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Radiation Safety Manual
The Texas A&M Health Science Center
Temple Campus (IRM and MRB)
The Texas A&M Health Science Center
Radiation Safety Manual
Level 2
Program:
Doc. No.:
Date:
Office:
Radiation Safety
RAM- L05494
02-2014
Environmental Health & Safety
Concurrence and Approval
This RADIATION SAFETY Manual was developed for use by The Texas A&M Health Science
Center (HSC), and has been approved by the HSC Director of Environmental Health and Safety
(EHS) and the HSC Radiation Safety Officer (RSO).
Document Custodian:
Erich Fruchtnicht, MS, CHMM, RSO
Approval:
RSO
Date
Director, EHS
Date
Change History
Revision
Number
000
001
002
003
004
Interim
Change No.
0
0
0
0
0
Effective
Date
01/2006
06/2012
08/2013
10/2013
02/2014
Description of Change
HSC Radiation Safety Manual
Update Manual to Match Bryan-IBT
Update branding to reflect new HSC logos
Update Section 11.1.10 for I125 monitoring
Explicitly added ALARA in new Section 12.3
ii
The Texas A&M Health Science Center
Radiation Safety Manual
Level 2
Program:
Doc. No.:
Date:
Office:
Radiation Safety
RAM- L05494
02-2014
Environmental Health & Safety
Table of Contents
Concurrence and Approval ............................................................................................................. ii
Change History ............................................................................................................................... ii
Section 1.
Radiation Safety Manuals ......................................................................................... 1
Section 2.
Radiation Safety Program ......................................................................................... 2
Section 3.
Radiation Safety Committee ..................................................................................... 4
Section 4.
Radiation Safety Officers(s) ..................................................................................... 6
Section 5.
Principal Investigators .............................................................................................. 7
Section 6.
Ordering/Receiving Radioactive Material .............................................................. 10
Section 7.
Transferring Radioactive Material .......................................................................... 15
Section 8.
Training Requirements for Personnel Working with Radioactive Materials.......... 16
Section 9.
Routine Laboratory Procedures .............................................................................. 19
Section 10.
Requirements for Posting/Labeling Labs Using Radioactive Material .................. 21
Section 11.
Additional Precautions for Users of Radioiodine, Phosphorus-32, and Sulfur-35 . 22
Section 12.
Personnel Monitoring.............................................................................................. 25
Section 13.
Emergency Procedures............................................................................................ 31
Section 14.
Guidelines for Area Contamination Surveys .......................................................... 34
Section 15.
Disposal of Radioactive Materials .......................................................................... 37
Section 16.
Use of Radioactive Materials in Animals ............................................................... 43
Section 17.
General Instructions for Auxiliary Personnel ......................................................... 45
Section 18.
Registering X-Ray Machines .................................................................................. 48
Section 19.
Radiation Safety Requirements for X-Ray Producing Machines ........................... 51
Section 20.
Registering Lasers ................................................................................................... 55
Section 21.
Radiation Safety Requirements for Lasers ............................................................. 58
Section 22.
Policy for Addressing Violations of Regulatory Requirements or Standards for Safe
Work with Radiation, Radioactive Materials, and Lasers ...................................... 66
Section 23.
APPENDICES ........................................................................................................ 72
iii
Section 1.
Radiation Safety Manuals
1.1 Introduction
This manual describes policies and procedure for the use of radioactive material and radiation
producing devices at the Texas A&M Health Science Center (HSC). The provisions of this
manual are applicable to all users. This manual has been approved by the Texas Department of
State Health Services, Radiation Control Division. Every attempt has been made to include
sufficient detail to enable safe use of radioactive material and radiation producing devices by
simply following its provision. It is impossible, however to anticipate all possible circumstances
and situations. Due to continuing changes in state and federal regulations governing radiation,
readers are advised to contact Environmental Health and Safety (EHS) at their respective
location with any questions:
1.1.1
Medical Research Building (MRB)
Location: 702 SW HK Dodgen Loop, Temple, TX 76504
Phone: 254-742-7024
1.1.2
Health Science Center Bryan Campus EHS
Location: 1022 Medical Research and Education Building
Phone: 979-436-0551
1.2 Who Needs a Manual?
The Radiation Safety Manual is issued through the Texas A&M Health Science Center’s EHS. It is
available to:
1.2.1
1.2.2
All personnel who use, supervise, or control the use of radioactive materials or radiation
producing devices.
Personnel who might have reason to enter areas where sources of radiation are present.
1.3 Location of Manuals
Manuals should be located in:
1.3.1
1.3.2
Every laboratory authorized to use radioactive materials and radiation producing devices.
Certain department offices (e.g. Security and Physical Plant).
1.4 Accountability
Manuals are numbered for purposes of inventory and updating.
Individuals to whom manuals are issued are asked to return their manuals if they terminate
employment. Manuals issued to particular departments, divisions, offices, work stations, etc., should
pass these on to their successors and notify EHS whenever there are changes to personnel or work
practices involving radioactive materials.
1.5 Updates to the Manual
Changes and corrections to this manual will be issued by Environmental Health and Safety (EHS)
when needed. Such updates will be distributed to all individuals who possess a copy of the manual.
Upon receipt of the update, make changes in accordance with instructions accompanying the update
and notify all individuals affected.
Radiation Safety Manual
1
Section 2.
Radiation Safety Program
2.1 Purpose
The Radiation Safety Program safeguards the health and well-being of the Health Science Center’s
community and the community-at-large from the potentially harmful effects of radiation. This is
accomplished by maintaining compliance with applicable federal, state, and institution regulations
and through the establishment of good health physics work practices.
2.2 Scope
The Radiation Safety Program applies to all persons who purchase, possess, transfer, store, use or
handle radioactive material and/or radiation producing devices on or in any HSC Campus, facility,
or space used by HSC personnel.
2.3 ALARA Policy
The Texas A&M Health Science Center requires that:
2.3.1
2.3.2
2.3.3
All users of radiation sources receive proper safety training, and
Be authorized by the Radiation Safety Committee and the Radiation Safety Officer, and
Comply with applicable regulatory requirements in order to ensure that all radiation
exposures are kept "As Low As Reasonably Achievable" (ALARA).
2.4 Radiation Safety Committee
THE RADIATION SAFETY COMMITTEE (RSC) establishes policies for the safe use of
sources of ionizing radiation on each HSC Campus holding a TDSHS-issued radioactive materials
license. The committee has the authority to curtail or prohibit the use of radioactive material by
anyone who is:
2.4.1
2.4.2
2.4.3
2.4.4
misusing radioactive material, or
misusing a radiation producing device, or
violating the terms of any radioactive material license or regulation, or
otherwise creating unsafe conditions.
2.5 Environmental Health and Safety (EHS)
The Office of Environmental Health and Safety (EHS) provides for compliance oversight and
management of the Radiation Safety Program, through the appointment of a Radiation Safety
Officer (RSO). The RSO reports to the Director of Environmental Health and Safety.
2.6 Radiation Safety Officers
2.6.1 The Institutional Radiation Safety Officer (RSO) is responsible for the management of
the Texas A&M Health Science Center’s Radiation Safety Program, and is designated as
the primary liaison between the HSC and all regulatory agencies involved with radiation
control. All changes to radiation licenses and registrations are submitted through the
Institutional RSO.
2.6.2
The Site Radiation Safety Officer (RSO) is responsible for local matters relating to
radiation safety and shall be the Committee's authorized representative regarding
radiation protection within each respective HSC Campus.
2.7 Principle Investigator (PI)
PRINCIPAL INVESTIGATORS (PI) are specifically authorized by the Radiation Safety
Committee to obtain and use radioactive materials and/or radiation producing devices at HSC. PIs
Radiation Safety Manual
2
are responsible for all parts and conditions of their Permit, their Authorized Users and their
compliance with all applicable policies, procedures and regulations.
2.8 Authorized Users
AUTHORIZED USERS are specifically approved to work with radioactive materials under the
permit of their PI. Authorized Users are responsible for working safely with radioactive material and
for complying with all applicable policies, procedures, and regulations.
2.9 Documentation
Policies, procedures, guidelines which define the Texas A&M Health Science Center’s (HSC)
Radiation Safety Program are found in the following documents:
2.9.1
2.9.2
The HSC’s Radiation Safety Manual, (this document)
Environmental Health & Safety Standard Operating Procedures
Radiation Safety Manual
3
Section 3.
Radiation Safety Committee
3.1 Introduction
The Radiation Safety Committee (RSC) reports to both the Office of Research and the Office of
Finance and Administration. The Committee meets as often as is necessary to conduct its business
but at least semiannually. Members may be contacted and polled at any other time concerning
specific issues. The RSC is specifically charged with ensuring that the HSC’s radiation safety
program is in compliance with all state licensing requirements.
3.2 Functions and Responsibilities
Specifically, the RSC will work with the RSO to:
3.2.1
3.2.2
3.2.3
3.2.4
3.2.5
3.2.6
3.2.7
3.2.8
Make policies and procedures for the protection of all individuals from the hazards
related to sources of ionizing radiation.
Identify areas in which radiation hazards exist or are likely to exist.
Ensure that radiation laboratories are clearly designated through the use of signs or other
visible indicators.
Ensure safe use of radioactive materials by approving and requiring training,
pre-approving sublicenses for specific use, and prohibiting use when necessary.
Ensure safe use of radiation producing devices by approving and requiring training,
pre-approving subregistrants, and prohibiting use when necessary.
Regulate HSC facilities using radiation producing devices and radioactive materials.
Investigate any possible misuse, apply and enforce any necessary disciplinary action, and
notify the State of any reportable incidents.
Review and approve amendment applications to the HSC Campus over which that RSC
has jurisdiction prior to submittal to the State.
3.3 Membership
Members of the Radiation Safety Committee and its Chair shall serve a two (2) year term.
Committee membership will normally include representatives from various user groups. Total
membership for the committee will consist of no fewer than four (4). All members of the Committee
shall be voting members and may come from the following groups:
3.3.1
3.3.2
3.3.3
3.3.4
Radiation Safety Officer(s)
Lab Operations (Administration)
Members of the Scientific Staff. These members must currently hold a permit to use
radioactive materials at the HSC, or have substantial experience with the use of
radioactive materials. One will serve as Chair for the Committee.
Representatives from the Technical Staff (Research Assistants, Lab Technologists, Lab
Coordinators, etc.)
3.4 Radiation Safety Program Evaluation
The RSC shall meet at least semiannually for the purpose of being briefed on the status of the
radiation safety program. The agenda shall include but not be limited to the following:
3.4.1
3.4.2
3.4.3
3.4.4
3.4.5
changes of the Committee membership
changes of the EHS staff
changes in regulations, policies, and procedures
review of incidents or accidents
proposed research programs
Radiation Safety Manual
4
3.4.6
future requirements of the EHS Office
The RSC will also evaluate the content and implementation of the Radiation Safety Program by
reviewing an annual audit performed by the RSO.
3.5 Safety Violations
Investigation of safety violations can be initiated by the RSC or the RSO and will follow the policy
items laid out in Section 9 below.
3.6 Annual Report
The RSC shall prepare an annual report for the Office of Research Compliance summarizing
committee and EHS activities for the year. These activities include but are not limited to:
3.6.1
3.6.2
3.6.3
3.6.4
3.6.5
3.6.6
3.6.7
3.6.8
Committee membership
Addition/Deletions of Principal Investigators
Incidents involving radioactive materials or overexposure to workers.
Statistics of Radiation EHS (i.e., number of packages received, labs audited and results,
waste disposal, etc.)
Changes in HSC policies and procedures involving usage of radioactive materials and/or
radiation producing devices
Major changes to the Texas Regulations for the Control of Radiation.
Results of the RSO's annual report.
Plans for the next year.
Radiation Safety Manual
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Section 4.
Radiation Safety Officers(s)
4.1 Radiation Safety Officers
Radiation Safety Program management at the Texas A&M Health Science Center is administered
through the Office of Finance and Administration, Office of Environmental Health & Safety.
4.1.1
4.1.2
The Institutional RSO provides program oversight throughout the HSC.
The Site RSO is the EHS official for the specific Health Science Center Campus.
4.2 Responsibilities
The Radiation Safety Officer is responsible for the following:
4.2.1 assists in the development of general policies for control of radiation
4.2.2 collects and disseminates information relative to radiation protection
4.2.3 evaluates equipment and physical facilities
4.2.4 evaluates operational techniques and procedures
4.2.5 instructs personnel in the practical aspects of radiation protection
4.2.6 conducts an inspection program to assure that laboratory facilities and procedures are in
accordance with HSC policies and Texas Regulations for Control of Radiation
4.2.7 provides advice on decontamination of facilities and equipment following spills or prior
to remodeling or modification of facilities
4.2.8 responds to emergencies and investigates accidental exposures
4.2.9 aids in the completion of all forms and documents associated with the Radiation Safety
Program
4.2.10 conducts a program of quarterly wipe tests in the laboratory areas where the radioactive
materials are handled
4.2.11 provides a personnel monitoring program (as needed)
4.2.12 receives, inspects and delivers packages containing radioactive materials
4.2.13 maintains and updates an inventory of radioactive materials
4.2.14 sets up and maintains a radioactive materials waste disposal program
4.2.15 calibrates or arranges calibration of survey instruments
4.2.16 liaisons with the State for all license and registration issues
4.2.17 maintains all records necessary for the administration of the license
4.3 Emergency Authority
The Radiation Safety Officer is authorized to take prompt remedial action in radiation emergency
situations without prior approval from the RSC or through the management chain. The RSO shall
notify supervisory authority of the event at the earliest opportunity.
Radiation Safety Manual
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Section 5.
Principal Investigators
5.1 Introduction
Licenses to possess and use radioactive materials have been issued to certain Texas A&M
Health Science Center (HSC) Campuses by the Texas Department of State Health Services
(TDSHS). The license is called a "specific license" and which requires that final approval of
Principal Investigators rests with TDSHS.
Under the terms of this license, the Radiation Safety Committee is given the responsibility to
review and approve applications for use prior to submittal to TDSHS.
5.2 Principal Investigator
Those faculty members who, because of their training and experience, have been designated by
TDSHS as being qualified to use radioactive material at a certain HSC Campus are referred to as
Principal Investigators (PIs).
A faculty member whose application has been denied by the RSC due to insufficient training
and/or experience may use radioactive materials as an Authorized User on another Principal
Investigators Permit with the condition that the training and experience requirements be
completed within six months of the RSC's decision or by the end of the next training course
presented by EHS to meet the training requirement.
5.3 Authorized User (AU)
Those faculty, HSC post-doctoral fellows or other HSC students and staff who may work in the
lab of a PI who has been authorized to work with radiation sources under the provisions of this
rule. An AU does not hold a permit to perform work with radiation sources and must work
under the supervision of a PI. All AUs must complete appropriate training as required by the
RSC, and the RSO, and shall have laboratory specific training provided by the PI under whom
the AU works.
5.4 Requirements
The following educational, training and/or experience standards are established to satisfy
requirements:
5.4.1
5.4.2
Formal course in radioisotope techniques, and six (6) months of experience and training
under the supervision of a licensed staff member, or
Having held a Radioactive Material License issued by the USNRC, an agreement
state or another recognized institution for similar work. If the applicant has
experience in using radioactive material but has not received formal training in
radiation safety principles, then they must attend and pass the Radioisotope Handling
and Procedures course offered by EHS.
5.5 Responsibilities
The Principal Investigator is directly responsible for all aspects of radiation safety associated with
his possession and use of radioactive materials. This responsibility includes:
5.5.1
5.5.2
5.5.3
5.5.4
complying with Texas Regulations for the Control of Radiation,
complying with conditions of the HSC Radioactive Materials License,
complying with the conditions of his or her permit,
complying with the HSC Radiation Safety Manual and policies of the Radiation Safety
Committee,
Radiation Safety Manual
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5.5.5
providing instructions on safe and proper radiation practices to all persons working
within the facilities of the Principal Investigator,
5.5.6 maintaining adequate control of the radioactive material to ensure that areas beyond the
Principal Investigator's control are not adversely affected by its use,
5.5.7 providing necessary equipment for safe work with radioactive material,
5.5.8 properly labeling all radiation sources and areas,
5.5.9 securing all radioactive material against theft or unauthorized use,
5.5.10 properly disposing of all radioactive waste,
5.5.11 notifying the EHS Office/Radiation Safety Officer of any accident or abnormal
incident involving or suspected of involving radioactive material, and
5.5.12 informing the EHS Office of any changes in personnel and any significant changes in
lab design or procedures.
5.6 Record Keeping
The following records shall be maintained by the Principal Investigator.
5.6.1
5.6.2
5.6.3
5.6.4
5.6.5
Radioisotope Tracking Form
Wipe Test Results
Survey Meter Calibration
Radiation Safety Survey
Most recent permit application, the approved permit and all correspondence relating
to the permit.
5.7 Application for Permit
Any qualified faculty member who wishes to become a Principal Investigator to use radioactive
materials must submit an application to the Radiation Safety Committee through the RSO.
5.8 Procedure
To obtain a permit to use radioactive materials:
5.8.1
5.8.2
5.8.3
5.8.4
5.8.5
5.8.6
5.8.7
5.8.8
Complete an application
Complete a facility inspection by the Radiation Safety Officer.
The completed application and RSO recommendation will be circulated to the Radiation
Safety Committee
If the application is approved by the RSC, an amendment will be submitted to the State to
add the new PI.
Once State approval has been obtained, an HSC “Permit to Use” will be issued to the PI
by the RSO.
The permit will list the Principal Investigators, Authorized Users, the radionuclides and
activity limits and authorized locations. Permits are valid for two (2) years.
Applications for permits and a guide for completing them are included as an appendix
to this Radiation Safety Manual or online by contacting the RSO.
