ATSDR - Oak Ridge Reservation - ORRHES Meeting Minutes

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ORRHES Meeting Minutes
April 13, 2004

Attendees

ORRHES Members:

Peggy Adkins, W. Donald Box, Robert Craig, Kowetha Davidson (Chair), Karen Galloway, George Gartseff, Jeffery P. Hill, Sandy Isaac, David H. Johnson, Susan Kaplan, James F. Lewis, Anthony Malinauskas, LC Manley, Peter Malmquist, Donna Mosby, Barbara Sonnenburg, William Taylor.

ORRHES Liaison Representatives:

Chudi Nwangwa (TDEC), Jon Richards (EPA), Brenda Vowell (TDH).

ATSDR Representatives:

Loretta Bush, Paul Charp, Jack Hanley, Marilyn Horton (DFO), Jerry Pereira, Peg Roberson, Susan Robinson, Terrie Sterling.

Guests:

Gordon Blaylock, Timothy Joseph, Janet Michelle, Phillip Morrison, and Teresa Robinson (Cambridge Communications).

Call to Order/Opening Remarks, Agenda ReviewApproval of February and March Minutes, Introductions, and Correspondence

Kowetha Davidson, Chair
Oak Ridge Reservation Health Effects Subcommittee (ORRHES)

Dr. Kowetha Davidson welcomed everyone to the meeting and asked Dr. Peter Malmquist if he would like to welcome the group to Kingston. Following Dr. Malmquist's gracious welcome, Dr. Davidson asked everyone in the room to introduce themselves.

Following the introductions, Dr. Davidson briefly reviewed the agenda for the day and then called for approval of the February and March meeting minutes. She indicated that several comments had been submitted with regard to the February meeting and that those comments would be incorporated into the minutes.

Motion

Mr. Robert Craig moved to approve the February meeting minutes with the submitted changes. Mr. Jeffrey Hill seconded the motion. The motion carried unanimously.

Motion

Dr. Tony Malinauskas moved to approve the March teleconference minutes. Dr. Robert Craig seconded the motion. The motion carried unanimously.

Status of Action Items

Marilyn Horton, DFO
Oak Ridge Reservation Health Effects Subcommittee (ORRHES)

Ms. Marilyn Horton directed the group's attention to the Action Items Handout in their packets, explaining that the Action Items List now include the following February 3, 2004 and March 9, 2004 action items. She reviewed the status of the pending action items as follows:

Tim Joseph will provide ORRHES a copy of the status of the new well installation project. That information was mailed out after the February meeting.

Paul Charp will provide information on the fiscal/biological/effective half-lives of the radionuclides, which he presented at a past meeting. That information was included in the handouts for the 4/13/04 meeting.

Jerry Pereira will report on specific budget changes to the ORRHES chairperson and chairs of the work groups, if it critically impacts the subcommittee. If there are no major impacts, he will present an update at the next meeting. Mr. Pereira will present an update on the budget issues.

NAWG will present more information on the proposed plan for collecting information about the ORR Community Adjusted Timeline. That presentation was made.

Ms. Horton then introduced Ms. Loretta Bush, because one of the recommendations that was made at the February 3, 2004 meeting was on the final PHA on the Y-12 Uranium Release. She indicated that most of the people in the room knew Ms. Bush, who acted as the DFO for the ORRHES when it first began several years ago. She is also a Lead Senior Community Involvement Specialist with the ATSDR. Ms. Bush explained how the Y-12 document was released.

Y-12 Document Release

Ms. Loretta Bush
Lead Senior Community Involvement Specialist
Agency for Toxic Substances and Disease Registry (ATSDR)

Ms. Bush indicated that the Y-12 documents were sent distributed to the community on March 19, 2004. These documents were followed up by a media press kit, which was disseminated to identified media outlets on March 24, 2004. The press release was distributed to over seventy media outlets in the area; however, the four main media outlets identified were the Oak Ridger, the Roane County News, the Crossville Chronicle, and the Knoxville News Sentinel. The press kits they received included: the PHA document, the CD-ROM, a fact sheet on ATSDR, and the summary and briefing documents on the Y-12.

Discussion Points:

Dr. Tony Malinauskas commended the ATSDR staff who worked on the document. He was particularly impressed with the two abbreviated versions that he had been requesting for many months. He thought that the job was well done. Dr. Davidson thanked Dr. Malinauskas for his kind comments.

Mr. James Lewis stated that in the body of the minutes of the last subcommittee meeting, the subcommittee had agreed upon a release plan. He suggested that someone locate that recommendation and read it, because he was concerned that the recommendation had asked that the Y-12 document have a "fanfare" release, and that there would be a public meeting or announcement regarding the release of that document. That was done as a compromise to the discussions that the subcommittee has had concerning the document. From Ms. Bush's comments, it seemed that had not been done. Although he agreed with Dr. Malinauskas that the documents were beautiful, he wondered what had happened to the recommendation that the subcommittee approved and forwarded to the ATSDR. He asked ATSDR to respond to this matter, to explain what the process was with regard to the release of the document, and where the breakdown occurred. He said that to the best of his knowledge, and in discussion with the press, they did not obtain the types of items that Mr. Lewis was looking for related to the release effort.

Upon checking her documentation, Ms. Horton read the recommendation for the record:

"The final PHA on Y-12 Uranium Releases will be publicly released in the ORR area, in the presence of both the public and the media, along with an official explanation regarding the differences between the ATSDR and the EPA methodology in determining risk versus dose, both of which reached the same conclusions."

Ms. Bush pointed out that Mr. Lewis was referring to the three release documents, which were in their handouts. These documents were entitled, "ATSDR's Cancer Comparison Value," "Uncertainty Analysis," and "Screening and Regulatory Dose Limits." She stated that after conversing with Mr. Lewis about this particular issue, she investigated the issue and found that the recommendation was actually made on March 3, 2004, at the last ORRHES meeting. She became re-involved with the ORRHES on March 9, 2004, after that ORRHES meeting. However, it was brought to her attention that the recommendation was for these particular documents, and these issues with which the ATSDR had disagreements with the EPA, and that the subcommittee wanted the ATSDR to mail information to media outlets on these particular items of concern. However, Ms. Bush explained that in accordance with ATSDR policies and procedures, even though the documents had been developed, in order for staff to release the information to the media, to the community, or even to any member of the ORRHES, final approval had to be received from management staff. At the time of the documents' release, the clearance process had not been completed.

Regarding the three handouts, Mr. Jon Richards asked if it was appropriate to correct items on the three ATSDR documents now or if there would be an opportunity later in the meeting. He was concerned about the term "EPA clean-up level."

Mr. Lewis apologized for interrupting, and he appreciated Ms. Bush's comments, but he wondered why the ATSDR did not implement the subcommittee's recommendation. This recommendation, which was a compromise between the subcommittee and ATSDR, was recommended by Dr. Herman Cember, and the recommendation was that the PHA on Y-12 Uranium Releases document would be released simultaneously with a public presentation of the information. Mr. Lewis said that Dr. Davidson indicated to him that the subcommittee would receive a written response from the ATSDR regarding why they did not comply with this recommendation. He thought that the recommendation was quite sound. Dr. Davidson clarified that she had stated that the ATSDR is not required to carry out the subcommittee's recommendations, but they are required to respond to them.

Mr. Lewis asked the ATSDR to respond to the recommendation. Dr. Davidson asked for clarification on what he was trying to ask: Was he asking for a response regarding the recommendation or was he asking why the information was not released? Did he want an additional explanation beyond that which Mr. Bush had given?

Mr. Lewis reminded the group that at the last meeting they had discussed the fact that they had not heard the EPA's position on the PHA on Y-12 Uranium Releases. In conjunction with the release of the PHA on Y-12 Uranium Releases, the subcommittee thought that they would have a public meeting where the subject might be discussed openly with the public. That meeting never happened, and Mr. Lewis wondered why.

Mr. Jerry Pereira explained that there were several reasons that the fanfare meeting did not happen. First, the three documents that the committee received were not ready. Second, he did not have a problem with conducting a public meeting in Oak Ridge, even though the PHA has already been distributed, however, he was not sure whether such a meeting would have any impact on the citizens of Oak Ridge. Still, if it was of concern to the subcommittee, the meeting could be scheduled. He reiterated that a press release was distributed, the handouts that Ms. Bush had provided would follow that press release, and he suggested that if there were any other issues for the citizens of Oak Ridge regarding Y-12 Uranium, ATSDR would address those. If it needed to be in a public forum, it would be done. If it needed to be on a one-on-one basis, it would be done that way.

