PFIZER GLOBAL MANUFACTURING, HOLLAND SITE - Executive Summary |
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SECTION 1 - REGISTRATION INFORMATION The Pfizer Global Manufacturing (PGM), Holland Site, manufactures a variety of life-saving and life-enhancing pharmaceuticals at its facility located at 188 Howard Avenue, Holland, Michigan. PGM - Holland uses two chemicals that are regulated by the EPA Risk Management Plan (RMP) rules (40 CFR Part 68) to manufacture several pharmaceutical products including: Neurontin and Dilantin (seizure control); Benadryl (anti-histamine); and Accupril (anti-hypertension agent). These chemicals are phosgene and anhydrous hydrogen chloride, and they are also regulated by the OSHA Process Safety Management (PSM) standard (29 CFR Part 1910.119). This Executive Summary introduces the key components of the PGM - Holland risk management program including a description of the regulated substances, hazard assessments, accident prevention program, and emergency response program. Specific elements of the PGM - Holland risk management program are presented in the attached Risk Management Plan. PGM - Holland has always acknowledged its civic responsibility to provide its colleagues and the residents of the Holland community with a safe facility. PGM - Holland strives to meet or exceed applicable EPA and OSHA rules and regulations, and periodically evaluates the quality of its environmental and safety programs. The facility's accident prevention and emergency response procedures have been designed to protect our colleagues, the community and environment, and PGM - Holland properties, to the greatest extent possible. PGM - Holland maintains extensive on-site emergency response equipment and trained personnel, and has integrated its emergency response procedures with those of the Holland Township Fire Department and the Ottawa County Local Emergency Planning Committee. The designated representative and contact person for environmental matters and this Risk Management Plan at the PGM - Holland facility is Mr. Tom Bauer, Director of Materia ls Management and Environmental Control. He can be contacted at the facility at (616) 392-2375. SECTION 2 - SUBSTANCE PROPERTIES, RMP PROCESSES, AND WORST CASE HAZARD SCENARIO Phosgene and anhydrous hydrogen chloride are critical to the manufacture of several pharmaceutical products at the Holland, Michigan facility. Both chemicals require careful storage and handling due to their potential toxic hazards. A detailed description of the chemical properties, regulated processes, process safety and control features, and the worst-case hazard scenario are provided below. Chemical Properties Phosgene is a toxic and corrosive liquid with a boiling point of 47 oF. Phosgene evaporates to form a gas at temperatures above the boiling point. Exposure may cause severe irritation to the respiratory system, skin and eyes. Inhalation of high concentrations of phosgene may cause headache, olfactory fatigue, respiratory irritation, difficulty breathing, lung congestion and, under extrem e conditions, death. In addition, symptoms may be delayed for a period of from 24 to 48 hours after exposure. It is critical that persons exposed to phosgene seek immediate medical attention for prompt treatment. The threshold quantity for phosgene is 500 pounds under the EPA RMP rules and 100 pounds under the OSHA PSM standard. Hydrogen chloride is a corrosive gas. Exposure may cause severe irritation to the respiratory system, skin and eyes. Inhalation of high concentrations of hydrogen chloride can cause respiratory irritation and corrosive burns, lung congestion, lung damage and, under extreme conditions, death. The threshold quantity for anhydrous hydrogen chloride is 5,000 pounds under both the EPA RMP rules and OSHA PSM standard. The EPA rules define a toxic endpoint for both phosgene and hydrogen chloride by reference to the Emergency Response Planning Guideline 2 (ERPG-2), developed by the American Industrial Hygiene Association (AIHA). The AIHA ERPG-2 is defi ned as "the maximum airborne concentration below which it is believed nearly all individuals could be exposed for up to 60-minutes without experiencing or developing irreversible or other serious health effects or symptoms that could impair an individual's ability to take protective action". The AIHA ERPG-2 for phosgene is 0.2 parts per million (PPM) while the ERPG-2 for hydrogen chloride is 20 PPM. Phosgene Process Safety Phosgene is used at the PGM - Holland facility to make three pharmaceutical products. Phosgene is stored in 2,000-pound cylinders located in a secured storage area. When needed in the manufacturing process, phosgene cylinders are transported about 25 feet to a dedicated phosgene charging building. Phosgene is then charged to a process reactor through a completely isolated system. At no time during normal process operation is phosgene released to the atmosphere. The phosgene process includes: cylinder storage; the phosgene charging building, distribution system and components; process equipment; process control and safety systems; and process scrubber systems. Since 1986, PGM - Holland has had the following safety measures in place to minimize the risk of an accidental release of phosgene. These measures include: 1. Phosgene cylinders are stored in a secure and fenced location that is dedicated to the storage of phosgene and hydrogen chloride cylinders. Full cylinders are stored on a concrete pad and protected from direct exposure to sunlight. The cylinder storage pad is isolated from other manufacturing activities. Only DOT-approved shippers, or trained and certified PGM - Holland colleagues, are allowed to move and handle phosgene cylinders. 