Billing Code:[HHS INSERT]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 83

RIN:[HHS INSERT]

Procedures for Designating Classes of Employees as Members

of the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000; Final Rule

AGENCY: Department of Health and Human Services

ACTION: Final Rule

SUMMARY: This document describes how the Department of Health and Human Services (“HHS”) will consider designating classes of employees to be added to the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000 (“EEOICPA”). Under EEOICPA, and Executive Order 13179, the Secretary of HHS is authorized to make such designations, which take effect 180 days after Congress is notified unless Congress provides otherwise. An individual member (or the eligible survivors of a member) of a class of employees added to the Special Exposure Cohort would be entitled to compensation if the Department of Labor (“DOL”) finds that employee incurred a specified cancer and the claim meets other requirements established under EEOICPA.

DATES: Effective Date: This final rule is effective [INSERT DATE OF PUBLICATION IN THE FEDERAL REGISTER].

Compliance Date: Affected parties are required to comply with the information collection requirements in §82.9 effective [INSERT DATE OF PUBLICATION IN THE FEDERAL REGISTER]

FOR FURTHER INFORMATION CONTACT: Larry Elliott, Director, Office of Compensation Analysis and Support, National Institute for Occupational Safety and Health, 4676 Columbia Parkway, MS-C-46, Cincinnati, OH 45226, Telephone 513-533-6800 (this is not a toll-free number). Information requests can also be submitted by e-mail to OCAS@CDC.GOV

SUPPLEMENTARY INFORMATION:

I. Background

A. Statutory Authority

The Energy Employees Occupational Illness Compensation Program Act (EEOICPA), 42 U.S.C. §§ 7384-7385, established a compensation program to provide a lump sum payment of $150,000 and prospective medical benefits as compensation to covered employees suffering from designated illnesses incurred as a result of their exposure to radiation, beryllium, or silica while in the performance of duty for the Department of Energy (“DOE”) and certain of its vendors, contractors and subcontractors. This legislation also provided for payment of compensation for certain survivors of these covered employees.

EEOICPA instructed the President to designate one or more Federal Agencies to carry out the compensation program. Pursuant to this statutory provision, on December 7, 2000, the President issued Executive Order 13179 (“Providing Compensation to America’s Nuclear Weapons Workers”), which assigned primary responsibility for administering the compensation program to the Department of Labor (“DOL”). 65 FR 77487 (December 11, 2000). DOL published a final rule governing DOL’s administration of EEOICPA on December 26, 2002 (67 FR 78874).

Executive Order 13179 directed HHS to perform several technical and policymaking roles in support of the DOL program:

(1) HHS was to develop procedures for considering petitions by classes of employees at DOE and Atomic Weapons Employer (“AWE”) facilities to be added to the Special Exposure Cohort established under EEOICPA. These procedures are the subject of this rule. HHS is also to apply these procedures in response to such petitions. Covered employees included in the Special Exposure Cohort who have a specified cancer, and eligible survivors of these employees, qualify for compensation under EEOICPA.

(2) HHS was to develop guidelines, by regulation, to be used by DOL to assess the likelihood that an employee with cancer developed that cancer as a result of exposure to radiation in performing his or her duty at a DOE facility or AWE facility. HHS published a final rule establishing these “Probability of Causation” guidelines on May 2, 2002 (67 FR 22296) under 42 CFR Part 81.

(3) HHS was also to develop methods, by regulation, to estimate radiation doses (“dose reconstruction”) for certain individuals with cancer applying for benefits under the DOL program. HHS published a final rule promulgating these methods under 42 CFR Part 82 on May 2, 2002 (67 FR 22314). HHS is applying these methods to conduct the program of dose reconstruction required by EEOICPA.

(4) Finally, HHS is to provide the Advisory Board on Radiation and Worker Health (“the Board”) with administrative and other necessary support services. The Board, a federal advisory committee whose members are appointed by the President, is advising HHS in implementing its roles under EEOICPA described here.

42 U.S.C. § 7384p requires HHS to implement its responsibilities with the assistance of the National Institute for Occupational Safety and Health (NIOSH), an Institute of the Centers for Disease Control and Prevention, HHS.