The RSO will assist all applicants in completing the forms.
5.9 Amendment of Permit
Requests for changes to an RAM authorization permit can be made by completing a
"Radioactive Material Permit Amendment Form" and returning it to EHS for review by the
Radiation Safety Committee.
5.10 Renewal of Permit
Radioactive Material Use Permits expire on the last day of the month indicated on the permit.
Radiation Safety Manual
8
Prior to that date, the RSO/EHS Office will send a completed renewal application for the PI to
review, sign, and return. All information previously submitted should be carefully reviewed to
ensure that it accurately describes current conditions and is sufficient to meet current criteria.
If the permit is not to be renewed, the application form is to be returned with a memo stating the
PI's intent to let the permit expire.
5.11 Compliance Inspections of Permits
EHS staff conducts audits of permit compliance at least quarterly in all areas authorized for
storage and use of radioactive material. In addition, EHS staff conducts routine wipe tests and
surveys to detect contamination in areas authorized for storage and use of radioactive material.
Radiation Safety Manual
9
Section 6.
Ordering/Receiving Radioactive Material
6.1 Introduction
After authorization for the use of radioactive materials (RAM) has been issued by the RSO, the
Principle Investigator (PI) may receive radioactive material in accordance with their permit.
All acquisitions of RAM require pre-approval from the RSO. The PI, prior to submitting a
purchase requisition to Purchasing, or prior to receipt of a free sample of radioactive materials,
must notify the RSO of the intended order or receipt.
6.2 Ordering
To order radioactive material (RAM), the following steps must be taken:
6.2.1
6.2.2
6.2.3
6.2.4
6.2.5
6.2.6
Complete a “Purchase Requisition Form” describing the material to be ordered. Must
include:
6.2.1.1
Radionuclide
6.2.1.2
Activity (total activity not specific activity)
6.2.1.3
Chemical / physical form
6.2.1.4
Vendor
6.2.1.5
Expected delivery date
NOTE: Packages must be scheduled to arrive between Monday and
Thursday.
Place the permit number of the PI who will be responsible for the use of the material
on the form
Have the form signed or initialed by the PI
Fax or email a scanned copy of the form to the HSC RSO
If approved for order, the originator of the request will be informed via email and/or
fax
When placing the order, specify your address as the “Bill to” address and give the
following “Ship to” address:
Radiation Safety Officer
Attn: (enter PI’s name)
(Building Specific Address)
6.3 Free Samples
The PI, prior to receipt of a free sample of radioactive materials, must notify the RSO of the
intended receipt.
6.4 Receiving
For MRB: All RAM shipments must enter the HSC campus through the EHS office. Delivery
carrier personnel will call the MRB EHS office upon the arrival of a radioactive material package.
EHS personnel will meet carrier and accept delivery of the radioactive material package. Within
three hours of receipt, EHS will:
6.4.1
6.4.2
take the package to room 320 of the MRB
perform the Package Acceptance Procedure as described in Section 6.6 below
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For IRM: All RAM shipments destined for the HSC IRM campus will be delivered directly to the
IRM. The TDSHS requires that shipments of radioactive materials be processed as soon as is
practicable but no later than three working hours after receipt of the package. To comply with this
rule, within three hours of receipt the IRM staff will:
6.4.3
6.4.4
take the package to the designated RAM usage area in C179 (which has been confirmed
clean by after-experiment swipe tests and Geiger-Mueller meter surveys)
perform the Package Acceptance Procedure as described in Section 6.6 below
6.5 Isotope Tracking Form
An Isotope Tracking Form shall be included with any package delivery at the time of package
transfer to PI or lab. This form shall be used to record any and all use of the delivered radionuclide
to provide an inventory record indicating zero final activity upon waste disposal.
6.6 Package Acceptance Procedure
6.6.1
6.6.2
6.6.3
Cautions
6.6.1.1
As with all exposure to radiation and radioactive material, it is important to
keep your exposure as low as reasonably achievable (ALARA).
6.6.1.2
Gloves should be worn at all times while checking in radioactive material
shipments.
6.6.1.3
A leaking or contaminated primary vial may result in personnel and surface
contamination. If a shipping container appears damaged or wet, survey the
package for contamination immediately and take extra care to prevent
contamination from spreading. If a leaking package is identified, notify the
EHSD immediately and survey for secondary contamination in the package
check-in area.
Instrumentation
To accurately measure radioactive contamination and radiation levels, you must use
appropriate calibrated instruments. Contact the RSO for information regarding annual
calibration of these instruments.
6.6.2.1
The meters you will need for this procedure are either:
6.6.2.1.1 an Ionization chamber, or
6.6.2.1.2 an Energy Compensated Geiger-Mueller probe or uncompensated
but with exposure filter attached
6.6.2.2
The instrument(s) you will need for this procedure are:
6.6.2.2.1 Liquid Scintillation Counter or similar
Ordering/Receiving Radioactive Material
6.6.3.1
6.6.3.2
6.6.3.3
Radiation Safety Manual
Before you order radioactive material, you must receive permission from the
EHSD to place the order. Please refer to “Ordering Radioactive Material” for
instructions.
If the order is approved, the order shall be assigned an RSO Number, or Ship
Code. If the order is denied, you will receive instructions regarding reducing
your present inventory or amending your Permit to allow possession of a
greater activity of the nuclide you are ordering.
The TDSHS requires that the shipment of radioactive material be processed
as soon as is practicable, but not later than three hours after receipt of the
package at the PI’s facility if it is received during working hours. If the order
is received after normal working hours (or during holidays), the shipment
11
must be checked in no later than 3 hours after the beginning of the next
regular business day. Crushed, wet, or damaged packages shall be inspected
immediately.
6.6.4
Package Survey
6.6.4.1
Prepare a Radioactive Materials Package Survey form. ALL BLANKS ON
THE FORM MUST BE FILLED IN.
6.6.4.2
Verify the package labeling and transport index (See Section 6.7) by
measuring external dose rates on contact and at one (1) meter with a properly
calibrated dose rate meter. If the exposure rates at the surface of the package
and at a distance of 1 meter from the package are less than 0.5 mrem/hr and
0.05 mrem/hr, respectively, these values can be recorded as simply <0.5
mrem/hr and <0.05 mrem/hr. If the radiation levels are above those values,
the actual readings need to be recorded. If the exposure rate exceeds 10
mR/hr at one meter from the package or 200 mR/hr at the surface of the
package, contact the RSO immediately.
6.6.4.3
Verify the type and quantity of radioactive material received as recorded on
the vial against the packing slip and the purchase requisition
6.6.4.4
Check the package for contamination using a swipe test as follows:
6.6.4.4.1 The liquid scintillation counter is the preferred method of counting
wipes for removable contamination. A GM survey meter will not
detect 3H and the detection efficiency of the LSC for all nuclides
typically found in the laboratory is higher than that of the GM survey
meter. The GM should be used only if a liquid scintillation counter is
not available. Wipe the exterior of the package with a filter paper or
a piece of tissue, wiping an area of at least 300 cm2. Wipe the
exterior of the pig and the primary vial each with a separate filter
paper or a piece of tissue.
The Minimum Detectable Activity (MDA) is an indication of the
minimum level of contamination that a counting system can
practically measure above background. At least two “blanks”
should be counted to determine the background count rate. A
“blank” is defined as a LSC vial with an unused tissue swipe
filled with the LSC cocktail. The MDA must be calculated and
entered on the receipt form. The package is then surveyed, with the
results entered on the receipt form.
The MDA for removable surface activity can be approximated by:
(
)
√
where:
MDA = activity level in disintegrations/minute
B = average background counts
t = counting time in minutes for sample and background counts
E = detector efficiency in counts/disintegration
Compare the wipe activity with the MDA. If the net wipe activity
(dpm), as calculated below, is less than the calculated MDA for
Radiation Safety Manual
12
that system, indicate as such by entering “< MDA” in the blank
provided for the contamination level on the surface of the package. If
the sample activity is greater than the MDA, indicate the calculated
wipe activity.
(
)
(
)
(
(
⁄
)
)
NOTE: if none of the sample results from the LSC are greater than
the average of the background samples, then the activity of “<MDA”
may be used without the need to perform the above calculation as
results below background will be below MDA.
6.6.5
6.6.6
6.6.7
The PI or designee is responsible for establishing the efficiency of
the LSC for the nuclide in question. Contact the EHSD for
assistance, if necessary.
6.6.4.5
WRITE THE INVENTORY NUMBER PROVIDED ON THE
APPROVED ORDER FORM ON THE PIG AND THE PRIMARY
VIAL WITH A PERMANENT PEN. If you do not have or cannot find the
inventory number, contact the RSO for a copy.
6.6.4.6
Prepare an Isotope Tracking Form
6.6.4.7
Fax a copy of the Radioactive Materials Package Survey Form to the RSO at
979-436-0082
The box in which the material was shipped in may be discarded as non-radioactive waste
as long as the PI ensures that the box is not contaminated (by performing and
documenting a contamination survey) and obliterates any radioactive signs or symbols.
6.6.5.1
The signs and symbols can be obliterated by covering them with duct tape,
destroying them by scraping them, or marking them out with a black marker.
The container may then be discarded as normal non-radioactive solid waste. All material
used during the package check-in procedure (gloves, wipes, etc.) should be considered
contaminated and discarded in a radioactive waste container. Some vendors participate
in a Styrofoam container recycling program. It is a requirement of the vendor as well as
EHS that a survey of the container for removable contamination be performed and
documented before the Styrofoam package is sent back to the vendor.
Any questions regarding this procedure may be directed to the RSO at 979-436-0551
6.7 Package Acceptance Supplemental Information
Figure 1 - White 1 Label
Radiation Safety Manual
Figure 2 - Yellow 2 Label
13
Figure 3 - Yellow 3 Label
Radioactive Material Labeling Criteria (49CFR 172.403)
External Dose rate @ 1 meter
(mR/hour)
≤ background
≤1
>1
External Dose rate on contact
(mR/hour)
≤ 0.5
0.5 < Dose rate ≤ 50
> 50
Label (shown above)
White 1
Yellow 2
Yellow 3
6.8 Average LSC Efficiencies
Isotope
Tritium (3H)
Carbon-14 (14C)
Phosphorus-32 (32P)
Phosphorus-33 (32P)
Sulfur-35
Calcium-45
Iodine-125
Iodine-131
Radiation Safety Manual
Type of Radiation










Energy (MeV)
0.0186
0.157
1.709
0.249
0.167
0.258
0.032
0.035
0.606
0.364
LSC Efficiency
40%
85%
95%
85%
85%
90%
20%
n/a
95%
n/a
14
Section 7.
Transferring Radioactive Material
7.1 Introduction
Radioactive materials shall not be transferred to or from anyone else, within or without the HSC,
without prior notification of and approval by the RSO. This approval can be obtained by telephone.
Four (4) transfer situations are identified:
7.1.1
7.1.2
7.1.3
7.1.4
Transfers within HSC of entire source vial
Transfers within HSC of activity less than the entire source vial
Transfers from HSC to another institution.
Transfers from off campus to HSC
7.2 Transfer Within the HSC
A PI may transfer a source vial of radioactive materials to another PI user provided that the:
7.2.1
7.2.2
7.2.3
Recipient is authorized for the isotope and activity involved.
RSO is notified prior to the transfer. RSO will generate a new inventory form for the
recipient.
Transferring user records the transfer on his/her inventory form
7.3 Multiple Transfers
Transfers of less than full vial quantities are also allowed provided that the following provision are
met:
7.3.1
7.3.2
7.3.3
Prior permission has been given by the RSO.
Transfers are noted on a "Multiple Transfer Form". An entry is made on the “Isotope
Tracking Form" in the lab which is supplying the RAM
Limits of the Receiving PI are not exceeded
7.4 Transfer to HSC from Off-Campus
The PI who will receive the radioactive material will:
7.4.1
7.4.2
7.4.3
Inform RSO of what they intend to have transferred
Remind the sender to contact his own Radiation EHS for further instructions
Provide RSO with the name and telephone number of the sender's EHS
7.5 Transfer from HSC to Off-Campus
The sender (HSC Principal Investigator) shall:
7.5.1
7.5.2
Notify the RSO at least five (5) days before the transfer date
Provide the RSO with the name and telephone number of the recipient. The RSO will
make arrangements for actual transportation to the recipient
The RSO shall:
7.5.3
7.5.4
Provide assistance in preparing the radioactive material for shipment (i.e., packaging,
labeling and documentation)
Contact the recipients EHS to obtain a copy of that institution’s license and further
shipping instructions
Radiation Safety Manual
15
Section 8.
Training Requirements for Personnel Working with
Radioactive Materials
8.1 Introduction
Appropriate training for all individuals who work with or in the vicinity of radioactive material is an
essential part of any radiation safety program. This includes all individuals who work with
radioactive materials at HSC laboratories, regardless of employment classification (e.g., faculty
member, post-doctoral fellow, graduate student, research associate, laboratory technical assistant).
The HSC has an obligation to its employees and students to provide them with:
8.1.1
8.1.2
8.1.3
a safe working environment
an awareness of the hazards to which they may be exposed
training in methods to protect themselves against those hazards
This training is required by the Texas Regulations for Control of Radiation (TRCR). It must be a
joint effort between the RSO and the individuals authorized to use radioactive material
8.2 HSC Instruction
In order to ensure that adequate training is obtained, the HSC EHS shall establish and administer a
use and safety course tailored to the potential exposure environments present with use of radioactive
materials (RAM) on the HSC campus.
All individuals who work with radioactive material must successfully complete the course prior to
commencement of their work with RAM. Successful completion of this course is a requisite for
working with RAM at the HSC.
The radiation safety course shall include the following topics:
8.2.1
8.2.2
8.2.3
8.2.4
8.2.5
8.2.6
8.2.7
Introduction to RAM
Instruction on the hazards presented when working with RAM and how to use them
safely.
Instruction on the proper use and maintenance (as appropriate) of the radiation detection
equipment
Emergency procedures
An exam meant to ensure all persons with access to RAM can demonstrate mastery of the
course materials. The exam must be passed with a grade of no less than 70% as graded
and determined by EHS. It is the sole discretion of EHS to grant a passing grade, and it
is the sole discretion of EHS to accept appeals in regards to a failing grade.
A biennial refresher will be required of individuals desiring continued access to and use
of the RAM. Failure to attend the biennial refresher training may result in access to and
use of RAM being revoked. Access revocation is at the sole discretion of the RSC and
access may be reinstated at the sole discretion of RSC.
PIs are exempt from the initial radiation safety training by virtue of the TDSHS’
acceptance of their status as sub-licensees. PIs are still required to complete the
refresher training.
8.3 Training Exemptions
Exemptions to the training requirements above will be granted on an individual basis to:
Radiation Safety Manual
16
8.3.1
8.3.2
8.3.3
8.3.4
8.3.5
Individuals who can provide a copy of a certificate or letter of completion for a course on
radiation safety from another institution and who successfully pass the HSC EHS
radiation safety training exam with a grade of 70% or higher
Individuals currently holding a certification by NRRPT and who successfully pass the
HSC EHS radiation safety training exam with a grade of 70% or higher
At the sole discretion of EHS, an individual who has no safety violations on his/her
record and is in need of taking the HSC EHS radiation safety training course or biennial
refresher training course may be allowed to take the exam without attending the course as
long as the test is passed with a grade of 70% or higher. Permitting the substitution of the
test for the refresher training is at the sole discretion of EHS
Individuals who have had comparable training but have no documentation may be
granted an exemption upon passing the HSC EHS radiation safety training exam with a
grade of 70% or higher
All other exemptions will be determined on an individual basis by the RSO in
conjunction with the Radiation Safety Committee
8.4 Note
Prior to successful completion of the course, or receiving an exemption, individuals may work with
radioactive material ONLY under the direct supervision and in the immediate physical presence of
another individual who has been appropriately trained.
This policy does not relieve Principal Investigators of their responsibility to provide laboratoryspecific training for personnel working in their laboratory.
Failure to comply with this requirement may be construed as a permit violation on the PI’s RAM use
permit as it creates a hazardous working environment for the untrained individual and all those
around him or her.
8.5 Laboratory Specific Training
The PI who is authorized to use radioactive material or appointee shall provide training to all
individuals who will be working in the laboratory before the individual begins working in the
laboratory.
Each individual should know:
8.5.1 AREA RESTRICTIONS - where radioactive materials are to be used, and restrictions of
use to include prohibited smoking, eating and drinking.
8.5.2 STORAGE - Location of material storage facilities and procedures for storage.
8.5.3 SIGNAGE - Proper posting of signs, labels and notices.
8.5.4 PERSONNEL MONITORING - The requirement of personnel monitoring including
radiation dosimetry and bioassays.
8.5.5 MATERIAL USAGE - Explanation of the research and levels used in the labs and
possible hazards from each type of RAM.
8.5.6 HANDLING - Special handling techniques to be used when handling RAM (e.g., the use
of remote handling devices, working behind appropriate shields).
8.5.7 PROTECTIVE EQUIPMENT - Use of lab coats, eyewear, gloves, etc.
8.5.8 RECORD KEEPING - Material accountability and preparation of radioactive waste
materials for disposal.
8.5.9 RESPONSIBILITIES - Responsibilities of the licensee and of the laboratory worker.
8.5.10 CONTAMINATION SURVEYS - The procedures and frequency for wipe tests. The use
of survey instruments for checking radiation levels and checking for contamination.
8.5.11 EMERGENCY PROCEDURES - Procedures to follow in case of a spill or other
accidents involving radioactive materials
Radiation Safety Manual
17
8.6 Documentation
All radiation safety-related training or education that employees receive, whether from the RSO or
within the laboratory, shall be properly documented and maintained on file for review by the
Radiation Safety Officer and the Texas Radiation Control Division. The RSO will provide
assistance in design of Laboratory - Specific training programs upon request.
