Bristol-Myers Squibb Company -Technical Operations - Executive Summary |
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This submittal has been prepared under the requirements of the Risk Management Planning (RMP) Program (40 CFR 68) and summarizes Bristol-Myers Squibb's (BMS's) initiatives under the RMP Program. ACCIDENTAL RELEASE PREVENTION AND EMERGENCY RELEASE POLICIES AT FACILITY - The Bristol-Myers Squibb Company is committed to ensuring the safety of their employees, local residents, and potential environmental receptors through the implementation of safe utilization practices, procedures, and measures at the Syracuse, New York facility. FACILITY DESCRIPTION AND REGULATED SUBSTANCES HANDLED - The Bristol-Myers Squibb Company owns and operates a bulk pharmaceutical manufacturing facility at 6000 Thompson Road, Syracuse, New York. The BMS-Syracuse facility comprises 84 acres and is bordered by residential, commercial, and industrial properties. Over 70 buildings are located at the site, providing facilities for two divisions of the company: Technical Operations and Pharmaceutical Resear ch Institute (PRI). The Technical Operations facilities consist of pharmaceutical manufacturing, quality control, chemical and biological development laboratories, pilot plants, and administrative offices. Pharmaceutical manufacturing activities include fermentation, chemical extraction, chemical synthesis, and bulk operations. The manufacturing operations produce primarily intermediate bulk antibiotics and other pharmaceutical compounds which are shipped outside the facility for final processing to finished product forms. PRI facilities consist primarily of research laboratories and administrative offices. The primary NAICS code for facility operations is "325411: Medicinal and Botanical Manufacturing". Specific operations which occur at the Thompson Road facility that are classified under this NAICS code include: (1) antibiotics: bulk, uncompounded and (2) chemicals, medical: organic and inorganic - bulk, uncompounded. BMS utilizes two chemicals at the Thompson Roa d facility at levels in excess of the established RMP thresholds: anhydrous ammonia and dimethyldichlorosilane (DDS). Anhydrous ammonia is maintained in one bulk storage tank at a working capacity of 22,050 pounds (the storage tank is located in a dedicated building). Dimethyldichlorosilane is maintained in one bulk storage tank at a working capacity of 80,314 pounds (this vessel is located in a dedicated building). The use of both anhydrous ammonia and DDS at the Syracuse facility are summarized below. Anhydrous ammonia is utilized in both fermentation and hydrolysis operations. Fermentation uses anhydrous ammonia for pH control. The Fermentation pH control system consists of a probe in each tank to measure the pH, a computer control system, a solenoid valve on the ammonia line to each tank, and associated piping. When the pH drops below the predetermined value, the solenoid valve is energized (opening for a short time) and ammonia flows into the tank with the air supply. In addition, the hydrolysis plant uses anhydrous ammonia for pH control during hydrolysis. Setpoints for pH control, hydrolysis time, and ammonia use are entered into the analog output control prior to hydrolysis. During hydrolysis, two pH probes in each hydrolyzer are monitored continuously. Total ammonia use and minimum hydrolysis time are also monitored during hydrolysis. Dimethyldichlorosilane is utilized in the manufacture of an antibiotic product. Within the manufacturing process, DDS is combined with solvents and the pharmaceutical precusor to form a "protected" intermediate. During the course of the reaction, the DDS is totally consumed by the reaction. The batch operation is controlled automatically via computer. The BMS-Syracuse facility operates 24-hours a day, seven days a week. In May 1999, Bristol-Myers Squibb employed approximately 850 full-time personnel at the Thompson Road facility. Access to the site is restricted by both fencing and security per sonnel/equipment. WORST-CASE AND ALTERNATE RELEASE SCENARIOS - As a requirement under the RMP Program, BMS has evaluated the potential impacts from both anhydrous ammonia and DDS releases (under both worst-case and alternate release scenarios). The planning distances and potential impacts of these release scenarios are discussed below. For the anhydrous ammonia worst-case release scenario, BMS has assumed a release of the entire contents of the bulk storage tank (working capacity maintained at 5,000 gallons) over a period of ten minutes. In the calculation of the release rate, BMS has accounted for the fact that the storage tank is maintained in a building (utilizing