Young v. U.S. Dep't of Health & Human Servs.

Decision Date06 August 2021
Docket NumberCivil Action 17-2428 (JDB)
PartiesSHANNON YOUNG and KEVIN YOUNG, Plaintiffs, v. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, Defendant.
CourtU.S. District Court — District of Columbia
MEMORANDUM OPINION

JOHN D. BATES, SENIOR UNITED STATES DISTRICT JUDGE

Plaintiffs Shannon and Kevin Young, sons of a former Department of Energy (“DOE”) contract employee who died of cancer, seek compensation for their father's death under the Energy Employees Occupational Illness Compensation Program Act (“EEOICPA”). The Department of Labor (“DOL”) denied their claim for compensation after determining that there was a less-than-even chance that their father's prostate cancer was caused by radiation exposure during his DOE employment. Plaintiffs dispute that finding arguing that it was based on an incomplete “radiation dose reconstruction” prepared by the National Institute for Occupational Safety and Health (“NIOSH”), a component agency of the Department of Health and Human Services (“HHS”). This incomplete dose reconstruction, plaintiffs contend, was conducted under an HHS policy regarding the feasibility of dose estimates that is both contrary to the EEOICPA and arbitrary and capricious in violation of the Administrative Procedure Act (“APA”). Pending before the Court are the parties' cross-motions for summary judgment. For the reasons stated below, the Court will grant summary judgment to HHS and deny plaintiffs' cross-motion for summary judgment.

Background
I. Statutory and Regulatory Framework

Congress passed the EEOICPA in 2000 to ensure that former DOE employees and contractors who “performed duties uniquely related to the nuclear weapons production and testing programs” receive “efficient, uniform and adequate compensation for . . . radiation-related health conditions.” 42 U.S.C. § 7384(a)(8). Part B authorizes a payment of $150, 000 and medical benefits to surviving family members of employees who died from cancer related to radiation exposure from their work at covered DOE facilities. See id. §§ 73841(1)(B) 73841(9), 7384n(b), 7384s(a)(1). DOL has primary responsibility for administering the program and adjudicating claims for compensation. See Exec. Order No. 13, 179, 65 Fed. Reg. 77, 487, 77, 488 (Dec. 7, 2000); 20 C.F.R. § 30.1.

“There are two methods set forth in the statute for claimants to establish that a cancer incurred by a covered worker is compensable under EEOICPA.” 42 C.F.R. § 83.0. The first method is to establish that the employee's cancer was “at least as likely as not” related to employment at the covered facility (i.e., the probability of causation was at least fifty percent). 42 U.S.C. § 7384n(b); 20 C.F.R. §§ 30.210-13.[1] This begins with the “dose reconstruction” process, which involves estimating the amount of radiation to which an employee was exposed while working at a covered facility. 42 U.S.C. § 7384n(d). The second method is to establish that the employee contracted one of twenty-two specified types of cancer and is a member of the “Special Exposure Cohort” (“SEC”)-meaning the employee worked at particular covered facilities during specific periods of time. Id. §§ 73841(9)(A), (14), (17), 7384q; 20 C.F.R. § 30.5(gg).

A. Dose Reconstruction

The EEOICPA requires the President to designate a federal agency (other than DOE) to “establish by regulation methods for arriving at reasonable estimates of the radiation doses received by” employees at covered DOE facilities for whom radiation monitoring records are inadequate or incomplete. 42 U.S.C. § 7384n(d). Although DOL is responsible for ultimately adjudicating EEOICPA claims, the President designated HHS to administer the dose reconstruction process. See Exec. Order No. 13, 179, 65 Fed. Reg. at 77, 488 (ordering HHS Secretary to “promulgate regulations establishing . . . methods, pursuant to [§ 7384n(d)], for arriving at and providing reasonable estimates of the radiation doses received by individuals applying for assistance under this program for whom there are inadequate records of radiation exposure”). HHS subsequently promulgated regulations “provid[ing] methods for determining a reasonable estimate of the radiation dose received by a covered employee with cancer under EEOICPA, through the completion of a dose reconstruction, ” and the agency tasked NIOSH with making those estimates. 42 C.F.R. § 82.1. HHS interprets the term “reasonable estimates” to mean “estimates calculated using a substantial basis of fact and the application of science-based, logical assumptions to supplement or interpret the factual basis.” Methods for Radiation Dose Reconstruction Under the Energy Employees Occupational Illness Compensation Program Act of 2000; Final Rule, 67 Fed. Reg. 22, 314, 22, 317 (May 2, 2002).

