Merck & Co., Inc., Flint River Plant - Executive Summary

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The Merck & Co., Inc., (Merck) Flint River Plant located in Albany, Georgia, produces active pharmaceutical ingredients in bulk form.  The products manufactured at the site include two diuretic products, ZOCOR for the treatment of high cholesterol, PRILOSEC, for the treatment of ulcers, COZAAR for the treatment of high blood pressure and among others CRIXIVAN for the treatment of HIV infection and AIDS.  The actual operating area is approximately 90 acres and is located on an approximately 800 acre site.  The Merck, Flint River Plant employs approximately 560 full time employees.  In the pharmaceutical manufacturing processes at the site, various compounds and raw materials are used including acids, bases, flammables and water reactive materials. 
There are two compounds at the site that are directly regulated by the Risk Management Plan regulations and are included in this 1999 plan submission.  They are anhydrous ammonia and methyl formate.  Anhydrous ammonia is used in the manufactu 
ring of diuretics.  Methyl formate is used in the manufacture of an ulcer medication.   
The concepts of the Risk Management Plan regulations, which are prevention, detection and response, are not new to the Merck, Flint River Plant.  It has been and is Mercks policy to implement effective programs to prevent releases of the compounds that we use.  Further, our policy is to maintain equipment and procedures to quickly detect a release if one were to occur, and to maintain trained emergency response personnel and the necessary equipment to effectively respond to a release that might occur.  Our management and our employees have been focusing on these activities for many years.  In 1987 we began a formal process safety management program at the plant which was five years before this same type of program was required by OSHA.  Our process safety management program involves a detailed, step-by-step evaluation of every process.     
This is just one aspect of our process safety management  
program.  Other areas include operator training, detailed operating procedures, management of change, hazardous work permits, auditing, incident investigation and pre-startup safety reviews.  All of these areas of process safety management work together to result in pharmaceutical manufacturing processes which are designed with safety in mind.  They also ensure that we have multiple layers of protection to prevent a problem from happening in every process. 
Part of those multiple layers of protection is detection of releases that might occur.  In critical areas of the plant we have specially designed monitors that stand ready 24 hours a day, 7 days a week to detect a release of hazardous compounds.  For anhydrous ammonia, monitors are strategically placed along the storage and transfer system to quickly detect a release.  In addition, the site is staffed around the clock by trained operating personnel.  These personnel undergo many hours of training in the operation of the processes, t 
he operation of specific equipment, the potential hazards involved and what to do in an emergency.  They know what to look for and what actions to take if they see something that is not consistent with standard operating procedures.  Additional monitoring and detection systems include the computer controls and instrumentation at the site, and around the clock video monitoring of specific areas and operations.  All these people, procedures, equipment and systems combine to ensure that if a release were to occur, it would be detected and addressed quickly. 
The third concept of Risk Management Plan regulations that is also not new to us is the idea of response.  Since the mid 1970s, we have maintained a trained on-site emergency response team.  In fact, our in-plant fire department, which is manned by operators, mechanics and engineers who volunteer as fire fighters, has recently achieved the status of a certified Fire Department.  Our Fire Department is one of only two industrial fire d 
epartments in the state that meets all the requirements of municipal fire departments such as the City of Albany or the City of Atlanta.  This is a significant accomplishment and one that took many hours of training and work for our volunteers to achieve.  This high level of training and preparedness of our responders combined with some of the best fixed and mobile fire-fighting and emergency response equipment anywhere in Southwest Georgia make for an excellent on-site emergency response capability.   
In addition, the work of members of our Safety Services department for years in the leadership of the Local Emergency Planning Committee further extends our emergency response capabilities by closely coordinating our activities with those of our community responders.  Merck was involved early on in the formation of what is now the Albany/Dougherty Local Emergency Planning Committee (LEPC).  This organization was first formed as a Community Awareness and Emergency Response (CAER) committ 
ee in the mid 1980s.  Back then and still today, Merck personnel are active in the leadership of the LEPC.  From time to time we participate in LEPC emergency drills to test the plants and the communitys emergency response plans and coordination among agencies.  Between drills, we conduct our own in-plant drills and "table top" exercises to further improve the plants readiness and ability to respond to an emergency.  
