Oak Ridge Reservation: Guidelines and Procedures Assessment Work Group

Guidelines and Procedures Assessment Work Group

July 12, 2004 - Meeting Minutes

Attendance

Members attending: Karen Galloway (Chair), Peggy Adkins (phone), David Johnson, James Lewis, Barbara Sonnenburg (phone), and Charles Washington

ATSDR Staff attending: Marilyn Palmer (phone) and Bill Taylor

ERG Contractor: Liz Bertelsen (phone)

Purpose

Karen Galloway called the meeting to order. Ms. Galloway made a motion to approve the minutes from the June 14, 2004, GPWG meeting. The meeting minutes were approved.

The purpose of the meeting was to select wording to describe the new ORRHES work groups: Exposure Evaluation Work Group, Community Concerns and Communications Work Group, Health Outcome Data Work Group, and Subcommittee Business Work Group.

Before beginning the discussion on the work group descriptions, Karen Galloway read a letter from George Gartseff (ORRHES member) to the work group.

Discussion on Letter Submitted by George Gartseff, ORRHES Member

Karen Galloway explained that she had received a letter from George Gartseff before the previous work group meeting. The GPWG had addressed some of his comments at its last meeting, but Ms. Galloway had told Mr. Gartseff that the work group would discuss his comments further during tonight's meeting.¹ According to his letter, Mr. Gartseff was out of town and was unable to attend the meeting. However, he wanted to offer some suggestions to the work group. Ms. Galloway read the following:

As I stated at the ORRHES meeting, I am not sure that the three health assessment building blocks that James [Lewis] displayed would necessarily translate into an effective organizational structure. How will the Exposure Assessment Work Group function and would it be noticeably different from the PHAWG [Public Health Assessment Work Group]? Also, I think it would be premature to establish a Health Outcome Work Group until, and if, the PHA [public health assessment] leads to any plausible health outcome scenarios. Perhaps GPWG could consider a Health Communications Work Group to consolidate and coordinate the overlapping priorities of health education, needs assessment, community concerns, and health outcomes.

On the bylaws issues, I have no objection to improving how the subcommittee operates. However, I was not aware that it was functioning so poorly. Based on the written rationale statements presented last week, I am skeptical whether the recommended changes are intended for overall improvement or simply the opinions of a few. Perhaps the GPWG could craft an objective questionnaire to poll the entire subcommittee prior to formulating the recommendations. It would also be helpful if the applicable portions of the bylaws were distributed to the subcommittee so we can compare the before and after language.

Karen Galloway explained that she had thanked George Gartseff for his comments, told him that the work group would discuss his letter, and informed him that the affected portions of the bylaws would be communicated to the subcommittee.

James Lewis wanted to make sure that he understood George Gartseff's comments related to the building blocks presented at the last ORRHES meeting. He asked Karen Galloway to re-read that portion of the letter and Ms. Galloway re-read the first three sentences above.

James Lewis said that the Agency for Toxic Substances and Disease Registry's (ATSDR's) organizational chart was set up to deal with these three areas. He noted that if their efforts were not effective, then ATSDR was not effective because the agency was set up according to this same structure. He provided examples to show that divisions in ATSDR existed to manage these areas: 1) needs assessments conducted by the Division of Health Education and Promotion (DHEP), 2) PHAs conducted by the Division of Health Assessment and Consultation (DHAC), and 3) registry data and cancer incidence data handled by the Division of Health Studies (DHS). Mr. Lewis disagreed with the comments made by George Gartseff and added that they were trying to align themselves with the structure of ATSDR.

Karen Galloway asked about the part of the letter that mentioned possibly forming a "Health Communications Work Group." James Lewis responded that the Communications and Outreach Work Group (COWG) and the Needs Assessment Work Group (NAWG) were primarily established to handle health communications. He said that DHEP had not performed its function properly, and as a result, DHEP had not completed an assessment that was accepted by ORRHES. He stated that COWG had not necessarily functioned well either, but noted that there were recent indications of improvement, such as the enhancement of the ORRHES Web site. He thought that George Gartseff was suggesting that they form a group that was already in existence. Mr. Lewis added that if Mr. Gartseff had contacted him, Mr. Lewis would have been able to explain these issues.

