2022 Radiation Safety Guide
2022 Radiation Safety Guide
2022
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Table of Contents
Preface…………………………………………………………………………………………………………………………………….4
Scope……………………………………………………………………………………………………………………………………….4
Radioactive Waste…………………………………………….…………………………………………………………….……….20
Radiological Clearances……………………….………………………………………………………………………….……….27
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Appendix A – Basic Physics of Radiation/Radioactivity………………………………………………….……….30
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Preface
The Radiation Safety Guide has long been used as official guidance for those working with ionizing
radiation at the National Institutes of Health (NIH). Historically the guide was revised every few years as
regulations and policies changed over time, the last being in 1998. When the earliest version of the
Radiation Safety website came out around 2000, the Radiation Safety Guide was presumed to be
present in an on-line form throughout the various web pages. Instead of revising the guide as a sole
document every few years, the web pages were updated as things changed over time. After a number
of years operating this way, the Division of Radiation Safety (DRS) is bringing back the Radiation Safety
Guide as a standalone guide that can be referenced for relevant policies all in one document for those
who would prefer that over navigating web pages to find information.
Scope
DRS provides oversight for the use of radioactive materials or ionizing radiation producing devices at
NIH. DRS does not have purview over any of the following (contact the Division of Occupational Health
and Safety instead) technologies at NIH: magnets or MRI, lasers, microwaves, ultraviolet, infrared, EMF
or ultrasound.
DRS provides its oversight of ionizing radiation activities for the following locations: main NIH campus in
Bethesda; Poolesville Animal Center; Integrated Research Facility (IRF) at Ft. Detrick in Frederick; The
NIA facilities in Baltimore; a few small leased labs in the Rockville area. DRS does not provide any
oversight whatsoever for the following NIH-affiliated areas, and each has its own separate radiation
safety program: NCI Research Facilities in Frederick; Research Triangle Park NC; Rocky Mountain Lab in
Hamilton MT; Indian Health Service in Phoenix AZ
Radioactive Materials
The vast majority of radioactive material in use at NIH is governed by the Nuclear Regulatory
Commission (NRC). The NRC has many regulations covering the possession, use and disposal of
radioactive material. They provide active oversight of NIH through the issuance of specific licenses
covering NIH activities and they conduct comprehensive unannounced inspections. DRS ensures that
regulations and license commitments are followed at all times by NIH personnel. The DRS Director is
also the NIH Radiation Safety Officer (RSO) who must meet specific NRC qualifications. Additionally, the
RSO is specifically named on NRC licenses and has been explicitly given the authority by the Deputy
Director of Intramural Research to maintain the radiation safety program at NIH, including the ability to
stop any activity at NIH that the RSO believes jeopardizes the safety of NIH staff, patients or visitors, or
stop any activity that will cause NIH to be in violation of NRC requirements.
All radiation workers have the right to contact the NRC directly with a concern regarding radiation safety
at NIH. There are postings in numerous locations, including any lab authorized to store or use
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radioactive materials that go into more detail about the rights and responsibilities of radiation workers,
including how to contact the NRC. While DRS hopes someone with a concern would contact DRS first to
address an issue, DRS recognizes and supports the right for workers to contact the NRC directly. Note
that trained radiation workers also have a responsibility to follow all radiation safety requirements.
There are instruments and equipment that contain sealed sources of radioactive materials that are
integral to the function of the device. Common examples at NIH include Liquid Scintillation Counters
(LSC), gas chromatographs and explosive sniffers. These devices are not covered by NIH’s specific NRC
licenses but are instead covered under 10 CFR 31 directly as “Generally Licensed Devices.” NIH
researchers can purchase these directly from a vendor and they do not come through Building 21 for
receipt or inspection. However, there are some regulations regarding their use that DRS must ensure
are followed. Therefore, DRS requests that anyone acquiring a generally licensed device notify DRS once
they receive it. Some of these devices require leak testing of the sources on a specified frequency and
they cannot be taken apart for repair unless specifically licensed by the NRC to do so. Additionally,
disposal of the device has requirements and anyone disposing of a generally licensed device should do
so with the coordination of DRS. For LSCs specifically, see the section on radiological clearances.
Note that modern smoke detectors are exempt from general license device requirements. Also note
that by NIH Policy, radioactive tritium (H-3) exit signs are prohibited on campus.
Devices that produce radiation as a part of how they operate are not regulated by the NRC. Ordinarily
the state would regulate these devices, but since NIH is a federal facility the State of Maryland has no
jurisdiction over its operations. Therefore, the Occupational Safety and Health Administration (OSHA) is
the regulatory authority over these devices (mostly x-ray units). DRS does strive to follow state
regulations when these devices are inspected for safety.
“Source Material”
Chemicals that contain (naturally) radioactive uranyl or thoriated compounds (often used in microscopy
applications) are defined by the NRC as “source material” and can be obtained without DRS involvement
from commercial suppliers. However, there are possession limits (1.5 kg per lab) and these materials
must be disposed as radioactive waste. DRS does conduct an annual contamination survey in spaces
that use source material.
DRS provides its oversight with the goal of ALARA heavily emphasized. ALARA means As Low As
Reasonably Achievable. It means that contamination and exposures shall be kept as low as reasonably
possible given the circumstances involved (lab setup limitations and economic considerations are the
usual limiting factors). It means that just being under the limits is not enough. Note, though, that
generally speaking it is not possible to reduce someone’s exposure to absolutely zero when working
with ionizing radiation. However, for most NIH staff exposure can be reduced to less than 1% of the
limits. NRC Regulatory Guide 8.29 discusses risks from occupational radiation exposure.
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DRS is obligated to comply with all regulations and licenses involving ionizing radiation. Violations of
policies by radiation workers can result in enforcement which is usually an official memo from DRS
describing the violation(s) and a request from the recipient to describe corrective actions. Some
violations may require targeted refresher training for lab staff involved in an infraction. Egregious or
repeated violations can also result in a radiation worker appearing before the Radiation Safety
Committee to explain their actions and how they will comply in the future. Although rare, the
Committee may choose to suspend a radiation worker’s use of ionizing radiation for any length of time
including permanently.
In the course of conducting work involving ionizing radiation, never falsify anything or intentionally
mislead DRS or NRC inspectors. The penalties for falsifying are steep and can include termination from
employment. Note the NRC can also impose monetary fines on individuals and prevent violators from
working with radioactive materials anywhere in the United States for up to 5 years. If you make a
mistake or fail to comply with a DRS requirement, just say so and implement corrective actions to
prevent recurrence. Covering up non-compliance will jeopardize your career and can impact NIH’s
ability to have radioactive materials.
The Radiation Safety Committee (RSC) has existed in one form or another back to the late 1940s at NIH
when it was first chartered by the NIH Director. Its primary function is to serve as an advisory body to
DRS and NIH on all matters related to ionizing radiation. NRC regulations mandate the composition of
some of the committee members – a chair, a member of NIH Management, members who are proficient
in specific medical modalities of the use of radiation/radioactivity in human patients. The NRC also
mandates some of the activities of the RSC such as the approval of Clinical Authorized Users for human
administration of radiation/radioactivity; approval of laboratory Authorized Users; approval of certain
uses of radioactive materials; approval of changes in DRS policies or the addition of new facilities that
work with non-trivial amounts of radioactivity.
Anyone 18 years of age or older wishing to work with radioactive material must register with DRS. The
registration page will ask what types of radioactive materials and what kind of work will be done with
them. DRS will then send the new user a link to the required baseline training modules that are
completed on-line. All users get a set of modules that cover basic aspects of working with ionizing
radiation at NIH, including topics mandated by 10 CFR 19.12. Specialty users of radioactivity will get
additional modules tailored to those specialties. Once all training is completed and the accompanying
test is passed, the new user is considered an Individual User (IU) and will be allowed to work with
radioactive materials under the supervision of an Authorized User (AU). There are limitations to the
amount and types of radioactivity allowed through the basic training course (RSL - Radiation Safety in
the Lab). See the section on the Activity Control System regarding these limitations.
Any former NIH Radiation Worker who has returned to NIH can resume working with radioactive
materials as before, provided the period of absence was under 4 years. Absences greater than 4 years
will require going through the initial training regimen again.
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If someone under the age of 18 will be present in a lab posted for radioactivity, there are specific
training requirements whether the individual will be working with radioactive materials or not. See the
section on minors for details on what to do for persons under 18 in the labs.
IUs must work under the supervision of a responsible AU. If an IU wishes to become an AU, the IU must
complete an additional on-line set of training modules (RSAU – Radiation Safety for Authorized Users)
and also complete an in-person practical demonstration designed to ensure the IU has sufficient
knowledge and skills to become responsible for radioactive materials at NIH. The IU would then take a
written exam. Upon passing the IU would need to formally apply for AU status, which is reviewed by
DRS and the RSC.
After an AU is formally approved, he/she may order radioactivity as prescribed in the Activity Control
System and be listed as the responsible individual for radioactive labs and other IUs.
