[ RadSafe ] Radiation Absorbed Doses to Others from Therapy Patients

[Carol Marcus]

December 8, 2008

Dear Radsafers:

In December of 2007, a paper was published which 
scientifically exposed the unjustified massive 
conservatism and absurd physiological modeling 
promulgated in NRC’s guidance for releasing 
patients who have been administered therapeutic 
radiopharmaceuticals (NUREG-1556 vol. 9, Appendix 
U).  The paper is Siegel, Jeffry A., Marcus, 
Carol S., and Stabin, Michael G.: Licensee 
over-reliance on conservatisms in NRC guidance 
regarding the release of patients treated with 
I-131. Health Physics 93(6):667-677, 2007.  On 
December 19, 2007, a letter was sent to Chairman 
Dale Klein and Commissioners Lyons and Jaczko of 
the NRC, enclosing a copy of the paper and 
requesting a scientific review of Appendix U in 
light of the substantiated criticisms in our 
paper; the letter was signed by Jeff Siegel and me.

On January 2, 2008, a short note was sent by 
Annette Vietti-Cook, Secretary of the NRC, 
stating that our letter had been received and 
that a response was being prepared and would be 
received shortly.  On January 23, 2008, a note 
was received from Luis A. Reyes, Executive 
Director for Operations, thanking us for our 
“continued efforts to make timely and relevant 
information available to medical use licensees 
for their use in complying with 10 CFR 35.75
” 
and for sending a copy of our paper to Chairman 
Klein.  He promised a review of our submitted 
material, and curiously, of another article that 
appeared in the same issue of Health Physics 
“
that expresses a somewhat opposing point of 
view.”  No reference to this paper was included.

On September 11, 2008, nearly nine months after 
submitting our original letter, a reminder letter 
was sent to Chairman Klein because no promised 
NRC response was ever received.  On September 29, 
2008 Annette Vietti-Cook sent a note stating that 
a response was under preparation which would be forwarded to us shortly.

On October 16, 2008 a letter was received from 
Charles L. Miller, Director of the Office of 
Federal and State Materials and Environment 
Management Programs (FSME).  He reiterated the 
intention to do as stated in Mr. Reyes’ previous 
note, alluded again to this mysterious unnamed 
paper which “
expresses a somewhat opposing point 
of view..”, and then states: “When NUREG-1556, 
Vol. 9 undergoes general revision, all available 
information relevant to the content of its 
Appendix U will be considered.  The fact that 
general revision of NUREG-1556, Vol. 9 has not 
yet occurred should not be interpreted as meaning 
that the information that you supplied will not 
be considered when NUREG-1556, Vol. 9 is 
reviewed, for general revision.  At this time, we 
have not identified a specific date for revision 
of this guidance due to other higher priority 
activities in our budget.  When we proceed with 
the revision of NUREG-1556, Vol. 9, we will inform you and other stakeholders.”

It took ten months for the NRC to produce what 
essentially amounts to a non-response, indicating 
to us that neither Miller, the EDO, nor the Chairman appears to care.

A dishonest and dismissive NRC needs to be taught 
a lesson.  For openers, I strongly recommend that 
you all completely ignore Appendix U.  The 
document contains multiple erroneous constructs 
to artificially inflate calculations regarding 
likely radiation absorbed dose to persons near 
patients receiving I-131.  These constructs were 
extensively discussed in our Health Physics paper.

I would also like to make a few points about Mr. Miller’s unacceptable letter:

1) There is no reason to wait for a complete 
review of Volume 9 to fix the scientifically 
unjustified and massive overconservatism 
expressed in Appendix U.  It would take a 
competent expert about an hour to read our paper 
in Health Physics and compare it with Appendix 
U.  A few more hours would go into drafting new 
sections.  Review by others could be accomplished 
within a week or so, and then it could go out for 
public comment.  Fixing incorrect material should 
be a very high priority item at the NRC.  NRC 
requires that each licensee not only achieve 
doses that are within regulatory limits, but also 
maintain these doses ALARA.  Appendix U cannot be 
considered an ALARA approach in that the likely 
doses to others are significantly overestimated 
in the first place.  No NRC regulation requires 
such massive overconservatism.  Therefore, how 
can one be expected to maintain an erroneous 
anticipated dose ALARA in any meaningful way?  If 
the methodology of Appendix U is “acceptable to 
the NRC staff”, as NRC claims, one should 
seriously question the qualifications and motivation of that staff.

