws. don't know where yet. Okay. I Scheduling and Conduct of Meetings; the opening paragraph, no comments. Paragraph 1.1.1. She's added a sentence that I think is required by FACA that said: Meetings must be approved or called by the designated federal official. with adding that. I have no problem We can't call a meeting ourselves. Does that start the section? That starts the section. She then DR. MARCUS: CHAIRMAN SIEGEL: suggested -- she added the words "at least two regular meetings." I'm not clear in terms of what the Commission's directive is. DR. GLENN: I think that's consistent. Okay. Yes. So add "at least" at CHAIRMAN SIEGEL: the beginning of that next full sentence. For clarity, she did the same thing I did. that last sentence down to the end. rather than "Additionally". She moved She said "in addition," It's a choice of whether you like 338 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 CHAIRMAN SIEGEL: We can add it. I've got no record? MS. BROWN: DR. GLENN: Oh, no. I think it's meant to be permissive that public." MS. BROWN: I think that clarifies. No. Does that mean we could not adverbs or adverbial phrases. 1.1.2; no change. 1.1.3; she wrote: will be open to the public. had: are open to the public. You can decide whether it makes a difference. doesn't matter to me. DR. MARCUS: Does anybody care? No. Okay. 1.1.4. The only thing she It We You can choose. CHAIRMAN SIEGEL: had: Electronic recording of the procedures by members of the public will be permitted. DR. QUILLEN: Proceedings? It should be proceedings. I agree CHAIRMAN SIEGEL: with that. That's correct. But I wonder if she had that, "by members of the CHAIRMAN SIEGEL: a member of the audience may also make an electronic recording. 339 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 problem. Television recording of the meeting will be permitted if the Chairman of the Committee determines. word was. I don't know. That's what her I She put that with a question mark. We've not been fortunate There's think we can live with it right now. enough to have any TV cameras at any of our meetings. very few Wall Street things rise and fall on the basis of our deliberations. 1.2. I think we can leave this one the way it is. This is really entertaining. She's suggesting a major change in the first one, which is that the -- and maybe she's implying that FACA requires this, I don't know. She's saying that the agenda for regularly scheduled meetings will be prepared by the Chairman of the Committee in consultation with NMSS staff rather than vice versa. I don't remember whether FACA requires it one way or the other. The truth of the matter is is that the staff is suggesting an agenda that I am then commenting on and modifying, and along the way any of us are able to suggest agenda items. My answer to her suggested change is, I'm just going to put a note that says: See Fonner's suggestion; is that, if FACA requires it, we can live with her language, but otherwise 340 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 problem. let's have it be what we're really doing. MR. CAMPER: Got it. Then she's added a sentence: The Okay? CHAIRMAN SIEGEL: ACMUI Chairman will query committee members for agenda items prior to agenda preparation. She's added a sentence that says: The DFO must approve the agenda. I can agree with that, because that's probably a FACA requirement. Yes. She says by regulation. Bob Quillen suggested a sentence about the timing of the agenda, and the question is whether John and Carl and Larry can live with that language or if it's too restrictive. We're asking for a draft agenda 30 days before the meeting and a final agenda a week before the meeting, or if that's too tight for you guys. DR. GLENN: Well, for the final agenda, that's no We can The 30 days might push us a little bit. certainly come up with a tentative agenda within 30 days, but there always is some flux going on. DR. QUILLEN: I understand. Yes. I said a draft agenda. CHAIRMAN SIEGEL: aspiring to. It's a standard of care we're We'd like to have a feel about what's going to be going on at the meeting at least a month before the meeting. 341 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Let's leave it in as suggested language, and we'll see if we can make it go. DR. MARCUS: It's not just us, Barry, it's members of the public who have to decide whether to work out in their busy schedule the time to come to the meeting. DR. GLENN: Well, again, I will remind you that FACA itself requires that we have the notice in at least 15 days ahead, and if it's the recommendation of the Committee we try to make that 30, we can try. CHAIRMAN SIEGEL: DR. GLENN: Okay. Maybe we just have to amend the notice, as we did this last time. CHAIRMAN SIEGEL: But, actually, this only says that That does a draft agenda will be provided to the Committee. not influence what you have to do under announcements -- under Sunshine Act announcements. You still can hold the -- you can provide us with one draft agenda in 30 days and an updated agenda in 15 days. Carl. least we'll have a feel for what's going on in 30. MR. PAPERIELLO: Committee like, 30 days? MR. CAMPER: (Nods affirmatively.) I believe that timeliness is next to I'm Carl Paperiello. What would the At MR. PAPERIELLO: 342 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Godliness. 30 days. DR. GLENN: Okay. In the next paragraph, about the John, I think we should give them a draft agenda in CHAIRMAN SIEGEL: conflict of interest, Susan simply suggested before the meeting that the Chairman and the DFO have to do that. Then she made the following suggestion in the last: Members found to have conflicts will be recused from discussion of those agenda items with respect to which they have a conflict. That's fine. That's lawyer talk, but that's okay. With respect to which they have a It's actually more precise. conflict. DR. WAGNER: Do you want chair instead of chairman? It should be "chair." I'm sorry. CHAIRMAN SIEGEL: That's one place I missed the gender neutral language. By the way, which word do you all want, chair or chairperson? (Chorus of "chair".) CHAIRMAN SIEGEL: Thank you. 1.3.1; she had no change. pretty straightforward. We had no change. That's Chairperson is a god-awful word. 343 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 meeting. 1.3.2; everywhere we had chair or chairmen, she added "of the committee." I suppose that is potentially to avoid If you insist confusion with the Chairman of the Commission. on having it in, be my guest. the time now. I'm not going to write it all "The chair of the Committee will reside over the The designated federal official will preside if the chairman is absent or if directed to do so by the Commission." We can accept her substitute language, so I'm just going to say: See Fonner. Okay? DR. BERMAN: For purposes of this document at the beginning, just say: "the chair" will refer to the chair of this Committee and may not be repeated each time. CHAIRMAN SIEGEL: We'll let the lawyers fine-tune it. I don't feel strongly I'm sure they'll have something to say. about it. 1.3.3. She wrote: "A majority of the current members of the Committee must be present at a Committee meeting for the conduct of business." I wrote: the same thing. "to constitute a quorum." I think they are The quorum is the minimum number of people you need to run a meeting, so I don't think we need to change it. 344 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 there. 1.3.4: "and by then is interrupted by." MR. SWANSON: Excuse me, Barry. Yes. CHAIRMAN SIEGEL: MR. SWANSON: I thought you said that the DFO had to be here in order to conduct a meeting and whether this Bylaws should cover this? CHAIRMAN SIEGEL: I think 1.3.1 covers this. "All meetings will be held in full compliance with FACA." MR. SWANSON: Okay. I think we're okay. CHAIRMAN SIEGEL: She did not like the second part of the paragraph on 1.3.4 about the Chair being able to throw people out of the room. She said this is troublesome, and recommended deletion. DR. STITT: Barry, I think in the first part it said Does Robert throw we operate under Robert's Rules of Orders. people out? Is that addressed in Robert's Rules of Orders so we can eliminate that? CHAIRMAN SIEGEL: DR. STITT: I don't have my copy with me. I don't either. The problem is we don't have a CHAIRMAN SIEGEL: Sergeant in Arms. We could appoint one. It probably addresses something like that DR. STITT: Does she want us to eliminate that section? 345 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 sentence. CHAIRMAN SIEGEL: I actually don't think we need it. CHAIRMAN SIEGEL: DR. STITT: No, not the section. That last half of it, I mean. She says this bit about objecting. CHAIRMAN SIEGEL: Here's the problem. The problem is, as I think I understand it, is this is a public meeting, and I'm not certain that I have the authority to do anything other than -- I or John have the authority to do anything other than close the meeting. not sure we have the authority to eject someone from the meeting. DR. ALMOND: Is the word "ejection" too strong? I mean Can I'm we just request that these people remain silent? "ejection" is out of the door. DR. MARCUS: I think you ought to just cut the whole I think if we found ourselves in a position where we could not conduct our business, we probably would recess the meeting. MS. BROWN: by itself. CHAIRMAN SIEGEL: delete that. I do too, so I agree that we should Yes. I think the first sentence stands I like simple Bylaws, anyway. Her sentence is: Actually, she does add a sentence. The DFO will adjourn a meeting when adjournment is in the 346 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 her. public interest. That's probably consistent with FACA language, and -MS. BROWN: What's that mean? And under what circumstances would that arise? DR. GLENN: If such disorder arose that nothing could be conducted, I would just bring the meeting to a close. CHAIRMAN SIEGEL: MS. BROWN: DR. MARCUS: being discussed. MS. BROWN: All right. So I'm going to say on my copy here Okay. If national security items were suddenly I actually think that's okay. CHAIRMAN SIEGEL: Larry that we should add Fonner's sentence about adjournment. has a question. (Mr. Camper and Dr. Siegel confer off the record.) CHAIRMAN SIEGEL: sentence about adjournment. 1.3.5; she wants to strike, and I actually agree with This whole bit about everything but the first sentence All right. So we'll add Susan's about the Chair biasing or limiting the discussion, she just says it's very troublesome. no authority to do so. DFO can't ensure any of this; has Can only say something doesn't mean There's no much or can adjourn meeting in the public interest. 