A pharmaceutical and chemical manufacturer and its parent company could have prevented an employee’s fatal injuries from an explosion on May 4, 2023, but lacked the required safeguards in a chemical manufacturing process. An investigation by OSHA identified numerous deficiencies in the facility’s process safety management program for highly hazardous chemicals for the production and drying of a chemical product called Dekon 139 and for combustible dust hazards. During the process, a pressure vessel exploded, causing the employee’s fatal injuries.
Specifically, OSHA investigators found that the facility did not:
- Determine the combustibility hazards of materials used in the Dekon 139 production process, exposing employees to fire and explosion hazards from combustible dust.
- Include safe upper and lower temperature limits to prevent the decomposition of Dekon 139.
- Evaluate the consequences of deviation in the Dekon 139 production process.
- Establish written procedures to maintain the ongoing integrity of process equipment and provide clear instruction on consequences of deviation from steps in the operating procedures.
- Update the process safety information to include steps to avoid consequences of deviation in temperature, properties and hazards of the chemicals used in the process.
- Update standard operating procedures for producing Dekon 139 and its safety data sheet.
- Review a November 2022 compliance audit report with all affected personnel whose job tasks are relevant to the report findings.
- Track contract employee’s injury and illnesses related to the contractor’s work in the process areas.
These conditions led OSHA to cite the facility for 11 violations, including eight serious and two repeat, and one other-than-serious. The agency assessed $298,254 in proposed penalties.
Citation 1 Item 1
Type of Violation: Serious; $15,625
OSH ACT of 1970 Section (5)(a)(1): The employer did not furnish employment and a place of employment which were free from recognized hazards that were causing or likely to cause death or serious physical harm to employees in that employees were exposed to fire and explosion hazards from combustible dust.
On or about 5/4/2023, the employer did not determine the combustibility hazards of materials used during the Dekon 139 production process such as but not limited to Unit 5: PFN2 – Drying Dekon, Unit 6 Sifting and Milling and Unit 7: Final Packaging) to protect employees from fire and explosion hazards of combustible dust.
Among other methods, one feasible and acceptable abatement method to correct these hazards are to comply with relevant provisions in NFPA 652 (2019) Standard on the Fundamentals of Combustible Dust.
Examples of such provisions include:
(1) Determine the combustibility and explosibility hazards of materials used in the Dekon 139 production process such as but not limited to Unit 5: PFN2 – Drying Dekon, Unit 6 Sifting and Milling and Unit 7: Final Packaging;
(2) Identify and assess any fire, flash fire, and explosion hazards to determine the likelihood and potential severity of a fire or explosion due combustible dust.
(3) Manage the identified fire, flash fire, and explosion hazards through risk mitigation implementation of various safeguards (management systems – engineered controls for controlling combustible dust hazards).
(4) Develop written procedures to address the hazards of combustible dust.
(5) Train all employees and contractors on the hazards of combustible dust.
(6) Conduct inspections, testing, and maintenance on all equipment affecting the prevention, control, and mitigation of combustible dust fires, deflagrations, and explosions.
(7) Ensure that equipment is maintained and operated in a manner that minimizes the escape of dust.
(8) Conduct a risk assessment to determine the risk of heat from mechanical sparks and friction, in accordance with NFPA 652 Section 9.4.12
Citation 1 Item 2
Type of Violation: Serious; $15,625
29 CFR 1910.119(f)(1): Written operating procedures providing clear instruction for conducting operations in a covered process safely and consistently with process safety information addressing all of the elements listed in 29 CFR 1910.119(f)(1)(i) through 29 CFR 1910.119(f)(1)(iv) have not been developed and/or implemented:
On or about 5/4/2023, the employer failed to implement a step in their written procedures when the PFN-2 agitator bolt was not checked for the proper tightness, as indicated on page 13 of the PFN-2 user manual as well as in step 18.4.8 in the general cleaning format procedures of the PFN-2 standard operating procedures (SOP). Implementing these steps would prevent loosening of the PFN-2 agitator bolt during operations, that could potentially cause catastrophic failure of internal components and expose employees to potential fire and explosion hazards.
Or in the alternative:
29 CFR 1910.119(j)(2): The employer did not establish written procedures to maintain the on-going integrity of process equipment.
On or about 5/4/2023, the employer did not implement written procedures to maintain the on-going integrity of the PFN-2 agitator bolt by checking the proper tightness of the bolt, indicated on page 13 of the PFN-2 user manual as well as in step 18.4.8 in the general cleaning format procedures of the PFN-2 standard operating procedures (SOP).
Citation 1 Item 3
Type of Violation: Serious; $15,625
29 CFR 1910.119(f)(1)(ii)(A): The employer did not develop and implement written operating procedures that addressed the consequences of deviations from the operating limits in the covered process;
On or about 5/4/2023, the employer did not establish written operating procedures that provided clear instruction on consequences of deviation from operations including, but not limited to, the following:
a) Written operating procedures did not address consequences of deviation for a step in the operating procedures, where vacuum pressure must be relieved to open the handway to take a sample.
b) Written operating procedures did not address consequences of deviation for a step in the operating procedures, where nitrogen pressure must be added to keep contaminants out of the vessel while taking a sample.
c) Written operating procedures did not address consequences of deviation for pressure needed during the cooling step of the Dekon 139 process.
d) Written operating procedures did not address the consequences of deviation for a step in the operating procedures, where argon was needed to inert 55-gallon drums of Dekon 139 product.
e) Written operating procedures did not address the consequences of deviation for the unexpected opening of the PFN-2 vessel discharge chute during the Dekon 139 production process.
f) Written operating procedures did not address the consequences of deviation for temperatures of the product within the PFN-2 process vessel during the Dekon 139 production process.
