Biosafety Manual

1.      Biosafety Specifics at UB

1.1   The Institutional Biosafety Committee (IBC):  Biosafety oversight at the University at Buffalo is the responsibility of the Institutional Biosafety Committee and the Biosafety Office.  The IBC is a joint committee assigned by the Vice President for Research and Economic Development (VPRED) with operational duties carried out by the Biosafety Office within the Office of Environment, Health, and Safety (EH&S).  Biosafety protocols are submitted to the Biosafety Office and approved by the IBC. 

The NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acids require that an IBC be constituted and given oversight authority by any Institution that performs research involving recombinant or synthetic nucleic acids.  The UB IBC also maintains oversight over research involving potential pathogens, and toxins of biological origin.

The IBC at UB is made up of a dedicated group of your peers whose goal is to ensure that the research enterprise at UB is able to carry out its mission safely and within the regulatory framework of the US and NYS governments.

1.2    The Biosafety Office & Biosafety Officer:  The Biosafety Officer is the secretary of and provides technical & regulatory consultation to the IBC.  The Biosafety Officer is a member of the Office of EH&S.  The Biosafety Officer also provides technical and regulatory consultation to the Laboratory Animal Facility, the IACUC committee, the IRB committee, and the leadership of the University. 

The Biosafety Office also provides technical expertise on all aspects of compliance and biological safety that are outside of the responsibilities of the IBC such as biological specimen shipping, regulated medical waste, biological field research, training, the OSHA Bloodborne pathogen rule, and biosecurity.

The Biosafety Officer is the manager of the Biological Safety Office within EH&S.

1.3  Risk Assessments: At the heart of biological safety is the Risk Assessment.  Risk assessments are a process where the likelihood or probability of an event is weighed against the consequences of that event.  Within this process, mitigations strategies are identified to reduce both likelihood and consequence, thus making a project safer for all stakeholders.

The World Health Organization (WHO), the NIH, and the CDC all provide generalized biosafety risk assessment strategies.  These strategies are similar in intent and provide an excellent framework for the Biosafety Office when reviewing protocols.  Key considerations for the risk assessment framework are listed below:

The first step of a risk assessment is to gather information.  Questions pertaining to these subjects should be asked:

•  laboratory procedures and activities planned (e.g. equipment, animal work, sonication, aerosolization and centrifugation)
• competency of laboratory personnel
• concentration and volume of the biological agent when manipulated
• infectious dose of the biological agent
• transmission and communicability of the biological agent
• severity of infection with the biological agent
• availability of prophylaxis or therapeutic interventions
• environmental and fomite stability of the biological agent
• health & susceptibility of laboratory personnel
• host range of the biological agent
• endemicity of the biological agent in the local population
• maintenance and condition of lab equipment and building infrastructure                
  

The project’s risks are assessed based on the responses to the questions above.  The assessment considers the likelihood and consequences of an exposure to the agent at each step in the research activities and procedures.  Particular activities such as high volumes and concentrations with an airborne or aerosol component may require advanced mitigation strategies. 

Mitigation of the risk is the next step in this process.  Risk mitigation strategies may be as unique as the research study itself.  Upon design and implementation of these risk mitigation strategies, the research proceeds.  Continual monitoring and improvement are used to ensure that the research is performed as safely as possible with minimal impact to the project.

1.4    Core Biosafety Requirements at UB

1.4.1    Protocol Submission: All projects using microbes, eukaryotic cells or tissues, potentially infectious materials, RNA, DNA, synthetic nucleic acid and genomic systems, and toxins of biological origin are required to have a biosafety protocol submitted to the IBC through the biosafety office.  Protocol submissions are done through the UB Pre-Award and Compliance System (PACS) otherwise known as CLICK.

Training for CLICK use can be obtained through the VPRED’s office.

1.4.2    Competency and training: All laboratorians should be trained by the Principal Investigator (PI) or their surrogate. Training should include proper technique and safe use of lab equipment. Training should also include a description of the specific hazards that each laboratorian may encounter and specific methods to mitigate these hazards. Lastly, Principal Investigators must provide proper personal protective equipment (PPE) and teach each lab member how to properly don and doff their PPE.

Principal Investigators should ensure that their laboratorians are comfortable and competent to work in the laboratory without supervision after their training period has ended. 

The CDC has published guidelines for core competencies for public health laboratory workers which easily translate to research-based laboratories.  These guidelines can be found here: https://www.cdc.gov/mmwr/preview/ind2015_su.html. 

All members of the lab should take the UB EH&S “lab safety” training on an annual basis.

If using a potential Biohazard, all members of the lab should take the “Biosafety and BBP training” offered by UB EH&S on an annual basis. 

These two trainings will fulfill both the OSHA BBP requirement and OSHA Right to Know/Understand training required by US Federal Law.

1.4.2.1    Good Laboratory Practice: All laboratorians should be trained in good laboratory or good microbiological practices. 