B. What is the Special Exposure Cohort?

The Special Exposure Cohort (“the Cohort”) is a category of employees defined under 42 U.S.C. § 7384l(14). In this definition, Congress specified classes of employees to comprise the Cohort initially, including DOE employees, DOE contractor or subcontractor employees, who were (1) employed an aggregate of at least 250 work days before February 1, 1992 at a gaseous diffusion plant in Paducah, Kentucky, Portsmouth, Ohio, or Oak Ridge, Tennessee, and who were monitored using dosimetry badges or worked in a job that had exposures comparable to a job that is or was monitored using dosimetry badges; or (2) employees of DOE or DOE contractors or subcontractors employed before January 1, 1974 on Amchitka Island, Alaska and exposed to ionizing radiation in the performance of duty related to the Long Shot, Milrow, or Cannikin underground nuclear tests. As provided in 42 U.S.C. § 7384l(9)(A), employees included in the Cohort who incur a specified cancer^[1] qualify for compensation (see DOL regulations 20 CFR Part 30 for details). Cancer claims submitted by these employees or their survivors do not require DOL to evaluate the probability that the cancer was caused by radiation doses incurred during the performance of duty for nuclear weapons programs of DOE, as is required for other cancer claims covered by EEOICPA.

C. Purpose of the Rule

EEOICPA authorized the President to designate additional classes of employees to be included in the Cohort, while providing Congress with the opportunity to review these decisions and expedite or reverse them. As noted previously, the President has delegated his authority in this matter to the Secretary of HHS. The purpose of this rule is to establish procedures by which the Secretary of HHS will determine whether to add to the Cohort new classes of employees from DOE and AWE facilities. The procedures are intended to ensure that petitions for additions to the Cohort are given uniform, fair, scientific consideration, that petitioners and interested parties are provided the opportunity for appropriate involvement in the process, and to comply with specific statutory requirements of EEOICPA. The procedures also address, within their relevant scope, the stated congressional purpose of the compensation program to provide timely compensation to covered employees or their survivors for covered illnesses incurred by such employees in the performance of duty.

D. Statutory Requirements for Designating Classes of Employees as Members of the Cohort

EEOICPA includes several requirements for these procedures. The Board is authorized to provide advice to the President (delegated by Executive Order 13179 to the Secretary of HHS) concerning the designation of additional classes as members of the Cohort. The Board’s advice is to be based on “exposure assessments by radiation health professionals, information provided by the Department of Energy, and such other information as the Advisory Board considers appropriate.” 42 U.S.C. § 7384q. Section 7384q specifies that HHS obtain the advice of the Board “after consideration of petitions by classes of employees . . . for such advice.” This section also mandates two broad criteria to govern HHS decisions, which are to be made after receiving the advice of the Board. Members of a class of employees at a DOE facility or AWE facility may be treated as members of the Cohort for purposes of the compensation program if HHS “determines that: (1) it is not feasible to estimate with sufficient accuracy the radiation dose that the class received; and (2) there is a reasonable likelihood that such radiation dose may have endangered the health of members of the class.” Finally, 42 U.S.C. § 7384l(14)(C) requires the Secretary to submit a report to Congress for each class of employees the Secretary designates to be added to the Cohort. The report must define the class of employees covered by the designation and specify the criteria used to make the designation. This section requires that the designation take effect 180 days after the date on which HHS submits the report to Congress “unless Congress otherwise provides.”

E. Relationship of Procedures to an Existing Rule Promulgated by HHS to implement EEOICPA

These procedures complement the HHS final rule: “Methods for Radiation Dose Reconstruction Under the Energy Employees Occupational Illness Compensation Program Act of 2000" promulgated by HHS on May 2, 2002 at 42 CFR Part 82 (67 FR 22314).

42 CFR Part 82 provides the methods by which NIOSH is conducting dose reconstructions to estimate the radiation doses incurred by individual covered employees who have incurred cancer. These estimates are required by EEOICPA for DOL to adjudicate a cancer claim for an employee who is not a member of the Cohort or whose claim is not covered by provisions of EEOICPA for compensating members of the Cohort. The methods to arrive at these estimates, however, will be directly considered by HHS in reviewing petitions to add classes of employees to the Cohort. In particular, HHS will consider these methods in determining for a petitioning class of employees, as required by EEOICPA, whether “it is not feasible to estimate with sufficient accuracy the radiation dose that the class received.”