Barbara Sonnenburg joined the call. James Lewis told her that George Gartseff had challenged the organizational structure that was presented at the last ORRHES meeting because, according to Mr. Lewis, Mr. Gartseff might not believe that the new structure will enhance productivity. Mr. Lewis noted that a PHA was comprised of these three components and that divisions within ATSDR were established to manage each component. Ms. Sonnenburg said that Mr. Gartseff may not have known that these three work groups were aligned with ATSDR's organizational structure.

Bill Taylor commented on the letter. He said that ORRHES had already passed the new work group names, but that the GPWG could take action if it decided that this was a significant issue. James Lewis agreed with Dr. Taylor. Mr. Lewis added that they needed to look at their productivity. He said that George Gartseff and other members who had not participated for the entire 3 ½ years might not have followed this project as closely as others involved during the entire time period. He said that the "general feeling" was that ATSDR is behind in their efforts, based on their expectations, an evaluation of the project plan, and missed "target dates."

James Lewis commented that he had examined other PHAs (e.g., the PHA for the Paducah Gaseous Diffusion Plant in Paducah, Kentucky) that contained health outcome data, and suggested that George Gartseff review these types of PHAs as well. Mr. Lewis had identified different philosophies between ATSDR's Public Health Assessment Guidance Manual (PHAGM) and products that he had seen; he thought that Mr. Gartseff may not be familiar with these other types of documents. He noted that, if available, most of these PHAs included health outcome data and an evaluation of the data incorporated into the PHA. Barbara Sonnenburg asked if this was currently being conducted at Oak Ridge, Tennessee; Mr. Lewis responded that it was not presently being carried out.

Barbara Sonnenburg suggested that Karen Galloway respond to George Gartseff and tell him that she had read the letter to the GPWG. Peggy Adkins recommended saying that they appreciated his comments and would "be especially focused" to address his concerns.

Discussion on New ORRHES Work Group Descriptions

Facilitator: Karen Galloway, Chair

Karen Galloway explained that they needed to select wording to describe the purpose of the newly formed work groups as approved by ORRHES on June 8, 2004.

James Lewis gave a brief overview of the three new work group areas based on his interpretation of the PHAGM definitions.

• Exposure Evaluation Work Group would focus on collecting relevant monitoring and sampling data, evaluating various pathways, and drawing conclusions based on related exposures.



• Community Concerns and Communications Work Group would include the former NAWG and COWG. This group would work with the community to identify issues and concerns, and also extract concerns that may be in newspapers and other information sources.



• Health Outcome Data Work Group would address areas of concern and potential causes for diseases. According to James Lewis, this group would be more focused on data associated with health outcome issues in the community that would be evaluated by epidemiologists, such as cancer and birth defects registries.

By using the definitions in PHAGM, James Lewis said that the work groups would be aligned with the key items in ATSDR's manual; he thought that most people would agree with this logic. Mr. Lewis added that activities had not been conducted under the health outcome data area. Barbara Sonnenburg asked which former work groups would fall under the community health concerns area. Mr. Lewis replied that the needs assessment and items in the community concerns database would fall under this category. Ms. Sonnenburg asked if the studies currently being conducted would be included under the Exposure Evaluation Work Group. Mr. Lewis said that she was correct and noted that this area would also include the U.S. Environmental Protection Agency (EPA) sampling and monitoring data.

