ORRHES Meeting Minutes
June 3, 2003

Agenda Review, Correspondence and Announcements

Agenda Review. In addition to the project update, work group reports, public comment periods and other standard ORRHES agenda items, Dr. Davidson announced that the following topics would be presented and discussed during the meeting:

• Overview of ATSDR’s collaboration with ORRHES by Dr. Falk.
• Presentation on public health and radiation safety standards by Dr. Herman Cember.
• Update on the NIOSH Occupational Energy Research Program by Dr. Ahrenholz.
• Follow-up presentation on ATSDR’s chemical screening process for surface water and groundwater by Dr. Karl Markiewicz.

None of the work groups would be presenting formal recommendations for ORRHES to consider; “Work Group Recommendations” were not scheduled on the agenda. Ms. Sandy Isaacs of ATSDR would present the project update during the “Unfinished Business” agenda item. Mr. Jerry Pereira, the ORR Project Manager, usually presents the report but he was unable to attend the meeting.

Correspondence. The following communications were displayed on the table of meeting materials. Dr. Paul Charp of ATSDR sent an e-mail message to Ms. LaFreta Dalton, the Designated Federal Official, to respond to an action item raised by Ms. Susan Kaplan during the previous meeting. Mr. Alfred Brooks, Chair of the Oak Ridge Environmental Justice Committee (OREJC), sent a letter dated May 20, 2003 to Mr. Pereira. The letter outlines several reasons for OREJC’s opposition to ATSDR’s proposal to produce an abbreviated public health assessment (PHA) for radioactive discharges from White Oak Creek (WOC).

Announcements. Dr. Elmer Akin, the ORRHES liaison to the U.S. Environmental Protection Agency (EPA), will no longer serve in this capacity after the current meeting due to his retirement from the agency. Mr. John Richards will begin serving as the EPA liaison to ORRHES at the next meeting. The June 3, 2003 edition of the Knoxville News Sentinel contains an article stating that Y-12 uranium releases are not judged to be a health threat. Several ORRHES members are quoted in the article.

Review of April 2003 ORRHES Meeting Minutes

Dr. Davidson entertained a motion to approve the previous meeting minutes. Comments submitted by Ms. Theresa NeSmith were noted in the draft minutes; the changes will be incorporated into the final document. A motion to approve the minutes with Ms. NeSmith’s revisions was properly made and seconded by Dr. Craig and Mr. Hill, respectively. There being no abstentions, opposition or further discussion, the April 22, 2003 ORRHES Meeting Minutes were unanimously approved.

Review of Current ORRHES Action Items

Ms. Dalton provided a status report of action items raised during the previous meeting.

1. ATSDR provided ORRHES with data on the uncertainties of air releases modeled in the Task 6 Report. [Completed]
   
2. ATSDR distributed copies of the letter from Senator William Frisk to former HHS Secretary Donna Shalala. [Completed]
   
3. ATSDR signed the letter on health statistics reviews (HSRs) that will be sent to Dr. Toni Bounds, Director of the Tennessee Department of Health Cancer Registry. [Completed]
   
4. ATSDR mailed CDC’s report of the 1998 health study of the Scarboro community to ORRHES following the April 2003 meeting. [Completed]

Several members were divided on the status of action item 1. On the one hand, Mr. Hill and Ms. Sonnenburg pointed out that the status should be changed from completed to pending. Ms. Kaplan made the request, but she was not present to confirm her satisfaction with ATSDR’s response. On the other hand, Dr. Davidson and Mr. Lewis noted that the action item was indeed completed because ATSDR provided the information Ms. Kaplan requested. ORRHES agreed that the status of the action item should be changed from completed to pending.

Overview of ATSDR's Collaboration with ORRHES

Dr. Falk conveyed that he attends community meetings on a regular basis to obtain first-hand input on ATSDR’s site activities. He undertakes this effort to emphasize the importance and value of communities in the federal advisory process. ATSDR is involved with 500-600 sites per year throughout the country to assess exposures to persons from toxic chemicals and evaluate associated health effects. Although science is critical to ATSDR’s mission, service is more important because data must be packaged in an appropriate format and interpreted for communities. ATSDR has not developed a standard approach to conduct site activities since all communities, exposures, pathways and other issues are different and require unique methods.

