Pfizer Global Manufacturing - Groton Plant - Executive Summary |
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PFIZER GLOBAL MANUFACTURING - GROTON PLANT Risk Management Plan Executive Summary 1. EXECUTIVE SUMMARY Pfizer Global Manufacturing is committed to operating in a manner that is safe for Pfizer employees, its contractors, the public, and the environment. The Groton Plant has established systems to help ensure safe operation of the processes at this facility. One part of these systems is a risk management program (RMP) that helps manage the risks at the Groton Plant and that complies with the requirements of the Environmental Protection Agency's (EPA's) rule 40 CFR part 68, Accidental Release Prevention Requirements: Risk Management Programs (the RMP rule). One of the requirements of the RMP rule is to submit a risk management plan (RMPlan) describing the risk management program at the Groton Plant. This document is intended to satisfy the RMPlan executive summary requirements of the RMP rule and to provide the public with a description of the risk management program at the Groto n Plant. 1.1 Accidental Release Prevention and Emergency Response Policies The Groton Plant is committed to the safety of Pfizer employees, its contractors, and the public, and to the preservation of the environment, through the prevention of accidental releases of hazardous substances. The Groton Plant implements reasonable controls to prevent foreseeable releases of hazardous substances. In the event of an accidental release, our trained personnel will respond to control and contain such releases. The Groton Plant evaluates each situation, evacuates workers and contractors as necessary, responds based on our capabilities and training, and if necessary, contacts the local fire department to assist in controlling and containing the release and to prevent and/or reduce the consequences of the release. The Groton Plant, in conjunction with the City of Groton local emergency planning committee (LEPC), and the local police and fire departments have also established a system to use for warning the community if an accident occurs that could threaten the community. The Groton Plant Manager has overall responsibility for the development and implementation of the risk management program for EPA-regulated processes at Pfizer Global Manufacturing - Groton Plant. However, the specific responsibilities for certain aspects of that program have been delegated by the Plant Manager to other personnel who report either directly, or through other management personnel, to the Plant Manager. Those relationships are depicted on the organization chart maintained by the Plant Manager's staff. Specific responsibility for the implementation of the process safety management (PSM) and accident prevention program has been delegated to the plant Health and Safety Manager. Similarly, responsibility for the RMP hazard assessment and risk management plan has been delegated to the plant Health and Safety Manager. The emergency response program, including compliance with the RMP aspects of that effort, is the responsibility of the Manager of Environmental, Health & Safety. In keeping with our policy that safe operation is part of everyone's job, many other personnel are also involved in RMP activities on an ongoing basis. 1.2 Pfizer Global Manufacturing - Groton Plant Regulated Substances The Groton Plant is a pharmaceutical drug substance manufacturing plant located in Groton, Connecticut. Two substances used at the Groton Plant are held above the threshold quantities specified by EPA in the RMP rule. Bromine is used in the manufacturing process and is stored in a 48,650 lb. storage tank. Anhydrous ammonia is used in four co-located refrigeration systems, having a total inventory of 19,600 lb. of anhydrous ammonia. Because Pfizer has taken measures in recent years to minimize or eliminate the use of toxic substances in its operations, these are the only two RMP-covered processes we have at Groton. 1.3 Offsite Consequence Analysis Pfizer has performed an offsite consequence analysis for bromine and anhydrous ammonia at the Groton Plant to estimate the potential for an accidental release that could affect the public or the environment. The offsite consequence analyses consists of evaluating both worst-case scenarios and alternative release scenarios. The Groton Plant does not expect a worst-case release scenario to ever occur. An alternative release scenario represents a release that might occur during the lifetime of a facility like the Groton Plant. Alternative release scenarios can be used to help the LEPC improve the community emergency response plan. We have shared that information with the LEPC and other organizations involved in emergency response activities. It is also available to local residents and businesses. If you are interested in this information, please contact our RMP coordinator (860) 441-3225. The main objective of performing the offsite consequence analysis is to determine the distance at which certain effects migh t occur to the public because of an accidental release (called the endpoint distance). When considering the release of a toxic substance, most people at the endpoint distance would be able to walk away from the exposure without any long-term health consequences, although some short-term consequences (e.g., strong eye or throat irritation) are likely. Some people who are particularly susceptible to the substance released could be affected to a greater extent. At distances less than the endpoint distance, the effects would be greater; at distances greater than the endpoint distance, the effects would be less. Worst-case Release Scenario The worst-case toxic release scenario, as defined by the RMP rule, associated with toxic substances in RMP-covered processes at the Groton Plant is a failure of the bromine storage tank, resulting in a release of 48,650 lb. of bromine liquid over a 10-minute period. Although we have numerous controls to prevent such releases and to manage their c onsequences, no credit for administrative controls was taken into account in evaluating this scenario. The released bromine would spill into a diked containment area surrounding the tank, which mitigates the release. Since this facility is located in a populated area, the toxic cloud formed by the evaporating bromine would reach endpoints offsite and nearby public receptors under this worst-case release scenario. Alternative Release Scenarios The alternative release scenario for bromine is failure of the unloading hose from a tank truck to the storage tank resulting in a release of 52 lb. (2 gal.) of liquid bromine until Pfizer personnel isolate the release within 10 minutes. The 10-minute release duration is the approximate time necessary for fully-equipped, trained, always-present Pfizer employees to identify, respond, and stop the release. No other mitigation measures were taken into account in evaluating this scenario. The toxic cloud formed by the evaporating bromine would not be expected to reach any residential or institutional public receptors. The alternative release scenario for anhydrous ammonia is failure of the relief valve from one of the refrigeration system high-pressure receivers resulting in a release of 1,640 lb. of ammonia gas through a vent stack releasing at a 136 ft. elevation. The release could last for 20 minutes until Pfizer personnel identify, respond, and stop the release. No other mitigation measures were taken into account in evaluating this scenario. The toxic cloud formed by the ammonia gas would not be expected to reach any residential or institutional public receptors. 