An Overview of Setting Occupational Exposure Limits (OELs) for Pharmaceuticals - Sponsored Whitepaper

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An Overview of Setting Occupational Exposure Limits (OELs) for Pharmaceuticals Robert H. Ku, Ph.D., CIH, Principal Toxicologist [Published in Chemical Health & Safety, January/February 2000]

Setting appropriate occupational exposure limits is an integral component in assuring the health and safety of workers

Introduction Occupational exposure limits (OELs) 1 for the protection of workers have been around at least since 1939 when the National (later changed to American) Conference of Governmental Industrial Hygienists (ACGIH) published its inaugural acceptable workplace exposure limits (now known as threshold limit values, or TLVs). In 1970, the U. S. Occupational Safety and Health Act incorporated by reference the 1968 ACGIH TLVs as enforceable limits. The Occupational Safety and Health Administration (OSHA) refers to these enforceable limits as permissible exposure limits (PELs).

Most TLVs and PELs are for commonly used industrial chemicals where a large number of workers potentially may be exposed. Very few pharmaceuticals fit this description, hence, very few pharmaceuticals are on ACGIH's list of TLVs or OSHA's list of PELs. Since adhering to OELs is considered an effective and proven way to protect workers from developing deleterious health effects caused by chemicals, many pharmaceutical companies have opted to determine OELs for their drug substances for internal use.

OELs, if appropriately determined and periodically monitored for in the workplace air, would offer a first line indication of whether exposures are acceptable or not. The challenge to toxicologists and other health professionals involved in setting OELs is to determine a value that has an adequate margin between a level that produces undesired health effects and one that does not. This is the safety margin. If an OEL is set with an inordinately large safety margin, then valuable resources may be expended unnecessarily in the form of extensive engineering containment equipment or overly protective personal protective equipment. If an OEL is set too high, then employee health may be compromised. This article provides an overview of how OELs have been determined historically, new approaches that are on the horizon, and approaches that are unique to pharmaceuticals.
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