publications.

Radiosensitivity is a relativistic-probabalistic concept that | believe has little intrinsic merit in the context of a
clear Congressional intent under EEOICPA. Yes, | am implying that Congress (unintentionally possibly) imposed
unnecessarily arbitrary limits on its own legislation, and that this perhaps well intentioned short-sightedness
should not be further compounded in the NIOSH proposed rule-making by more severely limiting compensable
cancer types. Broad classes of cancer such as "lung cancer" should be construed broadly to include the major
and minor subtypes since ALL of them can be caused by radiation, albeit with varying frequencies in a radiated
population due to inherent genetic and perhaps other environmental influences.

If a former worker develops a rare cancer of "radioresistant tissue" origin that metastasizes widely, is that less
a problem for him than if he/she develops a *acceptable cancer? from the Congressionally-mandated “fixed list? of
22 in his *radiosensitive? organ? Both cancers can maim or kill equally, both metastasize, both cause pain and
suffering and lead to huge medical costs (dwarfing the $150,000 award under EEOICPA) -- is this not the relevant
point?

| totally agree with GAP that no rationale exists why NIOSH has any legal or moral or ethical right to further
restrict the fixed list of 22 compensable cancers. It is likely that many radiation-associated cancers are, in fact,
multifactorial in etiology. Radiation is one necessary factor, but individual suspceptibility is determined by
genetic inherited factors as well as other environmental/chemical toxic exposures (smoking included) which may
add or synergize with radiation as a causative factor. These complex associations are just beginning to be
unraveled in the laboratory and in the clinic. Much is not known.

The key point here is that the cancer would not have developed were it not for the additional workplace
radiation exposure the worker received. In the still-ongoing Hanford nuclear worker class action lawsuit, the
important legal principle was affirmed by the court that it is not necessary for claimants to establish that their
particular cancer was caused by radiation. It is sufficient to establish the person worked in a higher-than-normal
risk radiation exposure environment where cancer causation is likely. In other words, it is a legal and medical
*given? that radiation causes and increases the risk for developing cancer. That should be enough to rebut and
have NIOSH rescind any attempt to further limit the original list of 22 compensable cancers under EEOICPA. The
scientific factual information is not available to them (or anyone) to do so fairly, equitably and wisely. If NIOSH is
allowed to limit the list of compensable cancers futher, this will establish major inequity between existing SECs
and those who seek to qualify to become an SEC.

Thank you for allowing the public, and me, to particpate in the rule-making process for this very important
piece of legislation.

-- end of comments --

Daniel W. McKeel, Jr., M.D. Director, ADRC

Assoc. Prof. of Pathology Neuropathology Core
and Immunology

WUSM Pathology Box 8118 — TEL: 314-362-7421

660 S. Euclid Ave. FAX: 314-362-4096

St. Louis, MO 63110 email: dan@ wubios.wustl.edu



Miller, Diane M.
~

From: Daniel W. McKeel, Jr., M.D. [dan@wubios.wustl.edu]
Sent: Tuesday, May 06, 2003 4:07 PM

To: niocindocket@cdc.gov

Ce: Daniel McKeel

Subject: Comments on Proposed Rulemaking SEC and EEOICPA

To: NIOSH Docket Officer
From: Daniel W. McKeel, Jr., M.D.
Date: May 6, 2003

Subject: Comments on notice of proposed rulemaking

The following comments are submitted per instructions in the Federal Register accompanying the March 7, 2003
proposed rule:

Comments Of Daniel W. McKeel, Jr., M.D.

regarding the HHS Notice of Proposed Rulemaking

for Designating Classes of Employees as Members of

the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of
2000 (42 CFR Part 83), Federal Register Vol. 68, No. 45, pp. 11294-11310 (March 7, 2003)

Below are my comments on the March 7, 2003 NIOSH Notice of Proposed Rulemaking Procedure for
Designating classes of employees as Members of the Special Exposure Cohort under EEOICPA, 68 FR 11294-
11310, March 7, 2003.