Barbara Sonnenburg asked about specific wording. Karen Galloway said that they would use direct quotes from the guidance manual. Ms. Sonnenburg asked if everyone would have a copy of the manual at the ORRHES meeting. James Lewis replied that Jerry Pereira had committed to providing copies to everyone once the new manual was published. Marilyn Palmer responded that the new manual had not been approved yet, but that everyone would receive a copy once the updated manual had been approved and published. Ms. Sonnenburg asked if the new manual would be available anytime soon. Bill Taylor said he thought this was unlikely. Ms. Sonnenburg suggested that they receive copies of the version that Mr. Lewis was using to extract information. Ms. Palmer said that they could print copies of the needed section for everyone. Mr. Lewis proposed the following action item: ATSDR will provide everyone with copies of Chapter 2. Health Assessment Overview, pages 2-1 to 2-8, from ATSDR's Public Health Assessment Guidance Manual.

The GPWG discussed the guidance manual and developed recommendations for each work group based on the definitions presented in ATSDR's manual. These recommendations, which are listed below, were unanimously approved.

The GPWG made the following recommendation: The Health Outcome Data Work Group will consider health outcome data as defined in Chapter 2. Health Assessment Overview, page 2-2, Section 2.1. Definition and Purpose, under the paragraph entitled health outcome data, in the ATSDR Public Health Assessment Guidance Manual. Health outcome data are defined as community-specific and may include databases at the local, state, and national level, as well as data from private health care organizations and professional institutions and associations. Databases to be considered include medical records, morbidity and mortality data, tumor and disease registries, birth statistics, and surveillance data. Relevant health outcome data play an important role in assessing the public health implications associated with a hazardous waste site and in determining which follow-up health activities are needed. The Health Outcome Data Work Group will use this definition as the basis for its activities.

The GPWG made the following recommendation: The Exposure Evaluation Work Group will consider environmental characterization data (exposure evaluation data) as defined in Chapter 2. Health Assessment Overview, page 2-1, Section 2.1. Definition and Purpose, under the paragraph entitled environmental characterization data, in the ATSDR Public Health Assessment Guidance Manual. Environmental characterization data are defined as information that is provided in site-specific remedial investigation (RI) reports, preliminary assessments, geological surveys, and site inspection reports obtained from EPA and pertinent state and local environmental departments. A site visit, conducted by ATSDR staff, is also an important source of environmental characterization data. The Exposure Evaluation Work Group will use this definition as the basis for its activities.

The GPWG made the following recommendation: The Community Concerns and Communications Work Group will consider community health concerns data as defined in Chapter 2. Health Assessment Overview, page 2-1, Section 2.1. Definition and Purpose, under the paragraph entitled community health concerns, in the ATSDR Public Health Assessment Guidance Manual. Community health concerns are defined by describing that the community associated with a hazardous waste site includes the population living around the site, local public health officials, other local officials, and the local media. In order to acquire information on community health concerns, the health assessor must become an investigator; obtaining that information provides the health assessor with an opportunity to involve the public in the health assessment process. In addition, community health concerns can serve as a guide in evaluating health outcome data. The Community Concerns and Communications Work Group will use this definition as the basis for its activities.

The GPWG made the following recommendation: The Subcommittee Business Work Group will include the former Agenda Work Group (AWG) and the Guidelines and Procedures Work Group (GPWG). This work group will handle any ORRHES business and will operate on an as needed basis.

James Lewis thought that these recommendations met their requirements. He noted that there were implications associated with ATSDR moving site responsibility from DHEP to Jerry Pereira under the Community Involvement Branch (CIB).

Barbara Sonnenburg said that people would ask how to select the work group chairs. Bill Taylor said that this procedure had been developed at the last GPWG meeting. He explained that the work group would prepare a slate of recommended work group chairs. The ballots would include those names and additionally the ballots would have blank lines. ORRHES members would also have written descriptions of the ORRHES members. The ballots would be provided at the ORRHES meeting and individuals could nominate additional candidates.