the release rate calculation methodology established in the USEPA's "Risk Management Program Guidance for Wastewater Treatment Plants" document). The planning distance for such a release has been estimated at 2,060 feet (release would leave facility boundaries; process would be categorized as a Program Level 3 ac tivity). This planning distance has been estimated by air dispersion modeling, utilizing the Inpuff model (with urban coefficients). This release event would have the potential to impact population receptors. BMS has a number of mitigation controls in place which would reduce the probability or minimize the impacts of such an event (these measures are described in the section entitled, "General Accidental Release Prevention Program and Chemical-Specific Prevention Systems", below). For the alternate release scenario, BMS has assumed that the anhydrous ammonia delivery hose would develop a significant leak during bulk unloading. For the scenario, BMS has assumed a 30-minute response time to isolate the leak (e.g., don personnel protective equipment and actuate valving at both the truck and tank). The planning distance for such a release has been estimated at 187 feet (this distance has been estimated by air dispersion modeling, utilizing the Inpuff model (with urban coefficien ts)). This release event would not have the potential to impact population receptors. BMS has a number of mitigation controls in place which would reduce the probability or minimize the impacts of such an event (these measures are described in the section entitled, "General Accidental Release Prevention Program and Chemical-Specific Prevention Systems", below). For the dimethyldichlorosilane worst case release scenario, BMS has assumed a release of the entire contents of the bulk storage tank over a period of ten minutes. In calculation of the release rate, BMS has accounted for the fact that the storage tank is maintained in a building (utilizing the release rate calculation methodology established in the USEPA's "RMP Offsite Consequence Analysis Guidance" document). The planning distance for such a release has been estimated at 53 feet (release would not leave facility boundaries; process would be categorized as a Program Level 1 activity). This planning distance has been e stimated by air dispersion modeling, utilizing the Inpuff model (with urban coefficients). As this release event would not leave the facility boundaries, offsite population/environmental impacts are not predicted. BMS has a number of mitigation controls in place which would reduce the probability or minimize the impacts of such an event (these measures are described in the section entitled, "General Accidental Release Prevention Program and Chemical-Specific Prevention Systems", below). GENERAL ACCIDENTAL RELEASE PREVENTION PROGRAM AND CHEMICAL-SPECIFIC PREVENTION SYSTEMS (Ammonia System) - Bristol-Myers Squibb has implemented a number of passive and active mitigation measures in an effort to reduce the probability or minimize the impacts of an anhydrous ammonia gaseous release. These measures include: (1) the bulk anhydrous ammonia tank is maintained in a diked building which would contain minor releases and dramatically reduce the impacts of a catostrophic release; (2) this building is protected by a foam suppresion system which would cover any ammonia release, reducing the volume of ammonia vaporized (this system can be actuated from four different locations); (3) the tank is equipped with two pressure switches for indicating a pressure drop within the tank (these units will trigger alarms at two separate, continuously-manned Control Rooms; (4) the building contains a Lower Flammable Limit (LFL) detector with two sensors; (5) a sample of the air inside the building is supplied to an ammonia analyzer (analyzer is maintained in an adjacent building); (6) the storage tank is protected from overpressurization by a dual set of pressure relief valves; (7) sections of the liquid ammonia piping are equipped with hydrostatic pressure relief valves; (8) BMS has developed and implemented standard operating procedures (SOPs) for processes involving the transfer, storage, and use of anhydrous ammonia; (9) BMS has developed and implemented a Process Safety Management (PSM) Program which aims at reducing the potential for a significant ammonia release; (10) the storage tank is equipped with excess-flow valves at each piping connection (which limit the potential for a catostrophic release); (11) the tank is equipped with an automatic high-level shut-off valve (to limit the potential for overpressurization due to overfilling); (12) the building is equipped with a sump/pump to allow for the controlled handling of