TEMPLE UNIVERSITY ENVIRONMENTAL HEALTH AND RADIATION SAFETY

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Purpose In accordance with applicable regulations and Temple University, this policy was developed to minimize exposure to glutaraldehyde. Applicability This policy is applicable to all Temple University employees, to all work conducted under the authority of Temple University, and to all equipment and property managed by Temple University. Non-Temple and contractor personnel must follow the provisions of this policy while at Temple University facilities. This policy applies to facilities, branches, or divisions with any of the following situations: 1. An employee who may be exposed to glutaraldehyde at levels greater than or equal to 0.1 parts per million (ppm). 2. Employees who work with solutions that contain greater than 0.1 percent glutaraldehyde. 3. Employees who show symptoms of formaldehyde exposure. Regulations Currently there are no federal regulations concerning the use, storage, or disposal of glutaraldehydecontaining chemicals and products. The National Institutes for Occupational Health and Safety (NIOSH) has established a recommended exposure limit of 0.2-ppm (parts per million) for 15-minutes of exposure. The American Conference of Governmental Industrial Hygienists has also established a threshold limit value (TLV) of 0.2-ppm. Health Effects NIOSH recognizes that glutaraldehyde irritates the skin, eyes, throat, and respiratory system, and is a potential mutagen and possible teratogen. Glutaraldehyde can also cause allergic sensitization of the respiratory system and skin after an individual receives an initial high exposure. Responsibilities for Glutaraldehyde Safety Environmental Health and Radiation Safety Department (EHRS) The EHRS has the following responsibilities related to glutaraldehyde activities: 1. Policy development. 2. Surveillance as requested by responsible supervisor. 3. Training as requested by responsible supervisor. 4. Exposure monitoring. Supervisors and Managers Supervisors and Managers have the following responsibilities related to glutaraldehyde activities: 1. Assessment of their site and operations to determine whether glutaraldehyde is present or used. 2. All persons designated as glutaraldehyde users shall be issued a copy of this section by their supervisor. The copy should be kept in the user's work place for reference. Additional copies are available through the EHRS.

3. Review and approve proposed uses of glutaraldehyde-containing products in areas within their jurisdiction. Such approval signifies that management will provide the resources necessary to control hazards and will establish, as organization policy, the procedures necessary to comply with OSHA, EPA, and other government regulations. Such compliance may include the following actions: Provide employee training regarding the safe use, storage, and disposal of glutaraldehyde. Maintain an adequate stock of required personal protective equipment (PPE). Provide equipment such as eyewash stations, showers, and ventilation devices when required. Make requests to the EHRS for required exposure monitoring and surveillance of work activities. Maintain relevant Material Safety Data Sheets (MSDSs) for glutaraldehyde products used. Arrange for transportation and disposal of glutaraldehyde-related waste. Make regular visual inspections for leaks and spills for facilities with glutaraldehyde. Glutaraldehyde Users Glutaraldehyde users are those workers who work with or handle glutaraldehyde-containing products in their job. These workers have the following responsibilities related to glutaraldehyde activities: 1. Attend required training classes. 2. Properly use and maintain PPE. 3. Comply with Temple University, OSHA, and EPA and other government regulations as they pertain to glutaraldehyde use. Exposure Monitoring There are no regulatory requirements for glutaraldehyde exposure levels or monitoring frequency, however Temple University had adopted the Recommended Exposure Limit of 0.2-ppm. Monitoring is performed when requested and to develop a base-line database of worker exposures. The Temple University defined action level (AL) for glutaraldehyde is 0.1-ppm, as an eight-hour time weighted average. Controlling Glutaraldehyde Exposure Engineering Controls - Ventilation Systems It is the policy of the Temple University that all glutaraldehyde-related work activities with potential for exceeding the Action Level shall implement feasible engineering controls. Examples of engineering controls include ventilation systems, air pollution control devices, laboratory hoods, enclosures, shields, barriers, isolation chambers, automatic emergency shut off valves, and remote-control equipment. The following considerations should be included in the design and installation process for such equipment: 1. On an annual basis, laboratory fume hoods must be evaluated for proper operation and airflow. The EHRS provides these services annually or upon request. 2. To minimize exposure and control the buildup of gases and vapors in the general work area, it is important that adequate room ventilation be provided. The recommended ventilation rate for laboratory areas is 4 to 12 air changes per hour.

Personal Protective Equipment (PPE) Certain types of PPE are effective in controlling glutaraldehyde exposure. For activities using greater than 1-% glutaraldehyde solutions, it is required that employees wear chemical protective clothing. In normal work situations, PPE should be used only as a supplement to engineering controls. Impermeable Gloves: Impermeable gloves will reduce exposure in cases of splash hazards or other skin contact. Rubber, nitrile, and neoprene are commonly used protective materials for glutaraldehyde. However, PPE manufacturers' data should be consulted for specific information about material types, breakthrough times, and permeation rates. Eye and Face Protection: Eye and face protection in the form of goggles and face shields will reduce exposure in cases of splash hazards. When a face shield is worn, chemical goggles are also required if a potential for eye splash exists. Respiratory Protection Respiratory protection, in the form of supplied air or air purifying type, is not allowed as a substitute for engineering controls, but may be required in cases where engineering controls alone will not adequately reduce exposures. For air purifying respirators, specific glutaraldehyde cartridges are available. When employees are required to wear respirators to reduce exposure, they must be enrolled in a Respiratory Protection Program, as required by OSHA. The Temple University requires respirator use in the following situations: 1. During emergencies, and entry into areas of unknown glutaraldehyde. 2. During the period to evaluate, purchase, and install engineering control equipment and/or modify work practices to achieve compliance with the RELs. 3. In work situations where engineering and work practice controls are not yet capable of reducing employee glutaraldehyde exposure to or below the REL. 4. During cleaning, maintenance, repair, and other work where engineering and work practice controls are not feasible.

