The Institutional Biological Safety Manual serves as a blueprint for implementing an effective biosafety program, which is integral to Mount Sinai’s commitment to establishing and maintaining a “Culture of Safety.”

The Mount Sinai Biological Safety Program Administration developed the Institutional Biological Safety Manual in consideration of pertinent federal, state, and city government regulatory documents, along with guidance documents from the Centers for Disease Control and Prevention, the National Institutes of Health, and the World Health Organization.

The Institutional Biological Safety Manual complements the Chemical Hygiene Plan and Clinical and Research Laboratory Safety manual developed by the Environmental Health and Safety (EnvH&S). The Chemical Hygiene Plan (CHP) applies to faculty, staff, and students on all campuses engaged in the laboratory use of hazardous materials, including those covered under the OSHA Standard 29 CFR 1910.1450, Occupational Exposure to Hazardous Chemicals in Laboratories (referred to as the Laboratory Standard).

The Institutional Biological Safety Manual is a living document, which the Mount Sinai Biological Safety Program Administration updates as necessary to address ever-changing federal, state, and city government regulations and guidance documents.

Environmental Health & Safety (EnvH&S) developed the Chemical Hygiene Plan  and Clinical and Research Laboratory Safety Manual as part of its Laboratory Safety program. The Chemical Hygiene Plan applies to all Mount Sinai faculty, staff, and students engaged in the laboratory use of hazardous materials, including those covered under the OSHA Standard 29 CFR 1910.1450, Occupational Exposure to Hazardous Chemicals in Laboratories (referred to as the Laboratory Standard). EnvH&S developed the Clinical and Research Laboratory Safety manual to assist Principal Investigators (PI’s) and Lab Supervisors with fulfilling the requirements of the OSHA Laboratory Standard.

OSHA Standard 29 CFR 1910.134, Respiratory Protection, requires Mount Sinai to develop and implement a written respiratory protection program that specifies required work-specific procedures and to identify work activities that require use of respirators. Environmental Health & Safety (EnvH&S) administers the Mount Sinai Respiratory Protection Program, including respirator fit testing, as part of its Occupational Safety and Health program.

The CDC and the NIH jointly published the Biosafety in Microbiological and Biomedical Laboratories,  Sixth Edition (BMBL, Sixth Edition). Although the BMBL is an advisory document on the biosafety practices and policies for biomedical research in the United States, best practices issued by non-regulatory organizations can be enforceable under OSHA’s General Duty Clause. 

WHO Laboratory Safety Manual, Third Edition, provides guidance on fundamental biosafety techniques for use in research laboratories at all levels in all countries.

The April 2019 NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) detail safety practices and containment procedures for basic and clinical research involving recombinant or synthetic nucleic acid molecules, including the creation and use of organisms and viruses containing recombinant or synthetic nucleic acid molecules. As a condition for NIH funding to the Institution (Mount Sinai) for recombinant or synthetic nucleic acid molecule research, compliance with NIH Guidelines is mandatory. This applies to both NIH-funded projects and non-NIH funded projects involving recombinant or synthetic nucleic acid molecules. 

The Occupational Safety and Health Administration Standard 29 CFR 1910.1030, Bloodborne Pathogens, applies to all occupational exposures to blood or other potentially infectious materials (OPIM). The Standard mandates that Mount Sinai establish a written Exposure Control Plan. The Icahn School of Medicine at Mount Sinai written Exposure Control Plan, Occupational Exposure Prevention and Control Plan for Bloodborne Pathogens in Laboratory Settings, is designed to eliminate or minimize exposure of employees to blood or OPIM. Section 1910.1030(g)(2)(vii)(A) of the Bloodborne Pathogens Standard requires that Mount Sinai provide each employee with an accessible copy of the regulatory text of the Standard and an explanation of its contents. OSHA’s Standard, Bloodborne Pathogens, applies to all Mount Sinai employees who have occupational exposures (including reasonably anticipated) to blood or OPIM. The Bloodborne Pathogens Standard is intended to prevent serious occupational infections resulting from employee exposure to blood or other potentially infectious materials.

The CITI Program training series, OSHA Bloodborne Pathogens, is required training for all School employees with known or suspected exposure to Bloodborne Pathogens, including Basic Sciences Researchers working in HIV, HBV, and HCV laboratories.

