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6. Regulations Concerning Radioisotopes
Radioisotopes must be acquired, used, stored, and disposed of in ways that will ensure compliance with federal, state, and local laws and maintain doses to workers as low as reasonably achievable.
6.2.1. Approval number - number issued by Radiation Safety (RS) used to identify a shipment of radioactive material for receipt, inventory, and waste disposal records.
6.2.2. DOT - U.S. Department of Transportation
No person may work with radioisotopes at any OSU-jurisdiction location unless safety training has been given and documentation is on file in the RS office. See section 9 for details.
6.4.1. Acquisition of any radioactive material, regardless of whether by purchase, gift, loan, transfer, or other means must be in accordance with a valid RUA, except for items listed in Section 4.1, and must have prior approval from RS via phone or written request to ensure that acquisition will not violate provisions of the RUA.
126.96.36.199. Approval number is assigned by Radiation Safety upon receipt of an isotope.
188.8.131.52. Approval number will be shown on each package inspection survey form, and on any other transfer document.
184.108.40.206. Approval number must be shown on all inventory and disposal documents (waste tags, etc.).
6.4.2. Each package containing radioisotopes, whether incoming or outgoing, must be inspected by RS or as directed by RS, to determine compliance with DOT packaging, labeling, and inspection regulations.
220.127.116.11. "Ship To" address for all incoming packages containing radioisotopes destined for the Corvallis Campus is:
Program Director's name and Department
c/o OSU Radiation Safety
100 Oak Creek Building
Corvallis, OR 97331-7404
18.104.22.168. "Ship To" address for incoming packages destined for non-Corvallis locations shall be determined by RS on a case-by-case basis.
22.214.171.124. Packages will be delivered to RS, or as requested by RS, who will inspect and deliver to the intended user or will arrange to have the package inspected and delivered.
126.96.36.199. Should a package inadvertently be delivered direct to the intended user, RS must be notified immediately to arrange the required inspection and to assign an approval number.
188.8.131.52. For outgoing packages, the shipping group must contact RS to arrange for inspection, labeling, preparation of shipping document, etc., and to arrange transportation to RS and from RS to the transporter.
6.4.3. Transfers between on-Campus and off-Campus OSU groups require the procedures in 6.4 above. Transfers between on-Campus groups require RS approval of transfer, packaging and containment. Original approval number will be retained on transferred item(s).
6.4.4. Nuclear gauges containing sealed sources of radioactive material transported for routine use are exempt from some of the package receipt requirements listed in 184.108.40.206 - 220.127.116.11 above. RS will inspect packaging of nuclear gauges upon initial receipt, label the gauge, and prepare the shipping papers and instructions for routine transport.
6.5.1. Each entryway to every location where radioisotopes are used or stored must be posted with a "Caution - Radioactive Material" (CRAM) sign or equivalent other sign.
6.5.2. Each hood wherein radioisotopes are used or stored must be posted with a CRAM sign.
6.5.3. Each refrigerator or freezer wherein radioisotopes are used or stored must be posted with a CRAM sign containing the statement "Store No Edibles." No edibles are permitted in posted freezers or refrigerators except when clearly labeled for experimental use only, with human consumption forbidden.
6.5.4. Each room wherein radioisotopes are used or stored must have posted a copy of Oregon "Notice to Employees" form or NRC Form 3, as appropriate, and an up-to-date copy of each applicable RUA.
6.5.5. Any container holding radioactive material must be labeled to show radioisotope, activity, and initial date, or must be kept in a container that is so labeled. This includes containers holding radioactive wastes, test tubes, vials, etc.
6.5.6. Any contaminated tools, articles or equipment must be labeled with CRAM tape.
6.5.7. Each transport container must be labeled in accordance with DOT regulations.
6.5.8. Any sign or label posted per above regulations must be removed when no longer applicable, and must be replaced when no longer legible or when otherwise no longer suitable for its intended purpose. Deface any labels that do not apply.
6.6.1. Any location where radioisotopes are used or stored shall have entry doors closed, and preferably locked, whenever using personnel are not present.
6.6.2. Access for such locations must be controlled sufficiently to prevent theft or loss of radioactive material.
6.6.3. Stock vials and sealed sources must be secured with a locking mechanism (in addition to the lock on the room) to prevent theft or loss when not in use. Access to these stock vials and sealed sources must be restricted to authorized radiation workers.
6.6.4. Access to portable gauges containing radioactive material must be restricted using three independent means.
6.6.5. Any known or suspected loss, including theft, of radioactive material must be reported immediately to RS.
6.6.6. Eating, drinking, smoking, or applying cosmetics is not permitted in any area where unsealed radioactive materials are stored or used.
6.6.7. Change of custody other than within the using group requires approval of RS.
6.6.8. Radioactive material shall not be stored or used in any area not authorized for radioactive material.
6.7.1. Inventory of all radioactive materials in possession must be maintained reasonably up-to-date by the using group, and must be available for inspection at any reasonable time. Inventory must include approval number for each item, initial receipt date, reasonable log of uses and disposals, date and method of final disposition. Inventory form must contain a running total or permit rapid, easy totaling by radioisotope.
