Institutional Biosafety Committee
The purpose of the Biosafety Program is to protect all employees, students, the public, as well as the environment from exposure to biological agents or materials being used at the Hamilton College that may cause disease or be harmful to humans. This manual provides a comprehensive overview of proper work practices, regulations, and requirements for proper use, containment and disposal of biological hazards.
Hamilton College is committed to providing a healthy and safe learning, teaching, research, and work environment. The goals of the College’s Biological Safety Program are to:
- Ensure a healthy and safe research environment
- Protect staff, students, and the community from exposure to infectious agents
- Prevent environmental contamination
- Secure experimental materials
- Comply with the most recent versions of the National Institutes of Health “Guidelines for Research Involving Recombinant DNA Molecules” (NIH Guidelines), the US Department of Health and Human Services “Biosafety in Microbiological and Biomedical Laboratories” (HHS Biosafety), and other appropriate local, state and federal regulations.
This Biological Safety Manual has been developed to provide the College with safety guidelines for working with biological hazards. It also outlines general policies and procedures for using and disposing of infectious or potentially infectious materials. This document is a guidance document that will change in response to changes in existing regulations and inclusion of new regulations. It may not address all hazards that could be encountered by faculty, students, staff, and the surrounding community.
Biological safety practices and procedures in all Hamilton College laboratories must comply with those outlined in this manual. Principal investigators, laboratory supervisors, or laboratory managers must contact the Biosafety Committee or the Office of Environmental Protection, Safety and Sustainability if they are uncertain how to categorize, handle, store, treat, or discard any material.
II. Definitions, Rules, and Regulations
Biohazards include infectious or disease causing agents of humans, animals and plants, toxins of biological origin, human-derived materials, recombinant DNA and any materials potentially containing infectious agents or biohazards. Biohazardous agents may include but are not limited to: Certain bacteria, fungi, viruses, rickettsiae, chlamydiae, parasites, recombinant products, allergens, cultured human or animal cells and the potentially infectious agents these cells may contain viroids, prions and other infectious agents as outlined in laws, regulations, or guidelines.
Rules and Regulations
The following is a brief summary of the regulatory authorities that either regulate or provide guidelines for the use of biological materials, infectious agents and recombinant DNA molecules. Copies of these documents are available.
National Institute of Health (NIH): Guidelines on Research Involving Recombinant or Synthetic Nucleic Acid Molecules
These guidelines address the safe conduct of research that involves construction and handling of recombinant DNA molecules and organisms containing them. A recombinant DNA Advisory Committee (RAC) was established in 1974 to determine appropriate biological and physical containment practices and procedures for experiments that potentially posed risks to human health and the environment. As a result of the committee’s activity, the initial version of the NIH Guidelines was published in 1976. It has been amended and revised many times since then. Included in the Guidelines is a requirement for the institution to establish an Institutional Biosafety Committee (IBC) with authority to approve or disapprove proposed research using the NIH Guidelines as a minimum standard. For more information, please refer to the web site above.
The Centers for Disease Control and Prevention (CDC) and the National Institute of Health (NIH) published the first edition of the BMBL in 1984. This document describes combinations of standard and special microbiological practices, safety equipment, and facilities that constitute Biosafety Levels 1-4, which are recommended for working with a variety of infectious agents in various laboratory settings. This document also outlines requirements for animal biosafety levels. The BMBL has been revised several times and is commonly seen as the standard for biosafety. For more information, please refer to the web site above.
Department of Health and Human Services (HHS) Possession, Use, and Transfer of Select Agents and Toxins
HHS published a set of rules that require facilities and institutions to be registered and approved in order to transfer or receive certain biological agents and toxins. As most of these agents are BSL 3 or 4, they are not permitted at Hamilton College; nevertheless, we provide this information and web site to identify these agents. For more information, please refer to the website above.
III. Roles and Responsibilities
Hamilton Institutional Biosafety Committee
The role of the Hamilton Institutional Biosafety Committee (HIBC) is to protect our community and environment from exposure to biological agents or materials in teaching or research laboratories that may cause disease or be harmful to humans. We will also provide advice and recommendations regarding the use of biological agent protocols and procedures for safety and compliance to federal guidelines and regulations.
The HIBC is composed of members of the Hamilton and surrounding community based upon their expertise. The HIBC will meet at least once a semester to review protocols and will be available to consult with members of the community regarding new protocols and procedures. Minutes will be recorded for all meetings and are available upon request. No member of the HIBC may be involved in the review in which she/he is or is expected to be involved. All HIBC meetings will be posted on the Hamilton College website and other members of the Hamilton community or outside community members are welcome to attend HIBC meetings. Any public comments made on the HIBC actions will be forwarded to the NIH Office of Science Policy.