1.4 Accidental Release Prevention Program The following is a summary of the general accident prevention program in place at the Groton Plant. Because processes at the Groton Plant that are regulated by the EPA RMP regulation are also subject to the Occupational Safety and Health Administration (OSHA) process safety management (PSM) standard, and becaus e the OSHA PSM requirements are very similar to the EPA RMP requirements, this summary addresses each of the OSHA PSM elements. The PSM program at this facility has been extended by the Groton Plant, where necessary, to satisfy EPA's Program Level 3 accident prevention program requirements. Employee Participation The Groton Plant encourages employees to participate in all facets of process safety management and accident prevention. Examples of employee participation range from updating and compiling technical documents and chemical information to participating as a member of process hazard analysis (PHA), incident investigation, and compliance audit teams. Employees have access to all information created as part of the Groton Plant PSM program. Specific ways that employees can be involved in the PSM program are documented in an employee participation plan that is maintained at the Groton Plant and addresses each PSM program element. In addition, the Groton Plant has a number of initiatives that address process safety and employee safety issues. These initiatives include teams to promote both process and personal safety. The teams typically have members from various areas of the plant, including operations, maintenance, engineering, and plant management. Process Safety Information The Groton Plant keeps a variety of technical documents that are used to help maintain safe operation of the processes. These documents address chemical properties and associated hazards, limits for key process parameters and specific chemical inventories, and equipment design basis/configuration information. Specific operating areas within the Groton Plant are assigned responsibility for maintaining up-to-date process safety information. A summary of reference documents and their location is readily available as part of the written employee participation plan to help employees locate any necessary process safety information. Chemical-specific information, including exposure hazar ds and emergency response/exposure treatment considerations, is provided in material safety data sheets (MSDSs). This information is supplemented, where necessary, by documents that specifically address known corrosion concerns and any known hazards associated with the inadvertent mixing of chemicals. For specific process areas, the Groton Plant has documented safety-related limits for specific process parameters (e.g., temperature, level, composition). The Groton Plant ensures that the process is maintained within these limits by using process controls and monitoring instruments, highly trained personnel, and protective instrument systems (e.g., automated shutdown systems). The Groton Plant also maintains numerous technical documents that provide information about the design and construction of process equipment. This information includes materials of construction, design pressure and temperature ratings, electrical rating of equipment, etc. This information, in combination with written procedures and trained personnel, provides a basis for establishing inspection and maintenance activities, as well as for evaluating proposed process and facility changes to ensure that safety features in the process are not compromised. Process Hazard Analysis The Groton Plant has a comprehensive PHA program to help ensure that hazards associated with the various processes are identified and controlled. Within this program, each process is systematically examined to identify hazards and ensure that adequate controls are in place to manage those hazards. The Groton Plant primarily uses the hazard and operability (HAZOP) analysis and What-If/Checklist analysis techniques to perform these evaluations. These analysis methods are recognized as appropriate for determination of the hazards of the process being evaluated. The analyses are conducted using a team of people who have operating and maintenance experience as well as engineering expertise. This team identifies and evalu ates hazards of the process as well as accident prevention and mitigation measures, and makes recommendations for additional prevention and/or mitigation measures when the team believes such measures are necessary. The PHA team recommendations are forwarded to management for resolution. Implementation of safety improvements in response to PHA findings is based on a relative risk ranking assigned by the PHA team. They ensure that potential accident scenarios assigned the highest risk receive priority. All approved safety improvements being implemented in response to PHA team recommendations are tracked until they are complete. The final resolution of each recommendation is documented and retained. To help ensure that the process does not eventually deviate significantly from the original design, the Groton Plant periodically updates and revalidates the PHA results. These periodic reviews are conducted at least every 5 years and will be conducted at this frequency until the proces s is no longer operating. The results and recommendations from these updates are documented and retained. Once again, the team findings are forwarded to management for consideration, and the final resolution of the recommendations is documented and retained. Operating Procedures The Groton Plant maintains written procedures that address various modes of process operations, such as (1) unit startup, (2) normal operations, (3) temporary operations, (4) emergency shutdown, (5) normal shutdown, and (6) initial startup of a new process. These procedures can be used as a reference by experienced operators and provide a basis for consistent training of new operators. Procedures are periodically reviewed and