347 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 way to put this in language. She is recommending that we leave in the sentence that says: the Chair makes a discussion of any subject before the Committee and may vote, and should delete the entire rest of that paragraph. It's okay with me. Fine. Any problem with that? I mean, it DR. MARCUS: CHAIRMAN SIEGEL: means that I can bias the discussion. DR. MARCUS: That's what you always do, Barry. Okay. That paragraph just got It's the first time I ever CHAIRMAN SIEGEL: killed, per lawyer's suggestion. agreed with anything OGC did. 1.3.6. Instead of "clarified their dissent for the record," she recommends: to state their dissenting views for the record. I can live with that minor change. The rest of that she left unscathed. I added the sentence about: if anyone on this committee is troubled enough to want to really know exactly how the individual members in the committee feel about something, they have a right to make a motion and request that an item be put to a vote. We can certainly do that. We've done it a few times, and when we felt the need to do it, we've gone through a voice 348 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 vote, so that we did a roll call vote. Yes, Dan. DR. BERMAN: On the previous paragraph, 1.3.5, that wasn't -- it seemed that the middle part was redundant -CHAIRMAN SIEGEL: DR. BERMAN: Right. -- but the bottom part, which says: Any dispute over the Chair's level of advocacy shall be resolved; it seems like that does leave in the mechanism for bringing into question whether the chair is being too strong. think that that part is redundant. MS. BROWN: We might need a remainder. That's okay. Well, then, the way I would CHAIRMAN SIEGEL: to fix that, Dan, is really to just leave in the second sentence, because what it does is it directs the chair not to be an advocate. Doesn't that operationally -- and if I am an advocate, or if the chair is an advocate, then someone using Robert's Rule of Order can make a point of order and say the chair is acting as an advocate on this issue, and Section 1.3.5 of the Bylaws preclude the chair from so acting, at which point a motion can be made to throw out the Chair. (Laughter) MS. BROWN: I like that part. 349 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 second -MS. BROWN: All right. I need a magic marker here to show -CHAIRMAN SIEGEL: You need the second. Without the though? MS. BROWN: I think the first sentence and the last CHAIRMAN SIEGEL: MS. BROWN: level of advocacy." CHAIRMAN SIEGEL: Well, then, do we need the rest, Which part? The "any dispute over the Chairman's sentence can capture the -DR. MARCUS: I think it's the first, the second, and CHAIRMAN SIEGEL: what we're leaving in. DR. MARCUS: Well, the federal official can decide I that he doesn't like your behavior and take care of that. don't know. Do we really need it written out? DR. GLENN: I believe that Susan Fonner's comment was that, in fact, the DFO does not have the ability to do that. All I can do is close the meeting and adjourn it. CHAIRMAN SIEGEL: This is going to get hard. The paragraph will now read: The Chair may take part Okay. Here's what we'll leave in. 350 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 in the discussion of any subject before the Committee, and may vote. The chair should not use the power of the chair to bias Any dispute over the or otherwise limit the discussion. chair's level of advocacy shall be resolved by a majority vote of those members present and voting, with a tie permitting continued participation of the chair in the discussion. That's fine. but it's fine anyway. MS. BROWN: Who's going to come after you? Someone with the wisdom of Solomon. It seems like it's not going to happen, CHAIRMAN SIEGEL: You can only hope. (Laughter) CHAIRMAN SIEGEL: 2.1. 1.3.6. We did that one already. You've seen my fix. Susan Fonner wanted the word "detailed" because I think FACA requires detailed, but I think we're already fixed because it requires detailed or a transcript, and we have both, so we can just leave Minutes. I added the thing about the meetings with the Commission because we don't prepare Minutes of those, and they were mentioned previously as if they were a meeting. I've made it also clear that the Minutes are based on the transcripts, and that's an important procedural point, 351 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Sally? MS. MERCHANT: The Commission has requested that we because, in the past, when the Minutes have been circulated, some of you have tried to change the slant of something as it was said in the Minutes in a way that you thought might have sounded better. Then I went to the transcript and said, no, you didn't actually say that at the meeting, and so we can't have that in the Minutes. I think that's true. She didn't really have anything substantive on 2.2, and my changes are there. I think it describes what we do. We can't editorialize post hoc, at least Any questions on that paragraph? Dennis raised a point, and I just don't know what the FACA requirements are, which is did we want to adopt a procedure whereby, even though the Minutes have already been certified by the Chairman, we would approve the Minutes as a Committee at the next meeting. The advantage of that is that it provides an opportunity for Minutes to be corrected. The only disadvantage of that is it certifies the Chairman as certifiable, because it means that the Minutes were not correct, and I don't like that. 352 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 get -CHAIRMAN SIEGEL: MS. MERCHANT: Please use a mike, Sally. The Commission in an Sally Merchant. SRM has requested that the Committee get the Minutes to them within four weeks, whenever possible, and we do try to meet that date. CHAIRMAN SIEGEL: No, I understand that. But we could still have a procedure whereby the Minutes are delphied, as they currently are; certified by the Chair, as they currently are, but nonetheless, reapproved at the next meeting. I personally think it's redundant, because I think that anyone who was troubled enough by something in the Minutes to want it brought up again at the next meeting, always has the opportunity to do so as a matter of new business, or as a matter of old business, under discussion. I don't think we need the procedure. suggested it. Dennis It's not required by FACA, is my understanding. Okay. Fine. I'm not stating that out DR. QUILLEN: of a concern, just more procedurally. CHAIRMAN SIEGEL: Procedurally. I think the federal approach is that the Minutes get circulated and certified rather than approved in a subsequent meeting, and we are under the gun to get the Minutes out quickly. 353 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 This mechanism -- the alternative to this mechanism - is one that you won't like, which is that we meet on Thursday and Friday, and then we stay on Saturday morning to finish the Minutes and write a letter to the Commission before we walk out the door, with every word agreed on. mechanism. I don't approve of that It's not acceptable, so let's do it this way. Am I trying to limit the discussion or bias the discussion? (Laughter) DR. QUILLEN: Let's take a vote. Why don't you eject me? CHAIRMAN SIEGEL: MS. BROWN: Then we can go home early. Then we can all go home early. CHAIRMAN SIEGEL: Okay. 3.1. 2.3. No changes. Let's see if she recommended any changes. We don't need the "thereby" in the first sentence. It's not useful. The NRC will solicit nominations by notice in the Federal Register; and then she adds here: means as are approved by the Commission. That's fine. addition okay. I'm just going to make a note: Fonner, And by such other Anybody have a problem with that? (No response.) 354 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 CHAIRMAN SIEGEL: Then she wants to make this next thing a new sentence, which I think will read better: Evaluation of candidates shall be by such procedures as are approved by the Commission. That's fine, and that's a period. Then it says: The Commission has the final authority for selection, and that's true. language here. MS. BROWN: What, on 3.2? No, 3.1. Okay. We're switching to CHAIRMAN SIEGEL: MS. BROWN: Okay. CHAIRMAN SIEGEL: 3.1 now reads as follows: The members of the Committee are appointed by the Committee, which determines the size of the Committee. The NRC will solicit nominations by notice in the Federal Register and by such other means as are approved by the Commission. Evaluation of candidates shall be by such procedures as are approved by the Commission. selection. In a way, it's not clear to me that this is really part of the Committee's bylaws. policy, but leave it. Okay. 3.2. This sounds like this is NRC The Commission has the final authority for It doesn't hurt anything. She has a big question mark on 3.2, on the whole paragraph, and says: Why is this in the Bylaws? 355 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 right. MS. BROWN: Yes, that's true, but even -This sentence is correct. MS. BROWN: Mel brings up a good point. What's that? Don't need. Because, in fact, this doesn't have anything to do with the Committee does for a living. MR. CAMPER: MR. SWANSON: Right. Why not take out this whole section, because this questions whether 3.1 should be in there. CHAIRMAN SIEGEL: Well, no. I actually think that 3.1 and 3.3, which will not become 3.2 are, in fact, needed, because it makes it clear; Roberts Rules of Order would say that the chair is elected by the body, and here we've got a distinct reason for doing otherwise. So why don't we kill 3.2. CHAIRMAN SIEGEL: DR. GRIEM: With NIH, they want a geographic balance and a whole bunch of things. CHAIRMAN SIEGEL: They may want it, but it's not CHAIRMAN SIEGEL: MS. BROWN: Yes. CHAIRMAN SIEGEL: This sentence is that you can't You have select, either for or against, based on these issues. 