Thursday, 

May 2, 2002 

Part IV 

Department of 

Health and Human 

Services 

42 CFR Parts 81 and 82 

Guidelines for Determining the 

Probability of Causation and Methods for 

Radiation Dose Reconstruction Under the 

Employees Occupational Illness 

Compensation Program Act of 2000; Final 

Rules 

22296 Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 81 

RIN 0920–ZA01 

Guidelines for Determining the 

Probability of Causation 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 rule implements select 

provisions of the Energy Employees 

Occupational Illness Compensation 

Program Act of 2000 (‘‘EEOICPA’’ or 

‘‘Act’’). The Act requires the 

promulgation of guidelines, in the form 

of regulations, for determining whether 

an individual with cancer shall be 

found, ‘‘at least as likely as not,’’ to have 

sustained that cancer from exposure to 

ionizing radiation in the performance of 

duty for nuclear weapons production 

programs of the Department of Energy 

and its predecessor agencies. The 

guidelines will be applied by the U.S. 

Department of Labor, which is 

responsible for determining whether to 

award compensation to individuals 

seeking federal compensation under the 

Act. 

DATES: Effective Date: This final rule is 

effective May 2, 2002. 

FOR FURTHER INFORMATION CONTACT: 

Larry Elliott, Director, Office of 

Compensation Analysis and Support, 

National Institute for Occupational 

Safety and Health, 4676 Columbia 

Parkway, MS-R45, Cincinnati, OH 

45226, Telephone 513–841–4498 (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 of 

2000(‘‘EEOICPA’’), 42 U.S.C. 7384–7385 

[1994, supp. 2001], established a 

compensation program to provide a 

lump sum payment of $150,000 and 

medical benefits as compensation to 

covered employees suffering from 

designated illnesses (i.e. cancer 

resulting from radiation exposure, 

chronic beryllium disease, or silicosis) 

incurred as a result of their exposures 

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 

to certain survivors of covered 

employees. 

EEOICPA instructed the President to 

designate one or more federal agencies 

to carry out the compensation program. 

Pursuant to this statutory provision, the 

President issued Executive Order 13179 

titled 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 77,487 (Dec. 7, 2000). 

DOL published an interim final rule 

governing its administration of 

EEOICPA on May 25, 2001 (20 CFR 

Parts 1 and 30). 

The Executive Order directed the 

Department of Health and Human 

Services (‘‘HHS’’) to perform several 

technical and policymaking roles in 

support of the DOL program: 

(1) HHS is to develop guidelines 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 duties 

at a DOE facility or Atomic Weapons 

Employer (‘‘AWE’’) facility. These 

‘‘Probability of Causation’’ guidelines 

are the subject of this final rule, and 

were initially proposed for public 

comment in a notice of proposed 

rulemaking published on October 5, 

2001. 

(2) HHS is also to establish methods 

to estimate radiation doses (‘‘dose 

reconstruction’’) for certain individuals 

with cancer applying for benefits under 

the DOL program, and HHS is to 

implement these methods in a program 

of dose reconstruction for EEOICPA 

claims. HHS published these methods 

as an interim final rule under 42 CFR 

part 82 on October 5, 2001, and is 

publishing them as a final rule 

simultaneously in this issue of the 

Federal Register. HHS is presently 

applying these methods to conduct the 

program of dose reconstruction required 

by EEOICPA. 

(3) HHS is to staff the Advisory Board 

on Radiation and Worker Health and 

provide it with administrative and other 

necessary support services. The Board, 

a federal advisory committee, was 

appointed by the President in November 

2001. It was first convened on January 

22, 2001, and is advising HHS in 

implementing its roles under EEOICPA 

described here. 

(4) Finally, HHS is to develop and 

apply procedures for considering 

petitions by classes of employees at 

DOE or AWE facilities seeking to be 

added to the Special Exposure Cohort 

established under EEOICPA. Employees 

included in the Special Exposure Cohort 

who have a specified cancer and meet 

other conditions, as defined by 

EEOICPA and DOL regulations (20 CFR 

30), qualify for compensation under 

EEOICPA. HHS has developed proposed 

procedures for considering Special 

Exposure Cohort petitions which will be 

published soon in the Federal Register. 

HHS will obtain public comment and a 

review by the Advisory Board on 

Radiation and Worker Health before 

these procedures are made final and 

implemented. 

As provided for under 42 U.S.C. 

7384p, HHS is implementing 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. Purpose of Probability of Causation 

Guidelines 

Under EEOICPA, a covered employee 

seeking compensation for cancer, other 

than as a member of the Special 

Exposure Cohort seeking compensation 

for a specified cancer, is eligible for 

compensation only if DOL determines 

that the cancer was ‘‘at least as likely as 

not’’ (a 50% or greater probability) 

caused by radiation doses incurred in 

the performance of duty while working 

for DOE and/or an atomic weapons 

employer (AWE) facility. These 

guidelines provide DOL with the 

procedure to make these 

determinations, and specify the 

information DOL will use. 

HHS notes that EEOICPA does not 

authorize the establishment of new 

radiation protection standards through 

the promulgation of these guidelines, 

and these guidelines do not constitute 

such new standards. 

C. Statutory Requirements for 

Probability of Causation Guidelines 

EEOICPA has several general 

requirements concerning the 

development of these guidelines. It 

requires the guidelines provide for 

determinations that are based on the 

radiation dose received by the 

employee, incorporating the methods of 

dose reconstruction to be established by 

HHS. It requires determinations be 

based on the upper 99 percent 

confidence interval of the probability of 

causation in the radioepidemiological 

tables published under section 7(b) of 

the Orphan Drug Act (42 U.S.C. 241 

note), as such tables may be updated. 

EEOICPA also requires HHS to consider 

the type of cancer, past health-related 

activities, the risk of developing a 

radiation-related cancer from workplace 

exposure, and other relevant factors. 42 

U.S.C. 7384n(c). It is also important to 

Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 22297 

note EEOICPA does not include a 

requirement limiting the types of 

cancers to be considered radiogenic for 

these guidelines. 

D. Understanding Probability of 

Causation 

Probability of Causation is a technical 

term generally meaning an estimate of 

the percentage of cases of illness caused 

by a health hazard among a group of 

persons exposed to the hazard. This 

estimate is used in compensation 

programs as an estimate of the 

probability or likelihood that the illness 

of an individual member of that group 

was caused by exposure to the health 

hazard. Other terms for this concept 

include ‘‘assigned share’’ and 

‘‘attributable risk percent’. 

In this rule, the potential hazard is 

ionizing radiation to which U.S. nuclear 

weapons workers were exposed in the 

performance of duty; the illnesses are 

specific types of cancer. The probability 

of causation (PC) 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 (BasRisk) plus the 

risk attributable to the radiation 

exposure, then multiplied by 100 

percent, as follows: 

RadRisk 

×100% = PC 

RadRisk + BasRisk 

This calculation provides a percentage 

estimate between 0 and 100 percent, 

where 0 would mean 0 likelihood that 

radiation caused the cancer and 100 

would mean 100 percent certainty that 

radiation caused the cancer. 

Scientists evaluate the likelihood that 

radiation caused 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. Simply explained, 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. 

If scientists consider this research 

sufficient and of reasonable quality, 

they can then translate the findings into 

a series of mathematical equations that 

estimate how much the risk of cancer in 

a population would increase as the dose 

of radiation incurred by that population 

increases. The series of equations, 

known as a dose-response or 

quantitative risk assessment model, may 

also take into account other health 

factors potentially related to cancer risk, 

such as gender, smoking history, age at 

exposure (to radiation), and time since 

exposure. The risk models can then be 

applied as an imperfect but reasonable 

approach to determine the likelihood 

that the cancer of an individual worker 

was caused by his or her radiation dose. 

E. Development and Use of the 

RadioEpidemiological Tables and 

Interactive RadioEpidemiological 

Program 

In 1985, in response to a 

congressional mandate in the Orphan 

Drug Act, a panel established by the 

National Institutes of Health developed 

a set of Radioepidemiological Tables. 

The tables serve as a reference tool 

providing probability of causation 

estimates for individuals with cancer 

who were exposed to ionizing radiation. 

Use of the tables requires information 

about the person’s dose, gender, age at 

exposure, date of cancer diagnosis and 

other relevant factors. The tables are 

used by the Department of Veterans 

Affairs (DVA) to make compensation 

decisions for veterans with cancer who 

were exposed in the performance of 

duty to radiation from atomic weapon 

detonations. 

The primary source of data for the 

1985 tables is research on cancer-related 

deaths occurring among Japanese atomic 

bomb survivors from World War II. 

The 1985 tables are presently being 

updated by the National Cancer Institute 

(NCI) and the Centers for Disease 

Control and Prevention 1 to incorporate 

progress in research on the relationship 

between radiation and cancer risk. The 

draft update has been reviewed by the 

National Research Council 2 and by 

NIOSH. DOL will employ the updated 

version of the tables, with modifications 

important to claims under EEOICPA 

(described below under ‘‘G’’ and in 

response to public comments under 

‘‘II’’), as a basis for determining 

probability of causation for employees 

covered under EEOICPA. 

A major scientific change achieved by 

this update is the use of risk models 

developed from data on the occurrence 

of cancers (cases of illness) rather than 

the occurrence of cancer deaths among 

1 Draft Report of the NCI–CDC Working Group to 

Revise the 1985 NIH Radioepidemiological Tables, 

May 31, 2000. 

2 A Review of the Draft Report of the NCI–CDC 

Working Group to Revise the ‘‘1985 

Radioepidemiological Tables’’, National Research 

Council. 

Japanese atomic bomb survivors. The 

risk models are further improved by 

being based on more current data as 

well. Many more cancers have been 

modeled in the revised report. The new 

risk models also take into account 

factors that modify the effect of 

radiation on cancer, related to the type 

of radiation dose, the amount of dose, 

and the timing of the dose. 

A major technological change 

accompanying this update, which 

represents a scientific improvement, is 

the production of a computer software 

program for calculating probability of 

causation. This software program, 

named the Interactive 

RadioEpidemiological Program (IREP), 

allows the user to apply the NCI risk 

models directly to data on an individual 

employee. This makes it possible to 

estimate probability of causation using 

better quantitative methods than could 

be incorporated into printed tables. In 

particular, IREP allows the user to take 

into account uncertainty concerning the 

information being used to estimate 

probability of causation. There typically 

is uncertainty about the radiation dose 

levels to which a person has been 

exposed, as well as uncertainty relating 

levels of dose received to levels of 

cancer risk observed in study 

populations. 

Accounting for uncertainty is 

important because it can have a large 

effect on the probability of causation 

estimates. DVA, in their use of the 1985 

Radioepidemiological Tables, uses the 

probability of causation estimates found 

in the tables at the upper 99 percent 

credibility limit. This means when DVA 

determines whether the cancer of a 

veteran was more likely than not caused 

by radiation, they use the estimate that 

is 99 percent certain to be greater than 

the probability that would be calculated 

if the information on dose and the risk 

model were perfectly accurate. 

Similarly, these HHS guidelines, as 

required by EEOICPA, will use the 

upper 99 percent credibility limit to 

determine whether the cancers of 

employees are at least as likely as not 

caused by their occupational radiation 

doses. 42 U.S.C. 7384n(c)(3)(A). This 

will help minimize the possibility of 

denying compensation to claimants 

under EEOICPA for those employees 

with cancers likely to have been caused 

by occupational radiation exposures. 

F. Use of IREP for Energy Employees 

The risk models developed by NCI 

and CDC for IREP provide the primary 

basis for developing guidelines for 

estimating probability of causation 

under EEOICPA. They directly address 

33 cancers and most types of radiation 

22298 Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 

exposure relevant to employees covered 

by EEOICPA. These models take 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. Also, the risk model 

for lung cancer takes into account 

smoking history and the risk model for 

skin cancer takes into account race/ 

ethnicity. None of the risk models 

explicitly accounts for exposure to other 

occupational, environmental, or dietary 

carcinogens. Models accounting for 

these factors have not been developed 

and may not be possible to develop 

based on existing research. Moreover, 

DOL could not consistently or 

efficiently obtain the data required to 

make use of such models. 

IREP models do not specifically 

include cancers as defined in their early 

stages: carcinoma in situ (CIS). These 

lesions are becoming more frequently 

diagnosed, as the use of cancer 

screening tools, such as mammography, 

have increased in the general 

population. The risk factors and 

treatment for CIS are frequently similar 

to those for malignant neoplasms, and, 

while controversial, there is growing 

evidence that CIS represents the earliest 

detectable phase of malignancy.3 

Therefore, for determining 

compensation under EEOICPA, HHS 

requires that CIS be treated as a 

malignant neoplasm of the specified 

site. 

Cancers identified by their secondary 

sites (sites to which a malignant cancer 

has spread), when the primary site is 

unknown, raise another issue for the 

application of IREP. This situation will 

most commonly arise when death 

certificate information is the primary 

source of a cancer diagnosis. It is 

accepted in medicine that cancercausing agents such as ionizing 

radiation produce primary cancers. This 

means, in a case in which the primary 

site of cancer is unknown, the primary 

site must be established by inference to 

estimate probability of causation. 

HHS establishes such assignments in 

these guidelines, based on an evaluation 

3 Kerlikowske, K, J Barclay, D Grady, EA Sickles, 

and V Ernster. ‘‘Comparison of risk factors for 

ductal carcinoma in situ and invasive breast 

cancer.’’ J. Natl. Canc. Inst. 89:76–82, 1997. 

Grippo, PJ, and EP Sandgren. ‘‘Highly invasive 

transitional cell carcinoma of the bladder in a 

simian virus 40 T-antigen transgenic mouse 

model.’’ Am. J. Pathol. 157:805–813, 2000. 

Correa P, ‘‘Morphology and natural history of 

cancer precursors’’ Chapter 4 in: Cancer 

Epidemiology and Prevention, 2nd Edition, D 

Schottenfeld and JF Fraumeni, Jr, eds. New York: 

Oxford University Press, 1996. 

of the relationship between primary and 

secondary cancer sites using the 

National Center for Health Statistics 

(NCHS) Mortality Database for years 

1995–1997. Because national cancer 

incidence databases (e.g., the National 

Cancer Institute’s Surveillance, 

Epidemiology and End Results program) 

do not contain information about sites 

of metastasis, the NCHS database is the 

best available data source at this time to 

assign the primary site(s) most likely to 

have caused the spread of cancer to a 

known secondary site. For each 

secondary cancer, HHS identified the 

set of primary cancers producing 

approximately 75% of that secondary 

cancer among the U.S. population 

(males and females were considered 

separately). The sets are tabulated in 

this rule (Table 1). DOL will determine 

the final assignment of a primary cancer 

site for an individual claim on a caseby-case basis, as the site among possible 

primary sites which results in the 

highest probability of causation 

estimate. 

Employees diagnosed with two or 

more primary cancers also raise a 

special issue for determining probability 

of causation. Even under the 

assumption that the biological 

mechanisms by which each cancer is 

caused are unrelated, uncertainty 

estimates about the level of radiation 

delivered to each cancer site will be 

related. While fully understanding this 

situation requires statistical training, the 

consequence has simple but important 

implications. Under this rule, instead of 

determining the probability that each 

cancer was caused by radiation 

independently, DOL will perform an 

additional statistical procedure 

following the use of IREP to determine 

the probability that at least one of the 

cancers was caused by the radiation. 

This approach is important to the 

claimant because it would determine a 

higher probability of causation than 

would be determined for either cancer 

individually. 

