Tippecanoe Laboratories - Executive Summary |
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Eli Lilly and Company (Lilly), a global research-based pharmaceutical corporation, is dedicated to delivering innovative pharmaceutical-based healthcare solutions that enable people to live longer, healthier and more active lives. Lilly manufactures both human health products and animal health products at its Tippecanoe Laboratories facility (Tippecanoe Labs). Tippecanoe Labs is located near Lafayette, Indiana. Operations at Tippecanoe Labs began in 1954. Tippecanoe Labs owns over 2000 acres, including farmland and a wildlife habitat. The plant itself includes 128 buildings on 500 acres. This document provides a brief overview of the comprehensive risk management activities that Tippecanoe Labs has designed and implemented, including: 1. Accidental release prevention and emergency response policies 2. The stationary source and regulated substances handled 3. The worst-case release scenarios and the alternative release scenarios, including administrative controls and mit igation measures to limit the distances for each reported scenario 4. The general accidental release prevention program and the specific prevention steps 5. Five-year accident history 6. The emergency response program 7. Planned changes to improve safety 1. ACCIDENTAL RELEASE PREVENTION AND EMERGENCY RESPONSE POLICIES: Tippecanoe Labs is committed to operating and maintaining all processes in a safe and responsible manner. This is especially important for those processes using hazardous substances. Tippecanoe Labs has numerous systems in place to manage these chemicals. Lilly uses a combination of accidental release prevention programs and emergency response planning programs to ensure the safety of employees and the public as well as protection of the environment. Tippecanoe Labs' accidental release prevention programs and contingency planning efforts help effectively manage the hazards that are posed to employees, the public, and the environment by the use of these chemic als. Lilly employees are highly skilled and trained to perform their jobs and safely design, construct, operate and maintain the company's facilities. Lilly is also thoroughly prepared to respond to accidents and other incidents with fully trained response teams. Tippecanoe Laboratories plays an active role in its Local Emergency Planning Committee (LEPC). A primary goal of the LEPC is to protect local citizens by developing and maintaining a coordinated emergency response plan and working with industry to minimize the impact of chemical hazards. Through the LEPC, citizens can obtain information about hazardous substances handled at local facilities and about emergency planning efforts designed to successfully cope with accidents if they occur. The LEPC maintains a coordinated emergency response plan for the community detailing operational procedures to be followed in the event of an accident involving hazardous materials. The plan is available for public inspection. Tippecanoe Laboratories actively supports local community outreach efforts through Community Advisory Panels and neighborhood groups. These panels provide feedback from the community and advise Lilly on community issues. Lilly also hosts plant tours and informative evening programs for nearby neighbors. 2. THE STATIONARY SOURCE AND REGULATED SUBSTANCES HANDLED: Tippecanoe Labs is divided into three main functional areas. Bulk Pharmaceutical Manufacturing manufactures bulk drug substances and clinical trials materials for human health products. This area includes manufacturing facilities, Incineration Services, Solvent Recovery, and storage tanks. Fermented Products Manufacturing manufactures antibiotics and animal feed additives. This area includes manufacturing facilities, Environmental Controls, Solvent Recovery, and storage tanks. The third functional area, Site Services, includes Utilities and maintenance areas that provide services to the entire site. The site also has laboratori es and pilot plant facilities supporting the research and development of human and animal health products. The facility has applied for, but not yet received, a Title V operating permit under the Clean Air Act. The following regulated substances are handled at Tippecanoe Labs in quantities above the threshold quantities established under the RMP regulations. TOXICS CHEMICAL QUANTITY USE Anhydrous Ammonia 35,000 pounds fermented products manufacturing Bromine 100,000 pounds pharmaceutical manufacturing Chlorine 10,000 pounds water treatment Chloroform 200,000 pounds pharmaceutical manufacturing (two covered processes) Hydrochloric Acid (conc. 37% or greater) 97,000 pounds pharmaceutical manufacturing Hydrochloric Acid (conc. 37% or greater) 55,000 pounds pharmaceutical manufacturing Hydrochloric Acid (conc. 37% or greater) 120,000 pounds fermented