June 22, 1990

Mr. Gerard L. Baril
Senior Industrial Hygienist
Lovell Safety Management Company, Inc.
161 William Street
New York, New York 10038-2607

Dear Mr. Baril:

This is in further response to your letter of April 30, requesting clarification of the Occupational Safety and Health Administration (OSHA) standard 29 CFR 1910.1450, Occupational Exposures to Hazardous Chemicals in Laboratories. You wanted to know if a pharmacy operation where cytotoxic drugs are mixed would fall under the requirement of the laboratory standard.

According to the laboratory standard, the word "laboratory" means a facility where "the laboratory use of hazardous chemicals occurs." As outlined in 29 CFR 1910.1450(a) (1), the determination of whether the laboratory standard applies is dependent on both "laboratory use" and "laboratory scale" criteria.

A pharmacy operation mixing cytotoxic drugs does not meet the "laboratory use" criteria because the operation simulates a production process. Laboratories generally have many hazardous chemicals present to which exposures are intermittent rather than a few substances to which there are regular exposures, as in the type of pharmacy you described. Because this pharmacy operation is not within the scope of coverage under the laboratory standard, your second question regarding the chemical hygiene plan would not be relevant.

OSHA has published guidelines on the handling of cytotoxic drugs entitled "Work Practice Guidelines for Personnel Dealing with Cytotoxic (Antineoplastic) Drugs." This OSHA Instruction PUB 8-1.l has been available to the public since January 29, 1986. Enclosed is a copy for your reference.

If we can be of further assistance, please do not hesitate to contact us again.

Sincerely,



Gerard F. Scannell
Assistant Secretary

Enclosure



April 30, 1990

Mr. Gerard Scannell
Asst. Secretary of Labor USDOL - OSHA
200 Constitution Avenue, NW
Washington, DC 20210

Dear Mr. Scannell:

I am writing this letter to seek clarification on the newly issued OSHA Standard 1910.1450, Occupational Exposure to Hazardous Chemicals in Laboratories.

I am seeking a clarification on the definitions of laboratory and laboratory scale. Specifically, I need to know if a pharmacy operation where cytotoxic drugs are mixed would fall under the requirements of the laboratory standard. As I interpret the definition of laboratory scale, a pharmacy involves handling of the substances which are designed to be easily and safely manipulated by one person. My interpretation is that the pharmacy does fall under the requirements of the standard.

The next question concerns subparagraph (e) chemical hygiene plan. Specifically, if the pharmacy falls under the requirements of this standard, then must that same pharmacy fall comply with the requirements of (e)(viii). These sections deal with the select carcinogen status as well as establishment of designated areas.

I look forward to your reply on this information. It is quite vital as it is my company services over 30 hospitals in the New York State area. Designation of the pharmacy as a laboratory scale operation would have a significant impact on these facilities. Thank you very much for your cooperation.

Sincerely,



LOVELL SAFETY MANAGEMENT CO., INC.

Gerard L. Baril, CIH
Sr. Industrial Hygienist

GLB/s