2. Phosgene cylinders are constructed of 13/32" thick steel in accordance with DOT regulations for over-the-road transportation. The cylinder ends are concave so that the two cylinder valves do not protrude beyond the end of the cylinder. The two cylinder valves are capped to prev ent leakage. A flanged and gasketed leak-proof bonnet is bolted over and covers the two-capped cylinder valves, protecting the valves from damage and providing an additional barrier to prevent leakage to the environment. 3. A dedicated phosgene cylinder charging building was constructed in 1986. This building eliminated the need to transport and use phosgene cylinders in process areas. The building is located near the storage pad to minimize on-site transportation. Phosgene cylinders have been used in this building since 1986 without a spill or leak incident adversely affecting the environment or community. 4. The phosgene cylinder charging building contains a sump area designed to hold the contents of one phosgene cylinder. If a liquid phosgene spill were to occur, it would be contained within the charging building, and transferred from the sump to a process vessel for neutralization by the PGM - Holland Hazardous Materials Response Team. The sump area is also vented to a de dicated scrubber and thermal oxidizer system that would destroy any vaporized material. 5. The phosgene cylinder rests securely within a steel cradle with the cylinder head inserted through a collar into a glove box located in the phosgene charging building. The operator can remove the bonnet and make process connections to the cylinder only when the cylinder head is inserted into the glove box. The air inside the glove box is continuously vented to a dedicated phosgene scrubber system. The scubber destroys the small amount of phosgene that can be released into the glove box when the cylinder is disconnected from process piping. The scrubber is then vented to a thermal oxidizer. If a leak occurred, phosgene would be vented through the scrubber and thermal oxidizer system and not released to the environment. 6. Liquid phosgene is piped to two reactor vessels through a double walled piping system. An inner welded steel pipe is contained within an outer glass pipe that is prot ected from damage by a metal protective guard. The annular space between the steel and glass pipes is vented to the dedicated phosgene scubber system. In addition, all phosgene valves are contained within valve boxes that are vented to the phosgene scubber system. The design of the valve boxes and double piped distribution system provides for phosgene containment from the cylinder valve to the reactor. If a leak occurred, phosgene would be vented to the scrubber and thermal oxidizer system and not released to the environment. 7. Nitrogen, an inert gas, is used to push phosgene from the cylinder through the double walled piping system to the reactor. Nitrogen is supplied from a dedicated bulk tank. Bottled nitrogen provides a backup source should the primary nitrogen source fail. Nitrogen pressure is controlled and process interlocks prevent phosgene from entering the nitrogen supply systems. 8. A 16-point phosgene monitoring system continuously samples plant and proce ss areas likely to be affected by a phosgene leak. The system will activate an alarm and automatically stop the phosgene charge. The monitoring system minimizes any potential leak by automatically closing all phosgene feed control valves when the leak is detected. 9. Phosgene is used in only two reactor vessels. Both reactors are glass lined and meet the American Society of Mechanical Engineers (ASME) codes for pressure vessels. Phosgene is charged while the reactor is being vented through the scrubber system to the thermal oxidizer. Reactors are equipped with high and low-temperature sensors that stop the phosgene charge if unusual process conditions occur. A high-pressure sensor stops the phosgene charge if reactor pressure exceeds 1 pound per square inch (PSI). Emergency cooling can be provided to the reactor jacket to help slow or stop an unusually fast phosgene reaction. Manual emergency stop buttons are provided in the phosgene cylinder charging building and near each rea ctor. 10. Phosgene reactors are protected with emergency relief devices to prevent vessel over-pressurization. Multiple rupture disks prevent leakage to the environment. A safety relief valve would stop vessel venting after excess pressure was vented from the reactor. Emergency venting would also activate a pressure sensor and phosgene monitor located in the vent line that would stop the phosgene charge. 