- Standard Number:
OSHA requirements are set by statute, standards and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at http://www.osha.gov.
May 18, 1998
Mr. Jack Coffey
Syncor International Corporation
6464 Canoga Avenue
Woodland Hills, CA 91367-2407
Dear Mr. Coffey;
This letter is in response to your faxed request of April 24 that we re-address how the Occupational Safety and Health Administration's (OSHA's) Bloodborne Pathogens Standard relates to unit dose radiopharmaceuticals. In our original letter to Mr. John Z. Wang of your company, we stated that the handling of these would fall strictly under the Nuclear Regulatory Commission's (NRC) Jurisdiction. Upon further discussion with the NRC and clarification from you, we have determined that several aspects of the process you have described would fall under our bloodborne pathogens standard (29 CFR 1910.1030). OSHA would have jurisdiction over any bloodborne pathogen and other employee safety issues created by handling of the syringe. The Nuclear Regulatory Commission (NRC) would retain Jurisdiction over the actual radiopharmaceuticals and their handling.
Your letter described two systems for handling radiopharmaceuticals. In the old system, the syringe is inserted directly into a lead-lead container called a "pig" which is supplied with the radiopharmaceutical. After injecting the material into the patient, the syringe is reinserted into the pig to shield employees from radiation emitted by the drug. These pigs come into direct contact with the used needle and the inside of the container would be regarded as having direct contact with blood and would fall under [1910.1030(d)(4)(iii)(A)(4)]. This paragraph states that any containers intended for reuse may not be opened, emptied or cleaned manually or in any other manner that would expose employees to the risk of percutaneous injury. A mechanical method must be in place, so that the process of removing the contaminated syringe from the pig, as well as decontamination and cleaning of the pig are engineered to eliminate any hazard to the employee. The container must also be inspected and decontaminated on a regularly scheduled basis and cleaned and decontaminated immediately or as soon as feasible upon visible contamination.
In the new system, the lead pig has a plastic insert into which the syringe is placed. A red plastic top slides over tile top of the syringe and affixes to tile lower portion of the insert creating an inner receptacle. This insert is not reused, but disposed of along with its contents. It can be removed manually as a unit with no risk of percutaneous injury. The pig, in this case, while still technically a receptacle, would need to be evaluated by the employer to determine if it does or does not have a reasonable likelihood of contamination. If it does not, then it would not have to follow a regular decontamination schedule.
In both methods, the pigs are transported in a delivery case which can hold between one and twelve pigs. To comply with the labeling requirements, the biohazard warning must be displayed on the outside of this container when the used syringes are returned to the pharmacy. The innermost container (which holds the syringe) must also be either labeled or color-coded. In the old system, the innermost container would be the pig itself In the new system, the insert would be the innermost container. Labeling the pig in the new system would not be required, if it is determined it is not contaminated during handling and when the above procedure is being followed.
We appreciate your comments and hope this information provides clarification of OSHA's position on handling syringes used for radiopharmaceuticals which might also be contaminated with blood. If you have any further questions please contact the [Office of Health Enforcement at (202) 693-2190]. Thank you for your interest in occupational safety and health.
John B. Miles, Jr., Director
[Directorate of Enforcement Programs]