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Oak Ridge Reservation

Historical Document

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ORRHES Meeting Minutes
August 26, 2003

Update on the ORR Needs Assessment [continued]

HENAWG Recommendations. Mr. Lewis noted that the recommendations on the final needs assessment report are a direct result of HENAWG’s findings from its critique of the overall methodology; assessment of the purpose, techniques and results of the four project components; review of the final draft report; and evaluation of the results. Ms. Mosby read HENAWG’s formal recommendations into the record.

The Needs Assessment Working Group (NAWG) of the Oak Ridge Reservation Health Effects Subcommittee (ORRHES) recommends that the ORRHES adopt the following recommendations and submit them to the Agency for Toxic Substances and Disease Registry:

"Whereas, the report, Assessing the Health Education Needs of Residents In the Area of the Oak Ridge, Tennessee – Final Report May 23, 2003, has been received by the NAWG and has been reviewed by members of both NAWG and the broader ORR community, and

Whereas, the totality of the many and diverse comments have been collected in detail and summarized by an ad hoc NAWG committee in an attached report, Summary and Compilation of All Comments on the GWU Health Education Needs Report, and

Whereas, the collected comments reveal serious deficiencies in the report and generally reject the report as a further basis for any Public Health Education Program (PHEP), be it therefore

Recommended that the subject report not be used as the basis for any future public health education program conducted in the ORR region, and be it further,

Recommended that any future ATSDR/PHEP activities related to PHA be based upon the findings of the Public Health Assessment Program (PHAP) which should, with the advice of ORRHES, ascertain the following:

  1. The degree to which releases of contaminants from the DOE sites contributed to regional public health problems,
  2. The degree to which there is a need for additional public health educational services,
  3. The degree to which the existing Public Health and medical services establishment can supply any substantive unmet public health education needs in both the rural and urban areas,
  4. The degree to which ATSDR might meet any additional needs by augmenting the current system by printed material or presentations by experts. Not to do this will very probably result in the duplication of much effort as well as be an affront to the existing health care system,
  5. The degree to which any necessary educational effort can avoid the onus of distrust that has cursed all previous efforts,

and be it further,

Recommended that ATSDR examine the project structural and management components which enabled the report and project to reach this state without ATSDR overview and without subcommittee or working group review that could have remedied its shortcomings.”

The recommendations and comments on the final draft needs assessment report were submitted into the record and are collectively appended to the minutes as Attachment 1. A motion for HENAWG’s formal recommendations and supporting materials to be adopted and forwarded to ATSDR was properly made and seconded by Dr. Malmquist and Ms. Sonnenburg, respectively. There being no abstentions, opposition or further discussion, the motion unanimously carried.

HENAWG Lessons Learned. Mr. Lewis conveyed that three major issues caused problems with the needs assessment process. First, ATSDR management did not perform periodic reviews of key steps. This approach would have provided an opportunity for HENAWG to inform GWU if efforts from previous site activities were being duplicated; if ORR historical data were being fully utilized; and if next steps in the project were appropriate. Regular status reports also would have provided an opportunity for ATSDR and HENAWG to review and modify the project time-line as needed. For example, in November 2000, HENAWG asked ATSDR to present a model needs assessment to strengthen the knowledge of the members in evaluating the ORR study. ATSDR did not respond to this request for nearly 28 months, but HENAWG met its deadlines in providing ATSDR with target areas and contact information for potential focus group participants.

GWU informed HENAWG of problems associated with Institutional Review Board approval, but these delays should have been anticipated when the project was originally developed and the time-line should have been modified accordingly. Poor planning and management of the project indicate that the time-line was not thoroughly reviewed before being presented to HENAWG. Overall, the lack of oversight resulted in a product that failed to meet ORRHES’s expectations.

Second, the decision by ATSDR management to block collaboration between HENAWG and GWU resulted in a loss of trust and suspicion in the needs assessment effort. After a HENAWG meeting, GWU refused to communicate with and provide feedback to the members. As a result, HENAWG was forced to conduct its activities without input from GWU. Third, GWU’s failure to identify historical health concerns from the literature or obtain similar information from the needs assessment interviews or telephone survey resulted in a loss of critical data essential to the public health assessment (PHA) effort and the community. According to ATSDR’s Public Health Assessment Guidance Manual (PHAGM), environmental data, community health concerns and health outcome data are the three major components of a PHA.