11. Phosgene scrubbers are equipped with high and low-level alarms, and a low caustic flow alarm that stops the phosgene charge if the scrubber caustic circulation stops. 12. All manufacturing facilities have been designed to minimize the potential for fire. The phosgene storage pad, cylinder charging and process buildings are constructed from non-combustible materials. These facilities are equipped with Class 1, Division 1, Group D, rated electrical equipment. The cylinder charging building is isolated from the storage and use of flammable liquids and plant process ar eas. A fixed fire protection system with aqueous film forming foam has been installed in all plant process areas. All hot work is controlled through a permit system. 13. Detailed mechanical and electrical system inspections and tests are conducted on the phosgene charging and distribution systems, process control and safety equipment. Phosgene piping and process vessels are pressure tested immediately prior to phosgene use to minimize the potential for a process leak. 14. Process operators working with phosgene have been trained and certified by PGM - Holland in accordance with OSHA PSM standard requirements. Process operators are required to follow written process operating procedures contained in batch cards that cover phosgene charging, processing, and emergency response. 15. PGM - Holland maintains a colleague staffed and fully trained Hazardous Materials team. The Haz-Mat team is equipped and trained to use full body Level A protective suits and self-contained br eathing apparatus. An emergency cylinder capping and patch kit is also available. The Haz-Mat team has conducted emergency response drills for potential phosgene leaks and emergencies. PGM - Holland has recently improved phosgene process control by upgrading to a distributed control system (DSC) which allows improved process monitoring, operational control, and alarm notification and response. The phosgene monitoring system, reactor temperature and pressure sensors, scubber controls, and other controls and interlocks have been integrated into the DSC. Hydrogen Chloride Process Safety Hydrogen chloride is stored at the PGM - Holland facility in two different manners. Hydrogen chloride is stored in 600-pound cylinders adjacent to where phosgene cylinders are stored. The total amount of hydrogen chloride contained in cylinder storage at any given time may exceed the applicable RMP rule threshold quantity of 5,000 pounds. Hydrogen chloride is also stored in a bulk storag e area consisting of six 3,500-pound cylinders supported by a DOT approved trailer. The facility has unloading facilities for three trailers. One trailer will normally be in transport while a second is in backup status. Only one cylinder of one trailer can actively supply the facility's bulk hydrogen chloride distribution system at any given time. Hydrogen chloride will be piped from the storage area to manufacturing for use in a number of pharmaceutical processes. The bulk hydrogen chloride process includes the storage facilities, evaporators, delivery piping and components, process equipment including batch reactors, process control equipment, and scrubber system. PGM - Holland has implemented a number of safety measures to minimize the risk of an accidental release of hydrogen chloride. These measures include: 1. 600-pound hydrogen chloride cylinders are stored in a secure, fenced, dedicated area on a concrete pad. The storage pad is isolated from other manufacturing act ivities. Only DOT approved shippers or trained and certified PGM - Holland colleagues are allowed to move and handle hydrogen chloride cylinders. These precautions help to prevent cylinder mishandling and damage. 2. 600-pound hydrogen chloride cylinders are constructed of steel in accordance with DOT regulations for over-the-road transportation. The cylinder valve is capped to protect it from damage during transportation. Cylinders are mounted and secured onto steel carts prior to transportation into process areas. All colleagues who use fork trucks to move hydrogen chloride cylinders are trained and licensed by PGM - Holland. 3. Temperature and pressure control equipment is used to maintain safe conditions during hydrogen chloride reactor charging from both tube trailers and 600-pound cylinders. 4. Bulk hydrogen chloride is delivered in DOT approved cylinder trailers. The trailer pad is isolated from other manufacturing activities. Only DOT approved shippers are allowed to move hydrogen chloride trailers. Trailers are posted "Empty", "On-line", or "Backup" and trailer wheels are chocked to prevent inadvertent movement. Each trailer is equipped with an anti-tow away device interlocked with the trailer brakes to prevent a trailer that is connected to the piping system from being moved. 