THE
WSU
ALARA PROGRAM
11.1)
Introduction
11.1.1) As Low As Reasonably Achievable (ALARA)
All Authorized Users of sources of ionizing radiation are expected to conduct their work in such a manner
that the collective exposure of all individuals is kept
As Low As Reasonably Achievable (ALARA)
. In
general, this means making every reasonable effort to maintain exposures to radiation as far below the dose
limits as is practical consistent with the purposes for which the licensed activity is undertaken. Cle
arly, any
action which has no cost in time or money and which will decrease the collective exposure shall be
adopted. To exceed ALARA is not to violate the regulations. ALARA is a professional standard of
excellence.
Although protection against external
radiation fields needs to be and is addressed, experience at the
Wichita
State University
indicates that contamination control and control over radioactive materials are the areas
requiring special procedures and/or ALARA guidelines.
This
document
constitutes the written
ALARA Program
approved by the Radiation Safety Committee
(RSC)
and mandated by state regulations. The ALARA Program commits all users of sources of ionizing
radiation to the principle that all “unnecessary exposure” is to be avoide
d. Secondly, where potential or
real exposures are unavoidable, every reasonable effort should be made to reduce the exposure. The
Program applies to all Authorized Users of sources of ionizing radiation at
Wichita State University
unless
an amendment
to a specific permit grants alternative means of satisfying equivalent control.
ALARA goals and levels of exposures or contamination requiring specific "action" are defined in this
program. The latter are called
action levels
because they trigger the nee
d for some specific response to the
situation. Because references are made to these action levels throughout this
document
, the action levels
are defined or stated first in Section 11.2 below.
The word
shall
is used for a required procedure. Failure t
o observe procedures and conditions introduced
with a "shall" is "noncompliance" with permit conditions.
The word
should
is used for highly recommended, but not absolutely required, procedures and conditions.
11.1.2) Regulatory Limits
The limits for t
he exposure of Authorized Users, members of the general public, minors, and declared
pregnant women are those specified in Part 4 of the Kansas
Radiation Protection Regulations
(Title 10,
Code of Federal Regulations Part 20). These regulations also apply
to exposure limits in unrestricted areas.
Authorized Users are by definition occupationally exposed. The RS
C
will determine which Authorized
Occupants (laboratory personnel) are included in the "occupationally exposed" category.
11.1.3) ALARA Goals
Th
e goal of the ALARA program is to keep all individual Total Effective Dose Equivalents (TEDE) below
1 mSv (100 mrem) per year. No annual Shallow Dose Equivalent (SDE) should exceed 10 mSv (1
,
000
mrem). No annual Lens of the Eye Dose Equivalent (LDE) shou
ld exceed 3 mSv (300 mrem). No Total
Organ Dose Equivalent (TODE) should exceed 10 mSv (1
,
000 mrem).
11.1.4) Achievement of Dose Equivalent Limits
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prevent recurrence are
implemented, and reports are submitted to the RS
O
and the RSC.
Two different IL's are used. These levels are as follows:
I.) For clearly marked and labeled work areas covered with absorbent paper,
contamination at more then 25 times the Table 1 "r
estricted" levels or 5 or more
spots at 10 times the Table 1 levels requires implementation of an Investigation
Level.
II.) For unmarked areas, including all floors, contamination at more than 10
times the Table 1 "unrestricted" levels requires implement
ation of an
Investigation Level.
11.3)
Control of Radiation Sources
11.3.1) Instruments Containing Radioactive Sources (Liquid Scintillation Counters and Gas
Chromatographs with radioactive sources) and Radiation Generating Devices
The Authorized La
boratory Supervisor shall:
11.3.1.1)
Ensure that the serial number(s) or some other unique identifying number has been
registered with the RS
O
under the permit which governs the use of the instrument and/or radiation
generating device.
11.3.1.2)
Ensure that the permit specifies where the instrument and/or radiation generating device
is located.
11.3.1.3) Ensure that a highly visible label with the following words shall remain attached to such
an instrument and/or radiation generating device.
N
otice: "Do not move without notifying the Radiation Safety
Officer.”
11.3.1.4)
Do not
transfer responsibility for the instrument and/or radiation generating device
unless prior written authorization from RS
O
and the Committee has been obtained.
Note:
These sources are covered together with all other sources of ionizing radiation under
standard permit conditions.
