R.W. Field SEC Proposed Rule Comments

Ill. Section 83.13 (b)(1) (ii) states in general, to establish a positive finding under
paragraph (b)(1)(i) of this section would require, at a minimum, that NIOSH have
access to reliable information on the identity or set of possible identities and
maximum quantity of each radioisotope (the radioactive source material) to which
members of the class were potentially exposed without adequate protection.

QUESTIONS

1. How will the range of possible exposures be determined?

2. What methods will be used to assess reliability and validity of maximum
quantities of radioisotopes used 30 to 50 years ago and the chemical form of
the radioisotope?

3. How will the adequate worker protection be documented?

COMMENTS

1. Detailed information is needed to assess exposure such as shielding,
chemical form of the radioisotope, distance between worker and source,
geometry of source material, presence of other materials (for example, Be)
that may alter the form and total activity of the radiation, etc. In my opinion,
it is a fatal flaw in the proposed rule to assume that an investigator 30 to 50
years after the fact can validly reconstruct work conditions and processes
that led to maximal exposures at the time of employment. For example,
even a small cut on an unprotected hand can allow the introduction of lethal
quantities of certain types of radioisotopes commonly handled by AEC
workers. In addition, because of the secrecy of the much of the former
AEC/DOE work especially on bomb construction and dismantlement, much
of the work process information has been intentionally suppressed or
destroyed.

IV. In preamble to the proposed Special Exposure Cohort rule, a statement is made,
“The Health Physics Society further recommended that determinations of the
feasibility of estimating doses with sufficient accuracy be limited to relevant
cancers. This comment reflects the fact that the feasibility of a dose reconstruction
can be specific to certain cancer sites in the body and hence to the type of cancer an
employee incurs. For example, internal doses of radiation resulting from inhalation,
ingestion, or absorption of internal emitters, such as radon progeny or uranium, only
concentrate and significantly irradiate certain organs and tissues. Hence, it may be
appropriate to limit the finding that it is not feasible to estimate radiation doses with


R.W. Field SEC Proposed Rule Comments

month, even though researchers knew in the 1960’s (Zelac R.E. 1968) that
because of neutron fading, dosimeters should not be worn for more than 2
weeks.

3. Additional information is needed in the rule to establish and assess the basic
requirements for reliable dosimetry.

Examples of the type of information needed to assess reliability follow:

a. Control dosimeter information and control charts to assess accuracy and
precision of detector

b. Logs of temperature and resulting effects on dose recording during the
exposure process and how temperature effects adjustments were
performed.

c. Information on chemicals in the work area and their effect on the film

d. Information on the variations in the latency period between film exposures
and film processing (image degradation) |

e. The variations in the chemical composition of mixtures used to develop
and fix the film

f. Calibration comparisons between real time instrumentation and control
films

g. Information on the film treatment and storage duration prior to usage

h. Duration of detector exposure period (neutron fading, etc.)

i. Documentation of the ability of dosimetry to detect the type and spectrum
of radiation encountered in the workplace

j. Complete documentation of external exposures including extremity
exposure information

k. etc.

COMMENT - THE NEED FOR RELIABLE INTERNAL DOSIMETRY

For internal dosimetry to be reliable, detailed QA/QC records are also
indispensable including other information such as sensitivity of measurement,
sampling frequency, etc. In most cases, these records are non existent in many
facilities prior to the 1980s. While workplace monitoring data may be helpful,
this data is also subject to reliability concerns and may have no correlation with
actual exposures.



R.W. Field SEC Proposed Rule Comments

sufficient accuracy to certain tissue-specific cancer sites relevant to individuals with
specific types of cancers.”

Further, Mr. Katz stated during the March 7, 2003 Radiation Advisory Board
meeting - “It's feasible if we can -- if we have access to sufficient information to
estimate the maximum radiation dose that could have been incurred in plausible
circumstances by any member of the class. If we can put an upper bound on the
dose to the class, then we can do the dose reconstructions. An example of radon
gas. If we can estimate all the radiation doses for an individual except for their
exposure to radon, radon daughters, then the tissue -- the organ that is exposed to
radiation is the lung. And for practical purposes, other tissues, other organs are not
exposed. And we can do a -- in effect, cap the dose for those individuals with
cancers other than lung cancer. We can't do it for lung cancer. And in that case, you
would establish a class that included anyone who has or incurs in the future lung
cancer and was exposed -- was at the site, et cetera.”

COMMENT:

1. Further limitation of cancer types based on the currently known health
effects of a certain type of exposures should proceed very cautiously. Mr.
Katz’s assertion that for all practical purposes other tissues other than the
lung are not exposed is misleading. The lung receives the largest dose from
radon progeny, but radon gas is lipophilic and can expose bone marrow,
brain, testis, breast, etc. Most of our existing knowledge about the adverse
effects of radon exposure comes from radon-exposed underground miners.
It is interesting to note that in many studies of laboratory tadon-exposed
animals; there was a higher rate of mammary tumors than lung tumors. A
causal link between radon exposure and breast cancer would obviously not
be elucidated in male dominated miner studies. Some researchers also think
the doses to the basal cells, particularly where the skin is thin like the face,
are also not negligible. In addition to lung dose reconstruction, the dose
from radon gas and decay products to other organs should be included within
the overall dose reconstruction process.