G. Limitations of IREP for Energy 

Employees 

NCI is developing IREP to serve the 

needs of DVA in deciding cancer 

compensation claims for veterans. This 

means IREP has to be adapted in various 

ways to meet the needs of DOL, because 

the radiation exposure experience of 

employees covered by EEOICPA differs 

substantially. 

Some employees covered by EEOICPA 

were exposed to radon and other 

sources of high linear energy transfer 

(LET) radiation. This type of radiation 

exposure has unique properties affecting 

cancer risk, which are not addressed in 

the risk models included in IREP. 

Specifically, the IREP risk models do 

not account for a possible inverse doserate effect for high-LET radiation 

exposures. This effect means at any 

particular dose level, especially higher 

dose levels, a dose of high LET radiation 

incurred gradually over time is more 

likely to cause cancer than the same 

total dose incurred quickly or at once. 

A substantial body of research supports 

this finding, including studies of 

uranium miners, 4 patients exposed to 

bone-seeking radium alpha particles,5 

and research on the cancer effects of 

high LET radiation in animals.6 Because 

high-LET radiation is an important type 

of radiation exposure among employees 

covered by EEOICPA, NIOSH has 

modified IREP to include uncertainty 

associated with the assumption of an 

inverse dose-rate effect for these 

exposures. 

The DOE workforce has been exposed 

to various types of neutron energies and 

these exposures are frequently 

documented in the worker’s dosimetry 

records. The relative biological 

effectiveness (RBE) of radiation 

exposure, a factor in cancer risk models 

that accounts for the differing level of 

cancer risk associated with different 

forms of radiation, varies as a function 

of neutron energy.7 This variation in 

RBE related to differing neutron energy 

is not accounted for in the current 

version of IREP, which contains a single 

neutron RBE distribution. Therefore, 

NIOSH has modified IREP for DOE 

workers to include different RBE 

distributions for neutrons of various 

energies. 

The currently public draft of IREP 

does not incorporate a unique lung 

cancer model for radon exposure, which 

is an important exposure for some 

workers covered under EEOICPA. Using 

epidemiologic evidence on the lung 

carcinogenicity of radon exposures, NCI 

4 Hornung RW, Meinhardt TJ. Quantitative risk 

assessment of lung cancer in U.S. uranium miners. 

Health Phys 52: 417–430, 1987. 

Lubin JH, Boice JD Jr, Edling C, et al. Radonexposed underground miners and the inverse doserate (protraction enhancement) effects. Health Phys 

69:494–550, 1995. 

5 Mays CW, Spiess H. Bone sarcomas in patients 

given radium-224. In: Radiation Carcinogenesis: 

Epidemiology and Biological Significance. Boice JD 

Jr, Fraumeni JF Jr (eds): New York: Raven Press, pp 

241–252, 1984. 

6 Luebeck EG, Curtis SB, Cross FT, Moolgavkar 

SH. Two-stage model of radon-induced malignant 

lung tumors in rats: effects of cell killing. Radiat. 

Res. 145:163–173, 1996. 

Hall EJ, Miller RC, Brenner DJ. Neoplastic 

transformation and the inverse dose-rate effect for 

neutrons. Radiat. Res. 128 (Suppl): S75–S80, 1991. 

7 International Commission on Radiological 

Protection (ICRP) 60: ‘‘1990 Recommendations of 

the International Commission on Radiological 

Protection.’’ Ann. ICRP 21 (1–3): 1–201. 

Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 22299 

has incorporated a lung cancer model 

for radon exposures into IREP. The data 

source for this model is the analysis 

conducted by the federal Radiation 

Exposure Compensation Act 

Committee.8 

NIOSH has changed IREP to modify 

an assumption for non-leukemia cancers 

that low-level acute radiation doses 

(defined in IREP as doses between 3 and 

30 cSv) cause less risk, per unit of dose, 

than higher level acute doses. NIOSH 

will use an uncertainty distribution for 

the dose and dose rate effectiveness 

factor (DDREF) that more heavily 

weights a DDREF of one, reducing the 

distinction in risk effects for low-level 

acute doses. A recent study of the 

Japanese atomic bomb survivors 

supports this change.9 

Additionally, some employees 

covered by EEOICPA were required, as 

a condition of employment, to undergo 

routine medical screening with x rays. 

The dose resulting from these x rays 

will be included in their dose 

reconstruction. This required NIOSH to 

add to IREP an RBE distribution 

appropriate to the low-energy form of 

radiation produced from some of these 

x rays. 10 

Research has found bone cancer risk 

substantially and significantly elevated 

among animals and humans exposed to 

certain forms of high-LET radiation. 11 

Although Japanese A-bomb survivor risk 

models for bone cancer have been used 

for a plutonium risk assessment, 12 they 

are based on highly unstable risk 

models. Therefore, NIOSH is using in 

IREP the risk model recommended in 

the NCI-IREP documentation, which is 

based on all residual cancers, including 

bone. 

Limitations of current research and 

development have prevented NIOSH 

from considering and implementing all 

8 Final Report of the Radiation Exposure 

Compensation Act Committee, submitted to the 

Human Radiation Interagency Working Group, July 

1996 (Appendix A), 30 pp (plus Figures). 

9 Pierce DA and Preston DL ‘‘Radiation-related 

cancer risks at low doses among atomic bomb 

survivors.’’ Radiat. Res. 154:178–186, 2000. 

10 ICRU Report 40: The quality factor in radiation 

protection. Internat. Commission on Radiat. Units 

and Meas., 33 pp, 1986. 

Hall EJ. ‘‘Linear energy transfer and relative 

biological effectiveness’’ Chapter 9 in Radiobiology 

for the Radiobiologist, 4th Edition. Philadelphia: 

J.B. Lippincott, 1994. 

11 International Agency for Research on Cancer 

(IARC). IARC Monographs on the Evaluation of 

Carcinogenic Risks to Humans, Vol. 78 Ionizing 

Radiation, Part 2: Some Internally Deposited 

Radionuclides. Lyon, France: IARC Press, 595 pp, 

2001. 

12 Grogan HA, Sinclair WK, and Voilleque ́ PG. 

‘‘Risks of fatal cancer from inhalation of 

239,240plutonium by humans: a combined fourmethod approach with uncertainty evaluation’’ 

Health Physics 80:447–461, 2001. 

possible improvements to IREP at this 

time. In the future, NIOSH may make 

additional changes in IREP to address 

differences in radiation-related cancer 

risk between Japanese atomic bomb 

survivors and employees involved in 

nuclear weapons production. Some 

research has shown substantial 

differences in risk for certain cancers, 

such as brain cancer and multiple 

myeloma 13. The radiation-related risk of 

these cancers is significantly elevated 

among employees involved in nuclear 

weapons production, whereas it is not 

among the Japanese study population. 

The IREP risk models for these cancers 

were produced using data from the 

Japanese study population. 

Similarly, it may be possible to 

improve the fit of IREP risk models to 

employees covered by EEOICPA with 

respect to differences between the 

frequency of certain cancers in the 

general population in the United States 

versus Japan. The IREP risk models 

include a simplistically derived factor 

(risk transfer) that accounts for these 

differences, based on expert judgment. 

For some cancers, such as breast and 

stomach cancer, sufficient research may 

exist to improve this factor. In addition, 

where current IREP risk models could 

be replaced with risk models based on 

studies of U.S. DOE workers, or other 

U.S. populations, this factor could be 

omitted entirely. The potential future 

use of risk models based on studies of 

U.S. DOE workers may also eliminate 

limitations arising because data are 

sparse for certain cancers among the 

Japanese atomic bomb survivors, such 

as most specific types of leukemia. 

Using data on the Japanese cohort, the 

effect on risk of age at time of exposure 

to radiation, an important modifier of 

leukemia risk, cannot be estimated for 

specific types of leukemia, except 

chronic myeloid leukemia. It can only 

be estimated for other leukemia types by 

using a general leukemia model that 

combines data from cases of different 

types of leukemia. 

Finally, NIOSH may make 

modifications in cancer risk models in 

IREP, as appropriate and if feasible, to 

account for the changing frequency 

among the general population (baseline 

rates) of certain types of cancer in the 

United States. Certain types of cancer 

(e.g., lung cancer among women, breast 

13 Alexander V and DiMarco JH. ‘‘Reappraisal of 

brain tumor risk among U.S. nuclear workers: a 10– 

year review.’’ Occupational Medicine: State of the 

Art Reviews 16(2):289–315, 2001. 

Cardis E, Gilbert ES, Carpenter L, et al. ‘‘Effects 

of low doses and low dose rates of external ionizing 

radiation: cancer mortality among nuclear industry 

workers in three countries.’’ Radiat. Res. 142:117– 

132, 1995. 

cancer) have become more frequent in 

recent decades. Similarly, NIOSH may 

make modifications in cancer risk 

models to reflect the differing frequency 

of certain types of cancer among 

different racial and ethnic groups in the 

United States (e.g., multiple myeloma). 

The effect of these modifications, at 

such time as they may become available, 

would be to improve the accuracy of 

probability of causation estimates. 

H. Procedures for Review and Public 

Comment on NIOSH–IREP 

As described under Section G above, 

some current and potential future 

changes to the cancer risk models in 

IREP are particularly appropriate for 

addressing the radiation exposures and 

statutory requirements of claimants 

under EEOICPA. As a result, the version 

of IREP to include NIOSH modifications 

will be unique and distinguished as 

‘‘NIOSH–IREP.’’ This version, which 

DOL will use to estimate probability of 

causation under EEOICPA, will be 

reviewed by the Advisory Board on 

Radiation and Worker Health. NIOSH– 

IREP is available for public review on 

the NIOSH homepage at: www.cdc.gov/ 

niosh/ocas/ocasirep/html. It includes 

documentation of underlying risk 

models and calculations. The public can 

obtain complete information about 

NIOSH–IREP by contacting NIOSH at its 

toll-free telephone information service: 

1–800–35–NIOSH (1–800–356–4674). 

The public may comment on NIOSH– 

IREP at any time. Comments can be 

submitted by e-mail to 

OCAS@CDC.GOV, or by mailing written 

comments to: NIOSH–IREP Comments, 

National Institute for Occupational 

Safety and Health, 4676 Columbia 

Parkway, MS–R45, Cincinnati, Ohio 

45226. All comments will be 

considered. In addition, NIOSH will 

forward all substantive comments to the 

Advisory Board on Radiation and 

Worker Health, which will have an 

ongoing role to review and advise 

NIOSH on possible changes to NIOSH– 

IREP, as described in this rule. 

I. Operating Guide for NIOSH–IREP 

DOL will use procedures specified in 

the NIOSH–IREP Operating Guide to 

calculate probability of causation 

estimates under EEOICPA. The guide 

provides current, step-by-step 

instructions for the operation of 

NIOSH–IREP. The procedures include 

entering personal, diagnostic, and 

exposure data; setting/confirming 

appropriate values for variables used in 

calculations; conducting the calculation; 

and, obtaining, evaluating, and 

reporting results. 

22300 Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 

An initial version of the NIOSH–IREP 

Operating Guide is available to the 

public online on the NIOSH homepage 

at: www.cdc.gov/niosh/ocas/ocasirep/ 

html. The public can obtain printed 

copies by contacting NIOSH at its tollfree telephone information service: 1– 

800–35–NIOSH (1–800–356–4674). 

II. Summary of Public Comments 

On October 5, 2001, HHS proposed 

guidelines for determining probability 

of causation under EEOICPA (42 CFR 

81; see 66 FR 50967). HHS initially 

solicited public comments from October 

5 to December 4, 2001. The public 

comment period was reopened 

subsequently from January 17, 2002 to 

January 23, 2002 for public comments, 

and from January 17, 2002 to February 

6, 2002, for comments from the 

Advisory Board on Radiation and 

Worker Health (67 FR 2397). 

HHS received comments from 12 

organizations and 24 individuals. 

Organizations commenting included 

several labor unions representing DOE 

workers, a community based 

organization, an administrative office of 

the University of California, several 

DOE contractors, and several federal 

agencies. A summary of these comments 

and HHS responses is provided below. 

These are organized by general topical 

area. 

A. Appropriateness of Adapting 

Compensation Policy Used for Atomic 

Veterans 

One commenter requested 

explanation of the appropriateness of 

adapting existing compensation policy 

for atomic veterans to a compensation 

program for nuclear weapons workers. 

The comment appears to question 

whether this existing policy for atomic 

veterans is an appropriate starting point 

from which to develop compensation 

policy under EEOICPA. In the notice of 

proposed rulemaking, HHS had 

solicited public comment on whether it 

had appropriately adapted 

compensation policy for atomic veterans 

to meet the needs of this workforce, 

which has a substantially different 

occupational and radiation exposure 

experience. 

Congress determined the veteran’s 

compensation policy as a starting point 

for HHS. It did so by requiring the 

determination of probability of 

causation based on radiation doses and 

the use of the NIH Radioepidemiological 

Tables, and by requiring that the cancer 

covered in a claim be determined to be 

‘‘at least as likely as not’’ caused by 

radiation doses incurred in the 

performance of duty, based on the upper 

99 percent credibility limit. These are 

defining features of compensation 

policy for atomic veterans. 

The public should also recognize that 

the Radioepidemiological Tables 

required years to initially develop and 

then additional years to update (the 

update is not completed). Without this 

critical, highly sophisticated element 

developed for the veterans’ program, it 

would not have been possible to 

establish and implement a policy for 

nuclear weapons workers in a timely 

fashion. 

HHS adapted these policies for 

nuclear weapons workers through two 

prominent measures, discussed in the 

notice of proposed rulemaking and 

below. HHS included provisions to 

allow NIOSH to adapt the cancer risk 

models in the latest version of the NIH 

Radioepidemiological Tables to reflect 

the unique radiation exposure 

experience of nuclear weapons workers. 

And HHS established transparent, 

objective procedures for DOL to handle 

a variety of circumstances in which 

various information relevant to 

determining probability of causation 

will be unknown. The majority of 

comments received on this rule suggest 

most commenters view as appropriate 

the measures HHS has taken to adapt 

existing compensation policy to this 

new program. 

B. Compensability 

Various comments relating to the use 

of these guidelines were received. 

Specifically, HHS received comments 

on: awarding compensation based upon 

a proportional level of probability of 

causation; the use of the upper 99 

percent confidence limit to estimate 

probability of causation; awarding 

compensation for employees who 

incurred radiation doses within 

regulated radiation safety limits; 

automatically qualifying employees who 

incurred doses in excess of the 

maximum allowable radiation dose 

under Atomic Energy Commission 

regulations; waiving dose reconstruction 

and probability of causation for 

employees with rare cancers; and 

automatically compensating employees 

for whom DOE is unwilling or unable to 

provide employment records. 

The development and use of these 

guidelines for determining 

compensability and the benefit structure 

are statutorily mandated and therefore 

these comments were not adopted. 

One commenter suggested prohibiting 

the use of probability of causation 

findings as proof of fault in litigation. 

This suggestion was not adopted 

because prohibiting the use of 

probability of causation findings for 

litigation purposes is not authorized by 

the statute. However, because these 

findings will be based on NIOSH dose 

reconstructions, which will not always 

produce complete or best estimates of 

the actual doses received by an 

individual, 14 HHS does not believe 

these findings should be used for any 

purpose other than the adjudication of 

claims under EEOICPA. 

C. Need for Peer Review 

Several commenters recommended 

that HHS obtain peer review of the 

cancer risk models that comprise 

NIOSH–IREP, and of changes to 

NIOSH–IREP, as it is updated based on 

progress in the underlying sciences. 

Several commenters recognized that the 

Advisory Board on Radiation and 

Worker Health is intended by HHS as 

one means of obtaining such peer 

review, but the commenters raised 

concerns about whether the Board 

would have sufficient expertise for this 

purpose. 

