August 25, 1993

Mr. Don Reich,
Program Manager
Syncor International Corporation
20001 Prairie St.
Chatsworth, CA 91311

Dear Mr. Reich:

This is in response to your letter of July 9, regarding the Occupational Safety and Health Administration (OSHA) regulation 29 CFR 1910.1030, "Occupational Exposure to Bloodborne Pathogens." You asked several questions relative to the unit dose syringes your company delivers to hospital nuclear pharmacy departments. We will answer your questions in the order presented in your letter.

Question 1: "Do the used syringes and needles meet the definition of a contaminated sharp and/or regulated waste?"

Answer: Because the prescription-containing needles are injected into patients, the used needles would be considered contaminated sharps. All contaminated sharps and syringes are to be disposed of as regulated waste.

Question 2: "Are the handling and disposal practices of this waste regulated under 1910.1030?"

Answer: Yes, section (d)(4)(iii)(A) specifies the discarding and containment requirements for contaminated sharps. Paragraph (d)(4)(iii)(C) states that disposal of all regulated waste shall be in accordance with applicable regulations of the United States, States and Territories, and political subdivisions of States and Territories.

Question 3: "Would the generator of this waste be required to comply with the regulated waste provisions of 1910.1030?"

Answer: Yes.

Question 4: "Would the recapping of a used needle be allowed under the provisions of 1910.1030?"

Answer: Paragraph (d)(2)(vii)(A) states that contaminated needles and other contaminated sharps shall not be bent, recapped, or removed unless the employer can demonstrate that no alternative is feasible or that such action is required by a specific medical procedure. Recapping needles to be returned to the manufacturer for disposal would not qualify for either exception and would be prohibited.

Question 5: "Would the extra handling step of placing the used syringes in the DOT container and then dumping the syringes in another disposal container be allowed under the provisions of 1910.1030?"

Answer: The transfer of contaminated sharps from one container to another is not permitted under the bloodborne pathogens standard. However, sharps containers may be placed into a larger secondary container without emptying the contents.

We hope this information has been responsive to your concerns. Thank you for your interest in employee safety and health.

Sincerely,



Roger A. Clark, Director
Directorate of Compliance Programs




July 9, 1993

Laura Lewis
Industrial Hygienist
DOL-OSHA-DCP-OHCA
200 Constitution Avenue
Room N3469
Washington D.C. 20210

Dear Ms. Lewis:

Per our telephone conversation of July 9, 1993, I am writing to describe a common sharps disposal practice in nuclear medicine. I request that you can provide clarification as to the appropriateness (regulatory compliance) of several issues.

BACKGROUND

Syncor International Corp. operates 100 radiopharmacies in the U.S.. We service approximately 5000 hospitals and clinic customers and deliver approximately 15,000 unit dose syringes with attached needles on a daily basis.

Unit dose pharmaceuticals are compounded and delivered to hospital nuclear pharmacy departments. A unit dose syringe (which is a syringe and attached needle with the specific patient prescription) is delivered to our customer's in D.O.T. approved shipping containers. Traditionally, the physician or technician would inject the patient with the radiopharmaceutical and place the used syringe back in the D.O.T. shipping container. The syringes were then brought back to the Syncor pharmacy where the pig was then manually emptied into a large medical waste shipping container, accumulated and sent for disposal with a licensed transporter and disposal facility.

Recently Syncor initiated a new policy with our hospital and clinic customers which requested that they, (the generator) manage their waste in accordance with the applicable OSHA 1910.1030 regulations specifically relating to the disposal of contaminated sharps. This new policy requires that the used syringes be immediately discarded into an appropriate sharps container. (see attached article from the Journal of Nuclear Medicine, Vol. 33, No. 3, March 1992, pp. 32N-33N.)

It is Syncor's opinion that the D.O.T. transport container is not an appropriate disposal container for contaminated sharps for the following reason. 1910.1030(d)(4)(ii)(C)(4) states: reusable 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 attached article emphasizes that the risk of unnecessary handling of the used syringes is not only a hazard to employees but to the patient as well.

Would you please respond to the following questions:

Do the used syringes and needles described above meet the definition of a Contaminated Sharp and/or Regulated Medical Waste?

Are the handling and disposal practices of this waste regulated under 1910.1030?

Would the generator of this waste be required to comply with Regulated Medical Waste provisions of 1910.1030?

Would the recapping of a used needle be allowed under the provisions of 1910.1030?

Would the extra handling step of placing the used syringe in the DOT container and then dumping the syringe in another disposal container be allowed under the provisions of 1910.1030?

Syncor will never compromise the health and safety of employees or our customers. It is our intent to be compliant will all applicable regulations and to provide our customers with accurate information regarding health, safety, and environmental compliance.

I look forward to your response. Please let me know if you require additional information of if I may have the opportunity to present any further information.

Sincerely,



Don Reich
Program Manager,
Safety Quality and Regulatory