AUs who leave NIH and later return do not have to start the Authorization process over other than re-
submitting an application. However, if the absence was more than 4 years the RSL would have to be
completed again. Additionally, any AU-specific training refreshers conducted during the absence would
need to be completed.
DRS runs several training programs at NIH. The most common are the RSL and RSAU courses described
earlier for individual users and authorized users respectively.
DRS provides refresher training for various populations at the NIH. Some groups, such as radiotherapy
nurses and oncology staff who use sealed sources within human subjects are required to receive annual
training per 10 CFR 35. These trainings are largely in-person sessions conducted by DRS staff. Further,
some groups receive in-person annual refresher training per DRS policy by virtue of their job, such as
police, firefighters and high activity radiochemists.
Additionally, anyone who receives 100 mrem or more whole body exposure during the year is required
by NRC License commitment to receive a refresher training specific to their work. This training can be
in-person or in an electronic format.
Further, on a periodic basis (every 2-3 years on average), refresher training for all radiation workers or
just all Authorized Users is administered electronically. Also included in these types of refresher training
are groups working with radioactive animal housing or housekeeping staff.
Regardless of situation, all staff who are offered refresher training must complete the training by the
specified deadline or will be suspended from their ability to work with ionizing radiation.
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Administering Radioactivity to Human Subjects
There are limitations to how much radioactive material an AU may possess at any one time. This has
been governed by DRS via the Activity Control System (ACS) since 2003. When an AU is first authorized,
he/she is allowed a baseline amount (ceiling) of basic life science radionuclides (“The Basic Set”), based
on completing the RSAU training course. If a lab wishes to use a nuclide not in the Basic Set, DRS must
be contacted. An Area Health Physicist (AHP) will evaluate the lab to ensure it is sufficiently set up to
use the requested materials – ability to survey for contamination, waste set-up, work area set-up,
dosimetry considerations and adequate shielding are among the items that will be evaluated. If the AHP
agrees the lab can handle the nuclide, the AU will be given a default ceiling for that radionuclide.
Ceilings are decay-corrected in real time. If a lab needs more than the default ceiling for a nuclide, the
AHP can evaluate the lab to ensure the higher amount of radioactivity can be worked with safely and in
compliance with policies. The AHP can raise the ceiling up to a maximum amount specified by policy.
The ceiling thresholds for common nuclides at NIH can be found in this table.
If a lab needs more than the maximum ceiling for a radionuclide (even for the Basic set), then a DRS
Protocol is required. DRS Protocols are written agreements between the lab and DRS that indicate what
kind of radioactive work will be performed and what radiation safety precautions and procedures will
apply. The AHP will verify the lab meets the protocol requirements and will conduct periodic oversight
of the work once the protocol is approved by the RSC. Protocols must be renewed every 2 years.
A few endeavors are exempt from the DRS lab protocol process:
• sealed sources
• human use of radioactivity
• experiments conducted in the Bldg. 21 Hot Lab Facility
• experiments conducted in a lab with DRS physically present (meant to be one-offs)
If a lab believes a DRS protocol will be required, it should contact DRS for a consultation on what needs
to be included in their protocol application.
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Working with Radioactive Animals
Anyone wishing to administer radioactive materials to animals must follow the process of their
institute’s Animal Care and Use Committee (ACUC) which requires an Animal Study Proposal (ASP) for
the work. The ACUC evaluates the ASP for appropriateness in a number of issues surrounding animal
welfare. If there is radiation or radioactive material involved, the ASP is forwarded to DRS for review.
DRS has a standard set of requirements for working with radioactive animals. If necessary for specific
ASPs, DRS may impose additional requirements, including submittal of a regular DRS Protocol if that
criteria is met.
Any Authorized User (AU) may order and receive radioactive materials. To do so, the AU must submit an
88-1 form which will tell DRS the nuclide and amount, chemical form, the intended users of the material
and where the material needs to be delivered. This is done solely electronically through the AU Portal.
Separately the AU must procure the material from a vendor through their own institute’s procedures for
buying chemicals. The institute order MUST indicate the address below is the receiving address for the
radioactive package and make sure the AU’s name and DRS number are listed as the clearance
name/number.
21 Wilson Drive
Bethesda, MD 20892-6780
All packages of radioactive material MUST be delivered to Building 21 for NRC regulated surveys and
inspections. After inspection, DRS will deliver the radioactive material to the location indicated on the
88-1 form. The delivery will include a Utilization/Disposal form (U/D sheet). When radioactivity is
aliquoted out of the source vial, the user must document this on the U/D sheet. If a user needs to
aliquot material but was not listed on the U/D sheet initially, the AU may handwrite the user’s name
with the pre-printed ones and sign their full name to indicate permission to use the material was
granted. Be sure to only allow users to be added to a U/D sheet who have completed the RSL training.
Once the material is used up or the source vial is sent to radwaste, the U/D sheet must be closed out
and a copy returned to DRS. If no users were added to the U/D sheet, simply closeout the item on the
AU Portal. If a user was added to the U/D sheet, please send a copy to DRS by Fax (301-480-9708) or by
campus mail (21/116).
DRS will also specifically alert the lab if contamination was found on the outer surfaces of the source vial
during the receipt inspection so that the lab can take precautions to prevent the spread of
contamination when opening/using the package.
If a radioactive package arrives at Building 21 and there is no accompanying 88-1 for it, DRS will contact
the AU and hold the package until an 88-1 is submitted. If the package causes the AU to exceed their
ceiling (see the section on the Activity Control System), the package will be held until the ceiling is raised
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by the AHP; the AU disposes of other items of that nuclide; or a DRS Protocol is in place to receive the
nuclide at that amount.
IMPORTANT – if you receive a radioactive package from someone not in DRS (commercial carrier such
as FedEx or UPS), do not open the package! Immediately notify DRS who will retrieve the package and
conduct the required inspections and surveys. The regulations require these steps within 3 hours of
receiving the package! One important clue that the package did not come to Building 21 first as
required will be that there is no U/D sheet accompanying it.
Once you receive a radioactive package it must not be left unattended and must immediately be taken
to a proper storage location within a posted space. Once the package is opened, survey the outer
packages for contamination (wearing lab coat and gloves) and fully deface any radioactive labeling prior
to disposing in the regular trash. If there are discrepancies with the order, notify DRS. If you suspect the
inner packaging container is contaminated, or you receive a message from DRS that we found it
contaminated, take great care to avoid spreading contamination once you access the inner packaging
items. If the material comes in a more durable container (e.g. an ammo can) that is meant to be
returned to the vendor at a later time, ensure that container is contamination-free before letting it leave
the laboratory.
If a lab wants to give some or all of a source vial to another AU, the receiving AU must go onto the AU
Portal and complete an 88-1 form. List the first AU as the supplier and clearly indicate the amount being
transferred. This procedure is also required if receiving material from a lab group that takes raw
radioactive materials and labels them to compounds as a service to other labs who do not want to do
this work themselves.
If a lab receives radioactive materials from the NIH Cyclotron directly, it MUST document the receipt of
this radioactive material via an 88-1 form on the AU Portal in a timely manner after receiving the
material. Fill out the form per usual but list NIH Cyclotron as the supplier. The NIH Cyclotron is NOT
responsible for documenting this transfer…they are only responsible for ensuring they give radioactive
materials only to labs who have been cleared by DRS to have them.
Labs can purchase radiation-producing devices without going through DRS. However, once such a
device is received, DRS must be contacted to register the unit to get an initial inspection and placement
on an annual inspection schedule. NOTE – open beam devices (fluoro, CT, etc.) require a DRS shielding
evaluation of the room where they will reside. This should be done prior to acquiring the unit to
prevent delays or expensive retrofitting of a space with shielding.
Note that DRS no longer tracks Electron Microscopes and notifying DRS of their existence is not
necessary unless the shielding integrity of the unit is in question. However, electron microscopes do
often utilize uranyl or thoriated compounds (source material) which are radioactive from naturally
occurring elements. DRS does need to know about the existence of these chemicals as there are some
regulations regarding their possession and disposal.
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DRS has training modules for both self-shielded and open beam machines. All users of radiation-
producing devices require training appropriate for the type of machine being used. When a registering
user indicates one of these kinds of machines will be used, the correct training module will be included.
Dosimetry is not required for self-shielded machines. Dosimetry is usually required for open beam
machines.
Working with shielded units is straightforward – do not defeat safety interlocks or other features
designed to prevent direct exposure to any part of the body. Contact DRS for an evaluation if the unit
becomes damaged and/or the integrity of its shielding is in question.
When working with open beam x-ray units, it is important to observe several work practices to prevent
unnecessary and potentially appreciable exposure:
• Wear lead aprons and organ shields if working in close proximity of the beam
• Always wear dosimetry assigned to you when working with open beam units
• Try to stay 6 feet from the beam if possible
• If you have to hold a patient/animal during a procedure, wear leaded gloves
• Use the lowest settings on the unit that will produce a useful result; use image hold on units
that have this feature
• In general, practices that reduce the exposure to the patient will also reduce occupational
worker exposure
Notify DRS if any radiation producing device is relocated – a shielding evaluation may be required.
