Top ten OSHA violations in the biotechnology and pharmaceutical industry

I am often asked "What are the most common OSHA violations that are cited in the biotechnology and pharmaceutical industry?" So with some research on the OSHA website, I created a list of the top ten OSHA violations for the pharmaceutical and biotechnology industry. From over 25 years of EHS auditing experience, these OSHA violations are consistent with what I’ve seen during a typical compliance audit. Here are the top ten OSHA violations:

Respiratory Protection Standard (29 CFR 1910.134)

Not surprisingly, properly maintaining a respiratory protection program is difficult work! Developing, implementing and maintaining a written program, medical qualifications, fit-testing, training, proper respirator storage, etc is tedious. It is necessary to go back and carefully review the respiratory protection standard. Are you complying with every requirement? Go to the compliance directives and make sure that you understand each of the requirements.

In addition, remember that engineering controls (i.e. containment) are to take priority and respiratory protection is only to be used when engineering controls alone are not effective at preventing exposures. If your company is handling highly potent compounds that may have occupational exposure limits (OELs) in the single ng/m3 range, it’s difficult to justify that respiratory protection alone is adequate. You must understand with a high degree of statistical accuracy what the airborne concentrations are, and determine if the protection factors of the respiratory protection being used is adequate.

Hazard Communication Standard (29 CFR 1910.1200)

Despite the fact that this standard having been around for many years, companies are still out of compliance in this area. In the pharmaceutical industry, the most common OSHA violations are failure to train employees on the specific hazards of the active pharmaceutical ingredients (APIs) that they may be handling, failure to have material safety data sheets for APIs, and improper labeling of containers or process equipment containing APIs. Just because it’s a drug ingredient doesn’t exempt it from the hazard communication standard.

Control of Hazardous Energy (lockout/tagout) (29 CFR 1910.147)

Whenever pharmaceutical manufacturing equipment such as tablet presses, v-blenders, mills, etc. are present, implementation of well thought out lockout/tagout program is a necessity. Common OSHA violations in this standard include failure to train all affected employees, failure to perform the required annual periodic inspections, and not having equipment specific lockout/tagout procedures to the detail required by the standard.

General Requirements – Machine Guarding (29 CFR 1910.212)

Tablet presses, V-blenders, packaging equipment, etc. all have some form of guarding. Frequently, operators or maintenance personnel will remove the guards to make an adjustment but fail to put them back in place once normal operation commence. This can result in a serious injury that may initiate an OSHA inspection.

General Requirements – Electrical (29 CFR 1910.303)

In this standard, common OSHA violations found during compliance audits include inadequate marking of electrical equipment, signage, and clearances around access panels.

General Requirements – Wiring Methods (29 CFR 1910.305)

The most common OSHA violation in this standard would be the use of extension cords in lieu of permanent wiring. Also, the improper use of multi-tap strips (i.e. plug strips) is often observed.

General Requirements – Walking/Working Surfaces (29 CFR 1910.22)

Inadequate clearances in hallways, aisles, and around equipment are common OSHA violations. Also, my favorite “OSHA candy” is not marking floor loads on plates where materials are stored above offices in manufacturing or warehouse areas.

Flammable and Combustible Liquids (29 CFR 1910.106)

Improper grounding, flammable liquids in non-rated containers, etc. are OSHA violations that frequently occur.

General Requirements – Personal Protective Equipment (29 CFR 1910.132)

Failure to provide and enforce the wearing of proper PPE, as well as not performing and documenting the required PPE hazard assessments are often cited.

Occupational Exposure to Hazardous Chemicals in Laboratories (29 CFR 1910.1450)

This regulation should be easy to comply with, but where I often find program gaps is where companies fail to perform an annual review of their program or fail to include procedures for approval of high hazard materials. Review the standard carefully and make sure that your chemical hygiene plan contains all the required program elements.

All of the above requirements have been around for at least 10 plus years, therefore, should not be common OSHA violations. The fact that these items are often OSHA violations points to the lack of environmental, health and safety management systems being deployed. EHS professionals in the biotechnology and pharmaceutical industry should carefully examine their programs to ensure that systems are in place to prevent the types of OSHA violations indicated above. Compliance management software is available that can make your job easier. If you have any questions or would like assistance in evaluating your environmental, health and safety program please contact me at

Published July 27, 2010