II. Summary of Public Comments

HHS published a first notice of proposed rulemaking (“NPRM”) specifying procedures for adding classes of employees to the Cohort on June 25, 2002 (67 FR 42962). Public comments on this first NPRM led HHS to make substantial changes in the proposal, which resulted in the publication of a second NPRM on March 7, 2003 (42 CFR Part 83; see 68 FR 11294). HHS solicited public comments on this second NPRM from March 7, 2003 to May 6, 2003.^[2] During this period, comments were also submitted by the Board.

HHS received comments on the second NPRM from 11 organizations and 19 individuals, including 14 Members of Congress. Organizations commenting included six national or local labor organizations representing DOE workers, the Health Physics Society, and four advocacy groups. A summary of these comments and HHS responses is provided below. These are organized by general topical area. The HHS responses in this section also serve to explain changes made to the proposed rule and to supplement explanations from both NPRMs concerning the intent of the final rule.

A. Feasibility of Dose Reconstructions: Timeliness, Cost, and Availability of Records

As discussed above, EEOICPA requires HHS to find that it is “not feasible to estimate with sufficient accuracy the radiation dose that the class received” as a condition for adding the class to the Cohort. The NPRM proposed the criterion that this condition would be met if NIOSH were not able to establish “that it has access to sufficient information to estimate the maximum radiation dose that could have been incurred in plausible circumstances by any member of the class.” 42 CFR Part 83.13(c)(1).

HHS received comments from several labor organizations, an advocacy group, and Members of Congress recommending that the rule establish additional criteria defining when dose reconstructions would not be feasible. Some commenters recommended distinguishing this requirement as separate and apart from the requirement for “sufficient accuracy.” The most common recommendation was for HHS to establish a time limit for completing dose reconstructions, after which the dose reconstruction would be determined to be not feasible. Commenters recommended time limits ranging from 180 days to 24 months.

HHS does not agree that a regulatory time limit on dose reconstructions would be appropriate in this rule, which establishes procedures for determining whether to add a class of employees to the Cohort. Some of the factors that could protract a dose reconstruction, such as a poorly defined employment history or work history, would be specific to the case of an individual employee, and would not be germane to a class of employees.

HHS does not believe a time limit on the duration of a dose reconstruction to be an appropriate addition to the dose reconstruction rule, either. Such a limit would eliminate the flexibility to address special circumstances and could effectively nullify the statutory requirements for dose reconstruction and the determination of probability of causation in their entirety by deeming all DOE and AWE employees to be members of classes of employees for whom dose reconstruction is not feasible.

In addition, a regulatory time limit could delay compensation for claimants whose dose reconstructions might exceed a regulatory deadline but would still be completed prior to the time at which a class of employees could be added to the Cohort. As this rule describes, Congress has 180 days to review any HHS decision to add a class to the Cohort, before such a decision could become effective.

One of the most important factors presently affecting the timeliness of dose reconstructions is the current backlog of dose reconstructions, which is a result of the extensive development requirements of the dose reconstruction program. NIOSH began receiving cases requiring dose reconstructions in October of 2001, long before the dose reconstruction program could establish even minimal capacity for completing dose reconstructions. HHS completed final rules establishing the methods of dose reconstruction in May of 2002. NIOSH awarded a contract to build external capacity for conducting dose reconstructions in September of 2002.

NIOSH and its contractor for dose reconstructions are now employing more than 300 staff (including more than 100 health physicists) and are working to complete tasks necessary to eliminate the backlog. These tasks include the completion of “site profiles,” which summarize site-specific exposure conditions, dosimetry, and other relevant information. In parallel with this necessary developmental work, NIOSH is completing dose reconstructions at an increasing pace for cases involving sites for which NIOSH has already issued site profiles and for which site profiles are not needed. It took NIOSH 26 months to complete the first 1000 dose reconstructions. NIOSH completed the second 1000 in 14 weeks. This rate is continuing to improve.

An advocacy group and some Members of Congress also recommended HHS consider the cost of dose reconstructions as a criterion for feasibility, to avoid incurring “prohibitive expense” in conducting a dose reconstruction.

HHS has not included a cost criterion in the rule. The NIOSH dose reconstruction program is designed with procedures specifically intended to minimize the time and financial resources required for dose reconstructions. Individual dose reconstructions are presently costing an average of less than $10,000 each. A regulatory cost criterion would require HHS to incur unproductive expenses and might delay the consideration of petitions substantially, since HHS would have to estimate dose reconstruction costs related to each Cohort petition.