Good laboratory or microbiological practices can be defined as:

• No eating, drinking, applying makeup, or contact lenses in the laboratory
• No mouth pipetting, ever
• Use an aseptic technique.
• Wash hands before and after handling lab ware.
•  Wear PPE (gloves, lab coat, eye protection, close-toed shoes, and pants or long skirt)
• Never recap needles, dispose of sharps immediately after use
• Handle all organisms as if they are infectious
• Use the proper engineering controls such as a biosafety cabinet (BSC) and ensure that they are functional and/or certified
• Label all material and store it accordingly.  Do not leave potentially infectious organisms unattended
• Make sure door sign is correct
• Avoid generating aerosols
• Use vacuum traps with disinfectant (check before use) and in-line filters to protect the vacuum pump.
• Follow the protocol, standard operating procedure (SOP), and/or manufacturer’s directions.
• Clean and disinfect all work surfaces and other potentially contaminated equipment.
• BIOSECURITY must be followed; never allow infectious or recombinant organisms to leave the lab or escape their primary containment vessel.
• Bleach all liquids for 30 minutes using a final concentration of 10% (~5000ppm sodium hypochlorite) bleach prior to drain disposal.
• All other biohazardous waste must be disposed of as Regulated Medical Waste (RMW)
• All accidents, injuries, spills, and close calls must be reported to your supervisor and to EHS using the Laboratory Incident Reporting website. (link)
• Perform your own risk assessment
• Contact EH&S with questions

1.4.2.2    PPE: All personnel working in wet labs at UB are required to wear PPE.  The minimum PPE at UB is:

•  Gloves
• Lab coat
• Eye protection
• Pants or long skirt that covers the legs
• Close-toed shoes

1.4.3   Regulated Medical Waste (RMW): NYS DEC and DOH have jointly promulgated rules regarding the treatment and disposal of regulated medical waste.  Most research activities fall under the umbrella of the DEC rules which are spelled out in 6 CRR-NY 360, 364, and 365.  Commensurate with this plan, the University at Buffalo has developed a written RMW waste management plan.  The RMW waste management plan is an appendix to this biosafety plan.   

1.4.3.1  Solid Waste: All solid materials that have come into contact with potentially infectious materials are considered regulated medical waste and must be disposed of in the red bag waste.  

1.4.3.2  Liquid Waste: Liquid waste such as microbial cultures can be sterilized using bleach.  Bleach should have a final concentration of 5000 ppm Sodium Hypochlorite which is roughly 10% of the total volume.  Treated waste should be placed in a fume hood or BSC for 30 minutes and then washed down the drain with water.

1.4.3.3  Sharps/Needles: Any item that can cut or puncture unprotected skin and comes from a biomedical or microbiological lab is considered a regulated medical waste sharp.  All sharps must be disposed of in a sharps container.  

1.4.3.4  RMW plan: Please review the RMW plan (an appendix to this document) and the UB website for further details. 

1.4.4  Disinfection & Decontamination: Most labs at UB use diluted household bleach (10% final concentration) or 70 % ethanol or iso-propyl alcohol as lab disinfectants.  Both of these disinfectants work well against common lab strains of bacteria, cell cultures, and viruses.  Diluted bleach is more powerful and will work against spores and non-enveloped viruses whereas the alcohol-based solutions are ineffective against these.  If there are any questions regarding affectivity of a disinfectant, please contact the BSO for guidance.  

1.5  Laboratory Animal Biosafety:  The lab animal facility works closely with EH&S and the Biosafety Office to ensure that projects within the animal facility meet the safety standards and regulatory compliance requirements put forth by Federal and State Agencies and Accrediting Bodies.  All animal studies using pathogens, toxins, or recombinant/synthetic nucleic acids are reviewed by the biosafety office.  A risk assessment of each project is performed and adequate biosafety measures are determined in cooperation with the LAF leadership and the IACUC.

1.6  Arthropod Research: Arthropod research should be performed using the Arthropod Containment Guidelines published by the American Committee of Medical Entomology; American Society of Tropical Medicine and Hygiene.  Arthropod use protocols should be submitted to the Biosafety Office for review and Arthropod Containment Level (ACL) assignment. Contact the BSO for assistance with implementing the ACL requirements.

1.7   Toxins of Biological Origin: Toxins of biological origin such as Botulinum toxin may fall under strict Federal regulations.  Prior to ordering a toxin of biological origin, contact the Biosafety Office for guidance.

1.8    Nucleic Acid Synthesis Screening: The Office of the President of the United States has published a policy and guidelines for the screening of synthetic nucleic acids.  All entities that receive Federal funding of any kind must adhere to this policy.  The University at Buffalo attests adherence to this policy by purchasing synthetic or synthesized nucleic acids ONLY from manufacturers that also attest to the policy.  

1.9    Enhanced Biosafety Requirements: Some projects require enhanced safety practices, PPE, and controls leading to either a BSL-2 enhanced (or +) designation or requiring the work be performed in a BSL-3 or animal BSL-3 (ABSL-3) facility.  The protocol’s risk assessment will determine any enhancements that may be required.  The PI should work closely with the Biosafety Officer to develop SOPs and protocols that describe the precautions used to mitigate the added risks.     

1.10    High Risk Organisms: Many infectious organisms are of “high consequence” and require added oversight or use of higher containment than found in a typical lab. 

The Federal Government has recently published policy and guidance documents for research classified as Category 1 and Category 2. Research that falls under these classifications must have biosafety and biosecurity oversight at both the funding agency level and local level (biosafety office).  This policy replaces the previous Federal Dual Use Research of Concern and Pathogens of Pandemic Potential policies. 

It is imperative that anyone who would like to work with Risk Group 3 or 4 organisms reach out to the biosafety office prior to obtaining the organism.

Anyone attempting to purposefully aerosolize a biological organism MUST contact the biosafety office prior to starting their project.

Any project that alters the tropism of an infectious agent or alters the virulence, transmissibility, or stability of a pathogen requires stringent review and oversight.

The IBC will act as the Institutional Review Entity for all research that potentially falls into Categories 1 and 2 research and the BSO will act as the Institutional Contact for Dual Use Research