Federal Register / Vol. 66, No. 194 / Friday, October 5, 2001 / Proposed Rules 50967 

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; Notice of Proposed Rulemaking

AGENCY: Department of Health and 

Human Services. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: This proposal would 

implement 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: Comments: The Department 

invites written comments on this Notice 

of Proposed Rulemaking from interested 

parties. Comments on the Notice of 

Proposed Rulemaking must be received 

by December 4, 2001. 

ADDRESSES: Address written comments 

on the notice of proposed rulemaking to 

the NIOSH Docket Officer. Submit 

comments electronically by e-mail to 

NIOCINDOCKET@CDC.GOV. See 

SUPPLEMENTARY INFORMATION for file 

formats and other information about 

electronic filing. Alternatively, submit 

printed comments to the following 

address: NIOSH Docket Office, Robert 

A. Taft Laboratories; M/S C34, 4676 

Columbia Parkway, Cincinnati, OH 

45226. 

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. Comments Invited 

Interested persons or organizations 

are invited to participate in this 

rulemaking by submitting written views, 

arguments, recommendations, and data. 

Comments are invited on any topic 

related to this rulemaking. Some generic 

topics for comment include the 

following questions: 

(1) Does the proposal make 

appropriate use of current science and 

medicine for evaluating and quantifying 

cancer risks for DOE workers exposed to 

ionizing radiation in the performance of 

duty? 

(2) Does the proposal appropriately 

adapt compensation policy as it has 

been applied for the compensation of 

veterans with radiation exposure from 

atomic bombs to compensation policy 

for radiation-exposed nuclear weapons 

production workers? 

(3) Does the proposal appropriately 

and adequately address the need to 

ensure procedures under this rule 

remain current with advances in 

radiation health research? 

Comments should identify the 

author(s), return address, and phone 

number, in case clarification is needed. 

Comments can be submitted by e-mail 

to: NIOCINDOCKET@CDC.GOV. If 

submitting comments by e-mail, they 

should be provided as a Word or Word 

Perfect file attachment. Printed 

comments can also be submitted to the 

address above. The Secretary will 

consider all communications received 

on or before the closing date for 

comments. All comments submitted 

will be available for examination in the 

Rule Docket both before and after the 

closing date for comments. A report 

summarizing each substantive public 

contact with personnel involved in this 

rulemaking will be filed in the docket. 

An electronic docket containing all 

comments submitted by e-mail will be 

available over the Internet on the 

National Institute for Occupational 

Safety and Health (NIOSH) homepage at 

www.cdc.gov/niosh. 

HHS will request the Advisory Board 

on Radiation and Worker Health, an 

advisory committee to HHS established 

under EEOICPA, to conduct a technical 

review of this proposal. Notices 

announcing the meetings of the Board 

will be published in the Federal 

Register. The record for this rulemaking 

will remain open until the Board has 

completed its review. 

II. Final Rule 

The Department of Health and Human 

Services (‘‘HHS’’) expects to issue a 

final rule within six months of 

publication of this notice of proposed 

rulemaking. 

III. Background 

A. Statutory Authority 

The Energy Employees Occupational 

Illness Compensation Program Act of 

2000(‘‘EEOICPA’’), Public Law 106–398, 

114 Stat. 1654, 1654A–1231 (October 

30, 2000), was enacted as Title XXXVI 

of the Floyd D. Spence National Defense 

Authorization Act for Fiscal Year 2001. 

EEOICPA 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 incurred as a result of their 

exposure to radiation, beryllium, or 

silica while in the performance of duty 

for the Department of Energy 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 DOL’s administration of 

EEOICPA on May 25, 2001 (66 FR 

28948). 

The executive order directed 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 proposal. 

(2) HHS is also to develop methods to 

estimate radiation doses (‘‘dose 

reconstruction’’) for certain individuals 

with cancer applying for benefits under 

the DOL program. These methods are 

being published simultaneously with 

this proposal as an interim final rule 

with request for comments under 42 

CFR part 82 in this issue of the Federal 

Register. HHS is to apply 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, will 

50968 Federal Register / Vol. 66, No. 194 / Friday, October 5, 2001 / Proposed Rules 

advise HHS in implementing its roles 

under EEOICPA described here. 