HHS recognizes the importance of 

peer review. Consequently, as indicated 

above, the National Cancer Institute 

obtained peer review of IREP by the 

National Research Council. NCI and 

NIOSH have made modifications in 

IREP consistent with this peer review. 

NIOSH has also obtained peer-review by 

independent subject matter experts of 

changes developed by NIOSH to adapt 

IREP to the experience of nuclear 

weapons workers. These peer-reviews 

are posted on the NIOSH website and 

are also available to the public by 

request. 

In addition, the Advisory Board on 

Radiation and Worker Health will be 

reviewing the cancer risk models in 

NIOSH–IREP, as indicated above and in 

the notice of proposed rulemaking. 

Contrary to the public comments noted 

above, HHS finds the Board has 

appropriate expertise for such a review, 

including eminent physicians and 

scientists from the field of health 

physics. Moreover, the Board maintains 

the option to commission additional 

independent scientists to participate in 

the Board’s review. HHS also has the 

option to obtain additional peer reviews 

by the National Academy of Sciences, as 

recommended by some commenters. 

In response to comments 

recommending peer review and to the 

recommendations of the Advisory Board 

on Radiation and Worker Health 

discussed below, HHS has added a new 

requirement to this rule to affirm the 

commitment of HHS to involve the 

14 For explanation of these possible limitations of 

NIOSH dose reconstructions, see the discussion 

under ‘‘II. Summary of Public Comments; A. 

Purpose of the Rule’’ in the preamble of 42 CFR Part 

82 (the HHS dose reconstruction rule). 

Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 22301 

Board in peer-review of future decisions 

to change NIOSH–IREP and to ensure 

this process is open to public 

participation. These provisions, which 

were previously contained in the 

preamble of the notice of proposed 

rulemaking, are now incorporated into 

the rule itself under § 81.12. 

One commenter recommended HHS 

extend the comment period of the rule 

to provide the public with additional 

time to review NIOSH–IREP. 

As indicated in the notice of proposed 

rulemaking and above, the public can 

comment on NIOSH–IREP at any time. 

The rule comment period applies only 

to provisions of the rule itself. 

D. Updating NIOSH–IREP to Remain 

Current With Science 

Commenters supported the intent of 

HHS to update NIOSH–IREP as 

scientific progress enables HHS to 

improve the cancer risk models. Two 

commenters recommended that DOL 

apply updates to NIOSH–IREP 

retrospectively to claims that were 

denied on the basis of a probability of 

causation finding that might change as 

a result of the update. 

Under 42 CFR 81.12 NIOSH will 

notify the public and DOL when 

changes to NIOSH–IREP are completed 

and explain the effect of changes on 

probability of causation estimates. This 

will enable DOL and claimants with 

denied claims to identify denied claims 

potentially affected by the changes and 

evaluate the effect of this new 

information. 

E. Chemical or Non-Occupational 

Radiation Exposures as Risk Factors 

Some nuclear weapons workers were 

exposed to potential and known 

chemical carcinogens as well as 

radiation in the performance of duty. 

Several commenters urged that cancer 

risk models in NIOSH–IREP take into 

account the effects that these combined 

or ‘‘mixed’’ exposures might have on 

risk associated with radiation exposure. 

There is no adjustment in NIOSH– 

IREP for chemical exposures. It is not 

clear that the state of science presently 

could support risk adjustments that 

account for possibly differing roles of 

chemical exposures. A second, probably 

overriding, practical concern is whether 

this compensation program for nuclear 

weapons workers, which already 

requires the collection and 

consideration of large amounts of 

information, could produce fair, timely 

decisions with the addition of a 

substantial new informational burden. 

New information would be required for 

each claim regarding the type, level, 

duration, and timing of relevant 

chemical exposures, as well as the use 

of administrative measures and 

protective equipment to protect exposed 

workers. 

Despite these limitations, NIOSH will 

consider taking into account the effect 

of mixed exposures at such time as this 

may become scientifically supportable 

and feasible. HHS has added section 

81.10(b)(4) to specifically include this 

possibility. 

Several other commenters made 

similar but distinct recommendations to 

modify the cancer risk models in 

NIOSH–IREP to account for cancer risks 

that might be independent of radiation 

risks, arising from occupational and 

community exposures to chemicals or 

non-occupational exposures to 

radiation. Some commonplace examples 

of such exposures might include 

exposures to solvents or preservatives 

used at work or home, radon in the 

home, second-hand tobacco smoke, or 

sun exposure. The recommendation 

relates to the fact that groups have 

different ‘‘background’’ risks of cancers 

depending on their exposure to these 

various carcinogens. Groups with higher 

than normal background risks might be 

shown in studies of radiation risks to 

have lower increases in cancer risk 

attributable to radiation. Likewise, 

groups with lower than normal 

background risks might be shown to 

have higher increases in risk attributable 

to radiation, depending on the form of 

interaction between radiation exposures 

and these other cancer risk factors. 

It is not scientifically supportable or 

feasible to adjust NIOSH–IREP risk 

models for the multitude of 

occupational and community exposures. 

The carcinogenic risks associated with 

most chemical exposures, and the 

appropriate form of their interaction 

with radiation, have not been 

adequately quantified. Moreover, DOL 

generally would not have access to 

exposure data on the individual’s 

exposure to chemicals or radiation in 

the community. As discussed above, 

access to data on occupational 

exposures to chemicals is also infeasible 

at this time. 

F. Covered Exposures 

A few commenters recommended 

changes in the set of exposures included 

by this rule to contribute to the 

probability of causation calculation. 

Several commenters recommended 

against HHS including medical 

screening x rays administered to nuclear 

weapons employees as a condition of 

employment. Similar comments were 

received on the interim final HHS dose 

reconstruction rule (42 CFR 82) as well. 

Commenters argue that the benefit of 

these exposures justifies their attendant 

risks, and therefore they should not 

contribute to the acceptance of a claim 

for compensation. 

HHS will not exclude radiation 

exposures resulting from these 

occupationally required medical 

screening x rays. The important factor in 

this decision is that the exposures were 

incurred ‘‘in the performance of duty,’’ 

as specified by EEOICPA. The 

employees were required to receive 

these x ray screenings and hence were 

exposed to radiation in performing this 

duty. 

Several commenters recommended 

HHS include cancer risks associated 

with chemical exposures and in effect 

calculate a probability of causation 

related to all occupational exposures, 

rather than radiation exposures alone. 

HHS cannot include the cancer risks 

associated with chemical exposures in 

the calculation of probability of 

causation. EEOICPA explicitly limits 

these guidelines and DOL to making 

determinations as to whether the cancer 

subject to a claim was caused by 

radiation doses incurred in the 

performance of duty (see § 7384(n)(c) of 

EEOICPA). 

G. Covered Illnesses 

HHS received several comments 

addressing the exclusion or inclusion of 

illnesses covered by these guidelines. 

Several commenters noted that 

EEOICPA only covers cancers but 

should cover other or all illnesses. A 

second commenter recommended that 

probability of causation should be 

determined for inherited genetic effects 

(among offspring of covered workers). 

The probability of causation 

guidelines cover only cancers because 

this is a statutory requirement of 

EEOICPA (see discussion of statutory 

requirements above). Moreover, science 

has not progressed sufficiently to permit 

probability of causation determinations 

for many radiogenic illnesses other than 

cancers; specifically not for inherited 

genetic effects. 

Readers should note, however, that 

part B of EEOICPA, which provides 

lump sum payments of $150,000 as well 

as medical benefits, provides coverage 

for chronic beryllium disease and 

silicosis (when incurred by workers 

exposed in connection with mining of 

tunnels for atomic weapons tests or 

experiments in Nevada or Alaska), two 

well documented occupational 

illnesses. Part B also provides for 

medical monitoring of covered workers 

with beryllium sensitivity. In addition, 

part D of EEOICPA provides assistance 

through a worker advocacy program 

administered by DOE to assist nuclear 

22302 Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 

weapons workers with illnesses that 

might have resulted from toxic 

occupational exposures who are seeking 

state workers’ compensation benefits. 

Panels of expert physicians appointed 

by HHS will review the medical records 

in connection with each of these cases 

and make a determination as to whether 

the illness was likely to have been 

caused by toxic occupational exposures. 

Another commenter recommended 

that HHS not permit probability of 

causation to be determined for cancers 

in situ—that is, cancers that have yet to 

spread to neighboring tissues. In other 

words, the comment recommends 

assigning a probability of causation of 

zero to individuals with this early stage 

of cancer. 

HHS is retaining the procedures it 

proposed for estimating probability of 

causation for carcinomas in situ, 

treating them within NIOSH–IREP 

identically to invasive cancers. 

Although more research is needed, some 

studies have shown the risk factors for 

a carcinoma in situ are similar to cancer 

at a later stage. In addition, for any 

given individual, it is not possible to 

determine which carcinomas in situ will 

progress to become invasive cancers. 

H. Radiation Dose Threshold for 

Calculating Probability of Causation 

Several commenters recommended 

HHS establish a radiation dose 

threshold below which DOL would 

deny the claim without calculating 

probability of causation. One 

commenter proposed NIOSH–IREP be 

modified to take into account alternative 

theories of radiation effects at low 

cumulative doses. The commenters 

argue that it is unknown whether 

cancers can be caused at radiation doses 

below 10 to 20 rem. In addition, several 

commenters note that claims for rare 

cancers, for which there is likely to be 

a high level of uncertainty about the 

dose-risk relationship, would have 

unfair advantage over claims for more 

common cancers, due to the use of the 

99 percent credibility limit. 

The National Research Council, 

which reviewed IREP, noted concern 

about the effect of uncertainty with 

respect to rare cancers. NCI has 

responded to this concern by grouping 

rare cancers in more general cancer 

categories, for which there is a more 

robust research basis for quantifying 

risk. 

HHS does not find that any further 

measures are necessary, particularly the 

application of a threshold. The issue of 

whether or not there is a threshold for 

causation of cancer by radiation is 

controversial. Moreover, the issue is 

avoided by the practical approach taken 

in this rule. Doses resulting in a 

probability of causation finding of 50 

percent or greater are determined based 

on current and cumulative 

epidemiologic findings. The NCI 

solution of grouping rare cancers 

addresses the concern about high levels 

of uncertainty for rare cancers. 

I. Non-Radiogenic Cancers 

One commenter recommended against 

the proposed rule’s consideration of 

chronic lymphocytic leukemia (CLL) as 

non-radiogenic (§ 81.30). This provision 

requires DOL to assign a probability of 

causation of zero for a claim for CLL. 

The commenter asserts that it cannot be 

proven that this form of leukemia is 

non-radiogenic. 

As discussed in the notice of 

proposed rulemaking and below, CLL is 

widely considered non-radiogenic by 

the radiation health research 

community and is not covered by other 

radiation compensation programs. 

Moreover, there is no risk model 

appropriate to CLL, nor data to support 

the development of such a risk model. 

Consequently, it is not possible to 

calculate probability of causation for 

CLL and it is both appropriate and 

necessary to consider CLL as nonradiogenic for the purposes of this rule. 

J. Documentation of NIOSH–IREP 

Several commenters recommended 

NIOSH fully document the risk models 

and calculations of NIOSH–IREP so that 

the basis for its calculations are fully 

transparent. One commenter added that 

in this documentation, NIOSH should 

explain how different sources of 

uncertainty are taken into account. 

NIOSH agrees with the comment and, 

as indicated in the notice of proposed 

rulemaking, is committed to 

maintaining and providing full 

documentation on NIOSH–IREP. To a 

substantial extent, this documentation is 

directly available to the public while 

using or examining NIOSH–IREP. The 

software, which is accessible for public 

use from the NIOSH homepage on the 

internet, has a feature that allows the 

user to call-up the formulae and 

information underlying each 

calculation. The user can also call-up 

graphic illustrations (pie charts) that 

quantitatively depict the role of 

different sources of uncertainty in 

contributing to the overall uncertainty 

calculated for use in a probability of 

causation estimate. 15 As noted above, 

15 The uncertainty distributions for the various 

sources of uncertainty involved in a probability of 

causation estimate are combined in NIOSH–IREP 

using a Monte Carlo simulation program that draws 

values randomly, repeatedly from each distribution 

the documentation is also available in 

print form by contacting NIOSH. 

K. Current Technical Elements of 

NIOSH–IREP 

HHS received a variety of comments 

on specific aspects of the cancer risk 

models in NIOSH–IREP. While these 

risk models are not themselves subject 

to this rulemaking, HHS is committed to 

receiving and responding to public 

comments on NIOSH–IREP, and making 

improvements as appropriate. As 

indicated in § 81.12 of this rule, 

recommendations for modifications to 

NIOSH–IREP will be addressed 

routinely through a public process 

involving the Advisory Board on 

Radiation and Worker Health. Hence, 

HHS addresses current comments 

submitted during the rulemaking 

comment period below, but notes that 

some of these issues may receive further 

consideration subsequent to this 

rulemaking, once HHS has obtained 

advice on these issues by the Advisory 

Board. The Advisory Board has received 

these public comments for review. 

One commenter generically 

recommended against making use in 

NIOSH–IREP of cancer risk models 

developed for determining probability 

of causation for atomic veterans. As 

discussed above and in the notice of 

proposed rulemaking, most of the risk 

models in IREP were developed based 

on the exposure and disease experience 

of Japanese survivors of the atomic 

bomb detonations in World War II. The 

commenter finds the differences 

between the exposure conditions of 

these survivors and those of nuclear 

weapons employees too great to support 

probability of causation determinations 

for the latter. 

HHS recognizes the substantial 

differences between the radiation 

exposure experiences of these two 

populations and discussed these 

differences above and in the notice of 

proposed rulemaking. To address these 

differences, NIOSH has adapted the 

available risk models to the extent 

feasible and supportable using current 

science. The difference in exposure 

characteristics is also part of the 

rationale for the provisions of this rule 

supporting updates of NIOSH–IREP, as 

scientific progress allows additional 

improvements. One of the specified 

goals of such updates is to use, as this 

becomes feasible, risk findings derived 

from occupational health studies of 

nuclear weapons workers. 

Nonetheless, NIOSH maintains that 

the current scientific basis applied in 

to derive a single, representative uncertainty 

distribution. 

Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 22303 

NIOSH–IREP is the best available at this 

time and that its use is both reasonable 

and fair. As discussed throughout this 

rule, NIOSH has taken into account, 

whenever feasible, recognized 

limitations in the current state of 

relevant sciences. 

Several commenters recommended 

changes in the way the lung cancer risk 

model adjusts risk according to the 

individual’s smoking history. The risk 

model produces a higher probability of 

causation that lung cancer was caused 

by radiation for a non-smoker than a 

smoker, at a given level and pattern of 

radiation exposure. 

One commenter indicated that the 

probability of causation estimate for a 

heavy smoker should be much lower 

than currently estimated by the risk 

model. The other commenters 

recommended the opposite, that NIOSH 

should eliminate adjustment for 

smoking history. They assert research 

indicates that smoking may have a 

multiplicative effect on lung cancer risk, 

when combined with radiation 

exposure. If this research were proven 

correct, then smoking history would not 

affect the contribution of radiation to 

cancer risk, and could indeed be 

omitted from consideration. 

