Text For Citation: 01 Item/Group: 002 Hazard:

29 CFR 1910.1000(e): Feasible administrative or engineering controls were not determined and implemented to achieve compliance with the limits prescribed in 29 CFR 1910.1000(a) through (d): CNC and Cleanroom Area: The employer does not ensure that feasible administrative or engineering controls are determined and implemented to prevent or reduce harmful exposures to hydrogen peroxide (HP) and acetic acid (AA), while employees clean surfaces with sporicidal disinfectants containing these chemicals. Employees are exposed in excess of the permissible exposure limits prescribed in 29 CFR 1910.1000(a) through (d): a) This violation was most recently observed beginning in the evening of January 08, 2023, extending into the morning of January 09, 2023, when an employee was exposed in excess of the cumulative exposure limit to an HP and AA mixture while cleaning the surfaces of cleanroom areas with a Spor-Klenz Ready to Use Cold Sterilant (Product Code: 6525) product. The employer did not make a determination for feasible administrative or engineering controls that would limit or reduce these exposures when an employee, who was overexposed to a mixture of HP and AA, cleaned in the following areas: 1) ISO Class 8 Exit Rooms, 2) ISO Class 8 Pre-Gown Rooms, 3) ISO Class 8 Sporicidal Sanitization Rooms 4) ISO Class 8 Pre-gown Room 232 To abate this violation, in accordance with the permissible exposure limits prescribed by the Occupational Safety and Health Administration (OSHA), the employer must ensure that feasible administrative or engineering controls are determined and implemented to reduce or eliminate exposure of hydrogen peroxide and acetic acid below a concentration of 1 ppm and 10 ppm, respectively. Controls must take into consideration workplace conditions during full-shift overnight and weekend sanitization tasks, among other possible exposure times and tasks, while cleaning takes place in the controlled not classified (CNC) area and the cleanrooms of ISO Class 5 through ISO Class 8 cleanroom areas. Prior violations referred to include an equivalent violation of this Occupational Safety and Health Standard during the following inspections: b) SCA Pharmaceuticals, LLC was previously cited for a violation of an equivalent Occupational Safety and Health Standard 29 CFR 1910.1000(a)(2), which was contained in OSHA inspection number 1402208, citation number 1, item number 2 group b, and was affirmed as a final order on October 14, 2020, with respect to a workplace located at 755 Rainbow Road, Windsor, CT 06095.