ATSDR’s ability to conduct site activities depends on community involvement and a strong relationship with residents. For example, ATSDR’s decision to establish ORRHES and the Oak Ridge Field Office was in direct response to the community’s request to maintain communications with staff in Atlanta. Dr. Falk is aware of ORRHES’s focus and input on several priority issues, including the HSR of Tennessee cancer registry data, the needs assessment and various PHAs for the site. In addition to these projects, ORRHES provides a forum for ATSDR to meet with the community and obtain advice on appropriate mechanisms to conduct site activities, communicate with the public and disseminate understandable materials.

In terms of the future, many federal agencies will experience budget decreases due to homeland security needs. ATSDR’s FY’03 funding is $82 million, but the President’s budget was proposed at a level of $73 million for FY’04. Moreover, ATSDR’s funding from DOE has steadily decreased each year from $12 million in FY’99 to ~$4 million in FY’03. Despite the budget cuts, however, ATSDR will maintain its strong commitment to continue to support the ORRHES process. PHAs and other activities at the site will be completed.

Another future change will be the consolidation of ATSDR’s management and administration functions with the CDC National Center for Environmental Health (NCEH). The advantage to the new structure is that ATSDR will be linked to a larger, stronger and more recognized public health agency. The disadvantage is the perception that ATSDR’s core mission and function will be lost in the larger CDC bureaucracy. Despite this concern, the HHS Secretary, CDC Director/ATSDR Administrator and other senior management are confident that the consolidation will be beneficial to both agencies. Because ATSDR was created by Superfund legislation, the agency’s mission and mandate cannot be changed by the consolidation. Only Congress has the authority to modify the Superfund program.

The consolidation will result in one office with responsibility for ATSDR’s and NCEH’s environmental health programs. However, the agencies’ missions, funding streams and operating units will remain separate. As with the future budget cuts, the consolidation will not diminish or detract from ORRHES activities. Dr. Falk emphasized that ATSDR continues to welcome ORRHES’s valuable input. The time, effort, dedication and continued commitment of members in attending meetings, reviewing documents and making recommendations are greatly appreciated.

Dr. Cember inquired about ATSDR’s relationship to NIOSH. Dr. Akin asked about opportunities the consolidation will provide in applying NCEH’s expertise to the ORRHES process. Dr. Falk responded to the questions as follows. First, NIOSH is an institute within CDC that focuses on occupational safety and health. ATSDR closely collaborates with the agency on research, site activities and other initiatives. Second, the consolidation will foster greater collaboration between the two agencies. The common leadership will also provide opportunities for ATSDR and NCEH to share skills and expertise on a more frequent basis. Most notably, ATSDR will have more access to NCEH’s laboratory after the consolidation, while NCEH will be able to rely more heavily on ATSDR’s toxicology experts.

Mr. Lewis thanked Dr. Falk for establishing the Oak Ridge Field Office, forming ORRHES and responding to other community needs. He acknowledged Dr. Charp and Mr. Jack Hanley for generating the PHA on Y-12 uranium releases in a short period of time and distributing the document for ORRHES to review and evaluate. He also commended ATSDR for its excellent investigation of the Scarboro community. Health concerns raised by local residents were quickly addressed and a report that was acceptable to the majority of the community was produced in a timely manner.

In contrast to these strengths, Mr. Lewis noted that one of ATSDR’s weaknesses is interpreting and disseminating data to the lay public in a timely manner. He raised the possibility of the work group chairs meeting with Dr. Falk to discuss this issue and obtain guidance. Dr. Falk hoped the ORRHES process would address the community’s longstanding concerns about the relationship between exposures from the site and the health status of Oak Ridge residents. He welcomed suggestions from the members on strategies ATSDR can implement to improve its production and distribution of documents to the public in a timely fashion.

Mr. Washington advised ATSDR to ensure that conclusions are accurately documented and supported by data. For example, the report of the Scarboro investigation did not mention that all of the sick children in the area were not examined. Dr. Davidson recognized the diligent efforts of other ATSDR staff who have made tremendous contributions to the ORRHES process: Mr. Burt Cooper, Ms. Dalton, Ms. Isaacs, Dr. Markiewicz, Mr. William Murray, Ms. NeSmith and Ms. Lorine Spencer. Dr. Davidson questioned whether ATSDR will maintain its commitment to complete Oak Ridge PHAs if funds continue to decrease over time.

Dr. Falk provided additional details about the budget to address this concern. ATSDR will protect its key projects by taking caution in undertaking new projects and becoming involved in long-term commitments. This approach will allow ATSDR to continue to support ongoing efforts. Moreover, the President’s FY’04 budget has only been proposed at this time; the actual allocation from Congress may be higher. ATSDR is also making efforts to leverage support from other agencies. For example, CDC allocated funding and full-time positions to support ATSDR’s involvement in terrorism and emergency preparedness activities. Dr. Falk reiterated that resources to complete Oak Ridge site activities are not expected to decrease.