Consult the refresher training module for a fuller discussion of open beam x-ray units.
All radioactive materials must be used or stored in spaces that have been posted for this purpose by
DRS. Radioactive items are not allowed to be used or stored in corridors except for the following two
situations:
• Film cassettes may be stored in a locked container labeled as containing radioactive film
cassettes
• Liquid Scintillation and Gamma Counters may be used in non-posted areas, provided the
counting vials are removed and placed in a posted space following their analysis. It is OK for
samples to be queued up inside the counter prior to counting.
Note that some NIH buildings do not allow corridor storage of any kind. The exceptions above are not
meant to circumvent building-wide prohibitions on corridor usage.
The security of radioactive materials at NIH is very important. All radioactive materials (includes waste,
any contaminated item and used LSC/gamma vials) must be locked up or attended by lab staff at all
times. It is permissible to lock these materials up within a room as opposed to locking the room itself.
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Additionally, since 2001 all source vials must be locked up within the room even if the door is locked
when unoccupied. This can be done by locking the freezer, etc. If the lab needs to leave the freezer
unlocked, the source vial can be placed in a locked box within the freezer and that box must be tethered
to the freezer. DRS can provide guidance on whether an intended security arrangement is compliant
with this policy.
DRS conducts periodic security sweeps of buildings and issues enforcement citations to AUs whose
radioactive material or waste can be accessed when no lab staff is present. The contractor who
performs the sweeps will restore a lab to a secured configuration if they are able to access radioactive
materials. In the event a lab cannot be restored to a secure configuration, the contractor, in
consultation with DRS Management, will attempt to relocate source vials to another posted room or
confiscate them and bring them to Building 21 for appropriate temperature storage until the non-
compliant lab is able to store materials properly.
Lab staff should be cognizant of unknown persons entering their areas and challenge them regarding
their entry. Legitimate visitors should be briefed on areas of the lab to avoid due to radioactive
materials or other occupational hazards.
Since 1997, DRS has directly applied the 10 CFR 20 criteria for wearing dosimetry. Workers who have a
reasonable potential to exceed 10% of the NRC exposure limits will be issued dosimetry. Each worker
upon completing training submits a Dosimeter Evaluation Form that describes the intended use of
ionizing radiation at NIH. DRS then determines if the worker meets the criteria for whole body or ring
dosimetry. Note that dosimetry is never required for work with these nuclides, regardless of the
amount: H-3, C-14, P-33, S-35, Ca-45, Fe-55, I-125 or I-129.
If you are issued dosimetry, you need to wear it whenever conducting work with ionizing radiation. Only
wear your dosimeter! Never take your dosimeter home or wear it anywhere outside of NIH. Store
dosimeters away from sources of radiation and away from heat sources (like a car) which could damage
the dosimeter. Dosimeters are exchanged on a frequency commensurate with the potential amount of
exposure. It is essential that dosimetry be promptly exchanged when replacements arrive so that your
dose amount will be known and applied to your record. Notify DRS immediately if you lose a dosimeter
or if you believe you were exposed to a potentially large amount of radiation (with or without a
dosimeter present).
Some workers will be issued both a chest dosimeter and a collar dosimeter. Be sure to always wear the
correct dosimeter in the correct location. Finger rings are marked L and R and should be worn with the
label facing inward on the finger with the highest potential for exposure. If you are an x-ray user and
are issued one dosimeter, wear it at the collar level outside any lead apron. If an x-ray user receives two
dosimeters, the second one should be worn underneath the lead apron.
DRS will provide dosimetry results annually to anyone who had dosimetry during the year. Separately, a
worker may request their exposure in writing ([email protected]) while either a current or
former employee and DRS will provide this information within 30 days as required by 10 CFR 19.13.
DRS tracks users’ cumulative dose totals over the course of a calendar year. Should a worker exceed
10% of any dose limit, an ALARA investigation is triggered. Reaching 30% and 50% also trigger additional
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investigations. DRS discusses the exposures with the worker and evaluates whether there are measures
that can be taken to reduce exposure - additional shielding, remote handling devices and sharing the
workload are common techniques. For some workers at NIH the workload is such that reaching 10% is a
normal outcome over the course of the year. In these cases, DRS ensures that nothing unusual is going
on and that engineering controls are in place that can reasonably be applied. The 30% and 50%
investigations are usually more involved and may involve a worker’s AU and/or supervisor. Any worker
reaching 70% of any limit during the year will be prohibited from performing further work involving
ionizing radiation for the remainder of the calendar year. DRS is obligated to prevent workers from
exceeding the regulatory limits.
The dose limits depend on who regulates the activity. Staff who only work with radioactive materials
are subject to the NRC limits. Staff who only work with x-ray equipment are subject to OSHA limits.
Staff who work in both arenas are held to both sets of limits by DRS policy and the NRC has jurisdiction
over all occupational exposure if ANY of it comes from NRC regulated activities.
DRS has the ability to conduct internal monitoring of staff who may have internalized radioactive
materials. The two main ways bioassay is conducted at NIH are urinalysis and body scanning. The
method employed depends upon the decay characteristics of the specific nuclide and/or the biological
characteristics of the element/compound itself.
Most workers at NIH do not require routine bioassays but instead might be required to undergo one if
involved in a contamination event or otherwise believe radioactive materials have gotten inside the
body.
Urinalysis can be a single sample or a 24-hour collection. DRS then analyzes the urine for radioactivity
(and nothing else). For body scanning, the worker would come to Building 21 and a sensitive detector
would be placed in front of the appropriate part of the clothed worker (thyroid, lung, gut, etc.).
If air sampling was performed in conjunction with a procedure that precipitates bioassay, the
concentration of the air sample can also be used to estimate internal dose.
For bioassays with detectable radioactivity, DRS calculates an estimated internal exposure plus an
equivalent whole body dose value that results from internalization of radioactivity, using the NRC tables
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for Annual Limit on Intake (ALI). As a part of that process the worker might be required to continue a
bioassay schedule to determine or verify the rate of elimination from the body via the combination of
radiological decay and biological elimination. DRS will investigate the cause of internalization of
radioactive materials so that measures can be put into place to prevent recurrence.
An embryo/fetus can be more sensitive to radiation than an adult (highly dependent on the stage of
pregnancy). Per NRC Regulatory Guide 8.13, DRS has a Declared Pregnancy policy in place. Any
pregnant worker can voluntarily be evaluated for the potential of internal/external exposure as part of
their job duties. The Authorized User or supervisor will be a part of the discussion. DRS will recommend
if any changes in duties are needed to prevent the embryo/fetus from exceeding the regulatory limit of
500 mrem for the pregnancy. DRS will prohibit working with radioiodines for declared pregnant workers
to prevent a damaging thyroid dose to the fetus. Other duties that may result in restrictions include
open-beam x-rays (fluoro/CT) or work involving hot cells. It is also recommended that any dose is evenly
spread out over the pregnancy. DRS will issue a dosimeter specifically to track this exposure.
The pregnant worker must declare formally in writing for the dose limits and monitoring to apply. This
can be done by campus mail (mark an envelope ‘confidential’) to Building. 21, Room 116 or by giving the
declaration to a DRS Health Physicist directly. You can choose to fax it to 301-496-3544 but
confidentiality cannot be guaranteed. DRS will contact the worker within 2 business days to arrange a
consultation.
Note that the Declared Pregnancy status is completely voluntary and a woman who chooses to
participate can withdraw at any time. Undeclared pregnant workers are not subject to the 500 mrem
dose limit.
Similar to the Declared Pregnancy program, DRS also offers a Declared Breastfeeding program. Some
chemical compounds or radionuclides can transfer to breast milk if ingested by the mother. For any
breastfeeding mother who declares, the consultation would evaluate the potential for the infant to
receive 100 mrem. DRS may recommend declared mothers refrain from certain kinds of work with
open-form radioactive materials and have the mother undergo periodic bioassay to ensure uptakes of
radioactive material have not occurred. The potential for uptake is greatest for volatile forms of
radioiodine, as well as potentially volatile forms of H-3, S-35, Br-76 and At-211.
The Declared Breastfeeding program works administratively exactly the same as the Declared Pregnancy
program.
If someone under the age of 18 is going to be in a location posted for radioactive materials, but not
working with them, he/she must complete the Radiation Safety Orientation training.
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• The minor must complete the Radiation Safety in the Lab (RSL) course and also the lab safety
course conducted by the Division of Occupational Health and Safety (DOHS)
• The minor must complete and submit an application to DRS for permission to work with ionizing
radiation, which includes parental consent and an affirmation by an adult in the lab who will be
present 100% of the time during any radiation work conducted by the minor
• The minor may not directly handle source vials or work with protocol quantities
General Practices
Any room/space that has radioactive materials stored (including waste) or the materials are being
manipulated must be posted by Radiation Safety. DRS will evaluate whether the room is set up
sufficiently to use the intended radionuclides – waste containers, monitoring capability, shielding if
needed.
Eating, drinking and smoking are all prohibited in a posted area, or in an adjacent area that is not
separated from the posted area by full height walls and has separate ventilation. This policy is
consistent with that of the Division of Occupational Health and Safety for working with chemical or
biological materials.
