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Biosafety Manual
The purpose of this program is to define the biological safety policies and procedures pertaining to research operations at Wellesley College. These policies and procedures are designed to safeguard personnel and the environment from biologically hazardous materials and to comply with federal and state regulatory requirements. All Faculty and laboratory employees must adhere to the biological safety policies and procedures in the conduct of their research and the management of their laboratories.
Biological agents include all infectious microorganisms (bacteria, fungi, parasites, prions, rickettsias, viruses, etc.) that can cause disease in humans or pose significant environmental or agricultural impact, as well as the toxins derived from such organisms. Additionally, recombinant or synthetic nucleic acid molecules; human or non-human primate tissues, fluids, cells, or cell cultures; transgenic plants or animals; and any work with animals and their tissues, which are known to be reservoirs of zoonotic diseases, are wholly or partly covered by the procedures and policies in this manual.
For information about specific biological safety programs for operations not covered in this manual, contact a member of the Institutional Biosafety Committee or the Biosafety Officer.
The following is a summary of federal and state regulations and guidelines that either regulate or provide guidelines covering the use of biological agents:
Select Agent Rule
Department of Health and Human Services: 42 CFR Parts 42 and 43 Possession, Use, and Transfer of Select Agents and Toxin; Final Rule; and the Department of Agriculture’s Animal and Plant Health Inspection Service: 7 CFR Parts 331 and 9 CFR Parts 121, Agricultural Bioterrorism Protection Act of 2002: Possession, Use, and Transfer of Biological Agents and Toxin; Final Rule. These regulations require institutions that possess, use, or transfer certain biological agents and toxins (“select agents”) to be registered and approved by DHHS and/or APHIS.
Other Regulatory Requirements
The Principal Investigator (PI) is directly and primarily responsible for the safe operation of the laboratory. His/her knowledge and judgment are critical in assessing risks and appropriately applying the recommendations in this Plan. However, safety is a shared responsibility among all laboratory and support staff. Many resources exist to assist the PI with these responsibilities, including the Institutional Biosafety Committee (IBC) and EHS.
Faculty and researchers at Wellesley College planning to carry out research using recombinant or synthetic nucleic acid molecules and/or biologically hazardous/infectious materials that pose a potential risk to the health of humans or animals, either directly through infection or indirectly through damage to the environment, must submit proposals for review and approval by the IBC prior to starting work.
When working with potentially infectious agents and human subjects or experimental animals, IBC review is necessary in addition to review by the Institutional Animal Care and Use Committee (IACUC) or the appropriate Institutional Review Board (IRB).
New Applications
Amendments
Wellesley College's Biosafety Program serves to protect faculty, staff and students from exposure to biohazardous materials, to guard against the release of biohazardous materials that may harm humans, animals, plants or the environment, and to protect the integrity of experimental materials. Responsibility for oversight of the program resides with the Environmental Health and Safety Office, the Science Center Office, and the Institutional Biosafety Committee (IBC). All recombinant DNA studies, pathogenic organisms, and bloodborne pathogens must be registered with the IBC.
If you transport any research materials including biological materials on the Wellesley College campus, you must utilize a secondary container that is labeled and leakproof. This includes transporting materials from one laboratory to another laboratory, or to/from cold/warm rooms and equipment rooms.
Shipping of materials to locations external to Wellesley College will require training if the shipment contains dry ice, batteries, radioactive materials, hazardous chemicals, or biological materials. The United States Department of Transportation (DOT) and the International Air Transport Association (IATA) have stringent requirements including training. Anyone who ships a hazardous material improperly and/or without proper training will be subject to serious penalties including civil and criminal punishment. Contact the Wellesley Biosafety Officer, Suzanne Howard, for training.
Note that if you receive a shipment of biohazardous material, you must be approved to work with the material prior to receipt. Contact the Biosafety Officer, Suzanne Howard, in advance of ordering or making arrangements to receive a biohazardous material.
When shipping internally or externally, NEVER put dry ice in a container that is not able to vent as this will lead to an explosion and serious injury! The dry ice sublimates to form carbon dioxide, which will exert pressure on the wall of an airtight container causing it to eventually explode.
The Wellesley College Institutional Biosafety Committee (IBC) and the Biosafety Officer (Suzanne Howard) are responsible for conducting risk assessments of work with biohazardous materials including recombinant DNA/RNA, human materials, microorganisms, and biological toxins. Before acquiring these materials and beginning any work, Wellesley College Principal Investigators must contact the Biosafety Officer to review the planned work and to determine what may need to be reviewed and approved by the IBC.
Communication of risks involved with work with biohazardous materials is done through a number of ways.