2) The staff has reviewed Appendix U multiple 
times, but there is no evidence that the 
scientifically flawed guidance was ever called 
into question by management or altered in any 
meaningful way.  According to the Fall, 2008 
issue of the FSME Licensee Newsletter 
(NUREG/BR-0117, No. 08-03), beginning at the 
bottom of the first column on page 2, the “
NRC 
staff finalized revisions to the NUREG-1556 
Guidance for Volume 9, ‘Program-Specific Guidance 
about Medical Use Licenses’.”  While they were 
reviewing it for compliance with the Energy 
Policy Act of 2005, they could/should have 
incorporated our suggestions for change.

Over the years I have noticed two changes to 
Appendix U, both unacceptable.  One has to do 
with the section on dose to infants from 
ingesting breast milk contaminated with a variety 
of radiopharmaceuticals.  Originally, there was a 
footnote explaining that Mike Stabin had made 
some calculations using the worst values for a 
variety of important parameters in order to 
achieve a theoretically worst case infant dose 
situation.  This was not meant to be actual 
dosimetry.  These were “take out” calculations 
that indicated that if the mother was 
administered less than some calculated activity 
of radiopharmaceutical, it would be impossible 
for the infant to receive an overdose.  NRC was 
passing this off as actual dosimetry, inflated by 
approximately a factor of ten.  When I complained 
bitterly about this several times, the NRC 
response was to remove the explanatory footnote 
“to save space” (!).  So now, it is impossible 
for other readers to realize that the table of 
dosimetry is completely misleading.

The second change was to arbitrarily increase the 
fraction of internalized I-131 by household 
members by a factor of ten.  There are no 
scientific data supporting this, as we pointed out in our paper.

The staff at NRC are obviously not the people 
that should be reviewing our paper for changes to Appendix U.

3) I have gone through the December 2007 issue of 
Health Physics, trying to identify this 
mysterious paper which “expresses a somewhat 
opposing view”.  There are only two other papers 
that address this area.  The first is Abdalla N. 
Al-Haj, Charlie S. Lagarde, and Aida Lobriguito: 
Patient parameters and other radiation safety 
issues in I-131 therapy for thyroid cancer 
treatment. Health Physics 93(6):656-666, 
2007.  This is a paper from Saudi Arabia in which 
the authors review the literature, regulations, 
and recommendations of various national and 
international groups on the subject.  They 
describe practices in Saudi Arabia, and support 
the concept of an absorbed dose-based principle 
guiding I-131 therapy practices rather than an 
activity-based construct.  Four of Dr. Siegel’s 
papers are referenced.  The paper does not get 
into pharmacokinetic modeling, which is a 
principle focus of our paper.  I see this Saudi 
paper as very generally supportive of what we 
said in our paper, and saw no opposition 
expressed.  The Saudi paper simply did not get 
into the advanced modeling that we covered.

The second paper is J. Willegaignon, Maria I. C. 
Guimaraes, Michael G. Stabin, Marcelo T. 
Sapienza, Luiz F. Malvestiti, Marilia M. S. 
Marone, and Gian-Maria A. A. Sordi: Correction 
factors for more accurate estimates of exposure 
rates near radioactive patients: experimental, 
point, and line source models.  Health Physics 
93(6):678-688, 2007.  This paper contains some 
excellent experimental measurement as well as 
comparison with point and line source 
models.  The first paper they reference is that 
of Dr. Siegel, me, and Rick Sparks in 2002.  As 
one of the co-authors is Mike Stabin, and he is 
also a coauthor on our paper, it would be highly 
unlikely that there would be any scientific 
disagreement between the two papers.  I found none.

So, the claims of the EDO and the FSME Director 
defy credibility. I wonder what staff person 
wrote this, and why it was accepted without any 
apparent credible scientific review?

Alternatives to Appendix U appear in our Health 
Physics paper.  I suggest you adopt this material 
in your institution.  Basically, most compliant 
patients who are not socioeconomically challenged 
may be treated as outpatients.  As NRC guidance 
is not a requirement, ignore it.  And express 
your scientific disgust with NRC guidance at every opportunity.

Carol S. Marcus, Ph.D., M.D.
<mailto:csmarcus at ucla.edu>csmarcus at ucla.edu