The adjustment for smoking history in 

NIOSH–IREP has been adopted from the 

approach developed by NCI, and fully 

takes into account the cumulative body 

of research evaluating the interaction 

between smoking and radiation risks, as 

well as leading scientific views on this 

research. The NCI review of relevant 

literature, and a scientific consensus 

panel opinion (UNSCEAR 2000 16), 

conclude that the best-supported risk 

models to evaluate the form of 

interaction between smoking and 

radiation are based on meta-analyses of 

radon-exposed workers. Combined 

analyses of these studies suggest that the 

most appropriate form of interaction is 

sub-multiplicative (i.e., the excess 

relative risk from radiation exposure 

among smokers is less than the excess 

relative risk among non-smokers), but 

greater than additive (Lubin and 

Steindorf 1995). NCI used this scientific 

basis to develop an uncertainty 

distribution for the form of interaction 

between smoking and radiation in the 

lung cancer risk models that is centered 

on a sub-multiplicative model (i.e., a 

model which assumes the excess 

16 United National Scientific Committee on the 

Effects of Atomic Radiation. 2000. Sources and 

Effects of Ionizing Radiation: UNSCEAR 2000 

Report to the General Assembly, with Scientific 

Annexes, Volume II: Effects; p. 201–203. 

Lubin JH and Steindorf K. 1995. Cigarette use and 

the estimation of lung cancer attributable to radon 

in the United States. Radiat. Res. 141:79–85. 

relative risk of cancer per unit of 

radiation dose is lower for individuals 

who smoke more), but includes the 

possibility of either a multiplicative 

model (i.e., that excess relative risk per 

unit of radiation dose is the same for 

various levels of smoking, including 

non-smokers) or a super-multiplicative 

model (i.e., that excess relative risk per 

unit dose is higher for individuals who 

smoke more). As with all assumptions, 

this uncertainty distribution is subject 

to modification in future revisions of 

NIOSH–IREP, pending the availability 

of new scientific information. 

Several commenters recommended 

against use of a factor that reduces 

cancer risk for workers who were 

exposed to radiation at older ages. In 

support of this recommendation, they 

contend atomic bomb survivor and 

occupational studies do not find an 

inverse relationship for adults between 

age at time of radiation exposure and 

cancer risk. 

NIOSH is using in NIOSH–IREP the 

NCI approach to adjusting radiation risk 

estimates for different exposure ages. 

This approach is based on new 

epidemiological analyses of atomic 

bomb survivors who were of working 

age when exposed during the blast, and 

uses an approach recommended by an 

international expert committee (Pierce 

et al. 1993, UNSCEAR 2000 17). It 

addresses all solid cancers except skin 

and thyroid. Thus, for most cancers 

NIOSH–IREP relies on direct evidence 

from the A-bomb survivors exposed as 

adults rather than as children. NCI did 

not incorporate any age at exposure 

effect for the following cancers: acute 

myeloid leukemia, chronic myeloid 

leukemia, lung cancer (non-radon 

exposures), and female genital cancers 

other than ovary. The NCI models do 

incorporate a trend of decreasing risk 

per unit dose with increasing age at 

exposure for the following cancer sites: 

acute lymphocytic leukemia, all 

leukemia other than chronic 

lymphocytic, basal cell carcinoma, and 

cancers of thyroid. For radon exposures 

and lung cancer, there is no direct 

adjustment for exposure age: risks are 

dependent on time since last exposure 

and on age at diagnosis. The effect of 

this adjustment is that, at a constant 

‘‘time since last exposure’’, the risk 

decreases for increasing age at last 

exposure; however, for constant ‘‘age at 

17 Pierce DA, Preston DL. 1993. Joint analysis of 

site-specific cancer risks for the A-bomb survivors. 

Radiat. Res. 137:134–142. 

United National Scientific Committee on the 

Effects of Atomic Radiation. 2000. Sources and 

Effects of Ionizing Radiation: UNSCEAR 2000 

Report to the General Assembly, with Scientific 

Annexes, Volume II: Effects; p. 208. 

diagnosis’’, the risk increases for 

increasing age at last exposure. For all 

other cancers, the NCI models 

incorporate a trend of decreasing risk 

per unit dose for exposure ages between 

15 and 30, and assume constancy (no 

effect of age) thereafter. 

There is substantial evidence from 

several key studies in addition to those 

of the A-bomb cohort that suggests 

radiation risk for many cancers 

decreases with increasing age at 

exposure. These include studies of 

breast cancer among x-ray tuberculosis 

patients (Boice et al. 1991 18), of thyroid 

cancer among medically- and 

occupationally-exposed populations 

(summarized in UNSCEAR 2000a3), and 

of skin cancer (UNSCEAR 2000b3). 

While some studies of DOE workers 

suggest no effect or find increased 

relative risk estimates for certain 

cancers from exposure to radiation at 

older ages, this information is 

insufficient to support the selection of 

appropriate cancers and an appropriate 

method for quantitatively incorporating 

this information into risk adjustments in 

NIOSH–IREP. As indicated in the rule, 

HHS will re-evaluate this issue in future 

revisions of NIOSH–IREP, as warranted 

by advances in scientific information. 

Several commenters recommended 

adding a risk adjustment factor to 

NIOSH–IREP to account for a possible 

‘‘healthy survivor effect’’ presently 

unaccounted for in the research on 

Japanese atomic bomb survivors. The 

theory underlying this comment is that 

atomic bomb survivors may be healthier 

than the general public and less likely 

to incur cancer. Therefore, according to 

this theory, it would be mistaken to 

equate the level of increased cancer risk 

from radiation among this robustly 

healthy population to the level of 

increased cancer risk among the U.S. 

population, with its normal distribution 

of health. If this were proven correct, 

the risk models in NIOSH–IREP should 

SU> Lubin JH, Boice JD Jr, Edling C, et al. 1995. Lung cancer risk 

in radon-exposed miners and estimation of risk from indoor exposure. 

J. Natl. Canc. Inst. 87TM817–827. 

Boice JD Jr, Engholm G, Kleinerman RA, et al. 

1991. Frequent chest x-ray fluoroscopy and breast 

cancer incidence among tuberculosis patients in 

Massachusetts. Radiat. Res. 125:214–222. 

United National Scientific Committee on the 

Effects of Atomic Radiation. 2000a. Sources and 

Effects of Ionizing Radiation: UNSCEAR 2000 

Report to the General Assembly, with Scientific 

Annexes, Volume II: Effects; p. 338–343. 

United National Scientific Committee on the 

Effects of Atomic Radiation. 2000b. Sources and 

Effects of Ionizing Radiation: UNSCEAR 2000 

Report to the General Assembly, with Scientific 

Annexes, Volume II: Effects; p. 402. 

Richardson DB, Wing S, Hoffmann W. 2001. 

Cancer risk from low-level ionizing radiation: the 

role of age at exposure. Occupat. Med.: State of the 

Art Reviews 16:191–218. 

22304 Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 

be adjusted to increase the level of 

cancer risk caused by a unit of radiation 

dose, since the U.S. population would 

presumably be more susceptible than 

the Japanese survivor population to the 

cancer-causing effects of radiation. 

The possible existence of a healthy 

survivor effect has been theorized by 

some researchers (Stewart and Kneale 

1990 19), and has been determined by 

others to be of small magnitude or nonexistent (Little and Charles 1990, NCRP 

1997). The NCI determined that 

insufficient information on the possible 

effect of this bias is available for use the 

IREP program. NIOSH, in consultation 

with the Advisory Board on Radiation 

and Worker Health, will consider 

whether to add an adjustment factor to 

future versions of NIOSH–IREP to 

account for a possible healthy survivor 

effect, if supported by new scientific 

information. HHS notes such a finding 

would be equally relevant for claimants 

under EEOICPA and under the Atomic 

Veterans Compensation Program, and 

thus should be decided by scientific 

consensus between these two programs 

whose relevant policies are both 

determined by HHS. 

Several commenters recommended 

changing the factor in NIOSH–IREP that 

reduces cancer risk for workers who 

were exposed to low linear energy 

transfer (LET) 20 radiation at low dose 

rates (workers who received many small 

doses of radiation, versus fewer large 

doses). They cite reports by the Nuclear 

Regulatory Commission and the 

International Agency for Research on 

Cancer as finding no relationship 

between the rate at which low LET 

radiation doses are incurred and the risk 

of cancer. 

HHS agrees that this is an area of 

substantial uncertainty. Many studies 

suggest that risks are reduced for 

particular cancers when doses are 

fractionated or received at low doserate, while other studies suggest no 

effect of dose-rate or dose fractionation 

on radiation risk. 

NIOSH–IREP accounts for this 

uncertainty. For chronic exposures, 

NIOSH–IREP adopts the approach used 

in the final revision of the NCI–IREP 

program, which more heavily weights a 

probability that there is no attenuation 

19 Stewart AM, and Kneale GW. 1990. A-bomb 

radiation and evidence of late effects other than 

cancer. Health Phys. 58:729–735. 

Little MP, and Charles MW. 1990. Bomb survivor 

selection and consequences for estimates of 

population cancer risks. Health Phys. 59:765–775. 

National Council on Radiation Protection and 

Measurements (NCRP). 1997. Uncertainties in fatal 

cancer risk estimates used in radiation protection. 

NCRP report 126. 112 pp. 

20 See § 81.4 in rule for a definition of LET. 

of risk at low dose rates of exposure. 

This uncertainty distribution also 

includes a small probability that doserate reduction or dose fractionation 

enhances, rather than reduces, radiation 

risk. 

One commenter recommends that 

NIOSH–IREP account for a possible 

inverse relationship between exposure 

to low doses of high LET radiation and 

cancer risk. The commenter cites recent 

research suggesting that individuals 

who incurred high LET radiation doses 

at lower rates had higher risk of cancer, 

compared with individuals who 

incurred the same cumulative doses at 

higher rates. 

As indicated in the notice of proposed 

rulemaking and above, NIOSH has 

incorporated the possibility of this 

inverse relationship into NIOSH–IREP 

for both neutron and low-LET 

exposures. Based on reviews of subject 

matter experts, the revised version of 

NIOSH–IREP includes a small 

probability of an inverse dose-rate effect 

for alpha radiation exposures as well. 

One commenter noted that a linearquadratic model of the dose-risk 

relationship is not equivalent to use of 

a dose-rate correction factor to reduce 

the per-unit contribution of low doses to 

cumulative risk of cancer. The 

commenter recommended either using a 

dose-rate correction factor to keep these 

model elements separate, or 

alternatively to explain why it is 

appropriate to use the linear-quadratic 

model to mimic a reduced cancer risk 

effect at low dose rates. 

This comment is contradicted by 

several research groups, including the 

NCI–IREP working group, the NIH Ad 

Hoc Working Group which initially 

developed the Radioepidemiological 

Tables (NIH 1985 21), and the Committee 

on Biological Effects of Ionizing 

Radiation (BEIR)V. The BEIR V 

committee explicitly states that ‘‘[Dose 

rate] reductions should be applied only 

to the non-leukemia risks, as the 

leukemia risks already contain an 

implicit DREF [dose rate effectiveness 

factor] owing to the use of the linearquadratic model’’ 22. The theoretical 

basis for this equivalence is the 

observation that the use of a linearquadratic dose assumption applies a 

reduction in risk that is equivalent to 

using a dose-and-dose-rate reduction 

21 National Institutes of Health (NIH). 1985. 

Report of the National Institutes of Health Ad Hoc 

Working Group to Develop Radioepidemiological 

Tables. US DHHS. NIH Publication No. 85–2748, p. 

88. 

22 National Research Council. 1990. Health Effects 

of Exposure to Low Levels of Ionizing Radiation: 

BEIR V. National Academy Press, Washington, DC. 

421 pp., p.174. 

factor of about two, which has been 

commonly recommended by advisory 

groups for modeling leukemia risk. 

One commenter recommended 

NIOSH change the dose and dose rate 

effectiveness factor (DDREF) for 

leukemia (for low LET radiation 

exposure) to three. This would reduce 

by two-thirds the probability of 

causation estimates for workers with 

leukemia who accrued their cumulative 

radiation doses slowly. The commenter 

cites two studies to support this 

recommendation. 

NIOSH–IREP uses the models 

developed by the NCI Working Group 

for leukemia risk from low-LET 

exposure. As discussed previously, 

rather than incorporating a DDREF of 

greater than one for leukemia risk 

models, the dose-response function for 

leukemia is of the linear-quadratic form. 

This corresponds approximately to a 

DDREF of two for leukemia risk at low 

compared to high doses and dose rates. 

This approach has been recommended 

by several expert committees, 

referenced above. 6, 7 While findings 

from individual epidemiological studies 

may vary from this approach, these 

individual study findings are subject to 

the limitations of the studies. For this 

reason, risk modeling requires 

consideration of the totality of scientific 

evidence regarding the effects of dose 

protraction. Consistent with the 

extensive expert analyses cited above, 

NIOSH–IREP uses a linear-quadratic 

model with uncertainty in the model 

parameters, which best captures the 

uncertainties associated with the effects 

at low doses and dose rates. 

One commenter recommends NIOSH 

obtain peer review for the radiation 

weighting factors used in NIOSH–IREP. 

These weighting factors take into 

account the differing biological effect 

potency of different types of radiation in 

inducing cancer. The commenter states 

that a factor of 40 used for alpha 

radiation in NIOSH–IREP, that this is 

‘‘too conservative’’ (i.e., results in 

probability of causation estimates that 

would be higher than scientifically 

justified), and notes that the 

International Commission on 

Radiological Protection (ICRP) intends 

to lower its recommended weight for 

alpha radiation from 20 to 10. 

The commenter misunderstands how 

information on the biological 

effectiveness of radiation types is used 

in NIOSH–IREP. The ICRP and other 

leading expert groups recommend 

weighting factors in the form of point 

estimates to summarize the differing 

biological effectiveness of various types 

of radiation for use by radiation 

protection programs. These programs 

Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 22305 

require a point estimate to calculate 

appropriate safety criteria that can be 

applied to protect populations. On the 

other hand, the task involving NIOSH– 

IREP is to calculate probability of 

causation for individual claims, taking 

into account sources of scientific 

uncertainty. There is substantial 

uncertainty of science in describing the 

biological effectiveness of various types 

of radiation, and in part due to this 

uncertainty, there are differences in the 

review findings of ICRP, the 

International Commission on Radiation 

Units and Measurements, and the 

National Council on Radiation 

Protection and Measurements. In 

addition, some radiation exposures are 

incompletely addressed by the reviews 

by these expert groups. 

To evaluate scientific uncertainty, 

NIOSH analyzed the reviews of 

biological effectiveness of radiation by 

each of the expert committees cited 

above and, where these reviews were 

incomplete, other expert reviews and 

primary research as well. Based on this 

analysis, NIOSH established the central 

tendency of ‘‘relative biological 

effectiveness’’ for each type of radiation 

and assigned a probability distribution 

to describe the scientific uncertainty 

about the central tendency estimate. To 

calculate probability of causation, 

NIOSH–IREP will apply these resulting 

uncertainty distributions derived by 

NIOSH, instead of point estimate 

weighting factors, to account for the 

differing biological effectiveness of 

various radiation types. 

The NIOSH analysis of relative 

biological effectiveness described here 

has been summarized in a scientific 

paper, peer-reviewed by subject matter 

experts, and revised accordingly. It is 

available to the public, along with the 

peer-review comments, from the NIOSH 

homepage on the internet or by direct 

request to NIOSH (addresses provided 

above) 23. 

One commenter questions how the 

lung cancer model for radon in NIOSH– 

IREP compares with the 

recommendations of the Committee on 

Health Risks of Exposure to Radon 

(BEIR VI) 24. 

As discussed in the notice of 

proposed rulemaking and above, the 

lung cancer model for radon in NIOSH– 

23 The paper was originally titled: ‘‘Proposed 

Radiation Weighting Factors for Use in Calculating 

Probability of Causation for Cancers’’ and is now 

published with revisions and more extensive 

explanation under the title: ‘‘Relative Biological 

Effectiveness Factors (RBE) for Use in Calculating 

Probability of Causation of Radiogenic Cancers.’’ 