Public Health and Radiation Safety Standards

Dr. Cember explained that the public health movement began in England due to the tremendous and rapid population growth in London from 960,000 persons in 1800 to 2.2 million individuals in 1840. Because the existing welfare system could not meet the needs of the city, the Poor Commission was established to explore alternative methods. In 1834, the Poor Commission issued a report stating that poverty causes disease and poor sanitary conditions lead to disease. The report recommended that the government bear the expense of improving sanitary conditions; civil engineers and other qualified professionals design and supervise sewers, water treatment plants and other public improvements; and local health departments be established.

Similar public health recommendations were outlined in a report on the sanitary conditions of Massachusetts in 1859. Persons were believed to have an inherent right to a healthful environment. The first state board of health was later established in Massachusetts in 1869. Public health is society’s collective actions to assure conditions in which individuals can be healthy and an organized community effort for disease prevention and health promotion. A community effort is needed to assure public health because an individual’s ability to structure the environment rapidly decreases due to a population implosion.

Clinical medicine and public health differ in many areas. In clinical medicine, an individual is the patient and has a particular disease that is either present or absent. The patient’s health status is evaluated by blood pressure, heart rate, body temperature and other factors. Clinical diseases can be caused by microbial agents, chemicals or trauma and are treated by medication or therapy. The individual pays for clinical care. In public health, the community is the patient and has all diseases at all times. Community health status is assessed by statistical and epidemiological data.

Causes of public health diseases include ecological issues, poverty, ignorance, poor housing and other social ills. Engineering, medical, mechanical, educational or social therapy is applied to correct the underlying pathology. Society or the community pays for public health care. Public health problems have dramatically changed over time. In previous eras, one agent caused tuberculosis, diphtheria, typhoid fever, bubonic plague or another disease that was clearly related to the agent and easily identifiable. The disease typically lasted for a short period of time and could be easily measured based on the number of sick or dead persons.

Absence of the disease was used to evaluate the health status of the population. The control objective with historical public health problems was to reduce the incidence of morbidity and mortality. Environmental control measures were clearly indicated. In the current era, asthma and other conditions last for a long period of time and do not have a unique relationship to an agent. Instead, diseases have a complex etiology that can be caused by multiple factors. The number of deaths or illness from current public health problems can only be measured statistically. The control objective with current public health problems is to increase the effectiveness of life. Control measures are not shown by relationships, such as plutonium workers who smoked or inhaled other toxic materials.

Radiation is a public health problem because individuals cannot structure their environments. Moreover, radiation health effects are not unique and are detected only statistically. Public health is translated into policy based on scientific information and societal acceptance. Although current knowledge is limited about biomedical effects from radiation on humans, more data have been collected on this public health problem than any other noxious agent.

Information has been gathered on occupational exposures among physicists, radiologists, dentists, radium dial painters, uranium miners and atomic energy workers. Data have also been collected on medical exposures from radiation therapy, diagnostic radiology, irradiation of the spine and diagnostic nuclear medicine. Studies have been conducted on several radiation events as well, including atomic bomb victims and survivors, nuclear weapons debris fallout, natural background radiation and nuclear accidents.

Radiation exposure will not necessarily lead to disease or death because adverse health effects are determined by the size and severity of the dose. Radiation data on occupational exposures, medical exposures and certain events have been instrumental in establishing current radiation safety standards. However, previous medical practices have caused cancer or other adverse health outcomes. For example, cancer of the thyroid gland was found among a significant proportion of adolescents whose severe acne was treated with low-energy x-rays. Thyroid cancer was detected in 7% of infants with an irradiated thymus.

An increased incidence of brain cancer was identified in patients who received a radiation dose of >140 rads when the scalp was irradiated for ringworm. A 26-fold increase in breast cancer was seen in female study participants who received weekly radiation doses from fluoroscopy for one year. The average radiation dose to an individual from radioactive materials in the ground, inhaled radon daughters, cosmic radiation and all other forms of background radiation is ~360 mrem/year in the United States, but background levels vary based on the part of the country or region of the world.

Concentrations in Denver are twice those in Chicago, while levels range from 2,000-5,000 mrem/year on the West Coast of India. No data have been collected to date demonstrating that geographical differences in background radiation cause more or less exposure to humans. Genetic effects from background radiation have not been seen in any human population exposed at any particular time, dose level or part of the world. In contrast to low doses from background radiation, high radiation doses are known to cause damage.