Radiation Safety Manual
18
Section 9.
Routine Laboratory Procedures
9.1 Introduction
A set of written procedures is required for each laboratory or area where radioactive materials are
used. These procedures must describe specific rules applicable to that area. The location of these
procedures shall be known and accessible to all individuals who work in the area. The following
general rules apply to all personnel who use radioactive material and should be incorporated into
each laboratory's written procedures.
9.2 Signs and Notices
Areas where radioactive materials are used must be posted in accordance with the Texas
Regulations for Control of Radiation. The following signs will be conspicuously posted and
replaced if defaced.
9.2.1
9.2.2
9.2.3
9.2.4
"Caution - Radioactive Materials" signs on all doors to laboratories and storage areas
"Notice to Employees" BRC Form 203-1
"Document Locator " (indicates the location of the TRCR and related documents)
"Emergency Procedures"
9.3 Personnel Protection
For your health and safety it is imperative that you follow the rules concerning radioactive materials.
If you have any questions about the following procedures, ask your supervisor or call the RSO.
9.3.1
9.3.2
9.3.3
9.3.4
9.3.5
When required by the RSO, wear whole body dosimeters and finger dosimeters
Wear lab coats or other protective clothing as an outer garment at all times when working
in the laboratory.
Maintain good hygiene by:
9.3.3.1 keeping fingernails short and clean
9.3.3.2 washing hands and arms thoroughly before handling any object that goes into the
mouth, nose or eyes.
9.3.3.3 not handling radioactive material if there is a break in the skin below the wrist or
by wearing 2 pairs of gloves when handling the material.
Label permanent areas used for radioactive work (including equipment) with "Caution
Radioactive Material" signs.
Do not eat, drink, smoke or apply cosmetics in work areas where radioactive material is
used or stored.
9.4 Storage of Radioactive Materials
9.4.1 Keep radioactive material in a leak-proof container
9.4.2 Label all radioactive material containers with an appropriate label stating:
9.4.2.1 the radionuclide
9.4.2.2 the amount of activity
9.4.2.3 the date
9.4.3 Label refrigerators or freezers with a "Caution - Radioactive Material" sign and do not
store food or beverages for human consumption in them.
9.4.4 Secure and lock storage areas when materials are left unattended.
9.5 Handling of Radioactive Materials
9.5.1 Disposable gloves shall be worn when handling unsealed radioactive materials. In some
uses, remote handling devices may be required by the RSO.
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19
9.5.2
9.5.3
9.5.4
9.5.5
9.5.6
9.5.7
9.5.8
Never pipette radioactive materials (or any other materials while working with
radioactive material) by mouth.
Use absorbent padding or other material in areas where radioactive material is handled.
Perform iodinations and use volatile radioactive material only in a fume hood specifically
approved for such use by the RSO.
When transporting radioactive material between labs, place primary container in a
secondary container (large beaker, pan, etc.) to help contain the material in the event of a
spill. Be sure to use appropriate shielding as needed.
When transporting between floors, use the service elevator.
When transporting several containers of radioactive materials, use a cart instead of
carrying.
All tools or other lab implements used with radioactive materials shall be considered
contaminated, labeled as such, and reserved for exclusive use with radioactive materials
until such time as they are either decontaminated and released for unrestricted use or
disposed of as waste in accordance with all applicable policies.
9.6 Surveys
Laboratory personnel will routinely survey the laboratory for contamination. See section entitled
"Guidelines for Area Contamination Surveys"
9.7 Bioassays
Laboratory personnel must comply with the policies of EHS and the Radiation Safety Committee for
bioassays or other personnel surveillance operations. (See Section 12.2 below).
9.8 Radioactive Materials Waste
9.8.1 Place radioactive waste only in specially marked receptacles.
9.8.2 For further information on disposal, refer to "Disposal of Radioactive Material".
9.9 Incident Reporting
Notify the RSO immediately by telephone of all incidents involving:
9.9.1 Radioactive contamination (external or internal) of personnel
9.9.2 Radioactive contamination of a large area or that you are unable to manage with the
resources readily available to you
9.9.3 Release to the environment of radioactive material
9.9.4 Loss of radioactive material (including radioactive waste)
9.9.5 Known or suspected excess radiation exposure to general public or lab personnel
9.10 Equipment Repair
Notify the EHS prior to the repair or removal of any equipment that may be contaminated with
radioactive material or that contains a source of radiation
Radiation Safety Manual
20
Section 10. Requirements for Posting/Labeling Labs Using Radioactive
Material
10.1. Radioactive Material Areas: Posting and Labeling
10.1.1. A sign or label with the words “CAUTION-RADIOACTIVE MATERIAL” shall be placed
on each door, refrigerator, or storage locker where radioactive materials are used or stored.
The sign or label will also be affixed to storage and waste containers, contaminated waste
cans, hot sinks, hoods, and work areas. In the event multiple nuclides are present, the “sum of
the ratios” shall not exceed a value of 1. The reporting levels of the most commonly used
radionuclides are provided in the table below.
Nuclide
H-3
C-14
P-32
S-35
I-125
Amount requiring posting
10 mCi
10 mCi
100 µCi
1 mCi
10 µCi
Table 1 - Activity Posting Requirements
10.1.2. Laboratory equipment and containers, including beakers, flasks and test tubes, pipetters,
centrifuges, and so forth, shall be labeled with a radiation symbol.
10.1.3. Containers holding radioactive materials must be labeled with the radiation symbol, the
words “Caution, Radioactive Materials,” and the isotope(s) and activity contained within.
10.1.4. Exemptions to these labeling rules include:
10.1.4.1. containers when they are in transport and packaged and labeled in accordance
with the regulations of the U.S. Department of Transportation.
10.2.
Empty Containers
Empty containers that are free of contamination and are to be discarded must have all radioactive
materials labels, all radiation symbols, and all markings related to radiation or radioactive
materials removed prior to disposal. If this is not possible, Radiation Safety should be contacted
for assistance.
10.3.
Other Postings
Other postings shall be established as required by the RSO to mark radiation areas, high-radiation
areas, airborne radioactivity areas, and/or controlled surface contamination areas (CSCA). A
CSCA is any area in which loose surface contamination levels exceed 1000 dpm/100 cm. Access
to controlled surface contamination areas shall be restricted by a physical barrier posted with a
sign noting “Controlled Surface Contamination Area, Do Not Enter.”
10.4.
Misuse of Caution Signs
Labels and signs required in this section shall not be used for any purpose other than to warn
against a radiation hazard.
Radiation Safety Manual
21
Section 11. Additional Precautions for Users of Radioiodine, Phosphorus32, and Sulfur-35
11.1 Radioiodine (125I)
Iodine-125 (125I) is one of the isotopes of iodine used in biological research. It is a gamma emitter
and also emits low energy electrons. This isotope is of special concern because the body
concentrates iodine - approximately 30% of the total free iodine in the body - in one small organ, the
thyroid gland. The biological residence time for stable iodine in the thyroid is approximately 100
days. With a physical half-life of 60 days, a significant fraction of the energy of these isotopes could
be delivered to thyroid tissue before appreciable excretion occurs. The following special techniques
and procedures are recommended to help control exposure to radiation from 125I:
11.1.1 Free iodine in solution has a very high vapor pressure. In solutions of pH 11 or greater
containing iodine, iodine is always present in the air above the solution. Acidic solutions
actually drive the iodine out of solution and into vapor. Elemental iodine sublimes to
vapor readily and free iodine is easily taken into the body by inhalation or absorption
through the skin. A chemical technique that produces free iodine as a reaction by-product
is therefore extremely hazardous. Among such techniques are iodine-labeling reactions
using solutions of sodium iodide at the millicurie level.
11.1.2 Users of radioiodine should receive specialized training particularly oriented towards the
hazards posed by this radioisotope.
11.1.3 Open radioiodine vials in an operating fume hood and inspect the container(s) before
placement in storage. Many of the chemical forms of radioiodine as shipped are volatile,
and breakage during shipment and release of vapors upon opening can present a serious
hazard.
11.1.4 Opening a vial of radioiodine can result in the release of a significant quantity of iodine
vapor. Try to control this by obtaining radioiodine stocks in vials with needle septa.
Withdrawals can be made using a microsyringe and needle.
11.1.5 Additions can be done by piercing the septum with a vent needle and adding reagents
through the septum with a second needle. If it is necessary to open the stock container,
first purge the air above the solution by forcing it through an activated charcoal trap (this
can be a syringe barrel fitted with a needle and filled with activated charcoal.)
11.1.6 Wear disposable gloves (double gloves are advisable) and change them frequently. Some
forms of iodine can penetrate the glove if they remain in prolonged contact. Monitor and
change outer gloves frequently.
11.1.7 Shield experimental set-ups and waste using sheet lead and lead glass. Also use shielding
to prevent eye and face exposure
11.1.8 Direct handling of high-level sources is discouraged. Use forceps, tongs, or other remote
handling equipment.
11.1.9 If required by the RSO, wear a whole body TLD (personnel monitor) and extremity
badge.
11.1.10 Submit to thyroid bioassays as required by the Radiation EHS (see Section 10.1.1 above
for Requirements and Section 12.2 of this manual for Bioassay Requirements and
Procedures)
11.1.10.1
If quantities of I-125 equal to or greater than 10mCi are ordered
by any PI, EHS will conduct weekly thyroid bioassays of the PI and
Authorized Users unless a procedure schedule is provided to EHS by the
responsible PI. The procedure schedule shall provide the dates on which
I-125 will be used to allow for pre and post procedure bioassays.
Radiation Safety Manual
22
11.1.11 Monitor hands, clothing, shoes, and work area after completion of work with radioiodine.
The recommended instrument for 125I is a thin-window sodium iodide crystal probe
sensitive to low energy gamma rays or a large volume GM detector such as a Ludlum
model 44-7 or similar. The unit must be at the workstation and turned on during all use of
radioiodine. If any significant contamination is detected during contamination surveys,
clean the area with appropriate decontamination solutions (e.g., sodium thiosulfate
solution). Contact the Radiation EHS for any instance of human contamination.
11.1.12 Store waste radioiodine in the fume hood, taking care not to disrupt airflow in the hood.
Use deep plastic tubs to contain any spills. Keep the pH of waste liquids between 8 and
11. Seal solid wastes in plastic bags to reduce release of vapors to the environment.
11.2 Phosphorus-32 (32P)
The use of phosporus-32 (32P) and other high energy beta emitters in research protocols requires that
special precautions be taken. 32P decays with the emission of 1.7 MeV betas which are sufficiently
energetic to penetrate the outer layers of skin and expose living tissues; it can also penetrate the eye
to expose the retina. In order to avoid unnecessary radiation exposure in work with 32P, the
following maxims are established:
11.2.1 Open and inspect all shipments of 32P in a radioisotope hood before placing the
container(s) into storage.
11.2.2 Safety glasses or goggles also provide additional protection against beta radiation. This is
important when quantities of one millicurie or more are in use. The incident dose to the
eyes is reduced by one-half with plastic goggles.
11.2.3 Always wear gloves and eye protection when handling 32P.
11.2.4 Use forceps or tongs when handling 32P to reduce exposure of the extremities.
11.2.5 Wash hands in lukewarm water with detergent and survey hands after use.
11.2.6 Very high exposure rates are possible when handling high-specific activity solutions of
32
P. The surface dose rate for 1 mCi in 1 ml is 780 rad/hr, which creates the potential for
an excessive and unnecessary radiation dose to the hands and face when handling
uncovered vessels. Never place your hand or any other part of your body over open,
unshielded containers containing large quantities of high – specific activity radioisotope.
11.2.7 Store stock solution in or behind appropriate beta particle shielding which minimizes
production of bremsstrahlung radiation. Place low-density materials, such as lucite or
plexiglas, close to or surrounding the source followed by lead or iron as necessary.
11.2.8 Use working shields of lucite or plexiglas 1 cm thick. Be certain the shield is tall enough
to protect the face and eyes. If the procedure or apparatus permits, placing a shield close
to the source can minimize the size of the shield.
11.2.9 If required by the Radiation Safety Officer, wear a whole body TLD (personnel monitor)
and extremity badge
11.2.10 Monitor hands, clothing, shoes, and work area after completion of work with 32P. The
recommended instrument for 32P is a Geiger-Mueller survey meter with an end- window
or pancake probe. The unit must be at the workstation and turned on during all use of 32P.
11.2.11 Take special care to avoid producing aerosols during operations such as centrifuging, etc.
11.3 Sulfur-35 (35S)
Radioactive sulfur-35 amino acid compounds (e.g., 35S -labeled methionine) are commonly used in
cell biology research. Protein labeling techniques employing 35S have been found to produce
airborne radioactive contamination in laboratory through the volatilization of 35S compounds from
incubated cell cultures.
The following remedial actions should be taken to minimize the amount of volatilization and
contamination that can result from work with these compounds:
Radiation Safety Manual
23
11.3.1 Whenever opening containers of 35S-labeled methionine, do so in an operating fume hood
to avoid area and personnel contamination. Whenever possible, use fresh, highly purified
35
S compounds or methionine in cultures. In this way, the build-up of decomposition
products will be minimized, which may be the cause of the volatilization.
11.3.2 Carefully monitor all work areas frequently, especially after handling open containers.
Disposable gloves are mandatory when performing any work with these compounds.
Radiation Safety Manual
24
Section 12.
Personnel Monitoring
12.1 EXTERNAL MONITORING
12.1.1 Introduction
The Texas Regulations for Control of Radiation (TRCR-TAC §289.202(q)) requires
external monitoring for:
12.1.1.1
adults likely to receive a dose in excess of 500 mrem/year to the whole body
or 1,500 mrem/year to the lens (eye) or 5000 mrem/year to any extremity
(10% of the limits set forth in 10CFR20); or
12.1.1.2
minors and declared pregnant women likely to receive a dose in excess of 50
mrem/year and 50 mrem/9 months, respectively (10% of the limits set forth
in 10CFR20); or
12.1.1.3
individuals entering a high radiation area (greater than 100 mrem/hour).
HSC's Radiation Safety Officer will make the determination when monitors
will be issued.
A TLD badge request form must be completed and signed by the individual meeting the
above criteria. Requests for personnel monitoring devices for special uses will be
evaluated on an individual basis and the approval of the RSO will be required
12.1.2 Monitoring Devices
12.1.2.1
HSC uses a National Voluntary Laboratory Accreditation Program (NVLAP)
certified dosimetry company to supply its personnel monitoring devices.
12.1.2.2
HSC employees requiring personal dosimetry (as determined by the RSO)
shall at a minimum be issued a TLD or OSL type dosimeter. Other methods
of personal dosimetry may also be worn, but never in place of the TLD or
OSL. In the event that multiple badges or dose detection devices are worn,
only the HSC issued TLD or OSL shall be considered the “dosimeter of
record.”
12.1.2.3
Finger TLD badges will be issued at the discretion of the RSO.
12.1.3 Monitoring Reports
All dosimeters and ring badges are processed by an off-site vendor. The exposure reports
are sent to the RSO and reviewed by the RSO. Any exposures that exceed the maximum
permissible limits or are much higher than average are discussed with the individual and
the individual's supervisor and appropriate steps are taken to prevent reoccurrence. Any
individual may receive a copy of his/her exposure history by requesting it in writing from
the RSO.
12.1.4 Purpose
The sole purpose of the dosimeter badge is to record a radiation exposure.
IT DOES NOT PROTECT AGAINST RADIATION!
12.1.5 Proper Use and Care of Badges
All dosimeters must be properly used and cared for in order to give an accurate reading.
The following guidelines outline proper care:
Radiation Safety Manual
25
For whole body badges:
12.1.5.1
Attach the badge near the collar of your upper garment (or at the waist) and
wear at all times while in controlled areas. If you are wearing a lead apron,
the badge should be worn at the collar outside the apron.
12.1.5.2
Leave the badge in a safe place when not being worn. Make sure it is away
from all sources of radiation. Personnel dosimeters should not be taken out of
the HSC.
12.1.5.3
Never wear a badge issued to another person or allow anyone else to wear
yours.
12.1.5.4
Take care not to send the badge to the laundry with your lab coat or other
clothing.
12.1.5.5
Make sure to return the badge at the proper time to exchange for a new one.
This is your responsibility and may delay badge replacement, which could
result in an interruption of your work with radiation if badging is required.
12.1.5.6
If you lose or damage your dosimeter, a replacement must be obtained from
the RSO. A "Lost or Damaged Film Badge" report must be obtained from
the RSO. Upon completion of this form, an exposure is assessed for the time
period lost and added to your personal exposure history.
12.1.5.7
Report any other incident relative to the wearing of the badge (such as
possible accidental exposure when the badge is not worn) to the Safety
Office.
12.1.5.8
Do not wear your badge during any medical procedure that involves radiation
or radioactive material in which you are the patient.
Special considerations for ring badges:
12.1.5.9
Wear ring badges directly on your finger in contact with your skin and under
any gloves or other personal protective equipment (PPE) to ensure the most
accurate reading of the dose your tissue may have received.
12.2 BIOASSAY PROGRAM
12.2.1 Thyroid Bioassay Program
12.2.1.1
Introduction
Because radioiodinated solutions and compounds undergo decomposition
which may result in the volatilization of radioiodine, individuals working
with these materials have a potential for accidental uptake of radioactive
iodine. This bioassay program will enable the safety staff to determine an
individual's radioiodine thyroid burden, so that a thyroid organ -dose can be
determined for those who have had an uptake. In addition the program will
monitor the effectiveness of isotope handling procedures. This program is
designed to meet State and Federal Regulatory Agency requirements for
bioassay of 125I.