There are several requirements for information that must be included in the actual Risk Management Plan.  One of these requirements is a 5-year accident history.  The Risk Management Plan regulations require that if a release of an RMP compound from a regulated process occurs that results in significant damage on-site or off-site or results in an injury to an employee or contractor on-site or anyone offsite, that event must be included in the 5-year accident history.  We have performed a detailed review of our accident records and have identified one accident that qual 
ifies for inclusion in the RMP 5-year accident history.  This event involved a small (less than 50 pound) release of anhydrous ammonia from the venting of a pressure safety valve.  One of our operators was nearby when this occurred and experienced irritation from the ammonia fumes.  Because medical treatment was needed, this event qualified for inclusion on the RMP 5-year accident history.  Fortunately, the operator did not experience any long term effects from the exposure.  After the release, we immediately investigated and determined the cause was a malfunctioning check valve.  Not only was the malfunctioning equipment replaced, but additional interlocks were installed to prevent a release even if the check valve were to fail in the future.  There were no other accidents that qualified for inclusion in the RMP 5-year accident history.  We believe the absence of other qualifying events in the anhydrous ammonia system and none for the methyl formate system is an indication of the safe 
ty we build into our operations. 
In addition to the process safety management aspects of the Risk Management Plan regulations, the regulations also require a facility to perform two types of evaluations related to potential offsite effects of a release of a regulated compound.  The first is what is frequently called the "worst case scenario."  This evaluation is prescribed in detail by the RMP regulations and requires the assumption that the largest tank in the RMP covered process releases its entire contents in a very short period (instantaneously for liquids and within 10 minutes for compressed gasses).  It also requires a facility to assume that none of the active layers of protection are there.  Finally, the RMP regulations require that a facility assume that all this happens at a time of the worst possible weather conditions.  Even though highly unlikely, this scenario can be used as a screening tool for emergency response planning.  
As indicated in this Risk Management Plan, we 
at the Merck, Flint River Plant have used the EPA recommended RMP*Comp software for all worst case scenario and alternate case scenario modeling.  RMP*Comp is an electronic version of EPAs Offsite Consequence Analysis Guidance and was chosen because it was provided by EPA for the purposes of preparing Risk Management Plans.  
One of our RMP regulated compounds, methyl formate, shows no offsite effects even under the worst case scenario evaluations.  Therefore, the lower concern for the risk posed by this compound at the site is reflected in the few requirements in the RMP regulations beyond the analysis of the worst case scenario.  This Risk Management Plan contains information regarding the methyl formate storage system and the worst case analysis performed. 
The worst case scenario for the other RMP regulated compound at the site, anhydrous ammonia, does indicate the potential for offsite effects under worst case conditions.  Therefore, further evaluation and planning is required f 
or the storage of this compound on site.  Risk Management Plan regulations require a formal process safety management program for this process, and also require more coordination with local emergency responders.  Finally the Risk Management Plan regulations require analysis of more likely release scenarios.  These more reasonable scenarios, or what some people call "alternate case scenarios" are more credible in three ways.  First, the entire content of the tank is not assumed to be released at once.  Instead, more common and more reasonable types of potential release events are evaluated such as leaks from pipelines, overfilling of the tank, releases that occur during filling operations and releases due to the malfunction of pressure relief valves.  These types of events are more likely to happen and serve as much more useful information for emergency response planning.  Second, the detection and emergency response systems that are in place are considered in the evaluation of alternat 
e case release scenarios.  It is important to include the beneficial effects of systems such as alarm and interlock systems, water curtains, fixed fire protection, effective emergency response teams and well trained operators.  When these factors are considered the greatly reduced potential offsite effects of a release are more accurately reflected.  Third, the alternate case release scenario evaluations are performed using more typical weather conditions.  Weather conditions frequently have the greatest single effect on a release of toxic or flammable compounds.  Evaluations at more commonly occurring weather conditions provide scenarios that emergency responders are much more likely to encounter.   
