Roche Carolina Incorporated - Executive Summary |
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ACCIDENTAL RELEASE PREVENTION AND EMERGENCY RESPONSE POLICIES Roche Carolina Incorporated (RCI) develops and manufactures active pharmaceutical ingredients (APIs) and is a member of the American Chemistry Council "Responsible Care Program". The RCI property is a 1,400 acre site of which approximately 120 acres have been developed for industrial use. The developed portion is located in the center of the property, ensuring a significant buffer or distance to the property boundary. RCI has implemented environmental and safety systems in order to minimize the potential release of a hazardous chemical. These systems include: a complete review and hazards analysis for all regulated processes operated on-site, detailed safety and environmental standards, a fully automated process control system (DCS) with built in safety interlocks, management of change program, pre-start up safety reviews and an on-going audit program. Prior to the start of a new process, all affected personnel are tra ined on the hazards, the safe use, storage, handling and emergency response procedures for all regulated compounds. FACILITY DESCRIPTION AND REGULATED SUBSTANCES HANDLED Manufacturing at the RCI site occurs from the Launch Bulk Manufacturing Building, which is comprised of 3 enclosed, multi-purpose production units. Support functions at the site include environmental, health and safety, maintenance, engineering, warehousing, utilities and administrative services. In January, 2001, a new pharmaceutical intermediate will be manufactured at the site. Phosphorous oxychloride (CAS# 10025-87-3) may be used in quantities in excess of the threshold quantity (5,000 pounds). Therefore, RCI is submitting a Risk Management Plan in order to satisfy all regulatory reporting requirements. As part of the Responsble Care initiative, a separate training session was given by the supplier reveiwing the hazards, safe handling, storage and emergency response procedures for this material. Phospho rous oxychloride will be received in 55 gallon polyethylene drums. Each drum will be enclosed and packaged in an 85 gallon over pack drum. The 85 gallon over pack is used for secondary containment. STATIONARY SOURCE AND ACCIDENTAL RELEASE PREVENTION OVERVIEW The drums of Phosphorous oxychloride will be transferred to the production building where the material will be charged or transferred to a 500 gallon carbon steel glass-lined feed tank. Administrative procedures are being employed to limit the amount of material charged and stored in the feed tank at any one time. When used in the process, the required amount of phosphorous oxychloride will be transferred from the feed tank to a process reactor vessel. The glass lined feed tank may contain up to 5,100 pounds of phosphorous oxychloride. Both the feed tank and the process reactor vessel are closely monitored using automatic control system software and displayed on computer terminals in the production control room. High lev el alarms and automatic shutoff controls are used in the event process parameters exceed predetermined setpoints. Each production unit includes an emergency stop, which enables a complete shutdown of the process to a fail safe state. Both vessels are protected with a sprinkler system to ensure the tanks are cooled in the event of fire impingement. WORST CASE RELEASE SCENARIO AND ATERNATIVE RELEASE SCENARIO Manufacturing operations are strategically located at the center of the property allowing for a considerable buffer to the property boundary. This significantly reduces or minimizes the impact of a chemical release to the nearby community. All hazard assessments were completed using the PHAST model - DNV Technica, Version 6.0. Worst Case Release Scenario - The worst case release scenario for the RCI site was evaluated following all Risk Management Program regulations as required by EPA. The identified worst case scenario is a rupture or failure of the glass lined feed tank containing 5,100 pounds of phosphorous oxychloride. It is assummed the material is spilled instantaneously and forms a liquid pool within the building sump. Worst case conditions using very conservative assumption include a wind speed of 1.5 m/sec, atmosphereic Stability Class F, no response from on-site emergency response personnel and no safety interlocks or devices. The worst case release scenario results in off-site phosphorous oxychloride concentrations at or above the Level of Concern (LOC) concentration of .003 mg/l. At the LOC concentration, individuals could be exposed for up to one hour without experiencing or developing irreversible or other serious health effects that could impair their abilities to take protective actions. See section 2 of the RMP submit report for more detailed information on this release scenario. Alternative Release scenario - As outlined in the RMP regulations, an alternative release scenario was evaluated to determine the distance from a more likely release of phosphorous oxychloride. Actual weather conditions and a reasonable application of safety devices and interlocks along with response by trained emergency response personnel were incorporated into this scenario. The alternative release scenario includes a leak of phosphorous oxychloride while transferring from the feed vessel to the process vessel. The planned transfer rate of the material to the process vessel is 19 pounds per minute. It is estimated that the release would occur for 15 minutes before operations and response personnel could isolate and stop the leak. The modeled release rate to the air from the pooled liquid is 1.7 pounds per minute. The PHAST model - DNV Technica, Version 6.0, was used to model the alternative release scenario. The results of the model indicate that the release for the alternate case would be contained on-site and would not have an off-site impact. See section 2 of the RMP submit report for more detailed information on this r elease scenario. GENERAL ACCIDENTAL RELEASE PREVENTION PROGRAM AND CHEMICAL-SPECIFIC STEPS RCI has implemented the Responsible Care Process Safety Code, OSHA Process Safety Management Standard and EPA's Risk Management Plan. Process hazards analysis (PHA) have been completed for all manufacturing process equipment as well as the individual batch processes introduced since start up of the facility. The Zurich risk analysis methodology is used for all manufacuring processes which exceed threshold limits. Equipment and manufacturing operating procedures are developed for all affected processes. A management of change procedure is in place and is used to ensure that all new processes or changes to existing processes are reviewed by appropriate personnel. These reviews are followed by pre-start up safety reviews and extensive training. Specific administrative procedures are being implemented to minimize the amount of phosphorous oxychloride stored and used on-site. Each 55 gallon drum of phosphorous oxychloride received on-site will be enclosed in an 85 gallon over pack drum in order to contain a leak from the inner drum. In order to minimize the impacts of a potential release, procedures have been written to ensure operating personnel monitor the transfer of phosphorous oxychloride. Emergency response procedures shall be reviewed with all affected personnel prior to start up. For additional information on the release prevention measures taken for the phosphorous oxychloride, see section 7 of the RMP submit program. FIVE-YEAR ACCIDENT HISTORY There have been no off-site accidental releases of this material. EMERGENCY RESPONSE PROGRAM RCI maintains a complete emergency response plan for all process operations and functions at the site. The purpose of the site emergency response plan is to establish actions that would be taken in the event of an emergency condition. The procedures outlined in the plan will be followed in the event of a release of a h azardous material from the RCI Site. The Incident Command System (ICS) has been established in order to provide for the orderly and consistent leadership during an emergency situation. All Hazardous Materials responders are trained to the technician Level as outlined in the OSHA Standard. In the event of a chemical release, the site maintains a hazardous materials response vehicle, which is fully equiped to respond to the types of chemicals stored and used on-site. Also, spill response supply cabinets are located throughout the process areas in order to minimize the impacts of chemical releases. PLANNED CHANGES TO IMPROVE SAFETY Roche Carolina believes continuous improvement of all environmental and safety systems is an essential function of development and manufacturing operations. RCI is a member of the American Chemistry Council Responsible Care Program. The environmental and safety programs and systems are periodically reviewed in order to continually improve performance a t the site. A complete evaluation of all new processes is completed to reduce the amount or toxicity of materials used where possible. All incidents are reported and investigated to ensure all causitive factors are identified and corrected. An extensive, ongoing training program is in place to ensure all operating personnel are familiar and knowledgeable of all environmental and safety systems. |