Biological toxins are toxic substances that can be produced by microorganisms, animals, or plants. Biological toxins are nonreplicating, noninfectious biological materials that can be hazardous even in small quantities.
This document describes Montana State University’s (MSU) policies and relevant Federal regulations that may apply to research with biological toxins. This policy includes Institutional Biosafety Committee (IBC), Federal Select Agent and Export Compliance regulations.
Biological Toxins Requiring IBC Approval
Research at MSU involving biological toxins on the Select Agent list or have an LD50 in vertebrates of ≤100 ng/kg must be approved by the IBC prior to initiation of work. To determine if the toxin in requires IBC approval, please consult the Toxin Table in Appendix 1 or contact the MSU Biosafety Officer Ryan Bartlett, [email protected], (406) 994-6733. Investigators working with a biological toxin that require IBC approval must complete the IBC protocol form.
Work involving recombinant or synthetic DNAs that encode the active subunit(s) of a biological toxin with an LD50 of ≤100 mg/kg in vertebrates, cells, organisms, or viruses must also have IBC approval before initiation of the biological toxin work. In some cases, additional review by the National Institutes of Health Office of Biotechnology Activities (NIH-OBA) as indicated in Section lll- B-1 of the NIH guidlines may be required.
Select Agent Toxins
Certain biological toxins are classified by the Federal Government as Select Agent due to their potential threat to public safety and health. The possession, use, or transfer of these biological toxins is highly regulated by the Federal Select Agent Program. Investigators using Select Agent Toxins are not required to register with the Select Agent Program if the amount does not exceed the permissible toxin amounts (see Appendix 1).
Investigators that possess a Select Agent Toxin less than or equal to the permissible amount must maintain an inventory of the amount of the Select Agent Toxin present in the laboratory. This inventory should document the number of vials, amount in each, amount remaining (if applicable) after each use, and how the toxin was inactivated when no longer needed for experiments. To meet this requirement, investigators should use the MSU Toxin Inventory Form.
The Federal Select Agent Program states that Investigators must show due diligence regarding any transfer of a Select Agent Toxin in order to prevent attempts by nefarious parties to stockpile toxins classified as a Select Office of Research Compliance Agent Toxin. In accordance with 42 CFR 73.16, Investigators must document the recipient(s) of any Select Agent Toxin and provide evidence that the individual(s) has a legitimate purpose to possess toxins. Prior to any transfer of a Select Agent Toxin, Investigators must submit an Application for Request of an Excluded Select Agent Toxin form. This form must be approved by the IBC prior to shipping the toxin to the recipient.
Export Controlled Toxins
Certain biological toxins, including genetic elements encoding these toxins, are restricted for export by the U.S. Department of Commerce and are subject to Export Control regulations.To see if the toxin requires IBC approval, please consult the table in Appendix 1 or contact the MSU Biosafety Officer Ryan Bartlett, [email protected], (406) 994-6733.
Biosafety and Biohazards Noncompliance
Research and Activity Requiring IBC Oversight
University policies and federal regulations require that all research involving biohazardous materials have oversight by Montana State University (MSU) Institutional Biosafety Committee (IBC). IBC oversight includes research, teaching and diagnostic activities that involve biohazardous material. The IBC defines biohazardous materials as having the potential to cause disease in humans, animals, or plants, or have significant negative environmental or agricultural impact. Biohazardous materials include, but are not limited to, recombinant nucleic acids, genetically modified organisms, pathogenic organisms (e.g., human, animal, plant), biological toxins, human or non-human primate materials, and animals or vectors known or suspected to be reservoirs of infectious agents. Research activities involving biohazardous materials must be reviewed and approved by the IBC prior to initiating the project.
Reporting Suspected Noncompliance
MSU is committed to operating with integrity and in full compliance with all university policies, state laws, and federal regulations. Suspected noncompliance violations may be reported by Principal Investigators (PI), laboratory staff, support staff or the general public. MSU provides a number of avenues to individuals reporting a suspected noncompliance violation involving biological related activities including to his or her supervisor, Human Resources, IBC Chair, Biosafety Officer, Director of Research Compliance, or the Vice President for Research and Economic Development. Also, MSU has selected a private contractor, EthicsPoint, 855-753-0486, to provide an independent avenue for confidential reporting of a suspected noncompliance violation. All concerns will be treated as suspected noncompliance when initially reported, will be treated as confidential to protect all parties involved and will be investigated promptly. MSU will not tolerate retaliation against individuals who report suspected noncompliance violations in good faith.
