Pharmacia & Upjohn Caribe Inc. - Executive Summary

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Pharmacia & Upjohn Caribe, Inc. (P&UCI), is commited to the protection of the health and safety of its employees and the general public, responsible stewardship of the environment and ensuring the safety of its products consistent with the requirements of the Risk Management Program. 
As stated before P&UCI is commited to worker and public safety.  This commitment is domonstrated by the resources invested in accident prevention, such as training personnel and considering safety in the design, installation, operation, and maintenance of company processes.  P&UCI's policy is to implement reasonable controls to prevent foreseable releases of regulated substances.  However, if a release does occur, P&UCI's trained personnel will respond to control and contain the release. 
P&UCI plans to meet or surpass all regulatory requirements.  In the attempt to accomplish this goal, the management systems at P&UCI have  
been developed in such a way that the hazards are identified, understood, and controlled to prevent accidents. 
P&UCI is dedicated to the manufacture of pharamceutical and chemical bulk products.  The facility's manufacturing processes include:  raw materials formulation, fermentation, extraction, crystallization, purification, chemical synthesis of atibiotics, finished products bulk packaging, and pharmaceutical dry products. 
P&UCI operates two (2) processes with materials exceeding RMP threshold: 
1.  Lincomycin Fermentation:  Ammonia (anhydrous) is used during the Lincomycin fermentation process.  As much as 56,000 pounds of ammonia is stored under this process.  This substance is stored on an aboveground tank with capacity of 10,000 gallons and is fed to the process area by a pipeline system. 
2.  Clindamycin Phosphate:  Phosphorus oxychloride is used as an ingredient during the manufacture of C 
lindamycin Phosphate.  In this process as much as 19,000 pounds of phosphorus oxychloride is stored on 55-gallon drums at the main materials storage warehouse (M-10) and is delivered by fingerlift to the production building (M-50). 
Both processes are considered a Program 3 process as defined by the risk management program rule. 
P&UCI has developed and implemented an accidental release prevention program to continously comply with OSHA's 29 CFR 1910.119, Process Safety Management of Highly Hazardous Chemicals, and EPA's 40 CFR Part 68 subpart D, Accidental Release Prevention provisions in the Risk Management Program.  The prevention program thus developed and implemented consists of twelve elements which are listed below: 
-  Process safety information 
-  Process hazard analysis 
-  Operating procedures 
-  Training 
-  Mechanical integrity 
-  Management of change 
-  Pre-startup review 
-  Comp 
liance audits 
-  Incident investigation 
-  Employee participation 
-  Hot work permit 
-  Contractors 
Some elements of the prevention program are intended to assure the designs are reviewed so the new plant and equipment are in conformance to safe design principles.  The remainder of the elements assure that the operation, maintenance and control of hazards are perfomed to prevent inadvertent changes outside the safe design and operating envelope. 
With regards to accidental release prevention for specific chemicals, P&UCI currently relies on the following programs:  chemical-specific personnel training, good engineering practices, safe material handling procedures, sound engineering design, Good Manufacturing Practices (GMPs), corrosion protection programs, container management programs, inspections targeted to specific chemical hazards, and the installation of release prevention equipment, such as pressure release valves, rupture disks, and others. 
[40 CFR 68.155 (e)] 
P&UCI has not had an accidental release which had off-site consequences over the past five years. 
Worst-Case Scenario Analysis for a Substance Release 
The worst-case scenario for a toxic substance at P&UCI is a hypothetical release of the entire contents of the anhydrous ammonia storage tank (10,000 gallons).  In accordance with RMP regulations, the entire 10,000 gallons of ammonia were assumed to be released as a gas cloud in ten (10) minutes.  The RMP comp Ver. 1.06 computer model was used to estimate the downwind concentrations under the EPA-mandated weather conditions of 1.5 m/s wind speed and F stability.  No passive mitigation measures were considered for this hypothetical release. 
The RMP Comp Ver. 1.05 model predicted a maximum distance of 2.8 miles to ammonia's toxic end point of 0.14 mg/L.   
Alternate Release Scenarios: 
A.  Ammonia (Anhydrous) - Ammonia is transferred from the storage tank 
to the process building by means of a 2" diameter steel pipe.   The alternate scenario evaluated a rupture (0.20 inch puncture) of the 2" pipe in which the entire contents of the storage tank are released within 116 minutes.  No mitigation systems were assumed for this scenario. 
The Comp Ver. 1.06 model predicted an estimated distance of 0.2 miles to ammonia's toxic end point. 
B.  Phosphorus Oxychloride (POX) - POX is used during the Clindamycin Phosphate process.  This alternate scenario evaluated the effects of the rupture of one drum (55 gallons) of POX during transportation to the process area (Building M-50).  No mitigation systems were assumed for this scenario. 
The Comp Ver. 1.06 model results predicted a distance of 0.4 miles to the POX toxic end point. 
P&UCI maintains a comprehensive written emergency response program to protect plant workers, the general public, and the environment.  The program include plans and procedures  
for responding to a wide range of events, caused either naturally or accidentally, which have the potential to result in a release of a regulated substance.  Periodic emergency drills are conducted within the plant to maintain preparedness and to identify areas for improvement.   The emergency response program is updated when necessary, based on modifications made to plant processes or facilities.  In addition, the plant has an emergency preparedness program that addresses maintenance, inspection and testing of response equipment, as well as instructions and training that govern use of the equipment. 
The overall emergency response program is coordinated with the Local Emergency Planning Committee (LEP-Arecibo Municipality).  This coordination includes periodic meetings of the committee, which includes local emergency response officials, and industry representatives.  P&UCI has around-the-clock communication with the LEPC to ensure notification of the public in the event of an incident 
, if necessary, as well as facilitating a quick response.  
In accordance to P&UCI's commitment for the safety of its employees, general public and the environment, P&UCI is evaluating several alternatives with regards to safety issues for the storage and handling of regulated substances.  Currently P&UCI is currently evaluating the need for additional control/mitigation system for the possible emissions of anhydrous ammonia during an emergency event.  Moreover, P&UCI is also evaluating the possibility of furtherly reducing our present ammonia (anhydrous) inventory. 
In the case of Phosphorus Oxychloride mitigation/control systems that have been evaluated at this time include the control of humidity during chemical transportation and handling. 
Other measures may be implemented in lieu of or in addition to these ones, depending upon P&UCI's final evaluation of emission control alternatives.
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