Anyone working with radioactive material must wear at a minimum a lab coat and gloves. Additional
protective clothing may be specified in a DRS Protocol. Open-toe shoes are not permitted while working
with radioactive material.
Areas/benches where radioactive work is taking place should be covered with absorbent paper or
equivalent to prevent the spread of contamination. All items that are expected to become
contaminated or come into direct contact with the radioactivity should be labeled in advance of the
work with Caution Radioactive Material (CRAM) tape. Items that are radioactive in some way that are
not waste must remain labeled to include nuclide, estimated activity, date and a radiation level if it is
significantly above background.
Where practical, work should occur within a fume hood, especially if thawing out a frozen source vial
containing H-3 or S-35. Note for procedures involving aerosols or inherently volatile work (e.g. halogens
like radioiodine) DRS will mandate that the work be conducted in a working fume hood.
Internal Hazards
There are four main ways radioactivity can end up inside your body – ingestion, inhalation, absorption
and puncture. The methods to prevent these pathways from being available include wearing protective
clothing (PPE), engineering practices such as hoods or ventilation controls, and prohibitions on eating,
etc. within the lab. In a few labs it is necessary to employ further controls such as fully enclosed boxes
and air monitoring.
External Hazards
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An external hazard means that radiation can impact living cells from sources outside the body. At NIH
this would be gamma radiation or high-energy beta radiation. The principles to minimize exposure from
external sources are:
• Time – limit the time handling radioactive materials. Do practice runs of procedures without the
radioactivity so that you will be efficient when using the radioactivity.
• Distance – keep the sources of radiation in locations not near work areas when not using them.
Use remote handling tools when practical while working with radioactive materials…even having
them a couple feet away from your body makes an appreciable difference in the dose rate when
compared to having the source up close due to the inverse square law nature of radiation
intensity over distances.
• Shielding – using appropriate materials in between you and the source to attenuate the
incoming radiation
Laboratories should conduct radioactive work in a way such that dose rates within the lab do not exceed
2 mrem/hr or cause a dose rate in an unrestricted area to exceed 0.5 mrem/hr. Shielding may be
required for source storage or waste collection areas to maintain dose levels ALARA. Note that labs
working with many mCi of radioactivity at a time may not feasibly be able to meet the 2 mrem/hr
standard in localized areas of a laboratory during the radioactive work. In these rare cases DRS will work
with the lab to have levels as low as can be reasonably achieved and may post the lab as a Radiation
Area as defined in 10 CFR 20. In all cases, the dose rates in unrestricted areas must be maintained
below 0.5 mrem/hr.
Labs must have the ability to perform contamination monitoring for the radionuclide(s) in use. For high-
energy beta emitters such as P-32, a Geiger-Mueller (GM) probe is required. DRS allows for either the
end window or pancake style of GM meter, but recommends the pancake style for better detection
efficiency. For low-energy emitters such as H-3 and C-14, the lab must be able to perform Liquid
Scintillation counting for smear/swipe analysis. For low-energy photon emitters like I-125, a NaI
scintillation probe is recommended or smear surveys can be performed.
Note that the lab MUST conduct a contamination survey any day that radioactive material is used.
Unless otherwise directed by DRS, these daily surveys are not documented. You should monitor the
work area, the floor below that area, the equipment used in the experiment, yourself and the traverse
route to waste containers.
Hand-Held Meters
When using a hand-held instrument for monitoring, it is vital that you ensure the instrument is working
properly prior to use by performing these steps:
• Battery check the instrument – most instruments have a setting called Bat Check or similar…the
needle should deflect to the Bat OK area on the dial. Do not use the meter if it fails this test,
even if it makes clicks
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• Calibration date check – the instrument should have a sticker on it with a calibration date within
the last year. If the date is greater than 1 year or there is no sticker at all, contact DRS
• Source check – the instrument has a check source attached to the side of it. The calibration
sticker has the cpm value that source reads with the probe of the instrument. Put the probe on
the source to ensure it deflects off the first scale. At least once a week you should adjust the
scale when performing this check to ensure you get within ±20% of the value on the sticker.
Prior to surveying, note the background level of the meter by turning it on in an area that should not
have any radiation sources present. While surveying if you find 100 cpm above background and is
repeatable, that is likely contamination and should be addressed.
When surveying with a hand-held instrument, move the probe slowly, no faster than 2 inches per
second and keep the probe within ½” of the surface being measured. Be careful not to touch the surface
with the probe, as it can be difficult to decontaminate a probe. Never cover the probe with plastic wrap
or anything else as this prevents beta particles from reaching the probe.
If the general background from nearby radiation sources (i.e. waste or source storage areas) reaches 200
cpm on an instrument, you have to survey more slowly to find low-level contamination. You should
consider shielding or moving those sources of radiation while surveying for contamination. If this is not
feasible, you can do a smear survey in a high background area OR if you need to do a quick check of an
area to ensure contamination from high-energy beta emitters is not present, take an area wipe with
absorbent paper or a Kimwipe, move to a low background area and survey the wipe with the instrument
probe.
If you are unsure of the radionuclide from contamination found with a pancake GM, there are some
techniques to narrow down the possibilities. First, turn the probe over – if the count rate drops to
essentially zero, it is a pure beta emitter. Second, place a thick card (index card works) between the
probe window and the contamination – if the count rate drops noticeably, it is a low energy beta
emitter.
One thing to keep in mind when using a pancake probe is that it tells you nothing about the dose rate to
the whole body. This is due to how the instrument works. If radiation interacts with a gas molecule
within the detection chamber, it sets off an ionizing avalanche that creates an electrical pulse signal.
The pulse size is the same no matter what the energy of the incident radiation was – if it can penetrate
the detector window, it generates a pulse. The instrument is actually counting how frequently the
pulses are occurring (thus a count rate). Since dose is defined as energy per mass of something (such as
air or tissue), not being able to discern the energy makes it impossible to use the instrument for a dose
rate measurement.
If a lab is concerned about the dose rate from their work, waste containers, source storage or from
something nearby, DRS can visit and take dose rate measurements with an instrument meant for that
purpose.
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Use smears or swipes that will dissolve in the LSC cocktail being used. Smear a reasonably sized area
when conducting a smear survey; otherwise, the location of a contaminated smear might be hard to
determine. Ensure your LSC is working by using a check source (internal or external radioactive
standard). DRS recommends an annual calibration by the manufacturer. Include a blank smear with
your set of smears as a background to ensure cross-contamination is not occurring. Be sure to apply a
counting efficiency to any positive results (consult user manuals for the specific machine or contact DRS
for estimates). Note that erroneous results can occur from chemiluminescence (chemical reactions in
the cocktail instead of radiation). This can usually be counteracted by dark-adapting the samples for at
least 30 minutes (store them inside the counter with the lid closed).
The chart below shows the recommended monitoring method for nuclides commonly used at NIH. If
you are using something not in this chart you can contact your Area Health Physicist for guidance:
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Contamination limits are in disintegrations per minute (dpm), whereas hand-held instruments read out
in counts per minute (cpm). To get dpm from the cpm value, simply take the cpm and divide by the
efficiency of the meter for that nuclide. P32 efficiencies are provided on the calibration sticker. Typical
efficiencies are estimated below. For example, 1,000 cpm of P32 would be (divide by 0.25) 4,000 dpm
while 1,000 cpm of C14 (divide by 0.05) would be 20,000 dpm.
Non-removable contamination is evaluated by DRS on a case by case basis to determine whether further
decontamination is necessary.
Shielding
If you are working with high-energy beta emitters, you must use plexiglass shielding (beta shield) to
reduce your exposure. If you are using a gamma emitter, DRS will advise on a thickness of lead shielding
recommended for keeping exposures ALARA. Never use lead for pure beta emitters like P-32, as doing
so produces Bremsstrahlung x-ray radiation from beta particles interacting with dense materials. This
creates an exposure hazard where there had been none with plexiglass. If you are working with a high-
energy beta-gamma emitter, shield with the heavy plastic first, then lead closest to the worker.
Additional Requirements
If you are working under a DRS protocol or an Animal Study Proposal (ASP), there may be additional job-
specific requirements imposed by DRS. Any additional requirement will be communicated to the lab as
part of the approval process for these types of procedures.
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Collaborating with Outside Entities
Researchers sometimes wish to collaborate with another institution with their research involving
radioactive materials. This can involve wanting to send radioactive materials (raw materials, labeled
cells, etc.) to another location. There are numerous Department of Transportation (DOT) regulations
surrounding the shipment of radioactive materials on public highways. Therefore, DRS must be
contacted to ship radioactive materials of any amount to a location outside the boundaries of the main
campus, even if it is to another NIH-owned site. DRS will package the item in accordance with DOT
requirements and ship it to the intended destination. Note that DRS requests 1 week notice for shipping
radioactive items, as it is necessary to do some prep work in advance of the shipment, such as verifying
the recipient is licensed to possess the radioactive material.