Regarding the three handouts that the subcommittee had been given regarding the Y-12 Uranium Releases, Mr. Richards commented that the EPA does not have a "clean-up level" for radiation or chemicals. For radiation and chemicals, it is the same. The risk range is the clean-up. The EPA does have what is called the "upper end" of their risk range that translates to 15 millirem, which is an easy solution. They could say that that number was the "upper end." In other words, the risk range is 10^-6, 10^-4. The EPA now declares 3 x 10^-4 as its "upper end," which is approximately 15 millirem per year, for a 30-year lifetime. That is the Superfund default, and it is in the Office of Solid Waste and Emergency Response (OSWER) guidance, which was released in 1997 and which clarified that risk range for all the Superfund clean-ups. He expressed his apologies if this draft had already been printed out, but ATSDR needed to correct the terminology on their handouts. He added that the term appeared on every sheet, clarifying that ATSDR could replace the phrase, everywhere it appeared, with the phrase "upper end of risk range," which would be appropriate.

Ms. Susan Kaplan stated that Mr. Richard's comments made it apparent that it is important to have the EPA's input in this process. She also thought that Mr. Lewis' frustration with how the subcommittee's recommendation was handled was apparent to everyone. She pointed out that Mr. Lewis had put in a great deal of effort into bringing the EPA into this process and to have an open discussion with the EPA. His hope was that there would be a public meeting at which to launch the PHA, or that a public meeting would be held preferably before this report, at which everyone might discuss outstanding issues. She said that evidently, she was the only subcommittee member who had received a hard copy of the PHA, other than the CD-ROM, which is nice to have. She also complimented the ATSDR on the report, because it has the potential of being the best, most readable public document she had ever seen. She briefly scanned the document earlier in the day, and found it to be a very well done document in terms of being easy to follow and read. Unfortunately, the PHA document was not a draft document that would be revised, but Ms. Kaplan thought with one more revision, it would be a great document.

Ms. Kaplan then indicated that she had something that she would like to read into the record, and some material that she wanted to submit for the subcommittee's consideration, because having the EPA's input is still very important. Following is a letter that Ms. Kaplan wrote to the subcommittee on April 13, 2004. The subject was the outstanding EPA issues on the Y-12 Uranium PHA.

"As a result of James Lewis' efforts to supply EPA with key sections of the meeting minutes on this issue, EPA Headquarters and Region IV agreed to participate in a public meeting on Monday, April 13 in Oak Ridge to provide the affected community the opportunity to have an open discussion on the outstanding issues on the Y-12 uranium PHA. They were also on the agenda to speak to ORRHES at today's meeting in Kingston.

The primary purpose of the proposed Monday night public meeting was to compensate for ATSDR's failure to fully implement the motion that was passed by ORRHES on Feb. 3, 2004, i.e., that 'the Final Y-12 Uranium Releases PHA be publicly releases in the ORR area, in the presence of both the public and the media, along with an official explanation regarding the differences between the ATSDR and the EPA methodologies, in determining risk versus dose, both of which reached the same conclusion.' The final report that was released was dated January 30, 2004 and a press release was issued March 24, 2004. No public meeting was held and today's ORRHES meeting is being held outside of Oak Ridge.

Because of ATSDR's unwillingness to aggressively pursue the issue of EPA's attendance, James Lewis decided to take on this effort himself. I would like to commend James for his efforts to convince EPA to have an open, public discussion. However, despite his successful efforts, ATSDR's actions resulted in the cancellation of that meeting last night and the talk today. Because of ATSDR's unwillingness to participate in these meetings, the desired goal, which was to have all parties at the table, would not have been achieved. So, James decided to agree with ATSDR on the premise that the discussions would be held in an open and timely manner.

In anticipation of these meetings, I compiled a timeline of the EPA controversy. Having ready access to the detailed meeting minutes allowed me to perform this analysis, which helps us understand complicated things like this. Please note that what was accomplished by James and me was made possible by the ready availability of detailed meeting minutesanother controversial issue that some members of ORRHES have fought hard for and which ATSDR has been reluctant to provide. See the Motion made by Karen Galloway in the February ORRHES meeting minutes, which was defeated. This was one of several such proposals over the course of ORRHES' existence. It is critical to recognize that having the tools that enable a member of the public or a Subcommittee member such as myself to do such an analysis is the only means that taxpayers have of holding our government accountable. So, although EPA did not come to Oak Ridge this week, I would still like to submit this draft document for the record. [See: EPA Controversy Timeline]

What do we want? I suggest the following as a start:

Regarding the June ORRHES meeting that EPA may be attending, in addition to the regular ORRHES meeting on Tuesday, ORRHES also should be convened on Monday evening in Oak Ridge to provide the Subcommittee, as well as the Oak Ridge community, the opportunity to hear from EPA without the time restrictions of a normal Subcommittee meeting.

The EPA controversy over the Y-12 uranium releases illustrates systemic problems that exist within ATSDR and how it interacts with the Subcommittee, attempts to control it, and how it responds to Subcommittee recommendations. Unfortunately, it appears the organization's public-participation process has broken down, something that threatens to undermine the public's trust in all the organization's efforts in Oak Ridgeand not for just the Y-12 uranium releases. A work group should be established to analyze this subject.

Letter signature: Susan Kaplan."

Ms. Horton thanked Ms. Kaplan for her comments, asked her to provide the writer/editor with a copy, and indicated that she would make sure that everyone received a copy of the letter and the timeline.

Mr. Jack Hanley pointed out that the EPA does attend the subcommittee meetings, through the form of their liaison representative, Mr. John Richards, from Region IV. After the December meeting, Mr. Richards recommended that ATSDR contact the Office of Radiation and Indoor Air (ORIA) directly. The ATSDR contacted ORIA directly and had a conference call to discuss the issues. They were invited to attend the meeting. They were also offered the opportunity to have a conference call with Dr. Davidson and Dr. Cember on these issues. They decided, instead, to write a return letter to Dr. Davidson. The ATSDR did make efforts and continues to make efforts to contact the EPA. The EPA does plan to attend the June ORRHES meeting.

Ms. Barbara Sonnenburg emphasized that the group needed to have the discussion now, while Ms. Kaplan was in attendance. Ms. Kaplan is quite ill and was going to have to leave, and so the subcommittee did not need to wait until the end of the meeting to discuss these issues.

Mr. Davidson pointed out that the EPA would be attending the June meeting to address these issues.

Ms. Sonnenburg re-emphasized the need to have a discussion now, for Ms. Kaplan's benefit. She added that she found it amazing that the Y-12 PHA handouts, which were public documents, quoted the EPA and the EPA was never asked to look at them and verify them before they were printed with the wrong information on them. If somebody was going to print her name and say that she said "so and so," they had better check with her to ensure that the facts were accurate. Evidently, no one checked with the EPA to ensure that the facts included on the Y-12 handouts, which were public documents, were accurate. While she did not know who prepared these documents, she thought that they should be destroyed and ones that EPA approves in writing should take their place. Second, she asked for a copy of the letter that the EPA sent to Dr. Davidson, because she had not seen a copy.

Dr. Davidson stated that the letter had been distributed at the February meeting, and that all of the subcommittee members received that letter at that meeting.

Ms. Sonnenburg asked her to send her a copy of the letter. Ms. Sonnenburg also wanted to know how they might put the contents of Ms. Kaplan's letter into a motion. She thought that the subcommittee needed to move certain things on which they could vote on in the next few minutes. She thought that they needed to condense the letter's contents and vote on the issue. She simply did not want to wait until the end of the meeting, when Ms. Kaplan would not be in attendance.

Mr. Lewis stressed that this has been quite a frustrating experience for him. He added that Ms. Kaplan had done a great deal of work on her timeline document, and he suggested that everyone take a moment to look at it, because it was a reflection of the subcommittee's detailed discussions regarding process issues. It also addressed the subcommittee's efforts to bring the EPA to the table, an agency that has a different perspective or point-of-view than ATSDR. The reason that the ORRHES wanted the EPA involved was so that they could share their perspectives with regard to the issue of concern with the public, so that the public was not hearing only someone else's interpretation of that perspective. He thought that the subcommittee should review the document and take a look at the number of times that things have been said about the issue and at the subcommittee's inability to get the EPA to the table. He did not want anybody to take the blame, because there might be reprisals, but he felt that there were some people here who should do their jobs.

As a citizen, he personally contacted EPA because all he had heard about the attempts to contact the EPA had been secondhand. He had read the letter and heard from ATSDR about their discussions with the EPA. He had personally contacted Headquarters and Region IV, and it was amazing what he found out. After a brief discussion, he told them that as a citizen he could not personally ask them to come, but he offered to share with them the minutes of the last meeting. He mailed the minutes to the appropriate people at the EPA, asked them to review those minutes, and asked them if they would come to Oak Ridge to present their viewpoints. The people at the headquarters said that it was not timely when they had received Dr. Davidson's original letter, so therefore they could not have coordinated their activities to attend the meeting. EPA directed him to contact Region IV. Region IV indicated that issues of this nature should not be handled on lower levels, that this type of conflict should be handled by the appropriate levels of management who would determine if they could work it out.