annually certified as current and accurate. Procedures are maintained current by revising them as necessary to reflect changes made to the process. In addition, the Groton Plant operating procedures provide guidance on how to respond to events that result in exceeding safe operating limits for specific process or equipment parameters. The written operating procedures are readily available to operators in the process units and for other personnel to use as necessary to safely perform their job tasks. Training To complement the written procedures for process operations, the Groton Plant has implemented a training program for all employees involved in operating a process. New employees receive basic training in The Groton Plant operations if they are not already familiar with such operations. After successfully completing this training, a new operator is paired with a senior operator to learn process-specific duties and tasks. After operators demonstrate (e.g., through tests, skills demonstration) having adequate knowledge to perform the duties and tasks in a safe manner on their own, they can work independently. In addition, all operators periodically receive refresher training on the operating procedures to ensure that their skills and knowledge are maintaine d at an acceptable level. This refresher training is conducted at least every 3 years. All of this training is documented for each operator, including the means used to verify that the operator understood the training. Contractors The Groton Plant uses contractors to supplement its work force during periods of increased maintenance or construction activities. Because some contractors work on or near process equipment, the Groton Plant has procedures in place to ensure that contractors (1) perform their work in a safe manner, (2) have the appropriate knowledge and skills, (3) are aware of the hazards in their workplace, (4) understand what they should do in the event of an emergency, (5) understand and follow plant safety rules, and (6) inform The Groton Plant personnel of any hazards that they find during their work. This is accomplished by providing contractors with (1) a process overview, (2) information about safety and health hazards, (3) emergency response plan requirements, and (4) safe work practices prior to their beginning work. In addition, the Groton Plant evaluates contractor safety programs and performance during the selection of a contractor. The Groton Plant personnel periodically monitor contractor performance to ensure that contractors are fulfilling their safety obligations. Pre-startup Safety Reviews The Groton Plant conducts a pre-startup safety review for any new facility or facility modification that requires a change in the process safety information. The purpose of the review is to ensure safety features, procedures, personnel, and the equipment are appropriately prepared for startup prior to placing the equipment into service. This review provides one additional check to make sure construction is in accordance with the design specifications and supporting systems are operationally ready. A review involves field verification of the construction and serves a quality assurance function by requiring verification that accident prevent ion program requirements are properly implemented. Mechanical Integrity The Groton Plant has well-established practices and procedures to maintain pressure vessels, piping systems, relief and vent systems, controls, pumps and compressors, and emergency shutdown systems in a safe operating condition. The basic aspects of this program include: (1) conducting training, (2) developing written procedures, (3) performing inspections and tests, (4) correcting identified deficiencies, and (5) applying quality assurance measures. In combination, these activities form a system that maintains the mechanical integrity of the process equipment. Maintenance personnel receive training on (1) an overview of the process, (2) safety and health hazards, (3) applicable maintenance procedures, (4) emergency response plans, and (5) applicable safe work practices to help ensure that they can perform their job in a safe manner. Written procedures help ensure that work is performed in a consistent manner and provide a basis for training. Inspections and tests are performed to help ensure that equipment functions as intended, and to verify that equipment is within acceptable limits (e.g., adequate wall thickness for pressure vessels). If a deficiency is identified, employees will correct the deficiency before placing the equipment back into service (if possible), or a management of change team will review the use of the equipment and determine what actions are necessary to ensure the safe operation of the equipment. Another integral part of the mechanical integrity program is quality assurance. The Groton Plant incorporates quality assurance measures into equipment purchases and repairs. This helps ensure that new equipment is suitable for its intended use and proper materials and spare parts are used when repairs are made. Safe Work Practices The Groton Plant has long-standing safe work practices in place to help ensure worker and process safety. Examples of these include: (1 ) control of the entry/presence/exit of support personnel, (2) a lockout/tagout procedure to ensure isolation of energy sources for equipment undergoing maintenance, (3) a procedure for safe removal of hazardous materials before process piping or equipment is opened, (4) a permit and procedure to control welding and other spark-producing activities, and (5) a permit and procedure to ensure that adequate precautions are in place before entry into a confined space. These procedures (and others), along with training of affected personnel, form a system to help ensure that operations and maintenance activities are performed safely. Management of Change The Groton Plant has a comprehensive system to manage changes to processes. This system requires that changes to items such as process equipment, chemicals, technology (including process operating conditions), procedures, and other facility changes be properly reviewed and authorized before being implemented. Changes are reviewed to (1) ensure that adequate controls are in place to manage any new hazards and (2) verify that existing controls have not been compromised by the change. Affected chemical hazard information, process operating limits, and equipment information, as well as procedures, are updated to incorporate these changes. In addition, operating and maintenance personnel are provided with any necessary training on the change. Incident Investigation The Groton Plant promptly investigates all incidents that resulted in, or reasonably could have resulted in, a fire/explosion, toxic gas release, major property damage, environmental loss, or