ORRHES Meeting Minutes
April 22, 2003

Work Group Recommendations

PHAWG

• Recommendation 1: ORRHES should adopt PHAWG’s recommendations to the TDOH Cancer Registry on health outcome data.
  
  Discussion: Phase I of the HSR will be designed with a narrow scope that will only focus on cancer incidence in the eight counties. Census tracts and zip codes will be examined in Phase II of the study. At that time, plumes and other events can be analyzed as well. The recommendations should be revised as follows: change the sentence to “ATSDR will provide the Cancer Registry with specific census tracts...;” change the sentence to “cancer incidences for all types of cancer.”
  
  Vote: A motion to approve the recommendation was properly made and seconded by ORRHES voting members. The motion carried with 13 votes in favor, no opposing votes, no abstentions and no further discussion. The recommendations as amended by ORRHES are appended to the minutes as Attachment 2.
  
• Recommendation 2: ORRHES should adopt PHAWG’s recommendation for ORRHES to draft a letter to the DOE-Oak Ridge Operations (ORO) Office Manager requesting DOE’s continued commitment to support the involvement of Dr. Joseph, the DOE liaison to ORRHES. The resolution was drafted in response to consideration by DOE-ORO to completely eliminate or limit Dr. Joseph’s involvement with ORRHES.
  
  Discussion: The recommendation may be more effective as an unsolicited acknowledgment of DOE’s valuable contribution of providing outstanding support to ORRHES. The resolution should be rewritten as a positive thank-you letter to DOE by removing the entire “Background” section; encouraging Dr. Joseph’s continued involvement; and deleting “and not vacate your responsibility to provide competent DOE liaison to ORRHES.” PHAWG should draft the letter and submit the document to Dr. Davidson for her signature.

  Ms. Sonnenburg suggested that the letter be submitted to the local newspaper. Dr. Akin pointed out that Dr. Joseph is not seated at the ORRHES table as an official liaison. He raised the possibility of ORRHES reconsidering Dr. Joseph’s role; Mr. Lewis wholeheartedly agreed with this proposal. Mr. Hill was not in favor of either of these suggestions. His personal belief was that ORRHES should not publicly thank DOE in a letter published in the newspaper. He reminded the members that ORRHES has taken many votes on whether or not to appoint DOE as an official liaison. Ms. Kaplan also did not support DOE serving as an official ORRHES liaison. Ms. Sonnenburg rescinded her suggestion; agreement was reached to address the issue of DOE as an official liaison in a separate discussion.

  Vote: A motion to approve the recommendation was properly made and seconded by ORRHES voting members. The motion carried with 13 votes in favor, no opposing votes, no abstentions and no further discussion. The letter as amended by ORRHES is appended to the minutes as Attachment 3.

The AWG, COWG, GPWG and HENAWG Chairs made no recommendations.

Unfinished/New Business and Outstanding Issues/Concerns

Dr. Charp reported that Dr. Cember did not notice any time frames on graphs illustrating the ingestion and inhalation MRLs. The ingestion MRL is based on a chronic lifetime intake over 365 days/year, while the inhalation MRL is based on an intermediate exposure for the most insoluble form of uranium. Before the PHA is finalized, these data will be referenced in the document in tables or footnotes as appropriate.

Mr. Hill suggested that the next ORRHES meeting be held in the mall because the YWCA facilities are continuing to worsen. For the next ORRHES meeting, Ms. Dalton announced that DOE offered its offsite conference facility to ATSDR at no charge. She asked the members to weigh in on this proposal. Mr. Hanley added that the DOE Information Center is located on the Turnpike and is designed to comfortably accommodate public meetings. Mr. Hill’s position was that ORRHES meetings should not be held in any DOE facility based on the agency’s image and history with the Oak Ridge public.

Mr. Washington conveyed that the Oak Ridge Site Specific Advisory Board (ORSSAB) holds its meetings at the DOE Information Center. He agreed with Mr. Hanley that the accommodations are excellent and easily accessible to the public since visitor’s badges are not required to enter the building. As another advisory group chartered under the Federal Advisory Committee Act (FACA), ORSSAB has received no negative feedback from convening its meetings at the facility. Mr. Washington mentioned that DOE has no presence in the building.