Some Members of Congress also recommended that HHS consider the deficiency or complete absence of records as a criterion for feasibility.

HHS included such provisions in the NPRM and in the final rule, as discussed in the following section discussing comments on “sufficient accuracy.” NIOSH internal procedures for evaluating petitions, available upon request from NIOSH (1-800-356-4674) or from the NIOSH Web page (www.cdc.gov\niosh\ocas), provide step-by-step practical information on how NIOSH will evaluate the availability of information needed to estimate the radiation doses of a class of employees with sufficient accuracy. These recommended procedures do not create any substantive rights on the behalf of petitioners.  Comments may be provided at any time about these procedures to OCAS at ocas@cdc.gov.  Any subsequent revision of the procedures will be posted on the NIOSH web site at www.cdc.gov/niosh/ocas. If there are any substantial revisions to these procedures, NIOSH will publish a Federal Register Notice including an indication that there have been substantial revisions, a paragraph summarizing the changes, and that the revised procedures can be found on the NIOSH web site at www.cdc.gov/niosh/ocas. Comments regarding these internal procedures or any revisions thereto are invited.

In addition, HHS has added a provision to section 83.13(c)(1)(i) of the rule, as part of the feasibility determination by NIOSH under this section, to require that NIOSH determine whether it has information regarding monitoring, source, source term, or process information from the site where the employees worked to serve as the basis for a dose reconstruction. EEOICPA requires that determinations of probability of causation for claimants under EEOICPA be based on the radiation dose received by the employee (or a group of employees performing similar work) at the facility where the employee(s) worked. 42 U.S.C. § 7384n(c)(3)(A). Consequently, for NIOSH to determine that dose reconstruction is feasible, dose reconstruction must, as a starting point, be based on some information from the site where the employee worked. This basis requirement does not limit NIOSH to using only or primarily information from the site where the employee worked, but it requires the use of some information from the site.

HHS has also added a new subsection 83.13(b) which authorizes the Director of the Office of Compensation Analysis and Support (OCAS) within NIOSH to determine that records and/or information requested from DOE, an AWE, or another source to evaluate a petition is not, or will not be, available on a timely basis. Such a determination will be treated, for the purposes of the petition evaluation, as equivalent to a finding that the records and/or information requested are not available. This will facilitate the efforts of NIOSH to evaluate petitions within a reasonable amount of time in relation to the records and/or information required to evaluate the petition and any other relevant factors.

Some Members of Congress also recommended that the rule clarify that EEOICPA does not require a demonstration that no “worst case estimate” can be reached for inclusion in the Cohort.

HHS has clearly and completely specified the statutory requirements of EEOICPA relating to the addition of classes of employees to the Cohort, under section I(D) above. The rule itself provides procedures by which HHS will implement these statutory requirements. Related specifically to the comment, to add a class of employees to the Cohort, EEOICPA requires that HHS find that “it is not feasible to estimate with sufficient accuracy the radiation dose that the class received;…” 42 U.S.C. §7384q(b). Subsection 83.13(c)(1) of this rule specifies clearly the approach HHS will use to evaluate feasibility. This approach, as it relates to the statutory requirement regarding feasibility, is discussed above, in sections B and C below, and was discussed extensively in the second NPRM (see INSERT FR cite). The ability to estimate the maximum radiation dose received by members of a class is technically a critical distinction between circumstances in which it is feasible to estimate radiation doses through dose reconstruction and those in which it is not feasible to do so.

B. Feasibility of Dose Reconstructions: Relevance of Type of Cancer to Feasibility Determinations

The NPRM included provisions that would have allowed NIOSH to define a class of employees that it would recommend be added to the Cohort according to the specific cancers for which dose reconstruction is not feasible and hence demonstrate a reasonable likelihood of a dose that may have endangered the health of members of the class. Several commenters questioned the scientific proposition that it could be feasible to estimate radiation doses for individuals with certain cancers, but not feasible to estimate doses for individuals with other cancers. The statutory provisions of EEOICPA neither require nor prohibit HHS from establishing cancer-specific classes.