Marilyn Palmer asked Karen Galloway if the work group names would be kept in the bylaws. Ms. Galloway replied that the GPWG had voted at the last meeting to remove all references to work group names from the bylaws. Ms. Palmer needed to coordinate with Ms. Galloway to ensure that the updated bylaws were sent to ORRHES members 15 days before the subcommittee meeting. According to Ms. Palmer, the August 2004 ORRHES meeting was canceled due to several people going out of town. The August and October 2004 meetings were being combined into an ORRHES meeting on September 14, 2004. Ms. Galloway said that she would make the changes and send a copy of the bylaws to Ms. Palmer. Ms. Palmer explained that the new and old versions would be provided to members, and that the changes would be in bold in the new version. Bill Taylor suggested that a few members of the work group review the bolded changes to ensure that all of the material was incorporated. Ms. Palmer would be "on travel" during the last week of July 2004, and therefore, she needed time to copy, collate, and send the bylaws to members by August 17, 2004.

Barbara Sonnenburg asked Marilyn Palmer if business would discontinue at the end of the year. Ms. Palmer responded that currently all memberships will expire on December 31, 2004. However, members would continue to serve 180 days past their term if an official extension is not approved. Presently, according to Ms. Palmer, ATSDR was in the process of extending all of the members for a further 1-year term, although, she would not know about the extension until a later time. Ms. Sonnenburg was concerned that the new work groups would only exist for 3 to 4 months. Ms. Palmer said that the same group would continue until June 2005, unless an extension was passed to continue members until December 2005.

James Lewis said that ATSDR did not have a product to present to ORRHES. In response, Barbara Sonnenburg questioned that ATSDR did not have the cancer data ready to show to the subcommittee. Marilyn Palmer said that the "49 census tract data" had not been included in the report, and that ATSDR was obtaining the data to evaluate and incorporate into the cancer incidence review. According to Ms. Palmer, ATSDR spoke with Pete Malmquist and he preferred to have one document released as opposed to two separate documents. Ms. Sonnenburg asked about the time frame since the document was requested. Mr. Lewis said that it had been between 8 months and 1 year; Bill Taylor stated that it had been more than 1 year. Mr. Lewis noted that their recommendation had included a request for three items: 1) data by county, 2) data by census tract, and 3) a detailed presentation of the findings. Ms. Sonnenburg thought that it was "pretty sad" that it took this long to receive one document.

Charles Washington believed that their restructuring of the work groups corresponded with the goals that they had wanted to accomplish. He suggested that everyone read the Compendium of Public Health Activities at the U.S. Department of Energy (DOE), Oak Ridge Reservation. According to Mr. Washington, this compendium discussed several issues that people had told them not to be concerned with because they did not affect the population. However, he said that the compendium illustrated that effects could occur to the population following short- and long-term exposures, and for younger and older workers.

James Lewis said that the current structure of PHAWG had suppressed discussions that related to health issues and health outcomes, which had resulted in a negative impact. He thought that they needed to focus their efforts on identifying and addressing issues raised by the public. Mr. Lewis explained that they had provided alternative methods to identify the public's issues and concerns after the needs assessment was unsuccessful in achieving this goal. He said that a "recovery plan" had been created to use as an alternative method, and he hoped that CIB understood all that this plan entailed. He added that they would now place the focus on the needs of the community, not solely on the exposure evaluation that had "dominated" their efforts up to this point. He said that if this was the case, then ATSDR could "do it in Atlanta [Georgia] by themselves and send it in." He wanted ATSDR to "listen to the public."

Additional Business

James Lewis brought up an issue related to wording used in a rationale for the recent GPWG's recommendations. He believed that the wording, such as "undue influence" and "inappropriate relationships" had been taken out of context by some ORRHES members. Mr. Lewis explained that they had to maintain a "proper" distance, but also needed to "stay close enough to ORRHES." He added that they had to be advocates for the communities' concerns.

Barbara Sonnenburg asked if the group would take action to deal with this issue. Karen Galloway replied that they had drafted a letter to respond to the issue and would send the letter to the work group for feedback. Instead of sending the letter to everyone who had received the original complaint, Ms. Galloway explained that the GPWG would only send the letter to Jerry Pereira who would handle the situation. Ms. Sonnenburg asked if the letter would be sent to the subcommittee chair. Charles Washington replied that the chair took the verbiage personally at the last meeting; although, the wording was not meant with that intent. Mr. Washington added that they were trying to increase their credibility. He cautioned that if they were seen as "overly contrived," then people might view their product differently.