24 National Research Council. 1999. Health Effects 

of Exposure to Radon: BEIR VI. National Academy 

Press, Washington, DC. 500 pp. 

IREP was developed based on an 

analysis of risk by the Radiation 

Exposure Compensation Act (RECA) 

Committee 25, as recommended by the 

National Research Council review of the 

NCI IREP software. The RECA 

committee recommended scientific 

methods for adapting the radon and 

lung cancer risk models derived from 

uranium miner research to 

compensation decisions. These research 

findings were an important component 

of the BEIR VI analyses as well. 

L. HHS Dose Reconstruction Program 

(42 CFR 82) 

HHS received several comments 

addressed to this rule that relate to HHS 

dose reconstructions under EEOICPA. In 

some cases, the comments were directed 

to this rule because dose reconstruction 

results serve as inputs to calculate 

probability of causation. The HHS rule 

establishing methods for dose 

reconstruction, 42 CFR Part 82, is being 

published simultaneously in this issue 

of the Federal Register. 

Several commenters recommended 

that these guidelines prescribe the 

selection of uncertainty distributions 

associated with radiation dose 

information supplied by the NIOSH 

dose reconstruction. 

As discussed in the dose 

reconstruction rule, uncertainty 

distributions associated with the dose 

information will indeed be defined by 

NIOSH in its individual dose 

reconstruction final reports provided to 

DOL, the claimant, and DOE. This 

information, also included in the 

electronic dose files provided to DOL by 

NIOSH, will be imported into NIOSH– 

IREP by DOL when it calculates 

probability of causation. 

These uncertainty distributions 

associated with dose information cannot 

be generically prescribed by these 

guidelines. This information will vary 

substantially depending on radiation 

exposure circumstances and 

informational sources associated with 

each claim. Therefore, NIOSH will be 

defining the use of appropriate 

uncertainty distributions on a claim-byclaim basis, based on technical 

procedures established by NIOSH to 

implement the HHS dose reconstruction 

rule. 

One commenter recommended 

NIOSH use a default assumption that 

characterizes radiation doses as chronic 

rather than acute. The commenter 

indicated that the radiation doses 

25 Final Report of the Radiation Exposure 

Compensation Act Committee, submitted to the 

Human Radiation Interagency Working Group, July 

1996 (Appendix A), 30 pp (plus Figures). 

incurred by many workers are more 

accurately characterized as chronic 

using traditional definitions. 

NIOSH will characterize radiation 

doses as chronic when it has 

information to substantiate this 

designation. However, in most cases 

NIOSH is unlikely to have sufficient 

information to make this distinction. 

For these cases, NIOSH will continue to 

characterize doses as acute as the 

default assumption, since this gives 

claimants the benefit of the doubt. As 

discussed above, this rule, consistent 

with the requirement of EEOICPA to 

calculate probability of causation at the 

upper 99 percent credibility limit, gives 

claimants the benefit of the doubt with 

respect to uncertainty. The use of 

chronic as a default assumption would 

reduce the level of probability of 

causation calculated for some claims. 

One commenter recommended 

NIOSH–IREP include as an input 

radiation doses from nuclides (types of 

radiation) associated with particle 

accelerators. 

The radiation weighting factors 

included in NIOSH–IREP cover the vast 

majority of exposures that have 

occurred or will occur in the claimant 

population. Exposures to the most 

unusual radiation exposure types, such 

as protons and other accelerator 

produced particles, will be addressed on 

an individual basis, as specified by 

NIOSH. It would not be useful to 

construct a priori probability 

distributions for these radiation types 

without knowledge of the range of 

energies likely to be involved in an 

actual exposure. Probability 

distributions developed for these 

unusual radiation types will be 

incorporated into the probability of 

causation calculation for affected 

claimants by DOL through a userdefinable feature of NIOSH–IREP. 

NIOSH will define the probability 

distribution to be applied by DOL and 

summarize its technical basis in the 

dose reconstruction report. 

One commenter questioned how 

NIOSH would know the energies of 

neutron doses, since this information 

will not always be available from DOE 

or AWE records. 

As discussed in the interim final and 

final dose reconstruction rules, NIOSH 

will assign the energies for claims in 

which this specific information is 

unknown. NIOSH will give the benefit 

of the doubt to the claimant in making 

such assignments, such that the energy 

selected is consistent with available 

information and represents the case 

most favorable to the claimant for 

calculating probability of causation. 

22306 Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 

One commenter recommended that 

NIOSH combine the internal and 

external dose reconstruction data into 

single annual dose values. 

It is unclear how this suggested 

change would be useful. Moreover, it 

would rarely be feasible. It would be 

feasible only when radiation doses in a 

given year are limited to a single type 

of radiation and the uncertainty 

distributions for the external and 

internal doses are identical. 

Several commenters questioned why 

HHS added a parameter to the definition 

of ‘‘covered employee,’’ under § 81.4 of 

the proposed rule, that is not specified 

in EEOICPA. HHS specified more 

narrowly than EEOICPA that a covered 

employee, for the purposes of the HHS 

rules, is a DOE or AWE employee for 

whom DOL has requested HHS perform 

a dose reconstruction. 

This distinction results practically 

from the separate responsibilities of 

DOL and HHS in implementing 

EEOICPA. DOL is solely responsible for 

initially reviewing each claim, 

evaluating whether the claim represents 

a covered employee with a covered 

illness, and determining whether or not 

the claim requires a dose reconstruction. 

The only claims DOL will forward to 

HHS for dose reconstructions are those 

involving a covered employee with a 

cancer not covered by provisions of the 

Special Exposure Cohort. Hence, HHS 

retains its proposed definition in this 

rule to be clear that NIOSH will only 

conduct dose reconstructions under 

EEOICPA for the subset of claims 

submitted by DOL to HHS for dose 

reconstructions. This is intended to 

avoid the possible confusion and delay 

that would arise if claimants or the 

public were to directly submit to NIOSH 

requests for dose reconstructions. 

M. Special Exposure Cohort 

HHS received several comments that 

provide recommendations, criteria, or 

concerns related to adding members to 

the Special Exposure Cohort established 

under EEOICPA. These comments fall 

outside the scope of this rule and 

address related but separate procedures 

to be established by HHS. 

As discussed above, HHS is proposing 

procedures by which it will consider 

petitions by classes of employees at 

DOE or AWE facilities to be added to 

the cohort, with the advice of the 

Advisory Board on Radiation and 

Worker Health. These procedures will 

be published soon in the Federal 

Register. The proposed HHS procedures 

and their accompanying explanation 

address the comments received and 

directly solicit additional public 

comments, which HHS will fully 

consider in establishing final 

procedures. 

N. DOL Responsibilities Under 

EEOICPA 

HHS received several comments that 

relate to DOL responsibilities under 

EEOICPA and thus fall outside the 

scope of this rule. 

One commenter recommended that 

claimants be provided with full 

documentation of the basis for the 

probability of causation estimate 

determined for their claim by DOL. 

DOL will provide the claimant with a 

recommended decision which will 

explain the decision based upon the 

probability of causation. In addition, 

NIOSH will provide the claimant with 

complete documentation on the dose 

reconstruction conducted for the claim, 

which, together with the DOL report, 

provides the claimant with a complete 

set of the claim-related data and 

information used to calculate 

probability of causation. 

The claimant would not, however, 

automatically receive documentation of 

the formulae and underlying research 

basis for the cancer risk models applied 

to the claim in NIOSH–IREP. This 

information is highly technical and 

complex and is unlikely to be of value 

to most claimants. Claimants who desire 

this information, however, can obtain it 

either from NIOSH–IREP, from the 

NIOSH homepage, or by contacting 

NIOSH directly (see contact information 

above). Some details of IREP 

documentation are only available at this 

time from NCI but will be incorporated 

into NIOSH informational resources as 

soon as possible. 

One commenter recommended that 

claimants be permitted to submit 

affidavits in lieu of medical records 

when necessary. 

DOL determines what types of 

information can constitute medical 

evidence of a diagnosis of cancer (see 20 

CFR 30.211.). More details can be 

obtained by contacting DOL. 

One commenter recommended that 

staff working for contractor support 

services offsite from the DOE facility 

should be treated as covered employees 

under EEOICPA. The comment 

identifies workers providing offsite 

laundry services as an example of such 

support staff. As discussed above, DOL 

is responsible for determining whether 

an individual is a covered employee 

within the scope of coverage defined by 

Congress in EEOICPA. Individuals who 

are concerned that certain employee 

groups involved in nuclear weapons 

production or related activities might be 

excluded from coverage under EEOICPA 

should consult DOL, which makes these 

determinations. 

III. Review and Recommendations of 

the Advisory Board on Radiation and 

Worker Health 

As discussed above, the Advisory 

Board on Radiation and Worker Health 

is required by Section 7384(n)(c) of 

EEOICPA to conduct a technical review 

of these HHS guidelines. The Board 

reviewed the guidelines during public 

meetings on January 22–23 and 

February 5, 2002. In preparation for the 

meeting, the Board members 

individually reviewed the notice of 

proposed rulemaking as well as the HHS 

interim final rule providing the methods 

of dose reconstruction (42 CFR 82) that 

govern the estimation of radiation doses 

to be used under these guidelines. The 

members also reviewed public 

comments on these rules and written 

comments by subject matter experts 

who evaluated technical elements of 

NIOSH–IREP. In addition, NIOSH staff 

members gave formal presentations on 

the HHS rules, implementation 

procedures, and related issues during 

the Board meetings. The transcripts and 

minutes of these meetings are included 

in the NIOSH docket for this rule and 

are available to the public. 

All of the Board members participated 

in the technical review of these 

guidelines and they unanimously 

concurred in establishing the Board 

findings and recommendations. The 

Board organized its findings and 

recommendations to correspond with 

the three general questions for public 

comment HHS identified in the notice 

for proposed rulemaking. The findings 

and recommendations are provided 

below, together with responses by HHS 

to the recommendations: 

Board Comment #1: The Board agrees 

that the NIOSH guidelines and 

procedures for probability of causation 

determinations have been developed 

using the best and most current 

scientific information relating radiation 

exposures to cancer risks. The use of 

current recommendations from 

independent expert bodies lends 

strength to the approach proposed by 

NIOSH. The NIOSH approach also 

implements the spirit of concern for 

nuclear workers that was inherent in the 

legislation underlying this 

compensation program. In this context, 

the NIOSH guidelines and procedures 

provide an appropriate application of 

existing science to the compensation 

process. 

HHS Response: No response is 

necessary, but it may be helpful to 

readers to explain the Board’s reference 

to the ‘‘spirit of concern.’’ HHS has 

Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 22307 

implemented the ‘‘spirit of concern’’ to 

which the Board refers by consistently 

and reasonably giving the benefit of the 

doubt to nuclear weapons workers, 

whenever feasible, with respect to 

policy decisions and technical 

procedures involving factual or 

scientific unknowns and uncertainty. 

Board Comment #2: ‘‘The Board has 

also noted the differences between the 

approach being used in this 

compensation program and that of the 

Atomic Veterans Act. There are 

significant differences in the categories 

of compensation covered by the two 

acts. In some cases, the Atomic Veterans 

Act required primarily that the 

claimants were present in a specific 

area, had one of the specified cancers, 

and were therefore compensated. This 

proposed rule is an effort to address 

much more complicated situations and 

to face the reality that simple exposure 

to radiation does not automatically 

presume the development of disease. 

The Board recognizes the excellent 

efforts of NIOSH staff and their subject 

matter experts in bringing the best 

known current science to an appropriate 

method for translating experience 

gained in the veterans exposure 

calculations to this civilian nuclear 

worker proposal.’’ 

HHS Response: No response 

necessary. 

Board Comment #3: ‘‘The Board also 

agrees that the proposed NIOSH 

procedures appropriately allow for the 

incorporation of new scientific 

information into the compensation 

procedures as this new information 

becomes available. However, given the 

limited time that the Board has had to 

review the details of the probability of 

causation procedures and the potential 

impact of changes in the NIOSH IREP 

on compensation decisions, the Board 

recommends that the regulations be 

amended to formalize the role of the 

Board in reviewing any substantial 

changes in these procedures (i.e., the 

NIOSH IREP). This change should 

include publication of the planned 

changes in the Federal Register, an 

appropriate opportunity for public 

comment, and then review by this Board 

before finalization. Although these 

actions are included in the Preamble 

‘‘Background,’’ (Section III, Subsection 

I, Paragraph 3) of 42 CFR Part 81, 

making them part of the rule itself 

would formalize the updating process, 

significantly strengthening assurance 

that review of revisions by the Board 

will occur.’’ 

HHS Response: HHS accepts this 

recommendation by the Board. 

Accordingly, as discussed above in 

response to public comments on peerreview, HHS has moved provisions for 

peer-review involving the Board from 

the preamble of the notice of proposed 

rulemaking into the body of the rule 

itself. These provisions can be found at 

42 CFR 81.12. 

IV. Summary of the Rule 

Congress, in enacting EEOICPA, 

created a new Energy Employees 

Occupational Illness Compensation 

Program to ensure an efficient, uniform, 

and adequate compensation system for 

certain employees. Through Executive 

Order 13179, the President assigned 

primary responsibility for administering 

the program to DOL. The President 

assigned various technical 

responsibilities for policymaking and 

assistance to HHS. Included among 

these is promulgation of this rule to 

establish guidelines DOL will apply to 

adjudicate cancer claims for covered 

employees seeking compensation for 

cancer, other than as members of the 

Special Exposure Cohort seeking 

compensation for a specified cancer. 

Sections 81.20–81.25 and 81.30 provide 

guidelines for determining the 

probability of causation with respect to 

all known cancers. 

In the summary below, HHS indicates 

all the changes in provisions of this rule 

made since the notice of proposed 

rulemaking. These occur under 

§§ 81.10(b) and 81.12. 

Introduction 

Sections 81.0 and 81.1 briefly 

describe how this rule relates to DOL 

authorities under EEOICPA and the 

assignment of authority for this rule to 

HHS. Section 81.2 summarizes the 

specific provisions of EEOICPA 

directing HHS in the development of 

this rule. 

Definitions 

This section of the regulation defines 

the principal terms used in this part. It 

includes terms specifically defined in 

EEOICPA that, for the convenience of 

the reader of this part, are repeated in 

this section. The citation to EEOICPA 

has been revised to reflect the 

codification of the Act in the United 

States Code. 

Data Required To Estimate Probability 

of Causation 

Sections 81.5 and 81.6 identify the 

sources and types of personal, medical, 

and radiation dose information that 

would be required by this regulation. 

Claimants will provide personal and 

medical information to DOL under DOL 

regulations 20 CFR Part 30. NIOSH will 

provide radiation dose information 

pursuant to 20 CFR Part 30. NIOSH will 

develop the dose information required 

pursuant to the HHS regulation under 

42 CFR Part 82, which was promulgated 

on October 5, 2001 as an interim final 

rule and is being promulgated as a final 

rule simultaneously with this final rule 

in this issue of the Federal Register. The 

application of this personal, medical, 

and radiation dose information to 

estimate probability of causation is 

described generally under §§ 81.22— 

81.25. 

