March 30, 2004
Mr. Chairman, and members of the Committee, my name is John Howard and I am the Director of the National Institute for Occupational Safety and Health (NIOSH), part of the Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS). I am joined today by Mr. Larry Elliott, Director of the NIOSH Office of Compensation Analysis and Support.
CDC's mission is to promote health and quality of life by preventing and controlling disease, injury and disability. NIOSH is a research institute within CDC that is responsible for conducting research and making recommendations to identify and prevent work-related illness and injury. Within this mission, NIOSH is the lead federal agency for research on the occupational health of U.S. workers, including nuclear weapons workers.
I am pleased to appear before you today to update you on HHS activities under the Energy Employees Occupational Illness Compensation Program Act ("the Act"). Under the Act, HHS, with the assistance of NIOSH, is charged with conducting a variety of compensation-related activities important to nuclear weapons workers and their families. My testimony today will focus on the set of activities we conduct to support the Department of Labor (DOL), which administers the federal compensation program under "Part B" of the Act. I will also briefly summarize other HHS activities under Part D and a separate provision of law relating to residual contamination.
Under Executive Order 13179, issued on December 7, 2000, the President charged HHS with five specific responsibilities related to Part B. I will briefly describe each of these five activities and summarize its progress.
Advisory Board on Radiation and Worker Health
First, the President charged HHS with administering a new federal advisory committee, the "Advisory Board on Radiation and Worker Health," to advise HHS on its activities under Part B. I will note the specific advisory roles and contributions of the Board in context throughout this testimony.
HHS nominated and the President appointed the initial members of the Board in 2001. The Board is chaired by Dr. Paul Ziemer, an internationally recognized health physicist, and includes 11 members, who are scientists, physicians, or representatives of nuclear weapons workers, a membership which reflects the Act's requirement that the Board include a balance of scientific, medical, and worker perspectives.
The Board held its first meeting in January of 2002. The Board has been exceptionally active, having met a total of 22 times in the first 26 months since the beginning of 2002. The board has advised HHS on all of our rulemakings and has begun the process of reviewing the validity and quality of the NIOSH dose reconstruction program.
Regulation for Dose Reconstructions and Cancer Causation
Second, HHS was charged with promulgating two regulations required under the Act. One regulation established methods for conducting radiation "dose reconstructions" for cancer claimants. Dose reconstruction is a science-based process for retrospectively estimating the amounts and types of radiation doses incurred by a person. Since dose reconstructions for a compensation program are very different from those used in research, HHS developed methods of dose reconstruction that build upon established approaches and principles of this discipline but are tailored to the unique purposes and needs of the Act, particularly striking a balance between the needs for accuracy and efficiency in a compensation program. This effort included substantial scientific work on the part of NIOSH to develop specialized analytical methods and tools needed to estimate the occupational radiation doses of nuclear weapons workers.
The Act required a second regulation to establish guidelines by which DOL would determine whether the cancer of an employee was "at least as likely as not" related to the radiation doses estimated for that employee through a dose reconstruction. This regulation for determining "probability of causation" (the probability that a person's cancer was caused by radiation) required the further development of a scientific tool for calculating probability of causation. This tool, the "Interactive RadioEpidemiological Program," or "IREP," is a complex computer program that uses "risk models" for associating radiation doses with risk information on different cancers. This tool estimates the probability of disease causation specific to each employee's unique history of exposures to different types and quantities of radiation during the course of his or her employment. The final development of this tool was undertaken by NIOSH in collaboration with the National Cancer Institute, which had created the initial version of this tool in the 1980s and was in the process of updating it as a result of an extensive scientific review by the National Research Council.
HHS promulgated both regulations in final form in May 2002, after issuing a notice of proposed rulemaking for the probability of causation regulation and an interim final rule for the dose reconstruction regulation in October of 2001 and obtaining and considering public comments. The Board also reviewed and advised HHS on both these rules during the public comment period and supported the final rules. The rules are based on the best available scientific evidence and have widely employed a policy to ensure that important limitations of science and available data are handled in ways that do not penalize the claimant. The rules are designed with efficiencies necessary to serve the high claims case load expected then and experienced now. The rules also are designed in recognition of the fact that science is always improving. Hence, the rules allow for new scientific findings and consensus to be integrated into dose reconstruction methods and probability of causation determinations as they become available, after proper scientific consideration.
Dose Reconstruction Program
The third responsibility of HHS, delegated to NIOSH, is the development and administration of a program of dose reconstruction to serve cancer claimants under the Act. This is the largest task assigned to HHS and required building a large internal and external capacity. The production scale and scientific complexity of the dose reconstruction program required by the Act are significant compared to other federal compensation programs requiring dose reconstructions.
I will report on the progress of this dose reconstruction program in two parts. First, I will outline the major milestones in the development of the program and the activities that remain to be completed. Second, I will report on the current status of dose reconstructions, both completed and under way.