12.2.1.2
Program Participation
All individuals who handle unsealed quantities of 125I in excess of those
listed in Table 1 and those individuals who work close enough to such
handling that uptake is possible (within a few meters) shall participate in this
bioassay program.
The quantity limits in Table 1 apply to that amount handled either in a single
usage or the total amount handled over a period of 3 consecutive months. It
shall be the responsibility of the individual Principal Investigators to notify
Radiation Safety Manual
26
the RSO of the names of those individuals working on his/her permit who
require bioassay for radioiodine.
Activity Handled in Unsealed Form
Type of Operation
Volatile or Dispersible
Bound to Non-Volatile
Agent
10mCi
Processes in open room or
1 mCi
bench, with possible escape
of iodine from process
Processes with possible
10mCi
100mCi
escape of iodine carried out
within a fume hood of
adequate design, face
velocity, and performance
reliability.
Processes carried out within
100 mCi
1000mCi
gloveboxes, ordinarily
closed, but with possible
release of iodine from
process and occasional
exposure to contaminated
box and box leakage.
Table 2 - Activity Levels Above Which Bioassay for 125I is Necessary
12.2.2 Frequency
Type of Bioassay
Baseline or Preoperational
Routine
Diagnostic
Emergency
Postoperational
Necessary when...
How Often?
beginning work with 125I in once, prior to beginning
quantities necessitating
work with radioiodine
participation in the
bioassay program
working with quantities of
radioiodine that necessitate
participation in the
bioassay program, to be
done within 72 hours (but
not less than 6 hours) of
working with radioiodine
an individual has exceeded as determined by the
action levels
Radiation Safety Officer
there is a possibility that an each time it is suspected
individual has received an
that an
uptake in excess of 0.5
individual has received an
mCi, to be done as soon as
excess
possible following the
uptake
incident
work with radioiodine is
once, before the individual
terminated, to be done
leaves
within three (3) days or 72
HSC
hours (but not less than 6
hours) after discontinuing
operations with radioiodine
Table 3 - Frequency of Thyroid Bioassays
After three (3) months of routine bioassays, the frequency of bioassay maybe reduced to
quarterly, at the discretion of the Radiation Safety Officer.
Radiation Safety Manual
27
12.2.2.1
Action Levels
The thyroid burden at the time of measurement should not exceed: 0.12 µCi
of 125I
12.2.2.2
Corresponding Actions
12.2.2.2.1 Whenever the thyroid burden at the time of measurement exceeds
0.12 µCi of 125I* the following actions will be taken:
12.2.2.2.1.1An investigation of isotope handling procedures shall be
conducted. If this investigation indicates that a continuation
of current operations would cause further uptake of
radioiodine in excess of the above limits, operations using
radioiodine in that lab shall be discontinued until corrective
actions can be implemented that will lower the potential for
uptake.
12.2.2.2.1.2The affected individual will be restricted from further work
with radioiodine until the thyroid burden is less that the
Action Level as described in Section 12.2.2.1 above.
12.2.2.2.1.3Diagnostic bioassays will be performed on the affected
individual at biweekly intervals until the thyroid burden is
less than the Action Levels.
12.2.2.2.1.4The committed thyroid dose shall be calculated based on
biological half-life determined from follow up bioassays.
12.2.2.2.1.5Exposure record entries shall be made and TDSHS shall be
notified as appropriate.
12.2.2.2.2 If the thyroid burden at any time exceeds 0.5 µCi of 125I, the
following actions should be taken:
12.2.2.2.2.1Carry out all steps described above.
12.2.2.2.2.2Refer the case to appropriate medical consultation.
12.2.2.2.2.3Perform diagnostic bioassays at weekly intervals until the
thyroid burden is less than 0.12 µCi of 125I.
*Note: If the affected individual or others working in the same area are
on a quarterly bioassay schedule at the time the action level is exceeded,
reinstate the "routine" schedule until it can be demonstrated that further
work with radioiodine will not cause the action level to be exceeded.
12.2.2.3
Bioassay Procedure
12.2.2.3.1 Prior to commencement of operations using quantities of 125I in
excess of those listed in Table 1.0 in Section 12.2.1.2 above,
Principal Investigators shall notify the RSO and provide the names
of those individuals who meet the criteria detailed in Section 12.2.1.2
above. PIs shall not permit any individual who meets the criteria of
Radiation Safety Manual
28
12.2.2.3.2
12.2.2.3.3
12.2.2.3.4
12.2.2.3.5
12.2.2.3.6
Section 12.2.1.2 to work with or near radioiodines until they have
undergone a baseline bioassay.
The RSO shall contact these individuals and schedule baseline
bioassays at a time and place convenient to both parties.
Individuals participating in this program shall notify the RSO
following their initial contact with radioiodine to schedule the first
routine bioassay (to be performed within 6-72 hours). Upon
completion of this first bioassay, a bioassay schedule shall be
established for the individual.
Any individual involved in a radiological incident who may have
exceeded the limits of Section 12.2.2.1 above, shall notify the RSO
immediately.
Any individual who is participating in this program shall notify the
RSO prior to terminating employment with or otherwise leaving the
HSC.
Bioassays shall be performed by individuals designated by the
Radiation Safety Officer.
12.2.3 Urinalysis Program
12.2.3.1
Introduction
As many compounds used in laboratory research and tagged with a
radionuclide other than radioiodine may be volatile, a bioassay program is in
place to ensure that all laboratory personnel who work with certain quantities
of any volatile substance are monitored and protected from overexposures.
12.2.3.2
Action Levels to Trigger Urinalysis
Urinalysis will be required for all personnel who handle stock vials
containing more than one Allowable Limit for Intake (ALI) of any volatile
radionuclide or radionuclide attached to a volatile chemical. The table below
describes the isotope-use limits requiring urinalysis. If isotope usage in a
single application exceeds these limits, urinalysis will be required.
Nuclide
H-3
C-14
S-35
1 ALI
80 mCi
2 mCi
20 mCi
Table 4 - Urinalysis Action Levels
12.3
12.2.3.3
Procedure
If the Action Levels listed in Section 12.2.2.1 above are to be triggered, the
RSO shall be notified. The RSO shall then arrange for the appropriate
urinalysis process depending on the radionuclide to be used.
12.2.3.4
Verification
Isotope use records will be reviewed by the RSO during inspections to ensure
that bioassays are performed as required.
HSC ADMINISTRATIVE DOSE LIMITS
The HSC restricts the dose limits to a greater extent than those set forth in TAC§289.202(f)(1).
This is to provide a higher degree of protection to those Radiation Workers who may be exposed
during their employment at the HSC and follows the TDSHS mandate as part of an ALARA
Radiation Safety Manual
29
program. The HSC RSO monitors the dose received by monitored personnel on a quarterly basis
and, as such, the HSC administrative limits are measured quarterly.
12.3.1.1
Annual Limit
The annual limit shall be the more limiting of:
12.3.1.1.1 Total Effective Dose Equivalent (TEDE) TAC§289.202(f)(1)(A)(i)
The HSC limits TEDE to one third (1/3) of the prorated TEDE as
defined in TAC§289.202(f)(1)(A)(i) resulting in an exposure not to
exceed: 417 mrem/qtr
12.3.1.1.2 The Sum of the Single Organ Committed Dose Equivalent (CDE)
and the Deep Dose Equivalent (DDE) TAC§289.202(f)(1)(A)(ii)
The HSC limits CDE+DDE to one third (1/3) of the prorated
CDE+DDE as defined in TAC§289.202(f)(1)(A)(ii) resulting in an
exposure not to exceed: 4167 mrem/qtr
12.3.1.2
Other Annual Limits
12.3.1.2.1 Lens of the eye dose equivalent (EDE)
TAC§289.202(f)(1)(B)(i)
The HSC limits CDE+DDE to one third (1/3) of the prorated
CDE+DDE as defined in TAC§289.202(f)(1)(A)(ii) resulting in an
exposure not to exceed: 1250 mrem/qtr
12.3.1.3
Shallow dose equivalent to skin of extremity (SDE)
TAC§289.202(f)(1)(B)(ii)
The HSC limits CDE+DDE to one third (1/3) of the prorated CDE+DDE as
defined in TAC§289.202(f)(1)(A)(ii) resulting in an exposure not to exceed:
4167 mrem/qtr
Radiation Safety Manual
30
Section 13.
Emergency Procedures
13.1 SPILLS PROCEDURE
13.1.1 Introduction
During the course or routine operations, radioactive material may be spilled, causing
contamination of lab areas, personnel, or equipment. Correct action taken during such an
emergency can prevent further spread of the contamination.
13.1.2 Written Instructions
A set of written procedures describing the specific steps to be taken in the event of a spill
of radioactive material shall be posted in a prominent location in each laboratory or area
where radioactive materials are stored or used. The procedures shall be established on an
individual basis applicable to the particular area, according to the type and quantity of
material used.
They should include:
13.1.2.1
13.1.2.2
13.1.2.3
specific location of radioactive waste containers
specific type and location of survey meters
emergency telephone numbers
13.1.3 Minor Spills
A minor spill shall be defined as one that results in contamination of small areas of
laboratory surfaces or equipment, but do not result in:
13.1.3.1
13.1.3.2
13.1.3.3
external or internal contamination of personnel
excessive external radiation exposure to personnel
serious delay in work procedures
The following steps should be taken in case of minor spills:
STEP
1
2
3
4
5
PROCEDURE
Notify all persons in the area that a spill has occurred.
Cover the spill with absorbent paper
Using disposable gloves carefully fold the absorbent paper
and pad, insert it in a plastic bag and dispose of it in a
radioactive waste container along with all contaminated
material such as disposable gloves.
After removing PPE to avoid contaminating the meter, use an
end-window GM survey meter, check the area around the
spill, and your hands and clothing for contamination. Perform
follow-up wipe tests and decontaminate as necessary.
Report the incident to EHS.
Table 5 - Procedure for Minor Spills
13.1.4 Major Spills
MAJOR SPILLS may result in any or all of the following:
13.1.4.1
13.1.4.2
Radiation Safety Manual
contamination of large surface areas
internal or external contamination of personnel
31
13.1.4.3
13.1.4.4
excessive external radiation exposure to personnel
serious delay in work procedure
The following steps should be taken in case of major spills:
STEP
1
2
3
4
5
PROCEDURE
Notify all persons not involved in the spill to vacate the room
Cover the spill with absorbent pads, but do not attempt to
clean it up. Confine the movement of all potentially
contaminated personnel to prevent the further spread of
contamination. Prevent personnel from entering the
contaminated area.
If possible, return stock vials to their shields, but only if it can
be done without further contamination or without significantly
increasing your radiation exposure.
Notify EHS.
Remove and store contaminated clothing for further
evaluation by EHS. If the spill is on the skin, flush thoroughly
and wash with mild soap and lukewarm water.
Table 6 - Procedures for Major Spills
13.2 EMERGENCY WEATHER PROCEDURES
13.2.1 Introduction
High water flooding and hurricane force winds can cause damage to laboratories that
could result in spread of radioactive contamination. This emergency procedure is
designed to minimize the potential for the spread of contamination. The specific response
will depend upon the existing and expected weather conditions.
13.2.2 Pre-Planning
Emergency weather preparedness begins long before the threat of inclement weather
exists. The following measures will make it easier to prepare the lab should the
emergency weather plan actually be implemented.
13.2.2.1
Dispose of used and/or decayed radioactive materials to keep the RAM
inventory in the lab at a minimum. Dispose of old materials in storage.
13.2.2.2
Do not allow radioactive waste to accumulate in your lab
13.2.2.3
If the lab has outside windows, identify secure areas within the lab for
storage, such as:
13.2.2.3.1 refrigerators
13.2.2.3.2 storage cabinets with doors
13.2.2.3.3 storage closets
13.2.2.3.4 rooms not susceptible to damage from high winds or flying debris
(interior rooms)
13.2.2.4
Ensure that emergency telephone numbers posted in the lab are current and
updated as necessary.
13.2.2.5
Keep plastic or other waterproof containers on hand to store your materials.
13.2.2.6
Keep a supply of "Radioactive" tape or labels at hand.
13.2.3 Emergency Actions
In the event of a weather emergency, the following minimum action should be taken:
Radiation Safety Manual
32
13.2.3.1
For Areas Susceptible to Damage from High Winds (Labs with windows)
13.2.3.1.1 If possible, place radioactive materials, in water-proof or plastic
containers.
13.2.3.1.2 Securely close all radioactive material containers so that they will
not lose their contents should they be upset or overturned.
13.2.3.1.3 Clearly mark all radioactive material containers as "Radioactive" and
note their contents (radionuclide, activity, and inventory number)
13.2.3.1.4 Move radioactive materials and wastes into secure locations, such as:
13.2.3.1.4.1refrigerators
13.2.3.1.4.2storage cabinets with doors
13.2.3.1.4.3storage closets
13.2.3.1.4.4rooms not susceptible to damage from high winds or flying
debris
13.2.3.1.5 Tape all storage cabinets closed that hold radioactive materials stored
in containers that do not have secure latches.
13.2.3.1.6 Close all radioactive waste containers and move them off of the floor
to a shelf or cabinet.
13.2.3.1.7 Verify that no radioactive material has been left out on an open lab
bench.
13.2.3.1.8 Label all storage locations not already so marked with "Caution
Radioactive Material" labels
13.2.3.1.8.1Labels on temporary storage locations must be removed after
the radioactive materials are returned to their normal location
13.2.3.1.9 Lock all areas where radioactive materials are stored (e.g., laboratory
doors, refrigerators, etc.)
Radiation Safety Manual
33
Section 14.
Guidelines for Area Contamination Surveys
14.1 Frequency of Surveys
The required frequency for area surveys depends on the frequency of radionuclide use.
14.1.1 Weekly:
14.1.1.1
Areas where radioactive materials are used in activities greater than 10 mCi
(i.e., use of RAM in activities of 10 mCi from a single source vial or use of
multiple source vials from which 10 mCi has been used.)
14.1.2 Bi-Weekly:
14.1.2.1
Areas where radioactive materials are used in activities ranging from 5 mCi
to less than 10 mCi (i.e., use of RAM in activities in the defined range from a
single source vial or use of multiple source vials, the activity of which is
within the range defined).
14.1.3 Monthly:
14.1.3.1
Areas where radioactive materials are used in activities less than 5 mCi (i.e.,
use of RAM in activities of 5 mCi from a single source vial or use of
multiple source vials from which 5 mCi has been used.)
For the purposes of this section, “use of RAM” shall be defined as each PI’s total inventory of that
radionuclide.
All non-use periods between these required surveys and wipe tests must be documented. RAM
storage areas will be surveyed and wipe tested at least monthly even if no actual use occurs.
14.2 The Principle Investigator is responsible for seeing that the required surveys are performed
according to the frequency described above. However, this does not relieve the Authorized Users
from performing surveys after each use of RAM.
These surveys include:
14.2.1 checking all work surfaces and equipment used
14.2.2 gloves and other personal protection equipment
14.2.3 any other area or objects that may have come into contact with the RAM during the
procedure
EHS will perform quarterly surveys during the Compliance Audit of the laboratory.
14.3 Using Survey Instruments
The purpose of survey instruments is to reveal the presence of otherwise undetectable loose or fixed
contamination and also to measure general area radiation levels to ensure that they are not excessive.
The use of a survey instrument for contamination survey does not eliminate the requirement to
perform scheduled wipe tests, but should be used to ensure that contamination is not present in other
areas of the laboratory, on personnel or equipment. A survey instrument should be available in any
laboratory where radioactive material is used in quantities sufficient to produce significant radiation
levels or contamination.
As a general rule, a survey instrument should be available if the quantities used exceed 100 µCi
(except for weak beta emitters such as tritium). Survey instruments are purchased by the Principal
Investigator. They are not provided by the RSO. The RSO does have information on different
makes of instruments and will consult with the PI On the purchase of the best instrument for their
lab).
Radiation Safety Manual
34
14.4 Instrument Calibration
EHS requires that all survey meters in all labs on any HSC campus or annex must be calibrated on
an annual basis. Verifying calibration is part of the EHS lab inspection and an out of calibration
survey meter is considered a violation of EHS radiation safety rules.
14.5 Instrument Selection
Instrument selection should be based on the following criteria:
14.5.1 Survey instruments should normally be of the Geiger-Mueller (GM) type.
14.5.2 Survey instruments should be lightweight, readily portable, and easily handled by
laboratory personnel.
14.5.3 The instrument should be simple to operate and the scale should read in counts per
minute (CPM).
14.5.3.1
GM type survey meters are not capable of accurately reporting a dose
rate value based on the physics of the detector equipment. If any GM tube has a
faceplate that reads out in both CPM and any other exposure or dose rate* unit,
the CPM scale is the only scale that may be recorded and used.
14.5.3.2
Any GM type survey meter’s faceplate that only reads in a unit of
exposure or dose rate should be sent to the manufacturer to have the faceplate
updated to only refer to CPM.
14.5.3.3
The ONLY GM type survey meters permitted by EHS to report in a unit
of exposure or dose rate are specifically referred to as Energy Compensated (EC)
GM tubes and have been specially designed to account for the physics of
detecting accurate exposure and dose values.
14.5.4 The Geiger-Mueller detector should be a thin-window type to permit detection of surface
contamination by such low-energy emitters as carbon-14 and sulfur-35. If iodine-125 is
used, a low energy gamma detection probe must be available during isotope use.
14.5.5 Instrument should be regularly calibrated by a vendor approved by EHS to do so.
14.5.6 Even though a laboratory may be working with only one radionuclide, a nuclide-specific
instrument should not be obtained unless the Principal Investigator knows with certainty
that no other nuclides will be added at a later date. This consideration is important in
order to reduce subsequent cost factors for purchase of new equipment.