6.7.2. Radiation Safety inventory records will be updated and sent to the laboratory for review on a semi-annual basis. Semi-annual inventory verification reports must be returned to Radiation Safety in a timely manner.
6.7.3. Inventory records must be preserved for later inspection and review. All such records must be given to RS should the using group disband or terminate radioisotope use.
6.8.1. Personnel dosimeters will be prescribed and provided by RS and listed in the RUA.
18.104.22.168. Personnel body dosimeters will be prescribed when annual deep body dose equivalent is likely to exceed 500 mrem or when annual shallow dose equivalent is likely to exceed 5000 mrem. Hand dosimeters will usually be prescribed where hand doses could exceed 50 mrem in any month.
22.214.171.124. Dosimeters usually will not be prescribed where use involves only isotopes that emit only alpha radiation and/or only beta radiation having maximum energy no greater than 0.26 MeV (e.g. 3H, 14C, 35S, 45Ca, 63Ni).
126.96.36.199. RS will prescribe on a case-by-case basis for all other situations.
6.8.2. Personnel dosimeters must be exchanged on schedule.
188.8.131.52. Persons beginning work at OSU for which dosimeters are prescribed will be on a quarterly routine exchange frequency.
184.108.40.206. Persons showing significant potential for body dose of 50 mrem or more per month or hand doses of 200 mrem or more per month will be placed on a monthly exchange frequency. Others will remain on a quarterly exchange frequency.
220.127.116.11. Program Directors are responsible for ensuring that their personnel exchange dosimeters at the required times and that exchanged dosimeters are returned to RS without delay.
18.104.22.168. RS may modify the exchange frequency on a case-by-case basis.
6.9.1. Routine bioassay is required before and 2-24 hours after handling unsealed 3H in any chemical form in quantity of 50 mCi or more in any week.
6.9.2. Routine bioassay is required before and 6-72 hours after handling unsealed radioactive iodine in any chemical form in quantities of 0.1 mCi or more.
6.9.3. For other radioisotopes, routine bioassay is required for personnel likely to receive greater than 10% of the applicable Annual Limit on Intake (ALI).
6.9.4. Other routine or special bioassays will be prescribed by RS on a case-by-case basis and listed in the RUA.
6.10.1. Routine surveys of facilities and equipment must be made at least once each week wherein radioisotopes are handled.
22.214.171.124. Each survey must include contamination swipes, and must include direct measurements via survey meters when appropriate.
126.96.36.199. Each survey must be documented and kept on file. State-approved units must be used, i.e. dose rates in mrem/hr and contamination rates in microcuries per 100 cm2 or disintegrations per minute (dpm) per 100 cm2. RS must be notified when surface contamination at or above 500 dpm/100 cm2 beta-gamma, or 10 dpm/100 cm2 alpha in an accessible area is found; corrective actions taken must be documented. Survey reports must be given to RS whenever the using group disbands or otherwise stops using radioisotopes.
6.10.2. In addition, each person handling unsealed radioisotopes or visiting an area where such was handled should survey the work area and self using an appropriate survey meter immediately upon completion of work using radioisotopes. Notify RS immediately if contamination is found outside of the immediate work area, on skin or personal clothing.
6.10.3. RS will perform surveys at least once every year to independently determine radiation levels and contamination levels, verify posting and labeling and ensure adequate radiation safety precautions in the lab. Report of finding will be sent to the using group, who will be responsible for any corrective actions needed.
6.10.4. Special surveys may be required by RS whenever conditions warrant. Surveys must be documented, with reports kept on file, in the same manner as routine surveys.
6.11.1. An operable appropriate radiation survey meter must be present whenever handling radioisotopes other than 3H in aggregate quantities exceeding 10 microcuries.
6.11.2. Each radiation survey meter must undergo routine calibration and maintenance at least once each year, and, when repaired, must be recalibrated before being placed back into service.
6.11.3. Routine calibration and maintenance shall include visual inspection and exposure to radiation levels or calibrated pulse signals appropriate for each operable scale. Responses must be within manufacturer's specifications. Records of calibration must be kept by or for the using group. (Instrument calibration is provided for a fee by the OSU Radiation Center.
6.12.1. Radioisotopes must be handled in such ways as to keep personnel doses and contamination incidents as low as reasonably achievable considering the nature of the activities to be performed.
188.8.131.52. Minimum protective apparel for handling unsealed radioisotopes is lab coat and impervious gloves (vinyl, rubber, etc.). Additional protective apparel required will be noted in the RUA.
184.108.40.206. Working with unsealed radioisotopes is not permitted by persons having an open wound.
220.127.116.11. Remote handling devices (tongs, forceps, pliers, etc.) must be used whenever contact dose rates exceed 100 mrem/hr., and should be used with lower dose rates. Additional remote handling needs will be listed in the RUA.
18.104.22.168. Care must be used in handling and storing used beakers, test tubes, pipette tips, and other contaminated items to prevent bumping, dropping, or otherwise inadvertently spreading contamination.