The full HIBC (not a subcommittee) is responsible for the approval or disapproval of protocols, makes recommendations for protocol improvements, and promotes the development of protocols. All recombinant DNA research must be registered with the HIBC (exempt or non-exempt). The committee is the link between Hamilton College and regulatory agencies, and reports, as required, to regulatory agencies and will directly notify PIs of the committee review. If it not possible to comply with regulations, the HIBC will stop further teaching or research. Furthermore, the NIH Office of Science Policy will be notified if any significant incidents, violations, accidents or illnesses occur.
All teaching and research with specific biological materials must have protocols registered with the HIBC for review and approval. Materials that must be registered include all transgenic organisms, recombinant DNA, human blood or tissues, or other potentially biohazardous materials. HIBC has overlapping roles with other college committees, including the Institutional Review Board and the Institution Animal Care and Use Committee, and will communicate with them when necessary and appropriate.
The Hamilton College Institutional Biosafety Committee is currently composed of the following members: Herman Lehman, Chair of HIBC (Prof. of Biology, Hamilton College), Wei-Jen Chang (Assoc. Prof. of Biology, Hamilton College, human gene transfer), Natalie Nannas (Assist. Prof. of Biology, Hamilton College, plant pathogen), Jeffrey Ritchie (Director of Sponsored Program Grants, Hamilton College), Brian Hansen (Director of Environmental Protection, Safety & Sustainability, Hamilton College), Mary Collis (Assistant Director of Environmental Protection, Safety & Sustainability, Hamilton College), Jonathan Cordeiro (Research Scientist, Masonic Medical Research Institute), and Coralie Poizat (Research Associate Professor, Masonic Medical Research Institute). All Members of the HIBC are appointed for a 3 year term by the Dean of the Faculty, Hamilton College.
Office of Environmental Protection, Safety and Sustainability
The Office of Environmental Health Protection provides instruction and training on safe work practices, conducts routine inspections of work areas, investigates accidents and recommends preventative/ corrective actions, and responds to emergencies.
The Principal Investigator (PI) is responsible for full compliance with approved research protocols, trainings required by the College, the Biological Safety Manual, and all local, state, and federal guidelines that apply to their research. The PI must complete and submit a biosafety research protocol application to the Hamilton Institutional Biosafety Committee for approval for all new research involving hazardous biological materials prior to the start of their research and shall not initiate any activity without receiving response back from the Institutional Biosafety Committee first. Modification of an activity covered by an Institutional Biosafety Committee approved protocol must also be approved by the Institutional Biosafety Committee before taking place. The PI is responsible for all personnel engaged in activity in their laboratory and must provide training to all of their staff and students on safe work practices. The PI shall report any spill or contamination to the Office of Environmental Protection, Safety and Sustainability. The Principal Investigator, together with the Office of Environmental Protection, Safety and Sustainability and other appropriate College officials, will direct cleanup procedures.
Employees and Students
Laboratory staff and students are responsible for following the principal investigator’s instruction. All personnel working with potentially infectious materials must be familiar with the College’s training requirements as well as the Biological Safety Manual. Staff and students must understand how to work with potentially infectious agents, be provided and wear the necessary PPE, keep their lab space clean, and follow regulations set forth about the handling and disposal of infectious waste.
IV. Biological Risks
This section includes those biological agents known to infect humans as well as selected animal agents that may pose theoretical risks if inoculated into humans. Included are lists of representative genera and species known to be pathogenic; mutated, recombined, and non-pathogenic species and strains are not considered. Non-infectious life cycle stages of parasites are excluded. View a comprehensive list of guidelines on the NIH website.
General Biohazardous Agents
The following agents are of general concern and include human pathogens, plant and animal pathogens, biological toxins, prions, recombinant DNA, and other select agents, animals, and cell lines.
Biosafety levels are biocontainment designations and recommendations intended to allow the most protection to the worker, occupants in the building, public health, and the environment when handling specific microbial agents. Each level of containment specifies the microbiological practices, safety equipment, and facility design for the corresponding level of risk associated with handling a particular agent. The four different biosafety levels (BSL) are explained below (Table 1).
Table 1. Biosafety Level Classifications
Risk Group Classifications
There are three primary hazardous characteristics associated with any biological agent. These characteristics include:
- The capability of an agent to infect and cause disease in a susceptible human or animal host.
- The virulence of an agent as measured by the severity of disease.
- The availability of the preventative measures and effective treatments for the disease.
A standardized methodology was developed to classify biological agents into four different risk groups by also taking transmission routes into consideration. Four Risk Group (RG) Classifications are explained below (Table 2).