14.5.6.1
If additional nuclides are requested at a later date for which the nuclidespecific instrument is not effective, EHS will require the PI purchase an
appropriate meter before any of the requested nuclide will be delivered
regardless of the ordering or delivery status of that nuclide.
*Note: examples units of exposure or dose rate are as follows: mSv/hr, µSv/hr, mGy/hr, rad/hr,
µrem/hr, µR/hr, and others.
14.6 Instructions for Conducting Contamination Survey
Surveys for contamination using a G-M survey meter should be conducted in the following manner.
(This procedure is for gross amounts of contamination only, and as such will only provide a
qualitative determination of the presence of contamination. It is not a substitute for wipe tests.):
STEP
1
2
Radiation Safety Manual
PROCEDURE
Turn survey instrument on away from the area of use or to be
surveyed, check for proper operation and obtain a background
reading.
Select several radioactive material work areas in the
laboratory and several areas where work with radioactive
35
3
4
5
materials does not occur, but where contamination might be
spread.
Move the probe very slowly over the surfaces to be checked.
The probe should be perpendicular to and within 1/4" of the
surface
If the instrument meter reading is twice background,
contamination is present
Decontaminate and perform follow-up survey.
Table 7 - Procedures for Contamination Survey
14.7 Important Note
Significant meter readings after decontamination and negative wipe tests may indicate fixed
contamination.
PLEASE CONTACT THE RSO IMMEDIATELY FOR ASSISTANCE
14.8 Area wipe tests should be conducted in the following manner:
STEP
1
2
3
4
5
6
PROCEDURE
Put on disposable gloves if you are handling potentially
contaminated items or if you are directly handling the wipe
medium. Note: If you suspect contamination on the floor,
wear shoe covers also.
Using filter paper, cotton tipped applicator or other suitable
wipe medium, wipe an area of 100 cm2 of a large surface.
(Wipe an entire surface if only a small item is being tested.)
Code the wipes or the counting vials and survey map for
identification of the area wiped.
Count the wipes in an appropriate counter for one minute
each. (If the same wipe is to be counted for gamma
radiation in a sodium iodide counter and beta radiation in a
liquid scintillation counter, be sure to do the gamma count
before adding the liquid scintillation cocktail.)
Convert counts per minute (cpm) to dpm.
Record this information and retain it for inspections.
Table 8 - Procedures for Wipe Tests
14.9 Contamination Action Levels
If wipes indicate 200 dpm/100 cm2 or greater above background, the area wiped shall be considered
contaminated. Decontaminate, re-wipe and determine new contaminated level. Repeat this cycle
until wipes indicate less than 200 dpm/cm2. Record these data.
Radiation Safety Manual
36
Section 15.
15.1
Disposal of Radioactive Materials
Introduction
Each Principal Investigator is responsible for ensuring that the material under his/her permit is
disposed of properly. All radioactive material waste is removed from the laboratory by the RSO
or EHS.
Unless approved in writing by the Institutional RSO, only EHS may dispose of radioactive
waste or remove it from HSC premises.
15.2
Signs and Notices
The RSO is responsible for the removal from the laboratory, storage and ultimate disposal of all
wastes contaminated with radioactive materials. For assistance in matters relating to waste
disposal, contact the RSO during normal working hours, 8:00 a.m. to 5:00 p.m., on weekdays. To
schedule a pickup of waste, call the RSO.
15.3
Principle Investigator Responsibilities
The Principal Investigator is required to implement effective radioactive waste management
procedures within the laboratory. Specifically, the PI shall:
15.3.1 Provide adequate and properly labeled receptacles for each type of radioactive waste
described in the following sections.
15.3.2 Ensure that radioactive wastes are placed in these assigned receptacles, and are not
disposed of as ordinary wastes. You must report any such incidents or improper waste
disposal to the EHS immediately upon discovery.
15.3.3 Maintain written records of the activity of all wastes on the appropriate forms
15.3.4 Assure that radioactive waste is not allowed to be stockpiled in the lab, either in the
designated waste storage area, or in any other areas used for temporary storage (e.g.,
fumehoods).
15.3.5 Designate an area of the lab to be used as a waste area using the following guidelines:
15.3.5.1
Located away from heavy traffic or constantly used areas
15.3.5.2
Large enough to allow for shielding if necessary. High energy beta
and gamma emitters must be stored behind the appropriate shielding material
to minimize the external exposure to lab personnel.
15.3.5.3
Allows for containment of liquid waste in the event of a spill or failure of the
plastic carboy.
As the generator of radioactive waste materials, laboratory personnel have first-hand knowledge
of waste content. Consequently, laboratory personnel have full responsibility for all handling
requirements and documentation associated with it.
15.4
Hazard Reduction
Radioactive waste containing chemical, biological, or infectious material must be treated to
reduce the potential hazard from non-radiological materials to the maximum extent practicable.
The goal is twofold:
15.4.1 to minimize the hazards for those persons who handle the waste at each step of the
disposal process.
15.4.2 to minimize the potential impact on the environment.
Accordingly, EHS requires the following:
Radiation Safety Manual
37
15.4.3 Adjust the pH of all aqueous radioactive waste as close to neutral as possible. For
aqueous waste containing 125I the pH shall be between 7 and 9. If necessary, solutions
should be buffered to maintain this pH.
15.4.4 Autoclave or chemically treat pathogenic and infectious material.
Do not autoclave if radioactive contamination will be spread as a result. Discuss
with the EHS Staff prior to taking any such steps.
15.4.5 If practical, treat carcinogens, teratogens, and other highly toxic materials to reduce their
impact on the environment.
15.4.6 Package syringe needles and other sharp objects so as to prevent injury to those handling
the waste.
15.5
Segregation of Waste
All radioactive waste (with the following exception) must be segregated according to isotope.
Only Tritium (3H) and Carbon-14 (14C) can be placed in the same container; all other isotopes
must be placed in separate containers.
In addition to segregation by isotope, radioactive waste must also be separated by physical form.
Five (5) basic physical forms of radioactive waste are identified:
15.5.1 Dry and Semi-Solid
15.5.2 Sharps
15.5.2.1
Metal sharps and glass
15.5.2.2
Plastic pipette tips
15.5.3 Liquid
15.5.4 Scintillation Vials
15.5.5 Biological
The following disposal guidelines apply to the six types of radioactive waste forms listed. For
radioactive wastes not adequately or properly described by one of these categories, contact EHS.
15.6
Dry and Semisolid Waste Disposal
This category will likely comprise the majority of the waste generated. It is comprised of most
disposable items, as well as labware that has been contaminated with radioactive materials (e.g.,
absorbent work surface coverings; plastic/rubber gloves, tubing, unbroken glassware, etc.).
Container for disposal:
15.6.1 Plastic bags. These bags must be placed in closeable waste receptacles (e.g., plastic foot
operated trash can). PIs must obtain their own receptacles.
Requirements for safe handling and disposal of this type of waste are:
15.6.2 Exercise extreme care when handling radioactive wastes in any quantity.
15.6.3 Attach a completed waste tag to all bags. The bag must be sealed and all accompanying
forms completed before calling the EHS for removal.
15.6.4 Deface or remove all container labels and labware labels before placing into the waste
containers.
15.6.5 Inspect the plastic waste bag for leaks prior to removal from the lab. Use a second bag to
contain the waste if necessary.
15.6.6 Do take care not to place anything in the bag in such a way that may tear it.
15.6.7 DO NOT, under any circumstances, place radioactive waste where it might be picked up
by housekeeping personnel and be disposed of as ordinary waste in the dumpster.
15.6.8 Waste receptacles must remain covered at all times.
Radiation Safety Manual
38
Compliance Note: The primary users of radioactive material shall have the responsibility for the
separation of short and long-lived isotopes. Regular monitoring of waste by the RSO will occur in
the individual labs.
15.7 Sharps
Sharps are defined as anything that could tear or puncture the bag (e.g., needles, broken glass, glass
pipettes, plastic pipette tips, razor blades, capillary tubes, etc.)
Containers for Disposal:
15.7.1
An approved sharps container as described by Office of Research Compliance
policies with an appropriate lid.
Requirements for safe handling and disposal of this type of radioactive waste are:
15.7.2 Care must be taken to not injure oneself during placement of sharps into box.
15.7.3 Do not try to overfill.
15.7.4 Do make sure that all sharps are dry before placing into container.
Special rules for plastic pipette tips:
15.7.5 Plastic pipette tips may be disposed of into an RSO approved plastic container.
15.7.6 RSO approved container may be disposed of into the dry waste container as defined
above.
15.8 Radioactive Liquid Waste
The category of liquid waste can be further divided into:
15.8.1 Aqueous
15.8.1.1
15.8.2 Organic
15.8.2.1
Aqueous - Water-based liquids such as saline and buffer solutions and which
contain no biological, pathogenic, or infectious materials. Washings from
contaminated laboratory glassware, weak acids and/or bases, etc.
Organic - Organic laboratory solvents such as alcohols, aldehydes, ketones
and organic acids. Note: This category does not include scintillation fluids.
15.8.3 Other Liquids
15.8.3.1
Other Liquids - Contaminated pump oil, etc.
15.8.4 Containers for Disposal:
15.8.4.1
Specially designated containers (carboys) obtained from EHS. These carboys
are not to be filled above the line marked on the carboy. DO NOT
OVERFILL THESE CONTAINERS.
15.8.5 Requirements for safe handling and disposal of this type of radioactive waste are:
15.8.5.1
While the container is in the laboratory it must remain in a secondary
container such as a spill tray as a precaution against leakage. This will
control the spreading of the liquid in the event the carboy fails, and is also
necessary as pouring can be accompanied by drips, or spills.
15.8.5.2
Do not use glass containers for storage of radioactive liquid waste. If plasticincompatible contaminated organic solvents are required to be kept in glass
containers, the bottle must be doubled contained.
Radiation Safety Manual
39
15.8.5.3
15.8.5.4
15.8.5.5
15.9
After emptying labware of radioactive liquid, the first rinse of the labware
must also be placed in the radioactive liquid waste container. Successive
rinses may be released to the sanitary sewer.
15.8.5.3.1 Secondary rinses of labware that would result in liquid waste that
may be hazardous for reasons other than radioactivity, must be
disposed of according to any rules and guidance that govern the
same
No radioactive liquid is permitted to be poured down the sink; sinks will be
surveyed during inspections of the laboratories.
Do not mix liquid waste types in the carboys (e.g., organic with aqueous).
Adjust the pH of all aqueous radioactive waste as close to neutral as possible.
For aqueous waste containing 125I, the pH shall be between 7 and 9. If
necessary, solutions should be buffered to maintain this pH.
Liquid Scintillation Vials
Examples: Glass or plastic vials containing aqueous based liquid scintillation fluid.
There are two types of scintillation vials:
15.9.1 Deregulated vials.
15.9.1.1
These are scintillation vials containing 3H, 14C and/or 125I only, containing
less than 0.05 µCi/mL. Since liquid scintillation counting (LSC) normally
can be successfully completed with activities below this level, LSC vials
containing only 3H, 14C and/or 125I are generally deregulated. These vials are
to be segregated from other LS vials and labeled "Deregulated" on Waste
Form.
15.9.2 Other scintillation or LSC vials.
15.9.2.1
This includes vials with all other isotopes in them or vials containing 3H, 14C
and/or 125I in greater than deregulated amounts.
15.9.3 Container for Disposal:
15.9.3.1
20 ml vials - must be emptied in the labs into a five (5) gallon plastic carboy
and the vials must be disposed of separately in a box lined with double
plastic bags. Place absorbent material with the vials to absorb residual
liquids. Do not place the empty vials in the regular solid waste.
15.9.3.2
7 ml vials - The vials should be returned to the tray for disposal.
Those individuals who order vials in bulk may place them in a box which is double-lined with
plastic bags. Please do not overfill the bags as they can get quite heavy.
Requirements for safe handling and disposal of this type of waste are:
Under no circumstances should stock radioactive material vials be discarded with scintillation
vials.
Compliance Note: ONLY BIODEGRADABLE LIQUID SCINTILLATION FLUIDS ARE
ALLOWED AT HSC. Contact EHS if you have any questions concerning your LS cocktails.
15.10 Biological Vials
This category includes waste containing biological, pathogenic, or infectious material and the
equipment used to handle such material (e.g., by-product animal waste: serum, blood, excreta;
contaminated capillary tubes and other equipment contaminated with animal fluids, radioactive
material labeled culture media.)
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Container for Disposal: Plastic bags for solids and carboys for liquids
(obtained from the EHS).
Requirements for safe handling and disposal of this type of waste are:
Liquids must be absorbed into another material such as paper towels, sponges, gauze, etc. prior to
placing into bags.
15.11 How to Complete a RAM Waste Form
The "Radioactive Waste Disposal Form" is used to identify the contents of each container and
must accompany each radioactive waste container that has been filled and is ready for removal
from the laboratory. It must be completed and attached to or near each waste container. Below
are instructions for filling out each section properly.
SECTION
WHAT INFORMATION IS NEEDED
PI Name / Room Number
Isotope
Self-Explanatory
List of all Isotopes present in the waste
container. (Remember-only 3H and 14C
can be mixed in the same container).
Circle the appropriate form of waste
Make an entry on the form for all
waste placed in the container. Record
activity in µCi units.
Must be an actual description of the
contents (e.g., plastic LS vials, glass
test tubes, gloves, etc.) The words
"Trash or Garbage" will not suffice.
For bulk liquids, list the chemical
names and concentrations in each
container.
The form must be signed by the
Principal Investigator
Form
Disposal Information
Physical / Chemical Description
Certification
Table 9 - Procedures for Completing RAM Waste Form
15.12 Requesting a Waste Pick-Up
When the waste containers are full, but before calling the RSO:
15.12.1 Close and properly seal the container(s). Bags are to be taped, carboys must have the lids
tightly in place, and boxes containing sharps must also be sealed.
15.12.2 Bagged dry and semi-solid waste must be removed from the waste receptacle and taped
shut to be considered ready for pickup.
15.12.3 Full waste containers that require shielding shall not be left outside of the shield while
awaiting pickup.
15.12.4 Complete the HSC Waste Disposal Form. All information requested MUST be supplied
including the signature of the person completing the form. Attach the form to the waste
container or have it clearly visible near the container.
15.12.5 Call the RSO and request a waste pick-up. If additional carboys are needed, please
request it when calling for a waste pick-up.
NOTE: Improperly documented or segregated waste will not be accepted by the RSO. If evidence of
improper segregation or documentation is discovered by the RSO after waste has been removed from
the lab, the waste container and its contents will be returned to the lab for proper segregation and
Radiation Safety Manual
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documentation as necessary.
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42
Section 16.
Use of Radioactive Materials in Animals
16.1 Introduction
The use of radioactive materials requires additional safeguards in the handling of affected animals.
In addition to their authorization to use radioactive materials, Principal Investigators (PIs) must
become specifically authorized to use radioactive materials in animals.
16.2 Obtaining Authorization
Complete the “Radioactive Material Use in Animals” application and return to the RSO. Procedures
involving animal systems vary widely as do applicable safety requirements. The information
provided on the application will enable the RSO to formulate necessary safety measures and assist
the PI in implementing these measures.
After review by the RSO, the application is submitted to the Radiation Safety Committee for
approval. Once approved, an Authorization Permit will be issued to the PI. The HSC Institutional
Animal Care and Use Committee (IACUC) will be notified and supplied a copy of the approved
application and permit.
NOTE: It is the PI’s responsibility to obtain the IACUC forms and seek separate approval of the
Committee for their research protocol. NO research activities can begin without the approval of both
the IACUC and the HSC Radiation Safety Committee.
16.3 Radiation Monitoring
Radiation monitoring includes but is not limited to:
16.3.1 Radiation monitoring of the animal(s), cages, and/or the actual procedure when
performed, pursuant to conditions of the Protocol.
16.3.2 Analytical determination of radioactivity in urine, feces, and bedding (when required)
16.3.3 Labeling cages containing radioactive animals. Tags for this purpose must indicate the
radionuclide, the activity (in µCi or mCi) and the date.
NOTE: Notify the Manager of Animal Care at least five working days prior to the actual use of
radioisotopes in animal.
16.4 Radioactive Waste Disposal
All animal remains, i.e., viscera, tissue, serum, or other fluids, and the carcass, containing
radioactive material (except tritium (3H), carbon-14 (14C) and iodine-125 (125I) as describe below)
are to be disposed of as follows:
16.4.1 Place the remains in a yellow radioactive materials waste bag.
16.4.2 Secure the bag shut with tape or other closure and label the bag with a radioactive
materials tag showing the radionuclide, the activity, the date and the initials of the
individual completing the tag.
16.4.3 Place the bag in the labeled container in the designated freezer.
NOTE: Be sure to complete a logbook entry for all waste you place in the freezer.
16.5 Deregulated Waste
Regulations promulgated by the Texas Department of State Health Services and applicable to the
HSC license, allow animal remains containing tritium, carbon-14 and iodine-125, in quantities NOT
EXCEEDING 0.05 microcuries (µCi) per gram body weight, to be disposed of as non-radioactive
Radiation Safety Manual
43
waste.
While disposals of this kind are essentially deregulated, be reminded the Principal Investigator must
continue to keep an inventory record with the Date, Activity, and Isotope (3H, 14C, 125I) used in the
animal and the date on which the remains were disposed.
Having confirmed that the carcass meets above stipulations, this “non-radioactive” animal waste is
to be placed in the non-labeled waste container and in the designated freezer. DO NOT place any
radioactive material labels on the bags or contents. DO NOT use a yellow radioactive materials bag.
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Section 17.