Risk assessment is a process used to identify the hazardous characteristics of a known biological agent or materials, the activities that can result in a person’s exposure to the agent or material, the likelihood that such exposure will cause a laboratory acquired infection, and the probable consequences of such an infection. The information identified by risk assessment will provide a guide for the selection of appropriate biosafety levels and microbiological practices, safety equipment, and facility safeguards that can prevent laboratory acquired infection. The risk assessment process is the responsibility of the laboratory principal investigators and laboratory supervisors, with assistance from the Wellesley College Biosafety Officer (Suzanne Howard) and Institutional Biosafety Committee.
Principal investigators and laboratory supervisors should use risk assessment to alert their students and employees to the hazards of working with infectious agents and to the need for developing proficiency in the use of selected safe practices and containment equipment. Successful control of hazards in the laboratory also protects persons not directly associated with the laboratory, such as other occupants of the same building, and the public. The primary factors to consider in risk assessment and selection of precautions fall into two broad categories: agent hazards and laboratory procedure hazards. In addition, the capability of the laboratory staff to control hazards must be considered. This capability will depend on the training, technical proficiency, and good habits of all members of the laboratory, and the operational integrity of containment equipment and facility safeguards.
The World Health Organization (WHO) has recommended an agent risk group classification for laboratory use that describes four general risk groups based on these principal characteristics and the route of transmission of the natural disease. The four groups address the risk to both the laboratory worker and the community. The NIH Guidelines established a comparable classification and assigned human etiological agents into four risk groups on the basis of hazard. The descriptions of the WHO and NIH risk group classifications are presented below in Table 1. They correlate with but do not necessarily equate to biosafety levels. The risk assessment will determine the degree of correlation between an agent’s risk group classification and biosafety level.
Wellesley College is equipped for work at Biosafety Level One (BSL-1) and Biosafety Level Two (BSL-2). The requirements for these biosafety levels are summarized in Table 2.
A fundamental objective of any biosafety program is the containment of potentially harmful biological agents. The term “containment” is used in describing safe methods, facilities and equipment for managing infectious materials in the laboratory environment where they are being handled or maintained. The purpose of containment is to reduce or eliminate exposure of laboratory workers, other persons, and the outside environment to potentially hazardous agents. The use of vaccines may provide an increased level of personal protection. The risk assessment of the work to be done with a specific agent will determine the appropriate combination of these elements.
Table 1: Risk Group Classifications for Biological Agents
| Risk Group Classification | NIH Guidelines for Research Involving Recombinant DNA Molecules - 2002 | World Health Organization (WHO) Laboratory Biosafety Manual – 2004 |
| Risk Group 1 (e.g. E. coli K12) |
Agents not associated with disease in healthy adult humans. | No or low individual and community risk. A microorganism unlikely to cause human or animal disease. |
| Risk Group 2 (e.g. Streptococcus pyogenes) |
Agents associated with human disease that is rarely serious and for which preventive or therapeutic interventions are often available. | Moderate individual risk and low community risk. A pathogen that can cause human or animal disease but is unlikely to be a serious hazard to laboratory workers, the community, livestock or the environment. Laboratory exposures may cause serious infection, but effective treatment and preventive measures are available and the risk of spread of infection is limited. |
| Risk Group 3 (e.g. Francisella tularensis) |
Agents associated with human disease that is rarely serious and for which preventive or therapeutic interventions are often available. | High individual risk and low community risk. A pathogen that usually causes serious human or animal disease but does not ordinarily spread from one infected individual to another. Effective treatment and preventive measures are available. |
| Risk Group 4 (e.g. Ebola Virus) |
Agents likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available. | High individual and community risk. A pathogen that usually causes serious human or animal disease and can be readily transmitted from one individual to another, directly or indirectly. Effective treatment and preventive measures are not usually available. |
Table 2: Biosafety Levels
| BSL | Agents | Practices | Primary Barriers and Safety Equipment | Facilities (Secondary Barriers) |
| 1 | None known to consistently cause diseases in healthy adults | Standard microbiological practices |
|
Lab bench and sink required |
| 2 |
|
BSL-1 practices plus:
|
|
BSL-1 plus autoclave |
Periodic internal audits and inspections of Wellesley College work areas including laboratories are conducted by the Environmental Health and Safety Office. They may be prearranged or unannounced. The purpose of these internal activities is to identify areas of non-compliance and remediate them quickly. In addition, local, state and federal regulatory agencies with jurisdiction over Wellesley College may make prearranged or unannounced inspections. Therefore, it is important that anyone who observes a potential non-compliance situation or unsafe condition reports the information to the Environmental Health and Safety Office.