As a departure point, | want to strongly endorse all of the comments on pages 1 - 14 made the Government
Accountability Project (GAP) which have been submitted separately. | am not affiliated with GAP in any capacity,
however, | do share many of their views and applaud their scholarship and long-term interest and constructive
participation in this important rule making process. In particular, | share their misgivings in both the way the
scientific and Congressional underpinnings of the NIOSH proposed rule are being interpreted by both NIOSH and
the Health Physics Society. | have come to these conclusions in my roles as a physician and experienced human
and experimental pathologist and neuropathologist on the full time faculty (tenured Associate Professor of
Pathology and Immunology) of the second-ranked U.S. Medical School, Washington University School of
Medicine in St. Louis, Missouri.

My interests in this proposed rule are as an informed citizen with a long-time interest in having our country,
and responsible government agencies such as DOE, address the medical harm suffered by scores of present and
former workers who are now included in the EEOICPA 2000 legislation. My particular interest is in helping to
secure Special Exposure Cohort (SEC) status and assistance for the former workers of the Uranium Division,
Mallinckrodt Chemical Works (MCW), at their three original plants that processed enriched fissionable uranium,
thorium and nuclear reactor fuels:

(a) at the downtown (Destrehan Street) plant; (b) at the Weldon Spring Nuclear Feed Materials (*Chemical’) plant
in St. Charles county, Missouri;

(c) and at the Hematite, Missouri nuclear fuels facility. All three of these operations could and should be
considered as one facility, because many of the approximately 3,700+ workers cycled among the various plants.
Site (a) is an active FUSRAP site and site (b) is a CERCLA (Superfund) remediation site. E. Dupree-Ellis and co-
authors have documented excess kidney disease and several cancers in 2,542 white male former MCW workers
(Am J Epidemiol, July 2000, see full citation below). NIOSH also completed a health study on these workers in
1998. MCW workers are covered under EEOICPA.

I have been intimately involved for the past three years as a concerned citizen-participant in the CERCLA
(Superfund) remediation of the Weldon Spring Site. More recently, | have been assisting former MCW workers
and their survivors as a medical adviser to the United Nuclear Workers of the St. Louis Region (UNWSLR), a
former MCW worker advocacy group (not a union). In this latter capacity | have become very familiar with the

1


difficulties these EEOICPA-targeted people are having getting dose reconstructions done and in gaining access
to crucial medical records through NIOSH and DOE. This is extremely difficult to understand and is highly
regrettable and deplorable performance by the concerned agencies, constituting a direct affront to the clearly
stated Intent of Congress when they passed EEOICPA legislation in 2000.

That was, as put forth in the GAP comments on page 11 of 14: *...the essential aim of the statute (i.e., timely
compensation) ...? Clearly the *timely? aim goal has not been met.

My comments concern former MCW workers, specifically and to other covered worker cohorts in general. The
three major specific concerns with proposed NIOSH rule and SEC Special Exposure Cohorts, in addition to
agreeing with the GAP comments and concerns, are as follows:

[COMMENT #1] AS ADDRESSED ON PAGE 11, SECTION 3 BY GAP AS A REASON RECONSTRUCTING A DOSE
MIGHT BE INFEASIBLE: *Finally, it might take too long...? My contention is that MCW dose reconstructions have
already taken far more time than is reasonable in view of certain facts concerning the potential former MCW
worker potential SEC.

(a) Radiation exposure doses for more than 2700 former MCW workers were published in abstract form in 1980
in the American J Epidemiology by Dr. Dupree-Ellis.