The Board, which specifically reviewed this issue, recognized that this situation “may be scientifically and theoretically possible.” Two theoretical examples of this situation, involving external radiation exposures (originating from outside of the body), were identified and considered during meetings of the Board and were not contested by members of the Board (See Transcript of the Advisory Board on Radiation and Worker Health, March 7, 2003, page 17; Transcript of the Advisory Board on Radiation and Worker Health, March 28, 2003, pages 46-48).

On the other hand, some members of the Board did contest the proposition that it could be feasible to estimate radiation doses from internal exposures (originating from radioactive materials that are taken into the body) for certain cancer sites and not others. This discussion clarified that all tissues and organs could be irradiated to some degree in cases involving internal exposures (See Transcript of the Advisory Board on Radiation and Worker Health, March 7, pages 36-37; Transcript of the Advisory Board on Radiation and Worker Health, March 31, 2003, pages 42-66). As a result, a scientific finding concerning the feasibility of estimating doses in cases involving internal exposures would have to apply to all cancers. This reduces the practical applicability of a policy for establishing cancer-specific classes on the basis of the feasibility of dose reconstruction, since additions to the Cohort are likely to involve internal radiation exposures.

A second scientific issue related to the issue of adding cancer-specific classes to the Cohort but not related to the HHS proposal, is whether or not certain cancers should be excluded from a class because the radiation exposure of concern is unlikely to have caused those cancers. The Health Physics Society advocated such a policy, providing an example of situations in which one might reasonably conclude the probability of causation would be very low for certain cancers. An advocacy group and several labor organizations recommended against such a policy. HHS did not propose and has not established such a policy, which relates to health endangerment rather than the feasibility of dose reconstruction.

The most prevalent comment HHS received on this rule did not concern the scientific justification for establishing cancer-specific classes, but argued that such a policy conflicted with EEOICPA and with congressional intent. These commenters included the 14 Members of Congress, advocacy groups, and labor organizations. Although the courts generally give little weight to statements by individual legislators when determining congressional intent, many of these commenters referenced an October 12, 2000 statement by Senator Jeff Bingaman to the full Senate. In this statement, Senator Bingaman said that groups of workers added to the Cohort “would be eligible for compensation for a fixed list of radiation related cancers,” meaning the list of 22 “specified cancers” established under EEOICPA and listed in section 83.5(m) of this rule. S10377, Congressional Record, October 12, 2000.

Many commenters also expressed the view that it would be unfair and contrary to EEOICPA for HHS to exclude from classes of employees to be added to the Cohort employees who incur certain specified cancers, since all specified cancers are compensable for members of the classes included in the Cohort by statute. The relevant portion of the statutory provision of EEOICPA reads as follows: “The term ‘covered employee with cancer’ means any of the following: [a]n individual with a specified cancer who is a member of the Special Exposure Cohort, ...” 42 U.S.C. § 7384l(9)(A).

In addition, while the Board indicated that it might be scientifically and theoretically possible for the situations addressed by the NPRM to exist, the Board recommended against the establishment of cancer-specific classes, as discussed below, stating that it was concerned about “providing some level of equity between the definition of new SEC classes and those already defined in the legislation.”

The provisions of EEOICPA that directly govern which classes of employees can be added to the Cohort are the feasibility and health endangerment provisions addressed under the “statutory requirements” section above. These provisions can be interpreted in different ways to either support or oppose the establishment of cancer-specific classes. They neither require nor prohibit HHS from establishing cancer-specific classes.

As discussed above, in support of cancer-specific classes, HHS has identified possible situations in which the feasibility of estimating doses would differ by type of cancer. In addition, the Health Physics Society and a member of the Board identified possible situations in which a determination of health endangerment might differ by type of cancer.

In opposition to including provisions for cancer-specific classes, one could interpret “it is not feasible to estimate with sufficient accuracy the radiation dose that the class received” to mean: it is not feasible to estimate with sufficient accuracy the radiation dose to any cancer site rather than the dose relevant to the cancer incurred by any particular employee. Similarly, health endangerment could be interpreted to mean an employee having been put at risk of certain types of cancers, regardless of whether the employee actually incurred one of the cancers for which the employee was at risk. Such interpretations would allow one to define a class without qualification, even when it would be feasible to estimate radiation doses for employees with all but one type of cancer, and even if most types of cancers were unlikely to have been caused by the radiation exposure of concern.