5. Each bulk hydrogen chloride cylinder is equipped with an automatic valve that will fail-safe closed with the loss of electrical power or instrument air. Continuous hydrogen chloride monitors are located at each unloading station and are interlocked to automatically close the cylinder and feed line valves if hydrogen chloride is detected at 5 parts per million. Manual valves have been installed on the trailer manifold and on the high-pressure tube connected to the trailer so that the Haz-Mat team may manually stop the flow of hydrogen chloride should the automated systems fail. Emergency stop buttons, located at the unloading station and in manufacturing areas, also close all automatic valves and stop hydrogen chloride flow. 6. The bulk hydrogen chloride distribution piping system is equipped with safety relief valves that vent through the scrubber system to the thermal oxidizer. These relief valves prevent a potential line rupture that could occur if liquid hydrogen chloride, isolated between two closed valves, thermally expanded. In addition, the low and high-pressure distribution systems are protected from over-pressure by additional emergency relief devices. A pressure gauge located between the rupture disk and safety relief valve is interlocked to automatically close the cylinder and feed line valves upon failure of the rupture disk. Hydrogen chloride is supplied to reactor vessels at low pressure. 7. The hydrogen chloride cylinder and trailer storage pads, and all process buildings are constructed from non-combustible materials and equipped with Class 1, Division 1, Group D, electrically rated equipment. The cylinder and tr ailer storage pads are isolated from the storage of flammable liquids and plant process areas. A fixed fire protection system with aqueous film forming foam has been installed in all plant process areas. All hot work is controlled through a permit system. These controls minimize the potential for a fire that would be capable of contributing to a hydrogen chloride release. 8. Detailed mechanical and electrical system inspections and tests have been conducted on the bulk hydrogen chloride trailers, charging, distribution, process, and control equipment. Hydrogen chloride piping systems are pressure tested prior to cylinder or trailer connection. Process vessels are pressure tested prior to each batch. 9. Process operators working with hydrogen chloride have been trained and certified by PGM - Holland in accordance with OSHA PSM standard requirements. Process operators are required to follow written process operating procedures contained in batch cards that cover hydrogen chlor ide charging, processing, and emergency response. 10. PGM - Holland maintains an on-site colleague staffed Hazardous Materials team and a separate fire brigade. The Haz-Mat team is equipped with Level A protection. An emergency cylinder capping and patch kit is also available. All colleagues not on the Haz-Mat team, contractors and visitors, would evacuate the plant if a hydrogen chloride release were to occur. Worst-Case Release Scenario The EPA rules required the development of worst-case release scenarios that assume the entire contents of the largest container of a highly hazardous chemical are released in ten minutes under adverse weather conditions. PGM - Holland developed a worst case release scenario for phosgene based on the maximum cylinder quantity of 2,000 pounds. Weather conditions assume a 98 oF ambient temperature, 73% relative humidity, 3.4 mile per hour (1.5 meter per second) wind speed, and F class atmospheric stability. The worst case modeling was cond ucted using the EPA approved SLAB model for dense gases. Model results are contained in the checklist portion of this plan. The phosgene worst-case scenario resulted in a greater downwind distance to the toxic end point than either hydrogen chloride (600 or 3,500 pound) scenario. Public and environmental receptors are located within the radius of the worst-case release scenario. These receptors include homes; small businesses; commercial, office and industrial areas; schools; hospitals; churches; public parks and recreational areas. PGM - Holland believes that the EPA defined worst case phosgene scenario can not occur due to the high level of phosgene process safety, and the process safety management and emergency response programs that have been implemented at PGM - Holland. SECTION 3 - ALTERNATIVE RELEASE SCENARIOS Recognizing that a worst-case scenario is extremely improbable and that companies like PGM - Holland have many safeguards in place to prevent and respon d to accidents, the RMP rules also require that alternative release scenarios be developed. Conservative Estimates Used for Alternative Release Scenarios The described alternative release scenarios are extremely conservative. PGM - Holland believes that the described scenarios for phosgene and hydrogen chloride are highly unlikely to occur due to the high level of process safety and the associated PGM - Holland process safety management and emergency response programs. PGM - Holland believes that any phosgene or hydrogen chloride release would have substantially less impact on potential environmental and public receptors than the described alternative scenarios. Specifically, the phosgene alternative release scenario requires the simultaneous failure