For acute in-vivo animal studies (i.e., animals sacrificed shortly after administration of the radioactive material), the PH is generally responsible for all radiation safety aspects of the procedure (e.g., post-procedure surveys, radwaste collection, etc.). The PH's permit will reflect any specific requirements or restrictions with regard to the study.
The requirements for chronic in-vivo animal studies which require the animal(s) to be housed in an "animal care facility" are more rigorous. These requirements are as follows:
- Following initial review and approval, an A-10, Precautions For Animals Containing Radioactive Materials, form will be prepared and signed by the RSO. Rules and restrictions will be specified on this form with several copies being forwarded to the PH.
- Once the animal(s) is/are administered the radioactive material, the remaining information on the A-10 form must be completed by the PH. This information generally includes:
- date and time of administration
- exposure rate at 10 centimeters and 1 meter (for gamma- and high energy beta- emitting radionuclides)
- number of animals/cage
- total activity/cage/day which would be found in any animal bedding if the radioactive material is excreted
- The PH should review Section II of the A-10 form to determine his/her responsibilities regarding routine care of the animal(s). Also, Section III of the form provides information regarding specific procedures which may be required (e.g., cage/area surveys, use of shoe covers, etc.).
- It should be noted that a new A-10 form must be affixed to each cage/pen as additional administrations of radioactive material are carried out. Additional forms will be provided by the RSO upon request. This form is valid for sixty days from the signed date on the form. After the unused forms have expired, they should be discarded and new ones should be obtained from the RSO. It should also be noted that these forms are approved specifically for the procedures which were initially reviewed and approved by the RSO. Therefore, any changes in the protocol (e.g., different radionuclide or amount administered) require an amendment, approval, and issuance of a new A-10 form by the RSO.
- When the animal(s) is/are transferred or removed from a cage and the contamination levels of the cage are found to be within acceptable limits, the completed A-10 form should be transferred to another cage along with the animal(s) or left in the animal care facility office if the animal(s) is/are either no longer radioactive or they are to be sacrificed.
- If a survey of the cage/pen is required per Section III of the A-10 form after the animal(s) is/are removed, the survey must be performed by the PH or his designee with the results recorded on an A-11, Contamination Survey For Animal Care Facilities, form. Once the survey is completed and contamination levels are within acceptable limits, the A-11 form should be attached to the A-10 form (from the cage/pen) and forwarded to the animal care facility office. The PH may be charged for the use of these cages until the animal care facility office receives the completed forms.
- If radioactivity is excreted by the animal(s), Section III of the A-10 form specifies how the excreta must be handled. In most cases, animal care personnel may dispose of the excreta. However, the PH has the following responsibilities regarding animal excreta which must be collected:
- The PH must provide the animal care facility with a solid radioactive waste disposal container, obtainable from the RSO, and a completed A-12, Log Sheet For Animal Bedding Contaminated With Radioactive Materials, form with the appropriate information completed.
- Once the disposal container is full or upon completion of the study (whichever comes first), the plastic liner must be sealed, the A-12 form placed on the container, and the container transported to the RSO by the PH or his/her designee. The RSO should be contacted prior to delivering the waste. If the animal care facility personnel are responsible for placing the contaminated bedding in the disposal container, the PH will be notified when the container is full and must remove it from the animal care facility within 48 hours of notification.
- The PH is responsible for the collection and transportation of contaminated animal excreta to the RSO if a metabolism cage is specifically required by the RSO to collect such excreta. If the PH requests the use of a metabolism cage but such cage is not required by the RSO, information will be provided on the A-10 form regarding the collection of excreta. In this situation, ultimate disposal of the contaminated excreta is still the responsibility of the PH.
Animals administered PET radiopharmaceuticals must have their cages posted with the A-10a, Precautions for Animals Containing PET Radiopharmaceuticals, form. This form may be removed and filed with the animal care center once the animal is deemed nonradioactive.