Approximately two weeks ago, in talking with an individual on the subcommittee, Mr. Lewis was made aware of the fact that the EPA was going to be put on today's agenda. When he found out that they were going to be put on the agenda, and the time and the location of the meeting, that increased his frustration because the affected community was not even aware of what was happening. Therefore, he personally contacted the EPA to alert them of the fact that it was fine for them to come, but if they were going to take advantage of the travel time, he suggested that they consider meeting with the general public on Monday evening and present their perspective. In his opinion, that appearance was aligned with the philosophy and policies that the subcommittee has be utilizing on all technical issues, which is go to the work group first, present those issues, boil them down, and bring them to the full subcommittee. He was challenged. He contacted the Chair and ATSDR staff, and the logic was that the public meeting was going to be held after the full subcommittee meeting. Mr. Lewis explained that he tries to follow policies and procedures, but after the ATSDR had failed to follow through on many recommendations, he felt it was his duty to at least request the additional meeting.

Ms. Kaplan, Mr. Lewis, and others examined how this subcommittee is interacting with the public and felt that this issue should be brought to the attention of this subcommittee. It was their opinion that a firm recommendation was on the table with regard to whether there would be one or two meetings. Mr. Lewis thought that an afternoon session, similar to the PHAWG meetings, was going to be needed for the EPA. He also thought that the group would need a facilitator who would listen to everyone, so that all of the information could be collected and compiled. He further thought that the group should return to convene a normal ORRHES meeting. He thought that they owed the public that attention.

He said he took full responsibility for this effort. He also believed that the ORRHES had gotten to the point in this process, inside and outside of the ORRHES, that people are feeling either oppressed or they are feeling frightened about doing what is right. He recommended that they ORRHES remove those issues and create mutual trust among the members of the ORRHES and with ATSDR, if these problems were ever going to be solved. He stressed that the process be conducted in an open fashion in order to do an excellent job. He added that they would have some key areas in which they had some recommendations, which they might share later in the meeting that might assist the ORRHES with closing the gap in obtaining mutual trust between ATSDR, ORRHES, and the community.

Dr. Davidson explained that she talked to Mr. Lewis after the fact and her response was that she thought that ORIA at EPA had said they were going to come and speak to the ORRHES. They did not come to the December ORRHES meeting because they did not have time. However, the ORRHES did not receive a response with regard to them attending the February meeting, which they would have had time for. They suddenly contacted ATSDR and wanted to be on the ORRHES's agenda. They have outstanding issues with the ORRHES, and so she thought they should come to the ORRHES to address those issues. Dr. Davidson agreed with EPA coming to the June meeting. She reminded the subcommittee that the June meeting would be in Oak Ridge. One issue was that EPA was not going to come to Kingston to discuss Oak Ridge, but since they are coming to the June meeting, that will not be an issue. Also, with regard to the EPA receiving ORRHES materials, that information is sent regularly to the EPA, so ORRHES activities should not be a surprise to them, because they are on the mailing list.

Ms. Kaplan addressed two issues: One was her timeline and the other was Ms. Sonnenburg's comment. She explained that the importance of having the timeline information and breakdown that she sees in the system is that if one looked at the June 16, 2003 entry, there was a PHAWG meeting. In those meeting minutes, it says, "James Lewis said that he would like a person from EPA headquarters to come and explain their process to give ORRHES an idea of their stances on certain issues. Then there was a motion for a letter or some other action. She then dropped down to August 18, 2003 where it said that Bill Taylor had said that a draft of the letter to the person from EPA had been prepared. On November 21, 2003, the letter actually went out. The meeting was held December 2, 2003. That is why the EPA did not attend that meeting. They did not receive the letter in a timely manner, even though all those months had passed from the time the ORRHES had asked for the letter. If the EPA is upset and not coming, that is another issue altogether, but another issue is that the ORRHES's process with regard to processing recommendations is broken. The only way to keep the process moving is for the ORRHES to nag.
Ms. Kaplan stated that Ms. Sonnenburg had asked for something tangible, which was in the letter, and she reiterated her earlier regulations which were: A strong recommendation that the EPA meeting be held on Monday evening before the normal ORRHES meeting on Tuesday. She thought that the public meeting needed to be a "free for all." The EPA has their comments and this issue needs to be straightened out. Second, the other work group needs to examine their process. There is a systemic problem with regard to getting things passed through the process. They are not doing a good job to impress upon ATSDR the need for these public meetings and things like this issue. The ATSDR tells the ORRHES "no" all of the time. Is that reasonable? It may be legal, but it is reasonable? The ORRHES comes together and gives of their time and then ATSDR completely ignores their recommendations.
Mr. Richards echoed that the EPA did not receive the letter, which did not go out before the Friday before Thanksgiving, for a meeting in December. That was a closure for EPA Region IV headquarters with ATSDR, which they tried to reflect in the January 9, 2004 letter. Unfortunately, the EPA did not make the February 3, 2004 meeting. The EPA had their Sixth National Superfund Radiation meeting, and all of those people were going to be there, including himself. The ORRHES told him that they did not even have a quorum for the February 3, 2004 meeting. He stated that it was difficult for him to tell someone to attend a meeting when he was not sure that the meeting was even going to take place. With regard to not coming to today's meeting, it did seem appropriate to push this off because they need to allow more time. EPA would have been there the day before and this day if it had gone through, but it was Region IV's request for them to be here, not ORIEPA headquarters. They have requested that two personnel attend the meeting.

Ms. Kaplan stated that in reviewing the PHA, the EPA put a lot of effort into submitting comments. However, in the Table of Contents, they are not even listed separately and instead are bundled into public comment, even though in the tables they are separated out. The EPA's comments should be listed in the document, but they are not the public and should be listed separately.

Mr. Pereira commended Mr. Lewis for getting the EPA to act based on his letters and their reviews of specific portions of the minutes that he sent them. However, he wanted to react to why the events took place as they did, because Mr. Pereira that stepped in between Mr. Lewis and EPA's Region IV, in Washington regarding the previous night's scheduled meeting and today's meeting. Mr. Pereira said he had also discussed his and Dr. Falk's reasoning with Dr. Davidson and Mr. Lewis. First, the EPA contacted ATSDR at some point to tell ATSDR that they were attending the April 13, 2004 meeting. At first, ATSDR was elated and shifted the agenda so EPA would have time to talk. However, ATSDR stressed that EPA had to be on the agenda, and that they could not simply be in the audience. The EPA agreed, items on the agenda were shifted around, and the meeting was pushed to later in the day. Then, the notion of the Monday evening meeting arose. After thinking that meeting through, ATSDR wondered if the ORRHES membership knew about the meeting, and whether that was something that the ORRHES should know and have some say in. Mr. Pereira stressed that he did not think the meeting was a bad idea, but he wondered whether it was appropriate for the event to occur with out the official knowledge of the ORRHES. Dr. Falk was informed of everything that had occurred. To the best of Mr. Pereira's knowledge, the ORRHES, including its Chair, did not have any knowledge of the meeting, except perhaps for a few members that Mr. Lewis might have informed. Then the question regarded whether the meeting was appropriate. Were ATSDR and EPA prepared to conduct this meeting with such short notice? Mr. Paul Charp was going to be at the meeting. Mr. Pereira explained that no matter when the meeting occurredin June or two years from todaythe EPA and ATSDR are never going to agree on how they make their findings. Mr. Pereira stated that although he is not a scientist, he has heard and seen enough to know that is not going to occur. He suggested is that EPA and ATSDR meet prior to the June meeting to discuss the differences in their methodologies and findings. The purpose of that meeting would not be an attempt to sway either side to the other's way of thinking. Instead, it would serve as a forum for the citizens of the ORR at which the EPA and the ATSDR could explain what the differences are, why there are differences, the meaning of those differences, and how they are applied to health and clean-up. Those are the things that are important to the ORRHES members and the citizens of Oak Ridge. Mr. Pereira said he would embrace the opportunity to assist with the facilitation of such a meeting. Based on all of this information, Dr. Falk directed the Senior Management of ATSDR to discuss these matters with the EPA to hopefully make EPA understand the position of coming in April versus in June for a full, open discussion of the issues. If the ORRHES decides, prior to the regularly scheduled ORRHES meeting, that there should be an open, public meeting, that is not a problem at all. In closing, he explained that after all of the battering that the ATSDR had taken this morning, he at least needed to make his position known as to what occurred in the last few days regarding the previous night's and the 13^th 's meeting.

Dr. Davidson explained that in preparation for that meeting, at the end of the PHA document on the Y-12, is a citizen's guide that explains the differences between a PHA and EPA's Risk Assessment. This was put together by people in ATSDR as well as EPA. So, she assumed that it met the approval of both agencies. In addition, she asked that the minutes from the PHAWG meeting, where Alan Susten discussed the differences between the two agencies' methodologies, be redistributed to the ORRHES members. She asked the subcommittee members to read the section of those minutes related to Mr. Hanley's response to the EPA comments. She said that Elizabeth Cockworth's letter and all of the other letters that have been submitted back and forth between EPA and ATSDR should be revisited, because there are differences between ATSDR's process and the EPA's process, and some of those are discussed in all of those documents. The ORRHES members should review these documents so that they become familiar with the subject matter before the June meeting. The reading should not be difficult as those documents are written in layman's language.