of multiple process control and safety systems, and the complete release of reactor contents without any response by chemical operators or the Haz-Mat team to minimize or respond to the release. Phosgene Phosgene is used in two batch records. In one batch record, an initial 440-pound charge of phosgene is made to the reaction mixture. The reaction undergoes a small temperature increase as the reaction is initiated. Once initiated, phosgene reacts as it enters the reactor and does not accumulate in an appreciable quantity. The only potential for any significant phosgene release is during the period of reaction initiation. The alternative release scenario assumes that the full 440-pound phosgene charge is released through the reactor emergency vent as a gas at a temperature of 149 oF and an elevation of 22 feet under typical weather conditions. Weather conditions assume a 48 oF ambient temperature, 62% relative humidity, 9.1 mile per hour (4.1 meter per second) wind speed measured at 9 meters and corrected to ground level, and D atmospheric stability. A ten-minute release is assumed. This is consistent with the worst case release period and approximates the time required to vent the reactor conte nts through a safety relief valve which is assumed to open and close to maintain reactor pressure between relief valve set points. Please note that PGM - Holland has never experienced a phosgene release such as described in this alternative scenario. The alternative case modeling was conducted using the EPA approved SLAB model for dense gases. Model results are contained in the checklist portion of this plan. Public and environmental receptors are located within the radius of the alternative release scenario. These receptors include homes; small businesses; commercial, office and industrial areas; schools; churches; public parks and recreational areas. Hydrogen Chloride The hydrogen chloride alternative release scenario assumes that the valve and protective cap is sheared off of a full 600-pound hydrogen chloride cylinder during transportation. Hydrogen chloride is released as a liquid at ground level under normal weather conditions and rapidly evaporates. Weather co nditions assume a 48 oF ambient temperature, 62% relative humidity, 9.1 mile per hour (4.1 meter per second) wind speed measured at 9 meters and corrected to ground level, and D atmospheric stability. The release is estimated to last about 3 minutes. Please note that PGM - Holland has never experienced a hydrogen chloride release such as described in this alternative scenario. The alternative case modeling was conducted using the EPA approved SLAB model for dense gases. Model results are contained in the checklist portion of this plan. Public and environmental receptors are located within the radius of the alternative release scenario. These receptors include homes; small businesses; commercial, office and industrial areas; schools; churches; public parks and recreational areas. SECTION 4 - FLAMMABLES: WORST CASE PGM - Holland does not use any of the listed flammable substances in an amount above the threshold quantity. SECTION 5 - FLAMMABLES: ALTERNATIVE RELEASE P GM - Holland does not use any of the listed flammable substances in an amount above the threshold quantity. SECTION 6 - ACCIDENT HISTORY During the five-year review period, PGM - Holland experienced only one chemical release from a regulated process that resulted in one on-site non-lost time injury to one contractor employee. On April 26, 1999, a phosgene release occurred due to a pipe leak located in the phosgene scrubber system immediately outside of the manufacturing building. Continuous air monitoring equipment confirmed the presence of phosgene inside the manufacturing building at a peak concentration of about 0.65 parts per million. Several colleagues who worked in the general area of the release were sent to a medical clinic for observation but no injuries were reported. It was estimated that less than one pound of phosgene was released. The incident was investigated and corrective actions were taken. On April 27th, a contractor employee experienced respirator y irritation and chest tightness and stated that he had smelled phosgene the previous day. The contractor was sent to a local medical clinic as a precaution. He was given a prescription medication and returned to work. PGM - Holland is including this incident in the RMP since the injury is OSHA recordable due to the contractor's receipt of a prescription medication. PGM - Holland has not experienced any other accidents from a regulated process in the last five years that resulted in on-site deaths, injuries, or significant property damage, or known off-site deaths, injuries, evacuations, sheltering in place, property damages, or environmental damage. To the best of current management's knowledge, PGM - Holland has never had any chemical release that resulted in colleague or contractor deaths, or any off-site injury to the public. SECTION 7 - PREVENTION PROGRAM 3 (PROCESS SAFETY MANAGEMENT PROGRAMS) PGM - Holland maintains an OSHA Process Safety Management program consisting of the