Karen Galloway explained that she had spoken with Kowetha Davidson (Chair, ORRHES) and had expressed that the wording was not meant as a "personal or professional insult to her or to call her ethics into question." Ms. Galloway said that in an attempt to summarize information, they might have inadvertently selected unfortunate language. She said that they were going to fix the situation and clarify what was actually meant by the statement. Bill Taylor thought that the group needed to further develop its intent and strategy before having this discussion in a public meeting.

James Lewis noted that the project administrator also had a responsibility to look at how he or she presented himself or herself because sometimes the chair was placed in a "precarious situation" when the administrator did not do his or her job. He added that this was not an isolated issue, and that clarification was needed on both sides.

The work group discussed scheduling its next meeting. Marilyn Palmer said that she would be in the Oak Ridge, Tennessee, field office during the last week of July 2004. The next meeting was scheduled for July 29, 2004, at 5:30 pm.

Karen Galloway adjourned the meeting at 6:40 pm.

Please see the last page of these minutes for one agenda item and a list of recommendations passed during the meeting.

Action Item: ATSDR will provide everyone with copies of Chapter 2. Health Assessment Overview, pages 2.1 to 2.8, from ATSDR's Public Health Assessment Guidance Manual. Recommendations: The GPWG made the following recommendation: The Health Outcome Data Work Group will consider health outcome data as defined in Chapter 2. Health Assessment Overview, page 2-2, Section 2.1. Definition and Purpose, under the paragraph entitled health outcome data, in the ATSDR Public Health Assessment Guidance Manual. Health outcome data are defined as community-specific and may include databases at the local, state, and national level, as well as data from private health care organizations and professional institutions and associations. Databases to be considered include medical records, morbidity and mortality data, tumor and disease registries, birth statistics, and surveillance data. Relevant health outcome data play an important role in assessing the public health implications associated with a hazardous waste site and in determining which follow-up health activities are needed. The Health Outcome Data Work Group will use this definition as the basis for its activities. The GPWG made the following recommendation: The Exposure Evaluation Work Group will consider environmental characterization data (exposure evaluation data) as defined in Chapter 2. Health Assessment Overview, page 2-1, Section 2.1. Definition and Purpose, under the paragraph entitled environmental characterization data, in the ATSDR Public Health Assessment Guidance Manual. Environmental characterization data are defined as information that is provided in site-specific remedial investigation (RI) reports, preliminary assessments, geological surveys, and site inspection reports obtained from EPA and pertinent state and local environmental departments. A site visit, conducted by ATSDR staff, is also an important source of environmental characterization data. The Exposure Evaluation Work Group will use this definition as the basis for its activities. The GPWG made the following recommendation: The Community Concerns and Communications Work Group will consider community health concerns data as defined in Chapter 2. Health Assessment Overview, page 2-1, Section 2.1. Definition and Purpose, under the paragraph entitled community health concerns, in the ATSDR Public Health Assessment Guidance Manual. Community health concerns are defined by describing that the community associated with a hazardous waste site includes the population living around the site, local public health officials, other local officials, and the local media. In order to acquire information on community health concerns, the health assessor must become an investigator; obtaining that information provides the health assessor with an opportunity to involve the public in the health assessment process. In addition, community health concerns can serve as a guide in evaluating health outcome data. The Community Concerns and Communications Work Group will use this definition as the basis for its activities. The GPWG made the following recommendation: The Subcommittee Business Work Group will include the former Agenda Work Group (AWG) and the Guidelines and Procedures Work Group (GPWG). This work group will handle any ORRHES business and will operate on an as needed basis.

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¹ Amended at July 29, 2004 GPWG meeting to read: "The GPWG had addressed some of his comments at its last meeting, but Ms. Galloway wanted to discuss his comments further during tonight's meeting because her only contact with Mr. Gartseff was immediately after she had received the letter."