Requirements for Risk Models Used To 

Estimate Probability of Causation 

Sections 81.10 and 81.11 describe the 

use of cancer risk models and 

uncertainty analysis underlying the NIH 

RadioEpidemiological Tables in their 

current, updated form, which is a 

software program named the 

‘‘Interactive RadioEpidemiological 

Program’’ (IREP). NIOSH–IREP, the 

version of IREP to be used by DOL to 

implement this rule, is discussed 

extensively in the notice of proposed 

rulemaking and above. These sections 

also propose criteria by which the risk 

models in NIOSH–IREP may be changed 

to ensure that probability of causation 

estimates calculated for EEOICPA 

claimants represent the unique exposure 

and disease experiences of employees 

covered by EEOICPA. In response to 

public comments, a criterion discussed 

above has been added to § 81.10. This 

criterion authorizes NIOSH to modify 

NIOSH–IREP to account for new 

understanding of the potential 

interaction between cancer risks 

associated with occupational exposures 

to chemical carcinogens and radiationrelated cancer effects (see § 81.10(b)(4)). 

Section 81.12 was added in response 

to comments and describes the 

procedure to update NIOSH–IREP. 

NIOSH may periodically revise NIOSH– 

IREP to add, modify, or replace cancer 

risk models, improve the modeling of 

uncertainty, and improve the 

functionality and user-interface of 

NIOSH–IREP. Principal sources of 

potential improvements in cancer risk 

models include new epidemiologic 

research on DOE employee populations 

and periodic updates from scientific 

committees evaluating such research 

(e.g., the Committee on Biological 

Effects of Ionizing Radiation). 

Improvements may also be 

recommended by the Advisory Board on 

Radiation and Worker Health, scientific 

reviews relevant to or addressing this 

program, public comment, or by DOL, 

which is the principal user and hence 

may require functional changes and 

improvements in the user-interface. 

Substantive changes to NIOSH–IREP 

(changes that would substantially affect 

22308 Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 

estimates of probability of causation 

calculated using NIOSH–IREP, 

including the addition of new cancer 

risk models) will be submitted to the 

Advisory Board on Radiation and 

Worker Health for review. Proposed 

changes provided to the Advisory Board 

for review will also be made available 

to the public, which will have 

opportunity to comment and have its 

comments considered by NIOSH and 

the Board. 

To facilitate public participation in 

updating NIOSH–IREP, NIOSH will 

periodically publish a notice in the 

Federal Register informing the public of 

proposed substantive changes to 

NIOSH–IREP currently under 

development, the status of the proposed 

changes, and the expected completion 

dates. NIOSH will also publish a notice 

in the Federal Register notifying DOL 

and the public of the completion of 

substantive changes to NIOSH–IREP. In 

the notice, NIOSH will address relevant 

public comments and recommendations 

from the Advisory Board received by 

NIOSH. 

Guidelines To Estimate Probability of 

Causation 

Sections 81.20 and 81.21 require DOL 

to use NIOSH–IREP to estimate 

probability of causation for cancers for 

which probability of causation estimates 

can be calculated using available cancer 

risk models. Section 81.21 also requires 

DOL to assume carcinoma in situ (ICD– 

9 26 codes 230–234), neoplasms of 

uncertain behavior (ICD–9 codes 235– 

238), and neoplasms of unspecified 

nature (ICD–9 code 239) are malignant, 

for purposes of estimating probability of 

causation. 

Sections 81.22–81.25 provide general 

guidelines for the use of NIOSH–IREP 

and specific applications to 

accommodate special circumstances 

anticipated. The special circumstances 

include claims in which: (1) The 

primary site of a metastasized cancer is 

unknown; (2) the subtype of leukemia 

presented lacks a single, optimal risk 

model in NIOSH–IREP; and (3) two or 

more primary cancers are presented, 

requiring further statistical adjustment 

of probability of causation estimates 

calculated using NIOSH–IREP. 

The procedure concerning subtypes of 

leukemia (2) is needed because of a 

26 ICD–9 is a version of the standard system of 

classifying diseases that will be used by IREP. The 

most recent version of this system, ICD–10, will not 

be used because the cancer risk models have been 

constructed using ICD–9. 

See: The International Classification of Diseases 

Clinical Modification (9th Revision) Volume I&II. 

[1991] Department of Health and Human Services 

Publication No. (PHS) 91–1260, U.S. Government 

Printing Office, Washington, D.C. 

limitation of the data on Japanese 

atomic bomb survivors, as discussed 

above and in the notice of proposed 

rulemaking. The general leukemia 

model in IREP allows for adjustment for 

age at exposure, which is an important 

modifier of leukemia risk. The data are 

too sparse, however, to allow for such 

an adjustment with respect to specific 

types of leukemia, with the exception of 

chronic myeloid leukemia. Since it is 

not possible to determine which factor, 

age at exposure or leukemia subtype, is 

more important to determining 

probability of causation for most 

specific types of leukemia, the 

guidelines require use of both the 

general model and the specific model. 

The guidelines require DOL to use the 

findings of whichever model produces 

the higher probability of causation 

estimate. 

Section 81.30 specifies one cancer to 

be considered non-radiogenic for the 

purposes of this rule: chronic 

lymphocytic leukemia (ICD–9 Code: 

204.1). DOL would assign a value of 

zero to the probability of causation for 

a claim based on this type of leukemia. 

There is general consensus among the 

scientific and medical communities that 

treatment of this leukemia as nonradiogenic is appropriate, and such 

treatment is consistent with other 

radiation illness compensation 

programs. 

V. Significant Regulatory Action 

(Executive Order 12866) 

This rule is a ‘‘significant regulatory 

action,’’ within the meaning of 

Executive Order 12866, because it raises 

novel or legal policy issues arising out 

of the legal mandate established under 

EEOICPA. The rule is designed to 

establish objective guidelines, grounded 

in current science, to support DOL in 

the adjudication of applicable claims 

seeking compensation for cancer under 

EEOICPA. The guidelines will be 

applied by DOL to calculate a 

reasonable, scientifically supported 

determination of the probability that a 

cancer for which a claimant is seeking 

compensation was as likely as not 

caused by radiation doses incurred in 

the performance of duty by the covered 

employee. The financial cost to the 

federal government of applying these 

guidelines is covered under 

administrative expenses estimated by 

DOL under its rule (see FR 28948, May 

25, 2001). 

The rule carefully explains the 

manner in which the regulatory action 

is consistent with the mandate for this 

action under § 3623(c) of EEOICPA and 

implements the detailed requirements 

concerning this action under this 

section of EEOICPA. The rule does not 

interfere with State, local, and tribal 

governments in the exercise of their 

governmental functions. 

The rule is not considered 

economically significant, as defined in 

section 3(f)(1) of the Executive Order 

12866. This rule has a subordinate role 

in the adjudication of claims under 

EEOICPA, serving as one element of an 

adjudication process administered by 

DOL under 20 CFR Parts 1 and 30. DOL 

has determined that its rule fulfills the 

requirements of Executive Order 12866 

and provides estimates of the aggregate 

cost of benefits and administrative 

expenses of implementing EEOICPA 

under its rule (see FR 28948, May 25, 

2001). 

VI. Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA), 

5 U.S.C. 601 et seq., requires each 

agency to consider the potential impact 

of its regulations on small entities 

including small businesses, small 

governmental units, and small not-forprofit organizations. HHS certifies that 

this rule will not have a significant 

economic impact on a substantial 

number of small entities within the 

meaning of the RFA. This rule affects 

only DOL, HHS, and some individuals 

filing compensation claims under 

EEOICPA. Therefore, a regulatory 

flexibility analysis as provided for 

under RFA is not required. 

VII. Paperwork Reduction Act 

The Paperwork Reduction Act (PRA), 

44 U.S.C. 3501 et seq., requires an 

agency to invite public comment on and 

to obtain OMB approval of any 

regulation that requires ten or more 

people to report information to the 

agency or to keep certain records. This 

rule does not contain any information 

collection requirements. It provides 

guidelines only to the U.S. Department 

of Labor (DOL) for adjudicating 

compensation claims and thus requires 

no reporting or record keeping. 

Information required by DOL to apply 

these guidelines is being provided by 

HHS and by individual claimants to 

DOL under DOL regulations 20 CFR 30. 

Thus, HHS has determined that the PRA 

does not apply to this rule. 

VIII. Small Business Regulatory 

Enforcement Fairness Act 

As required by Congress under the 

Small Business Regulatory Enforcement 

Fairness Act of 1996 (5 U.S.C. 801 et 

seq.), the Department will report to 

Congress promulgation of this rule. The 

report will state that the Department has 

concluded that this rule is not a ‘‘major 

rule’’ because it is not likely to result in 

1995 

Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 22309 

an annual effect on the economy of $100 

million or more. However, this rule has 

a subordinate role in the adjudication of 

claims under EEOICPA, serving as one 

element of an adjudication process 

administered by DOL under 20 CFR 

Parts 1 and 30. DOL has determined that 

its rule is a ‘‘major rule’’ because it will 

likely result in an annual effect on the 

economy of $100 million or more. 

IX. Unfunded Mandates Reform Act of 

Title II of the Unfunded Mandates 

Reform Act of 1995 (2 U.S.C. 1531 et 

seq.) directs agencies to assess the 

effects of Federal regulatory actions on 

State, local, and tribal governments, and 

the private sector, ‘‘other than to the 

extent that such regulations incorporate 

requirements specifically set forth in 

law.’’ For purposes of the Unfunded 

Mandates Reform Act, this rule does not 

include any Federal mandate that may 

result in increased annual expenditures 

in excess of $100 million by State, local 

or tribal governments in the aggregate, 

or by the private sector. 

X. Executive Order 12988 (Civil Justice) 

This rule has been drafted and 

reviewed in accordance with Executive 

Order 12988, Civil Justice Reform and 

will not unduly burden the Federal 

court system. Probability of causation 

may be an element in reviews of DOL 

adverse decisions in the United States 

District Courts pursuant to the 

Administrative Procedure Act. 

However, DOL has attempted to 

minimize that burden by providing 

claimants an opportunity to seek 

administrative review of adverse 

decisions, including those involving 

probability of causation. HHS has 

provided a clear legal standard for DOL 

to apply regarding probability of 

causation. This rule has been reviewed 

carefully to eliminate drafting errors and 

ambiguities. 

XI. Executive Order 13132 (Federalism) 

The Department has reviewed this 

rule in accordance with Executive Order 

13132 regarding federalism, and has 

determined that it does not have 

‘‘federalism implications.’’ The rule 

does not ‘‘have substantial direct effects 

on the States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government.’’ 

XII. Executive Order 13045 (Protection 

of Children From Environmental, 

Health Risks and Safety Risks) 

In accordance with Executive Order 

13045, HHS has evaluated the 

environmental health and safety effects 

of this rule on children. HHS has 

determined that the rule would have no 

effect on children. 

XIII. Executive Order 13211 (Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use) 

In accordance with Executive Order 

13211, HHS has evaluated the effects of 

this rule on energy supply, distribution 

or use, and has determined that the rule 

will not have a significant adverse effect 

on them. 

XIV. Effective Date 

The Secretary has determined, 

pursuant to 5 U.S.C. 553(d)(3), that there 

is good cause for this rule to be effective 

immediately to avoid undue hardship 

on and facilitate payment to eligible 

claimants. 

List of Subjects in 42 CFR Part 81 

Cancer, Government Employees, 

Probability of Causation, Radiation 

Protection, Radioactive Materials, 

Workers’ Compensation. 

Text of the Rule 

For the reasons discussed in the 

preamble, the Department of Health and 

Human Services is amending 42 CFR to 

add Part 81 to read as follows: 

PART 81—GUIDELINES FOR 

DETERMINING PROBABILITY OF 

CAUSATION UNDER THE ENERGY 

EMPLOYEES OCCUPATIONAL 

ILLNESS COMPENSATION PROGRAM 

ACT OF 2000 

Subpart A—Introduction 

Sec. 

81.0 Background. 

81.1 Purpose and Authority. 

81.2	 Provisions of EEOICPA concerning this 

part. 

Subpart B—Definitions 

81.4 Definition of terms used in this part. 

Subpart C—Data Required To Estimate 

Probability of Causation 

81.5	 Use of personal and medical 

information 

81.6 Use of radiation dose information. 

Subpart D—Requirements for Risk Models 

Used To Estimate Probability of Causation 

81.10	 Use of cancer risk assessment models 

in NIOSH–IREP. 

81.11	 Use of uncertainty analysis in 

NIOSH–IREP. 

81.12 Procedure for updating NIOSH–IREP. 

Subpart E—Guidelines To Estimate 

Probability of Causation 

81.20 Required use of NIOSH–IREP. 

81.21	 Cancers requiring the use of NIOSH– 

IREP. 

81.22	 General guidelines for use of NIOSH– 

IREP. 

81.23	 Guidelines for cancers for which 

primary site is unknown. 

81.24 Guidelines for leukemia. 

81.25	 Guidelines for claims involving two 

or more primary cancers. 

81.30 Non-radiogenic cancers. 

Appendix A to Part 81—Glossary of 

ICD–9 codes and their cancer 

descriptions. 

Authority: 42 U.S.C. 7384n(c); E.O. 13179, 

65 FR 77487, 3 CFR, 2000 Comp., p. 321. 

Subpart A—Introduction 

§ 81.0 Background. 

The Energy Employees Occupational 

Illness Compensation Program Act 

(EEOICPA), 42 U.S.C. 7384–7385 [1994, 

supp. 2001], provides for the payment of 

compensation benefits to covered 

employees and, where applicable, 

survivors of such employees, of the 

United States Department of Energy, its 

predecessor agencies and certain of its 

contractors and subcontractors. Among 

the types of illnesses for which 

compensation may be provided are 

cancers. There are two categories of 

covered employees with cancer under 

EEOICPA for whom compensation may 

be provided. The regulations that follow 

under this part apply only to the 

category of employees described under 

paragraph (a) of this section. 

(a) One category is employees with 

cancer for whom probability of 

causation must be estimated or 

determined, as required under 20 CFR 

30.115. 

(b) The second category is members of 

the Special Exposure Cohort seeking 

compensation for a specified cancer, as 

defined under EEOICPA. The U.S. 

Department of Labor (DOL) which has 

primary authority for implementing 

EEOICPA, has promulgated regulations 

at 20 CFR 30.210 et seq. that identify 

current members of the Special 

Exposure Cohort and requirements for 

compensation. Pursuant to section 

7384(q) of EEOICPA, the Secretary of 

HHS is authorized to add additional 

classes of employees to the Special 

Exposure Cohort. 

§ 81.1 Purpose and Authority. 

(a) The purpose of this regulation is 

to establish guidelines DOL will apply 

to adjudicate cancer claims for covered 

employees seeking compensation for 

cancer, other than as members of the 

Special Exposure Cohort seeking 

compensation for a specified cancer. To 

award a claim, DOL must first 

determine that it is at least as likely as 

not that the cancer of the employee was 

caused by radiation doses incurred by 

the employee in the performance of 

22310 Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 

duty. These guidelines provide the 

procedures DOL must apply and 

identify the information DOL will use. 

(b) Section 7384(n)(b) of EEOICPA 

requires the President to promulgate 

these guidelines. Executive Order 13179 

assigned responsibility for promulgating 

these guidelines to the Secretary of 

HHS. 

§ 81.2 Provisions of EEOICPA concerning 

this part. 

EEOICPA imposes several general 

requirements concerning the 

development of these guidelines. It 

requires that the guidelines produce a 

determination as to whether it is at least 

as likely as not (a 50% or greater 

probability) that the cancer of the 

covered employee was related to 

radiation doses incurred by the 

employee in the performance of duty. It 

requires the guidelines be based on the 

radiation dose received by the 

employee, incorporating the methods of 

dose reconstruction to be established by 

HHS. It requires determinations be 

based on the upper 99 percent 

confidence interval (credibility limit) of 

the probability of causation in the 

RadioEpidemiological tables published 

under section 7(b) of the Orphan Drug 

Act (42 U.S.C. 241 note), as such tables 

may be updated. EEOICPA also requires 

HHS consider the type of cancer, past 

health-related activities, the risk of 

developing a radiation-related cancer 

from workplace exposure, and other 

relevant factors. Finally, it is important 

to note EEOICPA does not include a 

requirement limiting the types of 

cancers to be considered radiogenic for 

these guidelines. 

