Mallinckrodt Inc. - Executive Summary

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At the Mallinckrodt Pharmaceutical Plant in Raleigh, Wake County, North Carolina, we are committed to operating and maintaining all of our processes (especially those using hazardous substances) in a safe and responsible manner.  We use a combination of accidental release prevention programs and emergency response planning programs to help ensure the safety of our employees and the public as well as protection of the environment.  This document provides a brief overview of the comprehensive risk management activities that we have designed and implemented, including: 
*  A description of our facility and use of substances regulated by EPA's RMP regulation 
*  A summary of results from our assessment of the potential off-site consequences from accidental chemical releases 
*  An overview of our accidental release prevention programs 
*  A five-year accident history for accidental releases of chemicals regulated by EPA's RM 
P rule 
*  An overview of our emergency response program 
*  An overview of planned improvements at the facility to help prevent accidental chemical releases from occurring and adversely affecting our employees, the public, and the environment 
*  The certifications required by EPA's RMP rule 
*  The detailed information (called data elements) about our risk management program 
Our facility produces para-aminophenol and acetaminophen using a variety of chemicals and processing operations.  Acetaminophen is a pain-relief medication for use by the pharmaceutical industry.  In our processes, we use the following chemicals that EPA has identified as having the potential to cause off-site consequences in the event of a substantial accidental release: 
Anhydrous Ammonia:  Anhydrous Ammonia is used as a neutralizer for an acidic phase in one of our process steps for manufacturing para-aminophenol.  [Subject to Program Level 3.] 
Hydrogen:  Hydrogen is used in the hydrogenation phase of one of our process steps for manufacturing para-aminophenol.   The process is very similar to the hydrogenation processing step used to make salad dressing or mayonnaise by food manufacturers.  [Subject to Program Level 1.] 
Our accidental release prevention programs and our contingency planning efforts help us effectively manage the hazards that could potentially be posed to our employees, the public, and the environment if one of these were mishandled or otherwise involved in an accident. 
EPA's RMP rule requires that we provide information about the worst-case release scenarios and alternative release scenarios for our facility.  The following are brief summaries of these scenarios, including information about the key administrative controls and mitigation measures to limit the exposure distances for each scenario: 
Worst-case Release Scenario - Regulated Toxic Chemical - Anhydrou 
s Ammonia 
The worst case release scenario is considered to be a catastrophic failure of one of the anhydrous ammonia storage tanks with its maximum allowable inventory (146,880 pounds).  In accordance with EPA regulations, it is assumed that the entire contents release within 10 minutes and all of the liquid ammonia will vaporize immediately.  The resultant plume from this event must be assumed to disperse downwind under meteorological conditions which will result in the greatest distance to the 14 mg/l toxic endpoint.  The estimated distance to this toxic endpoint using these assumptions is 5.4 miles from the tank.  The off-site impact would affect downwind receptors. 
The worst-case plume is a pie-wedge shape about 200 feet wide that would move in the direction of the wind.  We include all potential receptors within the circle of 5.4 mile-radius around the plant: 
Approximately 58,000 persons in private residences 
Various churches/places of worship 
Various public/private schools  
rious commercial, office, and industrial buildings 
Holly Hill/Charter Behavioral Health System (hospital) 
Several nursing homes/assisted living centers  
Falls Lake State Park 
The Neuse River 
Several city/county parks and recreational areas 
After completion of our ammonia safety project, each storage tank will be located within a dike which would contain the liquid pool formed during a catastrophic failure of a tank.  A water deluge system around the ammonia tanks will be available, in addition to the sites existing fire water system, to mitigate such an incident.  Specific operating procedures, extensive training, plus a program of periodic inspection and preventive maintenance helps minimize the likelihood of this event.  In addition, the anhydrous ammonia tanks will be equipped with ammonia leak sensors, high liquid level alarms, and high pressure alarms for early detection of a problem with the tank system.  Also, ammonia leak sensors and water deluge systems are being installed a 
t the ammonia unloading station and at the ammonia vaporizers. 
Alternative Release Scenarios - Regulated Toxic Chemical - Anhydrous Ammonia 
The alternative scenario is the rupture of a 2-inch liquid ammonia transfer line releasing 78 pounds of ammonia.  The quantity would be limited to this amount because of the presence of excess flow valves located throughout the liquid lines.  The analysis of the dispersion of the resultant vapor cloud was conducted using typical meteorological conditions for the Raleigh area.  The distance to the toxic endpoint is 0.18 mile and there would be no off-site impact. 
The ammonia sensors and remotely actuated water deluge systems which are being installed around the storage tanks, the truck unloading station, and the ammonia vaporizer shed will reduce the likelihood and duration of this potential event and reduces the potential impact of any ammonia release from the process.   The fact that the liquid lines are located in either low-traffic or no-traf 
fic areas also reduces the likelihood of this potential event. 
Worst-case Release Scenario - Regulated Flammable Chemical - Hydrogen 
The worst case scenario is a vapor cloud explosion following the catastrophic failure of one of the liquid hydrogen storage tanks at its maximum allowable inventory (11,280 pounds).  The estimated distance to the 1 psig exposure end point is 0.2 mile from the tank.  There is no off-site impact from this release scenario.  A program of periodic tank inspection and maintenance will minimize the likelihood of this event. 
We are using this information to help us ensure that our emergency response plan and the community emergency response plan address all reasonable contingency cases. 
We take a systematic, proactive approach to preventing accidental releases of chemicals.  Our management systems address each of the key features of successful prevention programs including 