following elements: A. Colleagues participate in programs related to facility and process safety. PSM program participation includes hourly and supervisory colleagues from chemical operations and maintenance crafts, safety and environmental engineers, PGM - Holland and contract engineers, departmental managers, and corporate safety professionals. B. PGM - Holland maintains an active program to retain and manage process safety information. The SAP Maintenance program contains a database that stores basic information for process equipment such as reactors, tanks, pumps, safety relief valves, etc. The Engineering Department retains preventative maintenance, inspection and test records along with process equipment and/or engineering project files that contain equipment drawings and specifications, P & IDs, manufacturer's literature, etc. Detailed manufacturing batch records contain information regarding process substances and chemistry, and detailed step-by-step manufac turing and safety instructions. The Hazard Laboratory maintains calorimetry and other test data for raw materials and process chemistry. Equipment qualifications (inspections and tests) are conducted prior to start-up to confirm equipment capabilities. The Engineering and Automation Departments retain qualification documents. The Safety Department maintains material safety data sheets and toxicity data. Additional databases and process safety files are maintained by PGM - Holland. C. PGM - Holland conducted the following process hazards analyses (PHA) for RMP regulated processes: 1. Original Phosgene PHA (1986) 2. Second Phosgene PHA (1993) 3. Original Hydrogen Chloride Cylinder PHA (1995) 4. Phosgene PHA Revalidation (1998 - 99) 5. Phosgene PHA - DCS Improvements (1999 - 00). 6. Bulk Anhydrous Hydrogen Chloride PHA (1997 - 00). PGM - Holland maintains a laboratory facility to test and evaluate the hazardous properties of new raw materials, intermediates, and process reactions. Process hazards are formally reviewed prior to pilot plant production, prior to transfer to manufacturing, or whenever the process is changed. PHA recommendations are tracked to their resolution. D. PGM - Holland develops and maintains comprehensive batch records that describe the manufacture of all pharmaceutical intermediates and include the safety and emergency information required by the OSHA PSM standard. E. PGM - Holland maintains a comprehensive training program for new mill and chemical operators, and maintenance crafts-persons. These colleagues receive safety training in hazard communication, personal protective equipment, process safety, hot work, confined space entry, line opening and other subjects. New mill and chemical operators also receive computer based safety training. New mill operators receive 40 hours of classroom operator training and additional on-the-job training and performance appraisals. New chemical operators receive an additional 40 hours of classroom operator training and additional on-the-job training and performance appraisals. Chemical operators were process safety re-certified in 1998 and were recently provided training specific to the phosgene DCS process improvements and the new bulk anhydrous hydrogen chloride process. F. PGM - Holland maintains safe work procedures for confined space entry, hot work, line breaking and equipment lockout. All such activities conducted on-site by PGM - Holland colleagues or contractor colleagues require the completion of a safe work permit. The permit assures that proper safety procedures are followed and that proper equipment is used. G. PGM - Holland maintains a contractor safety program to inform contractors of facility hazards and emergency procedures. PGM - Holland project engineers control contractor work and contractors are required to use PGM - Holland safe work permits. Contractor safety records are evaluated periodically. H. PGM - Holland maintain s qualification inspection and test procedures to assure that new or modified process equipment and facilities are safe to operate before hazardous substances are introduced into these systems. Qualification documents have been prepared for: the phosgene feed, reactor and scrubber systems; the bulk hydrogen chloride trailers, stations and distribution system; and 600 pound hydrogen chloride cylinder pressure and temperature control equipment, and reactor vessels. I. PGM - Holland maintains a mechanical integrity program that includes preventative maintenance, and the inspection and testing of process, safety and control equipment. Phosgene and hydrogen chloride process equipment is specifically covered by the mechanical integrity program and preventative maintenance procedures. J. PGM - Holland maintains change control programs and procedures to evaluate the potential effect of a change to facility and process equipment, process chemistry, and operating procedures, on plant a nd process safety. K. The Safety Department investigates all colleague injuries and illnesses that are recorded on the OSHA log as well as any substance release, fire or near miss involving a highly hazardous substance. All safety