The regulatory text of the Occupational Safety and Health Administration Standard, Bloodborne Pathogens, is available online: https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1030

Needlestick and other sharps injuries are serious occupational hazards in biomedical research and health care settings. Contact with contaminated needles, scalpels, broken glass, and other sharps may expose employees, students, and laboratory visitors to blood, bodily fluids, or other fluids that may contain disease-causing pathogens. The information packet, How to Prevent Needlestick and Sharps Injuries, provides guidance on safe handling of sharps, the reporting procedure for Needlestick/Blood or Body Fluid Exposures (BBFE), and the associated Employee’s Report of Injury form.

Transportation of Hazardous Materials/Dangerous Goods, including biohazardous materials, requires training and certification to prepare, ship, and receive Hazardous Materials/Dangerous Goods. The U.S. Department of Transportation (DOT) and the International Air Transport Association (IATA) regulate shipping of Hazardous Materials/Dangerous Goods (see Table). The IATA Dangerous Goods Regulations govern air transport of Hazardous Materials/Dangerous Goods worldwide. In addition to the brief overview below, the Institutional Biological Safety Manual provides entity-specific information on shipments of Hazardous Materials/Dangerous Goods.

Regulated Biological Materials

Biological Substance, Category A (UN 2814 or UN 2900) 

An infectious substance transported in a form that, when exposure to it occurs, is capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals.  

• Examples: the culture of the Hepatitis B virus, Canine Coronavirus, Klebsiella Pneumoniae, and E. coli (verotoxigenic strains). 

Biological Substance, Category B (UN 3373) 

An infectious substance transported not in a form that, when exposure to it occurs, is capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals.  

• Examples: Viral vectors (e.g., Adenovirus, HSV-1, Lentivirus), Human or Non-human primate cell lines, patient specimens (human or animal) with unknown or known pathogens present (e.g., human blood and its components, unfixed tissues). 

Genetically modified Organisms (GMOs/GMMOs) are non-pathogenic organisms or microorganisms whose genetic material has been intentionally altered in a manner (e.g., recombinant DNA techniques) that would not occur naturally. Pathogenic GMOs/GMMOs may be classified as either Category A or B. Replication of defective vectors typically handled at BSL2 can be considered Category B. 

• Examples: Baculovirus, Bacteriophages, Murine retrovirus (MLV) 

GMO/GMMO are not regulated in the United States when transported by ground. IATA guidelines and UN 3245 apply for air shipments. 

Exempt Human and Animal Specimens 

This category includes Clinical patient specimens for which there is minimal likelihood that the specimens contain infectious pathogens and Animal specimens for which there is minimal likelihood that the specimens contain infectious pathogens. 

Although they fall under exemptions, this is not the same as "unregulated." Specific criteria have to be satisfied for the material to meet the exempt status. In determining the likelihood, professional judgment is based on the known patient medical history, symptoms, and individual circumstances of the source and the human or animal endemic local conditions. 

• Examples: Cheek swabs for DNA testing and blood or urine taken from healthy individuals for routine drug testing, substances containing micro-organisms that are non-pathogenic to humans or animals 

Non-regulated Biological Materials 

Many research-related materials that are biologically derived are not regulated. The following are not subject to the regulations unless they meet the criteria for another type of dangerous goods (e.g., contain a preservative or fixative). 

• Examples: Purified proteins, monoclonal or polyclonal antibodies, certain plasmids and nucleic acids (RNA/DNA), fixed human tissues, non-infectious microorganisms such as E. coli K-12 or Saccharomyces cerevisiae, and many animal and insect cell lines (not including human or non-human primate (NHP)). 

Permits – CDC and U.S. Department of Agriculture (USDA)/Animal and Plant Health Inspection Service (APHIS)

Federal agencies tightly regulate the import, interstate movement, and export of infectious agents and/or biological materials suspected to contain such agents and may require permits. These permits minimize the risk of inadvertent release and inappropriate use of such materials. Compliance with multiple regulatory agencies may be required in some cases, depending on the nature of the material to be transported, the point of origin, etc. 

If a permit is required, the recipient of the regulated material must obtain the permit prior to transport. If you're sending the material, you’ll need to get a copy of this permit from the recipient and include it in the shipment. It is important to remember that most permits are issued to the individual and not to the institution; hence, the PI or the recipient is responsible for finding out about the permit requirements from the relevant agencies, applying for the permit, and obtaining it prior to transport. The permit application process may take several weeks, and sufficient processing time must be allowed before the materials are needed. 