Examples of Noncompliance
Noncompliance with university policies or federal regulations can be classified as serious or moderate. Serious violations are the result of willful and malicious violations of safety practices, federal regulations, or violations that pose a real or potential threat to individuals, the university, or the environment. Moderate violations include violations where university policies were unclear and do not pose a threat to individuals, the university, or the environment.
Examples of violations include:
- Failure to acquire the appropriate export, import or collection permits for applicable research activities.
- Failure to obtain IBC approval prior to initiating research that utilizes biohazardous materials or to Office of Research Compliance deviate from methods and procedures of an approved IBC protocol prior to approval (e.g., addition of biohazardous materials or procedures that increase the risks of the research).
- Failure to report any significant problems and/or violations of the NIH Guidelines, Select Agent Regulations, Federal and State regulations, or MSU policies.
- Failure to report work related accidents/exposures and illnesses to the Biosafety Officer and IBC.
- Failure to comply with International Air Transport Association (IATA) and/or Department of Transportation (DOT) shipping or transport requirements for biohazardous materials.
- Failure to instruct, train, and document training of personnel in the procedures and techniques consistent with safety practices and procedures for dealing with reporting accidents.
- Instances demonstrating that biohazardous material was not appropriately contained, inactivated, or disposed of properly.
- Failure to demonstrate and document the correction of work errors and conditions that may have resulted in the release of biohazardous materials.
Investigation of Suspected Noncompliance
MSU will investigate suspected noncompliance with the highest standards. The suspected noncompliance should be reported to the Director of the Office of Research Compliance (ORC) and the Biosafety Officer. Promptly after receiving a suspected noncompliance report, the Biosafety Officer will initiate an investigation to gather facts to allow determination of the nature and extent of the concern, whether individuals are in immediate risk, and if the concern involves noncompliance with university policy or federal regulations. The involved individual(s) will be informed by the IBC Chair of the noncompliance investigation that is being conducted by the Biosafety Officer. If the Biosafety Officer, in consultation with the IBC Chair, concludes that that the noncompliance is serious or complex, a subcommittee may be appointed to conduct the investigation. The following considerations are evaluated during the investigation of the suspected noncompliance:
- Whether the reported actions resulted in potential harm to the involved personnel.
- Whether humans, animals, or plants were at risk of harm by the noncompliance.
- Whether a significant negative environmental or agricultural impact has occurred or has the potential to occur.
- Whether the reported violations constitute serious or continuing noncompliance with university policies or federal regulations.
When the investigation deems that noncompliance has occurred with university policies or federal regulations, or that there is a past, present, or future threat to biosafety, the investigator(s) will provide a report to the IBC and the Vice President for Research and Economic Development. The report shall include:
- A description of the noncompliance violation and whether the violation resulted in any adverse events.
- A summary of the records and evidence reviewed during the investigation.
- Identification of university policies or federal violations under which noncompliance occurred.
- Corrective actions that should be implemented to avoid noncompliance in the future and an appropriate date by which the corrective actions will be implemented.
Formal Determination of Noncompliance
When the Biosafety Officer and IBC chair determine that a violation of university policies or federal regulations has occurred, the IBC Chair will notify the involved individual(s) in writing of the noncompliance violation and the corrective actions. In cases where the noncompliance is ongoing and represents a safety issue, the IBC can suspend the research activity. If corrective actions are required the individual(s) will have a timeline in which the corrective actions must be implemented. The individual(s) will have the opportunity to work with the IBC, the Biosafety Officer and the IBC Chair to modify the corrective actions if deemed appropriate by the IBC. The Office of the Provost and the PI’s Department Head, College Dean, and the Office of Sponsored Programs may be notified of the noncompliance violation.
Examples of Corrective Actions After Determination of Noncompliance
Most moderate noncompliance violations that are not a result of willful or malicious
intent of safety
practices, federal regulations, or that do not pose a safety threat to individuals, the university, or the
environment can be resolved administratively. For serious noncompliance violations the IBC may mandate remedial corrective actions. Such corrective actions may include, but are not limited to:
- Requiring specific training or retraining for involved individuals.