In light of the ambiguity of the statute, the limited practical applications of the option to establish cancer-specific classes, the nearly unanimous public opposition, and the opposition of the Board, HHS has omitted from the final rule the provisions in the NPRM that would have allowed the addition to the Cohort by HHS of cancer-specific classes of employees. Furthermore, HHS has revised section 83.13(c)(1) of the rule to state explicitly that NIOSH will make determinations of feasibility based on whether or not NIOSH is able to reconstruct doses for every type of cancer for which radiation doses are reconstructed.

The practical consequence of these changes is that HHS might designate classes of employees to be added to the Cohort under this rule despite the possibility that it might be feasible to estimate radiation doses with sufficient accuracy for some members of the class; specifically, that it might be feasible to estimate radiation doses with sufficient accuracy for a member of the class who incurs one of a subset cancer types for which there might be adequate dose-related information, as discussed above.

C. Accuracy of Dose Reconstructions

HHS received various comments and recommendations that relate to the determination as to whether it is feasible to estimate doses to members of a class of employees with sufficient accuracy.

The most frequent of these comments requested HHS provide additional detail, either in the rule or in guidelines, to define how NIOSH would establish, under section 83.13(c)(1), “that it has access to sufficient information to estimate the maximum radiation dose that could have been incurred in plausible circumstances by any member of the class...” HHS was asked to provide the methods by which maximum radiation doses would be estimated, and to define “sufficient information.” The Board also requested that NIOSH issue guidelines to provide additional clarification concerning sufficient accuracy, after promulgation of this final rule.

As discussed above, NIOSH is issuing internal procedures concurrently with the promulgation of this rule that provide more detailed procedures for how it will evaluate petitions. While these procedures do not establish any substantive rights, they specify how NIOSH will identify available information and the general methods for determining whether such information will be sufficient to estimate maximum radiation doses for employees in the class, when such estimates are necessary. The internal procedures supplement the guidelines already provided in this final rule under section 83.13(c)(1). The internal procedures also provide limited generic information on how maximum radiation doses can be estimated when necessary. More specific detail outlining how available information would be used to conduct dose reconstructions would be provided within each NIOSH evaluation of a petition that finds that it is feasible to estimate radiation doses with sufficient accuracy for the class.

One individual commented that the rule puts excessive emphasis on estimating the maximum possible doses of radiation.

This emphasis was unintended. The proposed rule defined only the limits of dose reconstruction. The public should realize, however, that HHS may receive petitions for classes of employees for whom there is sufficient information to conduct dose reconstructions that provide more precise estimates than maximum doses, using personal or area monitoring records. For these petitions, methods for estimating maximum radiation doses would not be addressed in the NIOSH evaluation because they would not be relevant, since more precise dose reconstructions would be feasible. HHS has clarified the rule on this point, adding the following provision (identified below in italics) to section 83.13(c)(1):

“Radiation doses can be estimated with sufficient accuracy if NIOSH has established that it has access to sufficient information to estimate the maximum radiation dose, for every type of cancer for which radiation doses are reconstructed, that could have been incurred in plausible circumstances by any member of the class, or if NIOSH has established that it has access to sufficient information to estimate the radiation doses of members of the class more precisely than an estimate of the maximum radiation dose.”

HHS has also supplemented the guidelines previously included in the rule regarding the feasibility of estimating the radiation dose of a class of employees with sufficient accuracy. A new section 83.13(c)(1)(iii) specifies the following additional guidelines:

“In many circumstances, to establish a positive finding under paragraph (b)(1)(i) of this section would also require information describing the process through which the radiation exposures of concern may have occurred and the physical environment in which the exposures may have occurred.”

One labor organization interpreted the NPRM as indicating that NIOSH would use analytic models, presumably to estimate maximum doses when necessary, at the expense of the timely completion of dose reconstructions.

The use of analytic models in such instances is efficient, not delaying. Dose reconstructions that rely more extensively on analytic exposure models can be completed far more quickly than dose reconstructions that require the collection and evaluation of extensive monitoring data, which may still involve the use of analytic exposure models as well.

An individual commented that this rule should define how NIOSH determines the reliability of dosimetry information for use

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in dose reconstructions. The commenter correctly noted that the accuracy of dosimetry results is affected by a variety of factors, some of which the commenter enumerated. The commenter also asserted that it was a “fatal flaw” of the NPRM to assume that maximum doses can be estimated 30 to 50 years after the fact.