Ms. Kaplan disagreed with Mr. Washington’s comments because DOE controls the ORSSAB agenda and enforces its 66% voting requirement. To maintain a high level of credibility in the community, Dr. Craig acknowledged that ORRHES activities should remain separate from DOE. This independence will continue to be critical to assure the public that DOE has no control or influence over ORRHES. Dr. Akin asked if free use of the DOE facilities could be used as leverage against DOE reducing the ORRHES budget in other areas.

Mr. Pereira remarked that the YWCA charges ATSDR $300 for ORRHES meetings, while the mall requires at least $500. Although the charges for both locations are nominal, meeting expenses quickly increase when multiplied by several ORRHES meetings per year. ATSDR staff who visited the DOE conference facility were extremely impressed; he planned to make a site visit to the building as well. In response to ORRHES’s concerns about its autonomy, Mr. Pereira was confident that the members will continue to generate independent, credible and meaningful products regardless of the meeting location.

Mr. Lewis announced that the DOE building also has video conferencing facilities. This technology could play a critical role in more effectively communicating technical information, increasing public involvement in activities and enhancing ORRHES’s overall function. With the more modern facilities, Mr. Lewis indicated that television stations could broadcast meetings. Although concerns about ORRHES’s independence from DOE are valid, his position was that advantages in terms of message dissemination to the public far outweigh disadvantages of a particular meeting location.

Mr. Hill followed up on some of the comments. DOE made the decision for ORRHES to be autonomous by authorizing and funding ATSDR to independently perform studies and conduct other activities at ORR. As the funding agency, DOE could have had oversight for ORRHES without ATSDR and held meetings at its onsite facilities. Mr. Hill asked the members to be mindful of the fact that DOE’s establishment of ORRHES as a separate body was based on concrete reasons.

Dr. Davidson provided clarification on the overall process. The ORRHES agenda, activities and operations are determined by the collective members and bylaws that can only be amended by the collective members. ORRHES’s only limitation is its requirement to operate within FACA guidelines. Dr. Davidson emphasized that DOE cannot control ORRHES’s agenda or operations under any circumstances. As another option to consider for a future meeting location, Ms. Sonnenburg announced that the Community Center has a large conference room. She committed to providing ATSDR with contact information for the facility.

Ms. Dalton called for a non-binding straw vote on whether or not the next ORRHES meeting should be held in the DOE Information Center. ORRHES’s comments, ATSDR’s budget constraints and other potential locations will be taken into consideration during the decision-making process. ATSDR will consult with ORRHES during this time. Nine members voted in favor of the DOE facility, four voted against and none abstained from voting.

New Action Items

Ms. Dalton reviewed the action items raised during the meeting.

• Mr. Hanley to follow up on the logic or rationale associated with the Scarboro modeling.
• Mr. Hanley to distribute CDC’s 1998 health investigation of the Scarboro community at the June 2003 ORRHES meeting.
• Dr. Charp to provide ORRHES with data on the uncertainties for air releases modeled in the ORDR Task 6 Report.
• Ms. NeSmith to send the needs assessment to HENAWG via FedEx when the document becomes available.
• Mr. Hanley to provide ORRHES with the letter by former HHS Secretary Shalala responding to requests made by Senator Frisk.

Mr. Hanley mentioned that the CDC study is included into the PHA and will be distributed to ORRHES by mail. The study contains an extensive discussion on the outcomes from the 1998 health investigation of the Scarboro community. Dr. Davidson requested details on ATSDR’s process to announce and disseminate the PHA to the public. Mr. Hanley replied that the document will be mailed to each individual on ATSDR’s comprehensive distribution list, but a review will be conducted to determine whether additional names should be added. The PHA will also be distributed as an electronic version on the ATSDR web site and by CD-ROM. Mr. Hanley made note of the members who asked for a hard copy or CD-ROM of the PHA.

Ms. Dalton added that ATSDR will issue a press release providing guidance to the public on the correct process to submit comments on the document. The notice for the current ORRHES meeting announced that the public comment draft of the PHA will be released in May 2003 and more details will be provided in the future. The meeting notice also directed the public to check local media sources for updates.

Housekeeping Issues

Ms. Dalton announced that the Oak Ridge field office will be closed the remainder of the week of April 22, 2003, but will be reopened at 2:00 p.m. on April 28, 2003 by Ms. Palmer. The office is in operation from Monday-Thursday 9:00 a.m.-6:00 p.m. and is closed on Fridays. Dr. Taylor is expected to report to the office the week of April 28, 2003. Any ORRHES member who is not a member of a work group can still attend meetings and participate as a non-compensated member of the public. In response to Ms. Sonnenburg, meeting notebooks can be returned to the field office for recycling by ATSDR.