(4) Finally, HHS is to develop and 

apply procedures for considering 

petitions to be added to the Special 

Exposure Cohort established under 

EEOICPA by classes of employees. 

Employees included in the Special 

Exposure Cohort who have a specified 

cancer and meet other conditions, as 

defined by EEOICPA and DOL 

regulations (66 FR 28948), qualify for 

compensation under EEOICPA. HHS 

procedures for considering Special 

Exposure Cohort petitions are under 

development. HHS expects to issue 

these procedures within the next six 

months. 

As provided for under section 3625 of 

EEOICPA, 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 proposed guidelines would 

not constitute such new standards. 

C. Statutory Requirements for 

Probability of Causation Guidelines 

Section 3623(c) of EEOICPA makes 

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’’ (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 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. It is also important to 

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 proposal, 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 

Radioepidemiological Tables and 

Interactive RadioEpidemiological 

Program (IREP) 

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. DOL will 

employ the updated version of the 

tables, with certain additional 

modifications important to claims under 

EEOICPA (described under ‘‘G’’ below), 

as a basis for determining probability of 

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. 

Federal Register / Vol. 66, No. 194 / Friday, October 5, 2001 / Proposed Rules 50969 

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 

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. 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 

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. The risk model for 

lung cancer takes into account smoking 

history as well. 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 is 

proposing 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 

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. 

site of cancer is unknown, the primary 

site must be established by inference to 

estimate probability of causation. 

HHS is proposing to establish such 

assignments in these guidelines, based 

on an evaluation 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, the set of primary cancers 

producing approximately 75% of that 

secondary cancer among the U.S. 

population was identified (males and 

females were considered separately). 

The sets are tabulated in this rule (Table 

1). HHS is proposing that the final 

assignment of a primary cancer site for 

an individual claim would be 

determined by DOL on a case-by-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 proposal, 

instead of determining the probability 

that each cancer was caused by 

radiation, DOL would have to 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 

IREP is being developed 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 

50970 Federal Register / Vol. 66, No. 194 / Friday, October 5, 2001 / Proposed Rules 

employees covered by EEOICPA differs 

substantially. 

Some employees covered by EEOICPA 

were substantially 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 dose-rate 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 will 

modify 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 will modify IREP for DOE 

workers to include different RBE 

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 

69:494–500, 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. 

distributions for neutrons of various 

energies. 

The currently-available 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 

is incorporating a lung cancer model for 

radon exposures into the revised version 

of IREP. The data source for this model 

is the analysis conducted by the federal 

Radiation Exposure Compensation Act 

Committee.8 

NIOSH will modify IREP to eliminate 

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. 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 requires NIOSH to 

add to IREP an RBE distribution 

appropriate to the low-energy form of 

radiation produced from some of these 

x rays.10 

There is no risk model in IREP for 

estimating the probability of causation 

of bone cancer by high-LET radiation 

exposure. Research has found bone 

cancer risk substantially and 

significantly elevated among animals 

and humans exposed to certain forms of 

high-LET radiation.11 NIOSH will add a 

risk model for bone cancer, based on 

recently completed assessments of risks 

associated with plutonium exposures.12 

Limitations of current research and 

development have prevented NIOSH 

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. 

from considering and implementing all 

possible improvements to IREP at the 

time of this proposal. In the future, 

NIOSH may make additional changes in 

IREP to address differences in radiationrelated 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 radiationrelated 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 

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. 

Federal Register / Vol. 66, No. 194 / Friday, October 5, 2001 / Proposed Rules 50971 

rates) of certain types of cancer in the 

United States. Certain types of cancer 

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

cancer) have become more frequent in 

recent decades. Similarly, HHS 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, 

skin cancers). The effect of these 

modifications, at such time as they may 

become feasible, 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, 

certain 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 will be available for public review 

on the NIOSH homepage at: 

www.cdc.gov/niosh, by September 30, 

2001. NIOSH–IREP will include 

documentation of underlying risk 

models and calculations. The public 

will also be able to obtain complete 

information about NIOSH–IREP, 

including printed reports, 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 should be 

sent to NIOSH following instructions at 

the NIOSH–IREP web page cited above, 

or by sending printed 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. 