356 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Bylaws. CHAIRMAN SIEGEL: the Bylaws here. Okay. Yes. It doesn't add anything to issue. CHAIRMAN SIEGEL: It's a Commission issue. Susan recommends it. DR. STITT: Yes. It's a Commission issue and not our say that. to select based on best qualified individuals to serve on the Committee. You're not under any specific -- correct me if I'm wrong -- you're not under a specific requirement to have a certain number of women, a certain number of minorities, a certain number of people from the West Coast, and you're not supposed to use those factors in deciding who is on the Committee. MS. BROWN: But this is distinguishing the way they They say extraneous factors will not be considered. CHAIRMAN SIEGEL: Guess what? That's why we deleted So 3.3 has been changed to 3.2 deleting the phrase: considering recommendations of the staff. MR. CAMPER: It's an internal procedural matter. It can be deleted. CHAIRMAN SIEGEL: MR. CAMPER: It really doesn't contribute to the 357 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Conduct of members, 4.1. Here's her suggestion: If a member feels that he or she -- I'm gender-neutralizing as we go -- that he or she may have a conflict of interest with regard to a subject to be addressed by the Committee -- that's fine -- he or she should divulge it to the chairman of the Committee and the DFO -- that's fine, also -- as soon as possible but, in any case, before the Committee discusses it as an agenda item. Committee members with a conflict of interest -deleting the word "divulged" -- if you keep it a secret, it doesn't make it less of a conflict -- must recuse themselves -and that's fine -- from discussion of any subject with respect to which they have a conflict. Okay. From discussion of any subject with respect to which they have a conflict of interest. Okay. 4.2. We're getting there. Instead of "when," she has: upon completing their tenure on the Committee. I like Bob Quillen's suggestions, which I incorporated last night: and accountable equipment. will return any privileged documents Because you don't want to fill a I'd be box with all of the pieces of paper you've sent me. happy to do it. 358 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 DR. GLENN: Anything that's been publicly released, you should be able to keep. CHAIRMAN SIEGEL: MR. SWANSON: Right. Okay. Is it important to put a clause in there: Any privileged documents and accountable equipment as so designated by the NRC? CHAIRMAN SIEGEL: We can certainly do that, but I would assume the privilege would be identified, clearly. We've just decided that that's what's going to happen in the future. MR. SWANSON: I just don't want somebody coming back and asking me for documents that haven't been so designated, because you're probably not going to get them, unless you want to come and help me search in my office. CHAIRMAN SIEGEL: Let's do it. All right. I'm adding as a parenthetical statement here: Upon completing their tenure on the Committee, members will return any privileged documents and accountable equipment (as so designated by the NRC), provided for their use in connection in ACMUI activities, unless directed to dispose of these documents or equipment in accordance with established federal procedures. MS. BROWN: This doesn't seem very real-world. Somebody's going to ask me in two years about something four years ago? 359 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 CHAIRMAN SIEGEL: I can you, for example, FDA ships a safe to your office, and then they come and look at your safe, and then you keep the documents in the safe, and the documents have to be returned either when you're off the Committee or when they want them back, and then they come and pick the safe up, if they gave you a safe. MS. BROWN: documents. CHAIRMAN SIEGEL: MS. BROWN: Well, we've had some. So we just haven't had any such They would have been flagged. They haven't been identified CHAIRMAN SIEGEL: previously, or they haven't always been identified. MS. BROWN: MR. CAMPER: Yes, true. Also, too, I think -- Judith, just so In trying to That is, you would be aware -- we've talked about this. accommodate this thing, we've been talking about it. clearly, we're going to get some questions answered; we're going to have documents identified clearly, and then we also need to establish some procedure for how we manage those documents. For example, it may be that we would ask to return at the conclusion of a particular meeting or at the conclusion of a quarter, or something, I don't know; but we need to develop 360 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 some procedure that's orderly so that all Committee members will understand just how we're going to process these documents. MS. BROWN: Like, what about this kind of stuff -- you know, the qualifications? CHAIRMAN SIEGEL: That's a privileged document. You can either return it or you can -- I think, in general, we've just been shredding them. MS. BROWN: MR. CAMPER: So I should be disposing these all along? For now, do as you have done. What we will do is provide some information to the Committee about how we're going to procedurally handle these documents. Again, it may be just the simplest thing to collect them at the end of the meeting. We want you to know how we're going to do it. Correct. CHAIRMAN SIEGEL: Okay. 4.3 is straightforward. 4.4; she's got a big question mark, and says: What does this mean? Either with the original wording, and I'm sure it would have applied to the subsequent wording. 4.4 is lifted, essentially, directly out of the SRM and, frankly, I don't know why we -MR. CAMPER: revisit this one. I think we'll have to go back and There's no It does come from an SRM. 361 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 to do. conflict. DR. GLENN: to have developed. 1.3.5 and 1.3.6, when a consensus appears We've already discussed that a consensus question about that. CHAIRMAN SIEGEL: But the SRM was to you. DR. GLENN: My question is maybe Section 1 really I know it does. I know it does. covers everything there. CHAIRMAN SIEGEL: DR. STITT: Which one? 4.1, where it says if you have a should be reached, and that's really all that 4.4 is saying. CHAIRMAN SIEGEL: 4.4 deals with two things. It deals with, one, that we're collegial -- ha-ha -- and, two, that none of us should be acting individually, officially, for the Committee; and then the next paragraph really goes on to do the same thing. MR. CAMPER: Well, it also provides a conduit where if the member were to feel so troubled about something of medical significance, that they would have an avenue to the Commission. CHAIRMAN SIEGEL: Let me tell you what I would like In 4.4, I'd actually like to delete the collegial sentence, but leave in my suggested altered language, which I 362 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 sentence: think will address the Commission's concerns and doesn't really change anything procedurally one way or the other. I mean, we all need to understand that when we're not at a Committee meeting, unless we've been specifically empowered to do something by the NRC for a particular purpose, we are no longer speaking or acting as advisory committee members. You can't go and give a speech at the Society of Nuclear Medicine meeting and say, I'm here today to tell you what the ACMUI thinks about this subject. You can only do that if you were specifically requested to do that by Dr. Paperiello or Dr. Glenn as a representative of the ACMUI and had official federal orders to go do it. MR. CAMPER: DR. MARCUS: Yes. Barry? I'm sorry. Correct? CHAIRMAN SIEGEL: MS. BROWN: Judy, go ahead. Can we take this all out, except the Members of the Committee should correspond with the Commission, and just stick that sentence in 1.3.6? CHAIRMAN SIEGEL: Well, I think it probably does belong in this paragraph under conduct of members. MS. BROWN: your sentence. Although that's where you say you clarify I see what you mean. Well, okay. 363 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 that. CHAIRMAN SIEGEL: Try this, in 4.4: delete the first sentence about the collegial body. that earlier. Try killing that. We've already addressed Leave in this thing about what you do outside of Committee meetings in terms of interpreting committee reports or actions, and leave in the thing about corresponding with the Commission. That will capture, I think, the sense of the Commission's concerns well, and it also gets rid of a lot of this other excess verbiage, which is inappropriate. Any of us can write to any of the Commissioners, to the President, to anybody we want to; we just can't do it saying, I'm writing to you in my official capacity as a member of the ACMUI, unless we're doing it as an ACMUI activity. DR. GLENN: There is one other aspect in reading further one, and maybe the Committee should consider it, and that is, that the Commission seems to be asking for disclosure if you do write as a member of the public, that this was discussed by the advisory Committee, and that you have had an opportunity. CHAIRMAN SIEGEL: I don't think that we can live with I think that I can't require that any of the people sitting at this table have to, first, come to this advisory committee to find out if it's okay to write a letter as a 364 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 member of the public. That's kind of the intent of this. This is a gag rule, and I don't think we can sit still for a gag rule. DR. GLENN: The aspect that I was trying to address is that if we've had the discussion, a consensus has been reached, if dissenting views have been solicited, then a letter comes in on the same subject, should there be disclosure to the recipient of the letter, that in fact this process has already been discussed under those rules of the Committee? CHAIRMAN SIEGEL: Again, my answer is, I don't believe we can -- we provide at our meetings an opportunity for dissent to be made part of our official record. I don't think that we can therefore compel individuals outside of the meetings, when acting as private citizens, to disclose what went on at the meetings that prompted them one way or the other to act as a private citizen. I think what you do when you're not at this meeting and what you choose to do because you feel that it's important to do it, isn't tied to what goes on at the meeting. If you're acting as a private citizen, you're acting as a private citizen, and it's not an official Committee activity. I know the Commissioners don't want to get a lot of letters from individual members of the ACMUI. 365 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 MS. BROWN: But they can't stop that. But they can't stop that. CHAIRMAN SIEGEL: MS. BROWN: Nobody can preclude me from saying I was bothered by something at the last ACMUI meeting and I wanted to tell you about it. blah. CHAIRMAN SIEGEL: Yes, it would. Yes, it would, As a member I was disturbed, blah-blah- because you're attempting now to write in an official capacity. MS. BROWN: Well, then, I don't like it. Well, Judy, the answer is you've CHAIRMAN SIEGEL: got to do it by way of Committee procedure, which is to strongly and clearly voice your dissent at the meeting and have it incorporated into the record, or -MS. BROWN: And hope they read it? And hope they read that little section on page 72 of the Minutes where you strongly object to something? CHAIRMAN SIEGEL: No. We don't individually have We have access to the Commissioners as Committee members. access as a Committee, through Dr. Paperiello, to the EDO, to the Commission, and that's the way we communicate. If you feel the need that you want to expand your position, it can become part of the official record of the meeting, and we can agree in advance, that even though we don't 366 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 have it, we've acknowledged that we're going to get a letter from you sometime in the next week, and that it's going to be made for the record. But you don't, as a member of the Committee, in my view and I think my view is legally correct, have the right to say, I'm writing outside of the Committee procedure, and this is dissent that I want directed to Dr. Sellen, and you need to know about this terrible thing that went on. it as part of the Committee procedure. If you choose to write as a member of the public, then be my guest. DR. PAPERIELLO: CHAIRMAN SIEGEL: DR. PAPERIELLO: I would offer an opinion. Yes. I will say, only offer an opinion. You've got to do 4.3 says: Members of the ACMUI are expected to conform to all applicable NRC rules and regulations. There is an NRC rule -- internal rule, a management directive -- on both open door and differing professional opinions. It would seem to me that, as a special government employee of the NRC, you are covered by that, and that offer is to any NRC employee open door access to any manager, including the Commissioners, as well as the ability to file a differing professional opinion. 