22.214.171.124. Containers holding non-trivial quantities of radioiodines or other volatiles must be opened in an operating fume hood. Waste and other materials containing such radiochemicals must be double bagged in plastic and sealed before disposal or storage.
126.96.36.199. Radioactive materials transported through hallways must be securely contained. Radioactive liquids require secondary containment via tray, bucket, bag, etc., sufficient to hold the liquid in case of breakage.
188.8.131.52. In case of spill or accident involving radioactive materials, contact Radiation Safety.
6.12.2. Radioisotope storage must provide adequate safety.
184.108.40.206. Liquids, including wastes, must be stored in secondary containers able to prevent contamination spread should the primary container break.
220.127.116.11. Radioisotope storage locations must provide adequate protection against bumping, falling, overheating, and other mechanical hazards.
18.104.22.168. Shielding should be used when necessary and appropriate.
6.12.3. Sealed radiation sources must be leak-tested and inventoried per State requirements.
22.214.171.124. Each sealed source that is designed to emit alpha particles and contains 10 microcuries or greater must be leak tested at intervals not to exceed six months.
126.96.36.199. Each sealed source that is not designed to emit alpha particles and contains 100 microcuries or greater must be tested for leakage or contamination at intervals not to exceed six months.
188.8.131.52. Copy of each leak test report must be kept on file at RS. Results must be in units of Becquerels (Bq) or microcuries.
184.108.40.206. Positive results must be reported to RS immediately, and corrective actions taken as directed by RS.
220.127.116.11. Sources placed in storage by RS are exempt from the leak test requirement. Sources in storage must be leak tested prior to use.
6.13.1. Radioactive waste may not be stored for decay in individual laboratories.
6.13.2. Radioactive waste may not be drain disposed.
6.13.3. Waste must be packaged per instructions from RS.
18.104.22.168. Dry wastes must be placed in containers supplied by RS and marked "Dry Radioactive Waste Only."
22.214.171.124. Liquid radioactive wastes must be placed in containers approved by RS. Liquid radioactive waste containers must be kept in secondary containers able to contain the liquid in case of breakage.
126.96.36.199. Liquid scintillation vials containing counting fluid must be placed in containers supplied by RS and marked "Scintillation Vials Only." Note that liquid scintillation counting fluid may be disposed of alternatively by treating as liquid waste, i.e., emptying into containers approved by RS. Liquid scintillation counting fluid must be segregated from aqueous liquid.
188.8.131.52. Biological wastes, i.e. animal carcasses or parts, blood, urine, feces, bedding, etc., shall be bagged, properly labeled to show radioisotopes, amounts, dates, and Program Director, and stored in a freezer until RS pickup.
184.108.40.206. Each container must have a proper waste tag attached that is kept up-to-date. Each container must also be marked as containing radioisotopes.
220.127.116.11. Waste must be segregated by half-life to the extent reasonable to permit efficient disposal by decay. Generally, this will involve two categories: radioisotopes with half-lives less than 90 days; and radioisotopes with half-lives greater than 90 days.
18.104.22.168. RS should be notified prior to generating any radioactive waste that contains other hazardous constituents or demonstrates hazardous characteristics (mixed waste). Mixed waste must be segregated from other radioactive waste.
6.13.4. Waste will be disposed of by RS
22.214.171.124. RS will pick up and dispose of properly packaged radioactive waste upon request from the using group.
126.96.36.199. RS will arrange disposal by sanitary sewer, by compaction, incineration, land burial, or other means as appropriate.
188.8.131.52. Cost of disposal will be borne by the generating group for mixed waste, sealed sources, improperly segregated or packaged waste and other non-routine wastes.
184.108.40.206. Disposal via the sanitary sewer may be permofrmed only by RS or upon specific approval of the RSC. Using groups must not pour radioactive waste down sinks, etc. For this purpose, liquid radioactive waste consists of the waste liquid plus the first rinse of the container, but not subsequent rinses or washes. Exceptions to either part of this rule will be listed on the RUA.
220.127.116.11. RS will notify affected individuals of any waste for which legal, safe disposal means is not available, and may refuse to pick up such materials thereafter.
6.14.1. Authorization to use radioactive materials in or on animals requires approval of the Institutional Animal Care and Use Committee in addition to authorization by RSC.
6.14.2. Quarters, caging, labeling requires approval as in 6.13.3.
6.14.3. Used cages, containers, food trays, etc. must be surveyed and found free of contamination before labeling is removed and before cages are released to Lab Animal Resources personnel.
6.14.4. Specific instructions to caretakers must be provided prior to feeding, handling, cleaning, etc. Instructions should be in writing, with a copy posted at the animal storage area.
6.15.1. Class uses require authorization in the same manner as does any other use.
6.15.2. Radiation safety training, and documentation thereof, for students must be ensured by the Program Director listed and must be approved by RSC as part of the RUA provisions.
6.15.3. Handling of radioisotopes by students must be closely supervised.
6.16.1. OSU's license and State regulations do not permit application of radioisotopes or radiation to humans unless by healing arts personnel for medical diagnosis or treatment.
6.16.2. License amendment to permit human use requires request to the RSC and request by RSC to State Radiation Protection Services, and will be handled on a case-by-case basis.