OSHA Inspection: SCA PHARMACEUTICALS, LLC

Issued

May 14, 2018

Abate by

Jan 10, 2019

Penalty

Initial $11,086 · Current $11,086

General-duty citation text

29 CFR 1910.132(d)(1)(i): The employer did not select and have each affected employee use, the types of personal protective equipment that would protect the affected employee(s) from the hazards identified in the hazard assessment:    Clean Room Lab;    On or about 11/21/17, the employer did not select the appropriate ppe to protect employees from the hazards of using Peridox, a cleaning chemical containing hydrogen peroxide and peracetic acid, to sanitize the clean room.  The material is corrosive to the skin and eyes and can cause burns. Inhalation can cause respiratory irritation and shortness of breath.

Issued

May 14, 2018

Abate by

Jan 10, 2019

Penalty

Initial $0 · Current $0

General-duty citation text

29 CFR 1910.132(f)(1)(iv): Employee(s) required to use PPE by this section were not trained to know the limitations of PPE:      Clean room;     On or about 11/21/17, the employer did not provide training in the limitations of the ppe provided to employees using Peridox, a cleaning chemical containing hydrogen peroxide and peracetic acid, to sanitize the clean room.  The material is corrosive to the skin and eyes and can cause burns. Inhalation can cause respiratory irritation and shortness of breath. Provided PPE includes skin protection, eye protection and respiratory protection.

Issued

May 14, 2018

Abate by

Jan 10, 2019

Penalty

Initial $11,086 · Current $11,086

General-duty citation text

29 CFR 1910.134(c)(1): A written respiratory protection program that included the provisions in 29 CFR 1910.134(c)(1)(i) - (ix) with worksite specific procedures was not established and implemented when respirators were necessary to protect the health of the employee:    Clean room;     On or about 11/21/17, the employer did not establish a written respiratory protection program to address respirator use for the hazards of using Peridox. Peridox is a cleaning chemical containing hydrogen peroxide and peracetic acid, to sanitize the clean room.  Inhalation can cause respiratory irritation, shortness of breath and mucous/fluid in the respiratory tract and lungs. The manner and quantity in which the material is used has resulted in an overexposure at a level that is four times the permissible exposure level of 1.4 mg/m3. A respiratory protection program was not established for respirator use in two instances:   1.    Employees were provided N95 and R95 respirators for use after initial complaints.   2.    Employees were later provided PAPR respirators with combination cartridges to address overexposures.

Issued

May 14, 2018

Abate by

Jan 10, 2019

Penalty

Initial $0 · Current $0

General-duty citation text

29 CFR 1910.134(d)(1)(i): Selection of appropriate respirators was not based on the respiratory hazard(s) to which the worker was exposed and user factors that affect respirator performance and reliability:    Clean room;    On or about 11/21/17, the employer did not provide the appropriate respiratory protection to employees using Peridox. Peridox is a cleaning chemical containing hydrogen peroxide and peracetic acid, to sanitize the clean room.  The respirators provided were N95 and R95 filtering facepiece masks for use with particulate hazards, but not for acid vapors and mists. Inhalation can cause respiratory irritation, shortness of breath and mucous/fluid in the respiratory tract and lungs. The manner and quantity in which the material is used has resulted in an overexposure at a level that is four times the permissible exposure level of 1.4 mg/m3.

Issued

May 14, 2018

Abate by

Jan 10, 2019

Penalty

Initial $0 · Current $0

General-duty citation text

29 CFR 1910.134(d)(3)(iii)(B)(2): The employer did not implement a change schedule for respirators not equipped with an End of Service Life Indicator that would ensure cartridges were changed before the end of their service life    Clean room;    On or about 2/2/18, the employer did not provide a change schedule for PAPR respirators used for the hazards of using Peridox. Peridox is a cleaning chemical containing hydrogen peroxide and peracetic acid, to sanitize the clean room.  Inhalation can cause respiratory irritation, shortness of breath and mucous/fluid in the respiratory tract and lungs. The manner and quantity in which the material is used has resulted in an overexposure at a level that is four times the permissible exposure level of 1.4 mg/m3.

