Checklist for Compliance with §5204: Respirable Crystalline Silica in Pharmaceutical Manufacturing

Ensuring compliance with OSHA's §5204 regulation on respirable crystalline silica is critical in the pharmaceutical manufacturing sector. This checklist is designed to guide your organization through the necessary steps to achieve and maintain compliance, keeping your workforce safe and your operations running smoothly.

Understanding §5204 Requirements

§5204 sets forth specific exposure limits and control measures to protect workers from the hazards of respirable crystalline silica. In pharmaceutical manufacturing, silica exposure can occur during various processes, including tablet production and handling of raw materials. Understanding these requirements is the first step towards compliance.

Conducting Exposure Assessments

Regular exposure assessments are crucial. I recommend starting with a baseline assessment to identify areas where silica levels may exceed the permissible exposure limit (PEL). Use certified industrial hygienists for accurate measurements and analysis. Keep detailed records of these assessments to demonstrate compliance during inspections.

Implementing Engineering Controls

Where exposure exceeds the PEL, engineering controls must be implemented. This might include installing local exhaust ventilation systems or using wet methods to control dust. From my experience, investing in these controls not only helps in compliance but also improves overall air quality in the facility.

Providing Respiratory Protection

When engineering controls are not sufficient, respiratory protection becomes necessary. Ensure that all affected employees are fitted with appropriate respirators, and that a comprehensive respiratory protection program is in place, including training, fit testing, and maintenance.

Offering Training and Education

Training is non-negotiable. All employees who may be exposed to respirable crystalline silica need to understand the hazards, the control measures in place, and their responsibilities under §5204. Regular refresher courses should be part of your safety training program to keep everyone up-to-date.

Establishing a Medical Surveillance Program

A medical surveillance program is required for employees who are exposed above the action level for 30 or more days per year. This program should include initial and periodic medical examinations to monitor the health of your workers. Based on available research, early detection through such programs can significantly mitigate the risks associated with silica exposure.

Maintaining Records and Documentation

Compliance with §5204 also involves meticulous record-keeping. Maintain records of exposure assessments, engineering controls, respiratory protection programs, training sessions, and medical surveillance. These records are not just for regulatory compliance; they are invaluable for continuous improvement of safety protocols.

Regular Review and Audits

Finally, regular reviews and audits of your silica control program are essential. These should be conducted by internal safety teams or external consultants to ensure that all aspects of the §5204 compliance are being met. We've found that proactive audits can prevent potential non-compliance issues before they arise.