Biosafety training is required by a number of biosafety regulations and guidelines. All employees and students who work with human materials must have Bloodborne Pathogens Training. To schedule training, contact the Wellesley College Biosafety Officer, Suzanne Howard, or go to the Wellesley College Environmental Health and Safety training website.
The Universal Biohazard Symbol is utilized on door signage, as well as stickers found on laboratory equipment, to denote a biological hazard. All rooms that contain biohazardous agents must be posted with the Universal Biohazard Symbol. The background must be red/orange in color with a black universal biohazard symbol and black lettering. All equipment (centrifuges, water baths, refrigerators/freezers, incubators, etc.) that comes in contact with biohazardous materials must be labeled with the universal biohazard symbol.
Research with certain biological agents may require medical surveillance. Medical surveillance is the term use to describe the program that has been implemented to help assure the health of employees and students who have potential workplace exposures to hazards including, but not limited to, animal allergens, biohazardous materials, and high noise levels. All projects involving work with biological agents must be reviewed by the Wellesley College Biosafety Officer, Suzanne Howard, prior to beginning work. A project registration and approval by the Wellesley College Institutional Biosafety Committee may also be necessary.
The medical surveillance program is coordinated by the Wellesley College Health Service and the Environmental Health and Safety Office. Participants typically complete a health history questionnaire and may also receive a medical examination by a licensed physician through the Health Service. These screenings are used to establish a baseline of the participant’s health. Periodic future assessments are compared to the baseline to monitor potential occupational exposures. In some cases, vaccinations may be recommended. For example, the Hepatitis B vaccination is recommended for all employees who have potential occupational exposures to human blood or other potentially infectious materials.
All injuries and illnesses that result from, or may lead to, exposure to biological materials must be reported to the Wellesley College Biosafety Officer, Suzanne Howard, no matter how minor they may appear. Suspected exposures and “Near Misses” must also be reported. Near Misses are defined as unplanned occurrences that did not lead to an injury or exposure, but could have. For example, if a researcher is splashed with a culture of an infectious organism, but is wearing sufficient personal protective equipment that no skin or mucous membrane contact was made, this event would be considered a “Near Miss.”
All workplace injuries and illnesses involving biological material, no matter how minor they may seem, must be promptly reported to the Wellesley College Health Service (781.283.2810) and the Environmental Health and Safety Office (781.283.3882). For injuries that require immediate medical attention and medical emergencies, call x5555.
Work with certain biological agents may be contraindicated during pregnancy or when contemplating a pregnancy. Women with concerns or questions about the biological materials they work with and their potential impact on pregnancy can contact Wellesley College Health Service (781.283.2810) for a confidential medical assessment.
The Occupational Safety and Health Administration (OSHA) requires that employers record employee workplace injuries and illnesses. This record is known as the OSHA 300 Log and each year a new 300 Log is completed for the period of January through December. All occupational injuries and illnesses incurred by Wellesley College employees that require more than first aid treatment must be recorded in the OSHA 300 Log. The log is posted by February 1 each year for the previous year’s injuries and illnesses. Names are not included in the posted OSHA 300 Log. The OSHA 300 Log allows Wellesley College to summarize the number of occupational injuries and illnesses in a given year and calculate the injury rate based on the number of employees.
All workplace injuries and illnesses, no matter how minor they may seem, must be promptly reported to the Wellesley College Health Service (781.283.2810) and the Environmental Health and Safety Office (781.283.3882). For injuries that require immediate medical attention and medical emergencies, call x5555.
For workplace injuries involving sharps such as needles and razor blades in a laboratory or health clinic setting, a similar log known as the Sharps Log is completed. The Sharps Log is used for recording percutaneous injuries from contaminated sharps. The Sharps Log must contain, at a minimum, information about the injury, the type and brand of device involved in the injury (if known), the department or work area where the exposure occurred, and an explanation of how the incident occurred. The log must be recorded and maintained in such a manner so as to protect the confidentiality of the injured employee (e.g., removal of personal identifiers).
Bloodborne pathogens are microorganisms such as viruses and bacteria that may be present in human blood and other human-derived materials such as, but not limited to, human cell lines, blood components, body fluids, tissues and organs. All work with human materials is covered by the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogen Standard. The requirements of the Standard address items such as exposure control plans, universal precautions, engineering and work practice controls, personal protective equipment, housekeeping, laboratories, hepatitis B vaccination, post-exposure follow-up, hazard communication and training, and recordkeeping.