Closing Session

The ORRHES members presented Dr. Davidson with a dogwood tree and two peonies to express their sorrow on the recent death of her father. The next ORRHES meeting will be held on June 3, 2003 beginning at 12:00 p.m. The location will be determined and announced by ATSDR.

There being no further business or discussion, Dr. Davidson adjourned the ORRHES meeting at 6:15 p.m.

I hereby certify that to the best of my knowledge, the foregoing Minutes of the proceedings are accurate and complete.

___________________
Date

________________________________
Kowetha A. Davidson, Ph.D., D.A.B.T.
ORRHES Chair

Attachment 1

FYI — This is for the ORRHES April 22, 2003 public comment record.

— Original Message —
From: E. L. Frome [mailto:FromeEL@ornl.gov]
Sent: Wednesday, April 23, 2003 10:20 AM
To: Kowetha Davidson
Cc: Palmer, Marilyn; jah8@cdc.gov; James Lewis
Subject: [Fwd: 1994 paper by Mangano]

Kowetha,

RE: Statistical Issues Related to "Health Statistics Review"

The discussion that I heard at the April 22 meeting and review of notes from the March 17, 2003 meeting of the Public Health Assessment Work Group indicate that a geographically base study (most likely at the county level) of cancer incidence and/or mortality is being considered. If such a study is undertaken then some of the details of data organization and statistical analysis should be discussed. I indicated some of my concerns in the following e-mail that was sent to ORRHES and ATSDR staff Aug, 2001. Since Dhelia Williamson has probably not seen my concerns about statistical analyses, and because of the time limitations I decided to limit my comments at yesterdays meeting. I would be glad to discuss my concerns with the Public Health Assessment Work Group.

Best,

Ed Frome

P.S. Would you please forward this e-mail to Dhelia.

On Tue Aug 28, 2001 Ed Frome wrote:
To: Jack Hanley
CC: ORRHES ATSDR-Staff

Jack,

RE: Cancer Mortality Near Oak Ridge Tn, 1994 paper by Mangano

As I indicated in our phone conversation last week this paper by Mangano uses a statistical method, i.e. age adjustment using the direct method, that in my opinion is not appropriate.

This method of analysis implicitly assumes that there is no "interaction" between age and other explanatory variables of interest, i.e., the relative difference among groups does not change with age at risk. Mangano gives no indication that this possibility has occurred to him or that he had undertaken preliminary analysis to justify this strong assumption. This and related issues, as well as more appropriate statistical methods are discussed (see in particular Eqns 7 and 8 and related discussion) in Frome, E. L. and Checkoway, H. (1985), “The Use of Poisson Regression Models in Estimating Incidence Rates and Ratios,” American Journal of Epidemiology, 309-323.

These methods and the necessary computer resources for a more appropriate analysis have been widely available since the mid80s and are described in the well know textbook by Breslow & Day. In particular, Example 2.5 page 61 of Breslow & Day illustrate this point with an example from the Connecticut Tumor Registry.

“Fig 2.3 shows age-adjusted rates ... calculated by the direct method relative to 1950 US population. While they show a smoothly rising incidence over the 40-year period, they miss an important feature of the data for females. Fig 2.4 shows age-specific rates to illustrate the problem ...”

N. E. Breslow and N. E. Day. Statistical Methods in Cancer Research, Volume II: The Design and Analysis of Cohort Studies. Number Scientific Publication 82. International Agency for Research on Cancer, Lyon, 1987.

On the issue of “causal inference” you may find the recent review by M.A. Hernan “Causal Methods for Longitudinal Studies” Vol 2001 No 1, in the Statistics in Epidemiology Report from Section on Statistics of the American Statistical Association of interest. This is available at in PDF format at URL http://www.csm.ornl.gov/asasie/ newsletter/
src="../../images/exit.gif" alt="exit" width="30" height="11" /> click on “Summer 2001.”

I see little point in trying to evaluate this paper since the methods used can lead to biased results of an unknown direction and magnitude based on statistical issues alone.

Best of luck,

Ed

P.S. On July 23, 2001 at FYI — This is for the ORRHES April 22, 2003 public comment record.