11.3.1.5
Promptly notify
the RSO
when the instrument and/or radiation generating device is no
longer needed.
Note: Authorized Laborator
ies, sources of ionizing radiation, and radiation generating devices
shall not be abandoned
by an Authorized Laboratory Supervisor.
11.3.1.6)
Do not
remove such instruments or radiation generating devices from the Equipment
Inventory unless prior approval has been obtained from the RS
O
.
11.3.1.7) Specify the location of storage for instruments, spare radiation generating devices and/or
X
-
ray tubes to
be used in instruments in the permit application, and shall not change location
without first notifying the RS
O
.
Authorized Users shall:
11.3.1.8) Use the radiation generating devices and/or sources of ionizing radiation only as
specified in the
applicable permit. This includes training requirements and procedures
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11.3.1.9) Not move a radiation generating device or source of ionizing radiation to another
location without prior approval from RS
O
. This is for the purpose of ensuring that the radia
tion
generating device or source of ionizing radiation will never become an "orphan,” or that its
location becomes unknown to the
RSO
.
11.3.1.10) Not remove the label specified in Section 11.3.1.3 above and/or "Caution Radioactive
Materials" labels. Onl
y RS
O
staff members are authorized to remove such labels subject to the
restrictions placed upon them by the License.
11.3.1.11) Maintain the storage of spare radiation generating devices and/or spare X
-
ray tubes,
(etc) in a secured fashion so that unaut
horized access is prevented.
Note: For Authorized Laboratory Supervisors who have only "sources" of the type addressed in
this section (11.3.1), the only other applicable sections are 11.4
and 11.8 below.
11.3.2) Outdated Radioactive Sources
The Authorized Laboratory Supervisor shall:
11.3.2.1) Arrange for approved transfer and/or disposal of all radioactive sources in the inventory
of the permit before leaving the university or terminating the permit.
11.3.2.2) Require an accounting by Au
thorized Users under their permit of all radioactive sources
created by the users before such users leave the university (This includes identification and
labeling of containers with levels of activity and isotope.)
11.3.2.3) Properly and promptly transfe
r to RS
O
for disposal any sources for which no use is
anticipated.
11.3.2.4) Place unused stock sources which have been on the inventory for more than five years
and for which potential use has been justified in a secondary container which shall be sealed
by
the RS
O
and shall bear a label with these words: "Notice: Do not break seal or change location of
this container without notifying the RS
O
." Sources will be placed in such containers at the time of
the physical inventory. See Section 11.3.2.5 below
.
11.3.2.5) Perform an annual physical inventory of all sources that are listed under the permit in
cooperation with the RS
O
. (Stocks in containers specified in Section 11.3.2.4 above with
unbroken seals are inventoried upon identification of the contain
ers.)
Note: The conditions of Section 11.3.2 are agreed upon by the Authorized Laboratory Supervisor when
responsibility for a permit and its conditions are accepted by signature of the acceptance letter.
11.4)
Control of External Radiation Fields
11.
4.1) Restrictions on External Gamma/X
-
ray Fields and Action Levels
The Authorized Laboratory Supervisor shall:
11.4.1.1) Ensure that the dose rate at the nearest occupyable unrestricted area where radioactive
sources are stored or where x
-
ray producing
machines are used is no greater than 2.0 μGy (0.20
mrem) in any one hour unless analysis by the RS
O
indicates that achievement of this level is not
practical and an exemption is granted explicitly in the permit.
Note: If x
-
ray units are placed in a room with interlocks and no occupancy during exposures is
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possible, the nearest accessible surfaces are the exterior sides of the walls. However, for units
which are operated inside occupied rooms, the above limit app
lies to the surface of the equipment
itself.
11.4.1.2) Evaluate, plan and perform all activities under the permit with the intent of meeting the
ALARA limits on exposure as specified in Section 11.2.
11.4.1.3) Notify the RS
O
immediately if there is any
reason (measurement or calculation) to
believe that the exposure of any individual exceeded the Investigation Level listed in 11.2.1 in any
one month. Section 11.2.1.1.b establishes this as an Investigation Level, therefore:.
a.) Identify causes for t
he contamination
b.) Establish Standard Operating Procedures designed to prevent recurrence of the
contamination.
c.) Cooperate with
the
RS
O
in assessing the level of exposure
d.) Submit a report to the RS
O
and the Committee within two weeks of the i
ncident.