Work Practices Each facility shall examine the work practices that employees use, and consider alternative work practices that will minimize exposure. An example of an acceptable work technique change might be to have workers store glutaraldehyde-releasing materials in sealed containers until immediately prior to use. Leak and Spill Detection Facilities with glutaraldehyde shall create and maintain a program to detect leaks and spills. The equipment leak and spill detection program shall include: 1. Regular visual inspections for leaks and spills; 2. Preventative maintenance of equipment, including surveys for leaks, at regular intervals; 3. Provisions for glutaraldehyde spill containment, surface decontamination, and waste disposal in work areas where spillage may occur; 4. Prompt cleanup of spills and repair of leaks using persons who wear appropriate protective clothing and equipment and are trained in the proper methods for glutaraldehyde cleanup and decontamination; 5. Placement of glutaraldehyde-contaminated waste and debris resulting from leaks and spills into sealed containers that bear a glutaraldehyde label. Container Labels Containers of glutaraldehyde must have labels indicating that they contain glutaraldehyde. The label must list the name and address of the responsible person; and must state that physical and health hazard information is readily available from the employer and from MSDSs. Emergency Showers, Eyewash Stations If there is an eye splash possibility eyewash stations must be present in the immediate work area. Showers must be present in the immediate work area if there is a splash hazard. The locations of the stations must be close enough so that an injured worker can reach one within ten seconds. Emergency Situations Laboratory workers can clean up a small spill that does not present an immediate health risk, such as a spill within a fume hood. The resulting waste must then be packaged, and then disposed of as a hazardous waste. For larger spills, call EHRS (215-707-2520) to provide cleanup assistance. If a worker is unsure of his/her ability to clean up a glutaraldehyde spill outside the control of a local exhaust ventilation device, he/she should call EHRS.

Any time respiratory irritation occurs, leave the area and get to fresh air. In case of skin/eye contact with liquid, immediately remove contaminated clothing and flush affected areas with water. Any unusual exposure (inhalation, absorption, ingestion) to glutaraldehyde shall require a visit to the Employee Occupational Health Office for evaluation. Spill control supplies (adsorbent, gloves, goggles, and disposal bags) shall be made accessible to chemical laboratories and storage sites. Contact EHRS for more information and details. Glutaraldehyde Waste Glutaraldehyde-containing products may not be disposed of into the sewer system or storm drains, unless prior approval from EHRS is obtained. Where no approval is provided by EHRS, discharge of glutaraldehyde or other hazardous material into the sewer system or storm drain is prohibited. Similarly, hazardous materials may not be disposed of by evaporation in a fume hood. If such an incident does occur, it may be reportable to local or Federal authorities, and shall be reported immediately to the EHRS. Where vapors may be exhausted as a by-product of work being done with glutaraldehyde (not as a means of disposal), the fume hood will be equipped with filters to prevent atmospheric releases. Medical Surveillance Program The medical surveillance program is provided to monitor the health of glutaraldehyde-exposed employees, and determine whether continued exposure will adversely affect their health. 1. The medical surveillance program is mandatory for the following groups of employees: Employees who are exposed at or above the AL. 2. The medical surveillance program is optional for the following groups of employees: Employees who show symptoms of glutaraldehyde exposure and employees who are exposed during an emergency. Hazard Communication Program The hazard communication program must address the following items: 1. Material Safety Data Sheets (MSDSs) 2. Container labeling of glutaraldehyde 3. Instructions to immediately report signs of glutaraldehyde exposure to the supervisor. 4. Uses and limitations of PPE. 5. Instructions for handling spills and emergency situations. 6. Proper work practices and the use of engineering controls. Employee Training Requirements Glutaraldehyde training is part of the workplace Hazard Communications Training that shall be provided to all employees. Information regarding this training can be obtained from the EHRS. This training must be provided at the time of the initial job assignment and whenever there is a change to the work process..

At a minimum, the topics addressed in the hazard communication training shall include: 1. The contents of the OSHA Hazard Communication Standard (29 CFR 1910.1200), as well as the location and availability of these regulations. 2. The contents of MSDSs. 3. Health risks of work place hazards 4. The medical surveillance program. 5. PPE use and limitations. 6. Instructions for the use of engineering controls in minimizing exposure. 7. Instructions for handling spills and emergency situations. 8. Access and location of training materials for the affected employees. 9. Container labeling requirements. Record-keeping Requirements The EHRS will keep accurate and complete records for all glutaraldehyde-related work areas. The records shall consist of: Exposure Monitoring Records 1. The date the measurement was taken. 2. The operation that is being monitored. 3. The sampling and analytical methods used and evidence of their precision and accuracy. 4. The number, duration, time of day, and results of samples obtained. 5. The types of protective devices worn. 6. The names, job classifications, social security numbers, and exposure estimate of employees whose exposure is represented by actual monitoring results. When it is felt that objective data will relieve exposure-monitoring requirements, records shall consist of the objective data and calculations that demonstrate that no employee is exposed to glutaraldehyde at or above the Action Level. Exposure monitoring records shall be kept for at least 30 years. Medical Evaluation Records Records shall consist of: 1. The name and social security number of the employee. 2. The physician's written opinion. 3. A list of employee health complaints that may be related to exposure to glutaraldehyde. 4. A copy of the employee's medical examination results, medical questionnaires, and results of medical tests that are required by the regulation or mandated by the examining physician. Medical evaluation records shall be kept for the duration of the employee's employment plus at least 30 years.