- Additional monitoring by the IBC, Biosafety Officer, or delegated individuals, of research activities that pertain to the noncompliance violation.
- Requiring submission and approval of a modification to an already approved IBC protocol prior to continuation of the research for which noncompliance was reported.
- Restricting or limiting the scope of activities that the individual(s) may engage in.
- Suspending approval or terminating an approved IBC protocol.
Procedures for Suspending Research
If at any time during the investigation it is determine that either university policies
or federal regulations have been violated, which pose a threat to individuals, the
university, or the environment, the Biosafety Officer in consultation with the IBC
have the authority to suspend the activity, and to take control of any biohazardous
materials present in the facility or laboratory. The decision to suspend an activity
will require IBC deliberation and vote. Such deliberation by the IBC may involve the
review the available evidence, possible consequences, and interview the individual(s)
under investigation. The IBC may
determine to not permit the research to continue until the appropriate corrective actions have been instituted. Corrective actions required before research activities may resume include, but are not limited to the following:
- Changes in procedures used in research to mitigate the risks.
- Request for documentation of the applicable permits have been granted for the activity.
- Training or retraining of individuals conducting research.
- Request of review and approval of an IBC protocol.
In extreme cases, the IBC may determine that a serious noncompliant violation poses such a risk that the activity is indefinitely suspended, vote to revoke an approved IBC protocol, or subsequently refer the matter to the Vice President for Research and Economic Development for consultation and resolution.
Collection of Human Biological Specimens Policy
This policy applies to human subject research in which biological specimens are collected from study participants/donors.
Research staff collecting human specimens are required to follow this policy and other plans/policies as outlined.
Donor: An individual from whom a human biological specimen is derived, with their consent.
Human Biological Specimens (specimens): Wide range of human specimen types and the data associated with them. These specimens include, but are not limited to:
- Blood and other bodily fluids (including saliva)
- Cells or tissues from any part of the human body
- Molecules derived from tissues (DNA, RNA, proteins, etc.)
- Gametes (ova and sperm)
- Stem cells
- Bodily products such as teeth, hair, urine, feces
IRB: Institutional Review Board
IBC: Institutional Biosafety Committee
Universal Precautions: All human blood, tissue, and certain human body fluids are treated as if known to be infectious for HIV, HBV, HCV, and other bloodborne pathogens.
All researchers collecting, handling, or transporting specimens must complete OSHA Bloodborne Pathogens training. Training may be completed via CITI online training or in-person training provided by the Biosafety Officer.
Prior to collection of human biological specimens, an approved IRB protocol is required. Please refer to the IRB website for more information on the protocol process.
If the researcher is only collecting, storing, or shipping specimens, an IBC protocol is not required. Any laboratory that handles, manipulates, or performs analysis on specimens requires an IBC protocol. Review the IBC Manual or contact the Biosafety Officer with any questions regarding IBC requirements.
Collection of Specimens
Researchers must observe Universal Precautions when collecting and handling specimens. See sections below for specific scenarios and requirements.
Collection of Specimens on MSU Campus
Researchers must wear protective clothing (e.g., lab coat, gown, scrubs), and disposable gloves when actively collecting specimens. Gloves will be worn when handling any specimen container.
Gloves and other potentially contaminated materials will be disposed of in biohazardous waste bags inside of a biohazard waste bin. Sharps will be disposed of in sharps containers.
Collection of Specimens Off-Campus
Specimens are often collected off-campus (e.g., in donor’s house). In these scenarios, researchers must wear disposable gloves when collecting specimens and handling specimen containers. Additional PPE may be required based on consultation with the Biosafety Officer.
If collecting specimens that require the use of sharps (e.g., lancet to collect blood), researchers will use a portable sharps container to dispose of used sharps. When full, sharps containers are collected and disposed of by MSU Safety and Risk Management.
Specimens are transported in hard-sided, leak-proof, shatter-proof secondary containers that are sturdy enough to remain closed if dropped. Secondary containers are labeled with the biohazard symbol.
Receiving Specimens from Donors
Donors often collect specimens at their home and then bring the specimens to researchers on campus. Researchers will identify a location on campus where they will meet the donor. Researchers will bring a labeled, hard-sided, leak-proof, shatter-proof secondary containers that are sturdy enough to remain closed if dropped to the meeting point. Donor’s will place their specimen into the secondary container and researchers will transport the specimen to the storage location.