Subpart B—Definitions 

§ 81.4 Definition of terms used in this part. 

(a) Covered employee, for purposes of 

this part, means an individual who is or 

was an employee of DOE, a DOE 

contractor or subcontractor, or an 

atomic weapons employer, and for 

whom DOL has requested HHS to 

perform a dose reconstruction. 

(b) Dose and dose rate effectiveness 

factor (DDREF) means a factor applied 

to a risk model to modify the dose-risk 

relationship estimated by the model to 

account for the level of the dose and the 

rate at which the dose is incurred. As 

used in IREP, a DDREF value of greater 

than one implies that chronic or low 

doses are less carcinogenic per unit of 

dose than acute or higher doses. 

(c) Dose-response relationship means 

a mathematical expression of the way 

that the risk of a biological effect (for 

example, cancer) changes with 

increased exposure to a potential health 

hazard (for example, ionizing radiation). 

(d) EEOICPA means the Energy 

Employees Occupational Illness 

Compensation Program Act of 2000, 42 

U.S.C. §§ 7384–7385 [1994, supp. 2001]. 

(e) Equivalent dose means the 

absorbed dose in a tissue or organ 

multiplied by a radiation weighting 

factor to account for differences in the 

effectiveness of the radiation in 

inducing cancer. 

(f) External dose means the portion of 

the equivalent dose that is received from 

radiation sources outside of the body. 

(g) Interactive RadioEpidemiological 

Program (IREP) means a computer 

software program that uses information 

on the dose-response relationship, and 

specific factors such as a claimant’s 

radiation exposure, gender, age at 

diagnosis, and age at exposure to 

calculate the probability of causation for 

a given pattern and level of radiation 

exposure. 

(h) Internal dose means the portion of 

the equivalent dose that is received from 

radioactive materials taken into the 

body. 

(i) Inverse dose rate effect means a 

phenomenon in which the protraction 

of an exposure to a potential health 

hazard leads to greater biological effect 

per unit of dose than the delivery of the 

same total amount in a single dose. An 

inverse dose rate effect implies that the 

dose and dose rate effectiveness factor 

(DDREF) is less than one for chronic or 

low doses. 

(j) Linear energy transfer (LET) means 

the average amount of energy 

transferred to surrounding body tissues 

per unit of distance the radiation travels 

through body tissues (track length). Low 

LET radiation is typified by gamma and 

x rays, which have high penetrating 

capabilities through various tissues, but 

transfer a relatively small amount of 

energy to surrounding tissue per unit of 

track length. High LET radiation 

includes alpha particles and neutrons, 

which have weaker penetrating 

capability but transfer a larger amount 

of energy per unit of track length. 

(k) NIOSH means the National 

Institute for Occupational Safety and 

Health, Centers for Disease Control and 

Prevention, United States Department of 

Health and Human Services. 

(l) Non-radiogenic cancer means a 

type of cancer that HHS has found not 

to be caused by radiation, for the 

purposes of this regulation. 

(m) Primary cancer means a cancer 

defined by the original body site at 

which the cancer was incurred, prior to 

any spread (metastasis) to other sites in 

the body. 

(n) Probability of causation means the 

probability or likelihood that a cancer 

was caused by radiation exposure 

incurred by a covered employee in the 

performance of duty. In statistical terms, 

it is the cancer risk attributable to 

radiation exposure divided by the sum 

of the baseline cancer risk (the risk to 

the general population) plus the cancer 

risk attributable to the radiation 

exposure. 

(o) RadioEpidemiological Tables 

means tables that allow computation of 

the probability of causation for various 

cancers associated with a defined 

exposure to radiation, after accounting 

for factors such as age at exposure, age 

at diagnosis, and time since exposure. 

(p) Relative biological effectiveness 

(RBE) means a factor applied to a risk 

model to account for differences 

between the amount of cancer effect 

produced by different forms of 

radiation. For purposes of EEOICPA, the 

RBE is considered equivalent to the 

radiation weighting factor. 

(q) Risk model means a mathematical 

model used under EEOICPA to estimate 

a specific probability of causation using 

information on radiation dose, cancer 

type, and personal data (e.g., gender, 

smoking history). 

(r) Secondary site means a body site 

to which a primary cancer has spread 

(metastasized). 

(s) Specified cancer is a term defined 

in § 7384(l)(17) of EEOICPA and 20 CFR 

30.5(dd) that specifies types of cancer 

that, pursuant to 20 CFR part 30, may 

qualify a member of the Special 

Exposure Cohort for compensation. It 

includes leukemia (other than chronic 

lymphocytic leukemia), multiple 

myeloma, non-Hodgkin’s lymphoma, 

renal cancers, and cancers of the lung 

(other than carcinoma in situ diagnosed 

at autopsy), thyroid, male breast, female 

breast, esophagus, stomach, pharynx, 

small intestine, pancreas, bile ducts, gall 

bladder, salivary gland, urinary bladder, 

brain, colon, ovary, liver (not associated 

with cirrhosis or hepatitis B), and bone. 

(t) Uncertainty is a term used in this 

rule to describe the lack of precision of 

a given estimate, the extent of which 

depends upon the amount and quality 

of the evidence or data available. 

(u) Uncertainty distribution is a 

statistical term meaning a range of 

discrete or continuous values arrayed 

around a central estimate, where each 

value is assigned a probability of being 

correct. 

(v) Upper 99 percent confidence 

interval is a term used in EEOICPA to 

mean credibility limit, the probability of 

causation estimate determined at the 

99th percentile of the range of 

Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 22311 

uncertainty around the central estimate 

of probability of causation. 

Subpart C—Data Required To Estimate 

Probability of Causation 

§ 81.5 Use of personal and medical 

information. 

Determining probability of causation 

may require the use of the following 

personal and medical information 

provided to DOL by claimants under 

DOL regulations 20 CFR part 30: 

(a) Year of birth 

(b) Cancer diagnosis (by ICD–9 code) 

for primary and secondary cancers 

(c) Date of cancer diagnosis 

(d) Gender 

(e) Race/ethnicity (if the claim is for 

skin cancer or a secondary cancer for 

which skin cancer is a likely primary 

cancer) 

(f) Smoking history (if the claim is for 

lung cancer or a secondary cancer for 

which lung cancer is a likely primary 

cancer) 

§ 81.6 Use of radiation dose information. 

Determining probability of causation 

will require the use of radiation dose 

information provided to DOL by the 

National Institute for Occupational 

Safety and Health (NIOSH) under HHS 

regulations 42 CFR part 82. This 

information will include annual dose 

estimates for each year in which a dose 

was incurred, together with uncertainty 

distributions associated with each dose 

estimate. Dose estimates will be 

distinguished by type of radiation (low 

linear energy transfer (LET), protons, 

neutrons, alpha, low-energy x-ray) and 

by dose rate (acute or chronic) for 

external and internal radiation dose. 

Subpart D—Requirements for Risk 

Models Used To Estimate Probability 

of Causation 

§ 81.10 Use of cancer risk assessment 

models in NIOSH IREP. 

(a) The risk models used to estimate 

probability of causation for covered 

employees under EEOICPA will be 

based on risk models updated from the 

1985 NIH Radioepidemiological Tables. 

These 1985 tables were developed from 

analyses of cancer mortality risk among 

the Japanese atomic bomb survivor 

cohort. The National Cancer Institute 

(NCI) and Centers for Disease Control 

and Prevention (CDC) are updating the 

tables, replacing them with a 

sophisticated analytic software program. 

This program, the Interactive 

RadioEpidemiological Program (IREP)1, 

models the dose-response relationship 

between ionizing radiation and 33 

cancers using morbidity data from the 

same Japanese atomic bomb survivor 

cohort. In the case of thyroid cancer, 

radiation risk models are based on a 

pooled analysis of several international 

cohorts1a. 

(b) NIOSH will change the risk 

models in IREP, as needed, to reflect the 

radiation exposure and disease 

experiences of employees covered under 

EEOICPA, which differ from the 

experiences of the Japanese atomic 

bomb survivor cohort. Changes will be 

incorporated in a version of IREP named 

NIOSH–IREP, specifically designed for 

adjudication of claims under EEOICPA. 

Possible changes in IREP risk models 

include the following: 

(1) Addition of risk models to IREP, 

as needed, for claims under EEOICPA 

(e.g., malignant melanoma and other 

skin cancers) 

(2) Modification of IREP risk models 

to incorporate radiation exposures 

unique to employees covered by 

EEOICPA (e.g., radon and low energy x 

rays from employer-required medical 

screening programs, adjustment of 

relative biological effectiveness 

distributions based on neutron energy). 

(3) Modification of IREP risk models 

to incorporate new understanding of 

radiation-related cancer effects relevant 

to employees covered by EEOICPA (e.g., 

incorporation of inverse dose-rate 

relationship between high LET radiation 

exposures and cancer; adjustment of the 

low-dose effect reduction factor for 

acute exposures). 

(4) Modification of IREP risk models 

to incorporate new understanding of the 

potential interaction between cancer 

risk associated with occupational 

exposures to chemical carcinogens and 

radiation-related cancer effects. 

(5) Modification of IREP risk models 

to incorporate temporal, race and 

ethnicity-related differences in the 

frequency of certain cancers occurring 

generally among the U.S. population. 

(6) Modifications of IREP to facilitate 

improved evaluation of the uncertainty 

distribution for the probability of 

causation for claims based on two or 

more primary cancers. 

§ 81.11 Use of uncertainty analysis in 

NIOSH–IREP. 

(a) EEOICPA requires use of the 

uncertainty associated with the 

probability of causation calculation, 

specifically requiring the use of the 

upper 99% confidence interval 

(credibility limit) estimate of the 

probability of causation estimate. As 

described in the NCI document,2 

uncertainty from several sources is 

incorporated into the probability of 

causation calculation performed by 

NIOSH–IREP. These sources include 

uncertainties in estimating: radiation 

dose incurred by the covered employee; 

the radiation dose-cancer relationship 

(statistical uncertainty in the specific 

cancer risk model); the extrapolation of 

risk (risk transfer) from the Japanese to 

the U.S. population; differences in the 

amount of cancer effect caused by 

different radiation types (relative 

biological effectiveness or RBE); the 

relationship between the rate at which 

a radiation dose is incurred and the 

level of cancer risk produced (dose and 

dose rate effectiveness factor or DDREF); 

and, the role of non-radiation risk 

factors (such as smoking history). 

(b) NIOSH–IREP will operate 

according to the same general protocol 

as IREP for the analysis of uncertainty. 

It will address the same possible sources 

of uncertainty affecting probability of 

causation estimates, and in most cases 

will apply the same assumptions 

incorporated in IREP risk models. 

Different procedures and assumptions 

will be incorporated into NIOSH–IREP 

as needed, according to the criteria 

outlined under § 81.10. 

§ 81.12 Procedure to update NIOSH–IREP. 

(a) NIOSH may periodically revise 

NIOSH–IREP to add, modify, or replace 

cancer risk models, improve the 

modeling of uncertainty, and improve 

the functionality and user-interface of 

NIOSH–IREP. 

(b) Revisions to NIOSH–IREP may be 

recommended by the following sources: 

(1) NIOSH, 

(2) The Advisory Board on Radiation 

and Worker Health, 

(3) Independent reviews of NIOSH– 

IREP or elements thereof by scientific 

organizations (e.g., National Academy of 

Sciences), 

(4) DOL, 

(5) Public comment. 

(c) NIOSH will submit substantive 

changes to NIOSH–IREP (changes that 

would substantially affect estimates of 

probability of causation calculated using 

NIOSH–IREP, including the addition of 

new cancer risk models) to the Advisory 

Board on Radiation and Worker Health 

for review. NIOSH will obtain such 

review and address any 

recommendations of the review before 

completing and implementing the 

change. 

1a Ron E, Lubin JH, Shore RE, et al. ‘‘Thyroid 1 NIOSH–IREP is available for public review on cancer after exposure to external radiation: a pooled 2 Draft Report of the NCI–CDC Working Group to 

the NIOSH homepage at: www.cdc.gov/niosh/ocas/ analysis of seven studies.’’ Radiat. Res. 141:259– Revise the 1985 NIH Radioepidemiological Tables, 

ocasirep/html. 277, 1995. May 31, 2000, p. 17–18, p. 22–23. 

22312 Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 

(d) NIOSH will inform the public of 

proposed changes provided to the 

Advisory Board for review. HHS will 

provide instructions for obtaining 

relevant materials and providing public 

comment in the notice announcing the 

Advisory Board meeting, published in 

the Federal Register. 

(e) NIOSH will publish periodically a 

notice in the Federal Register informing 

the public of proposed substantive 

changes to NIOSH–IREP currently under 

development, the status of the proposed 

changes, and the expected completion 

dates. 

(f) NIOSH will notify DOL and 

publish a notice in the Federal Register 

notifying the public of the completion 

and implementation of substantive 

changes to NIOSH–IREP. In the notice, 

NIOSH will explain the effect of the 

change on estimates of probability of 

causation and will summarize and 

address relevant comments received by 

NIOSH. 

(g) NIOSH may take into account 

other factors and employ other 

procedures than those specified in this 

section, if circumstances arise that 

require NIOSH to implement a change 

more immediately than the procedures 

in this section allow. 

Subpart E—Guidelines To Estimate 

Probability of Causation 

§ 81.20 Required use of NIOSH–IREP. 

(a) NIOSH–IREP is an interactive 

software program for estimating 

probability of causation for covered 

employees seeking compensation for 

cancer under EEOICPA, other than as 

members of the Special Exposure Cohort 

seeking compensation for a specified 

cancer. 

(b) DOL is required to use NIOSH– 

IREP to estimate probability of causation 

for all cancers, as identified under 

§§ 81.21 and 81.23. 

§ 81.21 Cancers requiring the use of 

NIOSH–IREP. 

(a) DOL will calculate probability of 

causation for all cancers, except chronic 

lymphocytic leukemia as provided 

under § 81.30, using NIOSH–IREP. 

(b) Carcinoma in situ (ICD–9 codes 

230–234), neoplasms of uncertain 

behavior (ICD–9 codes 235–238), and 

neoplasms of unspecified nature (ICD– 

9 code 239) are assumed to be 

malignant, for purposes of estimating 

probability of causation. 

(c) All secondary and unspecified 

cancers of the lymph node (ICD–9 code 

196) shall be considered secondary 

cancers (cancers resulting from 

metastasis of cancer from a primary 

site). For claims identifying cancers of 

the lymph node, Table 1 in § 81.23 

provides guidance for assigning a 

primary site and calculating probability 

of causation using NIOSH–IREP. 

§ 81.22 General guidelines for use of 

NIOSH–IREP. 

DOL will use procedures specified in 

the NIOSH–IREP Operating Guide to 

calculate probability of causation 

estimates under EEOICPA. The guide 

provides current, step-by-step 

instructions for the operation of IREP. 

The procedures include entering 

personal, diagnostic, and exposure data; 

setting/confirming appropriate values 

for variables used in calculations; 

conducting the calculation; and, 

obtaining, evaluating, and reporting 

results. 

§ 81.23 Guidelines for cancers for which 

primary site is unknown. 