Anhydrous ammonia is used in the manufacture of two diuretic active pharmaceutical ingredients at the site.  Both of these processes are currently not being produced and all anhydrous ammonia has been removed from the site.  Current plans are to resume production later in 1999 or in the f 
irst quarter of 2000.  Therefore, we have indicated in the Registration Information of this Risk Management Plan (question 1.16) that this RMP will involve a predictive filling.  This means that this Risk Management Plan reflects the storage facilities and maximum anhydrous inventories that will be at the site when production resumes.   
While the processes that use anhydrous ammonia are shut down and the ammonia has been removed from the site, we are using this opportunity to make two major improvements in the anhydrous ammonia storage system.  First we are reducing the anhydrous ammonia inventory to approximately one eighth of the previous capacity.  This is being done by replacing the current tank with a much smaller storage tank.  The tank is being replaced with a new smaller tank because our production requirements can be supported with a significantly smaller inventory of anhydrous ammonia.  This risk management planning process has shown us that maintaining a smaller inventory i 
s better in the long run.   
The second major improvement is that the new smaller tank facilitates the installation of a state-of-the-art water curtain that will totally encompass the ammonia storage tank during a release event.  This system, which can be remotely activated, will be installed before anhydrous ammonia is stored again on site.  If a release of anhydrous ammonia were to occur from the storage tank, the water curtain can be activated from one of several locations to effectively scrub ammonia vapors from the air before they leave the area.  This fixed protection system, along with our mobile fire truck and other fixed fire cannons combine to form a solid wall of protection in the event of a release of anhydrous ammonia.  The alternate case release scenario evaluation includes these improvements. 
A total of seven alternate case scenarios regarding anhydrous ammonia storage and handling were evaluated.  None of these scenarios, when considering the layers of safety protectio 
n in place, resulted in an offsite effect.  These layers of protection include, trained operators who can quickly detect a release, ammonia sensors that can also detect a release, safety interlocks that are triggered on pressure sensors that can detect a drop in line pressure and automatically shut off flow of ammonia, high flow shutoff valves that limit the release of ammonia if a transfer line were to break, a remotely operated water curtain which will effectively scrub an ammonia release once activated, and emergency response personnel who can further assist in controlling an ammonia release.  The fact that no alternate case release scenario resulted in offsite impacts is a very good indication that the multiple layers of protection are ample and appropriate prevention, detection and response measures for our anhydrous ammonia storage and transfer system. 
The alternate case release scenario for anhydrous ammonia chosen for inclusion in this Risk Management Plan was a line failure r 
esulting in a leak at just below setpoint of the high flow shutoff valves.  This scenario was chosen because it involves the largest release of anhydrous ammonia.  The layers of protection considered in this evaluation were: an interlock which prevents a release of this kind from occurring outside of the area protected by the water curtain; a concrete dike which contains the released anhydrous ammonia while it evaporates and reduces the evaporation rate of the released pool; a water curtain which, once activated, effectively scrubs vapors coming from the pool of released ammonia; and trained personnel who can stop the leak of ammonia once the released vapors are controlled.  Using the EPA recommended release evaluation software RMP*Comp and considering the layers of protection listed above, it was determined that this release scenario resulted in no offsite effects. 
We at the Merck, Flint River Plant will continue to maintain the safety systems, equipment and state of readiness needed 
to protect our workers and our community.  We will also continue our involvement in organizations like the Local Emergency Planing Committee (LEPC) to ensure that our emergency response activities are fully coordinated with community responders.   
As listed elsewhere in this Risk Management Plan, for more information on our safety activities please call Arthur C. Darden, Assistant Safety Manager, at (912) 420-2276.  For information on our plan or for other questions you might have please call David R. Orr, Environmental Services Supervisor, at (912) 420-2271.
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