Issued

May 14, 2018

Abate by

Jan 10, 2019

Penalty

Initial $0 · Current $0

General-duty citation text

29 CFR 1910.134(e)(1): The employer did not provide a medical evaluation to determine the employee's ability to use a respirator, before the employee was fit tested or required to use the respirator in the workplace:    Clean room;    On or about 11/21/17, the employer did not provide a medical evaluation for employees using respiratory protection for the hazards of Peridox, a cleaning chemical containing hydrogen peroxide and peracetic acid, to sanitize the clean room.  Employees were wearing N95 and R95 tight-fitting filtering facepiece respirators.

Issued

May 14, 2018

Abate by

Jan 10, 2019

Penalty

Initial $0 · Current $0

General-duty citation text

29 CFR 1910.134(f)(1): The employer did not ensure that employee(s) using a tight-fitting facepiece respirator passed the appropriate qualitative fit test (QLFT) or quantitative fit test (QNFT):    Clean room;    On or about 11/21/17, the employer did not provide a qualitative or quantitative respirator fit test to employees wearing a tight-fitting N95 and R95 filtering facepiece respirators for the hazards of using Peridox. Peridox is a cleaning chemical containing hydrogen peroxide and peracetic acid, to sanitize the clean room.  Inhalation can cause respiratory irritation, shortness of breath and mucous/fluid in the respiratory tract and lungs.

Issued

May 14, 2018

Abate by

Jan 10, 2019

Penalty

Initial $0 · Current $0

General-duty citation text

29 CFR 1910.134(k)(1): The employer did not provide respirator training that ensured that each employee could demonstrate knowledge of at least the following elements: Why the respirator is necessary and how improper fit, usage, or maintenance can compromise the protective effect of the respirator; What the limitations and capabilities of the respirator are; How to use the respirator effectively in emergency situations, including situations in which the respirator malfunctions; How to inspect, put on and remove, use, and check the seals of the respirator; What the procedures are for maintenance and storage of the respirator, and How to recognize medical signs and symptoms that may limit or prevent the effective use of respirators:    Clean room;    On or about 11/21/17, the employer did not provide respirator training to employees provided respirators for protection while using Peridox. Peridox is a cleaning chemical containing hydrogen peroxide and peracetic acid, used to sanitize the clean room.  Inhalation can cause respiratory irritation, shortness of breath and mucous/fluid in the respiratory tract and lungs. The manner and quantity in which the material is used has resulted in an overexposure at a level that is four times the permissible exposure level of 1.4 mg/m3.  1.    Employees were initially provided N95 and R95 filtering facepiece respirators .  2.    Employees were later provided PAPR respirators with combination filters.

Issued

May 14, 2018

Abate by

Jan 10, 2019

Penalty

Initial $0 · Current $0

General-duty citation text

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):    Clean room;    On or about 12/11/17, the employer did not implement feasible administrative or engineering controls to protect employees from exposure to Peridox RTU. The employees cleaning/sanitizing the clean room with Peridox RTU were exposed to an airborne concentration of hydrogen peroxide of up to 5.7 mg/m3, which is 4.07 times the permissible exposure limit of 1.4 mg/m3.

Issued

May 14, 2018

Abate by

Jan 10, 2019

Penalty

Initial $11,086 · Current $11,086

General-duty citation text

29 CFR 1910.138(b): The employer did not base selection of appropriate hand protection on an evaluation of the performance characteristics of the hand protection relative to the tasks to be performed, conditions present, duration of use, and the hazards and potential hazards identified:    Clean room;    On or about 11/21/17, the employer did not select appropriate hand protection for the employees using isopropyl alcohol and Peridox, a cleaning chemical containing hydrogen peroxide and peracetic acid, to sanitize the clean room.  Peridox is corrosive to the skin and can cause burns.