If the researcher must handle the specimen at the meeting point, gloves will be worn
to place the
specimen into the secondary container.
Transporting Samples on Campus
Researchers transporting samples between spaces on campus must follow the MSU Transporting
Biological Agents policy (below).
Microscope Imaging of Biological Agents
This document describesthe policy and proceduresfor imaging of biological agents with microscopes at MSU. Adherence to this policy will ensure that employees, students and members of the public are not exposed to biological agents.
Ensuring that microscopes are appropriately used, cleaned and decontaminated is the responsibility of the individual operating the microscope.
The MSU Biosafety Officer has established minimum requirements for proper decontamination
laboratory equipment that may have been exposed to biological materials, (see MSU Biosafety Manual.)
- BSL1 and BSL2 biological agents (excluding fungus and spore-forming bacteria) and viruses can be live imaged using appropriate disinfection protocols known to inactivate the biological agent. See step four for more information on disinfection.
- Spore-forming bacteria and all fungus, regardless of their containment level, must be contained (leak proof containers) or fixed prior to imaging.
- If microscope is located in a different laboratory room, samples must be prepared in the host lab and transported to the microscopy lab per MSU Transporting Biological Agents Policy (below).
- The minimum personal protective equipment (PPE) to wear when operating a microscope with a live BSL2 biological agent is a lab coat, gloves, and eye-protection. Additional PPE may be required depending upon the specific biological agent used.
- Use gloves when moving sample onto the stage. Remove gloves before touching the microscope or computer.
- After imaging, don new gloves and place sample back into transport container.
- After imaging, all microscopes and computer equipment used to image biological agents
must be decontaminated with an appropriate disinfectant for the biological agent that
is also safe for the instrument.
- An appropriate disinfectant is one that has demonstrated decontamination efficacy with regard to the biological material of concern and has been shown to not create additional hazards during use.
- Additional information is available through MSU’s Pathogen Safety Data Sheets, the
Biosafety Officer, or laboratory SOPs.
- After disinfecting the instrument, remove gloves and wash hands.
- Return sample to the host lab for disposal.
IBC Policy for Service/Assistance Animals in Teaching and Research Laboratories
The main role of the MSU Institutional Biosafety Committee (IBC) is to protect students, teachers, researchers, and community from potential exposure to the biological agents studied in MSU research and teaching laboratories. This mission depends on the execution of safe bioagent handling and containment, as prescribed by federal regulations and MSU biosafety policies and procedures. In addition, access to laboratories must sometimes be restricted in cases where particularly dangerous, opportunistic, or pathogenic bioagents are present. These cases require special consideration by the IBC, to ensure that MSU does everything in its power to accommodate the unique needs of individuals who rely on service/assistance animals.
In this policy, “individual” refers to students, researchers, and all other persons who may enter a research or teaching laboratory for the purposes of learning and performing experiments.
This policy does not apply to the Animal Resources Center (ARC).
A “service animal” is a dog, miniature horse, or other species that has been individually trained to do work or perform tasks for the benefit of an individual with a disability. On the MSU campus, there are also emotional support and other “assistance animals,” which are often registered with the MSU Office of Disability Services so that they are authorized to accompany individuals to MSU classes. For individuals who wish to bring their service/assistance animals into laboratories, Disability Services will serve as a liaison between the individual and the lab manager or other appropriate MSU employee, to engage in the process of determining whether and under what conditions an animal may be allowed in a specific laboratory. If an individual has not obtained prior approval from Disability Services, the animal may still be permitted, if it is deemed reasonable under the circumstances.
MSU employees are encouraged to reach out to Disability Services and the Biosafety Officer for assistance in determining whether an animal which has not received prior approval may be allowed in a lab.
Biosafety Containment Level 1 (BSL1) Research and Teaching Laboratories
Laboratories are categorized according to the relative risks associated with the bioagents under study. BSL1 containment laboratories are designed for the investigation of bioagents that pose a minimal potential threat to people or environment and are generally not associated with human disease. In the case of a BSL1 research or teaching laboratory, a service/assistance animal may accompany an individual on condition that lab safety and activities are not compromised or interfered with in any way. Consultation with Disability Services, the MSU employee in charge, and the Biosafety Officer will ensure that appropriate accommodations are made in advance.