367 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 It seems to me that is always an option that anybody who is an employee of the NRC has. I know the policy well, because I helped write it several years ago, so I'm just offering you an opinion. I'm not giving you a legal opinion, but it seems to be my observation that that particular procedure would hold. CHAIRMAN SIEGEL: So if I read you correctly, you're suggesting we should delete Section 4.4 and let Section 4.3 govern what we do, in which case, what I just said was wrong, and if you want to write a letter, Judy, you can write a letter. MS. BROWN: Thank you. But I think we still need the Individual members, first paragraph that you've changed: because we don't want individual members representing themselves to Congress or something like that. CHAIRMAN SIEGEL: But that's probably covered by 4.3. I don't think Dr. Glenn can go up to the Hill and claim that he's representing the NRC unless he's actually representing the NRC, so 4.3 probably does it. Actually, thanks, Carl. MS. BROWN: from me shortly. (Laughter) That actually helps a lot. You'll be getting something in the mail 368 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 CHAIRMAN SIEGEL: What's the feeling here, folks? Do we need the two parts of 4.4, except for that first sentence in the first two paragraphs for clarification, or do we simply want to strike 4.4 in its entirety and let 4.3 govern? Lou? DR. WAGNER: Barry, I am not familiar with all applicable NRC rules and regulations. CHAIRMAN SIEGEL: DR. WAGNER: They will be provided -- That must be a daunting problem. They could be provided for you if CHAIRMAN SIEGEL: you would like them. DR. WAGNER: No, I don't think so, but I'd like 4.4 kept in for clarification purposes. MR. CAMPER: "applicable". I think the operative word there is Maybe what we should do is provide to the Committee members those applicable NRC employee regulations that clarify these things that we can and cannot do. really not that extensive, actually. CHAIRMAN SIEGEL: We actually do get a fair number of It's those as sort of an annual briefing package that relate to things like what we're allowed to do under the Hatch Act, as SGEs, and actually we're allowed to do more than would be fulltime employees, and those kind of things. 369 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 I don't feel strongly about this. I actually think the language in 4.4, the two parts that we're talking about leaving in, is reasonably straightforward, but it might not be acceptable. I mean, Susan Fonner actually suggested just a deleting all of this. I wonder if she saw the SRM when she recommended deleting it. MS. BROWN: I'm reacting as someone who has no As a member of the standing with the Commission whatsoever. public, I don't have any credentials. I would just be dismissed unless I were able to add, as a member of the ACMUI, or when I was at the last meeting, or you know. CHAIRMAN SIEGEL: Wait a minute. That's why I think 4.3 alone is better, because of what Carl just told us, is that -MS. BROWN: Yes. -- despite what's in the SRM, the CHAIRMAN SIEGEL: implication of that is that the SRM is a gag rule that really should not apply. MS. BROWN: MR. CAMPER: Yes. I want 4.4 out, too. Well, you have the same point that Carl For example, if I were to take was making about a DPO. exception to something that our management decided they wanted 370 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 to proceed with, I have a mechanism whereby -- or any other employee does, for that matter -- a mechanism whereby you can file a differing special opinion. MS. BROWN: organization. MR. CAMPER: Oh, yes. Sure. Then you express your Can you mention your position within the professional opinion as to the process, but there is a process for doing that. CHAIRMAN SIEGEL: DR. WAGNER: Lou. Barry, I would agree to striking 4.4 if we could create a summary document and attach it as appendix. I would like to have available to me some kind of a summary document to know how I'm supposed to behave instead of just generally referring to applicable rules -- NRC rules and regulations. If there were some way to attach some summary document for applicable rules -- you say they're not very long -- I think it would be appropriate to have it in there. DR. MARCUS: MR. CAMPER: regulations as well. DR. WAGNER: OPM. We can get appropriate copies of It's in Title 10, right? Some of it is. Isn't it? Some of it's internal regulations and policies that apply to us as NRC employees into 371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Bylaws? CHAIRMAN SIEGEL: No. I don't think so. It'll our hands. MR. CAMPER: DR. WOODBURY: Yes. That doesn't seem to be a problem. Would that be incorporated into the simply be made -- we'll just make it as a matter of procedure that that's something that's made available to advisory committee members. We don't want it to be part of the Bylaws because then every time there's a change in those policies, we have to amend the Bylaws. MS. BROWN: We don't want to do that. How about a sentence saying: The members will be provided with applicable rules? CHAIRMAN SIEGEL: I think that's probably already supposed to be happening anyway because we're federal employees. MS. BROWN: Okay. Does anyone object to deletion of CHAIRMAN SIEGEL: Section 4.4? Anyone here present, because there are probably some people who are here, present, who may object to it. (No response.) CHAIRMAN SIEGEL: its entirety. 4.5. Good. I would submit that 4.3 address 4.5 too. Okay. That's fine. 4.4 is out in 372 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 DR. MARCUS: So let's get rid of that. We're going to get rid of 4.5. CHAIRMAN SIEGEL: I think if you get a document that says: This document is restricted to use by you, under Section Blank, Blank, Blank, Blank, of the Freedom of Information Act, that'll be clear; that if you release it to the Washington Post, that you may have committed a felony. Okay. MS. BROWN: Felony? Conceivably. Misdemeanor, felony, CHAIRMAN SIEGEL: who knows. MS. BROWN: (Laughter) DR. MARCUS: Not if they don't reveal their source. And, you know, the decisions made by the Agency as to what they consider secret under FOIA are always able to be questioned in court if you feel that it's inappropriate. CHAIRMAN SIEGEL: This thing in the Preamble about any conflicts regarding interpretation of Bylaws shall be decided by majority vote of the current membership of the Committee; where does that belong? DR. WAGNER: At the end under Amendment. End under Amendments. CHAIRMAN SIEGEL: 373 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 DR. WAGNER: Yes. Okay. CHAIRMAN SIEGEL: Under "Adoption and Amendments" -DR. QUILLEN: Can I just ask a question under 4.5. Please. CHAIRMAN SIEGEL: DR. QUILLEN: What's an unofficial document? I don't know. We deleted it, so CHAIRMAN SIEGEL: it's irrelevant. DR. QUILLEN: information. I just wanted to do, for general It would have been nice. I don't think we have an answer for you. MR. CAMPER: I might propose they might be deliberative documents. CHAIRMAN SIEGEL: Susan recommended that Section 5.4 actually become 5.1, and you can't amend the Bylaws until you've adopted the Bylaws. DR. WAGNER: I think that's pretty sensible. Logical. So we can do that. Then things CHAIRMAN SIEGEL: will re-number accordingly. She suggested: Adoption of these Bylaws shall require a vote of two-thirds of the current ACMUI membership and concurrence of the Director of the Office of NMSS -instead of "with." Bob, in his comments, said that if Dr. Paperiello 374 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 5.1. does not concur, he has to tell us why he does not concur, and we should make that a particular of the Bylaws. Of course, this gets a little bit circular, because we will never get them adopted as we exchange -MS. BROWN: have to concur and -CHAIRMAN SIEGEL: Let's work back. MS. BROWN: We're actually on 5.4, which is now Will you explain this? 5.3 means that we But they're the same. Oh. It means that we can adopt bylaws CHAIRMAN SIEGEL: until we're blue in the face, but unless Dr. Paperiello says "I agree," they're not bylaws. MS. BROWN: Okay. Okay? All right. Bob's comment was if he doesn't CHAIRMAN SIEGEL: agree he needs to tell us why he doesn't agree. My collegial approach to that is, I can't imagine he won't tell us why he doesn't agree. Therefore, I would suggest Bob, defend your we don't need to add it to the bylaws. position if you feel otherwise. We have another comment but, Bob, go ahead first. DR. QUILLEN: rationale. I just was asking that we have some The way it's written now he can just say no, and we're sort of left hanging. 375 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 boss. DR. GLENN: office director. CHAIRMAN SIEGEL: DR. QUILLEN: Okay. The way it's written, Bob Bernero is the CHAIRMAN SIEGEL: DR. PAPERIELLO: That would be a good thing. No, that's not the way. Talk to my So we could just go "no vote", and we wouldn't know what we were supposed to do from there, so I thought there should be some sort of rationale so we would know what to address, what to change. MR. CAMPER: Can your bylaws -I don't think we can compel. I CHAIRMAN SIEGEL: think that this is a known issue. I really believe that if there's something in the bylaws that are troubling and they need to be changed, that we will get an explanation why they need to be changed. The answer is simple. If we're told that something has to be changed and we don't like, we don't have to adopt it, so this could become a -DR. WAGNER: I was going to say something but I won't because you get a minority group -CHAIRMAN SIEGEL: need the Quillen comment. It'll be a standoff. So we don't 376 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 these? DR. MARCUS: an excellent job. CHAIRMAN SIEGEL: Torre, when we get these redone, I'd like to commend the Chair for doing 5.2 is about amendment. suggested changes. 