Text For Citation: 01 Item/Group: 001 Hazard:

OSH ACT of 1970 Section (5)(a)(1): Section 5(a)(1) of the Occupational Safety and Health Act of 1970: The employer did not furnish employment and a place of employment which were free from recognized hazards that were causing for likely to cause death or serious physical harm to employees in that employees were exposed to active pharmaceutical ingredients (APIs) which can cause illness, genetic defects and death: a) Medisca Laboratories - On or about April 16, 2014, the employer did not categorize the highly potent API to determine and provide adequate closed system containment of the powders based on the hazards and recommended exposure limits. Employees were exposed to highly potent API while repackaging the powders by scooping the material in kilogram quantities from large containers to smaller containers via open handling method. Accumulated API Powder was observed on the tables, floors, open face HEPA filtering systems, equipment, the employees? personal protective equipment, and on the exterior of the containers. The highly potent API included but was not limited to: - Lab 2C ?Diazepam. Hazards for Diazepam include but are not limited to, teratogen (damaging unborn child), mutagen (causing genetic defects), fatal if swallowed, contact with skin is toxic, and central nervous system depression. - Lab 3 ? Ketoprofen. Hazards for Ketoprofen include but are not limited to, possible teratogen (damaging unborn child) and possible mutagen (causing genetic defects). - Lab 2 ? Ketamine Hydrochloride. Hazards for Ketamine Hydrochloride include but are not limited to, possible circulatory and central nervous system damage. - Lab 3 ? Hydroquinone. Hazards for Hydroquinone include but are not limited to, possible carcinogen, possible mutagen (causing genetic defects), and sensitizer. 1) Develop and implement an active pharmaceutical powder exposure control program such as the Safebridge system, ?Occupational Health Toxicity/Potency Categorization and Handling Practices?. The program should include but not be limited to the following: Feasible abatement includes but is not limited to: 1) Develop and implement an active pharmaceutical powder exposure control program such as the Safebridge system, ?Occupational Health Toxicity/Potency Categorization and Handling Practices?. The program should include but not be limited to the following: Evaluation of API toxicity Evaluate acceptable occupational exposure levels. Evaluation of occupational exposure levels should include any regulatory established levels (OSHA), non-regulatory agencies (NIOSH), non-government professional organizations (ACGIH), and API manufacturer set levels. When there is limited or no data on occupational exposure levels for APIs, develop in-house occupational exposure limit ranges referred to as Occupational Exposure Bands (OEBs) or Control Bands. Assigning an OEB is the assignment of a compound to a hazard category that represents a range of occupational exposures and designates the correlating safe handling methods to contain the API to include engineering controls, administrative controls, and personal protective equipment. Several methods for setting OEBs are established in pharmaceutical focused journals. 2) Provide localized containment and ventilation such as a vented balance safety enclosure, isolator, or bulk powder handling enclosure to adequately capture contaminant and minimize employee exposure to below acceptable occupational exposure levels. 3) Conduct breathing zone and area air monitoring to ensure that the engineering controls contain the API to below the acceptable occupational exposure levels. 4) Develop and implement specific procedures for the handling of APIs with the engineering controls. 5) Train employees on methods to avoid unnecessary API exposure to include: Donning and doffing personal protective equipment Emergency spill mitigation techniques Decontamination procedures Waste handling Product transfer in and out of containment procedures Product transfer between container procedures 6) Establish a medical surveillance program to evaluate potential employee exposure to API. The program should include questionnaires, physical exams, baseline and frequent laboratory testing to determine potential exposure and symptoms.