personal injury. The goal of each investigation is to determine the facts and develop corrective actions to prevent a recurrence of the incident or a similar incident. The investigation team documents its findings, develops recommendations to prevent a recurrence, and forwards these results to The Groton Plant management for resolution. Corrective actions taken in re sponse to the investigation team's findings and recommendations are tracked until they are complete. The final resolution of each finding or recommendation is documented, and the investigation results are reviewed with all employees (including contractors) who could be affected by the findings. Incident investigation reports are retained for at least 5 years so that the reports can be reviewed during future PHAs and PHA revalidations. Compliance Audits To help ensure that the accident prevention program is functioning properly, the Groton Plant periodically conducts audits to determine whether the procedures and practices required by the accident prevention program are being implemented. Compliance audits are conducted at least every 3 years. Both hourly and management personnel participate as audit team members. The audit team, which includes corporate EHS personnel, develops findings that are forwarded to The Groton Plant management for resolution. Corrective actions taken in r esponse to the audit team's findings are tracked until they are complete. The final resolution of each finding is documented, and the two most recent audit reports are retained. 1.5 Chemical-specific Prevention Steps The bromine storage and ammonia refrigeration processes at the Groton Plant have hazards that are managed to ensure continued safe operation. The accident prevention program summarized previously is applied to these EPA RMP-covered processes as well as OSHA PSM-covered processes at the Groton Plant. Collectively, these prevention program activities help prevent potential accident scenarios that could be caused by equipment failures or human errors. In addition to the accident prevention program activities, the Groton Plant has safety features on the bromine storage and ammonia refrigeration processes to help (1) contain/control a release, (2) quickly detect a release, and (3) reduce the consequences of a release. The following types of safety features are used in b oth these processes, except when otherwise noted: Release Detection * Chemical transfers (even truck transfers) are computer-controlled and are attended by trained operators * Continuous sensors and alarm system Release Containment/Control * Process relief valves that vent to prevent overpressure damage to equipment (ammonia only) * Process and storage tank relief valves/rupture discs that discharge to a containment area to capture bromine to prevent overpressure damage to equipment (bromine only) * Scrubber to neutralize chemical releases (bromine only) * Manual and automatic valves to permit isolation of the process * Automated shutdown systems for specific process parameters (e.g., high level, high temperature, high pressure) * Curbing or dikes to contain liquid releases (bromine only) * Release mitigation systems * Fire suppression and extinguishing systems * Trained emergency response personnel * Personal protective equipment (e.g., protective clothing, self-contai ned breathing apparatus) * Remote emergency shutdown of the system 1.6 Five-year Accident History No releases of bromine or ammonia from RMP-covered processes have occurred from the Groton Plant in the last 5 years that have resulted in any deaths, injuries, or significant property damage on site, or known deaths, injuries, evacuations, sheltering-in-place, property damage, or environmental damage off site. 1.7 Emergency Response Program The Groton Plant maintains a written emergency response program, which is in place to protect worker and public safety as well as the environment. The program consists of procedures for responding to a release of a regulated substance, including the possibility of a fire or explosion if a flammable substance is accidentally released. The procedures address all aspects of emergency response, including proper first aid and medical treatment for exposures, plant evacuation plans and accounting for plant personnel after an evacuation, notification o f local emergency response agencies and the public if a release occurs, and postincident cleanup and decontamination requirements. In addition, the Groton Plant has procedures that address maintenance, inspection, and testing of emergency response equipment, as well as instructions that address the use of emergency response equipment. Employees receive training in these procedures to perform their specific emergency response duties. The emergency response program is updated when necessary based on modifications made to plant processes or facilities. The emergency response program changes are administered through the management of change process, which includes informing and/or training affected personnel in the changes. The overall emergency response program for the Groton Plant is coordinated with the Groton police and fire departments and the local emergency planning committee (LEPC). The local police and fire departments would be called to support emergency response efforts if r equired. This coordination includes periodic meetings of the LEPC, which includes local emergency response officials, local government officials, and industry representatives. The Groton Plant has around-the-clock communications capability with appropriate LEPC officials and emergency response organizations (e.g., fire department). This provides a means of notifying the public of an incident, if necessary, as well as facilitating quick response to an incident. The Groton Plant conducts periodic emergency drills that involve the LEPC and emergency response organizations, and the plant provides annual refresher training to local emergency responders regarding the hazards of regulated substances in the plant. 