11.4.2) External Beta Fields and Shallow Dose Exposures from Contamination
Authorized Users/Authorized Laboratory Supervisors should:
11.4.2.1) Use clear beta shields whenever high energy beta fields may be present.
11.4.2.2) Perform operati
ons involving microcurie amounts of a high energy beta emitter behind a
beta shield.
11.4.2.3) Store beta emitting sources so that betas will not penetrate to accessible areas, if this is
readily achievable. The dose rate should not be more than 2.0 μ
Gy (0.20 mrem) in any one hour.
11.4.2.4) Implement decontamination when measurable skin contamination is detected,
implement corrective actions if feasible, and document initial and final activities with estimates of
the duration of the contamination to
gether with corrective actions.
Note: Measurements are to be made with instruments specified in the Safety Data Sheet for the
radioactive source involved and under the conditions specified by the Safety Data Sheet (SDS).
Safety Data Sheets provi
de specific radionuclide data on predicted and measured dose and dose
rates, estimates of internal dose, and biological limits. Unless an RS
O
notation of a more accurate
calibration factor is entered into the SDS, the calibration factor or conversion fact
or suggested in
the SDS is to be used. If instruments specified in the general SDS are not available in the
laboratory, the Authorized Laboratory Supervisor shall request an RS
O
calibration for the
instruments that are to be used and these shall be noted
in the laboratory
-
specific SDS.
11.4.2.5) Notify
the
RS
O
immediately if the possibility exists that the exposure could exceed the
Investigation Levels.
a.) Identify causes for the contamination
b.) Establish Standard Operating Procedures designed to prevent recurrence of the
contamination.
c.) Cooperate with RS
O
in assessing the level of exposure
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d.) Submit a report to the RS
O
and the Committee within two weeks of the incident.
11.5)
Conta
mination Control
11.5.1) Guidelines and Requirements
Note: In this section, action levels defined in Section 11.2 are used. Section 11.2 should be
reviewed as needed.
Authorized Users shall:
11.5.1.1). Plan for and use procedures designed to preve
nt contamination.
11.5.1.2) Make reasonable attempts to remove any contamination found in
unrestricted
areas.
The goal is no measurable contamination.
11.5.1.3) Use judgment in determining when decontamination may be deferred for a limited
period of time
provided
that the contamination levels do not exceed the "Remedial Level".
Note: It always preferable to keep contamination levels in restricted ar
eas at the "not measurable"
levels, Dirty (many areas of contamination) areas are not acceptable.
11.5.1.4) Maintain floors in
all
areas below "Remedial Levels" for unrestricted areas.
Note: The only and "last resort" exception would be to establi
sh a Class IV Laboratory with the
approval of the Radiation Safety
Officer
and declare the lab off limits for housekeeping and other
personnel from facilities operations.
11.5.1.5) Maintain bench tops which are
clearly
marked and identified as restricted
areas below
"Remedial Levels" for restricted areas.
Note: Outside surfaces of equipment labeled and exclusively kept in such marked areas shall also
be below "Remedial Levels" for restricted areas.
11.5.1.6) Maintain all unmarked and unreserved area
s and equipment or clothes in such areas
below "Remedial Levels" for unrestricted areas and/or equipment.
Note: However, every effort should be made to keep levels well below this
-
preferably non
-
measurable. Destructive decontamination shall be consi
dered, if necessary.
11.5.1.7)
S
urvey laboratory coats and other items to be laundered before release to commercial
laundries. The lab coats shall not be released if there is measurable contamination.
Note: The use of two lab coats is encouraged but
not required.
Authorized Users/Authorized Laboratory Supervisors shall:
11.5.1.8) Immediately decontaminate, with the assistance of the RS
O
, any areas/materials which
exceed the Investigation Level of Contamination. (See Section 11.2.2.2.b above)
11
.5.1.9) Identify the causes and/or reasons for the contamination.
11.5.1.10) Establish changes in laboratory
-
specific standard operating procedures designed to
prevent recurrence of such incidents, and ensure that all appropriate personnel are trained in
those
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procedures.
11.5.1.11) Maintain written documentation as part of laboratory records.
The Authorized Laboratory Supervisor shall:
11.5.1.12) Report the incident to the RS
O
as soon as possible.
11.5.1.13) Provide a written report to the RS
O
and the Committee with review within two weeks
of the incident.