Program Development Milestones. NIOSH began developing this dose reconstruction program in the summer of 2001. We have accomplished the following milestones:
June – December 2001
There are several important points to note about the development of this program. First, while NIOSH has some of the leading expertise in conducting dose reconstructions for scientific purposes, the practical challenges of conducting dose reconstructions for a compensation program involving a high volume of cases are new to us. One key example is the need for site profiles.
A site profile is a compilation of basic information about radiation monitoring practices and radiation exposures at a facility over time. At the outset of developing the dose reconstruction program, NIOSH expected to conduct dose reconstructions in tandem with developing site profiles. By doing both at once, we thought we could complete a substantial number of dose reconstructions to limit the accrual of a backlog. We learned, however, that to be able to complete dose reconstructions for a compensation program with a high volume of cases we had to complete initial versions of the site profiles first. It is prohibitively inefficient to collect the general site-related information used in dose reconstruction on a case-by-case basis.
We have faced a number of logistical challenges in establishing the dose reconstruction program. The demands have been exceptional for developing unique computerized data systems, for recruiting and training a nationally dispersed workforce of experts and diverse professionals, for establishing operational procedures sufficient to guide a dispersed workforce, and for establishing effective communications within our dose reconstruction workforce and with the claimant population.
A second point concerning the development of this program is that the Department of Energy (DOE) has had to develop systems for identifying and retrieving records requested for individual cases. While DOE has extensive employee and site records, which are of great value for dose reconstructions, DOE did not have sufficient infrastructure to identify and produce relevant records on the scale required for NIOSH to conduct dose reconstructions under the Act. In 2003, DOE improved this capacity substantially. Almost all DOE sites are efficiently providing complete responses to NIOSH requests and DOE continues to improve this performance.
Finally, as we go forward, the Advisory Board will have an important role in advising NIOSH concerning the further development of the dose reconstruction program. The Board is charged under the Act with reviewing and advising NIOSH on the scientific validity and quality of the dose reconstruction program. This will include an independent review of a random sample of completed NIOSH dose reconstructions. The Board, with administrative assistance from NIOSH, has contracted for independent scientific support and has initiated its review, including the review of selected site profiles and related technical procedures.
Status of Dose Reconstructions. In most cases, a cancer claimant must obtain a dose reconstruction from NIOSH after the Department of Labor verifies that his or her claim is for a covered employee with cancer. DOL uses the results of this dose reconstruction and the HHS guidelines for probability of causation to determine whether the cancer of the employee was at least as likely as not to have been related to his or her exposure to radiation in the performance of duty.
Health physicists conduct dose reconstructions using radiation monitoring data, when it is available, as well as information on the radiation monitoring practices, the radiation sources to which a person was exposed, and the processes and environment through which the exposures occurred. NIOSH obtains the information from DOE, the claimants, and other sources. The process of conducting a dose reconstruction is completed in 11 steps, as follows:
As of March 19, 2004, NIOSH has completed more than 2000 dose reconstructions and sent them back to DOL to make a final decision on the claim. Since October 2001, NIOSH has received approximately 15,000 cases from DOL requiring dose reconstructions. We currently have approximately 13,000 active cases requiring dose reconstruction. According to the process outlined above, we have obtained initial data from DOE and other sources for 10,000 of these 13,000 cases. We have completed dose reconstruction interviews of claimants and co-workers for 8,000 of these cases. We have assigned more than 5,000 of these cases to health physicists to conduct the dose reconstructions, usually after the completion of site profiles related to the cases. And we currently have drafted more than 300 draft dose reconstruction reports that are being reviewed by claimants, who have up to 60 days for this review.
As this summary indicates, we have a substantial backlog of dose reconstructions to complete. This backlog arose because we had to begin accepting dose reconstruction requests in 2001, long before we had the structure or capacity to complete any dose reconstructions.
At this point, we steadily are increasing our capacity to complete dose reconstruction. Much of our program development is completed, as I described earlier in this testimony. The following chart shows our progress in producing completed dose reconstructions. Further, our rate of production is increasing. While it took NIOSH 26 months from when we received our first referral from DOL to complete the first 1000 dose reconstructions, NIOSH completed the second 1000 dose reconstructions in less than 4 months. I am hopeful that the next 1000 dose reconstructions will be completed in even less time.
The March data in this chart cover activity through March 19th of this year. While our capacity is increasing, the chart below shows that the number of new cases requiring dose reconstructions has been decreasing since the fourth quarter of Fiscal Year 2002. This declining number of new cases also will help us reduce the backlog of cases in 2004.
Special Exposure Cohort
The fourth and fifth responsibilities of HHS under Part B of the Act are directly related to the dose reconstruction program. They concern making additions to the "Special Exposure Cohort" ("the Cohort") established by the Act.