— Original Message —
From: E. L. Frome [mailto:FromeEL@ornl.gov]
Sent: Wednesday, April 23, 2003 10:20 AM
To: Kowetha Davidson
Cc: Palmer, Marilyn; jah8@cdc.gov; James Lewis
Subject: [Fwd: 1994 paper by Mangano]

Kowetha,

RE: Statistical Issues Related to "Health Statistics Review"

The discussion that I heard at the April 22 meeting and review of notes from the March 17, 2003 meeting of the Public Health Assessment Work Group indicate that a geographically base study (most likely at the county level) of cancer incidence and/or mortality is being considered. If such a study is undertaken then some of the details of data organization and statistical analysis should be discussed. I indicated some of my concerns in the following e-mail that was sent to ORRHES and ATSDR staff Aug, 2001. Since Dhelia Williamson has probably not seen my concerns about statistical analyses, and because of the time limitations I decided to limit my comments at yesterdays meeting. I would be glad to discuss my concerns with the Public Health Assessment Work Group.

Best,

Ed Frome

P.S. Would you please forward this e-mail to Dhelia.

On Tue Aug 28, 2001 Ed Frome wrote:
To: Jack Hanley
CC: ORRHES ATSDR-Staff

Jack,

RE: Cancer Mortality Near Oak Ridge Tn, 1994 paper by Mangano

As I indicated in our phone conversation last week this paper by Mangano uses a statistical method, i.e. age adjustment using the direct method, that in my opinion is not appropriate.

This method of analysis implicitly assumes that there is no "interaction" between age and other explanatory variables of interest, i.e., the relative difference among groups does not change with age at risk. Mangano gives no indication that this possibility has occurred to him or that he had undertaken preliminary analysis to justify this strong assumption. This and related issues, as well as more appropriate statistical methods are discussed (see in particular Eqns 7 and 8 and related discussion) in Frome, E. L. and Checkoway, H. (1985), “The Use of Poisson Regression Models in Estimating Incidence Rates and Ratios,” American Journal of Epidemiology, 309-323.

These methods and the necessary computer resources for a more appropriate analysis have been widely available since the mid80s and are described in the well know textbook by Breslow & Day. In particular, Example 2.5 page 61 of Breslow & Day illustrate this point with an example from the Connecticut Tumor Registry.

“Fig 2.3 shows age-adjusted rates ... calculated by the direct method relative to 1950 US population. While they show a smoothly rising incidence over the 40-year period, they miss an important feature of the data for females. Fig 2.4 shows age-specific rates to illustrate the problem ...”

N. E. Breslow and N. E. Day. Statistical Methods in Cancer Research, Volume II: The Design and Analysis of Cohort Studies. Number Scientific Publication 82. International Agency for Research on Cancer, Lyon, 1987.

On the issue of “causal inference” you may find the recent review by M.A. Hernan “Causal Methods for Longitudinal Studies” Vol 2001 No 1, in the Statistics in Epidemiology Report from Section on Statistics of the American Statistical Association of interest. This is available at in PDF format at URL http://www.csm.ornl.gov/asasie/ newsletter/
src="../../images/exit.gif" alt="exit" width="30" height="11" /> click on “Summer 2001.”

I see little point in trying to evaluate this paper since the methods used can lead to biased results of an unknown direction and magnitude based on statistical issues alone.

Best of luck,

Ed

P.S. On July 23, 2001 at http://www.csm.ornl.gov/~frome/orrhes/FINAL.html
src="../../images/exit.gif" alt="exit" width="30" height="11" /> I wrote:

I will be glad to follow the activities that are described on the OFFICIAL ORRHES web site, and if there are items on the agenda for a work group meeting that involve statistics or epidemiology I will try to participate in these discussions. I have checked the ORRHES web site and see no indication of any meetings.

On August 25 I received your letter data Aug 22, 2001 concerning the discussion of this paper. When this paper was mentioned at earlier meetings I had come prepared to explain the above issues and to discuss direct age adjustment, but time was not available. In your letter you indicated that there is a PHAWG meeting tonight, from 5:30 to 8 p.m. I do not feel my participation in this meeting would be helpful since I could add nothing to your discussion beyond the above.

I wrote:

I will be glad to follow the activities that are described on the OFFICIAL ORRHES web site, and if there are items on the agenda for a work group meeting that involve statistics or epidemiology I will try to participate in these discussions. I have checked the ORRHES web site and see no indication of any meetings.

