Clinton 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 Clinton Laboratories facility (Clinton Labs).  Clinton Labs is located approximately five miles north of Clinton, Indiana.  Excavation work to build Clinton Labs began in March of 1969; operations began in June of 1970.  Clinton Labs is located on a 700-acre site.  The plant itself includes 85 buildings on 140 acres. 
 
This document provides a brief overview of the comprehensive risk management activities that Clinton 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 scenario and the alternative release scenarios, including administrativ 
e controls and mitigation 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: 
 
Clinton 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. Clinton 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. Clinton 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 chem 
icals. 
 
Clinton Laboratories has a Plant Emergency Manual that contains procedures on how to handle emergencies that occur.  The emergency response plan includes procedures for notification of local authorities and notification of any potentially affected neighbors. 
 
Clinton Labs plays an active roll 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 impacts 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. 
 
Clinton Laboratorie 
s actively supports local community outreach efforts through Community Advisory Panels and neighbor groups.  These panels provide useful feedback from the community and advise Lilly on community issues.  Lilly also host plant tours and informative evening programs for nearby neighbors. 
 
2. THE STATIONARY SOURCE AND REGULATED SUBSTANCES HANDLED: 
 
Clinton Labs is divided into three main functional areas.  Bulk Pharmaceutical Manufacturing (BPM), on the north end of the plant, manufactures bulk drug substances for human health products.  BPM makes the intermediate form of these products and ships them to other sites for finishing into capsules or pediatric medications.  Animal Health, on the south end of the plant, manufactures feed additives and other animal health products.  These products are finished and packaged on site for worldwide delivery to customers.  The third functional area, site services, is located primarily in the center of the plant, with other buildings throughout the p 
lant. Services provided include: steam, water, heat transfer media, electricity, and maintenance support. The services area provides support for both the BPM and Animal Health areas.  The facility has applied for, but not received, a Title V operating permit under the Clean Air Act. 
 
The following regulated substances are handled at Clinton Labs in quantities above the threshold quantities established under the RMP regulations.  
 
TOXICS 
 
CHEMICAL                           QUANTITY          USE 
Anhydrous Ammonia        88,000 pounds       fermentation feed stock     
Bromine                            99,000 pounds       pharmaceutical manufacturing 
Chlorine                            41,000 pounds       pharmaceutical manufacturing, water treatment 
Methyl Chloroformate      56,000 pounds        pharmaceutical manufacturing 
 
FLAMMABLES - None 
 
3. THE WORST-CASE RELEASE SCENARIO AND THE ALTERNATIVE RELEASE SCENARIOS, INCLUDING ADMINISTRATIVE CONTROLS AND MITIGATION MEASURES TO LIMIT TH 
E DISTANCES FOR EACH REPORTED SCENARIO: 
 
EPA's RMP rule requires that Clinton Labs provide information about the worst-case release scenario 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 
 
Lilly uses anhydrous ammonia as a feed stock for fermentation.  This worst case release scenario involves the release of the entire contents of the tank (88,000 pounds) to escape in ten minutes.  According to the EPAs RMP Comp and EPAs standard weather conditions, the distance to the toxic end point is 5.4 miles.  Approximately 10,000 residents may be affected by this release.  Administrative controls, including written operating procedures, limit the amount stored in the tank to 88,000 pounds, which is approximately 52 percent of  
the tank capacity, to minimize the impact of a release. 
 
Alternative-Case Release Scenario - Regulated Toxic Chemical - Anhydrous Ammonia  
 
The alternative case release scenario for anhydrous ammonia is similar to the worst case.  The alternative release scenario involves a pipe from the tank being sheared, allowing the contents of the tank (88,000 pounds) to escape in 22 minutes.  According to the CHARM (Complex Hazardous Air Release Model) using typical weather conditions for the Clinton site, the distance to the toxic end point is 2.4 miles. Approximately 320 residents may be affected by this release. Administrative controls limit the amount stored in the tank to 88,000 pounds, approximately 52 percent of the tank capacity, to minimize the impact of a release.  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 v 
alves, experienced operators and a pre-start up hazards assessment. 
 