Radioactive Waste
Minimizing the amount of radioactive waste should be a goal of anyone working with radioactive
materials to reduce disposal costs and environmental impact. However, some radioactive waste is
inevitable. Some general requirements are delineated below. For more details on a particular type of
radioactive waste, see the Radioactive Waste section of the DEP Waste Calendar.
• Solid vs. Liquid – step cans with a plastic bag are provided for solid wastes and carboys are
provided for liquid radioactive waste collections. Step cans should not be overflowing –
schedule pickups to prevent this. Never fill the liquid waste carboys past the marked fill line.
Except for washing skin contamination off, NEVER put liquid radioactive waste down any NIH
sink.
• Half-life segregation – all radioactive waste with a half-life greater than 120 days should be kept
separate from those with a half-life less than that. Labs may not “decay in storage” any
radioactive waste, regardless of how short the half-life is. Have all radioactive waste collected
by DRS, who will conduct proper and formalized decay in storage to meet regulatory guidelines
for any waste that can be decayed in storage.
• Mixed waste vs. Regular Radwaste – any radioactive waste that contains another hazard
(flammable, oxidizer, organic etc.) must be kept separate from radwaste with no other hazards.
Consult the waste calendar to ensure your mixed waste is being collected properly based on
what your lab is working with.
Radioactive waste containers should be located in a defined area of the lab, with the floor underneath
lined with absorbent paper or equivalent. Liquid waste carboys should be inside a secondary spill
container. Radioactive waste is subject to the DRS Security Policy and therefore must be locked up
within the lab or else the lab door must be locked when unoccupied.
Take care when transferring waste from the work area to the waste container to avoid contaminating
the traverse area or the exterior of waste containers.
Disposal Information
Anything that is contaminated with radioactive material that cannot be completely decontaminated
must be picked up as radioactive waste. DRS collects radioactive waste on a standing schedule or
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through ad hoc pickups. Either can be arranged through the AU Portal or by calling 301-496-4451. Note
that off-campus locations may only do standing pickups on a specific day of the week. All radioactive
waste containers must be labeled with Caution Radioactive Material Tape/Labels and also have a
Radioactive Waste Tag completed and attached.
Empty source vials may be disposed as dry radioactive waste. Unused or partially used vials should be
placed in a small cardboard box with its own radioactive waste tag for pick up.
General MPW must be double bagged and packaged in MPW boxes. Label the boxes as radioactive
material and include a radioactive waste tag, in addition to writing directly on the box the origin of the
box.
If storing animal carcasses while awaiting pickup, the MPW boxes must be refrigerated if stored >4
hours and frozen if >24 hours.
Note that some animal facilities may have larger totes for marshalling MPW waste. These are intended
for non-radioactive wastes, although the totes are surveyed externally for signs of radiation prior to
being sent off campus.
Infectious Materials
Radioactive waste that also contains infectious agents must be inactivated biologically prior to pickup by
the Radioactive Waste Service. Note that use of an autoclave on radioactive items has a specific
procedure:
Sharps Disposal
Use the red puncture resistant containers for needles, syringes or anything sharp. Label the container as
radioactive and include a radioactive waste tag.
Separate out groups of vials by radionuclide (except H-3 and C-14 may be disposed together) and place
in cardboard trays. The tray must be labeled as radioactive material (not each vial) and a radioactive
waste tag is required.
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Emergencies Involving Radioactive Materials
Despite the best intentions of everyone, accidents do happen in the laboratory involving radioactive
materials. Following the proper course of actions following a contamination event will limit the spread
of contamination and reduce the likelihood of appreciable exposures from the event.
A spill is simply radioactive material where it is not wanted. When a spill occurs or is discovered, the lab
needs to take actions to determine its extent, minimize the spread, ensure others are aware in the lab of
the contamination and to get the contamination cleaned up. You MUST notify DRS (see notification
table below) if any of the following situations arise:
DRS is happy to respond to contamination events that do not meet the above criteria.
For fire or serious emergencies, call 911 on campus and 9-911 off-campus
On-campus IRF at Frederick All other off-campus
Normal working hours 301-496-5774 301-631-7226 or 301-496-5774
(7 a.m. to 5 p.m., Mon-Fri) 301-496-5774
Off-hours 911 301-496-5685 and ask for 301-496-5685 and ask for
radiation safety assistance radiation safety assistance
Spill Clean-up
In general, lab staff cleans inside their posted spaces and DRS cleans unrestricted areas.
NEVER ask housekeeping staff to assist cleaning radioactive spills and do not borrow their equipment.
When cleaning a spill, wear a lab coat, gloves and shoe covers/booties. Start at the outer edges of the
spill and work inward. Minimize the amount of water added to the spill clean-up. Treat all cleaning
materials as radioactive waste. Check your gloves and shoe covers for contamination regularly during
clean-up operations, limit the movement of people and materials inside/outside the spill area and check
all impacted lab staff carefully for contamination. Once you believe the spill is cleaned, monitor the spill
area with a hand-held instrument (if appropriate for the nuclide) and follow-up with a smear survey to
declare the area contamination free. If you find contamination with the meter that will not come up,
notify DRS so that they can confirm the contamination is fixed and evaluate if any further actions
(covering for decay, removing floor tile, etc.) are necessary.
During the clean-up be sure to let others in the area know there is a spill and to stay away from the area.
Mark the area(s) as best you can.
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Skin Contamination
If you find contamination on clothing or PPE, remove the top layer and survey underneath. Bag up any
contaminated clothing for decay or disposal as radioactive waste.
If you find contamination on the skin, notify DRS immediately. It is important to get a quantified
measurement with the instrument used. If the instrument reads higher than the highest scale you can
try the following techniques to get a usable reading:
• Cover the probe with thick paper or plastic, but not so much that it blocks all the beta particles.
Once you get a value on the instrument that is not off the highest scale, note what was used to
shield the probe for that reading and DRS can figure out the true unshielded value
• If the lab has an exposure rate meter with a window, open the window and measure the skin.
DRS can do an experiment later to quantify the amount of contamination
Do not unduly delay decontaminating the skin. Attempt to wash it off in the nearest sink. This is the
only exception to the sink disposal prohibition. After wiping/washing, take a new measurement and
document. Use gentle methods to remove skin contamination. Keep going until the contamination
level no longer drops or if the skin begins to redden. If decontamination continues on damaged skin it
could internalize the contamination which is usually a worse result that leaving it on the skin.
DRS may instruct the worker to wear something over any non-removable skin contamination to keep it
contained should the contamination start to work its way off the skin. DRS will follow-up the day after
to re-check the contamination to see if it is reducing at a faster rate than physical decay. Based on the
initial measurements and subsequent follow-up, DRS will calculate an estimated skin dose from the
contamination.
If the skin contamination is in the facial area DRS may request the worker undergo a bioassay to verify
radioactivity was not inhaled/ingested. DRS may also do some basic field measurements that determine
the likelihood of that occurring.
Eye contamination
Immediately flush the eyes with water and notify/report to OMS. Alert DRS who will report to OMS to
monitor the contamination.
Medical Emergencies
Life-saving ALWAYS takes precedence over contamination issues. If something happens and you would
normally dial 911 for emergency response, do that without regard to radiological contamination issues
that might be present. Someone in the lab should additionally notify DRS who will perform monitoring
of the lab and follow-up with first responders once the emergency is over.
If there is a minor injury involving radioactive material, notify DRS so that they can accompany the
worker to OMS who will want to know the contamination status of anyone who visits their clinic.
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Other Kinds of Emergencies
For floods or fires in a posted lab, notify DRS when safe to do so. DRS will conduct surveys of the
affected area once first responders deem it physically safe to enter. Do not dispose of collected flood
water (from a flood event or fire response) without DRS sampling it first.
Lost Material
If you believe a radioactive source vial has gone missing, conduct a thorough search in your lab. Check
to see that it wasn’t disposed as radioactive waste or in a non-radiological disposal outlet. Check other
freezers and storage areas within the lab and check with staff in neighboring labs, as well as asking
everyone who is listed on the U/D sheet if they know where it is. Once it is evident the source is
missing, notify DRS immediately, as under some circumstances it is necessary to notify the NRC of lost
material. DRS will come to the lab and attempt to locate the source vial in addition to verifying it was
not picked up as radioactive waste and brought back to Building 21.
DRS is obligated by NRC regulations and license commitments to ensure workers, patients and visitors
are protected from unnecessary exposure. For workers, this means ensuring contamination and
exposure limits are observed and work practices are utilized to minimize exposure from working with
ionizing radiation.
Because NIH is a large program with regard to ionizing radiation, DRS relies on its Authorized Users to
implement day-to-day oversight within the labs. For procedures that are novel or involve larger
potential for exposure, DRS may observe procedures in the lab.
In general DRS conducts its oversight through its comprehensive survey and lab inspection program.
While a lab using radioactive material must conduct a survey at least once a day it is used, DRS or its
contractors will conduct an unannounced monthly evaluation of all posted rooms and will do a
contamination survey regardless if any radioactive material was used during the month. Additionally, all
posted spaces and adjacent corridors undergo a comprehensive inspection at least twice a year. In
addition to conducting radiation and contamination surveys, a number of other radiation safety
inspection items are evaluated, such as use of absorbent paper and PPE, radioactive waste
management, radioactive material security and appropriate monitoring is being performed within the
lab. The inspection also includes looking at records to ensure DRS requirements are being carried out.