(b) Peer reviewed data for radiation exposure and mortality summary data with instructions how to access the
primary data sources on 2,542 former MCW workers were published in the May, 1999 issue of the Comprehensive
Epidemiologic Data Resource (CEDR) catalog by U.S. DOE. MCW data appears in summary form on pages A46-
A47 and B55-B58 of the same catalog. The data sets [MCW_BRTHRDON, MCW_FB, MCW_URIN, MCW_X-RAY,
MCD94A01] are available to qualified users and in anonymized form in electronic form. By making this data
available, DOE by definition acknowledges that the radiation dosages for the MCW former workers that are
included in the UNWSLR membership are already available. Hence minimal or no dose reconstruction time or
effort should be required by NIOSH staff other than accessing the DOE-owned and controlled CEDR datasets and
linking to individuals. This should be very straightforward and easy to accomplish.

(c) DOE/OARU-associated investigators led by Dr. Elizabeth Dupree-Ellis and her colleagues have published
much of the MCW *Mallinckrodt? external radiation dosage and mortality former worker data [Dupree-Ellis E,
Watkins J, Ingle JN, Phillips J. External radiation exposure and mortality in a cohort of uranium processing
workers. [Journal Article] American Journal of Epidemiology. 152(1):91-5, 2000 Jul 1]. NIOSH, in fact, presented a
preliminary report of this Dupree-Ellis data to MCW workers in St. Louis in 1998. Obviously, the key agencies had
the relevant radiation exposure data 4-5 years ago. This would not be unreasonable realizing that Weldon Spring
site uranium production operations concluded thirty-five years ago in 1966! One assumes published data by
OARU, DOE and NIOSH are both accurate and complete, inasmuch as no disclaimer to this assumption appeared
in the peer-reviewed publications | am aware of. In fact, missing data was not discussed at all in the July 2000 Am
J Epidemiology paper. Ergo, one can assume that little or no MCW data was actually missing in 2000. Why and
where, then, has the MCW dose data apparently either disappeared or become inaccessible to those who need
and have a legal right to have it?

Why then also, have (to date) no EEOICPA claims from MCW former workers been compensated? On the
contrary, there are numerous examples known to me of MCW workers and their survivors being told by DOE or
NIOSH or Mallinckrodt that they or their relatives never worked for Mallinckrodt or the contractors, their medical
records have been lost, their dosage data is not available, and many other implausible excuses for the agencies
failing to remit their properly (FOIA/PA, EEOICPA forms) requested personal data in a timely, EEOICPA-compliant
fashion.

Logically, there must be one of several explanations: (a) the agencies that keep the records, i.e., DOE and/or
NIOSH, are deliberately withholding them; (b) record keeping is very disorganized so the records are truly not
accessible even to the agencies who have lost or misplaced them; or (c) the data reported in CEDR and the
American J of Epidemiology by Dupree-Ellis and colleagues is other than as stated. Else, MCW radiation dose
exposure information clearly IS available RIGHT NOW as an electronic data set that requires only the anonymous
data set ID to be linked to specific Social Security or other information source that identifies individuals; some of
these sources used already are in the Dupree-Ellis 2000 article.

l agree with GAP's suggestion that 180 days is adequate time to allow for a dose reconstruction to be made.
However, in the MCW former white male worker's cases (at least 2,542 of them, at least), the radiation doses
received are already available in the above mentioned sources. Thus, no dose *reconstruction? should be

2



necessary since that was already done to get the data ready for the CEDR catalog and the Dupree-Ellis
publications mentioned above. If there is something wrong with my logic, | would be pleased to hear of where my
understanding and logic is in error.

