Griffith Micro Science - Ontario - Executive Summary

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Griffith Micro Science, Inc. (GMSI) submitted the Risk Management Plan on June 18, 1999, in compliance with 40 CFR 68.  Following a detailed annual review of the plan and the facility, it was determined that the off-site consequence analysis submitted in the RMP accounted for an indoor staging area rather than the outdoor staging area that is present at the facility.  GMSI has therefore revised the plan accordingly.  GMSI has also updated the remainder of the submittal as well to account for the recent safety inspection and review, emergency response plan review, and various training activities. 
Facilities that use or store more than 10,000 lbs of ethylene oxide are required to prepare and submit a Risk Management Program (RMP) to U.S. 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, proc 
edural, and technological controls that work together to minimize the risk of hazardous chemical releases to the community.  The RMP includes the following information: 
- Introduction 
- Facility identification and regulated substances 
- Policies to protect health, environment, and safety 
- Hazard Assessment 
- Prevention Program 
- Five-year Accident History 
- Emergency Response Plan; and 
- Planned Changes to improve safety 
Facility Identification and Regulated Substances 
GMSI operates a contract sterilization facility located in Ontario, California.  The facility is engaged in the sterilization of medical equipment using ethylene oxide.  Ethylene oxide is listed as a regulated toxic substance under US 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 - Ontario.  This RMP formalizes and documents these activities.  GMSI is committed to conducting its operations in a s 
afe and responsible manner and to reducing risks to human health and the environment. 
Prevention Program 
An Accidental Release Prevention Program is in place to minimize the risk of hazardous chemical releases in accordance with the EPA Risk Management Program Level 3 requirements (40 CR 68).  The prevention program provides a structured approach to preventing accidents.  Some of the specific activities in the prevention program include: 
- Process safety information is accessible at all times 
- A hazard review was conducted as part of the preparations for RMP compliance 
- Computerized process controls prevent unsafe conditions in the sterilizers 
- Written operating procedures are used for training and guiding the work of operators 
- Training is provided to all employees that operate the system 
- A program is in place to properly maintain the system and equipment 
- Incidents are investigated and actions are taken as part of a continuous improvement effort 
- Routine audits are conduct 
ed to assure that safe practices are being followed 
- A thorough Preventative Maintenance Program helps ensure equipment is in proper working condition 
The sterilization process subject to the Risk Management Program at the Ontario 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 electrical systems. 
In addition, process operators receive extensive training in the safe operation of the process, and are rquired to follow detailed operating procedures to help ensure safety. GMSI has also 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 re 
sponse plan providing procedures to be followed to minimize the potential impacts of a fire or release from the facility. 
Hazard Evaluation 
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 line failure that results in the greatest distance to an endpoint defined in Section 68.22 (a)" (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 Ontario facility, it is assumed that 400 lbs. of ethylene oxide is released over a 10-minute time period.  The ethylene oxide cylinders are maintained in a 3-walled staging area prior to 
use.  The staging area is directly exposed to the surrounding atmosphere therefore it is assumed that the entire contents of the cylinders are released to the atmosphere.  The release rate was then calculated and the distance to endpoint was determined.  This distance is beyond the facility fenceline.  However, based on knowledge fo the surrounding area, GMSI has determined that there are no residences within the impact zone. 
Although GMSI recognizes the maximum potential impacts resulting from a release of ethylene oxide, it believes this scenario to be unlikely.  GMSI has implemented extensive safeguards to prevent such a release such as: computer controls on all sterilizers, 21 separate interlock alarms associated with each sterilizer, and installation of process area monitors to detect any leaks. 
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 outside of the building, and the vapor cloud is assumed to travel 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 cylinder is assumed to be in use during the leak, therfore a 55% mitigation factor was taken into account resulting from containment within a permanent structure.  The release rate was then calculated and the distance to endpoint was determined.  This distance is beyond the facility fenceline. 
Five-Year Accident History 
Only accidents occurring in the past five years meeting the following requirements must be included: 
1. The release must be from a covered process and involve a regulated substance held above its threshold quantity in the process. 
2. The release must have caused at least one of the following: 
- On-site deaths, injuries, or significant property damage 
; or 
- Known offsite deaths, injuries, property damage, environmental damage, evacuations, or sheltering in place. 
Griffith 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 Ontario facility are coordinated with the Local Emergency Planning Committee and the Local Fire Department. 
Depending on the quantity and chemical involved in a "reportable spill," GMSI 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 activities.  Exposure risks to employees and the public have been minimized throgh ongoing inspections and regulatory requirements.  At this time, no further improvements have been id 
entified.  GMSI is in the process of upgrading their safety procedures and training programs. 
Chemical-Specific Safety 
Ethylene oxide is stored in an outdoor staging area that is cool, dry, well-ventilated and away from incompatible chemicals and sources of ignition.  Storage containers are insulated and have pressure relief valves.  Lower explosive limit (LEL) sensors are located near areas of potential leaks including gas storage areas, gas charging areas, and some of the chamber doors that will alarm with an audible alarm in the event of a major leak from the ethylene oxide cylinders of process.
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