Minor findings may be corrected on the spot, with some infractions being followed up by an Area Health
Physicist.
Labs with histories of non-compliance or who use larger quantities of high-energy radioactive materials
undergo these comprehensive inspections more often.
Annually all AUs undergo a material inventory to reconcile DRS records with what is actually in the lab.
Even AUs with no inventory will be visited to ensure source vials are not physically present that may
have inadvertently been cleared from an AU’s record. Additionally, several aspects of the AU’s
intersection with DRS will be reviewed to ensure our records are accurate. The AU Audit, a
comprehensive look at AUs over the previous 2 years, was discontinued in 2020 and folded into the
annual inventory for a much more streamlined process for both the AU and DRS.
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Separately, sealed sources of radioactivity are inventoried every 6 months and tested for leakage by DRS
in accordance with NRC requirements.
As the regulator of most radioactive materials and the issuer of NIH’s licenses to possess them, the NRC
conducts oversight of how DRS implements and complies with all relevant regulations and license
commitments. The NRC conducts unannounced routine inspections on a recurring frequency. During
these inspections they immerse themselves in the NIH radiation safety programs. The NRC visits
laboratories who use radioactive materials and talks with lab staff to see if they know DRS policies and
general radiation safety principles. For procedures with more exposure potential they may observe a
procedure or ask lab staff to demonstrate how they comply with policies. They also closely scrutinize
DRS’ recordkeeping and procedures.
The NRC may also conduct inspections after specific radiation safety incidents that have come to their
attention either through DRS notifying them as required or if a radiation worker contacts them directly.
In all cases, if the NRC contacts or visits you, please cooperate with the inspector(s). Answer all
questions truthfully to the best of your ability. If you do not know the answer then say so. The penalties
for misleading the NRC are very steep, so always be straightforward, even if it means the answer might
violate a policy or regulation.
All NRC inspections culminate in a written report that outlines any violations or findings that NIH should
address. Severe or repeated violations can result in monetary fines to the NIH or restrictions on NIH’s
ability to possess radioactive material. Radiation workers have the right to see this inspection report,
which is posted publicly in Building 21 or a copy can be requested.
The NIH has an extensive clinical program that includes using radioactive materials for diagnostic and
therapeutic purposes. The NRC regulates how radioactive materials are used in these contexts in 10 CFR
35, in addition to license commitments.
For any human administration of radioactivity, there must be a Clinical Authorized User (CAU) who has
been approved by the NIH RSC in accordance with 10 CFR 35. The CAU then has specific protocols for
human administration approved by the RSC as well. The CAU is responsible for prescribing the
radioactive dose for specific procedures and the radioactive material is delivered to an RSC-approved
radiopharmacist who dispenses the correct amount of radioactivity for the administration. Note that for
diagnostic procedures involving I-131 in an amount greater than 1.11 MBq (30 µCi) and ALL therapeutic
doses of radioactive material, a written directive must be completed by the CAU. See the Therapeutic
Procedures section below for details on the written directive.
Diagnostic Procedures
For diagnostic procedures, small amounts of radioactive material are administered to a patient. After a
brief (up to an hour) uptake period, the patient is evaluated on a radiation scanner, then released to go
home. The radionuclides used have half-lives ranging from 2 minutes up to a few days. Thus, some
patients are still radioactive when they are released from the diagnostic clinic. The exposure hazard to
anyone around them is low – NRC regulations require any patient with the potential to give 500 mrem
25
dose to another person must be quarantined at the facility where the administration occurred. Patients
who do not meet that standard are allowed to leave. Patients are given instructions on how to minimize
exposure to others and to limit contamination in their homes. Radioactive contamination is possible
from any form of excretion from the patient (urine, sweat, etc.) and the extent depends upon the
radiochemical used and how the body processes it (the same as if the compound were non-radioactive).
Pathology samples from diagnostic procedures contain trivial amounts of radioactivity and are not
labeled as radioactive. DRS is generally not directly involved in diagnostic administrations, except for
ones involving I-131.
Therapeutic Procedures
For therapeutic procedures, larger amounts of radioactive material are administered to a patient, or
patients are exposed to high doses of radiation from a radioactive sealed source. DRS is heavily involved
in the safety procedures that are followed by the nursing staff in caring for these patients and is
frequently present during the administration of radiopharmaceuticals. As with diagnostic procedures,
the CAU and the protocols involved are approved by the RSC. For new therapy applications, there must
be extensive consultation with DRS well in advance (months) to ensure that NIH is licensed to conduct
the intended radiotherapies. Therapies involving sealed sources or external radiation beams from a
radioactive source may involve implementation of physical security requirements and significant
radiation shielding is likely needed. Amendments to the NIH Broad Scope License generally take 2-6
months and require approval by the RSC and NIH Senior Management to proceed. Additionally, DRS will
develop specific safety operating procedures that highly depend upon the specific radionuclide, the
location of the therapies and whether the patient must be quarantined for some period of time.
All therapeutic procedures require a written directive. The written directive specifies the nuclide, the
amount administered and the route of administration, in addition to other basic information. It must be
signed by the CAU in advance of the administration. A written directive can be changed by the CAU as
long as it is prior to administration of the radiopharmaceutical. In a medical emergency that threatens
the life of the patient, this can be an oral change so long as a written change is done as soon as possible.
For new therapies, DRS will work with the CAU on ensuring a written directive template and
implementing procedures are in place that comply with 10 CFR 35.40 and 35.41. If an
overdose/underdose occurs, the radioactivity was the wrong nuclide/drug, the administration was the
wrong method or the wrong person was dosed, DRS must be notified immediately as it will be necessary
to evaluate the potential dose consequences to the patient and NRC notification may be required.
If a patient received enough radioactivity to cause someone near them to receive 500 mrem dose if they
were sent home, he/she must be quarantined until that is no longer true. Quarantine rooms are
restricted for entry to only nursing staff involved in caring for the patient’s medical needs. All nursing
staff for quarantine therapies receive specific annual training in contamination and exposure control
procedures. All objects within the quarantine room are monitored for contamination before release
outside the room.
All pathology samples from therapeutic administrations must be labeled as radioactive for the benefit of
the staff who process these samples and to ensure they are not inappropriately disposed as non-
radioactive.
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Once a patient is released from quarantine through DRS survey or other established method, he/she is
given instructions on how to minimize contamination and radiation exposure to others. DRS must
formally survey and release the quarantine room before general access can be restored.
Radiological Clearances
De-posting a Lab
If a lab no longer needs radioactive materials for storage or use, the Authorized User should initiate the
DRS Clearance process. If the lab has not used or stored radioactive materials for 12 months or more,
DRS will strongly suggest a clearance. Note that a lab can be reactivated with DRS within 48 hours if
needed.
To clear a lab from radiation safety controls, the AU needs to have all radioactive waste and the waste
containers moved to another lab that will remain posted or picked up by the Radioactive Waste Service.
Any item labeled with Caution Radioactive Material tape must be surveyed by the lab and once shown
non-contaminated, the tape must be removed. Alternatively, labeled items can be moved to a lab that
will remain posted.
Once all radioactive items are gone, the AU shall conduct a smear survey of the lab to establish it is not
contaminated. DRS will then come and conduct a more thorough survey that will take into account
whether the lab is being renovated or gutted, and will consider the entire known radiological history of
the space. A checklist for the process the AU needs to follow is available.
Note that only DRS can remove the door posting for radioactive materials.
If you are moving the lab to another building, follow the steps above to inactivate the old space.
However, if source vials need to be moved, please contact DRS who will come to the lab, inventory the
source vials, store them in Building 21 and deliver them to the new location once it is set up and posted.
The lab may move labeled items to the new location (must be posted by DRS) and may move
contaminated items (petri dishes, tubes, etc) so long as they are in double containment (bag in a box,
etc.) to prevent contamination escaping during transit.
Minor Renovations
If a portion of the lab will undergo renovation or repair (e.g. sink replacement, shelf removal, etc.),
contact DRS who will survey the portion of the lab involved and post a “partial clearance” sticker which
explicitly indicates to construction staff what part of the lab is released for their work. Lab staff should
not re-introduce radioactive items into the renovation area until the project is complete.
Any item that was labeled as contaminated must be surveyed by the lab prior to removing labels and
allowing the item to leave a posted space for repair, surplus, etc. This also includes equipment such as a
freezer that was used to store radioactive items. Labs conduct these surveys themselves. However, in
the case of equipment with complicated internals that were subject to radioactive liquid, it is best to
contact DRS for advice on the best way to conduct a meaningful survey.
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For releasing fume hoods that were used for volatile radioactivity, contact DRS to conduct a release
survey.
For LSCs and gamma counters that have internal sources, DRS must be involved in the clearance process.