*  Process safety information 
*  Process hazard analysis 
*  Operating procedures 
*  Training 
*  Mechanical integrity 
*  Management of change 
*  Pre-startup review 
*  Compliance audits 
*  Incident investigation 
*  Employee participation 
*  Hot work permit 
*  Contractors 
As part of our prevention efforts, we have implemented the following chemical-specific prevention steps: 
* A process hazard analysis (PHA) on both the ammonia system and the hydrogen system and made changes to the equipment, instruments, and operating procedures to minimize the potential for incidents; 
* Routine inspection of storage tanks and equipment (ammonia and hydrogen systems); 
* Initial and ongoing training for personnel working with the hydrogen and ammonia systems; 
* Review of major changes using engineers, supervisors, and operators before new equipment is started; 
* Review of operating procedures using operators, supervisors, and engineers to make sure procedures are current and to clarify an 
ything confusing or that could be misinterpreted; and 
* Upon completion of the ammonia safety project described above, resolution of all recommendations from prior audits and PHA reviews on the ammonia system. 
We currently have the following chemical-specific emergency and/or preventive equipment: 
* Excess flow valves at outlet piping on the liquid hydrogen tanks; 
* Excess flow valves throughout all liquid ammonia lines; 
* Level controls on the ammonia and hydrogen tanks; and 
* Water monitor nozzles located at the ammonia storage tanks.  
These individual elements of our prevention program work together to prevent accidental chemical releases.  Our company and our employees are committed to the standard that these management systems set for the way we do business, and we have specific accountabilities and controls to ensure that we are meeting our own high standards for accident prevention. 
This site is operated using a team approach designed to enhance communication and interaction 
between individuals and functional groups at the site and to improve performance in all aspects of our business.  Acting under the direct authority of the Plant Manager, the site's RMP Coordinator works closely with the site's PSM Coordinator to facilitate and oversee the implementation of the various elements of the Risk Management Program by various functional groups or teams at the site. 
We keep records of all significant accidental chemical releases that occur at our facility.  During the past five years there were no accidental chemical releases involving materials covered under the EPA's RMP rule that resulted in injuries, significant property damage, or environmental damage either on site or off site. 
We have a written Emergency Response Plan that includes the requirements of OSHA and the EPA for the safety and protection of our employees and the community.  Our program provides the essential planning and training for ef 
fectively protecting workers, the public, and the environment during emergency situations.  Furthermore, we coordinate our plan with Wake County's local emergency response plan.  Mallinckrodt is a founding member of the Wake County Local Emergency Planning Committee and continues to be very actively involved. 
As a result of previous process hazard analysis reviews, the site developed an ammonia safety improvement project.  During May 1999, the site began installing these improvements which will provide new controls, prevention systems, and active mitigation systems to minimize the potential for employee and public exposure resulting from accidental releases from the anhydrous ammonia process.  The revised Process Hazard Analysis for these improvements and the off-site consequence analysis were both completed prior to the submission of the RM Plan to the EPA (June 17, 1999).  Only the installation of the additional excess flow valves had an effect on  
the off-site consequence analyses presented in this plan, and these new valves were installed prior to submitting the RM Plan to the EPA. 
The other safety improvements from this project were not in place at the time of submission of this plan, but are expected to be completed by the end of Summer, 1999.  These improvements include: 
7    a containment berm around the anhydrous ammonia storage tanks, 
7    ammonia detection sensors throughout the anhydrous ammonia system, 
7    high pressure and high liquid level alarms on the liquid ammonia storage tanks, 
7    remotely-activated emergency isolation valves in the liquid ammonia lines, and 
7    a remotely-activated water deluge system to mitigate ammonia vapors during an accidental release at the liquid ammonia storage tanks, the ammonia unloading station, and the ammonia vaporizers. 
In addition, the following is a list of actions that we are planning to implement at the facility to help prevent and/or better respond to accidental chemical releases: 

   Conduct a functional exercise of our emergency plan involving external emergency responders and the local community. 
7    Continue to work with the Wake-New Hope, Falls, and Raleigh Fire Departments, the Fire Marshall's Office, and other emergency responders to insure that external personnel are familiar with our site, our safety improvements, and future Emergency Plan changes.
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