October 29, 1996

Mr. John Z. Wang
Corporate Attorney
Syncor International Corporation
20001 Prairie Street
Chatsworth, California 91311

Dear Mr. Wang:

This is in response to your letters of August 9, and the April 9, from Mr. Haig S. Bagerdjian concerning the status of a request for clarification of the Occupational Safety and Health Administration's (OSHA) Bloodborne Pathogens Standard (29 CFR 1910.1030) as it relates to syringes and needles contaminated with both a bloodborne pathogen and radioactive nuclear medicine. The primary question related to OSHA's jurisdiction over nuclear medicine, and the remaining questions were a followup based on the assumption that OSHA has jurisdiction. Please accept our regret in the delay in responding to your inquiry.

The Nuclear Regulatory Commission (NRC) has jurisdiction over the disposal of syringes and needles containing a mixed waste. The NRC and OSHA have jurisdiction over occupational safety and health at NRC-licensed facilities. OSHA and the NRC have a memorandum of understanding (MOU) that delineates the general areas of responsibility of each agency. The intent of the MOU was to minimize duplication of regulation and efforts. Each agency has its place in worker protection. NRC typically covers hazards associated with the following: radiation risk produced by radioactive materials; chemical risk produced by radioactive materials; and facility conditions which affect the safety of radioactive materials and thus present an increased radiation risk to workers. OSHA typically covers hazards associated with "facility conditions which result in an occupational risk, but do not affect the safety of licensed radioactive materials." Therefore, NRC has jurisdiction over the conditions and practices that affect the safety of licensed radioactive materials. In the case of syringes contaminated with a mixed waste, such as radioactive materials and bloodborne pathogens, if the components are covered by the NRC license, OSHA does not have jurisdiction.

Thank you for the information that you provided on the development of the "New System." OSHA does not have procedures to review and approve devices. Based on our understanding of the "New System" use in the workplace, the plastic insert appears to be an effective method to contain both the biological and radioactive wastes contained in the syringe. We appreciate your comments and hope this information provides clarification of OSHA's position.

Should you have further questions please contact Tom Galassi at (202) 219-8036. Thank you for your interest in occupational safety and health.

Sincerely,



Ruth McCully, Director
Office of Health Compliance Assistance




August 9, 1996

Ms. Ruth McCulley Director
Compliance Programs DOL-OSHA
Office of Health Compliance Assistance
200 Constitution Avenue, N.W.
Washington, DC 20210

Re: Copy of Letter Dated April 9, 1996 (Request for Clarification of Bloodborne Pathogen Standard)

Dear Ms. McCulley:

Enclosed is a letter we originally sent to Ms. Susan Harwood of you agency. We only recently learned that your office has no record of this, probably for obvious reasons. We convey our condolences on Ms. Harwood's passing.

As we remain very interested in presenting our opinion on the above issue, please accept this second copy of that same letter dated April 9, 1996 for due consideration.

If you have any questions concerning the foregoing, please telephone me at (818) 717-4579.

Very truly yours,



John Z. Wang
Corporate Counsel




April 9, 1996

Ms. Susan Harwood
Director of Risk Assessments
United States Department of Labor OSHA
Room N3718
200 Constitution Avenue, N.W.
Washington, DC 20210

Re: Request For Clarification of Bloodborne Pathogen Standard

Dear Ms. Harwood:

I am writing to request a clarification of several provisions of the bloodborne pathogen standard. My questions arise out of actual situations and conditions faced by Syncor International Corporation and its customers. For that reason, some background information relating to Syncor and how it conducts the relevant part of its business will be helpful.

Syncor operates 120 centralized nuclear pharmacies in the United States which dispense over 55% of all of the diagnostic radioactive drugs used in the nation. Most of these drugs are dispensed in a syringe equipped with a needle (the syringe and needle combination is referred to simply as a "syringe" throughout the rest of this letter). Syncor provides hospitals and clinics with single patient doses of radioactive drugs already measured and contained in a syringe. As part of our services, we deliver syringes filled with single patient doses of medicine. We then routinely pick up the empty syringes and return them to our pharmacies for proper disposal. In general outline, this practice is followed throughout the industry, by both Syncor and other providers.