Citation 1 Item 4
Type of Violation: Serious; $15,625
29 CFR 1910.119(f)(1)(ii)(B): The employer did not develop and implement written operating procedures that provide clear instructions for steps required to correct or avoid deviation from the operating limits in the covered process.
On or about 5/4/2023, the employer did not establish written operating procedures that provided clear instruction on steps to correct and avoid deviations from operations including, but not limited to, the following:
a) Written operating procedures did not address steps to correct or avoid deviations for a step in the operating procedures, where vacuum pressure must be relieved to open the handway to take a sample.
b) Written operating procedures did not address steps to correct or avoid deviations for a step in the operating procedures, where nitrogen pressure must be added to keep contaminants out of the vessel while taking a sample.
c) Written operating procedures did not address steps to correct or avoid deviations for pressure needed during the cooling step of the Dekon 139 process.
d) Written operating procedures did not address steps to correct or avoid deviations for a step in the operating procedures, where argon was needed to inert 55-gallon drums of Dekon 139 product.
e) Written operating procedures did not address steps to correct or avoid deviations for the unexpected opening of the PFN-2 vessel discharge chute during the Dekon 139 production process.
f) Written operating procedures did not address steps to correct or avoid deviations for temperatures of the product within the PFN-2 process vessel during the Dekon 139 production process.
Citation 1 Item 5
Type of Violation: Serious; $15,625
29 CFR 1910.119(l)(4): Process safety information required by paragraph (d) of this section was not updated when a change covered by this paragraph resulted in a change in the process safety information.
On or about 5/4/2023, the employer did not update the process safety information to include steps to avoid consequences of deviation in temperature, properties and hazards of the chemicals used in the process, and operating procedures and safe work practices for use of the temperature probe modification on the PFN-2 vessel.
Citation 1 Item 6
Type of Violation: Serious; $15,625
29 CFR 1910.119(l)(5): The employer did not update process safety information following a change in the covered process.
On or about 5/4/2023, the standard operating procedures (SOP) for the Dekon 139 production process were not updated to include the addition of the temperature probe and related operating limits for temperature.
Citation 1 Item 7
Type of Violation: Serious; $15,625
29 CFR 1910.119(m)(6): The November 2022 Compliance Audit report was not reviewed with all affected personnel whose job tasks are relevant to the incident findings including contract employees where applicable:
On or about 5/4/2023, the employer failed to review the November 2022 Compliance Audit report with all affected personnel whose job tasks are relevant to the report findings.
Citation 1 Item 8
Type of Violation: Serious; $15,625
29 CFR 1910.1200(d)(2): Chemical manufacturers, importers, or employers classifying chemicals did not identify and/or consider the full range of available scientific literature and other evidence concerning the potential hazards.
On or about 5/4/2023, the employer did not update the Safety Data Sheet (SDS) for Dekon 139 after tests were conducted on the product to determine thermal decomposition as well as flammability.
Citation 2 Item 1
Type of Violation: Repeat – Serious; $85,938
29 CFR 1910.119(d)(2)(i)(D): Information concerning the technology of the process did not include safe upper and lower limits for such items as temperatures, pressures, flows or compositions:
On or about 5/4/2023, the employer did not include the safe upper and lower limits for temperature to prevent the decomposition of the Dekon 139 product.
Business was previously cited for a violation of this occupational safety and health standard or its equivalent standard 29 CFR 1910.119(d)(2)(i)(D), which was contained in OSHA inspection number 1463040, Citation 1, Item 1-a and was affirmed as a final order on 11/19/2020, with respect to a workplace located in Newburyport, MA.
Citation 2 Item 2
Type of Violation: Repeat – Serious; $85,938
29 CFR 1910.119(d)(2)(i)(E): The employer failed to perform an evaluation of the consequences of deviations, including those effecting the safety and health of employees.
On or about 5/4/2023, the employer did not evaluate the consequences of deviation for the Dekon 139 production process, including possible consequences such as flammable substances spilling out of the PFN-2 discharge chute unexpectedly, exposing employees to fire and explosion hazards.
Business was previously cited for a violation of this occupational safety and health standard or its equivalent standard 29 CFR 1910.119(d)(2)(i)(D), which was contained in OSHA inspection number 1463040, Citation 1, Item 1-a and was affirmed as a 29 CFR 1910.119(d)(2)(i)(D), which was contained in OSHA inspection number 1463040, Citation 1, Item 1-b and was affirmed as a final order on 11/19/2020, with respect to a workplace located in Newburyport, MA.
Citation 3 Item 1
Type of Violation: Other-than-Serious; $1,378
29 CFR 1910.119(h)(2)(vi): The employer did not maintain a contract employee injury and illness log related to the contractor’s work in process areas:
On or about May 4, 2023, the employer did not have a program in place that tracked contract employee’s injury and illnesses related to the contractor’s work in the process areas.
CLICK HERE for the citations