St. Jude Medical, Inc. - Executive Summary

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I.  Approach to Prevention of Accidental Releases 
St. Jude Medical, Inc. - Woodridge Technology Center (SJM) has adopted a comprehensive, proactive approach to preventing accidental releases of hazardous chemicals.  SJM has incorporated applicable codes related to engineering and safe handling of hazardous materials, continuous training of operators and support staff, and best safety management practices.  SJM has a comprehensive emergency response plan which includes onsite emergency coordinators and coordination with the local fire department.    
SJM qualifies for Program 3 requirements for use of methyltrichlorosilane (MTCS) under the EPA Risk Management Program.  This material is used in the manufacture of mechanical heart valves.  SJM has previously implemented a process safety management program to prevent unplanned releases of  MTCS.  The SJM Risk Management Plan (RMP) refers to the process safety management plan for information on process hazards and prevention related to MTC 
II.  Sources and Hazardous Materials  
SJM has one process which qualifies for EPA Risk Management Program requirements:  
7 The SJM coating process uses MTCS, which is a toxic and flammable liquid, and is contained in DOT specification containers (portable tanks) of 1,000 pounds each during storage and use.  A maximum of 2,000 pounds of MTCS is kept online in exhausted storage cabinets, at any one time, and a maximum of 9,000 pounds is stored adjacent to the cabinets in a ventilated and fire rated room within the facility.  The threshold quantity for MTCS is 5,000 pounds. 
III.  Offsite Consequence Analysis 
SJM has used a computer model RMP Comp for performing off-site consequence modeling.  This modeling is required by EPA to determine the endpoint or distance traveled by a chemical release from the facility, where serious injuries or illnesses from short term exposures will not occur.  The MTCS release has been modeled to determine the toxic endpoint, and the propane has bee 
n modeled to determine the flammable endpoint. The population within a circle with a radius corresponding to the endpoint distance has been determined according to EPA requirements.   
MTCS - The offsite consequence analysis includes a worst case release of MTCS from the above-mentioned storage room, inside the building.  According to EPA requirements, this release assumes that the maximum quantity of MTCS in the largest vessel (1,000 pounds), is released as a liquid under pressure over a period of 10 minutes, due to an unspecified failure, with consideration of only passive mitigation measures.  An alternative scenario is also required for MTCS, and is defined as more likely to occur than the worst case release scenario.  The alternative release scenario was based on pressurization of the MTCS tank with helium, after receipt of the tank to prevent water vapor and other contaminants from entering the tank through outlet connections.  Active mitigation measures such as secondary cont 
ainment are considered in the alternative scenario.  The distance to endpoint for the worst case MTCS release has been determined to be 0.2 miles from the Woodridge Facility.  The distance to endpoint for the alternate release scenario has been determined to be < 0.1 miles from the Woodridge Facility.  
IV.   SJM Accidental Release Prevention Program 
Since SJM has already qualified for the OSHA Process Safety Management requirements for MTCS, it has already established a process safety program for the coating process.  Key elements include: 
7 Hardware and controls installed according to required codes and best engineering practices 
7 Bulk gas isolation and control system, and gas monitoring system 
7 Process gas scrubber system 
7 Process hazard analysis has been completed for the coating process, and updates have been completed for any changes in the process   
7 Written operator procedures and annual training for each facet of the coating process, according to FDA requirements 
7 Com 
prehensive preventive maintenance program for all process and support equipment associated the with coating process 
7 Internal engineering change procedures as required by FDA and ISO 9000 requirements 
7 Pre-startup safety review by Facilities, Quality and Coating Departments on all new process equipment used in coating 
7 Employee participation in development of safety information, hazard review, and development and updating of coating procedures 
7 Accident investigation procedures 
7 Training of contractors who work on the coating process equipment in potential hazards, and use of a work authorization system for contractors working near chemical hazards 
7 Welding/Hot Work permit system 
7 Compliance audit of program every two years 
V.  5 Year Accident History 
No accidental releases of MTCS have occurred within the last 5 years. 
VI.  Emergency Response Procedures 
SJM has developed an emergency procedures manual which is distributed to all employees in the Woodridge facility.  The ma 
nual covers response to chemical spills, fires, and medical emergencies.  Employees receive annual training in emergency response and evacuation procedures including recognition of gas system alarms and appropriate response.  The Little Canada Fire Department has reviewed these emergency procedures.  SJM has onsite Emergency Coordinators who are trained to assess response situations and initiate response procedures such as shutoff of emergency systems and summoning of outside emergency responders.  These personnel carry pagers during normal non-routine working hours.  SJM will request that their emergency plan will be incorporated into the Ramsey County emergency plan. 
VII.  Planned Safety Improvements 
A process hazard analyses was completed in October 1997 for the bulk gas system featuring MTCS.  Twenty seven recommendations were identified for consideration, and all recommended actions have been evaluated and implemented as required.  Safety improvements include hazard evaluations  
prior to the construction of the newest coating module, increased emergency shutdown capability, and improved gas sensor response.
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