February 15, 2008

Robert J. Lewis, Director

Division of Material Safety

and State Agreements

Office of Federal and State Materials

and Environmental Management Programs

U.S. Nuclear Regulatory Commission

Two White Flint North

11545 Rockville Drive

Rockville, Maryland 20852-2738

Dear Mr. Lewis

The Advisory Committee on the Medical Use of Isotopes (ACMUI) appreciates the

opportunity to comment on the report entitled "Radiation Source Use and Replacement"

prepared by National Academy of Science (NAS). The report represents the results of a

study, conducted by NAS under Section 651 of the Energy Policy Act of 2005, of the

industrial, research, and commercial (including medical) uses of Category 1 and 2

radioactive sources to identify technically and economically feasible replacements for

sources that pose a high risk to public health and safety in an accident or terrorist attack.

The purpose of the ACMUI is to provide advice to NRC on policy and technical issues

that arise in regulating the medical use of byproduct materials for diagnosis and therapy,

and, in that capacity, our review of the NAS report was focused on the impact of its

recommendations on the practice of medicine.

The ACMU I recognizes and appreciates the efforts put forth by NAS in preparing this

this report. The ACMUI, however, has several concerns and comments regarding the

report and its recommendations:

1. The report has suggested alternative replacements for CsCI, e.g., x-ray blood

irradiators. However, the report does not address the efficacy of these

alternative replacements for CsC!. Further study will need to be carried out on

the alternatives to assure that these alternative replacements have the capacity

for producing the desired result or effect and to identify any impacts. For

example, a linac could be used to irradiate blood in the evening (when it is not

being used to treat patients), but the hemotologists need the blood irradiated

immediately before use, which is generally in the daytime, not in the evenings.

2. The report does not address increased or enhanced security methods as an

alternative. Enhanced security features would provide a more cost effective

means of providing security.

3. Terrorist threat exist worldwide. Elimination of CsCI needs to have a global

solution, otherwise, the refurbished CsCI irradiator equipment will be sent to

underdeveloped countries where the environment is potentially less secure, thus

increasing the overall threat risk.

4. The report does not acknowledge the fact that the cost of replacement,

decommissioning, and disposal of current CsCI technology, as well as, the
increased operating cost of the Xray alternatives will likely be passed on to

patients, thereby increasing the already high cost of medical care. One estimate

suggests that implementation of the x-ray alternative could increase costs by

177% in comparison to Cs while being less reliable.

5. The report does not address the fact that the tax incentives to replace CsCI

technology would not work for most hospitals, which are generally not-for-profit.

6. The report does not adequately distinguish between Cs-131 and Cs-137. Cs-131

is a new and useful isotope which does not have the dispersal potential of Cs137. However, both isotopes may be viewed as having the same threat risk by

the public due to the word "Cesium". By not distinguishing between these two

isotopes of Cesium, any action on CsCI based on this report could potentially

deny the useful medical treatment of Cs-131 to the public.

7. The NAS report appears to have a bias against Gamma Knife Radiosurgery.

The Gamma Knife has proven medical benefit. This technology provides very

rapid, focused treatment versus the non-radioactive alternatives. However, the

NAS report places the Gamma Knife in a negative light compared to the Linac

xray alternatives. The successful Gamma Knife treatment method should not

eliminated as it would deny needed medical treatment to patients.

8. ACMUI agrees with the NRC staff observation that there are significant

environmental and worker risk of using Ethylene Oxide technology. These risks

were the reason that Ethylene Oxide technology was eliminated and hence

returning to the Ethylene Oxide technology would be a step backward. Further,

Ethylene Oxide is used for sterilizing equipment and not for sterilizing blood.

ACMUI would be happy to elaborate on the above concerns, and any additional

observations, resulting from our review with you, NAS, or Congress, at your

convenience.

Sincerely

~

Dr. Subir Nag

ACMUI