any released material; (13) the Syracuse facility maintains a trained/equipped Emergency Response Team; (14) several safety measures have been incorporated into the design of the anhydrous ammonia system, including: heavy-duty, Schedule 80 fill/transfer piping with 2000-pound fittings; elevated pressure rating for the storage tank; and, emergency shut-off valving (9 locations provided in one production area builiding alone); (15) major equipment components (tank, piping, pumps, ammonia heaters, etc.) are on a Preventative Maintenance Progra m in accordance with PSM requirements; and, (16) BMS has implemented a training program (including training specific to ammonia handling/utilization) in accordance with PSM requirements. These protective measures limit the potential for significant impact to the local population/environment from the anhydrous ammonia system. GENERAL ACCIDENTAL RELEASE PREVENTION PROGRAM AND CHEMICAL-SPECIFIC PREVENTION SYSTEMS (DDS System) - Despite the fact that DDS is a Program Level 1 chemical, Bristol-Myers Squibb maintains a protective release prevention program for this material. This program involves a number of passive and active mitigation measures aimed at reducing the probability or minimizing the impacts of a dimethyldichlorosilane release. FIVE YEAR ACCIDENT HISTORY - Bristol-Myers Squibb has not had any accidents from the anhydrous ammonia or dimethyldichlorosilane processes at their Syracuse operations which would be "reportable" under 40 CFR 68.42 ("reportable" accidents are incidents which have resulted in deaths, injuries, or significant property damage on site, or known offsite deaths, injuries, evacuations, sheltering in place, property damage, or environmental damage). EMERGENCY RESPONSE PROGRAM - The BMS-Syracuse facility has developed a formal, written Emergency Response Program. This program is coordinated with the local emergency response agencies (written agreements are in place). Any chemical spills and/or compressed gas releases which may pose a threat to the health and safety of BMS site personnel or the surrounding community is considered a spill incident. The "Emergency Response Procedure" outlined in the "BMS Emergency Response Plan" requires that all spill incidents discovered or suspected be reported immediately to Security. All spill incidents also require the notification of the Environmental, Safety, Industrial Hygiene (ESIH) Department. A qualified ESIH representative is responsible for determining the level of response required to mitigate the incident. There are three levels of Spill Incident Classification. Level I Incidents are any spill incidents that can be controlled using equipment immediately available to the Operating Department, and/or do not require the evacuation of employees and have no impact beyond the immediate area of the spill. Level II Incidents are any spill incident that can only be controlled utilizing the resources of the plant Emergency Response Team (i.e., the use of chemical protective gear and equipment), require the evacuation of employees beyond the immediate vicinity, and/or require reporting to any outside agency. Level III Incidents are any spill incident that require the assistance of an outside agency such as the Fire Department, impacts or has the potential to impact off-site locations, requires the evacuation of employees other than the department area, involves a fire, and/or causes serious injury or death. The ESIH Department is responsible for overs eeing the cleanup of a Level I Incident. The Plant Emergency Organization is used as the command structure for responses to Level II and III Incidents. All facility incidents which require a response by the ERT are documented, and the documentation is provided to the facility Safety Manager. The ERT Leader is responsible for conducting an incident debriefing and critique within 48 hours of the incident and submitting a written report, including recommendations for follow up actions, to the Safety Manager. The Safety Manager is responsible for evaluation and appropriate implementation of follow-up recommendations. The site-wide Emergency Response Procedure has been submitted to the New York State Department of Environmental Conservation (NYSDEC). PLANNED CHANGES ON ANHYDROUS AMMONIA SYSTEMS - Through the implementation of their PSM Program, BMS has identified a number of modifications (both equipment and procedural) aimed at providing additional safety of the anhydrous ammoni a system at their Syracuse, New York facility. These modifications have been implemented. BMS continues to review their safety programs and update the anhydrous ammonia system on a regular basis in accordance with OSHA/EPA requirements. |