If a counter is being moved off campus or surplussed, the internal source MUST be removed by a
qualified service technician who will formally ship the source to wherever the counter is going. Once
the source is removed, DRS will perform a contamination survey of the counter and put a clearance
sticker on it. For moving an LSC within the main campus, the source does not have to be removed.
However, it is recommended that the lead be removed by a qualified service technician to prevent
shifting which can damage the internals of the counter or breach the internal source.
Surplussing radiation-producing devices (x-ray units) requires no DRS involvement other than notifying
DRS the unit has been removed from service.
Generally Licensed devices (sniffers, gas chromatographs, etc.) can only be disposed through
coordination with DRS to ensure all requirements of 10 CFR 31 are followed. Contact DRS for guidance
on how to get rid of these kinds of items.
DRS allows housekeeping in posted spaces. The AU must ensure by surveying that the floor is not
contaminated prior to allowing mopping. Additionally, radwaste containers must be moved (plus survey
where they were) out of the area being cleaned.
Non-radioactive trash may be removed by housekeeping without specific additional steps. It is very
important that radioactive items/trash is never disposed in the regular trash.
For construction projects that involve substantial structural modifications to a room or series of rooms;
gutting entire laboratories, wings of buildings or entire buildings; or converting lab buildings to office
buildings, there is substantially more DRS involvement in the process.
Any construction project involving a space that involves or will involve a radiation safety interest gets
routed through DRS for review as part of the design phase of the project. DRS then researches the
radiological history of the affected spaces to determine how much DRS involvement is required at any
stage of the project.
For spaces that DRS determines had a history with long-lived radioactive materials at any point in the
past, DRS will conduct additional contamination surveys. Depending on the nature of the project this
could be when the lab is emptied, when certain structures are removed, or both. DRS works with the
Division of Environmental Protection (DEP) and the Project Officer for the project to make DRS
requirements known and coordinate when the project needs to pause for DRS surveys.
DRS surveys generally are 100% surveys of the spaces. However, if the footprint of a project makes it
impractical for DRS to conduct 100% surveys in a timely manner relative to the project schedule, the
NRC permits a surveying scheme that employs a statistically defensible proportion of survey coverage.
At NIH this is accomplished via a MARSSIM (Multi-Agency Radiation Survey and Site Investigation
Manual) survey. A contractor (through DEP with DRS consultation) is hired at the expense of the project
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to perform the MARSSIM survey that will allow free release of the affected area. This survey is done in
concert with other environmental clearances (mercury, asbestos, etc.) administered by DEP. Once a
final report is produced by the survey contractor, DRS reviews it. For an off-campus space that will be
relinquished from NIH control, this report MUST be reviewed by the NRC prior to allowing
relinquishment. NRC review takes 90 days and they sometimes visit the site to do an independent
inspection of the location and the survey process used. DRS recommends building a 6-month time
frame for NRC review into any project that in the end will relinquish an off-campus space from NIH
control.
For on-campus areas, the NRC reserves the right to inspect the clearance process and report before
allowing renovations to begin. Traditionally they have only reviewed on-campus clearances during
routine license inspections. However, for large scale renovations or entire building demolitions, the NRC
may exercise this right in the future.
New construction or renovation of NIH lab spaces may result in facilities that utilize radiation or
radioactivity. Projects where this is clearly the point of the project get routed through DRS as part of the
design phase. If the project results in labs working with radioactivity in traditional ways, DRS
involvement is generally limited to formally posting the space for radioactive materials once DRS
determines it is appropriate to do so.
For projects involving radiation producing devices or Positron Emission Tomography (PET) scanners
(animal or human), contact DRS as soon as it is known these devices are part of the project. Shielding
evaluations will need to be conducted on the spaces where these types of equipment will be housed.
For projects involving significant quantities of radioactive materials in use all at once (tens of mCi or
more), contact DRS as soon as that is known. DRS will need to specify shielding requirements for any
transfer lines or hot cells employed to handle large amounts of radioactive materials safely. There may
also be exhaust effluent issues to consider. Note that in some cases it may be necessary to obtain RSC
approval and/or an amendment to the NRC license.
It is crucial to contact DRS at the earliest stages of project conception to ensure the design will
incorporate DRS’ requirements. In addition to ensuring regulatory compliance, this prevents potentially
delaying the project or incurring costly changes to a project in progress.
Once a new facility involving shielding is completed, DRS will formally commission a facility by taking
dose measurements of the first use of the facility to verify shielding is correctly installed.
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Appendix A
The Basic Physics of Radioactivity
Radioactivity is the property possessed by a subset of atoms which are unstable (related to neutron-
proton ratio) and spontaneously emit various energetic particles in an attempt to reach stability.
For the purposes of radiation safety discussions, an atom has a nucleus containing neutrons and protons
(the total of these constitute the atomic mass) and an orbiting cloud of electrons in energy shells. The
number of protons dictates what element the atom is, while differing numbers of neutrons affect the
stability of the overall atom. Atoms with the same number of protons but different numbers of
neutrons are isotopes to one another. The term isotope is often used to mean radioactive but that is
not technically accurate – radionuclide is the correct term.
Depending on the ratio of neutrons to protons, a radioactive atom can emit differing particles (called
disintegration or decay). For radionuclides commonly used at NIH, the following emitted particles are
possible:
• Alpha particles – more common among heavier and man-made nuclides, this is a particle made
up of 2 neutrons and 2 protons. Alphas do not penetrate very far in material and are easily
shielded by a piece of paper or even the dead layer of skin on the human body. When ingested,
however, they are able to impart all of their energy into a small area (handful of cells at most)
and are considered to be the most damaging when internalized
• Beta particles – more common among lighter elements, this is an electron being ejected out of
the nucleus by virtue of a neutron splitting into a proton and an electron. Beta particles are
emitted in a wide array of energies and the higher the energy the deeper it can penetrate
materials such as plastics or live skin cells.
• Gamma or X-rays – these often accompany particle emission from atoms. Gamma rays originate
in the nucleus whereas x-rays originate from electrons changing shell locations outside the
atom. Both can penetrate large distances and can only be attenuated by dense materials.
• Positrons – in some lighter elements, positron decay can occur. A proton within the atom
converts into a neutron and emits a positively charged electron. Once emitted it acts like a beta
particle until it runs into an electron which annihilate one another and that produces two 511
keV gamma rays that are released 180 degrees from each other. Therefore, positron emitters
are a gamma hazard even if gammas are not part of the atom’s decay mechanism.
What the above 4 radiation types have in common is that they can ionize atoms they interact with after
being emitted from a radioactive atom. Ionization is the process of knocking electrons out of the orbit
of an atom. This does not normally make the impacted atom radioactive but instead causes it to behave
differently from a chemical standpoint as its electrical charge has been changed. When inside a living
cell this can disrupt cell function if enough atoms are ionized or if DNA is damaged.
Another emission from an atom that is possible (common in nuclear fission) but is only present at NIH
during cyclotron operations is the neutron. Neutrons cannot directly ionize another atom but instead
interact directly with a nucleus to lose its energy until a nucleus absorbs it entirely. Since this changes
the neutron to proton ratio in that atom, it may become radioactive and emit any of the 4 radiation
types described above. Because of this, neutrons are said to be indirectly ionizing.
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Radioactive Decay
Each radionuclide has a unique half-life which is the amount of time it takes for half of the radioactive
material to decay. This is a statistical property of a large quantity of radioactive atoms observed over
time. The time it takes for any one radioactive atom is not predictable and can be any length of time.
The half-life cannot be altered by any known means. Researchers need to take radiological decay into
account when procuring radioactive materials for experiments. The amount of radioactivity at any time
t is given by the following equation:
A = A0e-λt
Where A0 is the original amount of material (or a dose rate) and λ is (ln 2/half-life)
Most radionuclides at NIH decay to a non-radioactive atom. Sometimes, though, the progeny
(sometimes called daughter) is also radioactive. Depending on the half-lives of the two species of
atoms, there are three scenarios possible:
• If the half-life of the parent is long compared to the progeny, secular equilibrium is reached,
where the amount of radioactivity of the progeny is the same as the parent and appears to
decay at the same half-life as the parent
• If the half-life of the parent is only slightly longer than the progeny, transient equilibrium is
reached, where the activity of the progeny builds up to an amount greater than the parent, then
decays at the rate of the parent
• If the half-life of the progeny is longer than the parent, no equilibrium is reached and the
observed half-life of the progeny is constantly changing until all of the parent has decayed away,
leaving the progeny to then decay at its own half-life
Researchers using gamma emitters in the second and third scenarios above have to be cognizant that
the dose rate from their radioactivity may increase for a time before beginning to decline as one would
expect with radioactivity. DRS is available to give more detailed information on any nuclides that
behave this way.
Some radionuclides decay through a series of multiple radioactive elements (decay chain) and it gets
very complicated to describe what is happening with each of the radionuclides within the chain after a
period of time. A common example is household radon, which is in the middle of one of these decay
chains. Despite having a half-life of 3.8 days, it is constantly being produced by radioactive parents
above it in the chain and therefore never decays out unless the parents (uranium/radium in the ground)
are physically removed. An air sample from a basement with radon decays away at the 3.8-day half-life
because the uranium/radium sources are not in the air.