The PHAGM further states that community health concerns associated with a site constitute a key data point for all PHAs since this information is needed to evaluate exposures and health effects. Dr. Falk has made statements that are consistent with the PHAGM, but ATSDR’s implementation of these guiding principles is questionable. During the June 2003 ORRHES meeting, for example, Dr. Falk noted that public comment periods are not an effective mechanism to engage the public and address community health concerns. A review of historical data to capture comments previously voiced by residents in various counties would yield more meaningful results.

As evidenced in its recommendations to ORRHES, HENAWG has rejected the outcomes in three of the seven steps of the needs assessment: key resource interviews, telephone survey and focus groups. If ATSDR accepts ORRHES’s recommendations, the needs assessment will revert back to the literature review outlined in step two of the study design. Mr. Lewis acknowledged that HENAWG is uncertain about the future direction of the project at this time. However, the ORR community deserves a solid product and an accurate accounting of health concerns at the site, particularly since ATSDR and ORRHES have devoted nearly three years to the needs assessment. Several actions can be taken to improve overall performance and meet the needs of the ORR community.

A mechanism should be developed to identify and fully utilize existing resources. ATSDR should provide ORRHES with additional details about the health education plan and the process by which this activity will be integrated with documented community concerns. Some activities conducted by ORRHES Work Groups should be combined to complete the needs assessment in a more efficient and timely manner. The goals and time-line of the project should be clearly defined in writing; concrete examples of needs assessments completed at other sites should be provided to HENAWG as well. ATSDR should seek input and support from ORRHES.

Despite these deficiencies, Mr. Lewis was pleased that ATSDR’s efforts to gather community concerns and issues have significantly improved over the past three months. New staff members with community expertise have been hired; ATSDR has a stronger presence at workgroup meetings; and documents about ORR site activities are more widely disseminated. He clarified that HENAWG’s critique of the needs assessment is not intended to dwell on past mistakes. Instead, ATSDR should use the lessons learned to develop a solid plan and advance to next steps in the project.

Open Forum with ATSDR. Dr. Elizabeth Howze, the DHEP Director, thanked Mr. Lewis and the other HENAWG members for contributing their time and effort in providing valuable input during the needs assessment process, critiquing the final draft report and formulating solid recommendations. She emphasized that DHEP is committed to engaging in a collaborative effort with ORRHES to develop health education activities at the site. DHEP will also be responsive to issues and concerns ORRHES and the community have raised about the project. Similar to ORRHES, ATSDR also learned several lessons about the needs assessment and has expressed similar concerns about the final draft report.

The document did not meet DHEP’s expectations of a needs assessment since this activity is specifically designed to identify information, programs and other activities that will be useful to a site in the future. DHEP is currently discussing its concerns and lessons learned about the needs assessment with GWU. ORRHES’s comments, findings and formal recommendations will be communicated to GWU as well. Dr. Howze clarified that the cover page shows the May 23, 2003 version as a “final report,” but the document is actually a draft. A final report will be developed to reflect ORRHES’s concerns and formal recommendations and also to incorporate additional data requested by ATSDR. In the future, ATSDR will clearly define its expectations of a needs assessment before the project is developed. The community will be actively engaged throughout all components of the study. ATSDR will provide much more oversight and follow-up of its contractors.

Dr. Howze was pleased that despite the problems with the needs assessment, ORRHES is still willing to partner with DHEP in the project and advance to next steps. As an initial effort, DHEP proposes to meet with ORRHES to jointly identify and discuss the future direction of environmental health-related activities at the ORR site. She acknowledged that ATSDR is fully aware of the need for federal agencies to communicate with the community when site activities are conducted. As the first step in this direction, DHEP looks forward to its partnership with ORRHES in addressing critically important issues in the community.

Dr. Cember pointed out that the target audience is not clearly identified in the needs assessment report. The “community” covers a wide range of diverse populations, including physicians and kindergarten students. Dr. Howze agreed that this issue was another shortcoming in the report. A needs assessment should provide guidance in identifying residents with specific needs in certain geographical areas of a site, such as those who believe they are at higher risk of exposure or those who believe they need health information. She acknowledged that the ORR needs assessment failed to produce this information.

Ms. Sonnenburg noted that ATSDR contracted AOEC and GWU to conduct the needs assessment before ORRHES was established. Since the decision to focus on health education needs at the site was made without feedback from the members, ORRHES was not provided an opportunity to discuss the needs of the community and provide input on this issue early in the process. Although the ORR community can benefit from a needs assessment, the need to include “health education” in the project is uncertain. Based on Ms. Sonnenburg’s experience, ORR residents are more interested in prevention, care and treatment of environmental health problems rather than health education.