Table 2. Risk Group (RG) Classifications
Human Cells and Tissues
Human and non-human primate cells should be handled using Risk Group 2 (RG-2) practices and containment. All work should be performed in a biosafety cabinet and all material should be decontaminated by autoclaving or disinfection before discarding. Appropriate training in the handling of blood-borne pathogens and up-to-date hepatitis B vaccinations may be required.
Select Agents and Toxins
Select agents are specific pathogens and toxins that have the potential to pose a severe threat to public health and safety as defined by the USA PATRIOT Act and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Hamilton College must be registered with the CDC and/or USDA before these materials are obtained, used, or stored.
Recombinant DNA (rDNA)
Recombinant DNA (rDNA) includes molecules that are constructed or synthesized outside living cells by joining natural or synthetic DNA segments of DNA molecules that can replicate in a living cell. They may also result from the replication of such construction DNA molecules. rDNA also includes synthetic DNA segments which are likely to yield a potentially harmful polynucleotides or polypeptides and are considered as equivalent to their natural DNA counterpart. If the synthetic DNA segment is not expressed in vivo as a biologically active polynucleotide or polypeptide product, it is exempt from the NIH guidelines. Human gene transfer studies, creation of transgenic rodents, cloning genes using plasmids, and generating and use of vectors to deliver genes are considered types of work with rDNA.
V. What must be registered with HIBC
Any experiment involving one or more of following must be registered with the HIBC:
- Pathogens affecting humans, animals or plants.
- Materials potentially containing human pathogens (for example, unfixed human specimens, human blood).
- Recombinant DNA molecules including virus vectors. Note: use the reference chart below (Figure 1) to determine which recombinant DNA experiments must be registered with NIH and or HIBC, and when.
- Work that does not qualify under NIH Guidelines Appendix CI-IX
- Human cell lines that are not well-characterized or require Risk Group 2 containment
- Generation of de novo transgenic animals, defined as the addition of foreign DNA or subtraction of a portion of the animal genome using recombinant DNA technology. The breeding of transgenic animals to generate additional transgenic offspring does not require IBC approval. Those transgenic animals that already exist or which have been purchased also do not require HIBC approval.
- All research involving the use of recombinant or synthetic nucleic acid molecules containing no more than two-thirds of the genome of any eukaryotic virus, or biohazards.
- Animal Subjects: All research involving the use of recombinant molecules or biohazards in whole animals requires both HIBC and IACUC approval.
- Human Subjects: Any research involving the introduction of recombinant molecules or biohazards into human subjects must be approved by the IBC and by the IRB.
Figure 1. Recombinant DNA Research Registration Checklist
This chart should be used as a reference to determine when your experiment must be registered with HIBC and/or NIH, and when.
VI. Training Requirements and Supplemental Courses
General Lab Safety Training
Lab safety training requirements are generally spelled out in accordance with other specified Hamilton College plans, including:
- The Hazard Communication Plan:
For work with hazardous chemicals in lab settings
- The Chemical Hygiene Plan:
For work with occupational and/or environmental hazards in lab settings
- The Waste Management & Minimization Plan:
Which deals with waste handling, storage and disposal
The introduction and use of certain biological hazards into lab settings mandates additional training requirements, to both minimize lab acquired infections (LAI’s) and comply with this plan and other consensus and regulatory drivers. In general, employee/student use of and exposure to biological hazards at the BSL-1 level does not require additional training beyond that which is provided in accordance with the plans noted above, so long as such hazards are clearly stipulated in written lab hazard assessments.
Employee/student use of and exposure to biological hazards at the BSL-2/BSL-2+ level requires additional training to at a minimum cover the following:
- Laboratory Acquired Infections (LAI’s)
- OSHA Bloodborne Pathogens Standard:
- When human blood, tissues or OPIM (other potentially infectious materials) are in use
- Vaccinations (i.e. Hepatitis B, Rabies, etc.)
- Sharps and centrifuge safety
- Engineering controls through biological safety cabinets (BSC’s)
- Animal handling and biosafety (where applicable)
- NIH guidelines for research involving recombinant or synthetic nucleic acid molecules
Additional required training will require completion of appropriate CITI Program Training modules.
VII. Guidelines for the safe use of biological hazards
The NIH and CDC specifies hazard levels, standard microbiological practices, safety equipment, laboratory facility requirements for standard laboratory experiments for using specific BSL agents. Hamilton College laboratory containment requirements and practices follow these guidelines for BSL-1, BSL-2 and BSL-2+ agents (only allowable agents at Hamilton College) and are outlined in the chart below.
