Griffith Micro Science - Santa Teresa - Executive Summary
Facilities that use or store more than 10,000 lbs. of ethylene oxide are required to prepare and submit a Risk Management Plan (RMP) to the US EPA. The RMP consists of several elements, including an evaluation of potential accident scenarios and a comprehensive program to prevent accidental releases of regulated chemicals.
The RMP summarizes the management, administrative, procedural, and technological controls that work together to minimize the risk of hazardous chemical releases to the community. The RMP includes the following information:
7 Facility identification and regulated substances;
7 Policies to protect health, environment, and safety;
7 Hazard Assessment;
7 Prevention Program;
7 Five-Year Accident History;
7 Emergency Response Plan; and
7 Planned Changes to improve safety
Facility Identification and Regulated Substances
Griffith Micro Science, Inc. (GMSI) operates a contract sterilization facility located Santa Teresa. The facility is e
ngaged in the sterilization of medical equipment and spices using ethylene oxide. Ethylene oxide is listed as a regulated toxic substance under U.S. EPA's Risk Management Program regulations (40 CFR 68).
Policies to Protect Health, Safety and the Environment
Risk management and safety are important concerns at GMSI. This RMP formalizes and documents these activities. GMSI is committed to conducting its operations in a safe and responsible manner and to reducing risks to human health and the environment.
An Accidental Release Prevention Program is in place to minimize the risk of hazardous chemical releases in accordance with the US EPA Risk Management Program Level 3 requirements (40 CFR 68). The prevention program provides a structured approach to preventing accidents. Some of the specific activities in the prevention program include:
7 Process safety information accessible to employees at all times.
7 A hazard review was conducted as part of the preparatio
ns for RMP compliance.
7 Computerized process controls prevent unsafe conditions in the sterilizers.
7 Written operating procedures are used for training and guiding the work of operators.
7 Training is provided to all employees that operate the system.
7 A program is in place to properly maintain the system and equipment.
7 Incidents are investigated and actions are taken as part of a continuous improvement effort.
7 Routine audits are conducted to assure that safe practices are being followed.
7 A thorough Preventative Maintenance program helps ensure equipment is in proper working condition.
The sterilization process subject to the Risk Management Program at the GMSI - Santa Teresa facility is designed with extensive safeguards to protect against the accidental release of ethylene oxide. Examples of safety equipment in place include pressure relief devices, leak detection and alarm systems, electronic interlock safety systems for sterilization chambers, and explosion proof electric
In addition, process operators receive extensive training in the safe operation of the process, and are required to follow detailed operating procedures to help ensure safety. GMSI also has implemented a mechanical integrity program to monitor the physical condition of process equipment, and replace or repair equipment before it fails.
In the unlikely event of a spill or release involving a hazardous material, GMSI has developed an emergency response plan providing procedures to be followed to minimize the potential impacts of a fire or release from the facility.
Under the EPA regulations, GMSI is required to evaluate the potential consequences of a worst case release and an alternate release scenario. The following paragraphs provide a description of the worst case and alternate scenarios for the facility.
The RMP regulations define a worst-case release as "the release of the largest quantity of a regulated substance from a vessel or process l
ine failure that results in the greatest distance to an endpoint" (40 CFR 68.3). The worst-case scenario for toxic gases is assumed to be the total release of the single largest container in the process over a 10 minute time period. Thus, for the GMSI - Santa Teresa, it is assumed that 400 lbs. of ethylene oxide is released over a 10 minute time period. In this scenario, 100% of the ethylene oxide is released into the air in the enclosed staging area. The staging area is contained within a permanent structure, therefore a 55% mitigation factor was taken into account, as per the U.S. EPA Offsite Consequence Analysis Guidance Document (OCAG Document). The release rate from the building to the outside atmosphere was then calculated and the distance to endpoint was determined.
In accordance with the US EPA OCAG Document, the alternate scenario evaluated was assumed to consist of a leaking valve on a cylinder of ethylene oxide. The leaking valve results in a release of ethylene oxide to
the inside of the building, and the vapor cloud is assumed to travel outside and downwind. This release is assumed to result from a quarter-inch diameter leak from the valve on a 400-lb. vessel pressurized at 50 psig. The release rate was determined based on Equation 7-1 in the EPA's OCAG document. The staging area is contained within a permanent structure, therefore a 55% mitigation factor was taken into account. The release rate from the building to the outside atmosphere was then calculated and the distance to endpoint was determined.
Five-Year Accident History
Only accidents occurring in the past five years meeting the following requirements must be included:
7 The release must be from a covered process and involve a regulated substance held above its threshold quantity in the process.
7 The release must have caused at least one of the following:
7 On-site deaths, injuries, or significant property damage; or
7 Known offsite deaths, injuries, property damage, environmental dama
ge, evacuations, or sheltering in place.
GMSI - Santa Teresa has not had any accidental releases from the ethylene oxide process within the last five years that meet this definition.
Emergency Response Plan
The RMP regulations require that "response actions be coordinated with local emergency planning and response agencies" (40 CFR 68.12(b)(3)). Emergency response activities at the GMSI - Santa Teresa facility are coordinated with the Santa Teresa Volunteer Fire Department.
Depending on the quantity and chemical involved in a "reportable spill," GMSI - Santa Teresa also notifies certain local, state, and federal emergency planning and response agencies.
Planned Changes to Improve Safety
Safety and Emergency Preparedness is a part of GMSI's activities. Exposure risks to employees and the public have been minimized through ongoing inspections and regulatory requirements. At this time, no further improvements have been identified. GMSI is in the process of upgrading their safe
ty procedures and training programs.