Dr. Howze recognized that many residents often misinterpret health education as a classroom lecture, but the activity actually has a much broader scope. For example, a community member with exposure to a contaminant may present to a physician who has no knowledge or skills to address environmental health concerns. This situation would cause stress to the physician, patient, family members and ultimately the broader community. To address this concern, ATSDR would provide educational materials and hold training sessions to strengthen the capacity of local providers to diagnose, counsel, treat and follow patients with environmental health problems. In conducting health education activities, ATSDR also attempts to identify and utilize resources within the community. For example, many residents have expertise in health care, while others serve as strong leaders at the local level.

Mr. Lewis mentioned that ATSDR has completed several successful health education projects, such as materials on iodine-131 for the Hanford site and the chelation videotape. He questioned whether ATSDR plans to duplicate some of these models in the ORR community. Dr. Howze confirmed that ATSDR tailors environmental health materials for a particular site and distributes information to address specific concerns of the community. However, she reiterated that the decision to disseminate health education materials or conduct other types of projects at ORR will be made in full partnership with ORRHES. ATSDR will also seek ORRHES’s input on appropriate target audiences, effective delivery methods, and the proper strategy to translate scientific data for the lay public.

In the interim of these discussions, Dr. Howze described two site-specific health education projects for ORRHES to consider. After past chemical releases in Toms River, New Jersey were found to be the source of a cancer cluster among young persons, ATSDR attended public meetings, discussion groups and other events held by the community. ATSDR also met one-on-one with individual residents. In response to the community’s request, ATSDR facilitated grand rounds on leukemia and children’s health with local physicians. ATSDR also partnered with the school system to develop an environmental health curriculum and train teachers in disseminating age-appropriate materials and educating students in grades K-12. The legacy of the environmental health curriculum is a direct result of ATSDR’s extensive interaction with the Toms River community.

Dr. Howze also reported that in Fallon, Nevada, ATSDR assisted residents in developing a focused community response to childhood deaths from leukemia. The community provided support to affected family members by ensuring that mental health services and other programs were more accessible. Under the community response plan, agencies at federal, state and local levels actively involved Fallon residents in the ongoing investigation at the site. Mr. Washington agreed with Ms. Sonnenburg that the needs assessment will be beneficial to the ORR community. Residents are interested in obtaining credible information about fish, vegetable or milk consumption, air emissions, breast-feeding, exposure to contaminants, and other potential risks from living near the ORR site.

Mr. Washington was confident that solid data produced by the needs assessment will allow the community to separate fact from fiction. Dr. Howze confirmed that DHEP will communicate scientifically sound results from the needs assessment to the Division of Health Assessment and Consultation to ensure public health assessors apply these findings to ORR PHAs. Mr. Johnson noticed that ATSDR’s health education activities are targeted to providers. He asked if similar products have been developed for community residents. Dr. Howze replied that ATSDR has not developed community-based health education initiatives, but several projects are underway in this effort. A pilot program was recently launched and a community toolbox with information, references and other resources for residents is currently being developed.

Dr. Howze added that generic community-based health education activities are extremely difficult to design because issues, concerns and other site characteristics are different in each community. As a result, ATSDR partners with the community to tailor materials and activities that will be specific, appropriate and relevant to the site. In some areas, ATSDR is training local spokespersons, influential residents and other community leaders about health concerns and scientific issues at the site. The lay health advisors then educate the broader community and disseminate health education materials. This approach increases public access to health information.

Dr. Davidson acknowledged that the majority of ORRHES’s comments on the needs assessment were directed to GWU. As the contractor of the project, however, AOEC had a responsibility to oversee GWU’s activities. AOEC should have thoroughly reviewed and approved GWU’s deliverables before submission to ATSDR. Dr. Howze emphasized that ATSDR does not plan to subcontract any of its activities in the future. Moreover, ATSDR expects to develop Phase II of the ORR study in collaboration with ORRHES rather than use AOEC as a contractor on the project.

Dr. Malinauskas strongly suggested that ORR historical data be reviewed to strengthen the final needs assessment report. Specific concerns previously voiced by ORR residents and needs that were identified at the site should be included in the final document. This approach may address study fatigue at the ORR site that contributed to the low participation rate in the needs assessment. Dr. Malinauskas noted that the final draft report indicates GWU ignored existing data. Dr. Cember described a model for ATSDR to consider in providing environmental health education to physicians. A program was developed to increase the knowledge of physicians in radiation. Training sessions were held at a resort hotel for one weekend each year for ten years. Attendees who completed the course received continuing medical credits. The program was eventually tailored to school teachers.

