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SECTION
4: Authorization For Radioisotopes (Including Activated Materials) and Authorization
Procedures
Authorization (top)
1. All persons planning to possess or use radioisotopes at Princeton
University must obtain prior approval of the Radiation Safety Committee
and/or the "Health
Physicist"
for each radioisotope. Persons not qualified for authorization, according
to the requirements stated below,
must use radioisotopes only under the supervision of an "Authorized
User."
2. The first step to obtain authorization is the filing of an application
through the Office of Environmental Health and Safety. Applicants
are
advised that the application process may take several weeks (or longer
if an amendment to a University license must be obtained) and are,
therefore,
urged to submit their application sufficiently in advance of the
planned starting date to avoid delays. The filing of an application
sets in
motion a procedure which provides for a thorough review of the radiation
safety aspects of the proposed usage. The final step in the procedure
is the issuance by the Office of Environmental Health and Safety
of an Authorization Number or a Limited Possession Number.
3. Temporary Approval
The "Health Physicist" is authorized by the Committee to
grant a temporary approval, if specifically requested by the applicant.
However, such approval is granted at the discretion of the "Health
Physicist" and is dependent upon receipt of a completed application.
Temporary approval is valid for 30 days and is normally issued within
36 hours of receipt of a properly completed application.
4. Duration of Authorization
Each Authorization Number and Limited Possession Number is coterminous
with the applicable University license or terminates with the severance
from the University of the "Authorized
User." In some instances specific expiration dates are established
at the request of the "Health
Physicist."
5. Revocation
The Committee has the right and responsibility to revoke any authorization
granted by it if, in its opinion, sufficient justification exists for
such action.
6. Amendments
Any change in the use of a radioisotope from that described in the
application shall be discussed with the "Health
Physicist." Significant changes which could affect radiation
safety, such as the use of an open source as opposed to a "Sealed
Source," the in vivo use of radioisotopes in animals as opposed
to in vitro work, use of dry powders instead of a less hazardous form,
etc., require an amendment. Any such amendments may be approved by the
"Health Physicist"
except that the "Health
Physicist" has the option to refer proposed changes to the
Radiation Safety Committee. Increases in the amount of radioisotope
authorized for use require a new application.
Classes of Authorizations: Description (top)
Authorization Numbers
There are two kinds of Authorization Numbers: one for Radioisotopes
and one for Activations. They are distinguished as follows:
- A Radioisotope Authorization Number authorizes possession and use
of the requested amount of a specific radioisotope (and its daughters)
in accordance with the statements and representations made in the
application. Radioisotopes are generally acquired by purchase from
a commercial supplier.
- An Activation Authorization Number authorizes activation of a sample
for radioisotope production in an accelerator, reactor, etc., and
subsequent possession and use of the product radioactivities in accordance
with the statements and representations made in the application. Several
types of activations are recognized and are explained in paragraph
3 below.
- Only persons who are "Principal
Investigators," hold a faculty or research position,
and have had significant previous experience with radioisotopes
similar
to those being requested may apply for an Authorization Number. However,
upon recommendation of the Department Chairman and with concurrence
of the "Health Physicist," the requirement for a faculty
or research position may be waived provided the applicant has had
extensive radioisotope experience or the radiological hazards associated
with the use of the radioisotope are minimal.
- The amount of radioactive material and the scope of work permitted
under an Authorization Number is, in general, limited by the terms
and conditions of the relevant University license.
Limited Possession Numbers
- A Limited Possession Number is a restricted or limited Authorization
Number. The scope of the activities permitted and the required qualifications
of the applicant differ in the following ways:
- The applicant does not have to meet the qualifications established
for a "Principal
Investigator." Less emphasis is placed
on previous experience with "Sources
of Radiation." Therefore, the scope of work permitted
is restricted.
- The maximum amount of radioactivity authorized for use by an
individual holding a Limited Possession Number is limited to
100
times the amount listed in Appendix C of a single radioisotope
or the equivalent prorated quantity of several as illustrated
in the footnote to Appendix C, except that the total amount for
any radioisotope may not exceed 15 mCi. However, persons holding
at least one valid Authorization Number and therefore meeting
the qualifications of a "Principal Investigator" may
hold an unlimited number of Limited Possession Numbers, provided
no single quantity authorized exceeds the amount described above
for a single radioisotope.
- Limited Possession Numbers are issued at the discretion of the
"Health Physicist" and without Committee review, although
the Committee is periodically informed of all new Limited Possession
Numbers issued. The "Health Physicist" may, at his or
her discretion, elect to require full Committee review.
- Limited Possession Numbers are also issued to authorize possession
of "Generally Licensed Devices," such as smoke detector
heads, spark gaps, thickness gauges, etc., which contain radioactive
material. The licenses for all such devices have general requirements,
the specifics of which are dealt with in the application process.