I. Updating NIOSH–IREP 

NIOSH will 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. Primary 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). Further 

description of the rationale for such 

scientific improvements is described 

under paragraph II.G. above. 

Improvements may also be directly 

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 

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. Instructions for obtaining 

relevant materials and providing public 

comment will be provided in the notice 

of the Advisory Board meeting, 

published in the Federal Register. 

J. Public notice on plans and changes 

implemented to update 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 the 

public of substantial 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). In the notice, 

NIOSH will address relevant comments 

received by NIOSH. 

K. 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. 

An initial version of the NIOSH–IREP 

Operating Guide will be available to the 

public online on the NIOSH homepage 

at: www.cdc.gov/niosh, by September 

30, 2001. The public will be able to 

obtain printed copies by contacting 

NIOSH at its toll-free telephone 

information service: 1–800–35–NIOSH 

(1–800–356–4674). 

L. Cancer Unrelated to Radiation 

Chronic lymphocytic leukemia (CLL) 

is a form of leukemia not found to be 

radiogenic in studies conducted 

worldwide of a wide variety of 

radiation-exposed populations, 

including the Japanese atomic bomb 

survivors, persons exposed to x rays and 

Thorotrast during medical treatment, 

and nuclear industry workers.14 

Therefore, for the purposes of this 

proposed rule, the probability of 

causation for CLL would be assigned a 

value of zero. HHS may modify this 

provision in response to new scientific 

findings. 

IV. History of Rule Development 

A. NIOSH Research on the Health of 

DOE Workers 

Expert judgment has been applied to 

modify certain IREP risk models and 

develop guidelines for applying these 

models appropriately for employees 

covered by EEOICPA. An important 

basis for this judgment has been the 

research experience of NIOSH and its 

external research partners on radiationrelated cancers among DOE employees 

and U.S. uranium miners. NIOSH has 

conducted a program of federally 

sponsored health research on DOE 

employees since 1991. NIOSH 

completed the principal occupational 

health research establishing lung cancer 

risks associated with radon exposure 

among uranium miners. 

14 Andersson, M, Carstensen B, Visfeldt J. 

‘‘Leukemia and other related hematological 

disorders among Danish patients exposed to 

Thorotrast.’’ Radiat Res 134:224–233, 1993. 

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. 

Curtis RE, Boice JD Jr, Stovall M, et al. 

‘‘Relationship of leukemia risk to radiation dose 

following cancer of the uterine corpus.’’ J Natl Canc 

Inst 86:1315–1324, 1994. 

Darby SC Doll R, Gill SK, et al. ‘‘Long-term 

mortality after a single treatment course with x rays 

in patients treated for ankylosing spondylitis.’’ Br 

J Cancer 55:179–190, 1987. 

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 p, 

2001. 

Muirhead CR, Goodill AA, Haylock RGE et al. 

‘‘Occupational radiation exposure and mortality 

second analysis of the National Registry for 

Radiation Workers.’’ J Radiol Prot 19:3–26, 1999. 

Preston DL, Kusumi S, Tomonaga M, et al. 

‘‘Cancer incidence in atomic bomb survivors. Part 

III: Leukemia, lymphoma and multiple myeloma, 

1950–1987.’’ Radiat Res 137:S68–S97, 1994. 

50972 Federal Register / Vol. 66, No. 194 / Friday, October 5, 2001 / Proposed Rules 

B. Relationship With NCI–CDC Update 

of Radioepidemiological Tables 

Within HHS, NIOSH and NCI have 

worked closely together to adapt the 

NCI–CDC update of the 

radioepidemiological tables, developed 

as IREP, to meet as many of the needs 

of employees covered by EEOICPA as 

possible. Some potential changes could 

not be accomplished before initial 

implementation of the compensation 

program under EEOICPA. NIOSH and 

NCI will continue collaborating to 

address these needs. Other changes 

uniquely useful for employees covered 

by EEOICPA, as discussed in this 

Preamble, will be incorporated into the 

version of IREP designed specifically for 

employees covered by EEOICPA. 

C. Technical Review by the Advisory 

Board on Radiation and Worker Health 

NIOSH anticipates that the guidelines 

in this proposed rule will be reviewed 

by the Advisory Board on Radiation and 

Worker Health, which is required by 

Section 3623(c) of EEOICPA. HHS will 

consider any findings of this review in 

promulgating the final regulation. 