(a) In claims for which the primary 

cancer site cannot be determined, but a 

site of metastasis is known, DOL will 

calculate probability of causation 

estimates for various likely primary 

sites. Table 1, below, indicates the 

primary cancer site(s) DOL will use in 

NIOSH–IREP when the primary cancer 

site is unknown. 

Table 1 

Primary cancers (ICD–9 codes 3) for 

which probability of causation is to be 

calculated, if only a secondary cancer 

site is known. ‘‘M’’ indicates cancer site 

should be used for males only, and ‘‘F’’ 

indicates the cancer site should be used 

for females only. A glossary of cancer 

descriptions for each ICD–9 code is 

provided in Appendix A to this part. 

Secondary cancer (ICD–9 code) ICD–9 code of likely primary cancers 

Lymph nodes of head, face and neck (196.0) ... 141, 142 (M), 146 (M), 149 (F), 161 (M), 162, 172, 173, 174 (F), 193 (F). 

Intrathoracic lymph nodes (196.1) ...................... 150 (M), 162, 174 (F). 

Intra-abdominal lymph nodes (196.2) ................. 150 (M), 151 (M), 153, 157 (F), 162, 174 (F), 180 (F), 185 (M), 189, 202 (F). 

Lymph nodes of axilla and upper limb (196.3) ... 162, 172, 174 (F). 

Inguinal and lower limb lymph nodes (196.5) .... 154 (M), 162, 172, 173 (F), 187 (M). 

Intrapelvic lymph nodes (196.6) ......................... 153 (M), 154 (F), 162 (M), 180 (F), 182 (F), 185 (M), 188. 

Lymph nodes of multiple sites (196.8) ............... 150 (M), 151 (M), 153 (M), 162, 174 (F). 

Lymph nodes, site unspecified (196.9) .............. 150 (M), 151, 153, 162, 172, 174 (F), 185 (M). 

Lung (197.0) ....................................................... 153, 162, 172 (M), 174 (F), 185 (M), 188 (M), 189. 

Mediastinum (197.1) ........................................... 150 (M), 162, 174 (F). 

Pleura (197.2) ..................................................... 150 (M), 153 (M), 162, 174 (F), 183 (F), 185 (M), 189 (M). 

Other respiratory organs (197.3) ........................ 150, 153 (M), 161, 162, 173 (M), 174 (F), 185 (M), 193 (F). 

Small intestine, including duodenum (197.4) ..... 152, 153, 157, 162, 171, 172 (M), 174 (F), 183 (F), 189 (M). 

Large intestine and rectum (197.5) .................... 153, 154, 162, 174 (F), 183 (F), 185 (M). 

Retroperitoneum and peritoneum (197.6) .......... 151, 153, 154 (M), 157, 162 (M), 171, 174 (F), 182 (F), 183 (F). 

Liver, specified as secondary (197.7) ................ 151 (M), 153, 154 (M), 157, 162, 174 (F). 

Other digestive organs (197.8) ........................... 150 (M), 151, 153, 157, 162, 174 (F), 185 (M). 

Kidney (198.0) .................................................... 153, 162, 174 (F), 180 (F), 185 (M), 188, 189, 202 (F). 

Other urinary organs (198.1) .............................. 153, 174 (F), 180 (F), 183 (F), 185 (M), 188, 189 (F). 

Skin (198.2) ........................................................ 153, 162, 171 (M), 172, 173 (M), 174 (F), 189 (M). 

Brain and spinal cord (198.3) ............................. 162, 172 (M), 174 (F). 

Other parts of nervous system (198.4) .............. 162, 172 (M), 174 (F), 185 (M), 202. 

Bone and bone marrow (198.5) ......................... 162, 174 (F), 185 (M). 

Ovary (198.6) ...................................................... 153 (F), 174 (F), 183 (F). 

Suprarenal gland (198.7) .................................... 153 (F), 162, 174 (F). 

Other specified sites (198.8) .............................. 153, 162, 172 (M), 174 (F), 183 (F), 185 (M), 188 (M). 

3 The International Classification of Diseases [1991] Department of Health and Human Services Publication No. (PHS) 91–1260, U.S. Government

Clinical Modification (9th Revision) Volume I&II. Printing Office, Washington D.C.

Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 22313 

(b) DOL will select the site producing 

the highest estimate for probability of 

causation to adjudicate the claim. 

§ 81.24 Guidelines for leukemia. 

(a) For claims involving leukemia, 

DOL will calculate one or more 

probability of causation estimates from 

up to three of the four alternate 

leukemia risk models included in 

NIOSH–IREP, as specified in the 

NIOSH–IREP Operating Guide. These 

include: ‘‘Leukemia, all types except 

CLL’’ (IDC–9 codes: 204–208, except 

204.1), ‘‘acute lymphocytic leukemia’’ 

(ICD–9 code: 204.0), and ‘‘acute 

myelogenous leukemia’’ (ICD–9 code: 

205.0). 

(b) For leukemia claims in which DOL 

calculates multiple probability of 

causation estimates, as specified in the 

NIOSH–IREP Operating Guide, the 

probability of causation estimate DOL 

assigns to the claim will be based on the 

leukemia risk model producing the 

highest estimate for probability of 

causation. 

§ 81.25 Guidelines for claims including 

two or more primary cancers. 

For claims including two or more 

primary cancers, DOL will use NIOSH– 

IREP to calculate the estimated 

probability of causation for each cancer 

individually. Then DOL will perform 

the following calculation using the 

probability of causation estimates 

produced by NIOSH–IREP: 

EQUATION 1 

Calculate: 1¥[{1×PC1} × {1¥PC2} × 

... × 

{1¥PCn}] = PCtotal, 

where PC1 is the probability of 

causation for one of the primary cancers 

identified in the claim, PC2 is the 

probability of causation for a second 

primary cancer identified in the claim, 

and PCn is the probability of causation 

for the nth primary cancer identified in 

the claim. PCtotal is the probability that 

at least one of the primary cancers 

(cancers 1 through ‘‘n’’) was caused by 

the radiation dose estimated for the 

claim when Equation 1 is evaluated 

based on the joint distribution of PC1, 

. . ., PCn.4 DOL will use the probability 

of causation value calculated for PCtotal 

to adjudicate the claim. 

§ 81.30 Non-radiogenic cancers 

The following cancers are considered 

non-radiogenic for the purposes of 

EEOICPA and this part. DOL will assign 

a probability of causation of zero to the 

following cancers: 

(a) Chronic lymphocytic leukemia 

(ICD–9 code: 204.1) 

(b) [Reserved] 

—————— 4 Evaluating Equation 1 based on the 

individual upper 99th percentiles of PC1, 

. . ., PCn approximates the upper 99th 

percentile of PCtotal whenever PC1, . . ., PCn 

are highly related, e.g., when a common 

dose-reconstruction is the only nonnegligible source of uncertainty in the 

individual PCi’s. However, this 

approximation can overestimate it if other 

sources of uncertainty contribute 

independently to the PC1, . . ., PCn, whereas 

treating the joint distribution as fully 

independent could substantially 

underestimate the upper 99th percentile of 

PCtotal whenever the individual PCi’s are 

positively correlated. 

APPENDIX A TO PART 81—GLOSSARY OF ICD–9 CODES AND THEIR CANCER DESCRIPTIONS 1 

ICD–9 code 

140 ......................................
 

141 ......................................
 

142 ......................................
 

143 ......................................
 

144 ......................................
 

145 ......................................
 

146 ......................................
 

147 ......................................
 

148 ......................................
 

149 ......................................
 

150 ......................................
 

151 ......................................
 

152 ......................................
 

153 ......................................
 

154 ......................................
 

155 ......................................
 

156 ......................................
 

157 ......................................
 

158 ......................................
 

159 ......................................
 

160 ......................................
 

161 ......................................
 

162 ......................................
 

163 ......................................
 

164 ......................................
 

165 ......................................
 

170 ......................................
 

171 ......................................
 

172 ......................................
 

173 ......................................
 

174 ......................................
 

175 ......................................
 

179 ......................................
 

180 ......................................
 

181 ......................................
 

182 ......................................
 

183 ......................................
 

184 ......................................
 

185 ......................................
 

186 ......................................
 

Cancer description 

Malignant neoplasm of lip.
 

Malignant neoplasm of tongue.
 

Malignant neoplasm of major salivary glands.
 

Malignant neoplasm of gum.
 

Malignant neoplasm of floor of mouth.
 

Malignant neoplasm of other and unspecified parts of mouth.
 

Malignant neoplasm of oropharynx.
 

Malignant neoplasm of nasopharynx.
 

Malignant neoplasm of hypopharynx.
 

Malignant neoplasm of other and ill-defined sites within the lip, oral cavity, and pharynx.
 

Malignant neoplasm of esophagus.
 

Malignant neoplasm of stomach.
 

Malignant neoplasm of small intestine, including duodenum.
 

Malignant neoplasm of colon.
 

Malignant neoplasm of rectum, rectosigmoid junction, and anus.
 

Malignant neoplasm of liver and intrahepatic bile ducts.
 

Malignant neoplasm of gall bladder and extrahepatic bile ducts.
 

Malignant neoplasm of pancreas.
 

Malignant neoplasm of retroperitoneum and peritoneum.
 

Malignant neoplasm of other and ill-defined sites within the digestive organs and peritoneum.
 

Malignant neoplasm of nasal cavities, middle ear, and accessory sinuses.
 

Malignant neoplasm of larynx.
 

Malignant neoplasm of trachea, bronchus and lung.
 

Malignant neoplasm of pleura.
 

Malignant neoplasm of thymus, heart, and mediastinum.
 

Malignant neoplasm of other and ill-defined sites within the respiratory system and intrathoracic organs.
 

Malignant neoplasm of bone and articular cartilage.
 

Malignant neoplasm of connective and other soft tissue.
 

Malignant melanoma of skin.
 

Other malignant neoplasms of skin.
 

Malignant neoplasm of female breast.
 

Malignant neoplasm of male breast.
 

Malignant neoplasm of uterus, part unspecified.
 

Malignant neoplasm of cervix uteri.
 

Malignant neoplasm of placenta.
 

Malignant neoplasm of body of uterus.
 

Malignant neoplasm of ovary and other uterine adnexa.
 

Malignant neoplasm of other and unspecified female genital organs.
 

Malignant neoplasm of prostate.
 

Malignant neoplasm of testis.
 

22314 Federal Register / Vol. 67, No. 85 / Thursday, May 2, 2002 / Rules and Regulations 

APPENDIX A TO PART 81—GLOSSARY OF ICD–9 CODES AND THEIR CANCER DESCRIPTIONS 1—Continued 

ICD–9 code 

187 ......................................
 

188 ......................................
 

189 ......................................
 

190 ......................................
 

191 ......................................
 

192 ......................................
 

193 ......................................
 

194 ......................................
 

195 ......................................
 

196 ......................................
 

197 ......................................
 

198 ......................................
 

199 ......................................
 

200 ......................................
 

201 ......................................
 

202 ......................................
 

203 ......................................
 

204 ......................................
 

205 ......................................
 

206 ......................................
 

207 ......................................
 

208 ......................................
 

Cancer description 

Malignant neoplasm of penis and other male genital organs.
 

Malignant neoplasm of urinary bladder.
 

Malignant neoplasm of kidney and other unspecified urinary organs.
 

Malignant neoplasm of eye.
 

Malignant neoplasm of brain.
 

Malignant neoplasm of other and unspecified parts of nervous system.
 

Malignant neoplasm of thyroid gland.
 

Malignant neoplasm of other endocrine glands and related structures.
 

Malignant neoplasm of other and ill-defined sites.
 

Secondary and unspecified malignant neoplasm of the lymph nodes.
 

Secondary malignant neoplasm of the respiratory and digestive organs.
 

Secondary malignant neoplasm of other tissue and organs.
 

Malignant neoplasm without specification of site.
 

Lymphosarcoma and reticulosarcoma.
 

Hodgkin’s disease.
 

Other malignant neoplasms of lymphoid and histiocytic tissue.
 

Multiple myeloma and other immunoproliferative neoplasms.
 

Lymphoid leukemia
 

Myeloid leukemia.
 

Monocytic leukemia.
 

Other specified leukemia.
 

Leukemia of unspecified cell type.
 

1 The International Classification of Diseases Clinical Modification (9th Revision) Volume I&II. [1991] Department of Health and Human Services Publication No. (PHS) 91–1260, U.S. Government Printing Office, Washington, D.C. 

Dated: April 10, 2002. 

Tommy G. Thompson, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 02–10764 Filed 4–30–02; 8:45 am] 

BILLING CODE 4160–17–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 82 

RIN 0920–ZA00 

Methods for Radiation Dose 

Reconstruction 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 rule implements select 

provisions of the Energy Employees 

Occupational Illness Compensation 

Program Act of 2000 (‘‘EEOICPA’’ or 

‘‘Act’’). The Act requires the 

promulgation of methods, in the form of 

regulations, for estimating the dose 

levels of ionizing radiation incurred by 

workers in the performance of duty for 

nuclear weapons production programs 

of the Department of Energy and its 

predecessor agencies. These ‘‘dose 

reconstruction’’ methods will be applied 

by the National Institute for 

Occupational Safety and Health, which 

is responsible for producing the 

radiation dose estimates that the U.S. 

Department of Labor will use in 

adjudicating certain cancer claims 

under the Act. 

DATES: Effective Date: This final rule is 

effective May 2, 2002. 

Compliance Dates: Affected parties 

are required to comply with the 

information collection requirements in 

§ 82.10 May 2, 2002. 

FOR FURTHER INFORMATION CONTACT: 

Larry Elliott, Director, Office of 

Compensation Analysis and Support, 

National Institute for Occupational 

Safety and Health, 4676 Columbia 

Parkway, MS-R45, Cincinnati, OH 

45226, Telephone 513–841–4498 (this is 

not a toll-free number). Information 

requests may also be submitted by email to OCAS@CDC.GOV. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Statutory Authority 

The Energy Employees Occupational 

Illness Compensation Program Act of 

2000 (‘‘EEOICPA’’), 42 U.S.C. 7384– 

7385 [1994, supp. 2001], established a 

compensation program to provide a 

lump sum payment of $150,000 and 

medical benefits as compensation to 

covered employees suffering from 

designated illnesses (i.e. cancer 

resulting from radiation exposure, 

chronic beryllium disease, or silicosis) 

incurred as a result of their exposures 

while in the performance of duty for the 

Department of Energy (‘‘DOE’’) and 

certain of its vendors, contractors, and 

subcontractors. This law also provided 

for payment of compensation to certain 

survivors of covered employees. 

EEOICPA instructed the President to 

designate one or more federal agencies 

to carry out the compensation program. 

Pursuant to this statutory provision, the 

President issued Executive Order 13179, 

titled 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 (Dec. 7, 2000). 

DOL published an interim final rule 

governing DOL’s administration of 

EEOICPA on May 25, 2001 (20 CFR 

parts 1 and 30). 

The executive order directed the 

Department of Health and Human 

Services (‘‘HHS’’) to perform several 

technical and policymaking roles in 

support of the DOL program: 

(1) HHS is to develop methods to 

estimate radiation doses (‘‘dose 

reconstruction’’) for certain individuals 

with cancer applying for benefits under 

the DOL program. These methods are 

the subject of this rule. HHS is also to 

apply these methods to conduct the 

program of dose reconstructions 

required by EEOICPA. This program is 

delegated to the National Institute for 

Occupational Safety and Health 

(‘‘NIOSH’’), an institute of the Centers 

for Disease Control and Prevention. 

(2) HHS is also to develop guidelines 

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 duties at a DOE facility or atomic