Amount of Radioactivity
The quantity of radioactive material is normally described in terms of how many decays/disintegrations
are occurring over time. The traditional unit for this is the Curie (Ci) which is defined as 1 gram of Ra-
226. 1 gram of Ra-226 (half-life 1600 years) has 3.7E10 decays per second. This is a large amount in
terms of radioactivity, despite being a small amount of material in terms of its mass. Because every
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radionuclide has a different half-life or rate at which it is decaying, 1 Ci of any other nuclide would have
a different mass than 1 gram. For example, 1 Ci of C-11 (20 min half-life) is 0.001 micrograms.
The SI unit for radioactivity is the Becquerel (Bq). 1 Bq = 1 disintegration per second (dps) = 60 dpm.
Thus, the Bq is a very small unit.
Because the regulations are still mostly using the old Curie-based units, DRS mostly operates with those
as opposed to SI units. Typical radioactive benchwork involves microcurie or millicurie amounts. The
NIH Cyclotron and associated radiochemists do use Curie amounts of radioactivity.
Background Radiation
Radiation is all around us. The sources of this radiation are naturally occurring – rocks in the earth and
cosmic radiation from space contribute a consistent amount of radiation to any particular geographic
location. Locations that have a higher concentration of uranium/radium in the ground or are higher in
elevation receive more background radiation. For example, Denver CO (lots of granite and high
elevation) has a higher background radiation dose rate than Miami FL (not much rock and at sea level).
The average for the United States as a whole is roughly 1 mrem per day from background sources.
Regulatory authorities also consider medical radiation to be part of the background, since this source of
radiation is not occupational in nature.
NCRP 160 has the most recent analysis of background radiation and combining the medical radiation
with the natural background gives an average of 620 mrem per year. Note that this is a population
statistic and any one individual’s actual exposure from these sources can vary pretty widely. For
example, if you have no medical radiation this year, your background exposure will be closer to the 1
mrem/day value. If you received a typical CT scan, your dose total for the year will be closer to 1500
mrem. Almost nobody receives the 620 mrem average value in a year.
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Biological Effects of Radiation
The extent to which radiation causes biological effects is dependent upon broad factors such as how
much dose was received and over what time frame it was received; age of the individual; radiosensitivity
of the cells impacted; and overall health of the individual.
Biological effects from radiation are broadly categorized as being prompt (non-stochastic) and delayed
(stochastic). Prompt effects have dose thresholds and are a result of receiving this threshold in a very
short period of time. Examples of prompt effects are burns, hair loss, sterility and radiation sickness.
For prompt effects, the higher the dose received – the worse the effect will be. The chart below shows
some prompt effects and the doses required on average to observe them. Keep in mind that the
occupational exposure limit is 5,000 mrem and that 99% of NIH workers do not reach 10% of the limit.
Biological effects at various doses are shown in the two tables below. These dose amounts would need
to be received in a short period of time to cause the effect.
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Dose (localized) Effect
300,000 mrem to skin minor radiation burn threshold
1,000,000+ mrem to skin major burn including ulceration and necrosis
500,000 mrem to scalp temporary hair loss
1,000,000 mrem to scalp permanent hair loss
20,000 to 500,000 mrem to reproductive organs temporary sterility
500,000 to 1,000,000 mrem to reproductive organs permanent sterility
The most common examples of delayed effects are cataracts and cancer. For delayed effects, there is
no specific dose threshold, but rather the probability of the effect increases with the dose received.
Additionally, the severity of the effect is not related to the amount of dose received. Occupational dose
limits are designed to limit the increase of probability of these stochastic effects. Although the data is
inconclusive for very low exposures, for regulatory purposes the NRC assumes that any exposure has
some small increase in the risk for cancer (this mathematical theory is called Linear No-Threshold or
LNT). This is the basis for the ALARA philosophy – to avoid exposure when practical to do so. The cancer
statistic commonly cited (American Cancer Society) is that in a population of 10,000 people, 25% would
be expected to die of cancer from all causes. If they all received 1,000 mrem over a career, then 5 extra
people would be expected to die of cancer.
What does radiation actually do within the body? Since it ionizes atoms it interacts with, this changes
the electrical charge and therefore how the atom/compound behaves chemically. This creates free
radicals within cells which damage cell structures and cell function. Radiation can also break DNA
strands in a cell nucleus. If the cell repair works correctly, then there is likely no lasting impact. If the
cell repair is imperfect, then the cell may replicate with the wrong DNA sequence and cause a
proliferation of incorrect cells which can be harmful. Another potential outcome is cell death at the
time of the radiation interaction, which sounds bad but is actually a good outcome so long as it is not
happening to too many cells all at once.
The human body has a good mechanism to repair radiation-induced damage. Because of this,
therapeutic radiation can be given in higher amounts over a relatively short period of time instead of all
at once which could kill a person.
A theoretical delayed effect is genetic – radiation damage to an individual resulting in genetic effects to
that individual’s offspring. However, this has never been observed in human populations.
The following table shows various activities and the radiation dose that results. Note that occupational
exposures are on the low end of the table and that the table is logarithmic and not linear.
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Orange represents U.S. background sources
Source for the non-NIH values: American Nuclear Society and World Nuclear Association
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Appendix B
Glossary of Terms Related to Radiation Safety
ALARA: Acronym for ”As Low As Reasonably Achievable”, means making every reasonable
effort to maintain exposures to ionizing radiation as far below the dose limits as practical,
consistent with the purpose for which the licensed activity is undertaken, taking into account
the state of technology, the economics of improvements in relation to state of technology, the
economics of improvements in relation to benefits to the public health and safety, and other
societal and socioeconomic considerations, and in relation to utilization of nuclear energy and
licensed materials in the public interest.
ALI: Acronym for “Annual Limit on Intake”, which is the amount of a radionuclide taken
internally that will result in an effective dose of 5,000 mrem (annual occupational limit). These
values are prescribed in NRC Regulations – 10 CFR 20, Appendix B.
Bioassay: The determination of kinds, quantities or concentrations and, in some cases, the
locations of radioactive material in the human body, whether by direct measurement or by
analysis and evaluation of materials excreted or removed from the body.
Curie (Ci): The basic unit of activity. A quantity of any radionuclide that undergoes an average
transformation rate of 37 billion transformations per second. One curie is the approximate
activity of 1 gram of radium.
Cyclotron: A machine used to accelerate charged atomic particles to high energies by the
application of electromagnetic forces. These particles then bombard suitable target materials
to produce radioisotopes.
Dosimeter: A wearable detector for measuring and recording the total accumulated exposure
to ionizing radiation.
Dpm: (disintegrations per minute) the number of atoms of a radioactive substance decaying
(emitting ionizing radiation and changing to another substance) per minute.
Effective Dose: The whole body dose normalized to the radiological impact of a radiation
exposure summed over specified tissues/organs exposed. Mathematically it is the product of
the equivalent dose in a tissue and the weighting factor for that tissue, summed over all
organs. Quantities are recommended by the International Commission on Radiological
Protection (ICRP) 103. Tissue weighting factors recommended by ICRP 26 (1977), ICRP 60
(1991), and ICRP 103 (2007) differ in the tissues included and the numerical values of the
respective factors.
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chromatographs, static elimination devices, lead paint analyzers, liquid scintillation counters,
and ion mobility spectrometers.
Half-Life: The time in which half the atoms of a particular radioactive substance disintegrate to
another nuclear form. Measured half-lives vary from millionths of a second to billions of years.
Hot Cell: A heavily shielded enclosure for highly radioactive materials. It may be used for their
handling or processing by remote means or for their storage.
Isotopes: Radionuclides whose nuclei contain the same number of protons (therefore they are
the same element), but differing numbers of neutrons.
Ionizing Radiation: Photons or particulate radiation with sufficient energy to break chemical
bonds or ionize single atoms.
Radionuclide: Materials that produce ionizing radiation, such as gamma rays, alpha particles,
and beta particles.
Rem: One of the two standard units, along with the Sievert, used to measure the dose
equivalent (or effective dose), an individual receives from a radiation exposure. This measured
quantity combines the amount of energy (from any type of ionizing radiation that is deposited
in human tissue) with the biological effects of the given type of radiation. One Sievert (Sv)
equals 100 rem.
Scintillation: A scintillation detector, sometimes called a scintillator, is a device that emits light
when ionizing radiation interacts with the detector. The light is converted into an electrical
signal and recorded on a readout device. The amount of light is proportional to the amount of
energy deposited, allowing energy discrimination if desired.
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Source Material: Compounds of uranium and/or thorium, including depleted uranium, that are
not regulated by the NRC as byproduct material. Examples include uranyl acetate, uranyl
nitrate, thorium nitrate, and thorium citrate. Uranyl acetate is commonly used as a staining
technique in electron microscopy and is the most common form of source material at NIH.
Though not subject to NRC license requirements, source material must still be disposed of as
radioactive waste.
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Appendix C
Resources Related to Radiation Safety
Other Contacts
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