General Instructions for Auxiliary Personnel
17.1 INSTRUCTIONS FOR MAINTENANCE PERSONNEL
17.1.1 Introduction
Radioactive materials can be found in many locations at the HSC. Some general
guidelines for specific areas are outlined below.
17.1.2 “Caution Radioactive Material” Symbol
The universal symbol for radiation or radioactive material is the three-bladed caution
symbol (magenta or purple on yellow background) as shown below:
17.1.3 “Radiation Area” Instructions
Some general guidelines for “Radiation Area” marked rooms are outlined below:
17.1.3.1
Do not enter any of these areas without specific permission to do so either
from someone in authority in that area or from the RSO.
17.1.3.2
When specifically authorized to enter such an area:
17.1.3.2.1 follow instructions
17.1.3.2.2 only perform the work required
17.1.3.2.3 leave as soon as work is complete - do not waste time
STEP
1
2
3
4
5
6
7
PROCEDURE
Inform the RSO of any work planned for any areas that may
involve radioactive materials prior to the onset of work.
Enter room unless specific signs say "Keep Out."
Seek someone who works in the room and explain the work
that is to be done.
Before you begin work, have laboratory personnel check by
instrument survey or a wipe test, to ensure the work area is
free of contamination.
If you cannot find someone in the area to check with, leave
the room and contact EHS for further information.
If it is an emergency repair job and you cannot get help from
someone in the area, contact EHS.
If the area is free of contamination, proceed with the job.
While in the area:
 do not smoke, eat or drink
 do not enter other areas marked off as radioactive material
areas
 watch for signs of possible contamination, such as broken
labeled bottles or vials, or liquid pooled in an area
Table 10 - Procedures to Follow in Rooms Marked “Caution Radioactive Materials”
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17.1.4 Equipment Marked “Radioactive Material”
For sinks, hoods, or other equipment marked "Radioactive Material":
17.1.4.1
have lab personnel check by wipe test or survey instrument to ensure that
there is no contamination
17.1.4.2
if equipment must be taken back to shop, or there are any questions, call the
RSO for supervision
17.1.4.3
call the RSO to have a hood exhaust duct surveyed
17.2 INSTRUCTIONS FOR SECURITY PERSONNEL
17.2.1 Access to Radiation Areas
There is no hazard to security personnel if the guidelines below are followed:
17.2.1.1
A location labeled, "Radiation Area" can be entered for a short time to
provide assistance to personnel in the area or to protect property, but for
routine matters, contact the RSO personnel first.
17.2.1.2
A location labeled, "Radioactive Material" will be safe to enter unless
specifically marked "Do Not Enter". While in the area:
17.2.1.2.1 do not handle containers labeled with radioactive material symbols
17.2.1.2.2 do not eat or drink in these areas
17.2.1.2.3 be wary of evidence of spills or radioactive material
17.2.2 “Caution Radioactive Material” Symbol
The universal symbol for radiation or radioactive material is the three-bladed caution
symbol (magenta or purple on yellow background) as shown below:
17.2.3 When to Notify the RSO
You should notify the RSO:
17.2.3.1
Before entering a radiation area (with the exceptions noted above)
17.2.3.2
If any container labeled "Radioactive Material" is found broken, crushed or
leaking
17.2.3.3
In case of fire in any room labeled "Radioactive Material"
17.2.3.4
When in doubt, call the RSO.
17.2.4 Package Delivery
Carrier services making delivery of radioactive material packages to HSC deliver them to
the loading dock. In the event that you must receive the package(s):
STEP
1
If the package is . .
(1) Damaged (wet, crushed, open,
etc.)
(2) Intact
Radiation Safety Manual
PROCEDURE
Visually inspect the package(s) at the
time of delivery
Then . . .
1. Do not handle package.
2. Ask the carrier to stay until the RSO
has been contacted
1. Check to be sure that the package(s)
46
are addressed to HSC.
2. Sign for the package(s).
3. Call the RSO
Table 11 - RAM Package Receipt Procedures
17.3 INSTRUCTIONS FOR HOUSEKEEPING PERSONNEL
17.3.1 Introduction
In order to prevent the spread of radioactive contamination or improper disposal of
radioactive waste, it is important that housekeeping personnel are aware of the proper
way to conduct themselves in areas where radioactive materials are used.
17.3.2 “Caution Radioactive Material” Symbol
The universal symbol for radiation or radioactive material is the three-bladed caution
symbol (magenta or purple on yellow background) as shown below:
17.3.3 Conduct in Laboratories
Follow these guidelines in laboratories:
17.3.3.1
Note the "Caution-Radioactive Material" sign at entrance to the area
17.3.3.2
Look for and obey any other special instructions at entrances, such as "Do
Not Enter." If there are no special instructions, enter the room.
17.3.3.3
Do not smoke, eat, drink, or apply cosmetics while in these areas
17.3.3.4
Do required work as quickly as possible, then leave the area
17.3.3.5
Watch for problems:
17.3.3.5.1 If you see a tape-labeled container that has spilled or leaked, leave.
17.3.4 Tables of Instructions for Specific Areas
ITEM / AREA
INSTRUCTIONS
Bench tops labeled with tape
Do Not:
 lean on or against it
 put anything down on it
 handle anything that is on it
Floor areas labeled with tape
Do Not:
 walk into the labeled area
 clean the floor within the labeled
area
Lab equipment labeled with tape
Do not touch the equipment
Refrigerators labeled with tape
Do not open
Trash bags or cans labeled with tape or Do not empty this trash. If there is any
labeled as radioactive or containing
doubt whether or not it is radioactive,
radioactive material
do not empty it.
Sinks labeled with tape or signs
Do not use this sink to get water or
dispose of water
Table 12 - What to do with Items Marked “Caution Radioactive Materials”
If there are any questions or problems, contact the RSO
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Section 18.
Registering X-Ray Machines
18.1 PRINCIPAL INVESTIGATORS-SUBREGISTRANTS
18.1.1 Introduction
All x-ray use at the HSC must be first approved by the RSO and then approved and
authorized by the Radiation Safety Committee (RSC). These guidelines explain the
application, approval, and purchase process for x-ray machines and all other registerable
ionizing radiation producing devices at the HSC and should help Principal Investigators
(PIs) obtain their subregistration or amendment approvals as quickly and easily as
possible.
18.1.2 Registration Procedure
18.1.2.1
STEP 1: Application
18.1.2.1.1 New PIs
For new users, a subregistration application must be completed,
signed by the PI, and then sent to the RSO for approval by the RSO.
This subregistration application must include all x-ray machines, xray users with their x-ray machine qualifications, and locations of
use to be authorized under the PI. Personnel and students not listed
on the subregistration permit must not be allowed to use or work
with the xray machines.
18.1.2.1.2 Current PIs
For approved users planning to make changes to their
subregistration, a subregistration amendment application must be
completed, signed by the PI, and then sent to the RSO for approval.
18.1.2.1.3 Forms
There are two forms: one for equipment changes (i.e., additions or
deletions) and another for personnel and location changes (i.e.,
additions or deletions). Equipment additions will require the
approval of the RSC. The RSO will approve all other changes.
18.1.2.2
STEP 2: Purchase Approval
After the review and approval of the application by the RSO, it will be
presented to the RSC for purchase approval. The RSO will notify the PI
when the x-ray machine(s) may be purchased.
18.1.2.3
STEP 3: Procurement
All x-ray purchase requisitions must be sent to the RSO for approval by the
RSO. The RSO reviews the purchase requisition and makes certain that the
PI has the committee's purchase approval. Upon approval, the order is
immediately sent to the Purchasing Department for processing. X-ray safety
devices should be purchased with the x-ray machine if possible and installed
with the x-ray machine when received. Failure to plan and install safety
devices as required will delay the final approval by the committee for use of
the x-ray machine.
18.1.3 Receipt and Setup
18.1.3.1
Safety Devices
All safety devices must be installed and operational before final approval is
given.
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18.1.3.2
Notification
The RSO must be notified when the x-ray machine arrives and when it is set
up. The RSO will request an amendment to the HSC’s State Registration to
add the additional x-ray machine(s) within 30 days of receipt and installation.
18.1.3.3
Use
The x-ray machine must not be used without the final approval of the RSC.
The RSO may give permission to turn on the x-ray machine for test
procedures in the initial set up.
18.1.3.4
Associated Documentation
The RSO will require additional specific documentation for review before
final inspection.
18.1.3.4.1 X-ray machine specifications and information (part of the
manufacturer's manual)
18.1.3.4.2 Receipt records (new or transfer)
18.1.3.4.3 Installation records (where applicable)
18.1.3.4.4 Start-up and operational procedures (usually in the manual)
18.1.3.4.5 Maintenance and modification plans (where applicable)
18.1.3.4.6 Safety devices plan (interlocks, warning lights, etc.)
18.1.3.4.7 Personnel radiation dosimetry applications
18.1.3.4.8 Calibration records
18.1.3.4.9 Any other requested information
18.1.4 Final Approval for Use
Radiation Safety Officer Inspection
The RSO will inspect the x-ray machine set up before operation begins. Appropriate
installation or enclosure signs will be supplied and posted.
Final Approval
After finding the x-ray machine set up in compliance, the RSO will give final approval
for use. New subregistrants will receive an authorization permit and a subregistration
number. Upon final approval the PI may begin his or her research.
18.2 TRAINING AND RENEWALS
18.2.1 Radiation Safety Training
The RSO requires that all Authorized Users attend the X-ray Safety Short Course
presented by the RSO. PI’s are not required to attend unless the RSC determines that their
X-ray training and experience is inadequate. The PI will also assure that specific training
in the safe use of x-ray machines under his or her supervision will be provided.
18.2.2 Renewals
The PI's subregistration authorization is for a two year period. Near the end of the two
years, the RSO will send the PI a new subregistration application to be completed. Any
new information and/or experimental procedure changes should be added to this new
application. New personnel who have not completed the Radiation Safety Training
Requirements must be added separately by personnel amendment forms. The Radiation
Safety Committee will review the renewal application with or without changes for
approval. The PI's past safety and compliance record will also be considered at this time.
If there are no major problems, the RSC will then give its approval of the subregistration
for another two years. The PI's research will not be interrupted during this process unless
the RSC does not approve the renewal of the subregistration.
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18.3 DECOMMISSIONING AND REMOVAL OF X-RAY DEVICES
18.3.1 Introduction
It may become necessary to decommission and remove and X-ray device from use for the
purposes of either sending the equipment to surplus, disposing of the device and
removing it from the X-ray registration, or other reasons not stated above.
18.3.2 Process
Please contact the HSC RSO for the coordination of any decommissioning or removal
processes as there are special considerations involved in safety and compliance with
regard to X-ray or other radiation generating devices.
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Section 19. Radiation Safety Requirements for X-Ray Producing
Machines
19.1 ANALYTICAL X-RAY EQUIPMENT
19.1.1 Introduction
Texas Regulations for the Control of Radiation (TRCR) § 289.228, “Radiation Safety
Requirements for Analytical and Other Industrial Radiation Machines (effective July
1, 2000)”. A copy of any referenced section of the TRCR may be obtained from the
RSO.
19.1.2 Definitions
19.1.2.1
Analytical radiation machine: This includes, but is not limited to, x-ray
equipment used for x-ray diffraction, fluorescence analysis, spectroscopy, or
particle size analysis.
19.1.2.2
Fail-safe characteristics: Design features that cause the beam port shutters
to close, or otherwise prevent emergence of the primary beam, upon the
failure of a safety or warning device.
19.1.2.3
Local Components: Parts of an x-ray system that include areas that are
struck by x rays, such as radiation source housings, port and shutter
assemblies, collimators, sample holders, cameras, goniometers, detectors,
and shielding, but do not include power supplies, transformers, amplifiers,
readout devices, and control panels.
19.1.2.4
Normal operating procedures: Means operating procedures for conditions
suitable for analytical purposes with shielding and barriers in place. These do
not include maintenance but do include routine alignment procedures.
Routine and emergency radiation safety considerations are part of these
procedures.
19.1.2.5
Open-beam configuration: A radiation machine in which an individual
could accidentally place some part of his/her body in the primary beam path
during normal operation.
19.1.2.6
Primary beam: Ionizing radiation that passes through an aperture of the
source housing by a direct path from the x-ray tube located in the radiation
source housing.
19.1.2.7
Safety device: A device that prevents the entry of any portion of an
individual’s body into the primary x-ray beam path or that causes the beam to
be shut off upon entry into its path.
19.1.2.8
X-ray system: A group of components utilizing x-rays to determine the
elemental composition or to examine the microstructure of materials.
19.2 EQUIPMENT REQUIREMENTS
19.2.1 Safety Devices
19.2.1.1
Safety Device: A device which prevents the entry of any portion of an
individual's body into the primary x-ray beam path or which causes the beam
to be shut off upon entry into its path shall be provided on all open beam
configurations. A subregistrant may apply for an exemption from the
requirement of a safety device with the RSO if an experimental design
prevents the installation of the safety device. Such application shall include:
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51
19.2.1.1.1 A description of the various safety devices that have been evaluated.
19.2.1.1.2 The reason each of these devices cannot be used, and
19.2.1.1.3 A description of the alternative methods that will be employed to
minimize the possibility of an accidental exposure, including
procedures to assure operators and others in the area will be
informed of the absence of safety devices.
19.2.1.2
Warning Devices: Open-beam configurations shall be provided with a
visible indication of:
19.2.1.2.1 X-ray tube status (ON-OFF) located near the radiation source
housing, if the primary beam is controlled in this manner; and/or
19.2.1.2.2 Shutter status (OPEN-CLOSED) located near each port on the
radiation source housing, if the primary beam is controlled in this
manner.
19.2.1.2.2.1The x-ray control shall provide visual indication whenever
x-rays are produced.
19.2.1.2.2.2Warning devices shall be labeled so that their purpose is
easily identified and shall have fail-safe characteristics.
19.2.1.3
Ports: Unused ports on radiation machine source housings shall be secured
in the closed position in a manner which will prevent casual opening.
19.2.1.4
Labeling: Each registrant shall ensure that each radiation machine is labeled
in a conspicuous manner to caution individuals that radiation is produced
when it is energized. This label shall be affixed in a clearly visible location
on the face of the control unit. If the radiation machine is not visible from the
control unit, the radiation machine shall have a visible indication that it is
energized.
19.2.1.5
Shutters: On open-beam configurations, each port on the radiation source
housing shall be equipped with a shutter that cannot be opened unless a
collimator or a coupling has been connected to the port.
19.2.1.6
Generator Cabinet: Each x-ray generator shall be supplied with a protective
cabinet that limits leakage radiation measured at a distance of 5 centimeters
from its surface such that it is not capable of producing a dose in excess of
0.5 millirem in any one hour.
19.3 AREA REQUIREMENTS
19.3.1 Area Requirements
Sufficient shielding should be located so that no radiation levels exist in any area which
could result in a dose to an individual present in the area in excess of the dose limits
specified in 25 TAC § 289.231.
19.3.1.1
Surveys: Radiation surveys of all analytical x-ray systems shall be
performed:
19.3.1.1.1 Upon installation of the equipment
19.3.1.1.2 Following any change in the initial arrangement, number, or type of
local components in the system
19.3.1.1.3 Following any maintenance requiring the disassembly or removal of
a local component in the system
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19.3.1.1.4 During the performance of maintenance and alignment procedures, if
the procedures require the presence of a primary x-ray beam when
any local component in the system is disassembled or removed
19.3.1.1.5 Any time a visual inspection of the local components in the system
reveals an abnormal condition
19.3.1.1.6 Whenever personnel monitoring devices show a significant increase
over the previous monitoring period or the readings are approaching
the Radiation Protection Guides (radiation dose limits).
19.3.1.2
Posting: Each area or room containing analytical x-ray equipment shall be
conspicuously posted with a sign or signs bearing the radiation symbol and
the words "CAUTION - X-RAY EQUIPMENT," or words having a similar
intent.
19.4 OPERATING REQUIREMENTS
19.4.1 Operating Requirements
19.4.1.1
Procedures:
Normal operating and safety procedures shall be written and available to all
analytical x-ray machine operators. No person shall be permitted to operate
analytical x-ray equipment in any manner other than that specified in the
procedures, unless such person has obtained written approval of the
Radiation Safety Officer.
19.4.1.2
Bypassing:
No person shall bypass a safety device unless that person has obtained the
written approval of the Radiation Safety Officer. When a safety device has
been bypassed, a visible sign bearing the words "SAFETY DEVICE NOT
WORKING," or words having a similar intent, shall be placed on the
radiation source housing.
19.4.1.3
Repair or modification of radiation machine:
Except as specified above, no operation involving removal of covers,
shielding materials, or tube housings, or modifications to shutters,
collimators, or beam stops shall be performed without ensuring that the tube
is off and will remain off until safe conditions have been restored. The main
switch, rather than interlocks, shall be used for routine shutdown in
preparation for repairs.
19.5 PERSONNEL REQUIREMENTS
19.5.1 Personnel Requirements
19.5.1.1
Instructions: No person shall be permitted to operate or maintain analytical
x-ray equipment unless such person has received instruction in and
demonstrated competence as to:
19.5.1.1.1 Identification of radiation hazards associated with the use of the
equipment
19.5.1.1.2 Significance of the various radiation warning and safety devices
incorporated into the equipment, or the reasons they have not been
Radiation Safety Manual
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installed on certain pieces of equipment and the extra precautions
required in such cases
19.5.1.1.3 Proper operating and safety procedures for the equipment
19.5.1.1.4 Symptoms of an acute localized exposure; and
19.5.1.1.5 Proper procedures for reporting an actual or suspected exposure.
19.5.1.2
Personnel Monitoring:
Whole Body Dosimeters shall be worn at all times when working with
radiation generating devices or machines unless specific written approval is
given by the RSO.