Biosafety Containment Level 2 (BSL2) Research and Teaching Laboratories
BSL2 containment laboratories are designed for work on bioagents of moderate disease threat to healthy humans. MSU does not allow animals in BSL2 containment facilities because of federal regulations; the key biosafety regulatory guide, the CDC’s Biosafety in Microbiological and Biomedical Laboratories (Centers for Disease Control, BMBL), states that “Animals and plants not associated with the work being performed must not be permitted in the laboratory.” However, alternative solutions may be worked out in advance with the approval of the appropriate MSU employee in charge of the laboratory (laboratory manager, professor or principal investigator), so that individuals with service/assistance animals can be accommodated in some workable fashion.
The MSU Office of Disability Services, the IBC, MSU laboratory managers, and the Biosafety Officer will work together to accommodate individuals with service/assistance animals in our teaching and research programs as best we can. For questions, please contact the MSU Office of Disability Services and MSU Biosafety Officer, Ryan Bartlett, [email protected], (406) 994-6733.
Biohazardous Spill Cleanup Procedures
Spill Involving a Biohazardous Material Requiring BSL1 Containment
- Wear gloves, lab coat, and eye protection.
- Remove contaminated sharps from spill using forceps or tongs.
- Cover the spill with paper towels or other absorbent material
- Carefully pour bleach (1:10 dilution) around the edges of the spill and work from the edges to the center. Allow for 30-minute exposure time.
- Place towels in a biohazard bag for disposal.
- Clean spill area with fresh towels soaked in disinfectant.
Wash hands and any potentially contaminated skin before exiting thelaboratory. 8. Alert your supervisor and MSU Biosafety Officer, Ryan Bartlett, [email protected], (406) 994-6733.
If spill is inside a BSC – Keep BSC running for at least 15 minutes after the cleanup. Clean spill tray below work area and trough below air intake grill while BSC is running.
Spill Involving a Biohazardous Material Requiring BSL2 Containment
- Alert people in immediate are ofspill.
- Put on protective equipment (gloves, eye protection, and lab coat).
- Remove contaminated sharps from the spill using forceps or tongs.
- Cover the spill with paper towels or other absorbent material.
- Carefully pour bleach (1:10 dilution) around the edges of the spill and work from the edges to the center.
- Allow 30-minute contact period.
- Discard paper towels or absorbent material into biohazard bag.
- Clean fresh towels soaked in disinfectant.
Wash hands and any potentially contaminated skin before exiting thelaboratory. 9. Notify your supervisor and MSU Biosafety Officer, Ryan Bartlett, [email protected], (406) 994-6733.
If spill is inside BSC - Keep BSC running for at least 15 minutes after the cleanup. Clean spill tray below work area and trough below air intake grill while BSC is running.
Biohazard Spill Kit
Every biosafety laboratory that works with biological agents must have a biohazard spill kit on hand, that is readily accessible and easy to find in the laboratory. It should have appropriate equipment and supplies on hand for managing spills and accidents involving biohazardous materials.
Biosafety engineering equipment in the lab should include an eyewash station, a hand-washing sink with soap and paper towels, and a shower.
A biohazardous spill kit should also be kept on hand. The supplies available in a biohazard spill kit should include, but are not limited to:
- An autoclavable plastic bucket or bin to keep all contents in.
- A copy of this Spill Cleanup Protocol
- PPE - Nitrile disposable gloves, eye protection, lab coat (nearby if not in kit)
- N95 dust mask respirator(s)
- Disposable shoe covers (booties)
- Absorbent material, such as absorbent paper towels.
- All-purpose disinfectant, such as normal household bleach (freshly diluted 1:10 ) .
- Tongs and/or forceps, and/ or dustpan and hand broom for cleaning up broken glass or other contaminated sharps)
- Sharps waste container (in lab, nearby)
- Autoclavable biohazard waste bags
- Biohazardous spill warning signs
All non-disposable items should be autoclavable or compatible with the disinfectant to be used. Most of the listed items, as well as other biohazard spill control items, are available at Central Stores, and often are contained within various commercially-available biohazardous spill control kits.