On August 25 I received your letter data Aug 22, 2001 concerning the discussion of this paper. When this paper was mentioned at earlier meetings I had come prepared to explain the above issues and to discuss direct age adjustment, but time was not available. In your letter you indicated that there is a PHAWG meeting tonight, from 5:30 to 8 p.m. I do not feel my participation in this meeting would be helpful since I could add nothing to your discussion beyond the above.

Attachment 2

Public Health Assessment Work Group (PHAWG) Draft Recommendations:

to the Oak Ridge Health Effects Subcommittee (ORRHES)

April 22, 2003

The ORRHES recommends the following:

Phase I.

To address the community concerns about a possible increased rate of cancer in communities surrounding the DOE Oak Ridge Reservation, the ORRHES requests that the Tennessee Department of Health Cancer Registry conduct a health statistics review of cancer incidences for all types of cancers in the State’s cancer registry for the eight counties which surround the Oak Ridge Reservation (Roane, Anderson, Knox, Morgan, Loudon, Blount, Rhea, and Meigs).

Phase II.

To address community concerns about possible increased rates of cancer in the geographic areas identified in the Public Health Assessment (PHA) where exposure to hazardous substances may have occurred, the ORRHES requests that the Tennessee Department of Health Cancer Registry conduct a health statistics review of the incidence of cancer in those identified geographic areas of concern. ATSDR will provide the Cancer Registry with the specific census tracts that make up the geographic areas of concern, as well as the types of cancer to be examined.

Phase III.

If the Tennessee Department of Health Cancer Registry is unable to conduct the above mentioned health statistics reviews, the ORRHES requests that the Cancer Registry provide the pertinent data to ATSDR to conduct the health statistics review using the data provided by the Tennessee Department of Health.

Attachment 3

RESOLUTION

The Public Health Assessment Work Group (PHAWG) recommends to the Oak Ridge Health Effects Subcommittee (ORRHES) that ORRHES draft a letter to the Department of Energy, Oak Ridge Operations (DOE-ORO) Office Manager regarding the continued commitment of DOE to support the involvement of its liaison to the ORRHES.

ORRHES Position

Dr. Joseph is an exceptionally useful asset to the ORRHES whose role it is to provide public involvement and community guidance to the Agency for Toxic Substances and Disease Control’s (ATSDR) independent assessment of the health effects of the DOE’s past and present operations in Oak Ridge. Dr. Joseph’s professionalism and candid responses to questions and requests for information have greatly improved the efficiency of the subcommittee's deliberations, the quality of information provided to the public and the community satisfaction with the ORRHES/ATSDR process. On more than one occasion Dr. Joseph has volunteered facts and provided a perspective that resolved serious misunderstandings regarding DOE’s policies and past actions. Dr. Joseph has provided DOE credibility in the community that has been here-to-fore lacking. Because of his continuous involvement throughout the health effects investigations in Oak Ridge he has a unique perspective and irreplaceable corporate knowledge of what has transpired to bring us to the present conditions. Dr. Joseph represents DOE extremely well in one of its primary public interfaces and he provides an invaluable service to the citizens of Oak Ridge. We urge you to adhere to your office’s commitment to support the ORRHES mission

Glossary Key

ATSDR — Agency for Toxic Substances and Disease Registry
AWG — Agenda Work Group
CDC — Centers for Disease Control and Prevention
CHCD — Community Health Concerns Database
COWG — Communications and Outreach Work Group
DFO — Designated Federal Official
DOE — U.S. Department of Energy
EFPC — East Fork Poplar Creek
EMEG — Environmental Media Evaluation Guide
EPA — U.S. Environmental Protection Agency
ETTP — East Tennessee Technical Park
FACA — Federal Advisory Committee Act
FAMU — Florida A&M University
GAO — General Accounting Office
GPWG — Guidelines and Procedures Work Group
HENAWG — Health Education Needs Assessment Work Group
HHS — Department of Health and Human Services
HSRs — Health Statistics Reviews
LOAEL — Lowest Observed Adverse Effect Level
MCL — Maximum Contaminant Level
MRL — Minimum Risk Level
ORDR — Oak Ridge Dose Reconstruction
ORO — Oak Ridge Operations
ORRHES — Oak Ridge Reservation Health Effects Subcommittee
ORSSAB — Oak Ridge Site Specific Advisory Board
PHA — Public Health Assessment
PHAWG — Public Health Assessment Work Group
TDEC — Tennessee Department of Environment and Conservation
TDOH — Tennessee Department of Health

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