Wellesley College Biological Safety Plan
Purpose and Scope
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 DNA; 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.
Rules and Regulations
The following is a summary of federal and state regulations and guidelines that either regulate or provide guidelines covering the use of biological agents:
• Centers for Disease Controls and Prevention and the National Institutes of Health: Biosafety in
Microbiological and Biomedical Laboratories (BMBL), 5th Edition, 2007. This document contains guidelines for microbiological practices, safety equipment, and facilities that constitute the four established biosafety levels. The BMBL is generally considered the standard for biosafety and is the basis for this manual.
• National Institutes of Health: Guidelines for Research Involving Recombinant DNA Molecules (NIH
Guidelines). This document provides guidelines for constructing and handling recombinant DNA molecules (rDNA) and organisms containing rDNA. Although these guidelines are not subject to regulatory enforcement, institutions that receive any NIH funding for rDNA research are required to comply with these guidelines as a condition of funding. This document requires that each institution establish an Institutional Biosafety Committee with the authority to approve proposed rDNA research using the NIH guidelines as the minimum standard.
• Occupational Safety and Health Administration: Bloodborne Pathogens. This regulation covers occupational exposure to human blood and other potentially infectious materials, including human tissue and cells. OSHA specifies a combination of engineering controls, work practices, and training to reduce the risk of infection. Personnel potentially exposed to human blood and other potentially infectious material must be offered immunization against hepatitis B and receive annual training. Personnel who work with HIV or hepatitis B in a research laboratory must receive additional training and demonstrate proficiency in working with human pathogens. 29 CFR 1030.
• Commonwealth of Massachusetts Department of Public Health: The Center for Environmental Health regulates the storage and disposal of potentially infectious material, and includes requirements for labeling and recordkeeping. 105 CMR 480.
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
• U.S. Department of Transportation and the International Air Transportation Authority: These organizations have strict requirements governing the shipment and transportation of hazardous materials, including biological agents.
• Centers for Disease Control and Prevention: The CDC has established specific regulatory requirements for importation or transportation of etiologic agents, which include a permit application that must be submitted and approved prior to any such importations. The federal regulation governing the importation of etiologic agents is USPHS 42 CFR - Part 71 Foreign Quarantine. Part 71.54, Etiologic agents, hosts, and vectors.
• U.S. Department of Agriculture, Animal and Plant Health Inspection Service, and Veterinary Services:
USDA, APHIS, and VS regulate the importation of animals and animal-derived materials to ensure that exotic animal and poultry diseases are not introduced into the United States. Generally, a USDA veterinary permit is needed for materials derived from animals or exposed to animal-source materials.
Materials that require a permit include animal tissues, blood, cells or cell lines of livestock or poultry origin, RNA/DNA extracts, hormones, enzymes, monoclonal antibodies for in vivo use in non-human species, certain polyclonal antibodies, antisera, bulk shipments of test kit reagents, and microorganisms, including bacteria, viruses, protozoa, and fungi. Exceptions to this requirement are human and nonhuman primate tissues, serum, and blood.
• U.S. Department of Commerce: The DOC has specific regulatory requirements for exportation of biological materials. These regulations are both agent and country specific and must be followed strictly.
• Wellesley College Institutional Biosafety Committee: The IBC has promulgated a number of specific policies and procedures that are incorporated into this document as requirements or have been included as appendices.
Roles and Responsibilities
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 the Office of Environmental Health and Safety (EHS).
Registration and Approval Process
All forms can be found at this site. Contact EHS at x 3882 for username and password. Click on appropriate form name under the words Wellesley College and follow instructions.
Faculty and researchers at Wellesley College planning to carry out research using recombinant DNA 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 - click on eProtocol Submissions
A new registration form shall be submitted using on-line system above. IBC approval is good for 3 years. After three years, another application must be resubmitted for IBC approval.
* Renewals - click on Protocol Renewals
The rDNA and Biological Agent Project Renewal Form must be submitted to the IBC for review on an annual basis.
All proposed deviations from the protocol as initially approved (or since the last renewal notice); changes in laboratory location; changes in laboratory staff working on the project; and any project titles to be added must be included on the renewal form.
If there are significant deviations from the protocol, especially deviations that affect the containment level
(i.e., new study organisms, a new host-vector-donor system, or any other modifications that may affect the containment level), the IBC may ask the PI to seek an additional approval to cover the additional experiments.
* Amendments - click on Protocol Amendments
All changes should be detailed on the Amendment Form, for review and approval.. Title additions approval may be applied to several different granting agencies, but all grant titles must be registered with the IBC. Lab space additions approval applies only to work performed in registered lab space. For personnel changes, individuals must be trained in lab techniques and have completed necessary trainings.
If technical changes are extensive, the IBC may require the PI submit a completely new application. A change in PI also requires full committee review. The new PI must attach his or her CV (two-page NIH format) to the amendment.
Institutional Biosafety Committee
IBC Mission Statement
Biological Safety Cabients
See Yale University EHS video on the Proper Use of a Biological Safety Cabinet
Personal Protective Equipment
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:
- Laboratory coats (impervious).
- Side shields (for glasses).
- Face shields/masks.
- Safety glasses.
- Shoe covers.
- Respiratory protection – only if approved and in the Respiratory Protection Program
- Other site-specific PPE.
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.
Medical or Biological Waste Storage, Treatment, Dispoal and Transportation Plan
SOP for Autoclaving Biotechnology By-Product Effluents at BL1 and Bl2
SOP for Bleach Disinfection
Biowaste On-Site Log
Biowaste Off-Site Log