Dr. Howze agreed that federal agencies must explore innovative methods to increase health education to both physicians and the community. She pointed out that the clergy, teachers and other resources in the community could assist in this effort. Dr. Davidson thanked DHEP staff for attending and participating in the open forum. Based on the discussion, she charged HENAWG as follows. The members should closely collaborate with DHEP to identify next steps in the health education process for the ORR site; develop a strategy to achieve these goals; and present the plan to ORRHES for review, comment and approval. HENAWG should be prepared to present the plan no later than the December 2003 ORRHES meeting. Any HENAWG member who needs clarification on the new charge should contact Dr. Davidson.

Dr. Howze asked ORRHES to consider two additions to the charge. First, the plan should also include a clearly defined process for DHEP to collaborate and communicate with HENAWG and ORRHES. Second, HENAWG should be renamed to ensure that the members and DHEP begin developing health education activities for the ORR site without dwelling on past mistakes in the needs assessment. Dr. Davidson amended the charge to include Dr. Howze’s suggestions. The members should develop a strategy for DHEP to collaborate and communicate with ORRHES and HENAWG. The members should review and discuss HENAWG’s current role as outlined in the ORRHES bylaws.

If HENAWG determines that its purpose should be redefined and updated and the change requires a modification to the ORRHES bylaws, Dr. Davidson will assign this task to the Guidelines and Procedures Work Group. Ms. Sonnenburg asked the HENAWG co-chairs to invite Ms. Adkins and Ms. Kaplan to future meetings with DHEP. These ORRHES members can offer insights about the community’s lack of trust with local physicians that have been expressed by some residents. Ms. Mosby clarified that both Ms. Atkinson and Ms. Kaplan are HENAWG members.

Public Comment Period

The Chair called for public comments; no attendees responded.

Work Group Reports

Public Health Assessment Work Group (PHAWG). Dr. Malmquist mentioned that the members were charged with reviewing cancer incidence data at the ORR site and reporting these findings to ORRHES. In conducting this activity, however, PHAWG realized that a health statistics review (HSR) by ATSDR and the Tennessee Department of Health (TDOH) Cancer Registry would be more appropriate. PHAWG is now asking that its charge be amended to conduct the HSR rather than collect cancer incidence data. The members have already drafted a rough outline for the project. In collaboration with the TDOH Cancer Registry, Ms. Dhelia Williamson of ATSDR will collect existing data from the registry from 1990-1996 on 26 different types of cancer. Cancer incidence data by county and region will be compared to the state and age adjusted for each county.

TDOH will not release cancer incidence data by census tract due to the small population and the ability for individual residents to be identified. However, efforts will be made to identify cancer clusters in census tracts. The HSR will not be designed to link cancers to a contaminant or other source. Instead, the project will focus on the incidence of cancer at the ORR site from 1990-1996 only. PHAWG, Ms. Williamson and Dr. William Taylor of the Oak Ridge Field Office will convene a conference call within the next two weeks to review the draft outline and discuss next steps in the HSR. PHAWG hopes to present a status report of the project by the December 2003 ORRHES meeting.

Mr. Lewis proposed that all health outcomes at the ORR site from 1990-1996 be included in the HSR, but Dr. Malmquist did not support this suggestion. Although Dr. Cember agreed the HSR should only focus on cancer, he pointed out that the name is misleading. He clarified that a “cancer statistics review” (CSR) would be more appropriate. ORRHES accepted the name change by general agreement. A motion to approve the recommendation was properly made and seconded by Ms. Sonnenburg and Dr. Malinauskas, respectively. PHAWG will conduct the CSR in collaboration with ATSDR and the TDOH Cancer Registry. The CSR will be implemented in ORRHES’s geographical area of concern to support the PHA process. There being no abstentions, opposition or further discussion, the motion unanimously carried.

Dr. Davidson called ORRHES’s attention to the second PHAWG recommendation that was distributed in the pre-meeting briefing packets. PHAWG requested that the U.S. Environmental Protection Agency (EPA) Headquarters and Region IV be invited to a future ORRHES meeting to address concerns about the ORR site and discuss procedures EPA uses to interact with ATSDR and ORRHES. Dr. Davidson explained that PHAWG’s recommendation is based on two different sets of comments EPA Headquarters and Region IV submitted to ATSDR on the Y-12 uranium PHA. ORRHES was understandably confused and negatively impacted by this process. She asked if Headquarters and the specific EPA region for a site attempt to reconcile comments on public documents.