All employees who work with human materials will be offered the Hepatitis B vaccination free of charge. They may accept or decline, and if they initially decline they may change their mind at a later time and receive the vaccination free of charge. The vaccination is offered through the Wellesley College Health Service.
All employees and students that work with human materials in a laboratory setting or have the potential for occupational exposure through job duties must receive initial training and annual retraining. Contact the Biological Safety Officer, Suzanne Howard, for training.
Ultraviolet (UV) lights are used in a variety of laboratory applications. UV lights may be found as an accessory within a biological safety cabinet (BSC). UV lights may also be used to visualize gels or to induce DNA damage. UV light is hazardous to humans and can cause burns to skin and eyes with as little as a few seconds of exposure.
Prior to purchasing a new BSC, it is important to review the need for a UV light with the Biological Safety Officer (Suzanne Howard) and to purchase a BSC that has a sash interlock. Older models of BSC’s that may not have a sash interlock to disconnect the UV light when the sash is opened should be reported to the Biological Safety Officer for review. A UV light in a BSC is never a substitute for thorough cleaning and disinfection with a chemical disinfectant such as 70% ethanol or a freshly prepared solution of sodium hypochlorite (bleach).
Use of UV lights for other laboratory applications must be conducted with the appropriate personal protective equipment to shield skin and eyes from UV exposure. At a minimum, a lab coat, gloves, and a UV-rated faceshield should be worn.
An autoclave is a piece of laboratory equipment that uses high pressure and high temperature steam to sterilize materials such as microbiological media and glassware. It may also be used to sterilize biohazardous waste.
The use of an autoclave to sterilize biohazardous and sharps waste is regulated by the State of Massachusetts. All autoclaves used for this purpose must be periodically validated through the use of biological indicators. Biological indicators use thermophilic bacteria, typically Geobacillus stearothermophilus, to verify that cycle time and temperature are adequate to kill microorganisms that may be present in the waste.
When using an autoclave, it is important to remember that interior and exterior surfaces may be very hot. Therefore, wear appropriate heat-resistant protective equipment and allow the contents to cool prior to removing them from the autoclave.
There is no such thing as a “Universal Disinfectant”. All chemical disinfectants have pros and cons. For example, 70% ethanol is an effective disinfectant for some biological agents, does not leave a residue, but is flammable.
Disinfection is the process of applying a product directly to a surface or object to destroy or irreversibly inactivate most pathogenic microorganisms, but not usually bacterial or fungal spores. Disinfection reduces the level of microbial contamination to an acceptably safe level. Decontamination renders an area, device, item or material safe to handle, and may be accomplished through the process of cleaning with soap and water, disinfection or sterilization.
All work areas and equipment where biological materials have been used should be wiped down with an effective disinfectant after use and after any spills or contamination incidents. Appropriate laboratory disinfectants include 70% ethanol (except for bacterial or fungal spore-forming agents) and a freshly prepared 10% sodium hypochlorite (bleach) solution consisting of 1 part bleach in 9 parts water. Label all ethanol and bleach solution containers and bottles.
Spill kits should be readily available in all areas where biohazardous materials are used.
For BL-1; BL-2; rDNA; and blood spills:
Emergency eyewash and drench showers are located in areas where hazardous materials are used or stored. They must be kept accessible at all times. Do not store materials under or around the eyewash and drench shower as they may block access during an emergency situation. The emergency eyewash and drench showers are checked periodically by Physical Plant or the Chemical Hygiene Officer. Promptly report any malfunctions to the Science Center Office (x3136) for repair.
In the event that an exposure occurs to a hazardous material such as but not limited to a biohazardous material, quickly move to the eyewash or shower area. Inform others of the situation and ask for assistance and have someone report the event to Security (x5555). If there is an exposure to the eye, activate the eyewash and rinse for 15 minutes. If there is an exposure to the body, activate the shower and rinse for 15 minutes, removing clothing as necessary.
Personal protective equipment (PPE) is an essential element of primary containment and laboratory safety. PPE provided to Wellesley College students, staff and faculty includes, but is not limited to:
At a minimum, laboratory personnel should wear gloves and a laboratory coat whenever handling biological agents or cells and tissues. Safety glasses with side shields, goggles, or face shield shall be worn when these materials could potentially be splashed in the face. Laboratory personnel should wear other personal protective equipment (apron, face shield, mask, etc.) as needed or required to prevent potentially infectious materials from reaching their clothes, skin, eyes, mouth, or other mucous membranes. PPE must be removed prior to leaving the work area and placed in designated areas. PPE must be treated as medical waste when discarded. If PPE is not disposed, PPE shall be cleaned with disinfectant before and after use.
Revised 2022
