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Re: Internal Licensing
HHMI prepared a document "Consensus Radiation Protection Practices for
Academic Research Institutions," to address among other points the one on
authorization procedures. The goals were to maintain safe practices, meet
regulatory requirements and streamline the approval process reducing
paperwork. The guideline reads as follows:
"Authotization by the RSC for an individual to be responsible for the use of
radioactive materials depends critically upon the training and experience of
the individual. There is no particular requirement or need to impose
arbitrary limits on the quantity of radioactive materials that may be
possessed or ordered at one time, provided the quantity is not inconsistent
with the nature of the authorized use and does not exceed the institution's
license limits. The evaluation of an application to become a Reponsible
User includes:
1. The types and proposed uses of all radiation sources must be identified
and reviewed. This procedure may be initiated by the applicant completing a
form similar to Attachment A - Radioactive Material Use Application (not
included here). In addition, the applicant must agree to abide by all
policies and procedures for acquisition, use, storage and disposal of
radioisotopes. It is the Responsible User's responsibility to notify the
RSC or RSO about any changes in types or uses of radiation sources.
Possession limits do not necessarily need to be considered if active systems
are used to ensure there are appropriate controls and training in the
laboratory for the radioactive material being purchased.
2. The applicant must be a Qualified User, have the appropriate education,
training, and practical experience commensurate with the radiation sources
to be used. If the applicant does not meet these requirements, the
Responsible User may, with the approval of the RSC, delegate responsiblity
for all uses of radiation under the aurthorization to a Qualified User under
his or her supervision.
3. At some point prior to usage of radioisotopes, the applicant should be
interviewed in person by the RSO to review the above information and to
discuss the specific institutional procedures in the radiation safety program."
Anybody interested in the full text of this document can send me a fax
number to my email address below.
Here at Rockefeller, we have been following the same HHMI philosophy for
many years. In our case our unit is the laboratory not the PI, there may be
several PIs in each lab. A new lab completes an application which consists
of a series of forms that describe the research that will be done indicating
the hazardous materials to be used (biologicals, chemicals and radioactive)
and the experience of the head of the lab. The application is reviewed by
the Laboratory Safety Committe (LSC). Prior to the LSC review of the
application, the RSO meets with the lab head to discuss all relevant aspects
of the work to be done in the lab and determine the radioisotopes and amount
to be ordered on a regular basis. The laboratory space and requirements are
also reviewed by the RSO.
The radioisotope orders are handled through a computerized system that links
the inventigator, the Safety group and Purchasing. Based on the information
provided by the head of the lab at the time of the application a list of
radioisotopes and amount per order is created against which the computer
automatically checks every order placed by an investigator. If the order
either exceeds the amount or includes a radioisotope not in the list it is
left aside in a separate file that the RSO checks daily. At that point the
RSO can evaluate the request, find out if this is a one time occurrence or a
change in laboratory needs and can decide to approve it or not. If there is
any question on this change of work, it would be brought to the attention of
the LSC.
Yearly the RSO reviews the radiosotopes ordered by each laboratory and based
on that information decides on frequency of checks, dosimeter needs, etc.
This has proven a user-friendly system that allows for quick action to take
care of researchers needs and good control of materials.
Esmeralda Party
Assistant Director,
Phone: (212) 327-8324
Laboratory Safety & Environmental Health Fax: (212)
327-8340
The Rockefeller University
1230 York Ave e-mail:
partye@rockvax.rockefeller.edu
New York, NY 10021