Dr. Malinauskas pointed out that the lack of communication was another concern with this process. ORRHES discussed the article that was published in a local newspaper regarding the response by EPA Headquarters to the public comment version of the PHA on uranium releases from the Y-12 plant. Mr. Jon Richards of Region IV weighed in on PHAWG’s recommendation from EPA’s perspective. Although comments by Headquarters were more detailed than those by Region IV, both sets were consistent. Region IV reviewed all comments on the Y-12 uranium PHA made by Headquarters before submission to ATSDR and also convened conference calls with ATSDR to resolve any differences. Headquarters and Region IV submitted comments on the PHA by e-mail only to ATSDR and an ORRHES member upon request.

Comments by Headquarters were published in a newspaper through actions taken by an ORRHES member; EPA played no role in disseminating the comments to the media or public. Overall, Headquarters can become involved with any EPA activity throughout the country either independently or through the specific region for the site. Dr. Charp and Mr. Hanley weighed in on PHAWG’s recommendation from ATSDR’s perspective. ATSDR disagrees with EPA’s position that comments between Headquarters and Region IV were consistent. Nevertheless, ATSDR will respond to the two sets of comments submitted by both Headquarters and Region IV. One set of comments was in response to the initial release, while the other set addressed the public comment draft.

ATSDR generally communicates with Region IV for ORR activities, but Headquarters specifically requested a copy of the Y-12 uranium PHA. ATSDR received comments on the initial draft from Region IV and then received comments from Headquarters two months later after the public comment draft was released. The comments from EPA Headquarters related to the initial draft of the document; many of the comments had previously been addressed in the public comment version of the document. ATSDR will present its responses to comments by Headquarters and Region IV to both PHAWG and ORRHES. The difference between versions of documents is as follows. ATSDR only distributes an initial release or data validation document to DOE, EPA, the state or other agency involved with the activity. The purpose of this draft is for agencies to provide ATSDR with additional data, correct existing information in the report and submit comments.

For ORR activities, ATSDR agreed to also release data validation documents to ORRHES for review and comment. Despite this consideration, however, other agencies are still not required to submit comments on initial drafts to ORRHES. A data validation document serves as an internal government working draft and is not shared with the public. ATSDR revises the initial draft based on comments from the agencies and then widely releases the document to the public. Similar to EPA, ATSDR also has no knowledge of actions that were taken to distribute initial draft comments by Headquarters to the media and ORR community.

The publication confused ORRHES because comments in the newspaper related to the initial draft that ATSDR had previously addressed. Initial draft comments by Region IV were not leaked to the public. Dr. Davidson acknowledged that other agencies are not required to communicate with ORRHES, but adverse effects on the ORR PHA process from any source must still be conveyed. Ms. Mosby pointed out that this problem is another example of members fighting the ORRHES process. Her position was that ORRHES members cause more harm to the advisory process than agencies. Mr. Lewis indicated that the leak of EPA’s comments to the media and public stems from frustration in the community. If ORRHES convenes effective meetings and produces solid products in a timely manner, these types of problems will significantly decrease. Based on Mr. Richards’ remarks, Dr. Malinauskas suggested that PHAWG’s recommendation be withdrawn. No motion was made to approve the recommendation.

Communications and Outreach Work Group (COWG). Mr. Lewis underscored the need to emphasize key presentations in ORRHES meeting minutes. He plans to recommend to COWG that comments made by Dr. Falk during the June 2003 ORRHES meeting be incorporated into the record. This approach is extremely important since messages conveyed by Dr. Falk do not always filter down to ATSDR staff. Dr. Falk’s comments also need to be reviewed to identify the impact on ORRHES.

Agenda Work Group (AWG). Ms. Sonnenburg plans to discuss with the members at the next meeting whether AWG is still needed.

Guidelines and Procedures Work Group (GPWG). Ms. Galloway reported that the members have not met, but a process to correct minutes for all ORRHES workgroups is on the GPWG agenda. GPWG plans to meet soon to review a rough draft Ms. Galloway is currently developing. The new guidelines for correcting and editing workgroup meeting minutes will be based on a previously developed process as well as comments from ATSDR. Ms. Galloway plans to present the document to ORRHES at the next meeting for review and approval.

Mr. Lewis pointed out that workgroup members should specify the type of document needed, such as detailed minutes, a verbatim transcript, a record of discussion or minimum requirements of minutes based on Roberts Rules of Order. Solid meeting minutes will result in less challenges from the public. Most notably, key activities completed by the workgroups should be clearly documented to increase public awareness and sustain a strong legacy at the ORR site.

Public Comment Period

The Chair called for public comments; no attendees responded.

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