A. Hazard Levels
|Biosafety levels (BSL)||BSL–1||BSL–2||BSL–2+
*Agents that require enhanced BSL-2+ precautions below
|1. Degree of hazard||Low risk: Well characterized agents not known to cause disease in healthy adult humans||Moderate: Agents that cause human disease of moderate hazard||High: Agents involved in laboratory-acquired infections or where disease can have serious or potentially lethal consequences.|
|2. Examples||Escherichia coli (laboratory strain)||Streptococcus pyogenes||*See below|
|*BSL-2+ Agents include the following||*Escherichia coli (shiga toxin producing strains); Hepatitis B and C virus; Human immunodeficiency virus; Influenza virus; Infectious prions; Listeria monocytogenes; Lymphocytic choriomeningitis virus; Macaque tissue; Rabies virus or vectors; Salmonella typhi; Shigella dysenteriae (Type 1); Simian immunodeficiency virus; Toxoplasma gondii; Vaccinia virus or vector; Zika virus|
B. Standard Microbiological Practices
|Biosafety levels (BSL)||BSL–1||BSL–2||BSL–2+|
|1. Access to the laboratory||Access does not have to be restricted — however, doors cannot be propped open (fire code violation).||Doors to the laboratory are closed when BSL-2 work is being conducted to prevent public access.|
|2. Biohazard signage||Biohazard sign must be posted.|
|3. Biohazard solid waste decontamination||N/A—handle as standard solid waste.||Biomedical waste vendor or steam sterilize with EH&S approval. Pathological waste or infected animals must be incinerated.|
|4. Biohazardous liquid culture decontamination||N/A—direct sink disposal is permissible.||10% bleach/water made fresh daily with bleach having an EPA registration number (e.g., Chlorox) for 30 minutes or steam sterilize with EH&S approval.|
|5. Storage of biohazardous waste material||N/A—materials are not regulated medical waste||Double red bags held in rigid, leakproof containers with biohazard labels on the top and side. Biohazardous waste must be under direct control of the responsible laboratory until it is placed in an EH&S approved storage area.|
|6. Eating, drinking, application of cosmetics or contact lenses||Permitted only in designated clean areas.||Not permitted at any time.|
|7. Contaminated sharps (e.g., needles, blades, glass)||Safe handling practices must be developed and implemented. Substitute plasticware for glassware whenever possible.|
|8. Decontamination of work surfaces||Daily, after finishing work and following spills.|
|9. Pipetting||Mechanical device – no mouth pipetting.|
|10. Handwashing||Required after working with potentially hazardous materials and before leaving the laboratory.|
|11. Training||The laboratory supervisor must ensure that laboratory personnel receive appropriate training regarding their duties, the necessary precautions to prevent exposures, and exposure evaluation procedures.|
|12. Medical surveillance||Recommended where personal health status may result in increased susceptibility to infection or inability to receive vaccinations or prophylactic interventions.||Required. Laboratory personnel must be provided with medical surveillance and offered appropriate immunizations.|
|13. Equipment decontamination||N/A||Equipment must be decontaminated and green tagged by EH&S before repair, maintenance, or removal from laboratory.|
|14. Animals and plants not associated with the work||Allowed if approved by laboratory director/PI.||Not allowed in the laboratory.|
|15. Institutional Biosafety Committee approval required for use of glassware||N/A||Recommended||Required for HBV, HCV, and HIV|
C. Safety Equipment and PPE
|Biosafety levels (BSL)||BSL–1||BSL–2||BSL–2+|
|1. Class II Biological safety cabinet (with annual certification)||Not required.||Required for all aerosol generating processes.||Required for all work.|
|2. Sealed rotors or safety cups for centrifuging||Not required.||Required for high concentrations or large volumes of infectious agents. Exception: Centrifuges without secondary containment can be operated inside a certified biosafety cabinet.||Required for all work.|
|3. Laboratory coats||Required.|
|4. Gloves (alternatives to latex gloves should be available)||Required.|
|5. Eye protection (safety glasses, goggles)||Required. This includes work in the biosafety cabinet.|
|6. Sleeve protectors||Not required.||Recommended.|
|7. HEPA-filtered vacuum lines||Required.|
D. Laboratory Facilities
|Biosafety levels (BSL)||BSL–1||BSL–2||BSL–2+|
|1. Ventilation||Negative pressure is required if adjacent area is a lower biosafety level or non-laboratory space. Single pass air is required.|
|2. Handwashing facilities||Required.|
|3. Autoclave||Not required.|
|4. Eye wash station||Required.|
|5. Doors||Required.||Required. Doors should be self-closing and have locks.|
|6. Chairs||Chairs used in laboratory work must be covered with a non-porous material that can be easily cleaned and decontaminated with appropriate disinfectant.|
|7. Cleaning and decontamination||Laboratory design should allow the facility to be easily cleaned and decontaminated. Carpets and rugs are not appropriate.|
This information has been adapted, in part and with permission, from Clarkson College and Skidmore Colleges' Institutional Biosafety Committee documents.