With regard to EPA's comments and ATSDR's responses, Mr. Jack Hanley suggested that the subcommittee review comments #127, #155, #160, and #166. These comments are all pertinent to the two outstanding issues addressed in the January 9, 2004 letter, in the Dose Uncertainty Analysis, and in the dose base criteria that the ATSDR utilizes.

Mr. Jeffrey Hill recommended that a full subcommittee meeting be held on Monday evening, prior to June's Tuesday meeting, and that the meeting be similar in content to the meeting that was proposed for April 12, 2004. Ms. Barbara Sonnenburg seconded the motion.

Dr. Davidson suggested that if the ORRHES had a subcommittee meeting that Monday evening, it should focus on EPA issues. She thought it would be best to have all of the ORRHES members present at that meeting. Mr. Hill asked if Dr. Davidson was suggesting that the Monday meeting would take place in lieu of the Tuesday meeting. Dr. Davidson clarified that it could be in lieu of the EPA being on the Agenda for the Tuesday meeting. She thought that if they were going to have a meeting on Monday evening, all of the subcommittee members should be present.

Mr. Hill agreed and reiterated that his recommendation was that the full subcommittee be present at that Monday meeting.

Dr. Davidson asked if that should also be an official subcommittee meeting, where they require all subcommittee members to be present.

Mr. Hill stated that had been his intent.

Ms. Kaplan asked that the Monday meeting be highly publicized, so that the public would be made aware of the meeting. She suggested that it might be a joint EPA/ATSDR meeting, hosted by ORRHES, and then the ORRHES could have the normal meeting on Tuesday.

Dr. Davidson reiterated that if there was a meeting, then all ORRHES members should be present.

Mr. Hill clarified that his suggestion was that there be a Monday meeting, that all ORRHES members should be present, and then the regular meeting should be held on Tuesday.

Ms. Sonnenburg seconded the motion. She said she was somewhat concerned that if the ORRHES did not have a quorum of ORRHES members at that meeting, it might be cancelled. She suggested that the meeting be scheduled as a public meeting and not an official ORRHES meeting. All of the ORRHES members should be invited, but a quorum should not be necessary in order to hold the meeting.

Dr. Davidson thought that the ORRHES members were committed to the meeting and would be present.

Ms. Sonnenburg asked what would happen if only 12 people showed up.

Mr. Hill stated that they would still have the information.

Dr. Davidson pointed out that 12 members were a quorum.

Dr. Craig pointed out that such things are normally taken care of by a work group. The PHAWG normally meets on the Monday evening before the regular ORRHES meeting. He suggested that they announce the PHAWG meeting as a public, well-advertised PHAWG meeting. Then they would not have to worry about quorums and votes, and the technical issues could be discussed as part of the PHAWG meeting. Then no one would have to worry about how many ORRHES members attended.

Ms. Sonnenburg asked if Dr. Craig was willing to chair that meeting. Dr. Craig stated that he would yield the chair to Dr. Davidson or to Mr. Lewis.

Mr. Hill preferred to keep the meeting a regular meeting, but on Monday night, prior to the regular meeting, if there is no quorum, then it could be considered an information session. If anything arose that needed to be voted on, then it could be voted on. He also asked that full meeting minutes be taken, just like a regular meeting.

Dr. Davidson indicated that the motion on the table was that the ORRHES hold a full meeting on Monday evening, with ATSDR, EPA, and the public present.

Ms. Sonnenburg asked that the motion be amended to state that a quorum would not be necessary at that meeting.

Dr. Davidson stated that they could not do that.

Ms. Horton explained that if the meeting is a full ORRHES meeting, where minutes are taken, which would be required, then there must be a quorum present. She suggested that the Monday meeting be kept as an open forum meeting, as Dr. Craig suggested. Between now and June, there is enough time to make a press release to announce the meeting and hopefully get the public involved.

Ms. Sonnenburg stated that she would withdraw her second, unless the meeting was going to be held the way that Dr. Craig suggested.

Dr. Davidson stressed that her issue was that the people who were present that night would not want to revisit the issue again the next day. Therefore, if the meeting was not a full ORRHES meeting, then people would have to have to listen to the same material the next day, and there would be more people at the full ORRHES meeting who had already heard it than people who had not heard it. Having the full ORRHES meeting on Monday was one way of avoiding that situation.

Ms. Sonnenburg asked how many ORRHES members could attend the meeting Monday night, June 7, 2004.

Dr. Davidson stated that the time would be worked out, but it would not occur before 6:00 p.m.

Mr. Pereira commented that the Monday meeting is so specific and so germane to a particular topic, that the encumbrance of having the provisions of the ORRHES, including the formality of the proceedings, the name placards, et cetera, would be quite intimidating to the public. He thought that they wanted the public to participate, not just the ORRHES members. He recommended that they have the Monday night meeting. Every ORRHES member could attend if the wished, and then on Tuesday the ORRHES meeting should take place. He thought that Monday's meeting should focus on the EPA and ATSDR presentation of their positions. He also thought the issues were going to be addressed would take all evening to present. He did not think there would be time for a full ORRHES meeting.

Mr. Hill modified his original motion to recommend that the Monday meeting be an open forum meeting and not a ORRHES meeting.

Ms. Sonnenburg seconded the amended motion.

Dr. Davidson clarified that the motion on the floor was that there be an open forum meeting on Monday, June 7, 2004. The motion was seconded.

Mr. Lewis commented that having some kind of facilitation during this meeting would be important, because there would be so much going on that having a party for whom everyone had a mutual respect would be crucial. Mr. Lewis thought that there were some tensions in the community between certain people, the ORRHES, the EPA and ATSDR. He did not know if the EPA needed to facilitate, but he did think that they needed to consider the idea of facilitation, so that everyone would feel like they had been heard.

Dr. Davidson responded that all of the technical details would have to be worked out. She reiterated that there was a motion on the table.

Ms. Kaplan asked that the ORRHES provide a court reporter to provide verbatim minutes of the Monday meeting. With the ORRHES meeting, they obtain that, but at the PHAWG, they may not. She did not know what the official stance was on that issue. Secondly, Dr. Davidson had expressed a concern regarding repeating on Tuesday what was discussed on Monday. Ms. Kaplan hoped that the information discussed would not be on the agenda again on Tuesday.

Dr. Davidson stated that if there were going to be any recommendations for ORRHES from that Monday meeting, then that would have to be discussed again on Tuesday.

Ms. Kaplan indicated that there was no need for the ORRHES to rehash the presentations or the general discussion.

Dr. Davidson replied that if there were members of ORRHES who were not present at that Monday meeting, then they also needed to hear the information. Otherwise, they could not make an informed decision with regard to voting. So, the whole matter has to be discussed. ORRHES cannot just come in and make a recommendation without having a full discussion.

Mr. Pereira added that having the Monday meeting is predicated on the EPA's agreement to be there. What has been discussed with Region IV was related to the full ORRHES meeting. Although he assumed that they would attend the meeting, he could not speak for EPA. He added that as soon as he got back to his office he would contact the EPA to discuss their attendance at the Monday and Tuesday meetings.

Dr. Davidson called for the vote. The motion on the table is that the ORRHES hold a public forum on the Monday prior to the June ORRHES meeting to discuss the EPA issues. The EPA Region IV, members of ORIA, ATSDR, members of the public will be in attendance. ORRHES members will attend by choice.

Ms. Sonnenburg asked if they should amend the motion to include Ms. Kaplan's wish that a court reporter be present at the Monday, in order to take minutes.

Ms. Kaplan seconded the motion.

Motion

Mr. Jeffrey Hill moved that the ORRHES hold a public forum on the Monday prior to the June ORRHES meeting to discuss the EPA issues. The EPA Region IV, members of ORIA, ATSDR, and members of the public will be in attendance. This meeting will not be a full ORRHES meeting, and the ORRHES members may attend by choice. It was recommended that a court reporter be present to take verbatim minutes of the public meeting. Ms. Susan Kaplan seconded. The motion carried. It was noted that 3 were opposed.

Ms. Sonnenburg pointed out that Ms. Kaplan had two recommendations and Ms. Karen Galloway moved that the second recommendation, which involves a broken public participation process, be sent to the Communication and Outreach Work Group.

Ms. Kaplan seconded.

Dr. Davidson asked if the recommendation was in writing somewhere.

Ms. Sonnenburg indicated that it was located on the back page of her letter. The group has already voted on her first recommendation. She was now addressing her second recommendation, which read, "The EPA controversy over the Y-12 uranium releases illustrates systemic problems that exist within ATSDR and how it interacts with the Subcommittee, attempts to control it, and how it responds to Subcommittee recommendations. Unfortunately, it appears the organization's public-participation process has broken down, something that threatens to undermine the public's trust in all the organization's efforts in Oak Ridgeand not for just the Y-12 uranium releases. A work group should be established to analyze this subject." Although Ms. Kaplan had asked the ORRHES to establish a new work group, Ms. Sonnenburg added that she did not know that the ORRHES needed to adopt the entire paragraph, because the Communication and Outreach Work Group addresses that subject.