products manufacturing Hydrochloric Acid (conc. 37% or greater) 120,000 pounds pharmaceutical manufacturing Phosphorus Trichloride 90,000 pounds pharmaceutical manufacturing Trimethylchlorosilane 14,000 pounds pharmaceutical manufacturing FLAMMABLES CHEMICAL QUANTITY USE Ethyl Ether 44,000 pounds pharmaceutical manufacturing (three covered processes) Pentane 86,000 pounds pharmaceutical manufacturing 3. WORST-CASE RELEASE SCENARIOS AND ALTERNATIVE RELEASE SCENARIOS, INCLUDING ADMINISTRATIVE CONTROLS AND MITIGATION MEASURES TO LIMIT THE DISTANCES FOR EACH REPORTED SCENARIO: EPA's RMP rule requires that Tippecanoe Labs provide information about the worst-case release scenarios and alternative release scenarios for the facility. The following are brief summaries of these scenarios, including information about the key administrative controls and mitigation measures to limit the exposure distances for each scenario: Worst-Case Release Scenario - Regulated Toxic Chemical - Anhydrous Ammonia Tippecanoe Labs uses anhydrous ammonia as a raw material in fermented products manufacturing. This worst-case release scenario involves the release of the entire contents of the tank (35,000 pounds) in ten minutes. According to the EPA's RMP Comp program, using EPA's standard weather conditions, the distance to th e toxic endpoint is 3.1 miles. Approximately 55,000 residents may be affected by this release. Procedures and alarms limit the volume in the anhydrous ammonia tank to 85% of the tank capacity. Worst-Case Release Scenario - Regulated Flammable Chemical - Ethyl Ether Tippecanoe Labs uses ethyl ether as a solvent in pharmaceutical manufacturing. This worst-case release scenario involves the entire contents of the tank (44,000 pounds) vaporizing, resulting in a vapor cloud explosion. According to the EPA's RMP Comp program, using an endpoint distance of an overpressure of 1 psi., the flammable endpoint is 0.3 miles. No residents may be affected, but the explosion may reach a recreation area, the Wabash River. Alternative Case Release Scenario - Regulated Toxic Chemical - Anhydrous Ammonia The alternative release scenario for anhydrous ammonia involves a pipe from the tank being sheared, allowing the contents of the tank (35,000 pounds) to escape in 19 minutes. According to the CH ARM (Complex Hazardous Air Release Model) model using typical weather conditions for the Tippecanoe Labs site, the distance to the toxic endpoint is 1.4 miles. Approximately 3,200 residents may be affected by this release. Procedures and alarms limit the volume in the anhydrous ammonia tank to 85% of the tank capacity. Other systems in place to minimize the potential impact of this release include: routine vessel inspections, proactive maintenance, alarms on critical tank parameters, remote emergency system shutdown stations, excess flow valves, experienced operators and emergency response personnel, and a hazards assessment. Alternative Case Release Scenario - Regulated Toxic Chemical - Bromine Tippecanoe Labs uses bromine as a raw material in pharmaceutical manufacturing. The alternative release scenario for bromine involves a transfer hose failure when unloading a supply truck into the storage tank. This would allow 5,600 pounds of bromine to escape in 94 minutes. A remotel y activated emergency shutoff valve minimizes the amount of bromine released. According to the CHARM (Complex Hazardous Air Release Model) model using typical weather conditions for the Tippecanoe Labs site, the distance to the toxic endpoint is 1.2 miles. Approximately 1,500 residents may be affected by this release. Systems in place to minimize the potential impact of this release include: using a storage tank specifically designed for bromine located in a building, locating the storage tank in a concrete dike, routine vessel inspections, proactive maintenance, experienced operators and emergency response personnel, and a hazards assessment. Alternative Case Release Scenario - Regulated Toxic Chemical - Chlorine Tippecanoe Labs uses chlorine for water treatment. The alternative release scenario for chlorine involves a storage vessel leak. This would allow 2,000 pounds of chlorine to escape in 19 minutes. According to the CHARM (Complex Hazardous Air Release Model) model using typical weather conditions for the Tippecanoe Labs site, the distance to the toxic endpoint is 1.4 miles. Approximately 3,200 residents may be affected by this release. Systems in place to minimize the potential impact of this release include: alarms on critical process parameters, using a vessels specifically designed for chlorine, remote chlorine monitors, experienced operators and emergency response personnel, and a hazards assessment. Alternative Case Release Scenario - Regulated Toxic Chemical - Chloroform Tippecanoe Labs uses chloroform as a solvent in pharmaceutical manufacturing. The alternative release scenario