Alternative-Case Release Scenario - Regulated Toxic Chemical - Bromine 
 
Clinton Labs uses bromine in pharmaceutical manufacturing.  The alternative case release scenario for bromine involves a spill, scrubber failure, and fume transport system failure.  This would allow 21,000 pounds of bromine to be released in 120 minutes.  The vessel has secondary containment and automatic shut off valves. According to the CHARM (Complex Hazardous Air Release Model) using typical weather conditions for the Clinton site, the distance to the toxic end point is 2.0 miles. Approximately 220 residents may be affected by this release.  Systems in place to minimize the potential impact of this release include:  stored in specifically designed tank located in building, storage tank located in concrete dike, routine vessel inspections, proactive system maintenance, experienced operators and hazards assessment. 
 
Alternative-Case Release Scen 
ario - Regulated Toxic Chemical - Chlorine 
 
Clinton Labs uses chlorine in pharmaceutical manufacturing and water treatment.  The alternative case release scenario for chlorine involves multiple vessels leaking simultaneously. This would allow 40,000 pounds of chlorine to be released in 216 minutes.  According to the CHARM (Complex Hazardous Air Release Model) using typical weather conditions for the Clinton site, the distance to the toxic end point is 2.3 miles. Approximately 290 residents may be affected by this release. Systems in place to minimize the potential impact of this release include:  alarms on critical process parameters, tanks specifically designed for chlorine storage with recessed valves, experienced operators, and hazards assessment. 
 
Alternative-Case Release Scenario - Regulated Toxic Chemical - Methyl chloroformate 
 
Clinton Labs uses methyl chloroformate in pharmaceutical manufacturing.  The alternative case release scenario for methyl chloroformate involves a multip 
le vessel spill. This would allow 1,500 pounds of methyl chloroformate to be released in 108 minutes.  According to the CHARM (Complex Hazardous Air Release Model) using typical weather conditions for the Clinton site, the distance to the toxic end point is 1.2 miles. Approximately 80 residents may be affected by this release. Systems in place to minimize the potential impact of this release include:  methyl chloroformate drums have been tested, and it has been determined that they can be dropped from a height of at least six feet without splitting or leaking; inventories of spill absorbent material are kept at many locations around the plant, so they are readily available in the event of a chemical spill; and production area monitors are installed to provide early detection of a methyl chloroformate spill or release. 
 
4. THE GENERAL ACCIDENTAL RELEASE PREVENTION PROGRAM AND THE SPECIFIC PREVENTION STEPS:  
 
Clinton Labs is subject to OSHA's Process Safety Management requirements, as we 
ll 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 Protection 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:  
 respond to community concerns 
 develop chemicals and products that have a safe life cycle 
 make health, safety and environment a priority for new processes 
 report ha 
zards to employees, customers and the public 
 counsel customers on safe use, transportation and disposal of products 
 operate plants in an environmentally safe manner 
 increase knowledge of product and process safety 
 solve historical contamination problems 
 participate in government regulation development 
 promote Responsible Care . with other chemical companies 
 
In order to participate in CMAs 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 
Goal: 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:  
 
Clinton Labs has experienced four minor accidents as defined by Title 40 CFR 68.42 in the five year period prior to June 21, 1999.  Following is a brief description of each accident: 
 
On August  
2, 1995, a charge hose was disconnected from a tanker truck unloading ammonia.  As a result of the disconnect, residual liquid ammonia in the hose vaporized and exposed an employee.  Less than one pound of ammonia was released.  This incident did not impact the community; however, a plant employee was exposed to the ammonia vapors.  The employee was subsequently checked by medical personnel and released.  As a result, administrative controls and procedures were improved.  Affected employees were made aware of this and trained as needed.  This incident is identified as AccidentHistoryID:  8.  An amount of one pound was entered in the RPM Submit data field 6.5(b) because the program will not accept values less than one pound.  
 
