Catalytica Pharmaceuticals, Inc. - Executive Summary

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Catalytica Pharmaceuticals (C*P) operates a manufacturing facility in Greenville, NC, which synthesizes a variety of bulk pharmaceutical compounds in its Chemical Manufacturing Operation (CMO).  Pharmaceuticals are also formulated into final dosage forms and packaged at the Greenville site.  The site has been in operation since 1970 when it was built by Burroughs Wellcome.  The company merged with Glaxo in 1995 to become Glaxo Wellcome, and the Greenville manufacturing facility was sold to Catalytica Inc. in 1997. 
The facility includes several chemical production buildings in which a variety of chemical reactions and separations are performed for the purpose of producing bulk pharmaceutical chemicals.  Raw materials for these processes are stored in a tank farm and in warehouse areas.  Many of the bulk pharmaceutical chemicals produced at the facility are further processed into their final dosage forms and are packaged at the facility. 
The facility has experienced growth during its e 
xistence and is expected to continue to grow in the future as a contract manufacturer for the pharmaceutical industry. 
None of the flammable chemicals which are listed in the EPA's Risk Management Plan (RMP) are used at the site in quantities above the RMP's threshold amounts. Four of the chemicals listed on the Toxic Substances list are present at the Greenville facility in quantities above the threshold amounts.  These are:   
Stored in a bulk storage tank in the Chemical Manufacturing Operation's tank farm.  The covered process is the tank, its piping distribution system, and the bromine tanks within the CMO buildings that are connected to the piping system.  This storage system is listed as Process No. 1 in C*P's RMP, and is a Program Level 3 process.  The worst-case release scenario for this process has been defined as the release of the storage tank contents (about 52,000 pounds) into the dike which surrounds this storage tank.  The alternative release scenario is pos 
tulated to be the rupture of a 1-inch diameter pipe during the transfer of material from the tanker truck to the bulk storage tank in a non-diked area, which is estimated to release 16.5 pounds per minute of bromine for 30 minutes. 
Bromine is also stored in 10-gallon drums in a refrigerated storage room.  This storage system is listed as Process No. 2 in our RMP, and is a Program Level 3 process.  This process is defined as the bromine drums which are stored in the CMO refrigerated storage room.   
Chloroform Tanks:   
The Chemical Manufacturing Operation's tank farm includes three chloroform tanks.  Two tanks are horizontal tanks, each containing 2000 gallons of chloroform.  The third tank is a 5000 gallon vertical tank for recovered (recyclable) chloroform.  Each tank, its associated piping, and the tanks to which they are hard-piped in a production building constitutes the "covered process".  This system is listed as Process No. 3 in C*P's RMP, and is a Program Level 1 pr 
Hydrochloric Acid Storage:   
C*P stores 55-gallon drums of 37% hydrochloric acid inside of a building.  This storage is listed as Process No. 4 in our RMP, and is a Program Level 1 process.  This process is defined as the entire amount of hydrochloric acid drums stored at this location. 
Phosphorus Oxychloride Storage: 
C*P stores 55-gallon drums of phosphorus oxychloride in an open drum storage warehouse and in a closed drum storage warehouse.  This storage system is listed as Process No. 5 in our RMP, and is a Program Level 3 process.  This process is defined as the entire amount of drums stored at the CMO warehouse. 
The worst-case scenarios for the bulk bromine storage and the bromine drum storage have off-site impacts.  The worst-case scenario for the phosphorus oxychloride storage also has off-site consequences.  However, the chloroform tanks  and the hydrochloric acid drum storage do not have off-site impacts for their worst-case releases. 
Several other chemicals on the  
Regulated Substances list are used at the facility, but are not present in quantities above the RMP Threshold quantities.  These include:  acrylonitrile, aqueous ammonia, ethylene oxide, nitric acid, hydrogen, and propane. 
Catalytica Pharmaceuticals has an extensive safety program, which is designed to ensure that its workers are properly trained to handle chemicals safely.  C*P's processes are designed to minimize hazards, and procedures are in place to ensure that equipment is properly maintained.  C*P's goal is to prevent accidents and chemical releases by proper training and by proper maintenance of equipment.  The company has its own emergency response team and equipment.  The C*P Emergency Responders are trained and equipped to mitigate fires, chemical releases, and injuries.  C*P has identified "worst-case scenarios" under which chemicals could be accidentally released, as well as alternative release scenarios.  An EPA-approved dispersion model was used to calculate the distanc 
es in which the public could be affected by a release.   
The safety programs are administered and directed by the Environment, Health, and Safety division (EHS),  which is staffed by full-time safety and environmental professionals. 
The 1998 Environment, Health and Safety Action Plan for the site states that all new processes that enter an area of the site that has been identified as falling under the Process Safety Standard will have a process hazard analysis performed on it.  In addition, all existing process hazard reviews will be updated as required by the OSHA standard. 
The Employee Handbook for the Greenville Site (dated July of 1998) states that it is the policy of the Company to implement programs designed to help the Company meet its safety, health and environmental responsibilities.  This includes compliance with safety, health and environmental laws and regulations designed to protect our employees, the public, and the environment.  It is Company policy to monitor operati 
ons to ensure compliance with all environmental laws pertaining to air and water emissions.  Programs are established and monitored to achieve this goal.  In addition, contingency plans and emergency organizations will be developed to respond to any fire, explosion, spill, or environmental release to minimize adverse effects.  Continuous emphasis will be placed on risk analysis in order to identify potential safety, health, and environmental exposures.  Audits, engineering studies and reviews of new purchases will be used to assess the possibility of adverse impact.  The Company will implement programs and procedures to eliminate or minimize such exposures if identified. 
There have been three accidental releases of bromine resulting in employee injuries since Catalytica Pharmaceuticals assumed ownership of the facility.  The largest release was about 9479 pounds on August 15, 1999.  This incident resulted in injuries to two employees and evacuation of approximately 60 people from outs 
ide of the facility. Extensive changes to the bulk bromine system were made in response to this incident.
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