Docket Number: 21570-2005

EMPLOYEE: [Name Deleted]

CLAIMANT: [Name Deleted]

FILE NUMBER: [Number Deleted]

DOCKET NUMBER: 21570-2005

DECISION DATE: May 26, 2005

NOTICE OF FINAL DECISION FOLLOWING A HEARING

This is the decision of the Final Adjudication Branch concerning your claim for compensation under Part B of the Energy Employees Occupational Illness Compensation Program Act of 2000, as amended, 42 U.S.C. § 7384 et seq. (EEOICPA or the Act). For the reasons stated below, your claim for benefits is denied. A copy of this decision will be provided to your authorized representative. Adjudication of your Part E claim is deferred until after issuance of the Interim Final Regulations.

STATEMENT OF THE CASE

On January 8, 2002, you filed Form EE-2, Claim for Survivor Benefits under EEOICPA, with the Jacksonville district office. The claim was based, in part, on the assertion that your late spouse was an employee of a Department of Energy (DOE) contractor at a DOE facility. You stated on the Form EE-2 that you were filing for the breast cancer of [Employee] (hereinafter called the employee).

On the Form EE-3, Employment History, you stated that the employee was employed at the Savannah River Site (SRS) in Aiken, South Carolina, from 1951 to December 31, 1984. The Department of Energy verified employment as August 20, 1951 to December 31, 1984.

You submitted medical evidence establishing that the employee was diagnosed with left breast cancer on September 10, 1985. In order for you to be eligible for benefits, the evidence must establish that the cancer was at least as likely as not related to employment at a covered facility, within the meaning of Part B of the Act. 42 U.S.C. § 7384n.

To determine the probability of whether the employee sustained cancer in the performance of duty, the Jacksonville district office referred the application package to the National Institute for Occupational Safety and Health (NIOSH) for radiation dose reconstruction in accordance with § 30.115 of the Department of Labor’s implementing regulations. 20 C.F.R. § 30.115. NIOSH reported annual dose estimates from the date of initial radiation exposure during covered employment, to the date the cancer was first diagnosed. A summary and explanation of information and methods applied to produce these dose estimates, including your involvement through an interview and review of the dose report, are documented in the “NIOSH Report of Dose Reconstruction under EEOICPA.” On October 9, 2004, you signed Form OCAS-1, indicating the NIOSH Draft Report of Dose Reconstruction had been reviewed and agreeing that it identified all of the relevant information provided to NIOSH. The district office received the final NIOSH Report of Dose Reconstruction on October 15, 2004.

Pursuant to the implementing NIOSH regulations, the district office used the information provided in this report to determine that there was a 36% probability that the employee’s cancer was caused by radiation exposure at the Savannah River Site. 42 C.F.R. § 81.20. The Final Adjudication Branch (FAB) independently analyzed the information in the NIOSH report, confirming the 36% probability.

On December 17, 2004, the Denver district office issued a recommended decision concluding that the employee’s breast cancer is not covered under Part B of the Act and that you are not entitled to compensation. Attached to the recommended decision was a notice of claimant rights, which stated that you had 60 days in which to file an objection to the recommended decision and/or request a hearing. That 60-day period expired on February 15, 2005.

OBJECTIONS

On January 31, 2005, the Final Adjudication Branch received a letter from your authorized representative, dated January 19, 2005, objecting to the recommended decision and requesting a hearing. By letter dated February 8, 2005, your authorized representative requested a telephone hearing. The hearing was held by the undersigned by telephone on March 31, 2005. You and your authorized representative (your daughter) were duly affirmed to provide truthful testimony.

In the letter of objection, your authorized representative stated that the actual primary site of the cancer was probably unknown, since the cancer had already metastasized by the time the employee went to the doctor; that breast cancer is rare in men and there is no family history, so the likelihood that radiation exposure caused it is more likely; you could not obtain additional records from the oncologist since he is no longer in the area; that the employee worked at SRS for 33 years and was exposed to large amounts of radiation and other harmful elements; and that he began work at SRS before exposure records were kept.