Finger Dosimeters shall be provided to and shall be used by:
19.5.1.2.1 Analytical x-ray equipment workers using systems having an open
beam configuration and not equipped with a safety device; and
19.5.1.2.2 Personnel maintaining analytical x-ray equipment if the maintenance
procedures require the presence of a primary x-ray beam when any
local component in the analytical x-ray system is disassembled or
removed.
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Section 20.
Registering Lasers
20.1 PRINCIPAL INVESTIGATORS-SUBREGISTRANTS
20.1.1 Introduction
All laser use at the HSC must be first approved by the Laser Safety Officer (LSO), and
then approved and authorized by the Radiation Safety Committee (RSC). These
guidelines explain the application, approval, and purchase process for lasers at the HSC
and should help Principal Investigators (PIs) obtain their subregistration or amendment
approvals as quickly and easily as possible.
20.1.2 Scope
The laser devices governed by this manual are those that operate at energies described as
Class 3b (IIIb) or higher.
20.1.3 Registration Procedure
20.1.3.1
STEP 1: APPLICATION
Equipment additions require the approval of the RSC. The LSO will approve
all other changes.
20.1.3.1.1 New PIs
For new users, a subregistration application must be completed,
signed by the PI, and then sent to the LSO for approval. This
subregistration application must include all lasers, laser users with
their laser qualifications, and locations of use to be authorized under
the PI. Personnel and students not listed on the subregistration permit
must not be allowed to use or work with the lasers.
20.1.3.1.2 Current PIs
For approved users planning to make changes to their
subregistration, a subregistration amendment application must be
completed, signed by the PI, and then sent to the LSO for approval.
There are two forms:
20.1.3.1.2.1one for equipment changes (i.e., additions or deletions), and
20.1.3.1.2.2another for personnel and location changes (i.e., additions or
deletions).
20.1.3.1.3 Assistance
The LSO will provide assistance to any applicant who requires
additional information or has special situations. Occasionally
experimental designs may require partial exemptions to the
regulations. The LSO will seek an amendment to the HSC
Registration, if necessary.
20.1.3.2
STEP 2: PURCHASE APPROVAL
After the review and approval of the application by the LSO, he will present
it to the RSC for purchase approval. The LSO will notify the PI when the
laser(s) may be purchased.
20.1.3.3
STEP 3: PROCUREMENT
All laser purchase requisitions must be sent to EHS for approval by the LSO.
The LSO reviews the purchase requisition and makes certain that the PI has
the RSC's purchase approval. Upon approval, the order is immediately sent to
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55
Purchasing for processing. Laser safety devices should be purchased with
the laser system if possible and installed with the laser when received.
Failure to plan and install safety devices as required will delay the final
approval by the committee for use of the laser.
20.1.4 Receipt and Setup
20.1.4.1
Safety Devices
All safety devices must be installed and operational before final approval is
given.
20.1.4.2
Notification
The LSO must be notified when the laser arrives and when it is set up.
20.1.4.3
Use
The laser must not be used without the final approval of the RSC. The LSO
may give permission to turn on the laser system for test procedures in the
initial set up.
20.1.4.4
Associated Documentation
The LSO will require additional specific documentation for review before
final inspection.
20.1.4.4.1 Laser specifications and information (part of the manufacturer's
manual)
20.1.4.4.2 Receipt records (new or transfer)
20.1.4.4.3 Installation records (where applicable)
20.1.4.4.4 Start-up and standard operational procedures (usually in the manual)
20.1.4.4.5 Maintenance and modification plans (where applicable)
20.1.4.4.6 Safety devices plan (interlocks, warning lights, etc.)
20.1.4.4.7 Safety goggles information
20.1.4.4.8 Calibration records
20.1.4.4.9 Any other requested information
20.1.5 Final Approval for Use
20.1.5.1
Laser Safety Officer (LSO) Inspection
The LSO will inspect the laser system set up before operation begins.
20.1.5.2
Final Approval
After finding the laser set up in compliance, the LSO will give final approval
for use. New subregistrants will receive an authorization permit and a
subregistration number. Upon final approval, the PI may begin research.
20.2 TRAINING
20.2.1 Laser Safety Training
The LSO requires that all Authorized Users attend the Laser Safety Short Course
presented by EHS. PIs are not required to attend unless the RSC determines that their
Laser training and experience is inadequate. The PI will also assure that specific training
in the safe use of lasers under his or her supervision will be provided.
20.3 RENEWALS
20.3.1 Renewals
The PI's subregistration authorization is for a two year period. Near the end of the two
years, the LSO will send the PI a new subregistration application to be completed. Any
new information and/or experimental procedure changes should be added to this new
application. New personnel who have not completed the Laser Safety Training
Requirements must be added separately by personnel amendment forms. The RSC will
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56
review the renewal application with or without changes for approval. The PI's past safety
and compliance record will also be considered at this time. If there are no major
problems, the RSC will then give its approval of the subregistration for another two
years. The PI's research will not be interrupted during this process unless the RSC does
not approve the renewal of the subregistration
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57
Section 21.
Radiation Safety Requirements for Lasers
21.1 INTRODUCTION
21.1.1 Definitions
The following requirements are adapted from applicable sections of 25 Texas
Administrative Code § 289.301, “Registration and Radiation Safety Requirements
for Lasers – Texas Regulations for Control of Laser Radiation Hazards (effective
February 14, 1999)”. A copy of any referenced section of the Texas Regulations for
the Control of Radiation (TRCR) may be obtained from the LSO. If any conflict occurs
between these requirements and the Code, the latter shall prevail.
The following words and terms, when used in this program, shall have the following
meanings.
21.1.1.1
21.1.1.2
21.1.1.3
21.1.1.4
21.1.1.5
21.1.1.6
21.1.1.7
21.1.1.8
21.1.1.9
21.1.1.10
21.1.1.11
Radiation Safety Manual
Accessible emission limit (AEL) – the maximum accessible emission
level permitted within a particular class.
Aperture – an opening through which radiation can pass.
Apparent visual angle – the angular subtense of the source as
calculated from the source size and distance from the eye. It is not the
beam divergence of the source.
Attenuation – the decrease in the radiant flux of any optical beam as it
passes through an absorbing or scattering medium.
Beam – a collection of rays that may be parallel, divergent, or
convergent.
Class I laser – any laser that does not permit access during the
operation to levels of laser radiation in excess of the accessible emission
limits.
Class II laser – any laser that permits human access during operation to
levels of visible laser radiation in excess of the accessible emission limits
contained in 25 TAC §289.301(cc)(1), but does not permit human access
during operation to levels of laser radiation in excess of the accessible
emission limits contained in 25 TAC §289.301(cc)(2).
Class IIIa laser – any laser that permits human access during operation
to levels of visible laser radiation in excess to the accessible emission
limits contained in 25 TAC §289.301(cc)(2), but does not permit human
access during operation to levels of laser radiation in excess of the
accessible emission limits contained in 25 TAC §289.301(cc)(3).
Class IIIb laser – any laser that permits human access during operation
to levels of laser radiation in excess to the accessible emission limits
contained in 25 TAC §289.301(cc)(3), but does not permit human access
during operation to levels of laser radiation in excess of the accessible
emission limits contained in 25 TAC §289.301(cc)(4).
Class IV laser – any laser that permits human access during operation to
levels of laser radiation in excess of the accessible emission limits
contained in 25 TAC §289.301(cc)(4).
Electromagnetic radiation – the flow of energy consisting of
orthogonally vibrating electric and magnetic fields lying transverse to
the direction of propagation. X-ray, ultraviolet, visible, infrared, and
radio waves occupy various portions of the electromagnetic spectrum
and differ only in frequency, wavelength, or photon energy.
58
21.1.1.12
21.1.1.13
21.1.1.14
21.1.1.15
21.1.1.16
21.1.1.17
21.1.1.18
21.1.1.19
21.1.1.20
21.1.1.21
21.1.1.22
Radiation Safety Manual
Electronic product – any manufactured or assembled product that,
when in operation:
21.1.1.12.1 contains or acts as part of an electronic circuit; and
21.1.1.12.2 emits, or in the absence of effective shielding or other
controls would emit, electronic product radiation; or
21.1.1.12.3 or, any manufactured or assembled article that is intended
for use as a component, part, or accessory of a product
described in 12.1.1.12 above and that when in operation
emits, or in the absence of effective shielding or other
controls would emit, such radiation.
Entertainment laser – any laser manufactured, designed, intended, or
promoted for purposes of entertainment, advertising display, or artistic
composition.
Infrared radiation – electromagnetic radiation with wavelengths that
lie within the range 700 nm to 1 mm.
Laser – a device that produces an intense, coherent, directional beam of
light by stimulating electronic or molecular transitions to lower energy
levels. “Laser” is an acronym for light amplification by stimulated
emission of radiation. The term “laser” also includes the assembly of
electrical, mechanical, and optical components associated with the laser.
Laser product – any manufactured product or assemblage of
components that constitutes, incorporates, or is intended to incorporate
a laser and is classified as a class I, II, IIIa, IIIb or IV laser product
according to the performance standards set by the United States Food
and Drug Administration (FDA). A laser that is intended for use as a
component of an electronic product shall itself be considered a laser
product. A laser product contains an enclosed laser with an assigned
class number higher than the inherent capability of the laser in which it
is incorporated and where the product’s lower classification is
appropriate due to the engineering features limiting accessible emission.
Laser Safety Officer (LSO) – an individual who has knowledge of and
the authority and responsibility to apply appropriate laser radiation
protection rules, standards, and practices, and who must be specifically
authorized on a certificate of laser registration.
Maximum permissible exposure (MPE) – the level of laser radiation to
which a person may be exposed without hazardous effect or adverse
biological changes in the eye or skin.
Protective housing – an enclosure surrounding the laser that prevents
access to laser radiation above the applicable MPE level. The aperture
through which the useful beam is emitted is not part of the protective
housing. The protective housing may enclose associated optics and a
workstation and shall limit access to other associated radiant energy
emissions and to electrical hazards associated with components and
terminals.
Pulsed laser – a laser that delivers its energy in the form of a single
pulse or a train of pulses. The duration of a pulse is <0.25 seconds in a
pulsed laser.
Service – the performance of those procedures or adjustments
described in the manufacturer’s service instructions that may affect any
aspect of the performance of the laser.
Source – a laser or laser-illuminated reflecting surface.
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Transmission – passage of radiation through a medium.
Ultraviolet radiation – electromagnetic radiation with wavelengths
smaller than those of visible radiation; for the purpose of this manual
180 to 400 nm.
21.1.1.25 Visible radiation (light) – electromagnetic radiation that can be
detected by the human eye.
21.1.2 Laser Supervision and Control
21.1.2.1
Radiation Safety Committee (RSC)
The RSC establishes and maintains adequate written policies and
procedures for the control of laser hazards to assure compliance with
the state regulations. The RSC approves all use of lasers at the HSC.
21.1.2.2
Laser Safety Officer (LSO)
21.1.2.2.1 Protection against laser radiation hazards is under the
supervision of the LSO.
21.1.2.2.2 The LSO provides consultative services on laser hazard
evaluation and control.
21.1.2.2.3 The LSO ensures adequate safety practices to insure compliance
with the HSCs laser safety requirements.
21.1.2.2.4 The LSO has the authority to suspend, restrict, or terminate the
operation of a laser product or installation, if laser hazard
controls are deemed to be inadequate by the LSO.
21.1.2.2.5 The LSO maintains the records required by the Texas
Regulations for the Control of Laser Radiation Hazards.
21.1.2.2.6 The LSO approves all protective equipment for the protection of
personnel against laser radiation.
21.1.2.2.7 The LSO surveys all areas where laser equipment is being used to
assure compliance with the state regulations.
21.1.2.2.8 The LSO reviews planned installations or modifications of laser
equipment relative to laser hazards and their control, approving
the installation or modification only if he is satisfied that laser
controls are adequate.
21.1.2.2.9 The LSO is to investigate all real or suspected incidents or
injuries resulting from laser operations.
21.1.2.2.10 The LSO will approve a laser system for operation only if the
laser hazard controls are deemed adequate by the RSO.
21.1.2.2.11 The LSO makes certain that adequate warning systems and signs
are installed.
21.1.2.3
Principal Investigators (PIs)
21.1.2.3.1 A PI shall not permit the operation of a laser unless there is
adequate control of the laser hazards to employees, visitors, and
the public.
21.1.2.3.2 Except for Class I lasers, a PI must submit the names of persons
scheduled to work with lasers to the LSO. In addition, a PI shall
submit information requested by the LSO for medical
surveillance scheduling for incident or injury investigations.
21.1.2.3.3 When a PI knows of or suspects an incident or injury resulting
from a laser operated under his/her supervision, he/she shall
immediately notify the LSO of the incident or injury and the
names of the individuals involved.
21.1.2.3.4 A PI shall assist in obtaining appropriate medical attention for
individuals involved in a laser accident.
21.1.1.23
21.1.1.24
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21.1.2.3.5 A PI shall not permit the initial operation of a laser system which
is under his/her supervision without prior approval by the LSO.
21.1.2.3.6 If any modification of a laser system is made which has not been
evaluated by the LSO, the PI shall not energize the system until
the LSO has given approval.
21.1.2.3.7 Each PI shall submit plans for laser installations or modifications
to the LSO for approval.
21.1.2.4
Authorized Users (AUs)
21.1.2.4.1 A laser is not to be energized or worked with unless the AU has
been authorized to do so by the PI.
21.1.2.4.2 AUs must comply with the safety rules and standards prescribed
by the PI and the LSO.
21.1.2.4.3 When the AU knows or suspects that an incident or injury has
occurred involving a laser operation, the AU is to immediately
inform the PI and the LSO.
21.2 GUIDELINES FOR SAFE OPERATIONS OF LASERS
21.2.1 Maximum Permissible Exposure (MPE) and Nominal Hazard Zone (NHZ)
[25 TAC §289.301(d)(43) and (45); 25 TAC §289.301(u)]
An MPE is the level of laser exposure to which the eye or (less limiting) the skin,
may be exposed without adverse effects. NHZ is the space within which the level of
direct reflected or scattered radiation during operation exceeds the applicable MPE.
When any class IIIb or IV laser is used at levels at or above IIIb in an open beam
mode the MPE will be assumed to be exceeded in that room or area and appropriate
precautions shall be taken. In other words, the NHZ will comprise the enclosure
(room or area to which the beam is restricted to by virtue of walls, curtains or other
barriers) in which the laser is operating if operated at or above IIIb levels. This is
done to account for intentional or unintentional scattered or reflected beam. If the
PI believes the NHZ does not apply to the whole area he may justify a more limited
NHZ in the SOP by using information supplied by the laser manufacturer, by
measurement, or by using the appropriate laser range equations or other equivalent
assessments.
21.2.2 Laser Safety Standard Operating Procedures (SOPs)
[25 TAC §289.301(v)(2)(B)]
Each laser shall have a Standard Operating Procedure (SOP) written for its
operation. The SOP must be present at the operating console or control panel of
the laser. The SOP shall include at a minimum:
21.2.2.1
operating instructions
21.2.2.2
safety eyewear parameters and instructions for proper use
21.2.2.3
interlock instructions
21.2.2.4
checklist for operation
21.2.2.5
clear warnings to avoid possible exposure to laser and collateral
radiation in excess of the MPE.
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The SOP shall be available for inspection by the LSO or designate at any time. A
template for Laser Safety Standard Operating Procedures can be found in Appendix
B.
21.2.3 Safety Interlocks and Warning Systems
[25 TAC §289.301(v)(2)(B) and (D)]
A safety interlock is a device that automatically prevents human access above MPE
limits.
Safety interlocks shall be provided for any portion of the protective housing that by
design can be removed or displaced without the use of tools during normal
operation or maintenance, and thereby allows access to radiation above MPE limits.
Adjustment during operation, service, testing, or maintenance of a laser containing
interlocks shall not cause the interlocks to become inoperative except where a laser
controlled area, as specified in subparagraph (E) of the referenced regulation, is
established.
For pulsed lasers, interlocks shall be designed to prevent firing of the laser; for
example, by dumping the stored energy into a dummy load and for continuous wave
(CW) lasers, the interlocks shall turn off the power supply or interrupt the beam
(i.e., by means of shutters).
Each class IIIb or IV laser system shall provide visual or audible indication during
the emission of accessible laser radiation. The indication shall occur prior to
emission of radiation with sufficient time to allow appropriate action to avoid
exposure. Any visual indication (e.g., lights) shall be visible through protective
eyewear for the wavelength of the laser so that eyewear need not be removed to see
it.
21.2.4 Safety Interlocks – Alternatives
[25 TAC§ 289.301(r)(2)(E)(II)]
The regulations recognize that in situations where an engineering control
(automatic safety interlock) may be inappropriate, the LSO shall specify alternate
controls to obtain equivalent laser safety protection. Requests to use alternate
controls may be submitted in writing to the LSO and, if accepted, will be
documented in the SOP.
Where safety latches or interlocks are not feasible or are inappropriate, for example
during surgical procedures, a controlled area shall be established and the following
shall apply:
21.2.4.1
21.2.4.2
Radiation Safety Manual
All authorized personnel shall be trained in laser safety and appropriate
personal protective equipment shall be provided and worn upon entry.
A door, blocking barrier, screen, or curtains shall be used to block,
screen, or attenuate the laser radiation at the entryway. The level at the
exterior of these devices shall not exceed the applicable MPE, nor shall
personnel experience any exposure above the MPE immediately upon
entry.
62
If a laser is energized and operating at class IV levels then at the
entryway there shall be a visible or audible signal and other appropriate
signage indicating laser operations. This indicator may be interfaced
with the laser itself, the power supply, or manually operated in
accordance with the SOP requiring its use.