5.3. Susan did not have any We're almost done. Final proposed amendment may be voted on not earlier than the first regular meeting after it has been discussed at a committee meeting pursuant to 5.2. Okay. So "discussed at a committee meeting." Well, actually, that conceivably means that we could approve these at the next meeting. Okay. 5.3. She's recommending here -- let me just tell you, 5.3, which is now 5.4 -- a vote of twothirds of the current ACMUI membership and the concurrence of the Director of the Office of Nuclear Materials Safety and Safeguards shall be required to approve an amendment. That's fine. That's it. See Fonner change. We're done. Anybody have problems with the copy with my handwritten notes and a copy of Susan's version back in front should come back to me to look at the Bylaws as edited, so that I can make sure that everything got picked up. 377 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 us? CHAIRMAN SIEGEL: DR. STITT: Yes. You'll get it by E-mail. it. DR. STITT: Are you going to circulate that to all of Then we will circulate the edited bylaws to everyone as soon as we've got them so that ideally we'll be able to adopt them at the next meeting as soon as Mr. Bernero agrees that we can adopt them. It's time for -- did the E-mail address document get all the way around the table? DR. ALMOND: It came here and then went back again. Okay. I actually was going to take CHAIRMAN SIEGEL: Isn't that clever how that works? You'll get an E-mail message that, CHAIRMAN SIEGEL: if you're clever, you'll be able to convert to our automatic reply that will capture all of the Committee members. DR. STITT: Terrific. Dennis, you don't have E-mail? I have been resisting CHAIRMAN SIEGEL: DR. SCRIBNER: using my E-mail. CHAIRMAN SIEGEL: I have E-mail. Bob, the State of Colorado doesn't let you have E-mail or you're not allowed to give it out? DR. QUILLEN: We just have internal E-mail at the 378 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 present time. We don't have external E-mail. Okay. Dr. Wagner didn't know. CHAIRMAN SIEGEL: I'll have to call to get a few people's E-mail addresses. That's fine. All right. I'll figure this out. Good. Why don't we -- Dr. Griem and Dr. Almond need Before we take to leave in a couple minutes; is that correct? a break, we have another order of business that we need to deal with. Is that correct? In which case, Dr. Paperiello, I would like to recognize you at this time. DR. PAPERIELLO: We are approaching that time of the year that there is going to be a change in membership of the Committee. We have some people leaving the Committee, and we do have Certificates of Appreciation for those people who have served on the Committee. I recognize this is, in a sense, a burden on the people we ask. extent. I know we compensate people, to a certain I'm sure we don't compensate people for all they have The people on the Committee really make a I recognize we have contributed. valuable contribution to the Agency. controversial subjects. People don't always agree, but I think it's helpful to bring out all the different ways an issue can be looked at which this Committee does. I had to go to a Congressional aid about a month ago, 379 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Agency. Dr. Griem. I would like to thank you for all you've done for us and continue to do for us. DR. GRIEM: We appreciate it. It's in a sense, defend the existence of this Committee and its makeup. The fact that the people that we have on the Committee are either licensees of the NRC or licensees of an agreement state. I had to explain, I don't know where I can get people with the skills and the knowledge we need who don't possess a license from us. helpful. I do appreciate what people have brought to the They won't know anything that will be I just want to thank the U.S. NRC. been an enjoyable experience and interesting and sometimes controversial. Thank you. (Applause.) DR. PAPERIELLO: you very much. DR. ALMOND: (Applause.) DR. PAPERIELLO: Dr. Marcus. Thank you. I'm sure Thank you all. We shall see you. Dr. Almond. I would like to thank I'll still enjoy hearing from you. DR. MARCUS: Thank you for this interesting 380 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 consultation. (Applause.) DR. PAPERIELLO: MS. McKEOWN: Joan McKeown. I was going to go get my case. Thank you very much. DR. PAPERIELLO: MS. McKEOWN: (Applause.) CHAIRMAN SIEGEL: Thank you. Carl, thank you very much. Before we break, let me just bring up one item that, in fact, relates to membership. I think the Commission has Is that recommended that we be set at a Committee of 12. correct -- maximum? DR. GLENN: better than I do. MS. MERCHANT: Sally keeps tracks of these numbers Because of the request by the President that advisory committees eliminate overlap, the Commission has requested that those positions that are duplicated not be replaced, that those members be rotated in those positions, not be filled. 12 members as of July 1. CHAIRMAN SIEGEL: count right. Right. Let me see if I have this That should leave us at about Here's what we have as of July 1. We have nuclear medicine -- myself and also Dan 381 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 have? CHAIRMAN SIEGEL: key point I want to make. We have only one, and that's the The NRC has received a request, and Berman covering cardiology. Stitt and Dr. Flynn. Radiation oncology we have Dr. Radiopharmacy we have Dr. Swanson. State representative FDA, we have really Physics we are down to Dr. Wagner. Quillen. Consumer representative Judy. three people functioning as one. who also is nuclear medicine. Research we have Dr. Nelp, So we have three nuclear medicine people; two radiation oncologists. We have word out on the street for nominations for two people, an administrator and a radiation oncology -MR. CAMPER: medical dossimetrist. CHAIRMAN SIEGEL: Correct. The reason that the No. Radiation therapy technologist or technologist shift is radiation oncology from nuclear medicine is because, as you will notice, many of the things that we are going to be focusing on in the near term clearly relate to things like brachytherapy and some of the real problem areas that need our advice. DR. STITT: Barry, how many physics people do we I've received copies of the request, from which physics 382 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 organization? MR. CAMPER: AAPM. AAPM, indicating that having only CHAIRMAN SIEGEL: one physicist on the Committee is asking an awful lot of that one physicist. Dr. Wagner has done therapy physics during his lifetime but focuses more now on diagnostic radiology physics and nuclear medicine physics and has considerable expertise in radiobiology and epidemiology, thereby filling the shoes that were vacated when Dr. Webster left us. I think that the loss to this Committee, as someone with Dr. Almond's practical expertise in therapy physics and particularly brachytherapy physics, as well, is something that we should not let go unspoken, so I would entertain a motion from a member of the Committee that we recommend to the Commission that we need a therapy physicist on this committee. DR. STITT: I would like to recommend that because I feel very strongly, particularly with the issues of brachytherapy that we're going to being seeing more and more of. CHAIRMAN SIEGEL: DR. STITT: Yes. Could I take that as so moved? So moved. Seconded? CHAIRMAN SIEGEL: DR. GRIEM: Second. 383 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 physics. sorry. given. motion? Judy first, then Lou. MS. BROWN: Just that I understand that the hospital CHAIRMAN SIEGEL: Any further discussion of the administrator position is not going to have any special knowledge in this area. CHAIRMAN SIEGEL: That's always true. That's a You fed me the straight line, and I couldn't resist. (Laughter) CHAIRMAN SIEGEL: I apologize. DR. GRIEM: I didn't mean in this area. I'm I couldn't resist. I don't know a therapy physicist that runs a hospital. CHAIRMAN SIEGEL: Right. No. No. She didn't mean in the area of The hospital administrator, actually, brings an -- I mean, ideally, it would be a hospital administrator who has special experience in this area, and there have been some names suggested of people who really do have such experience. But, nonetheless, as health care reform looms, a hospital administrator brings to this table important information about the impact of the regulations in a shrinking health care reimbursement budget that, although we can talk 384 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 doesn't mean that that name should mean that he has expertise in all physics. Physics is a very broad field, and therapy and about it, we don't necessarily carry the same authority as someone who has to live these budgets and make these budgets. That's really the key point. MS. BROWN: By point, for the record, though, is we're down to 12, you're eliminating two positions, the hospital administrator and myself, who bring nothing to the table about your area of expertise. CHAIRMAN SIEGEL: We have an option for dealing with that, and that is, we do have an option of having consultants come to meetings to address issues that are of specific concern where we think we need broader input. My guess is the people leaving the Committee are going to not be NRC consultants any longer. They'll stay on as consultants, and we can bring them in as we need them. Lou. DR. WAGNER: Lou Wagner. I am not yet an official voting member of this Committee, but I would like to resoundingly support the concept of another physicist appointed to this Committee. Just because a person is called a physicist, 385 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 diagnostic are separable, and they should be considered two separate positions to be represented, not just a single one, simply because they use the same word physicist. CHAIRMAN SIEGEL: DR. MARCUS: Further discussion? Yes, just one. Yes, Carol. CHAIRMAN SIEGEL: DR. MARCUS: If there's something magic about the number of people on the Committee, is it possible to have an ad hoc member from the FDA or something? I'm sure we could continue to have all the input from the FDA, but as a sisterfederal agency, does it have to count in the 12, or whatever the magic number is? MS. BROWN: DR. MARCUS: We certainly don't pay travel expenses. That's right. You could still have all of the input and expertise. DR. GLENN: I don't believe that the Commission has actually settled on a magic number, but they have asked us to keep it as a small as is compatible with our getting the right input from the Committee. duplication. So they want us to eliminate You are making the argument this is not actually a case of duplication. DR. MARCUS: You could also do what the FDA did. They're They have panels, so they're not advisory committees. 