The HHS dose reconstruction rule (42 CFR Part 82) and related dose reconstruction guidelines specify how doses are reconstructed and explain how NIOSH takes into account various factors that affect the interpretation of dosimetry information, particularly the limitations of dosimetry programs from the early decades of nuclear weapons production. The types of studies the commenter cited, that have evaluated the shortcomings of dosimetry programs, are used by NIOSH to interpret the records of such dosimetry programs.

The NPRM and this final rule, however, do not reflect an assumption that it will be feasible to estimate maximum doses or to more precisely estimate doses. The determination by NIOSH, the Board, and the Secretary of HHS as to whether dose reconstruction is feasible for a particular class of employees is a central element of this rule.

Related to this latter point, an advocacy group and a labor organization questioned whether petitioning is “futile” under the provisions of this rule concerning feasibility, because, in the view of the commenters, NIOSH “raised the bar” for evaluating whether doses can be estimated with sufficient accuracy from the first NPRM to the second NPRM, from when a dose reconstruction cannot be completed to when maximum doses (nor more precise doses) cannot be estimated.

The provisions of the second NPRM discussed in the comment are no more exclusive than those of the first NPRM, only more specific. The specificity was requested by the Board and sought by other public commenters as well.

There is, however, a substantial difference between the minimal requirements for submitting a petition, when such a petition is not based on NIOSH having already found that a claimant’s dose reconstruction cannot be completed, and the requirements for adding a class of employees to the Cohort. Such petitions provide NIOSH with basic information necessary to begin the determination process but NIOSH is likely to have more extensive access to information for dose reconstructions than petitioners. NIOSH will consider all information as necessary, not only information provided by the petitioner, to determine whether or not the radiation doses of the class of employees can be estimated with sufficient accuracy.

One labor organization commented that NIOSH had failed to address limitations of the NPRM. In explanation, the commenter asserted that the estimation of maximum doses would not be sufficient to estimate lifetime exposure and would not be valid in circumstances involving a mixture of radionuclides.

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If NIOSH can estimate the maximum quantity of a radionuclide that could have been inhaled, ingested, or absorbed by an employee, then the maximum doses resulting from such internal exposure can be estimated for the entire period between exposure and the occurrence of cancer, as is necessary for NIOSH dose reconstructions.

With respect to mixtures of radionuclides, the critical issue is the extent of information about the mixture (e.g., quantities and identities). The involvement of multiple radionuclides is not inherently an obstacle to dose reconstruction. On the other hand, in situations involving exposure of a class of employees to a mixture of radionuclides of uncertain identity and quantity, NIOSH may not be able to estimate radiation doses and the class may be added to the Cohort, as provided for under this rule.

Two labor organizations questioned how NIOSH could estimate radiation doses for workers who move between buildings or facilities and who may not, themselves, have any knowledge of radiation sources.

If doses can be estimated for employees who worked steadily within a building or facility, then typically they could be estimated for employees who were in the building or facility episodically. A major difference in some such dose reconstructions, in cases in which the worker was not monitored at some or any of the locations, would be the need to allocate the worker’s time among various locations. It is relatively straightforward to do so, using assumptions that give the benefit of the doubt to the worker when information concerning the duration of the worker’s activities at different locations is insufficient.

An advocacy group, a labor organization, and some Members of Congress asserted that the provision of the NPRM requiring that NIOSH have sufficient information to be able to estimate maximum radiation doses, at a minimum, is incompatible with a provision of the dose reconstruction rule (42 CFR Part 82.10(k)(2)). Some of these commenters interpret the provision of the dose reconstruction rule as limiting the use of worst-case assumptions, which must be used in estimating maximum radiation doses, to non-compensable cancer claims (i.e., claims for which the probability of causation is below 50 percent). Furthermore, the commenters conclude that this perceived incompatibility could result in a situation in which NIOSH might find that it could not complete a dose reconstruction for a claimant and yet NIOSH could find, under this rule, that the claimants’ doses can be estimated, preventing HHS from adding a class of employees including the claimant to the Cohort. For this reason, the commenters recommended that HHS amend the dose reconstruction rule to be compatible with this rule.