The bloodborne pathogens standard is implicated, of course, in those parts of this practice which involve the emptied syringe -- both at the patient site, immediately after injection of the radioactive drug, and when handled by Syncor (or other pharmacies) thereafter. It is, therefore, necessary to explain the system used by Syncor to transport both the full and emptied syringe and to explain the prior system once used by Syncor.

In 1993, as part of its continuing efforts to protect the safety of its employees and its customers, Syncor began using a new system for transporting syringes to and from its customers. I will describe that system in detail below. The old system is of importance, however, because it highlights certain changes we have made. In addition, this "old" system is still used by other suppliers of nuclear medicines today.

I have enclosed two heavy lead containers known as "pigs". Pigs are used in the industry to contain syringes of nuclear medicine. (Please note that both of the enclosed pigs contain an empty syringe. Both pigs are clean and uncontaminated and neither syringe has ever been used or contained any nuclear medicine.) The white pig is labeled "Old Style Pig" and is the type of container used by Syncor prior to 1993 and still used by other providers in the market. The second container is gray and is labeled "New Style Pig With Insert". Both pigs are constructed of lead and provide protection against radioactivity. There is no need to return either pig to us. They are enclosed for your reference.

Under the old system, a syringe is filled at the pharmacy and then capped. They capped syringe is then placed directly in the old style pig and the pig is closed. This pig is then transported to the hospital or clinic. The pig is designed to be portable so that it can be brought directly to the patient. The pig is then opened and the medicine administered.

Once the syringe is emptied, it is, of course, at least potentially contaminated with blood. The emptied syringe is then simply placed into the pig and the pig is again closed. As you can see from reviewing the "Old Style Pig", the pig and the used syringe are in direct contact at this point in the process. The pig is then picked up by the supplier and returned to the pharmacy. At the pharmacy, an employee unscrews the top of the pig and empties its contents into a radioactive waste bin. This practice does expose employees to some risk of being pricked by the syringe.(1) The empty pig is then cleaned and reused.

________
FOOTNOTE(1)  In the past, when Syncor was using this old system, we noted
that some syringes were recapped by the doctor or nurse before being placed
back into the pig.  Syncor recognizes that this is an improper practice by
the medical provider.  Following proper practice, however, does result in the
employee who empties the pig at the pharmacy being exposed to uncapped
needles.

Recognizing that this old system could be improved upon, Syncor developed and now utilizes a new system of pig. The new pig is larger than the old style. This was done for two reasons. One, the pig is now more stable when placed in an upright position. Two, the added space allows us to use a plastic insert in the pig which, as I will discuss below, provides several important benefits. A review of the enclosed pig labeled "New Style Pig" will show just how the plastic insert is used.

Under Syncor's new system (which is not used by other providers in the industry), the plastic insert is placed in the pig. A filled, sterile syringe is then placed inside the insert and the pig is closed, ready for transport to the hospital or clinic. At this point in the process, the red "BIOHAZARD" cap is not on the insert. The needle is sterile and there is no biohazard. The red "BIOHAZARD" caps are provided to our customers in bulk for use later in the process.

After the filled syringe is placed in the plastic insert and the pig is closed, the pig is then transported to the hospital or clinic where it, like the old style pig, can be carried directly to the patient. The care provider then administers the medicine. The used syringe is then placed back into the plastic insert which remains nestled in the pig. The syringe should not be recapped, of course, and there is no need for, or advantage to, recapping under this new system. As I mentioned earlier, red BIOHAZARD caps are supplied in bulk to our customers. A cap is next placed on the plastic insert. As you can see from inside the enclosed new style pig, the cap is secured to the insert by a double-locking device. Once the cap is on the insert, the pig is then closed.

As in the old system, Syncor picks up the pig from its customer and returns it to Syncor's pharmacy. At this point, the new system again differs from the old. Instead of opening the pig and emptying the syringe itself into a radioactive waste bin, our employee opens the new pig and deposits the entire plastic insert, along with its contents, into a radioactive waste bin. The plastic insert is not reused and is never opened or emptied. Our employee is not exposed to any contaminated needles.

Another advantage to our new system as compared to our old system is that the contaminated needle never comes into contact with the pig itself. While the old style pig acts as the "container" for the contaminated needle, in the new system, the plastic insert acts as the container. The pig is merely a means of transport, as well as providing protection against radioactivity.