386 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 advisory panels, and then they don't feel so compelled. CHAIRMAN SIEGEL: I think we can conduct our business the way we're configured, but I really do think the physicist is a key element, not wanting to seem an advocate for this particular motion. All in favor of the motion? (Show of hands.) CHAIRMAN SIEGEL: (No response.) CHAIRMAN SIEGEL: Let the record show that the vote Any opposed? was unanimous, and that we strongly recommend a therapy physicist needs to be appointed to this Committee. Okay. Let's take just a five-minute break. Those who have to leave, ciao. (Recess) CHAIRMAN SIEGEL: Can we resume so we can finish, and people who want to get earlier airplanes can get earlier airplanes. Our final, official order of business is to talk about our topics for the Commission briefing. budgeted for this. We had two hours We don't need two hours for this and we're not going to spend it, at least I don't think we're needing to. 387 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 We have one other item of housekeeping that we need to deal with. Is Torre in or out of the room? She's out. We need to get a calendar for the October/November dates circulated so that people can state their potential availability or non-availability very soon, so that we can lock in the November dates, and ideally lock in next May's date as well. It's certainly better to try to get at least tentative dates on the calendar. We need to get a firm date on the calendar for November, and we need to try to get a tentative date on the calendar for May. Torre, sometime in the next week, calendars out to the members of the Committee with something like X through the days that you're not going to be available, that you know right now, so that we can plan the November meeting. Not everybody has their calendars with them so we can't just do it here, but we do need to plan that meeting. My understanding is is that if all goes well, the next meeting should be at White Flint and not in a hotel, and that will be good, because it means we have more access to all of the people at the NRC who might want to contribute to the meeting and/or listen to what we have to say. MS. BROWN: It's only good if there's coffee and 388 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 modesty shield. Those are two requests. Coffee, there probably won't be. Wear slacks, Judy. I'm I CHAIRMAN SIEGEL: don't know about modesty shields. sorry. The Commission briefing scheduled for June 22nd, I am now told is unequivocally not scheduled for June 22nd. We now have options of the week of July 11th, the week of 18 July, but excluding 19 July, and I don't have a clue at the moment which of those dates work for me, so I think probably what we need to do, as part of this calendar that needs to go out very quickly, we need to also address how many of us are available on what days during the week of July 11 and what days during July 18. DR. STITT: Any way to know if that's going to more sacred than the date I've been scheduling around for six months? CHAIRMAN SIEGEL: The problem, as you -- the reason we didn't have a February meeting was we just decided there wasn't enough to warrant doing it and it didn't seem like it was appropriate in February to waste federal dollars to just have 12 of us show up and talk to commissioners because there just wasn't much on the agenda. The reason the June meeting got re-scheduled is some ICRP, or some international meeting, has come up where most of 389 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 the Commissioners are going to be attending, and it came up relatively late. This date was sort of on again/off again, and we'll just pick a date. What do you all think we want to present to the Commissioners at a July briefing? Let me just preface the question by telling you that, although I think it's great that we have direct access to the Commissioners, it is a non-trivial responsibility for the chairman, the chairperson, the chair, and you all get to just fly to Washington and sit at the table and smile and make your comments as you wish. I spend 2-1/2 weeks getting ready for it and lose a lot of sleep because I want it to go well. So that if we don't have something important to say, I'd just as soon not do it, to be quite honest with you. I've now requested that three or four times that the Commissioners provide us with any specific requests that they might have, either formally or informally, by any mechanism known to man, to let us know if there where things that they really would like us to address because there are things that are troubling them. We have no requests. I'm not saying that pejoratively, one way or the other. If there are things that aren't really troubling them, and there have to be important things troubling us, 390 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 before we should go forward with this. Just to have a meeting for the sake of having a meeting seems like a big expense which will then be passed on to all licensees. Dr. Marcus. DR. MARCUS: I think there's only one important thing to discuss with the Commission and that's a whole paradigm shift in the medical program. I don't think that any of these trivial details that we discuss from time to time, such as patient notification, are really worth the effort of a commission hearing. I think the entire placement of the NRC into medical judgment and the entire medical program at this point in time is something that needs to be discussed with the Commission. These are areas that are going to be covered, I assume, at least in part, by the Institute of Medicine study, but that will not come out for some time. I think that the Commission needs to hear from the advisory committee as to the enormous problems being caused to medical specialties and pharmacy specialty by a construct that, at least in my opinion, no longer has value in its present form. I will not be at this meeting but, in my opinion, that is the only thing worth discussing with them. If they don't want to hear things like that, then maybe it's not worth 391 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 behavior. practice. having a meeting. But when you go to the Commission, it It should be with major shouldn't be with trivial issues. ones. CHAIRMAN SIEGEL: What are you recommending? DR. MARCUS: What's the paradigm shift, Carol? I recommend stopping dual regulatory I recommend stopping the intrusion into medical I recommend stopping a lot of the paperwork insanity of documenting and documenting and documenting that has no value in the carrying out of medical care. It's enormously expensive and is, I think, detrimental to this country at this point in time. I've estimated, starting with Norman McElroy's old numbers for the 1987 redo of Part 35, that it is now costing approximately a billion dollars a year to comply with NRC regulations in nuclear medicine, which comes to about a hundred bucks a scan. I think that this too much money, and I don't think it buys us anything. I think you have to look at low dose radiation and understand that people aren't dying of it and that there's no demonstrable horror doing on with low dose radiation. I think there's an important lack of understanding of 392 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 medical uses of isotopes by the Commission, none of whom have any expertise in the area, and I think that rather than wait until the Institute of Medicine comes out with whatever they'll come out with, that we basically presented them the very real possibility that between health care reform and the increasing regulations and expectations and requirements of the NRC, that they may well be on the way to regulating nuclear medicine and brachytherapy out of existence, more or less, in this country, because it simply will not be able to function under the construct that the NRC is perpetrating at this point in time. Ideas like the descriptions of how other agencies cover other areas of medicine and how other agencies, like FDA, actually have the regulatory authority to do much in byproduct medicine, need to be discussed. Our problems with NRC's inability to make some peace with EPA are problems. Our problems, I believe, with low-level waste sites are problems we face in medicine and in medical research that the Commission has absolutely refused to really address. These are the kind of things I think this Committee ought to be talking to the Commission about. The fact that they have not asked you for discussion, I think, indicates their unfamiliarity with medical practice 393 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 and medical economics, and that this is really an opportunity for us to tell them what we think is of critical importance, but I don't think that we should not take the opportunity to try to tell them. CHAIRMAN SIEGEL: What do the rest of you think about that -- about that generic, broad issue? MS. BROWN: In general, I don't agree. If you want concurrence, I would have to descend on a whole lot of things, but you know that. DR. MARCUS: I also would throw in the whole I know you situation with the agreement states right now. chose not to discuss the medical program in agreement states at this meeting, but I think it's a problem that really deserves Commission attention. The entire problem of the fiscal stability of NRC's materials program and what the agency is doing about it and how that affects us, I think is very important, and I think the Commission ought to know about it. CHAIRMAN SIEGEL: My concern with everything you've said, Carol, is I'm not sure that I feel prepared for us to present those issues before the Commission since we haven't really discussed those kind of major issues at recent meetings. We've been dealing with smaller things. 394 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 I am more than a little put off by the Institute of Medicine study, ongoing, and wanting to see what that entails. I think it would be naive for us to think that what we tell the Commission will have much impact while they're waiting for an Institute of Medicine, a very independent Institute of Medicine study, that's addressing many of the same issues, to be put together. I would rather put my efforts into making sure that we got our input into the Institute of Medicine folks and made sure they heard from us by whatever mechanism possible to hear those concerns, so that it got into their report. We could certainly do it, and we could have an interesting discussion. I'm just afraid that (A) Preparing for it would be non-trivial; and, (B) That since we haven't discussed those broad issues recently, it would be hard to make sure we had a consensus about what the view is. MS. BROWN: And also the major supporter of those views is not going to be at the meetings, so I don't think your message would be carried adequately without you being at the table. MR. CAMPER: Just a thought or two on it. Certainly, the Committee could do this if you decide to do so, it's up to you. But just a couple of observations. 