The dose reconstruction rule (42 CFR Part 82) does not require any revision with respect to this concern. It is not possible for NIOSH to determine that it cannot complete a dose reconstruction for a claimant under the dose reconstruction rule and simultaneously find the same dose reconstruction to be feasible under this rule (42 CFR Part 83).

The dose reconstruction rule very specifically restricted the condition on the use of worst-case assumptions to the case when they are used as an efficiency measure to limit time-consuming and resource-consuming additional research and analysis. This narrow restriction is stated in the dose reconstruction rule as follows (emphasis added):

"At any point during steps of dose reconstruction described [above], NIOSH may determine that sufficient research and analysis has been conducted to complete the dose reconstruction. Research and analysis will be determined sufficient if one of the following three conditions is met: ...(2) Dose is determined using worst-case assumptions related to radiation exposure and intake, to substitute for further research and analysis; ...

...Worst-case assumptions will be employed under condition 2 to limit further research and analysis only for claims for which it is evident that further research and analysis will not produce a compensable level of radiation dose (a dose producing a probability of causation of 50% or greater), because using worst-case assumptions it can be determined that the employee could not have incurred a compensable level of radiation dose." 42 CFR Part 82.10(k)

In contrast, this Cohort rule implies the use of worst-case assumptions for dose reconstructions in essentially the opposite situation, to estimate maximum radiation doses in cases in which NIOSH lacks extensive information that could be used to conduct “further research and analysis,” rather than as an efficient substitute for such further research and analysis.

The dose reconstruction rule does not assert or imply any restriction in circumstances in which the total information available is limited. In fact, the rule generally anticipates such circumstances in describing the hierarchy of information that might be used in a dose reconstruction, depending on availability. In the introductory section of the rule, it describes the dose reconstruction practice of using assumptions to substitute for a lack of data:

“For dose reconstructions conducted in occupational illness compensation programs, this practice may include use of assumptions that represent worst-case conditions.” 42 CFR Part 82.2(a).

Furthermore, the Cohort rule provides that whenever NIOSH finds under the dose reconstruction rule that it cannot complete a dose reconstruction, this finding will suffice, without exception or further consideration, to support a determination that it is not feasible to estimate the radiation doses of individual members of the class with sufficient accuracy. This was implicit in section 83.14 of the NPRM but has been made explicit, to eliminate any uncertainty in interpretation, with the following inserted text (in italics):

“(b) NIOSH will determine the health endangerment criteria for adding the class under paragraph (a)(1) of this section to the Cohort, using the procedures outlined under §83.13. NIOSH will report to the Board the results of this determination, together with its finding under 42 CFR Part 82 that there was insufficient information to complete the dose reconstruction. HHS will consider this finding under 42 CFR Part 82 sufficient, without further consideration, to determine that it is not feasible to estimate the levels of radiation doses of individual members of the class with sufficient accuracy.”

Two labor organizations asserted, in contrast with the comments discussed immediately above, that the NPRM and the dose reconstruction rule (42 CFR Part 82) were inappropriately linked through their implicit use of common criteria for determining the feasibility of dose reconstructions. EEOICPA required HHS to establish, by regulation, methods for arriving at

“reasonable estimates” of radiation doses incurred by individuals (42 U.S.C. § 7384n(d)). As discussed above, EEOICPA requires HHS to determine that it is not “feasible” to estimate with “sufficient accuracy” the radiation dose that a class received, for HHS to add a class of employees to the Cohort (42 U.S.C. § 7384q(b)(1)). The commenters believe the use of different terms in these two sections of EEOICPA (reasonable estimates of doses versus doses that are not feasible to estimate with sufficient accuracy) signals different intentions of Congress for determining the feasibility of dose reconstruction as it arises through the dose reconstruction program versus through a petition for adding a class to the Cohort. Accordingly, the commenters recommend that HHS establish different criteria for these two situations.

The statutory provisions concerning the development of dose reconstruction methods (42 U.S.C. § 7384n(d)) are concerned with how dose reconstructions are to be done, not a determination as to whether or not they can be done. It is implicit, nonetheless, that these dose reconstructions must be “feasible to estimate with sufficient accuracy.” It appears to HHS that the use of this phrase under provisions for considering the addition of classes of employees to the Cohort, and the omission of this phrase under provisions concerning dose reconstruction, simply reflects the fact that these two separate provisions of EEOICPA address different but complementary circumstances.