Dr. Davidson asked for some additional explanation regarding the recommendation. Is the organization being referred to ORRHES?

Ms. Sonnenburg reiterated that she was not recommending that they adopt the entire paragraph, but she was saying that the subject being discussed needed to be given the Communications and Outreach Work Group.

Dr. Davidson explained that she was simply asking for clarification to ensure that she understood the recommendation.

Ms. Kaplan clarified that "organization" referred to ATSDR because the ORRHES refers items back to them. Things do not seem to proceed in a timely manner.

Dr. Davidson asked if she was referring to ORRHES recommendations.

Ms. Kaplan stated that the EPA timeline reflects a problem with the recommendation process. The EPA issue is one example, but it could be anything that the ORRHES is attempting to push through. Things are dropped and do not move forward. She suggested that someone needed to talk about the issue, and it did not matter whether the issue was addressed by an existing or a new work group.

Regarding Ms. Kaplan's timeline, Dr. Davidson asked if she was referring to recommendations because recommendations are the only thing to which the ATSDR has to respond. They are not required to respond to individual comments made at meetings.

Ms. Kaplan indicated that she was referring to requests such as asking that a letter be written to invite someone to come to the meeting. Those things drag on forever. How can those tasks be expedited? There is not much time left and the ORRHES cannot let every issue drag out for a year like the letter did. What is wrong with the process? What can the ORRHES and ATSDR do better? Where should that issue be discussed?

Mr. Pereira responded that at the ORRHES meeting, any issue that is significant enough that ATSDR should respond to verbally or in writing, should go to Ms. Horton as an action item. Before the conclusion of the ORRHES meeting, action items should be reviewed one-by-one. Ms. Horton should read the list of action items for the day and everyone should concur with those. Those action items then become a matter of record that Ms. Horton tracks as action items in a database. The status of those action items are reviewed at every meeting. He suggested that perhaps the action item process needed to be followed closely to ensure that all the bases are covered.

Ms. Kaplan explained that was only for ORRHES. The issue under discussion was handled in PHAWG. PHAWG and the other work groups are handled in a different manner than ORRHES. They are not as formal. Still, she thought that the entire process needed to be reviewed, because it is moving too slowly, and this illustrates a problem.

Regarding the PHAWG, Mr. Pereira replied that whatever PHAWG recommends should come before the ORRHES as well.

Ms. Kaplan still thought the process needed to be examined.

In terms of the June Monday evening meeting, Dr. Malinauskas said he was concerned. The proposed subject was to discuss the issues with the EPA. That is quite vague. Mr. Pereira indicated that the ATSDR intends to meet with the EPA prior to that June meeting, in order to come to a meeting of the minds, not with respect to methodology, but to the inferences to the results or the application of that methodology. He strongly recommended that ATSDR and EPA meet, clearly define the meeting objectives, and agree to what would be discussed at the June 7, 2004 meeting, because he would hate to see EPA talking about harvesting oranges and ATSDR talking about planting turnips.

Dr. Davidson asked Dr. Malinauskas' to write down his recommendation as an action item.

Dr. Malinauskas indicated he would do so.

Dr. Davidson stated that if there were additional details to be worked out regarding the proposed June 7, 2004 meeting, those could be worked out later, so that the ORRHES could continue on with the meeting.

It was pointed out that there was still a motion on the table.

Ms. Sonnenburg reiterated that the #2 item on the second page of Ms. Kaplan's letter should be send to the Communications and Outreach Work Group for consideration, and Ms. Kaplan seconded the motion.

Mr. Lewis thought that it would be more appropriate to send the issue to the Guidelines and Procedures Work Group.

Ms. Sonneburg amended her original motion to indicate that the issue should be sent to the Guidelines and Procedures Work Group instead of the Communications and Outreach Work Group.

Ms. Robinson, from Cambridge Communications, asked the group to please remember to use their microphones.

Dr. Craig stated that he did not think the ORRHES needed to vote on this issue because they sent items to the work groups all of the time.

Dr. Davidson stated that she would talk to Ms. Kaplan to make sure that she understood all of the nuances of the issue, so that she could provide instructions for the work group.

Ms. Kaplan asked if they were not agreeing to send it to the work group.

Dr. Davidson clarified that she simply wanted to get clarification regarding what she was sending to the work group.

Ms. Kaplan asked for clarification on whether the issue was going to be sent to a work group.

Ms. Sonnenburg asked Ms. Kaplan to put the recommendation into specific language.

Ms. Kaplan indicated that there seem to be procedural problems with regard to the way that recommendations and action items from the ORRHES are being forwarded for action to the ATSDR. She recommended that the second bulleted item on page 2 of her letter be forwarded to the Guidelines and Procedures Work Group, so that they could examine ORRHES's procedures and determine how they might speed up the processes.

Dr. Davidson agreed, but said she still wanted to meet with Ms. Kaplan, to make sure that the subcommittee understood what she is recommending. Since the issue was going to be forwarded to the work group she asked Ms. Sonnenburg to withdraw her motion.

Ms. Sonnenburg stated that she would withdraw her motion if Dr. Davidson affirmed that the issue was going to be forwarded to the Guidelines and Procedures Work Group.

Dr. Davidson affirmed that the issue would be forwarded to the Guidelines and Procedures Work Group. She reiterated that she still wanted to meet with Ms. Kaplan, to ensure that she understood the recommendation correctly and that she is interpreting the paragraph in the same way that Ms. Kaplan is interpreting it.

Ms. Sonnenburg indicated that she thought what Ms. Kaplan was proposing was quite clear. She asked if Dr. Davidson did not understand Ms. Kaplan's motion.

Dr. Davidson responded that Ms. Kaplan did not make a motion.

Ms. Kaplan affirmed that she just made a motion.

Dr. Davidson stated that she was unaware that she had made a motion.

Ms. Sonnenburg stated that Ms. Robinson could probably read the motion back to the group.

Dr. Davidson explained that she had not heard her comment as a motion. She thought she had been explaining the paragraph, because Ms. Sonnenburg had withdrawn her motion and the group was going to send the items to the work group.

Ms. Kaplan replied that was fine, but she did put it into the form of a motion because she thought she was asked to, so that the ORRHES could send it to the Guidelines and Procedures Work Group. She suggested that if the group needed a motion she had already stated, that they could probably read back.

Dr. Davidson pointed out that if there were a motion, then the ORRHES would have to vote.

Ms. Sonnenburg asked Ms. Robinson to read the motion back to the group.

Ms. Robinson read from her summary notes, indicating that Ms. Kaplan had said that there seemed to be procedural problems with regard to the way that recommendations and action items from the ORRHES are being forwarded for action to the ATSDR. She recommended that the second bulleted item on page 2 of her letter be forwarded to the Guidelines and Procedures Work Group, so that they could examine ORRHES's procedures and determine how they might speed up the processes.

Dr. Davidson indicated that the Chair has heard the proposal and suggested that the recommendation be left as a proposal. She added that the recommendation would be sent to the Guidelines and Procedures Work Group, so that the ORRHES meeting could continue.

Ms. Donna Mosby pointed out that what the second bulleted item was saying was that from time-to-time people will bring things or say things and there is no action taken upon it. What this recommendation is saying is that when someone brings something up that is worthy of the subcommittee's review and consideration, it should not fall into a black hole and nothing happen. She did not know if they could write a procedure that would help with that process, but it does need to be examined, because it is unclear why things move so slowly. When someone brings something to the issue, is there some kind of action that can be taken right then?

Ms. Kaplan added that someone should at least respond to the item or ensure that things move on in a timely manner.

Dr. Davidson stated that there had been enough discussion on this issue and the ORRHES needed to move on to the next issue. She also informed Mr. Pereira that she was going to move his project management status update to just before the unfinished business. She then turned the floor over to Dr. Paul Charp.

Response to ORRHES Comments on the Initial Release of the White Oak Creek PHA

Dr. Paul Charp, Chair
Federal Facilities
Agency for Toxic Substances and Disease Registry (ATSDR)

Before he began his presentation, Dr. Paul Charp stated that he wanted to clarify something that was brought up by Ms. Kaplan and reiterated by Ms. Sonnenburg, in relation to the quote in the PHA from the EPA. First, Mr. Richard's comment about the "upper range" was correct. However, he wanted to show the group from where they obtained the "clean up" verbiage. He stated that Mr. Richards had mentioned the directive. Dr. Charp displayed the cover page for directive number 9200.4-18, from the ORIA. The title of this memorandum is called the "Establishment of Cleanup Levels for CERCLA Sites with Radioactive Contamination." CERCLA is the acronym for Superfund, and it stands for the Comprehensive Environmental Response, Compensation, and Liability Act. He pointed out, on page 5 of this 22-page document the phrase that says that when a dose assessment is conducted at the site, then 15 millirem per year effective dose equivalent should generally be the maximum dose limit for units. The ATSDR obtained the 15 millirem per year clean-up level from this EPA document. The document goes on to say, "This level equates to approximately 3 x 2^-4 increased lifetime risk and is consistent with levels that are generally considered in other governmental actions, particularly regulations and guidance developed by EPA and other radiation control programs. That is where ATSDR obtained the verbiage that appears on the fact sheet that Mr. Richard clarified in more precise, non-governmental language. Dr. Charp noted that ATSDR stood corrected and would make the proper adjustments on the language, so that it could be directly referenced to the displayed document.