recommendations resulting from an accident investigation are tracked to resolution on a Safety Recommendation Tracking Database that is updated quarterly. L. PGM - Holland participates in a compliance audit program maintained by corporate regulatory staff to assure audits of the PGM - Holland process safety management program, safety program, industrial hygiene program and environmental program on a three-year schedule. All safety recommendations resulting from a safety or process safety audit are tracked to resolution on a Safety Recommendation Tracking Database that is updated quarterly. In addition to the described process safety and risk management programs, PGM - Holland maintains comprehensive health and safety programs to control other p otential colleague hazards. These programs include fire protection, hazard communication, respiratory protection, personal protective equipment, industrial hygiene, medical surveillance, safety inspections, laboratory safety, and others. SECTION 8 - PREVENTION PROGRAM 2 PGM - Holland does not have any RMP Program Level 1 or 2 processes. Due to the application of the OSHA PSM standard, the phosgene and hydrogen chloride processes are Prevention Program Level 3. SECTION 9 - EMERGENCY RESPONSE PROGRAM PGM - Holland maintains a comprehensive emergency response program that includes a colleague-staffed Hazardous Materials (Haz-Mat) Team, Fire Brigade, Confined Space Rescue Team, and Medical/First Aid Team. Team members are trained as described below: 1. Fire Brigade - About 25 PGM - Holland colleagues serve as members of the Fire Brigade. Team members receive monthly training, participate in periodic drills and have the opportunity to attend a 40-hour industrial fire fighting course offered at Texas A & M. Annual testing of team members is performed. Two colleagues, who serve as fire chief, have received substantially more training including courses on command and have at least 10 years of fire brigade experience. 2. Haz-Mat Team - About 15 PGM - Holland colleagues serve as members of the Haz-Mat team. All members have been certified at the OSHA Hazardous Materials Technician level. Team members receive monthly training and participate in periodic drills. Many team members have attended a 40-hour hazardous materials course at the University of Nevada in Reno. Annual testing of team members is performed. PGM - Holland maintains a hazardous material truck and trailer fully equipped to respond to potential site emergencies. Team members can perform emergency response activities in fully encapsulating Level A protective suits and self-contained breathing apparatus. 3. Confined Space Rescue Team - About 10 PGM - Holland colleagues serve as members of the rescue team. All members have attended a 24-hour confined space rescue course at Texas A & M. A rescue team member must be present during potentially hazardous confined space entries. 4. Medical/First Aid Team - Over 45 colleagues are members of the medical response team. All members receive an initial 8 hours of first aid/CPR training, an annual CPR re-certification course, and a first aid re-certification course once every three years. In addition, PGM - Holland employs a part-time physician, plant nurse, 3 colleagues licensed as Emergency Medical Technicians, and 4 colleagues licensed as Medical First Responders. PGM - Holland maintains a written Emergency Response Plan describing facility evacuation and emergency response programs and procedures. Specific emergency response actions have been defined for a variety of hazardous chemicals including phosgene and hydrogen chloride. The pharmaceutical batch record also contains a detailed description of potenti al phosgene and hydrogen chloride releases and the appropriate emergency response actions. PGM - Holland maintains a good relationship with the Holland Township fire department. Township fire fighters normally tour the PGM - Holland facility once per year. PGM - Holland colleagues work closely with the Ottawa County Local Emergency Planning Committee (LEPC) and currently the PGM - Holland Director of Safety is the LEPC Vice-Chairman. The LEPC has developed an emergency response plan for the PGM - Holland site that was last updated in May 1999. PGM - Holland provided Risk Management Plan information and plant tours to local community leaders, fire and police department personnel, school and hospital administrators, local media, and others in May and June, 1999. PGM - Holland printed and distributed a pamphlet that described the facility's Risk Management Plan and included worst-case scenarios for phosgene and hydrogen chloride. PGM - Holland assisted in the development of an Ottawa County LEPC public awareness pamphlet that explained Risk Management Planning requirements. On January 19, 2000 the Ottawa County LEPC hosted a public meeting during which PGM - Holland provided the public with a summary of the off-site consequence analysis section of the facility Risk Management Plan. PFIZER GLOBAL MANUFACTURING, HOLLAND SITE - RMP EXECUTIVE SUMMARY Page 1 of 9 PFIZER GLOBAL MANUFACTURING, HOLLAND SITE - RMP EXECUTIVE SUMMARY |