D. Consultation With Experts and 

Interested Parties 

HHS has consulted individually with 

a wide variety of experts and interested 

parties to help ensure the quality and 

practicality of these guidelines. Reports 

on these consultations are available in 

the regulatory docket for public review. 

V. Summary of Proposed 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 proposed 

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. 

Introduction 

Sections 81.0 and 81.1 briefly 

describe how this proposed 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 proposed rule. 

Definitions 

This section of the regulation 

proposes definitions for 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. 

Data Required To Estimate Probability 

of Causation 

Sections 81.5 and 81.6 propose 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 (published in this issue 

of the Federal Register), which is being 

promulgated concurrently with this 

proposed rule. 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 the 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). IREP is discussed 

extensively above. These sections also 

propose criteria by which these risk 

models may be changed to ensure that 

probability of causation estimates 

calculated by EEOICPA represent the 

unique exposure and disease 

experiences of employees covered by 

EEOICPA. HHS seeks comments on 

these criteria. 

Guidelines To Estimate Probability of 

Causation 

Sections 81.20 and 81.21 propose 

requiring 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 proposes requiring 

DOL to assume carcinoma in situ (ICD– 

9 15 codes 230–234), neoplasms of 

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

classifying diseases that will be used by IREP. The 

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. HHS seeks comment on these 

assumptions and any conditions or 

limitations that should be considered 

with regard to these assumptions. 

Sections 81.22–81.25 propose 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 

limitation of the data on Japanese 

atomic bomb survivors, as discussed 

previously in this proposal. 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 would require use of both the 

general model and the specific model. 

The guidelines propose requiring DOL 

to use the findings of whichever model 

produces the higher probability of 

causation estimate. 

HHS seeks comments on the strategies 

adopted in this proposed rule to address 

each of these special circumstances, and 

on other needs not identified in this 

proposal. 

Section 81.30 proposes nonradiogenic cancers for which DOL 

would assign a value of zero to the 

probability of causation. Chronic 

Lymphocytic Leukemia (ICD–9 Code: 

204.1) is the only cancer specified. HHS 

is seeking comments on this section. 

The public should be aware that the 

addition of cancers to this section 

would require broadly established 

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. 

Federal Register / Vol. 66, No. 194 / Friday, October 5, 2001 / Proposed Rules 50973 

consensus of non-radiogenicity among 

the medical and scientific communities. 

VI. 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 proposed rule carefully explains 

the manner in which the regulatory 

action is consistent with the mandate 

for this action under section 3623(c) of 

EEOICPA and implements the detailed 

requirements concerning this action 

under this section of EEOICPA. The 

proposed rule does not interfere with 

State, local, and tribal governments in 

the exercise of their governmental 

functions. 

The proposed rule is not considered 

economically significant, as defined in 

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

12866. This proposal 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). 

VII. 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. We certify that this 

proposed rule will not have a significant 

economic impact on a substantial 

number of small entities within the 

meaning of the RFA. This proposal 

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. 

VIII. 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 

proposed 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 

recordkeeping. Information required by 

DOL to apply these guidelines is being 

provided by HHS and by individual 

claimants to DOL under DOL 

regulations 20 CFR part 30 (see 66 FR 

28948, May 25, 2001). Thus, HHS has 

determined that the PRA does not apply 

to this proposed rule. 

IX. 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 proposed 

rule prior to its effective date. The 

report will state that the Department has 

concluded that this proposed rule is not 

a ‘‘major rule’’ because it is not likely 

to result in an annual effect on the 

economy of $100 million or more. 

However, this proposed 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. 

X. Unfunded Mandates Reform Act of 

1995 

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 proposed 

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. 

XI. Executive Order 12988 (Civil 

Justice) 

This proposed 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 proposal has been 

reviewed carefully to eliminate drafting 

errors and ambiguities. 

XII. Executive Order 13132 

(Federalism) 

The Department has reviewed this 

proposed rule in accordance with 

Executive Order 13132 regarding 

federalism, and has determined that it 

does not have ‘‘federalism 

implications.’’ The proposed 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.’’ 

XIII. 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 proposed rule on children. The 

agency has determined that the rule 

would have no effect on children. 