11.6) Laboratory Surveys
11.6.1) Survey Frequency
Authorized Users should:
11.6.1.1) Survey floors and/or other areas that may have become contaminated at the end of the
day or at t
he end of the experiment, whichever comes first.
Note: When surveys have been performed at the end of the experiment and no new experiments
are performed, surveys do not need to be performed at the end of a day when new experiments
were not performed.
11.6.1.2) Survey areas shortly after any high level operation, any stock has been opened, or any
operation which is highly vulnerable with respect to inadvertent contamination (mixing, blending,
centrifugation, etc).
Authorized Users shall:
11.6.1.3) P
erform surveys as soon as possible whenever there is reason to believe that
contamination has occurred.
11.6.1.4) Perform comprehensive documented surveys at the minimum frequency specified in this
section as applicable.
a.)
In Class IV Laboratories
(High Level)
Comprehensive Surveys are required: 1) at the end of the day
whenever a stock is
handled; 2) before an area reserved for work with radioactive materials is returned to
unrestricted (unmarked) status.
b.)
In Class III Laboratories
(Medium Level)
Comprehensive Surveys are required: 1) whenever a stock is handled so that a bioassay
must be performed within a day or week; 2) before an area reserved for work with
radioactive materials is returned to unrestricted (unmarked) status; 3)
at least once a week
of selected areas, including the floor, which could become contaminated.
c.)
In Class II Laboratories
(Low Level)
Comprehensive Surveys are required: 1) before an area reserved for work with
radioactive materials is returned to un
restricted (unmarked) status; 2) at least biweekly of
selected areas, including the floor, which could become contaminated.
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d.)
In Class I Laboratories
(Very Low Level)
Comprehensive Surveys are required: 1) before an area reserved for work with
radioac
tive materials is returned to unrestricted (unmarked) status; 2) at least monthly on
selected areas, including the floor, which could become contaminated.
Note:
The following exception shall apply to all laboratory classes given above:
During a period of
time when radioactive materials are not being used and materials are in storage
only, area surveys do not need to be performed
if and only if
an extensive "close out" survey has
been performed and recorded as such at the time usage was discontinued. Surv
eys are required
during such a period if any accidents occur in the storage areas.
11.7) Actions Prompted by RS
O
Surveys/Reviews
11.7.1) Actions based upon RS
O
surveys
The RS
O
shall
11.7.1.1)
I
nitiate corrective procedures
immediately
. The RS
O
will provide the necessary
assistance.
The Authorized User/Authorized Laboratory Supervisor shall:
11.7.1.2) Provide the necessary effort to achieve prompt corrective action. See Sections 11.5.1.8
to 11.5.11.
The RS
O
may:
11.7.1.3) Initiate the pro
cedures described in Section 11.8 if a survey by the RS
O
finds
contamination at Remedial Levels (Section 11.2.2.2.).
Note: Because the actual occurrence of contamination is assumed to be accidental it is not in
itself deemed "noncompliance." However fa
ilure by the users to identify such contamination by
appropriate surveying and/or to decontaminate to the extent required by this program could be
noncompliance.
Therefore, if surveys performed by RS
O
were always after the completion of an experiment or
a
fter the end of a day's work, the discovery of contamination above the remedial level by them
could indicate "noncompliance" in that laboratory. Because surveys by the RS
O
are performed
during the day and may occur while experiments are still in progress,
such findings will not
automatically be deemed "noncompliance."
However, the frequency with which RS
O
finds such contamination should be low and the
escalating actions specified in Section 11.8 below will be taken. Authorized Laboratory
Supervisors sh
ould investigate causes for any contamination above remedial levels and should
implement additional procedures designed to prevent recurrence if appropriate. High frequency of
contamination will most likely result in mandatory changes in the procedures ap
plicable under the
relevant permit.
The RS
O
shall:
11.7.1.4) Implement the Noncompliance Procedures of Section 11.8 below when levels exceed
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the Investigation Level (See Section 11.2.2.2.b)
11.7.2) Actions by the RS
O
when Investigation Levels are Exc
eeded (whether reported by the laboratory
or found with their own surveys)
The Radiation Safety
Officer
shall:
11.7.2.1) Attempt to determine the reason for any exposure in excess of the levels specified in
Section 11.2.1.2.b above and to help the labo
ratory institute procedural changes designed to
prevent recurrence of such exposure if feasible under ALARA constraints.
Note: Exposures in excess of these levels are not "noncompliance" when reported by the
laboratory but are action levels for triggerin
g an analysis. They are "noncompliance" if found by
the RS
O
.