“The basic principle of dose reconstruction is to characterize the radiation environments to which workers were exposed and to then place each worker in time and space within this exposure environment.” 42 C.F.R. § 82.2. Then, “methods are applied to translate exposure to radiation into quantified radiation doses at the specific organs or tissues relevant to the types of cancer occurring among the workers.” Id. NIOSH estimates both “internal” and “external” radiation doses. Id. § 82.5 (j)-(k). An “internal” radiation dose is radiation exposure “from radioactive materials taken into the body, ” id. § 82.5(k), whereas an “external” dose is exposure “from radiation sources outside of the body, ” id. § 82.5(j). To estimate doses, NIOSH uses a “hierarchy of methods” depending on the “data available to characterize the environment.” Id. § 82.2; see also id. § 82.14.

If individual worker monitoring data (i.e., bioassay data) is available, NIOSH gives that data the highest priority. Id. §§ 82.2(a), 82.14(b)-(c). But when individual monitoring is not available or adequate, NIOSH may use monitoring data from coworkers with “comparable activities and relationships to the radiation environment” to develop a coworker model. 42 C.F.R. §§ 82.2(b), 82.17(a). Alternatively, NIOSH may develop an exposure model from “a quantitative characterization of the radiation environment in which the covered employee worked, based on an analysis of historical workplace monitoring information” such as air sampling data. 42 C.F.R. § 82.17(b); see also id. §§ 82.2(b), 82.14(e).

The individual, coworker, or workplace monitoring data is “interpreted using additional data characterizing the workplace radiation exposures.” 42 C.F.R. § 82.2(a); see also Id. §§ 82.2(b), 82.14(f)-(g). To get this workplace characterization data, NIOSH “characterize[s] the internal and external exposure environments for parameters known to influence the dose.” 42 C.F.R. § 82.10(i). “For internal exposures, examples of these parameters include the mode of intake, the composition of the source term (i.e., the radionuclide type and quantity), the particle size distribution and the absorption type.” Id. “When it is not possible to characterize these parameters, NIOSH may use default values, when they can be established reasonably, fairly, and based on relevant science.” Id.

To determine “default” values for workplace exposure parameters, NIOSH uses a “maximum dose” approach. See Decl. of Timothy D. Taulbee (“Taulbee Decl.”) [ECF No. 37-1] ¶¶ 13, 15.[2] That is, [w]hen NIOSH cannot establish exposure conditions with sufficient specificity, the dose calculation will assume exposure conditions that maximize the dose to the organ under consideration.” 42 C.F.R. § 82.18(b). In other words, if NIOSH cannot precisely determine workplace exposure parameters, it uses “assumptions that represent the worst case conditions.” Id. § 82.2(a). For example, one parameter is the “solubility class” of the radioactive material, which “categorize[s] how fast the inhaled radioactive material transfers from the lungs into the remainder of the body and is subsequently excreted in urine and measured via bioassay.” Taulbee Decl. ¶ 15. In a case where “the solubility classification of an inhaled material can not be determined, the dose reconstruction would use the classification that results in the largest dose to the organ or tissue relevant to the cancer and that is possible given existing knowledge of the material and process.” 42 C.F.R. § 82.2(a).

In sum, when NIOSH lacks adequate information to establish workplace exposure parameters (such as solubility class), NIOSH will attempt to use scientifically defensible assumptions to develop a dose reconstruction model capable of providing the maximum dose that could have been incurred by the organ under consideration in plausible circumstances. NIOSH uses the maximum dose approach both because it is claimant-favorable and for efficiency reasons. See 67 Fed. Reg. at 22, 316, 22, 317; see also Taulbee Decl. ¶ 13. Since this approach “gives the benefit of the doubt to claimants, ” it “tend[s] to overestimate radiation doses for employees.” Id. at 22, 317.

If adequate individual, coworker, or workplace monitoring data is not available, NIOSH may-as a last resort-“rely substantially on process description information to analytically develop an exposure model.” 42 C.F.R § 82.2(c); see also id. § 82.14(h). Put differently, NIOSH may develop a “quantitative characterization of the radiation environment in which the employee worked, based on analysis of data describing processes involving radioactive materials, the source materials, occupational tasks and locations, and radiation safety practices.” 42 C.F.R. § 82.17(c). For internal exposures, an exposure model based on process description information includes factors such as “the quantity and composition of the radioactive substance (the source term), the chemical form, particle size distribution, the level of...

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