XIV. 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 proposed rule on energy supply, 

distribution or use, and has determined 

that the rule is not likely to have a 

significant adverse effect on them. 

List of Subjects in 42 CFR Part 81 

Cancer, Government Employees, 

Radiation protection, Radioactive 

materials, Workers’ compensation. 

Text of the Rule 

For the reasons discussed in the 

preamble, the Department of Health and 

Human Services proposes to amend 42 

CFR to add part 81 to read as follows: 

50974 Federal Register / Vol. 66, No. 194 / Friday, October 5, 2001 / Proposed Rules 

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 

rule. 

Subpart B—Definitions

81.4 Definition of terms used in this rule. 

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. 

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; E.O. 13179, 65 

FR 77487. 

Subpart A—Introduction

§ 81.0 Background.

The Energy Employees Occupational 

Illness Compensation Program Act 

(EEOICPA), Pub. L. 106–398, 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 and 30.213 that 

identify current members of the Special 

Exposure Cohort and requirements for 

compensation. Pursuant to section 3626 

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 

related to radiation doses incurred by 

the employee in the performance of 

duty. These guidelines provide the 

procedures DOL must apply and 

identify the information DOL will use. 

(b) Section 3623(b) of EEOICPA 

requires the President to promulgate 

these guidelines. Executive Order 13179 

assigned responsibility for promulgating 

these guidelines to the Secretary of 

Health and Human Services. 

§ 81.2 Provisions of EEOICPA concerning

this rule.

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 rule.

(a) Covered employee: For purposes of 

this rule, 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): 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: 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: The Energy Employees 

Occupational Illness Compensation 

Program Act of 2000, Public Law 106– 

398, as amended. 

(e) Equivalent dose: 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: The portion of the 

equivalent dose that is received from 

radiation sources outside of the body. 

(g) Interactive RadioEpidemiological 

Program (IREP): 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: The portion of the 

equivalent dose that is received from 

radioactive materials taken into the 

body. 

(i) Inverse dose rate effect: 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 

Federal Register / Vol. 66, No. 194 / Friday, October 5, 2001 / Proposed Rules 50975 

dose and dose rate effectiveness factor 

(DDREF) is less than one for chronic or 

low doses. 

(j) Linear energy transfer (LET): 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: 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: A type of 

cancer that HHS has found not to be 

caused by radiation, for the purposes of 

this regulation. 

(m) Primary cancer: 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: 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: 

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): 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: 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: A body site to 

which a primary cancer has spread 

(metastasized). 

(s) Specified cancer: A term defined 

in section 3621(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, 

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), and bone. 

Pursuant to section 2403 of Pub. L. 107– 

20, this definition will include renal 

cancer effective October 1, 2001. 

(t) Uncertainty: 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: 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: A term used in EEOICPA to 

mean credibility limit, the probability of 

causation estimate determined at the 

99th percentile of the range of 

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), 

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 

cohorts.1 

(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., 

bone cancer, 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 

1 Ron E, Lubin JH, Shore RE, et al. ‘‘Thyroid 

cancer after exposure to external radiation: a pooled 

analysis of seven studies.’’ Radiat. Res. 141:259– 

277, 1995. 
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

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


50976 Federal Register / Vol. 66, No. 194 / Friday, October 5, 2001 / Proposed Rules 

to employees covered by EEOICPA (e.g., 

incorporation of inverse dose-rate 

relationship between high LET radiation 

exposures and cancer; removal of the 

low-dose effect reduction factor for 

acute exposures). 

(4) 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. 

(5) 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 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 

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. 

Subpart E—Guidelines To Estimate

Probability of Causation

§ 81.20 Required use of NIOSH–IREP.

(a) NIOSH–IREP is an online 

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 of this section indicates 

the primary cancer site(s) DOL will use 

in NIOSH–IREP when the primary 

cancer site is unknown: 

Table 1—Primary Cancer Sites 

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 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. 

2 Draft Report of the NCI–CDC Working Group to 3 The International Classification of Diseases Publication No. (PHS) 91–1260, U.S. Government

Revise the 1985 NIH Radioepidemiological Tables, Clinical Modification (9th Revision) Volume I&II. Printing Office, Washington, D.C.