Failure to comply with regulations when transporting regulated biological materials may result in shipment delays or destruction at the port of entry, refusal of the shipment by carriers, and being subject to fines and/or criminal penalties. 

• CDC Import or Transport Permits: The CDC Import Permit Program, or IPP, regulates the importation of infectious biological materials that could cause disease in humans to prevent their introduction and spread into the United States. The program ensures that the importation of these agents is monitored and that facilities receiving permits have appropriate biosafety measures in place to work with the imported agents. A CDC Import permit is required prior to importing the following into the United States: 

• Infectious biological agents capable of causing illness in humans 
• Material known or reasonably expected to contain an infectious biological agent 
• Vectors of human diseases (such as insects or bats) 
• Subsequent transfers of pathogens of high consequence 

Please refer to the CDC IPP website for the application process. 

• USDA/APHIS Import or Transport Permits: USDA APHIS issues Controlled Import Permits (CIP) to ensure the safe import and transport of plant or animal materials that may potentially harm U.S. agricultural products, including livestock, poultry, and crops. These permits outline the controls necessary for importing, exporting, interstate transporting, and releasing these regulated products. 

The Veterinary Services branch of USDA APHIS issues the Veterinary Services (VS) Import, Export, or Transport permits, and the Plant Protection and Quarantine (PPQ) branch of APHIS issues the PPQ permit. APHIS also regulates the movement of certain genetically engineered organisms through its Biotechnology Regulatory Services (BRS).  

USDA/APHIS uses an online system, APHIS eFile, for users to apply for and receive import, interstate movement, transit, release permits, apply for permit renewals and amendments, submit annual reports, and receive regulatory guidance. Shippers must read and follow the guidance appropriately to prevent regulated materials from being held at the port of entry until the applicable permit is provided to avoid delays and/or denial of entry. 

Shipping Approval

Environmental Health and Safety (EnvH&S) must review and approve all packages of Hazardous Materials/Dangerous Goods prior to shipment from the Mount Sinai campus. EnvH&S provides guidance on Hazardous Materials Shipping to assist investigators in preparing Dangerous Goods packages. EnvH&S will ensure all research and clinical packages are packaged, marked, and labeled in accordance with applicable local, state, and federal regulations. The Principal Investigator (PI) or designated Laboratory Safety Officer (LSO) must e-mail a completed HazMat Shipping Approval Form to EnvH&S at least 24 hours prior to the expected shipping date from the Mount Sinai campus for Category A or Category B packages. The PI must complete the Export Checklist if any of the packaged materials shipped from the Mount Sinai campus are subject to U.S. Export Controls or are excluded from the Export Administration Regulations (Fundamental Research Exclusion).

Shipments of biological materials onto the Mount Sinai Campus may require an import permit from the CDC Import Permit Program or the USDA/APHIS Veterinary Services. Contact the Institutional Biological Safety Program for guidance on import permits.

Laboratories may arrange shipment of Category B packages if the individual involved in preparing and packaging of dangerous goods is compliant with IATA training requirements for Division 6.2, Infectious Substances. Training certification for Division 6.2, Infectious Substances, is valid for two years or until regulatory changes are implemented and must be retaken at that time if needed. EnvH&S must inspect and approve Category A packages before they are received by the transportation courier.

The Biological Safety Program is in the process of updating biological safety-related forms on this page. Please contact us if you have a specific request. Principal Investigators (PIs) or designated Laboratory Safety Officers (LSOs) should submit completed forms via email to biosafety-program@mssm.edu.

Certificate of Decontamination

OSHA and United States Environmental Protection Agency (EPA) regulations require that any analytical equipment freezers, refrigerators, and incubators that were used with infectious agents or Human blood or body fluids receive decontamination prior to disposal or return to manufacturer or a service company. The Principal Investigator (PI) or designated Laboratory Safety Officer (LSO) must complete this form to record the date and method of decontamination and provide tracking documentation in the event of an inquiry by the biological safety professionals or regulatory agencies.

Biological Safety Self-Inspection Form

The Principal Investigator (PI) or designated Laboratory Safety Officer (LSO) should complete the Biological Safety Self-Inspection Form to assess compliance with biological safety guidelines and best practices described in Guidelines and Policies.

Biological safety templates available for Principal Investigator Use:

• Biohazard Notification
• Autoclave Use Log