Categories of Activation Authorizations
An "onsite-internal" activation
for radioisotope production is one performed at a University facility
by and for University personnel and their collaborators. Persons desiring
authorization must obtain an Activation Authorization Number.
There is also the case of "onsite-internal" irradiations
not performed for the specific purpose of radionuclide production,
which
may cause the incidental activation of target holders, machine components,
shielding, etc., e.g. target irradiations to produce secondary particle
beams. The irradiation may be arranged at the discretion of the "Authorized
User" responsible for the facility, and no Authorization Number
is issued, provided the irradiation meets the following criteria:
- It is performed with the active participation of an individual associated
on a full-time basis with the University facility at which the irradiation
is done; and,
- No activated material will leave the facility in which the material
was incidentally produced.
The "Authorized User" may, however, request a review of
the proposed irradiation by the "Health Physicist" and the
Radiation Safety Committee. The "Authorized User" has the
responsibility for radiation safety, including the inventory and management
of any
radioactive materials produced.
An "onsite-external" activation
is one performed at a Princeton University facility to produce radioactive
materials used by non-University personnel at either an on or off campus
location. Regardless of where the material is ultimately taken, any
person desiring such an activation must file an application for an
Authorization
Number with the Radiation Safety Committee through the Office of Environmental
Health and Safety. If the proposed use includes any transport of the
activated material
outside the facility at which it was produced, a formal agreement (part
of the application procedure) must be executed by a duly authorized
representative of the applicant's organization. Certain conditions
regarding
such activations have been established by the New Jersey Bureau of
Radiological Health. These are:
- The person desiring the activation must demonstrate to the Office
of Environmental Health and Safety that his or her organization is
duly authorized to possess and use the requested materials under the
provisions of an appropriate government license.
- The "Health Physicist" is responsible for reporting the
transfer on the next monthly radioisotope inventory, indicating the
amount of activity, and the date of transfer, the recipient, and the
address of organization.
An "offsite" activation is one
performed for Princeton University personnel at an off campus facility
not owned or operated by the University when the resulting radioactivity,
however small or purified, is to be brought on campus. Persons desiring
such an activation must obtain an Activation Authorization Number.
How to Apply for Authorization (top)
- Obtain the necessary forms from the Office of Environmental Health
and Safety and discuss the proposed work with the "Departmental
Safety Manager" and the "Health Physicist."
- Complete the forms, making sure that they are consistent with the
guidelines given in Section B above for Authorization Numbers or Limited
Possession Numbers. Please type or print in black ink.
- Consult with the "Health Physicist" to review the proposal
and to obtain any assistance needed to complete the application.
- Sign the completed application and obtain the signature of the "Departmental
Safety Manager" (or in his or her absence the signature of the
department chairman). Forward the completed application to the Office
of Environmental Health and Safety.
Processing and Review of Applications for Authorization
(top)
1. Authorization Numbers
Upon receipt of a completed application:
- The "Health Physicist" reviews the application, interviews
the applicant, inspects the proposed facilities, and, on the basis
of the information obtained, recommends either that the application
be approved, conditionally approved, or denied. At this time, if requested,
the thirty day temporary approval will be considered.
- Copies of the application with the "Health Physicist's"
recommendations regarding approval or denial, any conditions suggested
by the "Health Physicist," and all supporting documentation
are sent to the Radiation Safety Committee.
- Each member of the Committee reviews the application and may approve,
conditionally approve, or deny it. Since an application must be unanimously
approved by all available Committee members, a reasonable attempt
is made to remove any objections and resolve any concerns. Before
making a final decision, committee members are urged to discuss with
the "Health Physicist" and the applicant any conditions
they wish to impose and objections which could lead to a denial. The
Committee members sign the application, annotating it with any comments
or conditions, and return it to the Office of Environmental Health
and Safety. Denials must be specifically indicated.
- Following final processing and review of the application, the applicant
is notified by memo that the application has been approved and authorization
granted. Copies are sent to the Chairman of the Radiation Safety Committee
and "Departmental Safety Manager." This memo indicates the
Authorization Number that has been assigned, the relevant University
license, and any conditions or other pertinent information. A copy
of the application and all supporting documentation is also returned
to the "Authorized User."
- If the application is denied, a copy of it and all supporting documentation
is returned to the applicant, indicating the reasons for denial. The
applicant may appeal the decision at a special meeting of the Radiation
Safety Committee, requested through the Secretary of the Committee.
2. Limited Possession Numbers
- The procedure followed for a Limited Possession Number is the same
as that for an Authorization Number except that:
- The application and supporting documentation is not distributed
to the Radiation Safety Committee and the Committee does not review
the application.
- The Committee is notified of all Limited Possession Numbers issued
by the "Health Physicist."
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