1.8 Planned Changes to Improve Safety The Groton Plant constantly strives to improve the safety of its operations through periodic safety reviews, the incident investigation program, and a program soliciting safety suggestions from the workers. The Groton Plant resolves all fin dings from PHAs, some of which result in modifications to the process. The following types of changes are planned during the next 5 years: * Improve process controls and area detection systems for the ammonia refrigeration system * Review/revise the operating procedures for the ammonia refrigeration system * Review/revise the operating procedures for the bromine storage system * Perform vessel inspections on the bromine storage vessel * Design a computer-based training system for the ammonia refrigeration system * Review/revise emergency training procedures for bromine and ammonia system 10 1 PFIZER GLOBAL MANUFACTURING - GROTON PLANT Risk Management Plan Executive Summary 1. EXECUTIVE SUMMARY Pfizer Global Manufacturing is committed to operating in a manner that is safe for Pfizer employees, its contractors, the public, and the environment. The Groton Plant has established systems to help ensure safe operation of the processes at this facility. One part of these systems is a risk management program (RMP) that helps manage the risks at the Groton Plant and that complies with the requirements of the Environmental Protection Agency's (EPA's) rule 40 CFR part 68, Accidental Release Prevention Requirements: Risk Management Programs (the RMP rule). One of the requirements of the RMP rule is to submit a risk management plan (RMPlan) describing the risk management program at the Groton Plant. This document is intended to satisfy the RMPlan executive summary requirements of the RMP rule and to provide the public with a description of the risk management program at the Groton Plant. 1.1 Accidental Release Prevention and Emergency Response Policies The Groton Plant is committed to the safety of Pfizer employees, its contractors, and the public, and to the preservation of the environment, through the prevention of accidental releases of hazardous substances. The Groton Plant implements reasonable controls to prevent foreseeable releases of hazardous substances. In the event of an accidental release, our trained personnel will respond to control and contain such releases. The Groton Plant evaluates each situation, evacuates workers and contractors as necessary, responds based on our capabilities and training, and if necessary, contacts the local fire department to assist in controlling and containing the release and to prevent and/or reduce the consequences of the release. The Groton Plant, in conjunction with the City of Groton local emergency planning committee (LEPC), and the local police and fire departments have also established a system to use for warning the community if an accident occurs that could threaten the community. The Groton Plant Manager has overall responsibility for the development and implementation of the risk management program for EPA-regulated processes at Pfizer Global Manufacturing - Groton Plant. However, the specific responsibilities for certain aspects of that program have been delegated by the Plant Manager to other personnel who report either directly, or through other management personnel, to the Plant Manager. Those relationships are depicted on the organization chart maintained by the Plant Manager's staff. Specific responsibility for the implementation of the process safety management (PSM) and accident prevention program has been delegated to the plant Health and Safety Manager. Similarly, responsibility for the RMP hazard assessment and risk management plan has been delegated to the plant Health and Safety Manager. The emergency response program, including compliance with the RMP aspects of that effort, is the responsibility of the Manager of Environmental, Health & Safety. In keeping with our policy that safe operation is part of everyone's job, many other personnel are also involved in RMP activities on an ongoing basis. 1.2 Pfizer Global Manufacturing - Groton Plant Regulated Substances The Groton Plant is a pharmaceutical drug substance manufacturing plant located in Gro ton, Connecticut. Two substances used at the Groton Plant are held above the threshold quantities specified by EPA in the RMP rule. Bromine is used in the manufacturing process and is stored in a 48,650 lb. storage tank. Anhydrous ammonia is used in four co-located refrigeration systems, having a total inventory of 19,600 lb. of anhydrous ammonia. Because Pfizer has taken measures in recent years to minimize or eliminate the use of toxic substances in its operations, these are the only two RMP-covered processes we have at Groton. 1.3 Offsite Consequence Analysis Pfizer has performed an offsite consequence analysis for bromine and anhydrous ammonia at the Groton Plant to estimate the potential for an accidental release that could affect the public or the environment. The offsite consequence analyses consists of evaluating both worst-case scenarios and alternative release scenarios. The Groton Plant does not expect a worst-case release scenario to ever occur. An alternative relea se scenario represents a release that might occur during the lifetime of a facility like the Groton Plant. Alternative release scenarios can be used to help the LEPC improve the community emergency response plan. We have shared that information with the LEPC and other organizations involved in emergency response activities. It is also available to local residents and businesses. If you are interested in this information, please contact our RMP coordinator (860) 441-3225. The main objective of performing the offsite consequence analysis is to determine the distance at which certain effects might occur to the public because of an accidental release (called the endpoint distance). When considering the release of a toxic substance, most people at the endpoint distance would be able to walk away from the exposure without any long-term health consequences, although some short-term consequences (e.g., strong eye or throat irritation) are likely. Some people who are particularly suscept ible to the substance released could be affected to a greater extent. At distances less than the endpoint distance, the effects would be greater; at distances greater than the endpoint distance, the effects would be less. Worst-case Release Scenario The worst-case toxic release scenario, as defined by the RMP rule, associated with toxic substances in RMP-covered processes at the Groton Plant is a failure of the bromine storage tank, resulting in a release of 48,650 lb. of bromine liquid over a 10-minute period. Although we have numerous controls to prevent such releases and to manage their consequences, no credit for administrative controls was taken into account in evaluating this scenario. The released bromine would spill into a diked containment area surrounding the tank, which mitigates the release. Since this facility is located in a populated area, the toxic cloud formed by the evaporating bromine would reach endpoints offsite and nearby public receptors under this worst- case release scenario. Alternative Release Scenarios The alternative release scenario for bromine is failure of the unloading hose from a tank truck to the storage tank resulting in a release of 52 lb. (2 gal.) of liquid bromine until Pfizer personnel isolate the release within 10 minutes. The 10-minute release duration is the approximate time necessary for fully-equipped, trained, always-present Pfizer employees to identify, respond, and stop the release. No other mitigation measures were taken into account in evaluating this scenario. The toxic cloud formed by the evaporating bromine would not be expected to reach any residential or institutional public receptors. The alternative release scenario for anhydrous ammonia is failure of the relief valve from one of the refrigeration system high-pressure receivers resulting in a release of 1,640 lb. of ammonia gas through a vent stack releasing at a 136 ft. elevation. The release could last for 20 minutes until Pfizer personnel id entify, respond, and stop the release. No other mitigation measures were taken into account in evaluating this scenario. The toxic cloud formed by the ammonia gas would not be expected to reach any residential or institutional public receptors. 