[COMMENT #2] CONCERN WITH EXCESSIVE TIME ALREADY SPENT REACHING A DECISION WHETHER OR NOT
DOSE RECONSTRUCTION CAN BE DETERMINED FOR FORMER MCW AND OTHER EEOICPA-COMPENSATED
WORKERS:

a) First, | want to echo GAP‘s statements on page 11 of their rulemaking comments that a modified no-
threshold linear risk model is the accepted international standard. Medical-scientific evidence for hormesis
having a significant modifying effect on the no threshold model is very limited, and it is not clear at all how, or if,
any of these postulated *beneficial? repair mechanisms affect HUMAN radiation-induced carcinogenesis dose-
response curves.

b) Second, NIOSH and the Health Physics Society (HPS) place undue emphasis on virtual modeling, maximum
dose *estimates? (e.g., dose capping) and other semi-theoretical constructs rather than hard data on actual
radiation doses given and received by actual people. This is the ONLY credible exposure data in the long run. As
stated in my first concern, there is considerable reason to doubt the accuracy and validity of radiation dose
estimates for (at least) the former MCW workers. It is not possible to determine a priori, without organ
radioactivity analyses and real (as opposed to virtual) measurements using many simplifying assumptions, where
particular radionuclides will end up over time being distributed among the bodily organs in specific
concentrations, as NIOSH and HPS imply can be done.

1 must add a friendly reminder to those in NIOSH that physicians, specifically MD-oncologists, have the sole
legal authority to order that radiation treatment be carried out for cancer treatment in today's best hospitals.
Anesthesiologists, for example, may be licensed physicians, however their hospital staff privileges do not include
administering curative treatment for cancer patients. Health physicists are necessary and valuable members of
the care team. However, they cannot make medical diagnoses, prescribe treatments by themselves, or administer
medications unless they have also graduated from medical school and been licensed by state Boards to practice
medicine and surgery AND have the requisite hospital staff privileges. In my opinion, therefore, NIOSH should
place far more reliance than it has done thus far, in the opinions of acknowledged expert medical and radiation
MD-oncologists in considering and implementing EEOICPA regulations and the proposed NIOSH rule for
assigning Special Exposure Cohort status to atomic industry workers.

c) The 10 REM threshold recommended by HPS must be viewed as serving some other inapparent agenda
(expediency, service to their employers?) than scientific truth. The suggestion is simply not sustained by any
available scientific evidence.

d) The epidemiologic-statistical way of looking at risk of cancer development due to nuclear/atomic weapons
industry exposures may not be the optimal or correct way to evaluate EEOICPA compensation claims. Congress
had the wisdom in 2000, as GAP does now, to note that such methodology might cripple the real Presidential (Bill
Clinton's) and Congressional intent to provide DECADES OVERDUE compensation to workers whose basic rights
to know about, and to be protected from, harm to their health. As understood today by Institutional Review
Boards for human research, former workers health and safety rights were knowingly and grossly violated to the
great detriment of the workers and their survivors. This is the *heart and soul’ consideration that underlies
EEOICPA legislation. Rather, the old truism among practicing medical doctors should be heeded. That is, to
individuals, statistical statements such *your chance of getting pancreatic cancer are 1 in 10,000? are
meaningless when the patient confronts their oncologist who has just told them that pancreatic cancer is
present. The statistical chance for that person developing pancreatic cancer is 100%!

[COMMENT #3] THE ORIGINAL CONGRESSIONAL BASIS FOR ACKNOWLEDGING ONLY 22 RADIATION-INDUCED
CANCERS FOR EEOICPA COMPENSATION, AND NIOSH’S AND THE HEALTH PHYSICS SOCIETY'S ATTEMPT TO
FURTHER LIMIT THIS LIST FURTHER IN THE CURRENT PROPOSED RULE, IS SUBJECT TO CHALLENGE ON
MEDICAL-SCIENTIFIC GROUNDS. The very concept of *radiosensitive* and *radioresistant? tissues in cancer
causation is itself open to serious challenge in the context of EEOICPA. It only becomes an issue since DOE and
NIOSH have so much trouble reconstructing accurate radiation doses, requiring them apparently to feel a need to
limit economic liability under EEOICPA, an obscure mandate indeed that does not appear to be the intent of the
legislation. Radiation can cause different types of cancer in almost (made every) organ and tissue type in the
body -- that is established incontrovertible scientific fact documented in thousands of peer-reviewed

3