11.7.2.2) Document their findings and include a summary in reports to the Committee.
11.8) Noncompliance Items and Undetected Remedial Level Contamination
A
violation
is a finding by th
e RS
O
of "noncompliance" with state and federal regulations, permit
conditions, and/or required ALARA procedures and/or conditions. Regulations and conditions have
varying degrees of safety, safeguards, or environmental significance.
Level A Noncompli
ance
addresses violations that are more significant and are of considerable concern.
Violations involving training
,
personnel protection, required surveys not performed or documented, and
other procedures that would greatly affect the health and safety o
f individuals are examples of this level.
Level A Noncompliance violations are more severe than Level B Noncompliance violations.
Level B Noncompliance
addresses violations that are significant and are of concern.
Examples are not
correctly posting and
labeling areas and/or equipment, eating or drinking in restricted areas, not performing
the required surveys and/or inspections, leaving radioactive sources unsecured, working in unrestricted
areas, not wearing personnel dosimeters, not preparing or maint
aining the required record keeping, placing
labeled equipment in unrestricted areas, etc. There may be incidents when these violations would be
considered Level A Noncompliance depending upon the level of risk. Some violations are listed as Level
A and L
evel B Noncompliance (for example, failure to perform and document surveys) to show that the
severity of these violations depends upon the effects to health and safety.
Sanctioned actions for noncompliance could include immediate attention by the Authoriz
ed Laboratory,
written corrections or written responses from the Authorized Supervisor, interview with RSO and/or
Committee, increased RS
O
inspections, additional training requirements, increased assessments by the
Authorized Users, suspended shipments of
radioactive materials, established restrictions on Authorized
User, decreased scope of permit, confiscated radioactive materials, or suspended or permanently terminated
permit.
11.8.1) Level A Noncompliance Violations
The Radiation Safety
Officer
shall:
11.8.1.1) Require individuals working with radioactive materials to immediately cease working if
training has not been certified at the proper level.
11.8.1.2) Require individuals working with radioactive materials to immediately cease working if
gloves and lab coats are not being used in a procedure that requires personnel protection.
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11.8.1.3) Place ordering radioactive materials on a contingent status if the required documentation
for surveys has not been completed by the Authorized Laboratory
and has a significant impact on
health and safety.
Note: Normally this precaution would only be initiated following the action of Section 11.8.2.3.
Contingent implies that radioactive materials may be ordered upon completing the required
survey.
11.8.1.4) Require individuals working with radioactive materials to immediately cease working if
Level B Noncompliance violations have a significant impact on health and safety.
11.8.2) Level B Noncompliance Violations
11.8.2.1) First Violation or Und
etected Remedial Level of Contamination
The Radiation Safety
Officer
shall:
a.) Submit a letter to the Authorized Laboratory Supervisor identifying the details of the
violation and explaining the required corrective action, and/or condition b. A verbal
notice should also be given by the RS
O
.
b.) Note the violation on the RS
O’s
survey sheet in the "noncompliance" section.
11.8.2.2) Second Violation or Undetected Remedial Level of Contamination
The Radiation Safety
Officer
shall:
a.) Send the Aut
horized Laboratory Supervisor a notice of violation.
b.) Send a copy to the Chair of the Committee.
11.8.2.3) Third Violation or Undetected Remedial Level of Contamination
The Radiation Safety Officer
shall:
a.) Send a warning letter to the Au
thorized Laboratory Supervisor.
b.) Send copies to the Chair of the Department and to the Chair of the Committee.
11.8.2.4) Fourth Violation or Undetected Remedial Level of Contamination
The Radiation Safety Officer
shall:
a.) Request the Chair of the Committee to arrange for an interview between the
Authorized Laboratory Supervisor and the Committee for the purpose of determining
steps that need to be taken to prevent recurrence of the noncompliance.
Note 1: In the event
of serious, health
-
threatening violations, the Radiation Safety
Officer
may
take appropriate action, including stopping work under a permit, until an interview with the
Committee has been completed and it has made recommendations with respect to the safet
y issues.
Note 2: If the interval between violations is more than eighteen months, the sequence again
begins with Section 11.8.1.
The Radiation Safety Committee shall:
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11.8.2.5)
Take necessary actions to address the problems and monitor the adequacy of
those
actions.
On Radiation #
3
:WSU ALARA