At the hearing, you discussed the employee’s medical and employment histories. The authorized representative stated that the employee had bumped his chest and noticed a lump and finally went to the doctor when it wouldn’t go away, and that he had had knots throughout his body for some time but never told anyone. She noted that this could indicate the primary site was not the breast since he didn’t live long enough for the physicians to actually determine the primary site with testing and diagnostics. She stated that she believed the primary site was the lung, since that was the area the doctors chose to treat.

In accordance with §§ 30.314(e) and (f) of the implementing regulations, a claimant is allowed thirty days after the hearing is held to submit additional evidence or argument, and twenty days after a copy of the transcript is sent to them to submit any changes or corrections to that record. 20 C.F.R. §§ 30.314(e), 30.314(f). By letter dated April 8, 2005, the transcript was forwarded to you. No response, additional evidence, argument, changes or comments were received.

The objections raised before and during the hearing have been reviewed. Part B of the Act defines that the probability of causation shall be based on the radiation dose received by the employee, and states that cancer must be “at least as likely as not related to employment at the facility specified….” 42 U.S.C. §§ 7384n(b), 7384n(c). The implementing regulations state that the FAB may evaluate factual findings or arguments concerning the application of dose reconstruction methodology. 20 C.F.R. § 30.318. However, § 30.318(b) of the implementing regulations states that the methodology used by NIOSH in arriving at reasonable estimates of the radiation doses received by an employee is binding on the FAB.

In your first objection, you stated that the actual primary site of the employee’s cancer is unknown. However, as discussed at length during the hearing, the medical records all indicate a breast primary with metastasis to the lymph system and lungs. The implementing regulations state that the establishment of a cancer diagnosis is based on medical evidence that sets forth the diagnosis of cancer and the date on which that diagnosis was made. 20 C.F.R. § 30.211. Your belief that the medical evidence of record is incorrect is a challenge of a fact, and is insufficient to override the evidence of record.

Your second objection relates to the rarity of breast cancer in men and the lack of a family history of breast cancer in either sex. Scientists evaluate the likelihood that radiation causes cancer in a worker by using medical and scientific knowledge about the relationship between specific types and levels of radiation dose and the frequency of cancers in exposed populations. If research determines that a specific type of cancer occurs more frequently among a population exposed to a higher level of radiation than a comparable population (a population with less radiation exposure but similar in age, gender, and other factors that have a role in health), and if the radiation exposure levels are known in the two populations, then it is possible to estimate the proportion of cancers in the exposed population that may have been caused by a given level of radiation.

The probability of causation (PoC) means the probability or likelihood that a cancer was caused by radiation exposure incurred by a covered employee in the performance of duty. The PoC is calculated as the risk of cancer attributable to radiation exposure (RadRisk) divided by the sum of the baseline risk of cancer to the general population. 42 C.F.R. § 81.4(n). The Department of Labor (DOL) uses NIOSH-IREP to estimate the probability that an employee’s cancer was caused by his individual radiation dose. The model takes into account the employee’s cancer type, year of birth, year of cancer diagnosis, and exposure information such as years of exposure, as well as the dose received from gamma radiation, X-rays, alpha radiation, beta radiation, and neutrons during each year.

Complex factors associated with cancer incidence are taken into account in NIOSH-IREP in calculating probability of causation (PoC) at the 99^th percentile credibility limit for any given cancer, including breast cancer. These factors include gender-specific rate differences as well as the gender-specific ratios between U.S. and Japanese incidence rates. However, PoC depends more on excess risk due to radiation exposure than to gender differences. In fact, PoC under EEOICPA is calculated as the risk of cancer attributable to radiation exposure (RadRisk) divided by the sum of the baseline risk of cancer (BasRisk) plus RadRisk, converted to a percentage.

By definition, a PoC of 50% is obtained whenever radiation exposure doubles the natural baseline incidence of cancer, regardless if the baseline is low or high. Consequently, similar doses are required for males and females to qualify for compensation for breast cancer because the risk coefficient is similar for males and females.