1.4 Accidental Release Prevention Program The following is a summary of the general accident prevention program in place at the Groton Plant. Because processes at the Groton Plant that are regulated by the EPA RMP regulation are also subject to the Occupational Safety and Health Administration (OSHA) process safety management (PSM) standard, and because the OSHA PSM requirements are very similar to the EPA RMP requirements, this summary addresses each of the OSHA PSM elements. The PSM program at this facility has been extended by the Groton Plant, where necessary, to satisfy EPA's Program Level 3 accident prevention program requirements. Employee Participation The Groton Plant encourages employees to participate in all facets of process safety management and accident prevention. Examples of employee participation range from updating and compiling technical documents and chemical information to participating as a member of process hazard analysis (PHA), incident investigation, and compliance audit teams. Employees have access to all information created as part of the Groton Plant PSM program. Specific ways that employees can be involved in the PSM program are documented in an employee participation plan that is maintained at the Groton Plant and addresses each PSM program element. In addition, the Groton Plant has a number of initiatives that address process safety and employee safety issues. These initiatives include teams to promote both process and personal safety. The teams typically have members from various areas of the plant, including operations, maintenance, engineering, and plant management. Process Safety Information The Groton Plant keeps a variety of technical documents that are used to help maintai n safe operation of the processes. These documents address chemical properties and associated hazards, limits for key process parameters and specific chemical inventories, and equipment design basis/configuration information. Specific operating areas within the Groton Plant are assigned responsibility for maintaining up-to-date process safety information. A summary of reference documents and their location is readily available as part of the written employee participation plan to help employees locate any necessary process safety information. Chemical-specific information, including exposure hazards and emergency response/exposure treatment considerations, is provided in material safety data sheets (MSDSs). This information is supplemented, where necessary, by documents that specifically address known corrosion concerns and any known hazards associated with the inadvertent mixing of chemicals. For specific process areas, the Groton Plant has documented safety-related limits for speci fic process parameters (e.g., temperature, level, composition). The Groton Plant ensures that the process is maintained within these limits by using process controls and monitoring instruments, highly trained personnel, and protective instrument systems (e.g., automated shutdown systems). The Groton Plant also maintains numerous technical documents that provide information about the design and construction of process equipment. This information includes materials of construction, design pressure and temperature ratings, electrical rating of equipment, etc. This information, in combination with written procedures and trained personnel, provides a basis for establishing inspection and maintenance activities, as well as for evaluating proposed process and facility changes to ensure that safety features in the process are not compromised. Process Hazard Analysis The Groton Plant has a comprehensive PHA program to help ensure that hazards associated with the various processes are iden tified and controlled. Within this program, each process is systematically examined to identify hazards and ensure that adequate controls are in place to manage those hazards. The Groton Plant primarily uses the hazard and operability (HAZOP) analysis and What-If/Checklist analysis techniques to perform these evaluations. These analysis methods are recognized as appropriate for determination of the hazards of the process being evaluated. The analyses are conducted using a team of people who have operating and maintenance experience as well as engineering expertise. This team identifies and evaluates hazards of the process as well as accident prevention and mitigation measures, and makes recommendations for additional prevention and/or mitigation measures when the team believes such measures are necessary. The PHA team recommendations are forwarded to management for resolution. Implementation of safety improvements in response to PHA findings is based on a relative risk ranking ass igned by the PHA team. They ensure that potential accident scenarios assigned the highest risk receive priority. All approved safety improvements being implemented in response to PHA team recommendations are tracked until they are complete. The final resolution of each recommendation is documented and retained. To help ensure that the process does not eventually deviate significantly from the original design, the Groton Plant periodically updates and revalidates the PHA results. These periodic reviews are conducted at least every 5 years and will be conducted at this frequency until the process is no longer operating. The results and recommendations from these updates are documented and retained. Once again, the team findings are forwarded to management for consideration, and the final resolution of the recommendations is documented and retained. Operating Procedures The Groton Plant maintains written procedures that address various modes of process operations, such as (1) unit startup, (2) normal operations, (3) temporary operations, (4) emergency shutdown, (5) normal shutdown, and (6) initial startup of a new process. These procedures can be used as a reference by experienced operators and provide a basis for consistent training of new operators. Procedures are periodically reviewed and annually certified as current and accurate. Procedures are