On March 17, 1995, a release of less than one pound of bromine occurred when a hazardous waste line was being cleaned. This incident did not impact the community; however, a plant employee was exposed to a small amount of bromine vapors.  The employee was subseque 
ntly checked by medical personnel and released.  As a result, administrative and engineering controls were improved. Employees were made aware of this and trained as needed.  This incident is identified as AccidentHistoryID:  9. An amount of one pound was entered in the RPM Submit data field 6.5(b) because the program will not accept values less than one pound.  
 
On May 4, 1997, a release of less than one pound of bromine occurred when transfer pump was being replaced. This incident did not impact the community; however, a plant employee was exposed to a small amount of bromine vapors.  The employee was subsequently checked by medical personnel and released.  As a result, administrative and engineering controls were improved. Employees were made aware of this and trained as needed.  This incident is identified as AccidentHistoryID:  11. An amount of one pound was entered in the RPM Submit data field 6.5(b) because the program will not accept values less than one pound.  Similarly, the 
exact time and duration of the event were not recorded.  A start time of 12 AM and a duration of 30 minutes were estimated.   
 
6. THE EMERGENCY RESPONSE PROGRAM: 
 
EMERGENCY MANAGEMENT AT CLINTON LABORATORIES 
The Clinton Laboratories emergency response plan is linked to the plans of the Vermillion County Emergency Response Committee and the Parke County Emergency Management group. The sites response is coordinated by plant security using the plants emergency response 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. It includes response procedures for each building/area of the plant. Regular drills test readiness and help employees practice responses to alarms and incidents. 
 
COMMUNITY ALERT NETWORK (CAN) SYSTEM 
Clinton Laboratories implemented an innovative community emergency notification system in 1996. The Community Alert Network, or CAN, is an aut 
omated phone messaging system. Within ten minutes it can send a recorded message to everyone who lives or works within three miles of the plant site. The system calls every number up to three times if there is no answer initially. It also generates a report advising what phones were not answered. In conjunction with the Parke and Vermillion county emergency planning organizations, Lilly tests the CAN system annually. The Clinton Laboratories Neighbor Team helps keep the phone numbers used by CAN up to date by contacting the plants near neighbors in Parke and Vermillion counties once a year. .                                                                                                                                                                            
EMERGENCY RESPONSE TEAMS 
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. In a 
n emergency situation, a member of the plant security staff becomes the incident commander. The plant safety and security staff have responsibility for custom-designed, state-of-the-art response equipment. Vehicles on site include an ambulance, a fire fighting foam truck, a hazardous materials response truck and a rescue truck.   .                                                                                                                                                                            
 FIRE BRIGADE/HAZARDOUS MATERIAL (HAZMAT) TEAM 
-Team members are employees who hold full-time jobs in other parts of the plant. Around 80 people from various work shifts make up the team. 
-Professionally-trained responders are always on site, and all responders wear pagers when not at work. 
-Hazardous material response includes responding to hazardous spills or vapor releases. Responders are trained to use proper equipment and techniques to stabilize a hazardous area and rescue employees w 
ho may need help. 
-Team undergoes rigorous monthly training in fire fighting and/or hazmat response. 
-Several members of the fire brigade/hazmat team are also members of the confined space rescue team. 
 
 CONFINED SPACE RESCUE TEAM 
This group specializes in rescue from tanks, pits and other confined areas. They are trained to use ropes and mechanical rescue techniques. Team members are also certified first responders. 
 
 FIRST RESPONDERS 
First Responders are trained to give emergency medical aid.  Some members are also trained in confined space rescue. All are certified in CPR, first aid and defibrillation. 
 
 COMMUNICATIONS DISPATCHERS 
Communications dispatchers are trained to manage the communications hub in plant security during emergency situations. 
 
7. PLANNED CHANGES TO IMPROVE SAFETY: 
 
Clinton Labs is committed to ongoing safety improvement.  A system to conduct Process Hazard Assessments is in place.  The system will assure Process Hazard Assessments are conducted for each of t 
he appropriate process as Clinton Labs. 
 
The mechanical systems are routinely tested to insure proper operation and performance.  Any problems found are corrected and opportunities for improvement are noted and evaluated.     
 
Practice drills are also conducted to practice and improve the procedures for responding to emergencies.
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