Dr. Charp then reviewed some of the responses that the ATSDR received on the White Oak Creek PHA to illustrate what the ATSDR did in response to these comments. He directed the group to their handouts on this issue, which included comments submitted to ATSDR from the ORRHES as well as the DOE and the EPA. Overall, there were sixteen pages of these comments. On page two was a flow chart that was developed by Dr. John Merkle. Dr. Merkle stated that the ATSDR should provide a flow chart for all of the calculations of the scenarios that the ATSDR selected in the PHA or in Task 4. Dr. Charp indicated that when he worked all of the calculations for the PHA, he had done them on a spreadsheet, and did not go through flow charts and so forth. However, the ATSDR would probably choose several different scenarios and fill in the blanks for this type of flow chart.

On page 4, one reader commented that the PHA document should have better maps. For example, the map of X-10 did not show where the storage tanks were located within the facility. ATSDR has added the map displayed on page 4 of the comment document. The new map details the location of the gunite tanks in both the North and South Tank Farms at the X-10 site. On page 5, one ORRHES member asked that the PHA include a table showing the radioactive and biological half-lives of the pertinent radionuclides. Table 6 and it is accompanying explanations were sent to the ORRHES and added to Section II.W. Health Effects Evaluation Process of the PHA to explain radioactive and biological half-lives. Radionuclides of concern in the PHA are presented as examples in the table and detailed in the descriptive text.

Dr. Charp explained that the body removes compounds as a function of the biological elimination of that particular compound from both the specific organ and the body. Likewise, radioactive materials are removed from the body. Because the material is also radioactive, with a defined radiological or physical half-life, the combined elimination rate is called the effective half-life. The effective half-life can be determined from the combined physical and biological half-life. For example, as shown in Table 6, the radiological half-life of strontium 90 is about 29 years and the biological half-life is about 49.2 years (18,000 days) for bone. Therefore, the effective half-life of strontium 90 deposited in the bone is 17.5 years (6,400 days). Table 6 shows the half-lives of selected radionuclides in the White Oak Creek Public Health Assessment as follows:

Radionuclide	Physical Half-Life	Biological Half-Life	Effective Half-Life
Tritium	12.3 years	12 days (whole body)	12 days (whole body)
Cesium 137	30 years	70 days (whole body)	70 days (whole body)
Strontium 90	28.8 years	18,000 days (bone)	6,400 days (bone)
Cobalt 60	5.3 years	9.5 days (whole body)	9.5 days (whole body)
Yttrium 90	64.2 hours	14,000 days (bone)	64 hours (bone)

Page 7 includes the DOE comments. The DOE sent in general comments and editorial comments. The first few comments related to their Comprehensive Epidemiologic Data Resource (CEDR), so the ATSDR included references with regard to how CEDR could be accessed and what the CEDR database is. For the second reference, ATSDR added a sentence to Section II.F.2. TDOH that stated, "All of the technical reports produced for the TDOH Oak Ridge Health Studies are accessible in portable document format (PDF) at http://cedr.lbl.gov .

On page 8, the DOE noted that Figure 5 was missing. At the time the draft document had to be distributed, Figure 5 was not ready. Figure 5 is a timeline that details the major processes, environmental data, and public health activities associated with the X-10 site. The figure is an oversized document that measures 11" x 17" and will be incorporated into the public comment version of the PHA.

On page 11, comment #17 in the DOE comments suggests that the ATSDR should improve the wording here by replacing "human" with "average American." Dr. Charp did not think there was any such thing anymore because the United States is a melting pot. So, the "average American" could be Asian, Native American, Caucasian, African American, et cetera. Instead the wording was replaced with the following: "ATSDR, in its evaluation of the radiation doses associated with the Oak Ridge Reservation, has used site-specific parameters and variables more related to the Southern lifestyle than to the typical U.S. population." He noted that most people in Oregon are not really going to be worried about what somebody who lives East Tennessee is eating.

Finally, the EPA sent in several technical comments and a few editorial comments. The EPA technical comment #1, on page 12, stated that the EPA wanted ATSDR to clarify for iodine whether it was iodine-129 or 131. ATSDR has modified the text to clarify that iodine-131 (not I-129) was included in the Task 4 study. The document now gives more information on the Task 4 study and indicates that that information could be obtained from the State of Tennessee's web site. The web site is also given.

Discussion Points:

Mr. Richards explained that the dose equivalent given for the upper end of EPA's risk range, where they always start at 10-6 and if they do a comparison dose, the upper end will be 15 millirem. They do not, however, say that is their clean up level. They had hoped to do that in 1996 or 1997, but it did not work. So the "risk range" is the official terminology.

Dr. Malinauskas thought the effective half-life for strontium 90 in bone was less than Table #6 indicated. It should be somewhere between the physical half-life and the biological half-life.

Dr. Charp responded that he would check those calculations and let them know before the meeting was over.

Dr. Charp then indicated that Mr. Jack Hanley wanted to review the fact sheets with the ORRHES, so that they could understand how they were developed.

Mr. Jack Hanley
ATSDR/DHAC

Mr. Hanley explained that in response to outstanding issues regarding the EPA issue, and after the January 9, 2004 letter from EPA Headquarters, the ATSDR attempted to take the information in the PHA and develop a response in the form of three community-friendly fact sheets entitled:

ATSDR's Cancer Comparison Value
Uncertainty Analysis
Screening and Regulatory Dose Limits

Of all of the comments received from the EPA, there were only two outstanding issues. Those have been simplified in these documents. One of them was the comparison value that the ATSDR uses as a screening tool. Basically, the doses that the ATSDR estimated in the Y-12 Uranium PHA are lower than not only ATSDR's comparison value of 5,000 millirem over 70 years, but also, if analyzed, it is less than the EPA level of 15. Therefore, with regard to past exposure, the ATSDR estimates 155 millirem over 70 years, which is only 2 millirem per year. The EPA's upper limit is 15, and if one takes 5,000 millirem and analyzes that, it comes out to approximately 71 millirem per year. To assist the ATSDR with comparing like items, the ATSDR broke it out into 70 year and the annual doses.

Mr. Hanley then addressed the handout on the Screening and Regulatory Dose Limits. The purpose of this document was to compare dose limits with other regulatory levels. The comparison values used, which Dr. Charp mentioned several times, were based on a literature review and other documents. If one compares doses on an annual basis, then takes the 5,000 millirem, and on an annual basis it is 71, which is lower than the International Commission on Radiation Protection (ICRP), and the National Council on Radiation Protection and Measurement (NCRP) criteria for the public, the result is the EPA clean-up level of 15. He pointed out that if they do what is called, "first approximation" of 5,000, over 70 years, it is still in that range between the other regulatory agencies. They have the worker exposures with a maximum of 5,000 millirem per year. Mr. Hanley reiterated that this was a screening tool. If the dose comes out above the 5,000, then ATSDR could do a more in-depth evaluation using real, site-specific exposures to look at levels where health effects take place and try to determine what the likelihood is of an effect taking place. These doses that ATSDR estimated are lower than the past and occur much lower than these comparison values.

On the back of the Screening and Regulatory Dose Limits document is the Thermometergraph, which has been modified. This graph is somewhat different in that the scale is different from the previous one. This is millirem above background. He asked the group to remember that background is 360. Mr. Hanley pointed out the sources for background, the largest source being radon, and then continued to read the rest of the thermometergraph dose limits and estimated doses for Scarboro and typical doses from ionizing radiation sources.

Dr. Hanley next discussed the third document, which was ATSDR's response to comments regarding the appropriateness of uncertainty analysis in the Y-12 Uranium PHA. This topic has come up in meetings several times, and Dr. Charp used criteria from NCRP commentary 14 to determine if there was a need to do uncertainty analysis. There are two basic criteria. The first is, "if conservatively biased calculations indicate that the risk from possible exposure is clearly below regulatory or risk levels of concern, a quantitative uncertainty analysis may not be necessary." The ATSDR used conservatively biased calculations when estimating radiation doses from the Y-12 uranium exposures. Thus, the estimated radiation doses in the ATSDR Y-12 Uranium PHA are highly unlikely to underestimate the true dose. Furthermore, the estimated uranium doses are clearly below regulatory and health levels of concern, and any further detailed analysis will likely demonstrate that the true dose is even less. Thus, a quantitative uncertainty analysis is not recommended by the NCRP, and ATSDR has determined that it is not necessary."

Mr. Hanley stated that the table at the bottom of the page demonstrated the number of times lower the screening estimates are than the comparison values. He indicated that the same material that was included in these more community-friendly documents was presented in much more detail in the PHA.