maintained current by revising them as necessary to reflect changes made to the process. In addition, the Groton Plant operating procedures provide guidance on how to respond to events that result in exceeding safe operating limits for specific process or equipment parameters. The written operating procedures are readily available to operators in the process units and for other personnel to use as necessary to safely perform their job tasks. Training To complement the written procedures for process operations, the Groton Plant has implemented a training program for all employees involved in operating a process . New employees receive basic training in The Groton Plant operations if they are not already familiar with such operations. After successfully completing this training, a new operator is paired with a senior operator to learn process-specific duties and tasks. After operators demonstrate (e.g., through tests, skills demonstration) having adequate knowledge to perform the duties and tasks in a safe manner on their own, they can work independently. In addition, all operators periodically receive refresher training on the operating procedures to ensure that their skills and knowledge are maintained at an acceptable level. This refresher training is conducted at least every 3 years. All of this training is documented for each operator, including the means used to verify that the operator understood the training. Contractors The Groton Plant uses contractors to supplement its work force during periods of increased maintenance or construction activities. Because some contractors wor k on or near process equipment, the Groton Plant has procedures in place to ensure that contractors (1) perform their work in a safe manner, (2) have the appropriate knowledge and skills, (3) are aware of the hazards in their workplace, (4) understand what they should do in the event of an emergency, (5) understand and follow plant safety rules, and (6) inform The Groton Plant personnel of any hazards that they find during their work. This is accomplished by providing contractors with (1) a process overview, (2) information about safety and health hazards, (3) emergency response plan requirements, and (4) safe work practices prior to their beginning work. In addition, the Groton Plant evaluates contractor safety programs and performance during the selection of a contractor. The Groton Plant personnel periodically monitor contractor performance to ensure that contractors are fulfilling their safety obligations. Pre-startup Safety Reviews The Groton Plant conducts a pre-startup safet y review for any new facility or facility modification that requires a change in the process safety information. The purpose of the review is to ensure safety features, procedures, personnel, and the equipment are appropriately prepared for startup prior to placing the equipment into service. This review provides one additional check to make sure construction is in accordance with the design specifications and supporting systems are operationally ready. A review involves field verification of the construction and serves a quality assurance function by requiring verification that accident prevention program requirements are properly implemented. Mechanical Integrity The Groton Plant has well-established practices and procedures to maintain pressure vessels, piping systems, relief and vent systems, controls, pumps and compressors, and emergency shutdown systems in a safe operating condition. The basic aspects of this program include: (1) conducting training, (2) developing written procedures, (3) performing inspections and tests, (4) correcting identified deficiencies, and (5) applying quality assurance measures. In combination, these activities form a system that maintains the mechanical integrity of the process equipment. Maintenance personnel receive training on (1) an overview of the process, (2) safety and health hazards, (3) applicable maintenance procedures, (4) emergency response plans, and (5) applicable safe work practices to help ensure that they can perform their job in a safe manner. Written procedures help ensure that work is performed in a consistent manner and provide a basis for training. Inspections and tests are performed to help ensure that equipment functions as intended, and to verify that equipment is within acceptable limits (e.g., adequate wall thickness for pressure vessels). If a deficiency is identified, employees will correct the deficiency before placing the equipment back into service (if possible), or a management of change t eam will review the use of the equipment and determine what actions are necessary to ensure the safe operation of the equipment. Another integral part of the mechanical integrity program is quality assurance. The Groton Plant incorporates quality assurance measures into equipment purchases and repairs. This helps ensure that new equipment is suitable for its intended use and proper materials and spare parts are used when repairs are made. Safe Work Practices The Groton Plant has long-standing safe work practices in place to help ensure worker and process safety. Examples of these include: (1) control of the entry/presence/exit of support personnel, (2) a lockout/tagout procedure to ensure isolation of energy sources for equipment undergoing maintenance, (3) a procedure for safe removal of hazardous materials before process piping or equipment is opened, (4) a permit and procedure to control welding and other spark-producing activities, and (5) a permit and procedure to ensure th at adequate precautions are in place before entry into a confined space. These procedures (and others), along with training of affected personnel, form a system to help ensure that operations and maintenance activities are performed safely. Management of Change The Groton Plant has a comprehensive system to manage changes to processes. This system requires that changes to items such as process equipment, chemicals, technology (including process operating conditions), procedures, and other facility changes be properly reviewed and authorized before being implemented. Changes are reviewed to (1) ensure that adequate controls are in place to manage any new hazards and (2) verify that existing controls have not been compromised by the change. Affected chemical hazard information, process operating limits, and equipment information, as well as procedures, are updated to incorporate these changes. In addition, operating and maintenance personnel are provided with any necessary trainin g on the change. Incident Investigation The Groton Plant promptly investigates all incidents that resulted in, or reasonably could have resulted in, a fire/explosion, toxic gas release, major property damage, environmental loss, or personal injury. The goal of each investigation is to