The Act provides members of the Cohort with a different claims adjudication procedure than that applied to most cancer claimants. Claims for members of the Cohort who have any of 22 "specified cancers" designated by the Act do not require dose reconstructions, nor do they require a determination by DOL of probability of causation.
Congress included in the Cohort certain employees of three DOE facilities, known as the gaseous diffusion plants, as well as employees of a nuclear weapons test site in Amchitka, Alaska. In addition, Congress gave the President (delegated to the Secretary of HHS) the authority to designate other classes of employees to be members of the Cohort, subject to Congressional review, provided that each class of employees meets two tests:
This authority allows HHS to designate classes of employees for addition to the Cohort in situations in which a class of employees had potential radiation exposure but the available records and data are insufficient for NIOSH to complete dose reconstructions.
HHS is in the final stage of promulgating a final regulation that will set out procedures by which classes of employees can petition HHS for addition to the Cohort, and by which HHS will consider such petitions. HHS issued an initial Notice of Proposed Rulemaking (NPRM) for the Cohort petition process in June 2002. In response to public comments, NIOSH made substantial changes to the proposal and issued a second NPRM in March of 2003. The final regulation, which takes into account all of the public comments, is being developed by HHS, is undergoing final review and is expected to be released soon.
Once the Cohort regulation is promulgated, HHS will solicit and begin considering petitions by classes of employees. The process of considering petitions will involve the review of such petitions by NIOSH and by the Board, which will advise HHS on each petition. Some of the technical aspects of the NIOSH review will be similar to those of dose reconstructions, since a principal question that must be addressed is the feasibility of conducting dose reconstructions for members of the petitioning class. The final step in the petition process, as required by the Act, will be an opportunity for Congress to review each designation by the Secretary of HHS of classes of employees to be added to the Cohort. The decisions to add a class to the Cohort become effective in 180 days, unless Congress provides otherwise.
Part D of the Act
HHS also has a small but important role under Part D of the Act, which requires DOE to establish a program of assistance to certain employees of DOE contractors in state workers' compensation proceedings. DOE operates a set of physician panels that evaluate the relationship between an illness of a DOE employee and exposure to toxic substances in a DOE facility. When the findings of such evaluations affirm a work-related illness, meeting criteria specified by DOE in regulations, then DOE has procedures for assisting the employee in pursuing a state workers' compensation claim.
HHS is responsible for appointing the physicians who serve on the DOE physician panels and has made several rounds of appointments to date. HHS has selected a total of 215 physicians to serve on these panels, of which 167 have been referred to DOE. In response to DOE concerns that the number of physicians has been insufficient to address the DOE caseload in a timely fashion, HHS has recently expanded its criteria for identifying qualified physicians and is focusing on the recruitment of physicians who are making a transition from a full clinical practice to retirement or who have recently retired and are willing to undertake this non-clinical work. We are committed to recruiting as many physicians as possible to serve on DOE's physician panels.
Finally, pursuant to Public Law 107-107, NIOSH was responsible for conducting a residual contamination study. The study, conducted by NIOSH, evaluated whether significant residual contamination remained at atomic weapons employer or beryllium vendor facilities after such facilities had concluded work for DOE or its predecessor agencies.
NIOSH submitted a final report on this study to Congress in November 2003. The study evaluated 219 AWE facilities and 72 beryllium vendor facilities. It found insufficient information to make a determination for 34 AWE facilities and 12 beryllium vendor facilities. Among facilities that could be evaluated, the study found that Atomic Weapons Employer sites were almost equally divided between those that had and did not have potential for significant residual contamination outside of the periods in which weapons-related production occurred (96 and 89 facilities, respectively). On the other hand, most of the beryllium vendor facilities (57) continue to have potential for significant residual contamination.
We regret the mistake recently identified in part of the report. The report wrongly stated that there was a potential for significant residual contamination at the Bethlehem Steel site in New York beyond the period when weapons related work was completed at the site. Documentation reviewed indicates that there is little potential for significant residual contamination outside of the period in which weapons-related production occurred. We are working to release an updated report as quickly as possible with this corrected information.
In conclusion, HHS and NIOSH are working intensively to meet our responsibilities under the Act. The major tasks are difficult because they employ dose reconstruction expertise and systems on an unprecedented scale. We remain keenly aware, however, that nuclear weapons workers and their families are relying on us to accomplish this work as quickly as possible. We understand that "doing the best we can" is not good enough from the perspective of our claimants, some of whom are dying of cancer or have lost a spouse, parent or sibling to cancer. As we proceed, we will continue to strive to produce dose reconstructions that are as timely as possible, that are fair, and that are grounded in the best available science.
Thank you for this opportunity to provide an update on the status of HHS activities under the Act. Mr. Elliott and I would be pleased to respond to any questions of the Subcommittee
Last Revised: March 30, 2004