21.2.4.3.1 For indoor controlled areas, during tests requiring continuous
operation, the individual in charge of the controlled area may
momentarily override the safety interlock. The sole purpose is to
allow access to other authorized persons if it is clearly evident
that there is no optical hazard at the entry area and protective
eyewear is worn by the entering person.
21.2.4.3.2 When removal of panels or protective covers and/or overriding
interlocks becomes necessary, such as for servicing, testing or
maintenance and laser radiation exceeds the MPE, a temporary
controlled area must be established and posted.
21.2.4.3
21.2.5 Protective Eyewear
[25 TAC §289.301(t)(1)]
Each Sublicensee shall provide protective eyewear that meets the requirements of
25 TAC §289.301(t)(1). The eyewear shall be located where persons who operate
the laser have unrestricted access to the eyewear. The eyewear shall be worn during
any operation where a class IIIb or IV beam is not enclosed. This normally includes
alignments. Training on identification, proper fit, location, and use of eyewear shall
be included in the specific laser safety training.
Protective eyewear shall meet the following requirements:
21.2.5.1
Provide a comfortable and appropriate fit all around the area of the eye
21.2.5.2
Be in good physical condition to ensure the lenses retain all protective
properties during its use
21.2.5.3
Be of optical density adequate for the laser energy involved
21.2.5.4
Have the optical density or densities and associated wavelengths
permanently labeled on the filters or eyewear
21.2.5.5
Be examined at intervals not less than 12 months, to ensure the
reliability of the protective filters and integrity of the holders. Unreliable
eyewear shall be discarded and replaced.
21.2.5.6
The optical density of the protective eyewear shall be appropriate for
the specific frequency and pulse length of the laser beam in use, and
shall provide reduction of the incident energy to less than the MPE of the
laser. It is important to include the pulse length and frequency of pulse
repetition of pulsed lasers in selecting appropriate protective eyewear.
21.2.6 Training
[25 TAC §289.301(q)(1)]
Every person who operates or works with a laser shall complete training in laser
safety provided by the LSO or LSO-approved equivalent. This training is referred to
as the General Laser Safety Training. Persons completing General Laser Safety
Training shall also complete specific laser safety training given by the Sublicensee.
No person may work in a NHZ prior to completing both laser safety training classes.
Miscellaneous Safety and Training Issues:
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63
21.2.6.1
21.2.6.2
Persons working in a laboratory with multiple lasers shall be made
aware of the various wavelengths and other operating parameters by the
laser operator/users
Persons working with tunable lasers, or any laser which is frequency
doubled or frequency tripled, shall be aware of the effect of frequency
manipulation and shall choose protective eyewear which will provide
protection for the effective wavelength of the laser.
21.2.7 Skin Protection
[25TAC §289.301(t)(2)]
When there is potential for skin exposure to levels exceeding the skin MPE for the
laser, persons in the controlled area shall wear appropriate clothing, gloves, and/or
shields.
21.2.8 Magnification of Laser Beam
[25TAC §289.301(r)(2)(C)(ii)]
If at any time a laser beam is optically magnified or concentrated, special
precautions shall be taken by the Sublicensee to prevent specular or diffuse
reflection or other exposure greater than the MPE for the laser. The special
precautions shall be documented in the SOP for the laser.
21.2.9 Non-Radiation Hazards
Each Sublicensee shall evaluate or have an evaluation made of nonradiation
hazards. This evaluation shall include electrocution, chemical, cutting edge,
compressed gases, noise, confined space, fire, explosion, ventilation, and other
physical safety hazards. The evaluation shall be made part of the SOP’s and be
available for review.
21.2.10 Surveys
[25TAC §289.301(w)]
The LSO shall perform biannual surveys of all lasers. These surveys shall include:
21.2.10.1 Ascertaining that all lasers and protective devices are labeled correctly
and functioning within the design specifications.
21.2.10.2 Ascertaining that all warning devices are functioning within their design
specifications.
21.2.10.3 Ascertaining that the laser installation is properly posted with warning
signs.
21.2.11 Records
[25TAC §289.301(ee)]
Records of Surveys, Training, NHZ and MPE calculations, and other laboratoryspecific information shall be maintained in the laboratory, and shall be available for
inspection/review by the LSO at any time. Records shall be maintained for a period
of not less than 5 years.
21.2.12 Incident Reporting
[25TAC §289.301(z)-(bb)]
Each Permittee shall immediately seek appropriate medical attention for the injured
individual and notify the LSO by telephone of any injury involving a laser possessed
by the HSC. The LSO shall be notified within 48 hours of any non-injury incident
(near miss) which involves potential exposure to laser radiation exceeding the MPE.
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A written summary of an injury or non-injury incident shall be forwarded to the LSO
not later than five working days following the incident. Records of any incident shall
be maintained by the LSO and the Sublicensee.
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Section 22. Policy for Addressing Violations of Regulatory
Requirements or Standards for Safe Work with Radiation,
Radioactive Materials, and Lasers
22.1 VIOLATION POLICY
22.1.1 Introduction
Laboratory inspections are performed to ensure compliance with the applicable state and
federal regulations and with the policies set forth in this manual. Violations of
requirements will be addressed by the policies of this manual. This policy recognizes that
specific circumstances and severity of violations call for different corrective or, if
necessary, disciplinary actions.
This policy applies to all personnel using radiation-producing devices, radioactive
materials, or laser devices at any Texas A&M Health Science Center owned and/or
operated facility and to all personnel using radiation-producing devices, radioactive
materials, or lasers at off-site locations under the auspices of a Texas A&M Health
Science Center radioactive materials license.
22.1.2 Policy
22.1.2.1
22.1.2.2
22.1.2.3
22.1.2.4
22.1.2.5
22.1.2.6
Radiation Safety Manual
Violations may be noted at any time. Reporting of violations is not limited to
formal inspections.
Violations will be classified as either major or minor. A list of major and
minor violations is in section 22.1.3 and 22.1.4 below. Two minor violations
will be considered the equivalent of one major violation.
Violations may be corrected on the spot by the person noting them if
appropriate. Although no notice of such violations will be issued in these
circumstances, the Permit Holder will be notified and a comment will be
entered into the Permit Holder’s record.
Violations will be counted against the specific room in which they were
noted and will be charged against the permit under which that room is listed.
Violations that take place in unposted laboratory spaces will be charged
against the permit holder responsible for the research being performed.
Violations noted in common areas (corridors, equipment rooms, etc.),
unposted areas, or in laboratory space that does not belong to a radioactive
materials user will be charged against the permit under which the radiation
worker is listed or under which the radioactive materials were ordered, as
appropriate.
All letters of violation shall be approved by the RSO prior to issuing to the
Permit Holder.
Upon issuance, the Permit Holder shall provide a written response to the
RSO within 10 working days. This written response must provide a brief
description of circumstances causing the violation and note actions to be
taken to prevent a recurrence of the violation. If the Permit Holder feels the
violation was issued in error or that there are mitigating factors, the violation
may be contested to the RSO, who will decide whether or not to withdraw
the violation. All communications with the Permit Holder will be retained in
the Permit Holder’s file, where they will be available for review by the
Radiation Safety Committee (RSC) upon request. Permit holders who do not
66
22.1.2.7
22.1.2.8
22.1.2.9
22.1.2.10
22.1.2.11
22.1.2.12
provide a written response within 10 working days will be referred to the
Chair of the RSC for further action.
Any Permit Holder receiving more than four major violations or the
equivalent in major and minor violations in any six-month period will be
subject to further review and possible disciplinary action. In these instances,
the RSO will notify the user, conduct a review to determine root causes for
violations, and request the user to respond in writing detailing corrective
actions. The RSO will then refer the case to the chair of the RSC together
with his recommendation for disposition. If the chair considers that actual or
proposed corrective actions are adequate, no further action will be taken and
the RSC will be informed of the case at the next regularly scheduled meeting
of the RSC. If, however, the chair of the RSC considers that disciplinary
action or suspension of the permit may be warranted, he will refer the case to
either the entire RSC or appoint an ad hoc subcommittee to review the case
and make a determination. If warranted, the permit holder may be requested
to appear before the ad hoc subcommittee or the entire committee.
Disciplinary actions will be intended to discipline the Permit Holder or the
responsible party for repeated violations or for particularly flagrant or
egregious violations of regulations or radiation safety practices. A list of
possible corrective and disciplinary actions is in sections 3 and 4 below.
In the case of particularly willful, flagrant, or egregious violations of
regulatory requirements, radiological safety requirements, or health and
safety practices, the RSO may immediately suspend a Radioactive Materials
Permit and all work under it. Such suspensions will be immediately referred
to the RSC Chair for concurrence. In the absence of concurrence, the Permit
will be reinstated immediately. If the RSC Chair agrees with the suspension,
a subcommittee of the RSC will be formed to determine subsequent actions
to be taken.
Upon completion of all corrective or disciplinary actions, the RSO will
perform a follow-up inspection of all spaces listed under the Permit in
question to verify compliance with all required actions, regulations, and
standards. Following successful completion of this inspection, the RSO will
recommend restoration of the Permit and resumption of radiological work.
Following Permit restoration, inspections will be performed monthly for a
three-month probationary period, after which the normal (quarterly)
inspection periodicity will resume.
Further violations noted during this probationary period will result in a
recommendation for further corrective or disciplinary actions.
Copies of all notices of major violations will be sent to appropriate
Department Heads. Copies of correspondence resulting from an excessive
number of violations will be sent to appropriate Department Heads and
Deans. Copies of correspondence regarding Permit suspensions will be sent
to appropriate Department Heads, Deans, and Vice Presidents.
22.1.3 Major Violations
22.1.3.1
Loss of security for radioactive materials in excess of 1 mCi aggregate
activity
22.1.3.2
Eating, drinking, or food storage in radiologically posted laboratory space
22.1.3.3
Use of radioactive materials by untrained personnel
22.1.3.4
Use of radioactive materials in an unposted lab or room
22.1.3.5
Radioactive contamination in excess of 10,000 dpm/100 cm2 in a posted area
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22.1.3.6
22.1.3.7
22.1.3.8
22.1.3.9
22.1.3.10
22.1.3.11
22.1.3.12
22.1.3.13
22.1.3.14
22.1.3.15
22.1.3.16
22.1.3.17
22.1.3.18
22.1.3.19
22.1.3.20
Radioactive contamination in excess of 1000 dpm/100 cm2 in any unposted
area
Unauthorized receipt, transfer, or shipping of radioactive materials
Loss of radioactive materials
Evidence of internal exposure of radioactive materials resulting from
abnormal incidents
Failure to wear required radiation dosimetry
Radioactive materials in nonradioactive waste containers
Evidence of liquid radioactive waste disposal into laboratory sinks
Persons using radioactive materials while person or laboratory is under
suspension
Unlabeled contaminated laboratory equipment
Failure to wear proper personal protective equipment (lab coat, gloves, etc.)
Failure to participate in required bioassay programs (if appropriate)
Failure to perform and document monthly radioactive contamination surveys
during months in which radioactive materials were used
Pipetting by mouth
Use of radioactive materials or a class IIIa or higher laser by untrained
personnel, OR use of radioactive materials or a class IIIa or higher laser
without the proper PPE.
Defeating or disabling any safety interlocks or other safety features on any
class IIIa or higher laser
22.1.4 Minor Violations
22.1.4.1
Evidence of eating or drinking in a radiologically posted room (i.e., presence
of candy wrappers, soda cans, coffee-stained cups, etc.)
22.1.4.2
Loss of security for any amount of radioactive materials less than 1 mCi
aggregate activity
22.1.4.3
Presence of radioactive contamination more than 1,000 dpm/100 cm2 and
less than 10,000 dpm/100 cm2 in a posted room
22.1.4.4
Presence of detectable radioactive contamination less than 1000 dpm/100
cm2 in any unposted area
22.1.4.5
Survey meter out of calibration or use of inoperable survey meter
22.1.4.6
Radioactive check source not available for contamination survey meter
22.1.4.7
Incorrect documentation of radioactive materials inventory (i.e., no decay
corrections; total activity present in waste plus stock vials does not agree
with activity received and not disposed; failure to return inventory
verification form)
22.1.4.8
Improper waste segregation
22.1.4.9
Score of less than 50% on verbal quiz administered during inspection (Note:
Personnel failing a verbal quiz may be suspended from radioactive materials
use pending attendance at a normally scheduled Radiation Safety training
class.)
22.1.4.10 Failure to demonstrate proper radiological survey techniques
22.1.4.11 Poor radiological housekeeping
22.1.4.12 Improper use of a fume hood, absorbent pads, or bench covers not used in
radiological work or storage areas
22.1.4.13 Failure to post Texas State information notice
22.1.4.14 Failure to remove or obliterate radiological symbols from empty containers
22.1.4.15 Failure to report a radiological incident (spill, skin contamination, loss of
radioactive material, etc.) to RSO within 2 hours of its occurrence
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22.1.4.16
22.1.4.17
22.1.4.18
22.1.4.19
Failure to take appropriate immediate actions in the event of radiological
emergencies such as spills or skin contamination incidents
Use of a class II or lower laser by untrained personnel, OR use of a class II or
lower laser without the proper PPE.
Defeating or disabling any safety interlocks or other safety features on any
class II or lower laser
Any other activities that violate Texas State regulations or the provisions of
the referenced documents.
22.1.5 Examples of Possible Recommended Corrective or Disciplinary Actions
22.1.5.1
Temporary suspension of an individual’s authorization to use radioactive
materials pending refresher training
22.1.5.2
Permanent suspension of a specific individual’s authorization to use
radioactive materials at the HSC
22.1.5.3
Mandatory refresher training for all personnel listed under a radioactive
materials permit
22.1.5.4
Suspension of authorization to order radioactive materials under a specific
Permit for various periods of time up to two months
22.1.5.5
Suspension of Radioactive Materials Permit for periods of time up to one
year
22.1.5.6
Complete revocation of Radioactive Materials Permit and the ability of
specific individuals to use radioactive materials under any other permit at the
HSC
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Section 23.
Records
23.1 GENERAL RECORD-KEEPING REQUIREMENTS
23.1.1 MRB and IRM campuses
Retention periods are included in parentheses.
23.1.1.1
permit records (life of permit)
23.1.1.1.1 approved application for permit with original RSC signatures
23.1.1.1.2 all amendments, requests for amendment, and Permit renewals
23.1.1.2
receipt, transfer and disposal records for every licensed source of radiation (1
year after final disposal)
23.1.1.3
copies of inventory reports (1 year)
23.1.1.4
radiation surveys (3 year)
23.1.1.4.1 contamination surveys
23.1.1.4.2 radiation field surveys in restricted areas
23.1.1.4.3 radiation field surveys in unrestricted areas
23.1.1.5
survey instrument calibrations (3 years)
23.1.1.6
personnel records (1 year)
23.1.1.6.1 worker/user lists
23.1.1.6.2 training records
23.1.1.7
operating and emergency procedures (current)
23.1.1.8
procedure manuals (current)
23.1.1.9
records of radiation safety training performed by the Permittee (3 years)
23.1.2 In addition to maintaining duplicates of all records in step 1 (except 1.d, 1.g, and 1.i
above), the RSO shall maintain the following records which are available for review
during normal office hours.
23.1.2.1
original copy of all radioactive material licenses issued to HSC
23.1.2.2
official inventory records
23.1.2.3
inspection reports and copies of all “Notices of Violation” issued by state or
federal regulatory agencies and the HSC responses to those Notices.
23.1.2.4
current version of all policy manuals and procedure manuals
23.1.2.5
calculations and reports as required for compliance with the Clean Air Act
for radionuclide releases from HSC facilities
23.1.2.6
dosimetry records
23.1.2.7
leak test results
23.1.2.8
survey instrument calibrations
23.1.2.9
Radiation Safety Program review
23.2 INFORMATION REQUIRED ON SPECIFIC RECORDS MAINTAINED BY RSO
23.2.1 Radioactive material receipt surveys, radiation surveys, and contamination surveys
23.2.1.1
records shall be in units of dpm, becquerels (Bq), µCi, mR/h, mrem/h, etc., as
appropriate. Units of “cpm” or “counts” are not acceptable for quantitative
survey records.
23.2.1.2
records shall uniquely identify the source of the radiation
23.2.1.3
records shall clearly indicate the areas surveyed (include a map)
23.2.1.4
records shall indicate the person performing the survey and date of survey
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23.2.1.5
records shall uniquely identify the survey instrument used, i.e., serial
number, or other unique description
23.2.2 Training records are specified in Section 8
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Section 24.
APPENDICES
A. Signs and Labels
1. Notice to Employees / Document Locator
2. Laboratory Safety Data Sheets
B. Forms
1. Application for a Permit for the Use of Radioactive Materials at HSC
2. Permit to Use Radioactive Material at HSC
3. Radioactive Materials Permit Amendment Form
4. Radioisotope Package Survey Record
5. Isotope Tracking Form
6. Radioactive Material Waste Disposal Record
7. Request for External Dosimetry Service
8. Declaration of Pregnancy
9. Thyroid Bioassay Record
10. Radioisotope Lab Contamination Survey Record
11. Application for Subregistration of X-Ray Producing Machines
12. Permit to Use X-Ray Machines at HSC
13. Application for Subregistration Amendment (X-Ray) – Equipment Change
14. Application for Subregistration Amendment (X-Ray) – Personnel / Location Change
15. Application for Use of Radioactive Materials in Animals
16. Application for Subregistration of Laser Systems
17. Permit to Use Lasers at HSC
18. Application for Subregistration Amendment (Laser) – Equipment Change
19. Application for Subregistration Amendment (Laser) – Personnel / Location Change
20. RAM Purchase Requisition Form
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