Respondent owns and operates a biopharmaceutical facility that stores and uses anhydrous ammonia in parts of the storage and refrigeration process. Respondent’s storage and refrigeration process does not meet the eligibility requirements for Program 1 under 40 C.F.R. § 68.10(g) and is subject to the OSHA process safety management standard since the process involves ammonia above the threshold quantity in 29 C.F.R. § 1910.119, App. A. Therefore, Respondent’s storage and refrigeration process is subject to Program 3 pursuant to 40 C.F.R. § 68.10(i) and must meet the requirements of Program 3 set forth at 40 C.F.R. § 68.12(a) and (d).
On June 19, 2018, and July 24, 2018, representatives from EPA conducted an inspection at the facility. The purpose of the inspection was to determine whether the Respondent was complying with Section 112(r) of the Act and the Risk Management Program regulations. Based on the inspection conducted by EPA, EPA alleges that Respondent failed to comply with the Risk Management Program regulations at the facility for Program 3 requirements as set forth below:
Hazard Assessment
- The facility failed to use the most recent Census data or other updated information to estimate the population potentially affected, as required under 40 C.F.R. § 68.30(c).
- The facility failed to review and update the offsite consequence analyses at least once every five years, as required under 40 C.F.R. § 68.36(a).
- The facility failed to maintain records on the offsite consequence analyses that include for the worst-case release scenario, a description of the vessel or pipeline and substance selected as the worst case, assumptions and parameters used, and the rationale for the selection, and any anticipated effects of controls and mitigation on the release quantity and rate, as required under 40 C.F.R. § 68.39(a).
- The facility failed to maintain records on the offsite consequence analyses that include for the alternative release scenarios, a description of the scenarios identified, assumptions and parameters used, the rationale for the selection of specific scenarios, and the effects of controls and mitigation on the release quantity and rate, as required under 40 C.F.R. § 68.39(b).
- The facility failed to maintain records on the offsite consequence analyses that include the data used to estimate population and environmental receptors potentially affected, as required under 40 C.F.R. § 68.39(e).
Process Safety Information
- The facility failed to compile written process safety information including information pertaining to the equipment in the process, specifically electrical classification, as required under 40 C.F.R. § 68.65(d)(1)(iii).
- The facility failed to compile written process safety information including information pertaining to the equipment in the process, specifically relief system design and design basis, as required under 40 C.F.R. § 68.65(d)(1)(iv).
The facility failed to compile written process safety information including information pertaining to the equipment in the process, specifically ventilation system design, as required under 40 C.F.R. § 68.65(d)(1)(v).
- The facility failed to document that equipment complies with recognized and generally accepted good engineering practices, as required under 40 C.F.R. § 68.65(d)(2).
Process Hazard Analysis
- The facility failed to perform a process hazard analysis that addressed the hazards of the process, identification of previous incidents which had a likely potential for catastrophic consequences, engineering and administrative controls applicable to the hazards and their interrelationships, consequences of failure of engineering and administrative controls, stationary source siting, human factors, and a qualitative evaluation of a range of the possible safety and health effects of failure of controls, as required under 40 C.F.R. § 68.67(c).
- The facility failed to establish a system to promptly address the team’s findings and recommendations; assure that the recommendations are resolved in a timely manner and that the resolution is documented; document what actions are to be taken; complete actions as soon as possible; develop a written schedule of when these actions are to be completed; communicate the actions to operating, maintenance, and other employees whose work assignments are in the process and who may be affected by the recommendations or actions, as required under 40 C.F.R. § 68.67(e).
Operating Procedures
- The facility failed to develop written operating procedures that provide clear instructions for safely conducting activities involved in each covered process consistent with the process safety information and that address emergency shutdown including the conditions under which emergency shutdown is required and the assignment of shutdown responsibility to qualified operators to ensure that emergency shutdown is executed in a safe and timely manner, as required under 40 C.F.R. § 68.69(a)(1)(iv).
- The facility failed to develop written operating procedures that provide clear instructions for safely conducting activities involved in each covered process consistent with the process safety information and that address emergency operation, as required under 40 C.F.R. § 68.69(a)(1)(v).
Mechanical Integrity
- The facility failed to implement written procedures to maintain the ongoing integrity of process equipment, as required under 40 C.F.R. § 68.73(b).
- The facility failed to perform inspections and tests on process equipment at a frequency consistent with applicable manufacturers’ recommendations and good engineering practices, and more frequently if determined to be necessary by prior operating experience, as required under 40 C.F.R.§ 68.73(d)(3).
- The facility failed to correct deficiencies in equipment that are outside acceptable limits before further use or in a safe and timely manner when necessary means are taken to assure safe operations, as required under 40 C.F.R. § 68.73(e).
Management of Change
- The facility failed to implement written procedures to manage changes to process chemicals, technology, equipment, and procedures, as required under 40 C.F.R. § 68.75(a).
- The facility failed to assure that the procedures addressed the time period necessary for the changes, as required by 40 C.F.R. § 68.75(b)(4).
Compliance Audit
- The facility failed to promptly determine and document an appropriate response to each of the findings of the compliance audit and document that deficiencies have been corrected, as required under 40 C.F.R. § 68.79(d).
Hot Work
- The facility failed to issue a hot work permit that identified the object on which hot work is to be performed, as required by 40 C.F.R. § 68.85(b).
Emergency Response
- The facility failed to develop and implement an emergency response program that included an emergency response plan with procedures on the use of emergency response equipment and for its inspection, testing and maintenance, as required under 40 C.F.R. § 68.95(a)(2).
Risk Management Plan
- The facility failed to revise and update the RMP within six months of a change that requires a revised PHA or hazard review, as required under 40 C.F.R. § 68.190(b)(5).
Civil Penalty
The complainant has determined that an appropriate civil penalty to settle this action is $527,144.
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