May 31, 2000, p. 17–18, p. 22–23. [1991] Department of Health and Human Services

Federal Register / Vol. 66, No. 194 / Friday, October 5, 2001 / Proposed Rules 50977 

Secondary cancer

(ICD–9 code)

Liver, specified as secondary (197.7) ......................................................

Other digestive organs (197.8) .................................................................

Kidney (198.0) ..........................................................................................

Other urinary organs (198.1) ....................................................................

Skin (198.2) ..............................................................................................

Brain and spinal cord (198.3) ...................................................................

Other parts of nervous system, (198.4)

Bone and bone marrow (198.5) ...............................................................

...................................................

Ovary (198.6) ............................................................................................

Suprarenal gland (198.7) ..........................................................................

Other specified sites (198.8) ....................................................................

ICD–9 code of likely primary cancers

151 (M), 153, 154 (M), 157, 162, 174 (F)

150 (M), 151, 153, 157, 162, 174 (F), 185 (M)

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

153, 174 (F), 180 (F), 183 (F), 185 (M), 188, 189 (F)

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

162, 172 (M), 174 (F)

162, 172 (M), 174 (F), 185 (M), 202

162, 174 (F), 185 (M)

153 (F), 174 (F), 183 (F)

153 (F), 162, 174 (F)

153, 162, 172 (M), 174 (F), 183 (F), 185 (M), 188 (M)

(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 

among 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.

(a) For claims including two or more 

primary cancers, DOL will use NIOSHIREP 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 

§ 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: Chronic lymphocytic 

leukemia (ICD–9 code: 204.1). 

Appendix A to Part 81—Glossary of 

ICD–9 Codes and Their Cancer 

Descriptions 

ICD–9

code

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

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 

non-negligible 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. 

ICD–9

code Cancer description

155 ........... Malignant neoplasm of liver and

intrahepatic bile ducts.

156 ........... Malignant neoplasm of gall bladder and extrahepatic bile

ducts.

157 ........... Malignant neoplasm of pancreas.

158 ........... Malignant neoplasm of

retroperitoneum and peritoneum.

159 ........... Malignant neoplasm of other and

ill-defined sites within the digestive organs and peritoneum.

160 ........... Malignant neoplasm of nasal

cavities, middle ear, and accessory sinuses.

161 ........... Malignant neoplasm of larynx.

162 ........... Malignant neoplasm of trachea,

bronchus and lung.

163 ........... Malignant neoplasm of pleura.

164 ........... Malignant neoplasm of thymus,

heart, and mediastinum.

165 ........... Malignant neoplasm of other and

ill-defined sites within the respiratory system and intrathoracic organs.

170 ........... Malignant neoplasm of bone and

articular cartilage.

171 ........... Malignant neoplasm of connective and other soft tissue.

172 ........... Malignant melanoma of skin.

173 ........... Other malignant neoplasms of

skin.

174 ........... Malignant neoplasm of female

breast.

175 ........... Malignant neoplasm of male

breast.

179 ........... Malignant neoplasm of uterus,

part unspecified.

180 ........... Malignant neoplasm of cervix

uteri.

181 ........... Malignant neoplasm of placenta.

182 ........... Malignant neoplasm of body of

uterus.

183 ........... Malignant neoplasm of ovary

and other uterine adnexa.

184 ........... Malignant neoplasm of other and

unspecified female genital organs.

185 ........... Malignant neoplasm of prostate.

186 ........... Malignant neoplasm of testis.

187 ........... Malignant neoplasm of penis

and other male genital organs.

188 ........... Malignant neoplasm of urinary

bladder.
...........


50978 Federal Register / Vol. 66, No. 194 / Friday, October 5, 2001 / Proposed Rules 

ICD–9 Cancer description

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

code

Malignant neoplasm of kidney

and other and unspecified urinary organs.

190 Malignant neoplasm of eye.

191 ........... Malignant neoplasm of brain.

192 ........... Malignant neoplasm of other and

unspecified parts of nervous

system.

193 ........... Malignant neoplasm of thyroid

gland.

194 ........... Malignant neoplasm of other endocrine glands and related

structures.

195 ........... Malignant neoplasm of other and

ill-defined sites.