for chloroform involves the storage tank venting during a fire. This would allow the entire contents of the storage tank (200,000 pounds) to escape in 72 minutes. According to the CHARM (Complex Hazardous Air Release Model) model using typical weather conditions for the Tippecanoe Labs site, the distance to the toxic endpoint is 0.79 miles. Approximately 360 r esidents may be affected by this release. Systems in place to minimize the potential impact of this release include: routine vessel inspections, proactive maintenance, alarms on critical process parameters, remote solvent system shutdown stations, explosion limit monitors, experienced operators and emergency response personnel, and a hazards assessment. Alternative Case Release Scenario - Regulated Toxic Chemical - Hydrochloric Acid (conc. 37% or greater) Tippecanoe Labs uses hydrochloric acid as a raw material in pharmaceutical and fermented products manufacturing. The alternative release scenario for hydrochloric acid involves a pipe leak during the unloading of a supply truck into the storage tank for the fermented products area. This would allow 19,000 pounds of hydrogen chloride to escape in 52 minutes. According to the CHARM (Complex Hazardous Air Release Model) model using typical weather conditions for the Tippecanoe Labs site, the distance to the toxic endpoint is 1.3 m iles. Approximately 3,400 residents may be affected by this release. Systems in place to minimize the potential impact of this release include: routine vessel inspections, proactive maintenance, storage tank located in concrete dike, experienced operators and emergency response personnel, and a hazards assessment. Alternative Case Release Scenario - Regulated Toxic Chemical - Phosphorus Trichloride Tippecanoe Labs uses phosphorus trichloride as a raw material in pharmaceutical manufacturing. The alternative release scenario for phosphorus trichloride involves a multiple vessel spill. This would allow 2,800 pounds of phosphorus trichloride to escape in 88 minutes. According to the CHARM (Complex Hazardous Air Release Model) model using typical weather conditions for the Tippecanoe Labs site, the distance to the toxic endpoint is 0.52 miles. Approximately 90 residents may be affected by this release. Systems in place to minimize the potential impact of this release include: ex perienced operators and emergency response personnel, and a hazards assessment. Alternative Case Release Scenario - Regulated Toxic Chemical - Trimethylchlorosilane Tippecanoe Labs uses trimethylchlorosilane as a raw material in pharmaceutical manufacturing. The alternative release scenario for trimethylchlorosilane involves a vessel leak. This would allow 620 pounds of trimethylchlorosilane to escape in 166 minutes. According to the CHARM (Complex Hazardous Air Release Model) model using typical weather conditions for the Tippecanoe Labs site, the distance to the toxic endpoint is 0.21 miles. No residents would be affected, but the release may reach a recreation area, the Wabash River. Systems in place to minimize the potential impact of this release include: using vessels specifically designed for trimethylchlorosilane, experienced operators and emergency response personnel, and a hazards assessment. Alternative Case Release Scenario - Regulated Flammable Chemical - Ethyl Ethe r Tippecanoe Labs uses ethyl ether as a solvent in pharmaceutical manufacturing. The alternative release scenario for ethyl ether involves 30,000 pounds vaporizing, followed by a confined explosion. According to a model based on TNT-equivalent methods with a yield factor of 10%, the distance to the flammable endpoint is 0.23 miles. No residents would be affected, but the release may reach a recreation area, the Wabash River. Systems in place to minimize the potential impact of this release include; having materials on-site only when being used, experienced operators and emergency response personnel, and a hazards assessment. 4. GENERAL ACCIDENTAL RELEASE PREVENTION PROGRAM AND SPECIFIC PREVENTION STEPS: Tippecanoe Labs is subject to OSHA's Process Safety Management requirements, as well as other OSHA requirements. The facility is also subject to regulation by other agencies, including the Indiana Department of Environmental Management, and the United States Environmental Pro tection Agency. Specific prevention programs include conducting pre-startup and design hazard assessments, proactive maintenance programs, routine vessel inspections, emergency response training, safe to work programs, employee and contractor safety programs, and accident investigation programs. As a member of the Chemical Manufacturers Association (CMA), Lilly participates in a program known as Responsible Care.. The purpose of Responsible Care. is to commit companies to performance improvement in health, safety, and environmental quality. The Responsible Care. initiative is driven