Male breast cancer rates are indeed quite low compared to females. Further, this is true in both the U.S. and in Japan. Thus, as would be expected, the net effect in IREP of these differing gender incidence rates for breast cancer is that the same dose, holding all other IREP inputs constant, produces a higher PoC for males compared to females. However, gender differences in baseline rates are already taken into account in IREP calculations. This is a challenge of the PoC portion of the dose reconstruction methodology and cannot be addressed by the FAB per

20 C.F.R. § 30.318(b).

The last objection concerns the accuracy of the dose reconstruction, since the employee began work before exposure records were kept. The basic principle of dose reconstruction is to characterize the occupational radiation environment to which a worker was exposed using available worker and/or workplace monitoring information. In cases where radiation exposures in the workplace environment cannot be fully characterized based on available data, default values based on reasonable scientific assumptions are used as substitutes. The approaches for determining the employee’s external and internal dose are discussed in detail in his dose reconstruction report and are summarized below.

Dosimetry records from the Savannah River Site were used as a starting point in determining the employee’s external dose, including the addition of missed dose (when zeros were reported in his dosimetry records). Maximizing dose conversion factors were used to convert potential whole body exposure dose to the brain.

The employee participated in the bioassay program, but all of his measurements showed activities less than the level of detection used in the program. Based on certain bioassay results, internal doses were calculated for tritium.

On-site ambient doses and doses received from diagnostic medical X-ray procedures that were required as a condition of employment were also included in the overall estimate of the dose to the breast.

For the purposes of the dose reconstruction, NIOSH assigned the employee the highest reasonably possible radiation dose related to radiation exposure and intake using available dosimetry data, when available, and worst-case assumptions in the absence of documented exposures. The NIOSH approach is based on current science, documented experience and relevant data. A part of the approach does include checks of dosimetry results against work place exposure indicators. This is a challenge of the dose reconstruction methodology and cannot be addressed by the FAB per 20 C.F.R. § 30.318(b).

Your concerns about other “harmful elements” the employee may have been exposed to is a challenge of a fact, in this case the EEOICPA Part B requirement of exposure to beryllium or ionizing radiation related to nuclear weapons production.

FINDINGS OF FACT

1. You filed a Form EE-2, Claim for Survivor Benefits under the EEOICPA, on January 8, 2002.
2. The Department of Energy verified the employment at the SRS as August 20, 1951 to December 31, 1984.
3. The employee was diagnosed with breast cancer on September 10, 1985.
4. In proof of survivorship, you submitted copies of your marriage certificate to the employee and the employee’s death certificate. Therefore, you have established that you are a survivor as defined by the implementing regulations. 20 C.F.R. § 30.5(ee).
5. Based on the dose reconstruction performed by NIOSH, the district office calculated the probability of causation (the likelihood that the cancer was caused by radiation exposure incurred while working at a covered facility) for breast cancer. The district office calculated a probability of causation of 36% and determined that this condition was not “at least as likely as not” (a 50% or greater probability) related to employment at the covered facility. The Final Adjudication Branch confirmed this probability of causation calculation.
6. On December 17, 2004, the Denver district office issued a recommended decision concluding that the employee’s breast cancer is not covered under Part B of the Act, and that you are not entitled to compensation.
7. A hearing was held on March 31, 2005. Your objections were reviewed and determined to be challenges to the dose reconstruction methodology or a challenge of fact concerning the coverage of the law.

CONCLUSIONS OF LAW

The undersigned has reviewed the facts, the recommended decision issued by the Denver district office on December 17, 2004, and the information received before and during the hearing. The evidence in the record does not establish that you are entitled to compensation under Part B of the Act because the calculation of “probability of causation” does not show that there is a 50% or greater likelihood that the employee’s cancer was caused by radiation exposure received at the

Savannah River Site in the performance of duty. Therefore, I find that the decision of the district office is supported by the evidence and the law, and cannot be changed based on the objections you submitted.

Since the evidence does not establish that the employee’s breast cancer was at least as likely as not related to employment at a covered facility, you are not entitled to benefits under Part B of the Act, and the claim for compensation is denied. 42 U.S.C. § 7384s(e).

Jacksonville, FL

Sidne M. Valdivieso

Hearing Representative