determine the facts and develop corrective actions to prevent a recurrence of the incident or a similar incident. The investigation team documents its findings, develops recommendations to prevent a recurrence, and forwards these results to The Groton Plant management for resolution. Corrective actions taken in response to the investigation team's findings and recommendations are tracked until they are complete. The final resolution of each finding or recommendation is documented, and the investigation results are reviewed with all employees (including contractors) who could be affected by the findings. Incident investigation reports are retained for at least 5 years so that the reports can be review ed during future PHAs and PHA revalidations. Compliance Audits To help ensure that the accident prevention program is functioning properly, the Groton Plant periodically conducts audits to determine whether the procedures and practices required by the accident prevention program are being implemented. Compliance audits are conducted at least every 3 years. Both hourly and management personnel participate as audit team members. The audit team, which includes corporate EHS personnel, develops findings that are forwarded to The Groton Plant management for resolution. Corrective actions taken in response to the audit team's findings are tracked until they are complete. The final resolution of each finding is documented, and the two most recent audit reports are retained. 1.5 Chemical-specific Prevention Steps The bromine storage and ammonia refrigeration processes at the Groton Plant have hazards that are managed to ensure continued safe operation. The accident prevention progra m summarized previously is applied to these EPA RMP-covered processes as well as OSHA PSM-covered processes at the Groton Plant. Collectively, these prevention program activities help prevent potential accident scenarios that could be caused by equipment failures or human errors. In addition to the accident prevention program activities, the Groton Plant has safety features on the bromine storage and ammonia refrigeration processes to help (1) contain/control a release, (2) quickly detect a release, and (3) reduce the consequences of a release. The following types of safety features are used in both these processes, except when otherwise noted: Release Detection * Chemical transfers (even truck transfers) are computer-controlled and are attended by trained operators * Continuous sensors and alarm system Release Containment/Control * Process relief valves that vent to prevent overpressure damage to equipment (ammonia only) * Process and storage tank relief valves/rupture discs that discharge to a containment area to capture bromine to prevent overpressure damage to equipment (bromine only) * Scrubber to neutralize chemical releases (bromine only) * Manual and automatic valves to permit isolation of the process * Automated shutdown systems for specific process parameters (e.g., high level, high temperature, high pressure) * Curbing or dikes to contain liquid releases (bromine only) * Release mitigation systems * Fire suppression and extinguishing systems * Trained emergency response personnel * Personal protective equipment (e.g., protective clothing, self-contained breathing apparatus) * Remote emergency shutdown of the system 1.6 Five-year Accident History No releases of bromine or ammonia from RMP-covered processes have occurred from the Groton Plant in the last 5 years that have resulted in any deaths, injuries, or significant property damage on site, or known deaths, injuries, evacuations, sheltering-in-place, property damage, or environment al damage off site. 1.7 Emergency Response Program The Groton Plant maintains a written emergency response program, which is in place to protect worker and public safety as well as the environment. The program consists of procedures for responding to a release of a regulated substance, including the possibility of a fire or explosion if a flammable substance is accidentally released. The procedures address all aspects of emergency response, including proper first aid and medical treatment for exposures, plant evacuation plans and accounting for plant personnel after an evacuation, notification of local emergency response agencies and the public if a release occurs, and postincident cleanup and decontamination requirements. In addition, the Groton Plant has procedures that address maintenance, inspection, and testing of emergency response equipment, as well as instructions that address the use of emergency response equipment. Employees receive training in these procedures to perfor m their specific emergency response duties. The emergency response program is updated when necessary based on modifications made to plant processes or facilities. The emergency response program changes are administered through the management of change process, which includes informing and/or training affected personnel in the changes. The overall emergency response program for the Groton Plant is coordinated with the Groton police and fire departments and the local emergency planning committee (LEPC). The local police and fire departments would be called to support emergency response efforts if required. This coordination includes periodic meetings of the LEPC, which includes local emergency response officials, local government officials, and industry representatives. The Groton Plant has around-the-clock communications capability with appropriate LEPC officials and emergency response organizations (e.g., fire department). This provides a means of notifying the public of an incident , if necessary, as well as facilitating quick response to an incident. The Groton Plant conducts periodic emergency drills that involve the LEPC and emergency response organizations, and the plant provides annual refresher training to local emergency responders regarding the hazards of regulated substances in the plant. 1.8 Planned Changes to Improve Safety The Groton Plant constantly strives to improve the safety of its operations through periodic safety reviews, the incident investigation program, and a program soliciting safety suggestions from the workers. The Groton Plant resolves all findings from PHAs, some of which result in modifications to the process. The following types of changes are planned during the next 5 years: * Improve process controls and area detection systems for the ammonia refrigeration system * Review/revise the operating procedures for the ammonia refrigeration system * Review/revise the operating procedures for the bromine storage system * Perform ves sel inspections on the bromine storage vessel * Design a computer-based training system for the ammonia refrigeration system * Review/revise emergency training procedures for bromine and ammonia system 10 1 |