by the following guiding principles: o respond to community concerns o develop chemicals and products that have a safe life cycle o make health, safety and environment a priority for new processes o report hazards to employees, customers and the public o counsel customers on safe use, transportation and disposal of products o operate plants in an environmentally safe manner o increase knowledge of prod uct and process safety o solve historical contamination problems o participate in government regulation development o promote Responsible Care . with other chemical companies In order to participate in CMA's Responsible Care . program, Lilly has committed to meet these guidelines and incorporate them into the way it does business. All Lilly sites regulated by the Environmental Protection Agency (Indiana and Puerto Rico sites) participate in this national program. Similar programs have also been initiated in European and Canadian plants. The heart of the Responsible Care . initiative is the six Codes of Management Practices: COMMUNITY AWARENESS & EMERGENCY RESPONSE Goal: Ensure emergency preparedness and foster community right-to-know EMPLOYEE HEALTH AND SAFETY Goal: Protect the health and safety of employees and people visiting company sites POLLUTION PREVENTION Goal: Promote efforts to protect the environment by generating less waste and reducing emissions PROCESS SAFETY Goa l: Prevent fires, explosions and accidental releases DISTRIBUTION Goal: Reduce the risk to public carriers, customers, contractors, employees and environment posed by the transportation and storage of chemicals PRODUCT STEWARDSHIP Goal: Promote the safe handling of chemicals and products from initial manufacture to distribution, sale and ultimate disposal Lilly is proud to participate in this forward-looking industry initiative. It is one way Lilly can demonstrate its commitment to ensuring the safety of its employees and the community and to protecting the environment. 5. FIVE-YEAR ACCIDENT HISTORY: Tippecanoe Labs has had no accidents as defined in 40 CFR 68.42 during the past five years. 6. EMERGENCY RESPONSE PROGRAM: EMERGENCY MANAGEMENT AT TIPPECANOE LABS The Tippecanoe Labs emergency response plan is linked to the plans of the Tippecanoe County Local Emergency Planning Committee. The site's response is coordinated by plant security using the plant's emergency respo nse teams and equipment. The emergency response plan spells out the "hows" of emergency response and the roles and responsibilities of the incident response and management response teams. Regular drills test readiness and help employees practice responses to alarms and incidents. COMMUNITY ALERT NETWORK (CAN) SYSTEM Tippecanoe Laboratories has implemented an innovative community emergency notification system. The Community Alert Network, or CAN System, is an automated phone messaging system that can place more than 1000 calls in ten minutes to neighbors announcing a site emergency. The phone call will ask the neighbors to shelter-in-place until the emergency is over. Tippecanoe Labs routinely tests the CAN system. EMERGENCY RESPONSE TEAMS Tippecanoe Labs maintains a fully trained emergency response organization that is on-site 24 hours a day, 7 days a week. The site has approximately 100 fully trained emergency response personnel. Site emergency response teams undergo regular training by security coordinators and officers. These trainers attend and receive certification from the best emergency response schools in the country. Each response team member receives at least 40 hours of training in handling industrial fires and hazardous materials. The emergency response organization has responsibility for custom-designed, state-of-the-art response equipment. Vehicles on site include a fully equipped chemical response van, an ambulance, an incident command vehicle, and two modern fully equipped fire trucks. Tippecanoe Labs also has an on-site medical facility. 7. PLANNED CHANGES TO IMPROVE SAFETY: Tippecanoe Labs is committed to ongoing safety improvement. Accident prevention is incorporated into each stage of the facility's life cycle, from the up-front design and construction through start-up, operation and maintenance to any facility expansion or modification. The multiple safeguards ensure accident prevention. Ongoing safety improvements include s afely designing, building, or modifying facilities. Employees and contractors are appropriately trained and tested. Equipment is safely started or re-started following pre-startup safety reviews. The plant is safely operated using detailed operating procedures that include safe operating limits. Equipment is regularly inspected and maintained. Process hazard reviews are completed and periodically updated. Approximately 15,000 man-hours per year are put into process hazard reviews at Tippecanoe Labs. The entire safety system is regularly audited. |