395 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 You're at a period in time where the Commission has directed the staff to have an independent audit of the medical program. You're also at a time when the Commission, in approving the medical management plan, said, amongst other things, make a major revision to Part 35. Dr. Paperiello has indicated to you and to others in various discussions that, as part of that process, we intend to do an advance notice of proposed rulemaking. ANPR is an exploratory approach to defining the parameters and the considerations that will ultimately be addressed in a rulemaking. It's a very broad process. We are interested and have committed to conducting public meetings and workshops as part of that process. Issue of compatibility, agreements states; the Commission has deliberated and reviewed items associated with that topic at great length of recent. I think if you want to do this, I do think there is an issue that Barry has raised appropriately, and that is, you are taking -- Carol, you're expressing a global concern that you would need to come to grips with and define your positions and so forth. In many ways, I think, if one looks at all that is going on, at this point in time, that really is germane to your 396 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 that. concerns, you would probably be better served by being more specific in defining concerns that don't seem to be under construction at this point in time, if you will, but it's entirely up to you. MS. BROWN: Is someone outside the field, and they are certainly outside the field, only thing that I think we would say to them is all that -- at least I'm hearing of the concerns about brachytherapy and where that's going and what the charge of this Committee is going to be in the near term -just to let them know that's happening, but I can't imagine that the staff hasn't already let them know that's happening. I don't know that we need to assemble to tell them I don't have any agenda items, other than that. CHAIRMAN SIEGEL: MR. SWANSON: Dennis? Being new on the Committee, I don't know what I would discuss with the Commissioners at this point. I am somewhat dismayed at this meeting, to be very frank with you, with the lack of response of the Office of General Counsel to some of our requests. I guess that brings to mind a question as to what is the appropriate interaction between the NRC and this Committee, and what should we expect as an appropriate response to these requests. 397 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 I think it was stated this morning that one of the functions of the Office of General Counsel is to respond to questions raised by this Committee, and they have not responded at this meeting, and I can't speak for the past. certainly strikes me as being unusual. MS. BROWN: I was wondering about that myself. I But it wonder if their hesitancy to respond -- I attributed it to just they all run and put their heads together and come up with the right answer because anyone saying something off the cuff at this meeting would have the weight of the office but not everyone's deliberations. I interpreted it a little differently, that nobody's really qualified until they all thought very seriously about our series of questions. CHAIRMAN SIEGEL: And that's okay, except we're expected to deliberate in a Committee environment and make some quick determinations of a consensus based on our experience -MS. BROWN: But we get to talk among each other, You're just sending one person down ourselves, and they don't. from the office. CHAIRMAN SIEGEL: Well, they could certainly have had There was no requirement that more than one in the audience. only one person come. 398 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 MS. BROWN: Well. Be that as it may, I don't know CHAIRMAN SIEGEL: that we want to necessarily present that, but the Minutes will reflect the fact that that was a concern. If we talked about specific issues, the issues that came up at this meeting, that strike me as potentially worthy of things to be brought to the Commissioner's attention, include the concerns we raised about the apparent double-speak associated with patient notification; the fact that the rules seem to suggest that you might not have to notify patients if you thought it would harm them but, in fact, you have to notify patient's families, which would end up harming the patient most of the time or could end up harming the patient much of the time. That's one thing. The very early -- well, it's probably too early because we haven't seen the language about this breast-feeding thing that we talked about yesterday, which I am personally, as I understand what's being discussed, very troubled by the fact that the NRC seems to be making an absolute, that under no circumstances could a physician commit an act that would result in the exposure of a breast-feeding infant to more than 500 millirems, as a result of the administration of radiation to the mother. 399 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 modified. I'm not sure that that is necessarily something that should be an absolute. In order to frame the question, I think I'd probably need to see the proposed Part 20 language to frame the question. MS. BROWN: I assumed it would be modified just as a result of the discussion here. CHAIRMAN SIEGEL: MS. BROWN: Commission. CHAIRMAN SIEGEL: I'm not sure that it would be I don't think so. You would have to bring it to the This would be an area -- this would be an intrusion into medical practice, albeit infrequent, that we could point out. I'm not disagreeing with you. I'm just telling you items that I thought could be raised to the level of consciousness. DR. MARCUS: You might also, in that same vein, inquire as to why something that important was not brought to the attention of the ACMUI first. You have a Commission and staff and management with no medical expertise whatsoever, making rules about the practice of medicine without coming to their ACMUI, or at least calling the chair and saying, do you see any real objection to 400 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 this? I think that that typifies the problems medicine is having with the NRC. CHAIRMAN SIEGEL: Go ahead, Larry. MS. BROWN: MR. CAMPER: I have a question -I need to correct that, somewhat. We Okay. have discussed the patient -- this nursing infant/fetus issue with the Committee before. We will be discussing the language We are not doing it in the of the rule with the Committee. vacuum you indicate. DR. MARCUS: All right. We had talked about inadvertent administration. It was never, ever suggested by NRC that purposeful administration of radioactive material to pregnant or breast-feeding women, when there was some medically overriding reason, would ever be made illegal by the NRC. MR. CAMPER: that that will happen. And I wouldn't jump to the conclusion I think what you have, you have a status report that has raised an issue that is of concern to you and to other members of the Committee, I suspect. some concern to members of management present here. It is of We will be working with the Office of Research, and obviously we will be communicating and discussing this rule with this Committee. I wouldn't jump to that conclusion. This is a rule 401 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 there -DR. MARCUS: decisions. MS. BROWN: Right. Okay. I know what you're saying. That's not enough to make medical medicine. MS. BROWN: DR. MARCUS: MS. BROWN: Well, still, that's something -That's technologists. -- that's something. I'm just saying that's under construction, if you will. MS. BROWN: I wanna address something, Carol, that you've said frequently, that has, I think, misled me, not being so familiar with NRC. You say a lot that NRC has absolutely no medical experience, outside of Myron Pollcove, and I don't know whether that's true or not. But -DR. MARCUS: MS. BROWN: It's true. -- but what I've found in talking to the staff and getting to know them more, they all have a lot of clinical experience somewhere -DR. MARCUS: Only technologists, and that is not But the way you have phrased it and it has always gone unchallenged, has been misleading to me, and I just wanted to say that I found a lot more depth of experience that reassures 402 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 me that NRC has been in hospitals and worked in the medical -DR. MARCUS: MS. BROWN: DR. MARCUS: That's irrelevant --- environment, more than what you said. -- when it comes to making medical Technologists are not judgments about patient management. capable of doing so, and there is no state in the United States that lets technologists practice medicine. MS. BROWN: Yeah, that's fine. What I am saying is, the way you oppose these things over the years that I have heard them, has been misleading to me. What you are saying there clarifies it, and I would agree with it. DR. MARCUS: Technologists' judgment, fine. But technologists are trained to do certain activities, and physicians are educated to do other activities, and when we're talking about medical judgment -MS. BROWN: DR. MARCUS: MS. BROWN: Okay. I'm not disputing -- -- it's different. -- what you're saying, Carol. I'm just saying perhaps in all these years of listening to you say it, I have been led to believe one thing and now I am just saying that I've come to believe another, none of -DR. MARCUS: You're welcome to believe whatever you like, but I still maintain there is no medical expertise in 403 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 this agency. MR. CAMPER: I believe I can comment just to try and help bring this to a settlement. Dr. Marcus is certainly correct that there are no physicians on the medical and academic sections of the staff. There are individuals who have been technologists in their careers, medical physicists, health physicists, radiation safety officers, radiation biologists and so forth. Dr. Myron Pollcove as the only clinician. We do have I think that the basis, in my observation, is really as Carol's perception or opinion or belief as to where the practice of medicine begins and ends. What is the definition thereof. Clearly, she viewed that in a very broad context that's entirely her right to, and there are obviously other considerations that have to be borne out as well -- public concerns, congressional concerns, Commission concerns, and so forth. What we try to do is to use the staff that we have that does have substantial professional technical experience and somewhat of a clinical nature, and use the expertise of this Committee, hopefully, to develop some reasonable regulations and guidelines, but I suspect we'll never come to a point where Carol would be completely satisfied with that. 404 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 That's okay. clarification. MS. BROWN: MR. CAMPER: Sure. But, anyway, where are we? Another potential issue that could That's okay. At least I offer that as CHAIRMAN SIEGEL: be discussed is the whole issue of the need for new brachytherapy standards and regulations. I'm not sure we're far enough in our thinking to know what needs to be included, other than the highlight, this is a problem. We did that at the last Commission briefing as well, so whether we need to do it again remains to be seen. For those of you who were there, you will remember that at the first Commission briefing -- the pre-Cleveland Plain Dealer briefing -- we had planned to address the item of training and experience and elected to basically not do so other than to just say this is a complicated problem that needs to be dealt with some day. We can certainly do that, but I don't think we'll have any unanimity in talking about the need for a paradigm shift. My sense is is that we'll get up there and we'll say these are some things we see as a problem. Here are a few of them that we think have