In the context of both the old and new systems described above, Syncor requests interpretations of the bloodborne pathogens standard. Our first question is a threshold question of jurisdiction:

1. The contaminated syringe and, under the old system, the pig itself is a mixed waste, both radioactive and biohazard. Section 4(b)(1) of the Occupational Safety and Health Act provides that the Act shall not apply to conditions with respect to which other agencies exercise authority. The Nuclear Regulatory Commission (or NRC) does regulate and inspect the operations of nuclear pharmacies. See, e.g., 10 CFR Part 20. Given the fact that the NRC does exercise authority over the contaminated syringes, does OSHA have jurisdiction to enforce the bloodborne pathogen standard as to the conditions described in this letter?

2. If OSHA has retained jurisdiction, how does Section 1910.1030(d)(4)(ii)(C) apply to the two systems described above? That section requires that all receptacles intended for reuse "which have a reasonable likelihood for becoming contaminated with blood or [OPIM] shall be inspected, decontaminated, ...." This section would appear to apply to the old style pigs previously used by Syncor and still used by other providers in the industry. These pigs come into direct contact with blood or OPIM and they are intended for reuse. As a result, under the concept of universal precautions, is it correct, as we believe, that these pigs must be handled as if they were contaminated with blood or OPIM?

Does the section apply to the new system? While the plastic insert does come into contact with blood or OPIM, it is not reused, but disposed of along with its contents. The new style pig is, of course, reused, but the insert prevents contact between the pig and blood or OPIM.

In other words, we would interpret this section of the standard as it applies to the two systems described above in this way: Under the old system, the pig is a "receptacle" intended for reuse which does come into contact with blood or OPIM and does, therefore, have a "reasonable likelihood of becoming contaminated". It must be handled using universal precautions. Under the new system, the pig is not a "receptacle" within the meaning of this section, only the plastic insert is the receptacle and the insert is not reused. Alternatively, the pig, even if technically a "receptacle", is not reasonably likely to become contaminated because of the use of the plastic insert so that universal precautions are not necessary in the handling of the new pig. Is this consistent with OSHA's interpretation of the standard?

3. Again, assuming that OSHA has jurisdiction, how does Section 1910.1030(d)(4)(iii)(A) apply to the two systems described above? For clarity, I will discuss the relevant subsections of this provision:

a. Subsection 1 requires contaminated sharps to be discarded immediately in containers which are "closeable", "puncture resistant", "leakproof on sides and bottom" and properly "labeled or color-coded".

Certainly the old system appears to satisfy the first three of these requirements. The old style pig (as well as the new pig) is closeable, puncture resistant and leakproof on sides and bottom; but it is not labeled or color-coded. Does this subsection apply to the container into which the contaminated syringe is immediately placed at the place where the medicine is administered? Under the old system, this would be the pig itself. Our question is whether the old style pig has to be labeled or color coded as a biohazard.

Under the new system used by Syncor, the "container" into which the contaminated syringe is placed is the plastic insert onto which the red BIOHAZARD cap is placed. This insert is, of course, closeable, puncture resistant, leakproof on sides and bottom and is both labeled and color-coded. The insert appears to satisfy the requirements of this subsection, assuming it applies in this setting. Is Syncor's new procedure consistent with the subsection's requirements?

b. Subsection 4 states that "[r]eusable containers shall not be opened, emptied or cleaned manually or in any other manner which would expose employees to the risk of percutaneous injury". The old style pig appears to be a "reusable container" which comes into direct contact with the contaminated needle. When it is opened and emptied the employee faces a direct risk of exposure to the needle. Is the old system consistent with the requirements of this section?

As we interpret the standard, the new system places the needle in a non-reusable container, i.e., the plastic insert which is not reused, must less emptied or cleaned. The new style pig is certainly a container in the ordinary sense of the word, but is it a container within the meaning of this subsection? It contains the plastic insert and does not come into contact with the contaminated needle. Further, because the needle is completely contained within the insert there is no exposure to percutaneous injury when the outer pig is opened. Is this consistent with OSHA's interpretation of the Standard?

Syncor has devoted great attention and resources to the issues raised here and to our efforts to protect our employees and to create a system which will protect the medical providers also. Syncor strongly believes that its new system is the best available by providing the maximum protection of safety and health. Because of the resources devoted to this project, we would appreciate your attention to the issued raised in it.

Sincerely,



Haig S. Bagerdjian
Vice President and General Counsel