Transporting Biological Agents
This document describes the policy and procedures for transporting biological agents between MSU laboratories and buildings. Accidents can result in the release of these agents and potentially cause serious harm to people, community, and environment. It is the intention of this policy to provide a set of procedures to minimize risks of exposure during transport.
Researchers should consider the degree of risk associated with biological agents. Risk Group 1/ Biosafety Containment level 1 (RG1/BSL1) agents pose a minimal potential threat to people and the environment, while Risk Group 2/ Biosafety Containment level 2 (RG2/BSL2) agents are associated with human diseases, pose a moderate health hazard, and must be handled accordingly. For agent classification, refer to your IBC protocol or MSU Pathogen Safety Data Sheets.
Like other university personnel, researchers must adhere to all Montana state policies regarding transportation (see SRM Automobile Insurance webpage for details).
Laboratory personnel that are transporting any biological agents must comply with the procedures in this policy. It is the responsibility of the Principal Investigator to ensure that 1). all laboratory personnel read and understand this policy and 2). all laboratory personnel have readily available access to the policy itself, as well as the materials required to properly and safely transport biological agents.
Transporting Biological Agents between Labs in the Same Building
- Biological agents must be placed in a labeled (names of biological agent, researcher, date), closed, leak- proof, shatter-proof primary container, preferably with a screw-cap lid (e.g. conical tubes, specimen cups). In the absence of a screw-cap, use parafilm to seal the container top.
- Primary container(s) must be placed in a secondary tray (e.g. autoclave bin), and then transportedon a lab cart.
- Spray primary container(s) with appropriate disinfectant. (e.g. 70% ethanol for 20-minute exposure time).
- Take special care when moving through public spaces; PPE is placed on the cart and not worn.
Fig. 1. RG2/BSL2 agent being transported between labs.
Transporting Biological Agents between Buildings
- Biological agents must be placed in a labeled (names of biological agent, researcher, date), closed, leak-proof, shatter-proof primary container, preferably with a screw-cap lid (e.g. conical tubes, specimen cups). In the absence of a screw-cap, use parafilm to tightly seal the top of the container to minimize the potential forspillage.
- The primary container(s) must be placed in a labeled, leak-proof, shatter-proof secondary container that is sturdy enough to remain closed if dropped (see Fig. 2).
- Disinfect the secondary container with appropriate disinfectant (e.g. 70% Ethanol for 20-minute exposuretime).
- Take special care when moving through public spaces, and do not wear PPE, including gloves.
Fig. 2. Labeled, sealed, shatter-proof container for transporting agents between buildings.
Updated/Approved by MSU IBC on March 10 2021
Working With Sharps
Careful handling of sharps will prevent injury and reduce the risk of infection. An accident or injury involving a sharp contaminated with human blood or other infectious material may result in an individual being infected with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or other pathogens.
SAFE DISPOSAL OF SHARPS
- Used sharps must be discarded immediately into sharps containers.
- Sharps containers must be kept upright.
- Never reach into a sharps disposal container or broken glass box.
- Sharps containers must be easily located in the immediate area where sharps areused. • Never overfill sharps containers past the pre-marked “fill-line”.
- Close and lock lid when moving sharps containers from the area of use.
- Puncture-resistant sharps containers are provided by Safety and Risk.
- When full, sharps containers may be autoclaved and then picked up by Safety andRisk Management (SRM). http://www.montana.edu/srm/forms/waste/
- SRM will also replace sharps containers by request.
PROPER HANDLING OF NEEDLES AND RAZOR BLADES
- Never bend, break, or shear needles.
- Never remove needles from syringe barrels.
- Never recap needles after using.
*Recapping is permissible if it can be demonstrated to the Biosafety officer and SRM that no alternative is feasible or that such an action is required by a specific procedure.
RESPONDING TO NEEDLE STICKS
- Expose the wound.
- Express blood from the wound.
- Flush wound for 5 minutes.
- Cover wound.
- Report incident to yoursupervisor.
- Immediately seek medical treatment.
- Report incident to the Occupational Health Manager (Laurie Shute, SRM, 994-7384).
For more information or assistance, contact the MSU Biosafety Officer: Ryan Bartlett, [email protected], (406) 994-6733.
April 18, 2018
Biohazardous Waste Disposal Chart