Microbiological laboratories are special, often unique work environments that may pose identifiable disease risks to person in or near them. The following information describes the requirements for Syracuse University researchers as defined by the Institutional Biosafety Committee (IBC) and the Environmental Health and Safety Services (EHSS) Office. It is the responsibility of each Principal Investigator to ensure the laboratory is in compliance.
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2.1 Biological Materials
The U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) have published guidelines for handling microbiological organisms entitled, “Biosafety in Microbiological and Biomedical Laboratories” (BMBL). The BMBL describes combinations of microbiological practices, safety equipment, and facilities that are recommended for working with a variety of microbiological agents in laboratory settings. Syracuse University has adopted the guidelines listed in the BMBL and have incorporated them into the requirements of this program.
All Principal Investigators are required to notify the IBC of all biological materials in their possession by completing an online Biological Inventories Form. The IBC must maintain accurate information regarding the possession and use of all biological materials at the University. Principal Investigators must update this information as inventories of biological materials are added or deleted, and on an annual basis regardless of change.
Principal Investigators conducting work with biohazardous material (biosafety level 2 and higher) must complete and submit an Institutional Biosafety Committee Protocol Application to the IBC for review and approval. The IBC review and approval process is designed to ensure that the research with biohazardous material is conducted in a manner that complies with applicable Federal, State and Local regulations, as well as, the requirements of this Program.
All laboratories using biosafety level 2 or higher organisms, will be assessed by the Biosafety Officer for compliance with the requirements of this Program. A biosafety assessment will be conducted using a Biosafety Assessment Form. The Biosafety Assessment Form will be used to assess the adequacy of the laboratory equipment, work practices, and administrative controls used for experiments that require the use of biohazardous material. Based on the biosafety assessment, the Biosafety Officer will make recommendations in regards to the practices used in the laboratory.
All Principal Investigators are required to train each researcher under their supervision in both basic biosafety principals and the specific microbiological procedures that will be used for the experiment. PI’s may receive training on the contents and requirements of this program by contacting EHSS (315-443-2447).
2.2 Recombinant DNA Research
Regulatory directives for Recombinant DNA (rDNA) Research are provided in “Guidelines for Research Involving Recombinant DNA Molecules“, from the Department of Health and Human Services, National Institutes of Health (NIH). These guidelines are applicable to all rDNA research in the U.S. that is conducted at or sponsored by an institution that receives any support for rDNA research from NIH. Research conducted at or sponsored by SU, irrespective of the source of funding, shall comply with NIH Guidelines. Noncompliance with NIH Guidelines may result in suspension, limitation or termination of activities conducted for rDNA research at SU.
Recombinant DNA experiments involving certain agents require IBC notification before initiation. In addition, IBC approval is required prior to the commencement of any proposed rDNA project that involves pathogenic agents, human subjects, live animals, plants, and/or planned release of rDNA organisms into the environment. The University will not allow experiments utilizing rDNA that involve the deliberate transfer of a drug resistance trait to Select Agents, or experiments involving deliberate formation of rDNA containing genes for the biosynthesis of select toxins lethal for vertebrates at an LD50<100ng/kg body weight.
All Principal Investigators are required to notify the IBC of all rDNA experiments conducted under their supervision by completing an online Recombinant DNA Registration. The IBC must maintain accurate information regarding the rDNA research conducted at the University. Principal Investigators must update this information anytime rDNA experiments are modified, and on an annual basis regardless of change.
All rDNA experiments classified as “Non-Exempt” according to the NIH Guidelines requires, at a minimum, IBC review and approval before initiation. Certain experiments may require approval from the Federal Office of Biotechnology Activities or Recombinant DNA Advisory Committee.
2.3 Select Agents
The Centers for Disease Control (CDC) and United State Department of Agriculture (USDA) are required to regulate the possession of biological agents and toxins that have the potential to pose a severe threat to public health and safety. CDC’s and USDA’s Select Agent Program oversees these activities. The Select Agent Program currently requires registration of facilities including government agencies, universities, research institutions, and commercial entities. Syracuse University is currently restricted by the Federal Government from possessing Select Agents in nonexempt quantities. Before a Syracuse University Laboratory can receive a Select Agent, the facility must submit an application to the CDC for approval. The initial application process is time consuming and may require a 12-24 month delay in research until approval is granted. Before an experiment involving Select Agents may be conducted, the University must comply with the Department of Health and Human Services (HHS) Regulation, 42 CFR Part 73, “Possession, Use, and Transfer of Select Agents and Toxins” and United States Department of Agriculture (USDA) 7 CFR 331 and 9 CFR 121, “Agricultural Bioterrorism Protection Act of 2002”. These documents establish requirements regarding possession and use in the United States, receipt from outside the United States, and transfer within the United States, of select agents and toxins. These documents include requirements concerning:
- Registration
- Security risk assessments
- Safety plans
- Security plans
- Emergency response plans
- Training
- Transfers
- Record keeping
- Inspections
- Notifications
The IBC will review the proposed use, storage, disposal and transfer of any of the Select Agents/Toxins PRIOR to possession and use at Syracuse University. It is essential to inform the IBC of intended select agent or toxin work so that the University’s registration with the CDC covers the intended uses on campus. Failure to account for agent and toxin possession or usage will jeopardize the University’s research privileges to possess or use these materials and may result in a criminal investigation.