some very specific things that you need 405 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 to address because there's specific problems. Then there's some big issues that we think you need to be aware of and really need to be moved to a very high priority in terms of Commission activities and things the staff ought to be looking at. The staff is working on them already. I guess I'm I don't having trouble getting very excited about doing this. know if that's the right answer. MS. BROWN: Tell me again why we need to? What? CHAIRMAN SIEGEL: MS. BROWN: Tell me again why we need to? Why we need to what? CHAIRMAN SIEGEL: MS. BROWN: Meet with them this summer. Because the Commission has CHAIRMAN SIEGEL: requested that we have an annual meeting with it, with the Commissioners. We've taken that as a good opportunity to have a direct access to the Commission. One argument against having the meeting is that the transition that has occurred in this Committee over the course of the last four years. I think when I became chairman of this Committee, when all of the new members of this Committee came on, when the Committee went from being a staff-run Committee to a more independent Committee, We have, over the last four 406 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 years, evolved into a Committee that I don't think feels bashful about getting our input per the NRC. The need for direct access to the Commissioners, except when there's some very important philosophical issues to discuss with them, or when they want to pick our brains, seems to me less compelling than it was when the notion of meeting with the Commissioners first came on the table. I don't want to lose the opportunity to meeting with them if we feel the need to do so and they feel the need to talk with us. But I also don't want to spend $25,000 in travel money and hotel bills and all of our own personal time if we don't have a great need -MS. BROWN: Just to save our slot. -- to save our slot. That may not CHAIRMAN SIEGEL: be an acceptable answer and, Carol, probably not to you, but you don't have to prepare for it, and I don't want to just make work if we don't have to make work. DR. MARCUS: One thing you might really consider presenting to them -- and I don't know how much work it would be for, you, Barry -- is to explain the economics of American medicine right now to them and their effect on our ability to provide care to patients. issues pretty well. You know those medical economic 407 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 CHAIRMAN SIEGEL: I know some of them, and I don't I don't mean that I don't know I don't know They're going to think we know them well enough. them well enough. I know what they are today. what they're going to be 18 months from now. be worse, they're not going to be better. given. I think that's a In a way, I really -- maybe I'm just being wimpy here, because -MS. BROWN: Since you do all the work, I think you have the right to be wimpy. CHAIRMAN SIEGEL: To be wimpy. I really feel that I would love to be sitting talking to the Commissioners with the Institute of Medicine report in hand and saying -MS. BROWN: It's something to react to. -- these are items that have a lot CHAIRMAN SIEGEL: of meaning, and we strongly endorse this, but we think that this thing is totally bogus, and here's why. On the other hand -MS. BROWN: with the IOM people. DR. STITT: Right. What is our status with them? I And possibly spend that money meeting know we discussed it briefly yesterday. CHAIRMAN SIEGEL: Let me tell you what I know about 408 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 on that. CHAIRMAN SIEGEL: I think I need to have some our status. Their meeting on July 11th and 12th, is their next I have been asked to go to that meeting and regular meeting. tell them what the ACMUI has been doing -- which I have to ask you all an interesting question about that -- tell them what the ACMUI has been doing, and then what issues that I think the ACMUI has been addressing that are important, and then they're going to pick my brains. The question is, can I go there; am I representing the ACMUI or am I going there as a private citizen? MS. McKEOWN: Who's paying the bill? Well, the NRC is probably paying CHAIRMAN SIEGEL: the bill either way. MS. McKEOWN: DR. GLENN: Then you're representing us. We need to consult and get back with you clearance about whether I'm going there as a private citizen with special expertise or I'm going there as an NRC employee. MS. BROWN: Also, I'm disturbed that we're learning this as a result of a question from -CHAIRMAN SIEGEL: MS. BROWN: No. Were you going to tell us? I was going to tell you. CHAIRMAN SIEGEL: 409 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 here. CHAIRMAN SIEGEL: yesterday. No. I actually knew that I talked to Kate MS. BROWN: Oh. I'm sorry. I'm thinking we're adjourning CHAIRMAN SIEGEL: MS. BROWN: It's okay. Dr. James didn't know I knew it. Gadfrey two months ago. MS. BROWN: Oh. I don't know if there's going to be CHAIRMAN SIEGEL: any way for us to insert ourselves beyond that, into their process. They're defining the process. MS. BROWN: I don't know. I think you would represent us very well. I think that's a great solution. I believe, also, when the representative I think, in essence, what they were MR. CAMPER: was here, this came up. saying is they would consider inviting a representative of the Committee, but the idea of meeting with the entire Committee is not something they might want to -CHAIRMAN SIEGEL: MS. BROWN: No. However -When I heard the Committee's meeting face to face, I saw -CHAIRMAN SIEGEL: MR. CAMPER: No. We talked about that. 410 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 CHAIRMAN SIEGEL: -- a basis -- We talked about that They're a big Committee, and thought that was impractical. even bigger than we are. their public meeting. There's no reason why we cannot go to We might even be able to do it as an official NRC act in some way, and we might want to have a special meeting somehow in relationship to their public meeting, so that we have an agenda -MS. BROWN: Yeah, especially if you thought they were going astray and reported back to us in some way. CHAIRMAN SIEGEL: I doubt that they will be. That's my big concern, is that it seems like to try to second guess the Institute of Medicine, with the paradigm shift issue, Carol -- I mean, I agree with you about the paradigm shift. I'm on the record as saying there needs to be something other than a patchwork quilt of regulation of radiation and medicine. I'm also on record as saying nothing, not even the rain, has such small hands, if I can quote E.E. Cummings, but 2 percent of ionizing radiation used in medicine at the NRC is responsible for, and it's the tail wagging the dog, and there needs to be regulation that's across the board and uniform and that makes sense and is consistent with the economics of health. If you get me on a soapbox, I'm prepared to talk about 411 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 that. It seems like I would love to hear the Institute of Medicine say it about the same time we're saying it. MR. SWANSON: I think the reality is this Committee has been saying this to the NRC for the last several years anyway, and I can't really see we're going and saying it to it again without the support of a document from the Institute of Medicine, for example. It seems to me that if we have that document, then we'd really have something concrete to talk about. On the other side of the coin, getting back to meeting with the Commissioners, I do think it would be to the benefit of the new members of this Committee to have the opportunity to meet the Commissioners, if nothing more than so they know who we are, we know who they are. If that could be done in perhaps a more informal process, even at our next annual meeting, might be an approach to that. DR. GLENN: possibility. I'll just comment. We can raise the One thing that Susan Fonner told you about this morning was the Sunshine Act, and so bringing the Commissioners together, more than two at any one time, does constitute a meeting of the Commission, so there are some aspects there that would have to be looked at. 412 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 CHAIRMAN SIEGEL: the same cocktail party? DR. GLENN: MR. CAMPER: I guess they can't even all go to Is that correct? No, that's beyond my knowledge. Well, the fashion in which they communicate with each other is very -CHAIRMAN SIEGEL: MR. CAMPER: It's pretty amazing, yes. Right. It's the holdover from the days CHAIRMAN SIEGEL: when people were worried about atomic bombs a lot, and that kind of stuff. I'm just looking through the last few sets of Minutes to see if there are other issues that we've had on our previous agendas that are worth elevating to a Commission point. My sense of listening to most of you -- Carol excepted -- is that we don't feel compelled to have a July meeting with the Commission. MS. BROWN: Also, the people that would be at such a meeting, the ones that haven't rotated off yet, are pretty much new members, so I appreciate Dennis' interest in meeting the Commission, but there doesn't seem to be any festering things left over from the old, except for Carol's concern, and wouldn't be there, from the old members. CHAIRMAN SIEGEL: Could I propose, therefore, that 413 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 message. CHAIRMAN SIEGEL: Is that right, or are the rest of I'm willing to be very Dr. Glenn, Dr. Paperiello, and Mr. Camper suggests that we're not certain we want to waste your money, but if compelled to do so we'll come up with an agenda. DR. PAPERIELLO: CHAIRMAN SIEGEL: Okay. We'll do the calendar bit, we'll try to find a date, but just as we did in February, it may be, why waste $25,000 or $20,000, or whatever it costs, of there really is no compelling reason to do so. I mean, I think people generally are so eager to get access to administrators of federal agencies that they would be falling over themselves for the opportunity. Here is a group of your special government employees, saying, we'd just as soon sit tight and watch the way things develop. spend the money, we'll do it. DR. PAPERIELLO: I understand. I'll relay the If they want us to you not in agreement with that? flexible on this. (No response.) CHAIRMAN SIEGEL: understand. We've heard from you, Carol, and Her lips are sealed. Failing that, I think I have no other Okay. 414 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 gone. her. (Laughter) DR. GLENN: I think Dr. Griem and Dr. Almond have additional items of business. Are there other matters that other members wish to bring before the Committee? Professor? DR. GLENN: I will just ask that Carol and Joan stay We do have photographers here and behind after we adjourn. we'd like to take a picture. MS. McKEOWN: I'm not getting my picture taken with But with that announcement, I declare that this meeting of the advisory committee is adjourned. (Whereupon, at 11:40 p.m., the meeting was adjourned.)