Discussion Points:

Dr. Craig asked for clarification on the numbers in the last row on the Screening and Regulatory Dose Limits handout. Mr. Hanley indicated that the number was over 70 years. That is the current data based on 70 years, using EPA data.

Ms. Kaplan stated that the reviewers made comments regarding the fact that Scarboro has a tendency to be chosen as the primary public health concern for uranium, simply because it is the community closest to the facility. The reviewers say that this is premature and that further analysis of population distribution, wind patterns, and surface water features are needed. Although she knew that it was not within the ATSDR's mandate to use existing data, she asked who would be looking at existing data with regard to future activities, to future research. Mr. Hanley asked Ms. Kaplan what she meant by "future research." She clarified her comment, asking him who was looking at wind patterns, surface water, and other future exposures. Mr. Hanley stated the ATSDR considers future exposures, and if it is a scenario, ATSDR can examine it and give its opinion with regard to public health issues. He said that he would talk to her after the meeting.

Ms. Adkins asked if anyone has, or if it was possible, to do something like a full body count on the people who would have been the closest and who are the oldest with regard to radioactive exposure, including the bodies that have already been buried. The count should include all of those people, living and dead, who might have had maximum exposure. She explained that so far, all of the numbers have been estimates. She wondered if anyone has actually counted all of those people. Dr. Charp responded that that had not been done for people in the Oak Ridge Reservation, but some of the bodies of radium doll painters have been exhumed to measure the actual whole body counts for radium, as opposed to the estimated dose. These doll painters were high school-aged women who painted the radium on the dolls in the 1920s and stopped during the 1930s. Usually, if someone had an intake of, for example, Uranium, they would do a lung count to determine what the lung burden was. He did not know what the minimal concentration would be before a count showed positive.

Dr. Craig explained that it was thought that Scarboro was the area of greatest deposition. Obviously, it was not, with the least concentration of people. For example, Dr. Craig suggested going to the east end of Y-12, past the process buildings, all the way through the ORNL buildings, out to the open area, out in front, where the sign is. Then going down Union Valley, across Highway 62, through the old land fill that is not used, but which is now a driving range, and then hit Roger's Quarry. No people ever lived there, down in that whole main valley, which is where the wind blows. Certainly, one has to look at who the receptors could have been, and who the most likely receptors were another 200 feet, up and over the hill, where the wind did not blow, but probably those were the greatest receptors. That seemed to be the point people were attempting to make. Beyond that is Melton Hill Lake. So, there a contaminant is traveling that has not lifted very high in the air because it is extremely heavy, and all of the models would show that there is not going to be a receptor down that way.

Ms. Kaplan emphasized that was the point that she was attempting to make. There are past, current, and future exposures. What are the future land uses? What is the depth of contamination in the soil? Is there any effort or planned effort to do any soil sampling? One of the reviewers greatest complaints was that ATSDR needed to do core sampling, because others (Florida A & M) have only done surface sampling. Mr. Hanley pointed out that the EPA conducted core sampling. Ms. Kaplan asked for the data from that study.

Mr. Richards stated that the EPA is looking at the off-site areas. They may not have been covered before, but as part of the future assessment, going to Superfund sites is being done. Ms. Kaplan asked if the ORRHES would be informed of that effort. Mr. Richards explained that was part of the normal CERCLA process. At this point, they do not have the effort on the timetable, but normally, when nearing the end of a clean up, those things are done. For example, in Paducah, Kentucky, some of those outside areas have already been addressed, which are natural fish and wildlife areas. Then there is the ongoing Clean Air Act program, which Tennessee has been delegated, that still looks at offsite pathways of uranium releases from Y-12. Those are still on-going. That is their job, to set some doses to the nearest business, school, or home. So, they would just look at the nearest business that is not a DOE property.

Dr. Charp added that in the health assessment, the ATSDR looked at air concentrations and found some new samples that were collected off-site well down toward Clinton and Claxton. ATSDR looked at the uranium content in some gardens and the foods. They did not find anything of particular interest, or even above background, which is pretty remarkable considering the steam plant there with all of the coal and lye ash.

Dr. Davidson said it was her understanding that if there was any additional soil sampling to be done in this area, it would be done after this PHA process was completed. She asked if that was anyone else's understanding. Other agreed. Dr. Hanley affirmed that was correct.

Part of that is the post-facilities agreement, looking at all the CERCLA waste at all three ORR sites. He did not have a timeline citing this. Scarboro was another issue based on TB and other things.

Mr. Donald Box had issues with the Cancer Comparison Value document. He said ATSDR mention that these doses are in addition to background doses. That should be stated on all of the handouts. Mr. Hanley and others agreed that was a good point, and said they would add something along those lines.

Regarding the 70-year lifetime dose, Mr. Richards asked whether NCRP and ICRP use a different lifetime. He thought that they used a 50-year lifetime. He knew that ATSDR was extrapolating the 70-year, but he recommended that if the others are using a different lifetime, then the ATSDR should use an asterisk to indicate that this is the way that the ATSDR calculates the lifetime dose. The EPA does not recognize that number because they have extrapolated the 70-year lifetime from CERCLA's 30-year lifetime. Dr. Charp indicated that ICRP 30 was for workers and the extrapolated things from over a 50-year working life span. After Chernobyl, in 1986, they saw that the needed to start doing it for public exposures, and they began to calculating dose conversion factors for infants. He thought that somewhere buried in that information was something about 70 years and an ICRP 60 further up the line.

Mr. Richards asked if they actually calculate from the 7,000 in their documents. Dr. Charp responded that they did not.

Mr. Hanley explained that, in the narrative, the ATSDR has the first approximation of the ICRP and recommended dose of 100.

Mr. Richards stated that he was just making it clear that the ATSDR has calculated that for its own purposes. Mr. Hanley responded that they did that so they could compare the ATSDR's numbers with others' numbers.

Mr. Richards also recommended using EPA's upper range for an upper level. He suggested that they might use NRC's clean-up level, because theirs was 25 millirem. He thought that would help, with another comparison of a clean-up number instead of the public exposure.

Dr. Davidson thought it also sounded like that there should be some footnotes on some of the calculations.

Mr. Hanley stated that there were many regulations that they could have located that contradict each other. Therefore, they attempted to find ones that fit the circumstances on which they were working. That is why they picked these particular numbers. Also, regarding, the 25 millirem for the NRC, ATSDR wanted to say out of the controversy going on between the regulations limit.

Mr. Hill asked if the CFR used a 70 or 50-year lifetime. Dr. Charp responded that the CFR did not use anything. It only states that the dose limit to workers and the general public is not to exceed 100 millirem per year.

Mr. Hill suggested that if they took the ATSDR's 5,000 over 50 years, they would be right at the 100, which is the limit. It is interesting that ATSDR uses 70. As a worker, he is used to seeing 50. And if ATSDR uses 50 in these documents, then they are right back at the 100, which is the magic number.

Dr. Charp indicated that another issue is that if someone has an intake when they are 50 years old, and it is calculated over 70 years, he did not expect them to live to be 140 years old. So, that is overestimating.

Ms. Adkins appreciated the data, but in order to convince the community and in order to convince her, she asked if there was any way that the ATSDR could balance the speculation with the opportunity for people to have whole body counts, to be tested for the various things that they are going to go through over the next several months. If everything is based on conjecture, they can rationalize that there is no problem and that there has never been a problem. Everything is wonderful. However, people are not going to believe it until they are given proof that they have not been harmed by the effects of Oak Ridge. She said she would continue to bring this up at every meeting until someone could come up with a way that people can be checked to see if they have been hurt by radiation exposure. Then they will believe it.

Dr. Charp admitted that he was not an internal dosimetry expert or an expert on whole body counting, but he did know that the average concentration of the uranium in the soils around Oak Ridge, when one adds up all of the isotopes, is approximately 3 picocuries per gram. The total uranium in the human body is somewhere around 31to 35 picocuries per gram, based on the water someone drinks, the food they eat, et cetera. Thus, the question is: Is the whole body counting sufficiently precise to detect the 10% variation in the uranium in the body? He did not know himself, but that would be one of the larger problems with whole body counting, because he did not know how precise it was. He said there are many experts at the lab who would be the ones to explain the limitations of whole body counting. When he was looking at some radium problems in Philadelphia, where people were actually sleeping on beds that were 1,000 times above the clean-up level in a nuclear power plant, ATSDR estimated that they would have to have 1,000 times more radium in their body than is normally present before they would see any effects. The people who the ATSDR talked to, who do the whole body counting, said that it would not be worthwhile to do it unless someone had thousands of times more radium in their body. Uranium is even more difficult to check by whole body count, so he did not know if it was feasible and thought it would be very difficult to show something.

Dr. Davidson wondered if it would be possible to find out what the minimum detectable levels would be for whole body counting. She knew that the lower the levels the longer one would have to count, because this is done for worker exposures if they are suspected of having high level exposures.

Ms. Karen Galloway replied that she did not know the answer to Dr. Davidson's question, but she worked for people who would know. She offered to bring her supervisor to an ORRHES meeting.