Issued

May 14, 2018

Abate by

Jan 10, 2019

Penalty

Initial $11,086 · Current $11,086

General-duty citation text

29 CFR 1910.151(c): Where employees were exposed to injurious corrosive materials, suitable facilities for quick drenching or flushing of the eyes and body were not provided within the work area for immediate emergency use:    Clean room;    On or about 11/21/17, the employer did not provide a suitable eye wash or safety shower for employees using Peridox, a cleaning chemical containing hydrogen peroxide and peracetic acid, to sanitize the clean room.

Issued

May 14, 2018

Abate by

Jan 10, 2019

Penalty

Initial $11,086 · Current $11,086

General-duty citation text

29 CFR 1910.1200(e)(1): The employer did not develop and implement at the workplace a written hazard communication program which describes how the criteria specified in 29 CFR 1910.1200(f), (g), and (h) will be met:    Clean room;    On or about 11/21/17, the employer did not implement a written hazard communication program to address the hazards of using chemicals, including but not limited to, Peridox, prior to their use. Peridox is a cleaning chemical containing hydrogen peroxide and peracetic acid, used to sanitize the clean room.  Hazards include eye and skin burns,  respiratory irritation, shortness of breath and mucous/fluid in the respiratory tract and lungs.

Issued

May 14, 2018

Abate by

Jan 10, 2019

Penalty

Initial $0 · Current $0

General-duty citation text

29 CFR 1910.1200(g)(8):   The employer did not ensure that Safety Data Sheets were readily accessible during each work shift to employees when they were in their work area(s)    Clean room;    On or about 11/21/17, the employer did not make safety data sheets readily available to employees cleaning the clean room. The cleaning employees regularly worked with Peridox and isopropyl alcohol.  Peridox is a cleaning chemical containing hydrogen peroxide and peracetic acid, used to sanitize the clean room.  Hazards include eye and skin burns,  respiratory irritation, shortness of breath and mucous/fluid in the respiratory tract and lungs.

Issued

May 14, 2018

Abate by

Jan 10, 2019

Penalty

Initial $0 · Current $0

General-duty citation text

29 CFR 1910.1200(h)(1): Employees were not provided effective information and training on hazardous chemicals in their work area at the time of their initial assignment and whenever a new hazard that the employees had not been previously trained about was introduced into their work area:    Clean room;    On or about 11/21/17, the employer did not provide hazard communication training to employees using Peridox and isopropyl alcohol. Peridox is a cleaning chemical containing hydrogen peroxide and peracetic acid, used to sanitize the clean room.  Hazards include eye and skin burns,  respiratory irritation, shortness of breath and mucous/fluid in the respiratory tract and lungs.

Issued

May 14, 2018

Abate by

Jun 29, 2018

Penalty

Initial $110,856 · Current $11,086 Reduced

General-duty citation text

29 CFR 1910.1000(a)(2): Employee(s) were exposed to an airborne concentration of hydrogen peroxide listed in Table Z-1 in excess of the 8 hour Time Weighted Average concentration of 1.4 mg/m3:    Clean room;    On or about 12/11/17, employees cleaning/sanitizing the clean room were overexposed to an airborne concentration of hydrogen peroxide in four instances. The 8-hr TWA exposure for each of the employees sampled are as follows:     A. 5.66 mg/m3, 4.04 times the permissible exposure limit of 1.4 mg/m3  B. 5.34 mg/m3, 3.81 times the permissible exposure limit of 1.4 mg/m3  C. 5.7 mg/m3,  4.07 times the permissible exposure limit of 1.4 mg/m3  D. 5.04 mg/m3, 3.6 times the permissible exposure limit of 1.4 mg/m3

Issued

May 14, 2018

Abate by

Jan 10, 2019

Penalty

Initial $5,544 · Current $5,544

General-duty citation text

29 CFR 1910.1020(e)(1)(i): When an employee or designated representative requested access to a record, the employer did not ensure that access was provided in a reasonable time, place, and manner:    Clean room;    On or about 2/6/18, the employer did not provide exposure records for monitoring performed on 11/20/17, 12/4/17 and 12/11/17 to exposed employees who had requested them.