REFERENCES
Griffith, R.V., Hankins, D.E., Gammage, R.B., Tommasino, L., Wheeler, R.V.

Recent Developments in Personnel Neutron Dosimeters — A Review. Health
Physics, 36: 235-260, 1979.


Page 1 of 1

Miller, Diane M.

From: R. William Field [bill-field@uiowa.edu]

Sent: Tuesday, May 06, 2003 11:50 PM

To: NIOCINDOCKET@CDC.GOV.

Subject: Comments Regarding Designating Classes of Employees as Members of the Special Exposure
Cohort

Importance: High

Comments Regarding Designating Classes of Employees as Members of the Special Exposure Cohort
Attached.

R. William Field, M.S., Ph.D.
College of Public Health
Department of Epidemiology
University of Iowa

Towa City,IA 52242
319-335-4413 (phone)
319-335-4748 (fax)

http://myprofile.cos.com/Fieldrw

5/8/2003


R.W. Field SEC Proposed Rule Comments

Larson, H.V., Unruh, C.M., Beetle T.M., Keene, A.R. Factors Involved in
Establishing Film Dosimeter Performance Criteria, in Radiation Dose
Measurements, Their Purpose, Interpretation, and Required Accuracy in
Radiological Protection. European Nuclear Energy Agency, pp. 191- 208, 1967.

Sims, C.S., Swaja, R.E. Personnel Dosimetry Intercomparisons Studies at the
Health Physics Research Reactor: A Summary (1974-1980). Health Physics, 42(1):
3-18, 1982.

Zelac, R.E. Track Fading in Neutron Personal Monitoring Film under Typical
Conditions, Health Physics, 15:545-548, 1968.



t

fir

THE UNIVERSITY OF IOWA

Comments Regarding the HHS Notice of Proposed Rulemaking for Designating
Classes of Employees as Members of the Special Exposure Cohort Under the
Energy Employees Occupational IlIness Compensation Program Act of 2000

Federal Register Vol. 68, No. 45, pp.11294-11310 (March 7, 2003)

FROM

R. William Field, M.S., Ph.D. , College of Public Health, Department of
Epidemiology, N222 Oakdale Hall, University of Iowa, Iowa City, [A 52242
319-335-4413 (Phone) email:bill-field@uiowa.edu

Scientific Questions and Concerns Regarding the Proposed Rule

I. Section 83.13(b)(1)(i) states that NIOSH will determine that “radiation doses can
be estimated with sufficient accuracy if NIOSH has established that it has access to
sufficient information to estimate the maximum radiation dose that could have been
incurred in plausible circumstances by any member of the class”

QUESTIONS

1. How will NIOSH evaluate whether or not there is sufficient information to
estimate the maximum dose to an individual?

2. What is the scope of information and minimum amount of information
needed to estimate the maximum dose to an individual?

3. What methods of retrospective dose assessment will be allowed in assessing
the maximum dose to an individual?

COMMENTS

1. In order to have consistency between dose assessments for individuals, a
detailed a priori methodology needs to be established prior to any formal
dose reconstruction.

2. Minimum data requirements needed to assess whether or not a valid dose
reconstruction is possible needs to be placed in the public record prior to any
dose reconstruction efforts.



R.W. Field SEC Proposed Rule Comments

II. Section § 83.13 (a) states (a) NIOSH will collect information on the types and
levels of radiation exposures that potential members of the class may have incurred,
as specified under 42 CFR 82.14, from various sources as necessary. Subpart (ii)
states that in general, to establish a positive finding under paragraph (b)(1)(i) of this
section would require, at a minimum, that NIOSH have access to reliable
information on the identity or set of possible identities and maximum quantity of
each radioisotope.

QUESTION
1. What is meant by reliable information?
COMMENTS - THE NEED FOR RELIABLE EXTERRNAL DOSIMETRY

1. For reliable dose assessment, dosimetry must accurately reflect actual
personal exposure (dose). However, studies of film badges, performed under
controlled and ideal conditions, as recent as 1981 indicated that the film
dosimetry, commonly used prior to the 1980s lacked both precision and
accuracy and yielded underestimates of true neutron exposure approaching
80% in some instances (Sims et al. 1982). The radiation dosimetry film in
the 1950s through the mid 1970s produced even less accurate and precise
estimates of the true personal exposure. For example, a study (Larson et al.
1967) of film detector performance performed by Pacific Northwest
Laboratories for the Atomic Energy Commission as late as the mid 1960s
documented that the relative error of the film badge for common types of x-
ray and neutron exposure exceeded 500%.

2. Reliable assessment of neutron exposure is particularly problematic. As
Griffith et al. pointed out in 1979, “Care must be taken when using
dosimeter data to infer the dose or dose-equivalent to the whole body or
individual organs. The data must be augmented by instrumental survey
information if it is to provide a complete picture of personnel exposure.” It
is extremely problematic to get either reliable or valid retrospective exposure
estimates 30 to 50 years after the fact when the instrumental survey
information is no longer available. It is well documented in the scientific
literature the limited energies that neutron dosimetry can record. Even in
cases where the neutron film badge can theoretically record the neutron
activity for a specific energy, historic neutron dosimeters worn for a month
will not produce reliable (accurate) results because of fading. Nonetheless,
AEC/DOE employees often retained the same neutron film dosimetry for a