Dr. Davidson thought the other question regarded how much above background someone would have to have in order to have detectable, whole body counting. She reminded the group that they were talking about environmental exposures as opposed to occupational exposures.

Public Comment Period

Dr. Kowetha Davidson, Chair
Oak Ridge Reservation Health Effects Subcommittee (ORRHES)

Dr. Davidson then announced the public comment period and asked if anyone would like to speak. With no members of the public coming forward, Dr. Davidson asked the group to continue their discussion regarding the community friendly handouts until a member of the public was ready to address the ORRHES.

Discussion Points:

Mr. Lewis applauded ATSDR for consolidating some of the key issues within the body of the community-friendly documents. He thought that they had made a good attempt to get the key points down in a way that lay people could understand them. Mr. Hanley credited Ms. Melissa Fish for her efforts because she did a lot of the work that went into creating these documents.

Mr. Lewis said that although there may be resource constraints, when one is dealing with controversial issues such as the issues with EPA, documents like this should be presented to the ORRHES in advance of asking for its endorsement, so that everyone can have a better and clearer understanding. He noted that Dr. Malinauskas and others had asked for a document that was approximately ten pages. Timing is everything. He did not know how the various branches worked at ATSDR, but these types of efforts, in his opinion, helped to improve the properties. This is what Ms. Kaplan was talking about. Whatever it is that ATSDR is doing, they need to get this kind of information down to this subcommittee level as early as possible, and he knew that it should be done prior to asking the ORRHES to review and endorsing these documents.

Mr. Hill stated that he was getting confused on the thermometergraph. When he looked at it, and then looked on the right hand side in red, "Doses below 5,000 mr over 70 years are not expected to result in adverse health effects. Doses at 5,000 mr per year are not expected to result in adverse health effects." He thought that would also be a safe statement. He was hoping that a layperson would read that and say, "Well, gosh, above 5,000 mr over 70 yrs, you would expect health effects." When, in fact, a factor of 10 or 100 or even 1000 could occur before one would expect health effects. It is a bit misleading, and if someone looks at this document and then nothing else, they would think that doses above 5,000 mr over a 70- year period would result in a health effect, when it is actually some number far greater than that. Mr. Hanley suggested that the phrase could be wordsmithed to get that point across.

Mr. Hill pointed out that someone would be up to 5 r before any of the documents needed to say that some health effects may be observed. Dr. Charp explained that for acute health effects, it would be approximately 25,000 when blood effects would begin to be seen. Some studies suggest, for shipyard workers, something around 2,000 to 3,000 millirem. Mr. Hill asked if that was chronic effects. Dr. Charp affirmed that would be for chronic effects.

Mr. Richards pointed out that this has always been one of EPA's fundamental disagreements, but clarifying that they are talking about acute effects and not chronic effects is still one of the key points left out of these documents. Of course, everyone would always agree that acute effects would occur at around 10,000 or 25,000 millirem, but obviously, the EPA fundamentally disagrees with this position and only looks at adverse health effects and chief effects. They look at the potential incidences of cancer, and even in a lot of creek studies, they look at moderately increased cancer, and that carries an amount criteria for fish advisories. 1 in 1,000 to do to a fish advisory on PPBs. ATSDR and EPA look at chronic, long-term cancers differently, which is unfortunate. That was one of the issues he was hoping the EPA headquarters and ATSDR could address, but he did not know if that was going to happen. Nevertheless, it needs to be clear in the documents when talking about adverse public health effects that are acute and not chronic.

Dr. Davidson asked for clarification on Mr. Richard's comments. He wondered what Mr. Richard's bottom line comment was related to the thermometergraph. Mr. Richard said he believed that the ATSDR was referring there to acute health effects, going off of Mr. Hill's comments about the 5,000 millirem per worker. Again, just like the 10^-4 risk range is not based on acute health effects, it is based on long-term chronic health effects and the potential increase of cancer. He thought that one thing that has been left out of these documents was that ATSDR should clarify which numbers related to acute adverse health effects and which relate to chronic health effects. Dr. Charp responded that 5,000 over 70 years is for chronic, long-term exposures.

Dr. Davidson suggested that they could probably safely say that anything averaged over 70 years would be chronic, because they are looking at a dose for over a period of 70 years. Dr. Charp explained that over seventy years would be chronic exposure. Mr. Richards asked if the minimum risk levels (MRLs) were set on acute. Dr. Charp responded that they were not set on acute. The toxicological profile for uranium shows that there is an acute MRL and an intermediate MRL. Depending on what the top of the compound is, there could be acute, intermediate, and chronic MRLs. Mr. Hanley agreed that there could be an MRL if the data was available, on any contaminant, in acute (less than fourteen days); intermediate (less than a year); and chronic levels (more than a year exposure). Therefore, depending on available data in the literature, they could have three different MRLs, depending on the type of exposure.

Dr. Craig added that radiation is all chronic, so they would only have chronic with a toxic chemical. There is not an acute unless someone is opening up a reactor.

Dr. Charp explained that someone actually developed an acute exposure at 400 millirem, but they did state that the chronic MRL for ionized radiation goes with 100 millirem per year, and that was based on the fact that they could not find any studies. MRLS are not cancer. The people who developed the TOC profile could not find any studies where the endpoint was not cancer. So, they could not develop a true MRL that had non-cancerous results. Therefore, they said, "Well, we can't find any studies that serve as a non-cancer health effect. We know people who are exposed to the U.S. air are exposed to about 160 millirem per year. So, based on some fudge factors, they decided to take the average annual background in the U.S., divide by three, and then round it down to 100 as the MRL. They say that any exposure to less than 100 millirem per year would most likely not have any non-cancerous health effects. That is the true definition of the MRL as Dr. Charp perceives it.

Dr. Davidson said that someone could have a chronic exposure, which is exposure occurring over a very long period of time, and someone can have a chronic effect. The chronic effect can occur from an acute or a chronic exposure. If a person received a dose of 5,000 millirems at one time, and that person is being studied over 70 years, one is looking for a chronic effect with an acute exposure, because the exposure occurred within a short period of time. However, an acute exposure can result in chronic effect. She believed this was confusing some people.

Dr. Davidson announced that a member of the public wished to address the ORRHES.

Ms. Janet Michelle introduced herself and explained that she had a comment about the current discussion. Several years ago, she found a study that was done in France which had to do with low dose, chronic exposures to radiation. They did find an unusual health effect. They found that an autoimmune process began in the heart muscle that lea to heart failure. She never heard that one before, and she reminded the group that there had been many heart attacks in the work force at ORR. She did not remember the name of the study, but she offered to find it for the subcommittee. Dr. Davidson asked her to please send the information on that study to the ORRHES, so that they could review it. She asked Ms. Michelle to send the information to Mr. Bill Taylor in the Oak Ridge field office. Dr. Davidson then asked if there was another member of the public who wished to speak. After no one stepped forward, Dr. Davidson instructed the group to continue their discussion.

Mr. Jeff Hill asked that it become an action item to distribute the study information from Ms. Michelle, if the ORRHES receives it.

Mr. Lewis stated that he had had an opportunity to look at one of the finer documents, the one that Ms. Fish produced on past and current exposures. He asked if anyone had a copy of that document. After receiving a copy of the document, Mr. Lewis indicated that the way that ATSDR uses its language, it seems that they do not expect issues for current exposures. However, they use the same language for both the past and the present exposures. They talk about how the levels of uranium that people might be receiving today are not a public health hazard. ATSDR does not expect kidney problems, cancers, et cetera. That makes good sense for the present, because there are no issues currently. However, when ATSDR talks about the past, they use the same language. The past includes the years of 1944 to 1995 and, according to the ATSDR, they do not expect any kidney problems, cancers, et cetera from past exposures either. ATSDR says that there are no data, but people do not believe that the exposures they have received in the past are not causing them problems. Mr. Lewis asked that any data available about health outcomes from past exposures be included in the PHA, otherwise, it cannot be explained clearly to the public.

In response to Mr. Lewis, and in going back to the reviewers listed in the PHA's appendix, Ms. Kaplan pointed out that the reviewers specifically say that there could be some incidences of cancer in Scarboro, caused from uranium exposure. The problem is that they cannot prove it. There are no data. No one has the statistical ability to go in and make a statement. Also, if 2 or 3 cancers were caused by exposure, what is anyone going to do? There is no recourse set up to deal with that. Also, in response to Mr. Richard's original statements regarding "chronic" and "acute," she thought that comment was in response to Mr. Hill's attempt to interject about the 5,000 millirem per year for workers. So, Mr. Richard's statement is for acute effects or chronic. She just wanted to draw the group back to that comments, because she did not think that original statement was clarified.

Mr. Richards said his initial comments were made in response to Mr. Hill, that he was confusing work with the public. He was also attempting to make the comment that the EPA would say that potential cancer at 5,000 millirem over seven years was still a health effect that would be above the EPA's level of concern. Ms. Kaplan responded that those were the issues that the ORRHES would like to at least hear about and understand.

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