Prior to transferring Select Agents to and/or from a unique mailing address, a CDC EA101 form must be completed. These forms can be obtained through EHSS. Both the transferor and requestor must sign this form. Principal Investigators must also list the Responsible Facility Official on this form. The Responsible Facility Official for SU is the Vice Chancellor and Provost. The completed from must be sent to EHSS for approval before a transfer can be made. In addition, no transfers between facilities, storage area, or labs at SU can be performed without advance IBC approval and notification to the Biosafety Officer.
Specific information regarding the possession and use of Select Agent and toxins at Syracuse University is listed in Section 6 of this document.
2.4 Animals
All research experiments involving animals must be conducted in accordance with the associated Institutional Animal Care and Use Committee (IACUC) approved protocol. No person, whether faculty, staff or student, may directly participate in activities involving the handling and use of live vertebrate animals without certification of completion of training in the humane care and use of animals, the ethics of animal use in research and teaching, and the regulations governing such use, as provided by the IACUC and Office of Laboratory Animal Resources (OLAR).
Research or teaching involving animals shall be conducted by, or under the immediate supervision of, a qualified Principal Investigator. It is the responsibility of the Principal Investigator to certify, in writing, that all other personnel working on the project or teaching the class have been appropriately trained in IACUC approved procedures.
No cadaveric animal parts or whole animals, whether from commercial or other sources (e.g. slaughterhouses) shall be brought into SU research or teaching facilities absent notification to OLAR provision of the required data, and approval, which will not be unreasonably withheld.
For additional information please contact IACUC at 315-443-3013 or visit http://researchintegrity.syr.edu/animal-research/about-iacuc/.
2.5 Human Blood and Cell Lines
The Occupational Safety and Health Administration (OSHA) created the Occupational Exposure to Bloodborne Pathogens Standard, 29 CFR Part 1910.1030 to minimize or eliminate exposure to infectious agents that may be present in human blood, tissues or certain body fluids. The Bloodborne Pathogens Standard applies to all employers having employees that are “occupationally exposed” to the following:
- Whole human blood, any of its parts (serum, platelets, etc.), products made from human blood, or any human body fluids contaminated with blood.
- Any unfixed tissue or organ (other than intact skin) from a human (living or dead).
- HIV-containing cell or tissue cultures, organ cultures, and HIV or HBV or HCV-containing culture medium or other solutions.
- Blood, organs, or other tissues from experimental animals infected with HIV, HBV or HCV.
All cell and organ cultures of human origin, including well established cell lines, shall be handled in accordance with the Syracuse University Bloodborne Pathogen Program, the Syracuse University Biosafety Program and under Biosafety Level 2 (BSL2) containment.
The possession and use of primary cell lines must be approved by the IBC and all individuals with access to primary cell lines must be enrolled in the Syracuse University Bloodborne Pathogens Program and attend annual training, provided by EHSS.
Principal Investigators must notify the University’s Biological Safety Officer (315-443-2447) prior to the use of human cell lines and must submit and maintain an inventory of cells lines in their possession, which must be communicated to EHSS annually, or as needed.
Please refer to the Syracuse University Bloodborne Pathogens Program for additional information on the exposure control plan, training requirements, work practices, housekeeping, engineering controls, personal protective equipment, signs/label requirements, Hepatitis B vaccination, emergency actions, exposure incident procedures, post-exposure evaluation and follow-up, and record-keeping. Please contact the Biosafety Officer (315-443-2447) for more information on Bloodborne Pathogens.
2.6 Controlled Substances
The acquisition, use and disposal of Controlled Substances at Syracuse University are subject to strict Federal and State regulations. These regulations set specific requirements and restrictions on registration, acquisition, usage, record keeping transfer, storage and disposal. Individuals who manufacture, distribute, dispense, import, export, conduct research or perform chemical analysis with any Controlled Substances are subject meeting the requirements set forth in Tile 21 CFR, Part 13001399 and Part 80, Subchapter K of the New York State Public Health Law.
No University personnel shall possess a controlled substance without obtaining a license from the New York State Department of Health and registering with the Federal Drug Enforcement Agency as appropriate. Please refer to the Syracuse University Controlled Substance Program for more information regarding registration, acquisition, usage, record keeping transfer, storage and disposal.