A dose of <100 rads will primarily affect bone marrow; a whole-body dose of 400 rads from x-rays will result in a 50% probability of death within two months; and doses of 1,000 to >2,000 rads will damage the gastrointestinal tract or central nervous system and certainly lead to death in no more than one week. In a hemopoietic syndrome with a dose of hundreds of rads, bone marrow can be replaced and the patient will survive. Other acute radiation effects include skin burns, loss of hair, cataracts, and temporary or permanent sterility among both males and females.

Genetic effects, cataracts and retarded growth from early exposure are among the delayed biomedical effects from radiation exposure. Several studies have conclusively shown that leukemia and cancers of the bone, lung, breast and thyroid are also caused by radiation. A definite relationship has been established between atomic bomb survivors and several health effects, including leukemia; thyroid, breast and lung tumors; lymphocyte chromosomal aberrations; lenticular opacities; microcephaly and mental retardation following in utero exposure; and retardation of growth and development following exposure during early life.

A population is currently being studied to identify an association between accelerated aging and atomic bomb survivors. Women who were irradiated compared to those in the control group experienced an earlier onset of menopause by three years. Data show that 75,991 atomic bomb survivors with known radiation doses of +15% are five times more likely to develop certain types of cancer than unexposed populations. Among atomic bomb survivors, the excess number of cancer cases is ~500 and the observed cancer thresholds are 10 rads to bone marrow for leukemia and 40 rads for solid tumors. A linear dose-response relationship was seen in all cases above the observed threshold. Additional information on radiation effects can be obtained for free from the Radiation Effects Research Foundation.

The linear no-threshold (LNT) model is used to establish safety standards, while the collective dose concept is used to apply data into public policy. Using radiation as an example, the number of excess cancer cases in a group would be determined by adding all doses in the cohort. The model is based on a theory that for every 1 million person-rads, 120 excess cancer cases will develop regardless of the distribution of person-rads. The collective dose concept cannot be verified because the annual variation in cancer cases is larger than the number of excess cancer cases outlined in the theory. The inability to confirm the model results in uncertainty.

The collective dose concept was applied in a study of atomic bomb survivors to identify the risk of mouth cancer. A full-mouth examination with dental x-rays showed doses of 8,380 mrad to the skin and 1,202 mrad to salivary glands. Using a risk coefficient for salivary glands cited in the third report of the Biological Effects of Ionizing Radiation Committee, every 1 million person-rads would result in 0.5 cases of salivary gland cancer. The study further speculates that six additional cases of salivary gland cancer would develop for every 10 million individuals who receive a complete mouth examination.

Data from atomic bomb survivors was used to calculate risks per rem of dose. An 8.3% cancer risk was estimated based on 3,435 cases among 41,719 exposed persons. A 7.3% cancer risk was calculated for 2,499 cases among 34,273 residents in other cities, military personnel who were absent at the time of the bombing and other non-exposed persons. The excess cancer rate of 1% was determined by subtracting the cancer risk of the exposed population from the control group. The collective dose in the exposed population was 1.3 million person-rems. The calculation demonstrates a probability of three chances in 10,000 of one individual developing cancer from a single rem.

The International Commission on Radiological Protection (ICRP) used the LNT dose-response model to establish a nominal risk coefficient for lethal cancer at 5 x 10?4/rad. The ICRP made several observations of risk estimates in making this recommendation. First, risk estimates should be regarded only as an upper limit of risk. The risk per unit dose at very low doses is unlikely to be any greater than at high doses and will probably be much less. Second, risk estimates are developed for doses less than those at which quantitative information had been obtained. Third, risk estimates may lead to a gross overestimate of the incidence of effects and some effects may not occur at all.

In terms of rule-making, EPA establishes basic radiation safety standards, while various regulatory agencies enforce the standards and adapt guidance to specific needs. Radiation dose limits have been established at 5-50 rems/year for occupational exposures and 0.1 rem/year for an individual member of the public. In general, an activity that will result in <1/10,000 probability of serious injury or death is accepted by society as “safe.” “Risk” is objective and can be quantified, while “safety” is subjective and cannot be measured.

Ms. Sonnenburg noted that the past practice of measuring children’s feet for shoes with x-rays may have also resulted in adverse health effects from radiation. Dr. Cember confirmed that children received large radiation doses from x-rays of the feet, but he was not aware of any studies to identify associated health effects. In the interest of time, Dr. Davidson tabled further deliberations until the “Unfinished Business” agenda item. Alternatively, an open discussion could be scheduled for the next meeting.

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