196 ........... Secondary and unspecified malignant neoplasm of the lymph

nodes.

197 ........... Secondary malignant neoplasm

of the respiratory and digestive organs.

198 ........... Secondary malignant neoplasm

of other tissue and organs.

199 ........... Malignant neoplasm without

specification of site.

200 ........... Lymphosarcoma and

reticulosarcoma.

201 ........... Hodgkin’s disease.

202 ........... Other malignant neoplasms of

lymphoid and histiocytic tissue.

203 ........... Multiple myeloma and other

immunoproliferative neoplasms.

204 ........... Lymphoid leukemia.

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

206 ........... Monocytic leukemia.

Myeloid leukemia.

207 ........... Other specified leukemia.

208 ........... Leukemia of unspecified cell

type.

1The 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, DC.

Dated: September 21, 2001. 

Tommy G. Thompson, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 01–24878 Filed 10–4–01; 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;

Interim Final Rule With Request for

Comments

AGENCY: Department of Health and 

Human Services. 

ACTION: Interim final rule with request 

for comments. 

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 interim final 

rule is effective October 5, 2001. 

Compliance Dates: Affected parties are 

not required to comply with the 

information collection requirements in 

§ 82.10 until the Department of Health

and Human Services publishes in the

Federal Register the control numbers

assigned by the Office of Management

and Budget (OMB) to these information

collection requirements. Publication of

the control numbers notifies the public

that OMB has approved these

information collection requirements

under the Paperwork Reduction Act of

1995.

Comments: The Department invites 

written comments on the interim final 

rule from interested parties. Comments 

on the rule must be received by 

November 5, 2001. Comments on the 

collection of information requirements 

should be received by October 22, 2001. 

ADDRESSES: Address written comments 

on the interim final rule to the NIOSH 

Docket Officer. Submit comments 

electronically by e-mail to 

NIOCINDOCKET@CDC.GOV. See 

SUPPLEMENTARY INFORMATION for file 

formats and other information about 

electronic filing. Alternatively, submit 

printed comments to the following 

address: NIOSH Docket Office, Robert 

A. Taft Laboratories; M/S C34, 4676

Columbia Parkway, Cincinnati, OH 

45226. 

Written comments on the collection of 

information requirements should be 

sent to Anne O’Connor, CDC Assistant 

Reports Clearance Officer, 1600 Clifton 

Road, MS–D24, Atlanta, GA 30333. 

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. Comments Invited

Interested persons or organizations

are invited to participate in this 

rulemaking by submitting written views, 

arguments, recommendations, and data. 

Comments are invited on any topic 

related to this rulemaking. Some generic 

topics for comment include the 

following questions: 

(1) Does the interim rule make

appropriate use of current science for 

conducting dose reconstructions to be 

used in an occupational illness 

compensation program? 

(2) Does the interim rule

appropriately balance the potential 

precision of dose reconstructions and 

the necessary efficiency of the dose 

reconstruction process? 

(3) Does the interim rule implement

an appropriate process for involving the 

claimant in the dose reconstruction? 

Comments should identify the 

author(s), return address, and phone 

number, in case clarification is needed. 

Comments can be submitted by e-mail 

to: NIOCINDOCKET@CDC.GOV. If 

submitting comments by e-mail, they 

should be provided as a Microsoft Word 

or Word Perfect file attachment. Printed 

comments can be submitted to the 

NIOSH Docket Office at the address 

above. The Secretary will consider all 

communications received on or before 

the closing date for comments before 

taking action on the interim final rule. 

All comments submitted will be 

available for examination in the Rule 

Docket both before and after the closing 

date for comments. A report 

summarizing each substantive public 

contact with personnel involved in this 

rulemaking will be filed in the docket. 

An electronic docket containing all 

comments submitted by e-mail will be 

available over the Internet from the 

National Institute for Occupational 

Safety and Health (NIOSH) homepage at 

www.cdc.gov/niosh. 

II. Final Rule

The Department of Health and Human

Services (‘‘HHS’’) expects to issue a 

final rule within six months of 

publication of this interim final rule. 

Upon publication of the final rule, dose 

reconstructions completed under this 

interim final rule will be reviewed and 

revised, as necessary, to conform with 

any substantive changes that might be 

included in the final rule.