Biological Safety Manual - NYU · Biological Safety Manual October 11, 2016 Incidents, Exposures and Emergencies Emergency Numbers NYU DIAL 911 from a campus phone NYU Washington

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Biological Safety Manual October 11, 2016

Biological Safety Manual

Last Reviewed Date: 10/11/2016 Revised by: Tekechia Hester Effective Date: 02/25/2009 Applies To: Employees, Faculty, Students, Others For More Information Contact: Biosafety 212-998-1440

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Table of Contents

Forward ........................................................................................................................................... 6

Incidents, Exposures and Emergencies .............................................................................................. 7 Emergency Numbers .............................................................................................................................................................................. 7 On-Campus Medical Emergencies Requiring an Ambulance ................................................................................................ 7

Rules, Regulations and Guidelines Governing the Use of Biological Agents ........................................ 8 National Institute of Health (NIH) ........................................................................................................................................................ 8 Centers for Disease Control and Prevention (CDC) and the NIH ............................................................................................. 8 Occupational Safety and Health Administration (OSHA) ........................................................................................................... 8 The Select Agent Rule .................................................................................................................................................................................. 8 United States Department of Agriculture (USDA) ......................................................................................................................... 8 New York Department of Health ............................................................................................................................................................ 8 Other Agencies and Entities ..................................................................................................................................................................... 9

Responsibilities and Administration ................................................................................................ 10 Senior Biosafety Specialist ...................................................................................................................................................................... 10 Institutional Biosafety Committee (IBC) .......................................................................................................................................... 10 Academic Chairs, Department Heads ................................................................................................................................................ 10 Principal Investigator (PI) ...................................................................................................................................................................... 10 Laboratory Personnel................................................................................................................................................................................ 11

Biosafety Requirements ................................................................................................................. 12 Biological Laboratory Survey ................................................................................................................................................................ 12 Registration of Recombinant and Synthetic Nucleic Acid Molecule (r-sNA) Experiments ....................................... 12 Human Blood, Body Fluids, Tissues and Other Potentially Infectious Materials ........................................................... 12 Animal Use ...................................................................................................................................................................................................... 13 Biological Safety Cabinets (BSC), Laminar Flow Benches (LFB) and Chemical Fume Hoods ................................. 13 Training ........................................................................................................................................................................................................... 14 Standard Operating Procedures........................................................................................................................................................... 15

Risk Assessment and Exposure Sources ........................................................................................... 16 Risk Assessment ............................................................................................................................................................................................ 16

Biological Agent Hazards ................................................................................................................ 16 Exposure Sources ......................................................................................................................................................................................... 16 Risk Groups ..................................................................................................................................................................................................... 17

Routes of Exposure ......................................................................................................................... 18 Percutaneous Exposure (through the skin) ...................................................................................................................................... 18 Inhalation of Aerosols ............................................................................................................................................................................... 18 Mucous Membrane ..................................................................................................................................................................................... 18 Ingestion .......................................................................................................................................................................................................... 18

Biosafety Levels .............................................................................................................................. 19

Signs and Labels ............................................................................................................................. 22

Laboratory Practices ....................................................................................................................... 23 Microbiological Standard Practices ................................................................................................................................................... 23 Hazard Controls ........................................................................................................................................................................................... 24

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Engineering Controls ...................................................................................................................... 25 Biological Safety Cabinets ....................................................................................................................................................................... 25 Centrifugation ............................................................................................................................................................................................... 25 Vacuum Line Chemical Traps and Filters ........................................................................................................................................ 26 Syringes and Needles ................................................................................................................................................................................. 26 Safety Blenders, Sonicators, and Mixers ........................................................................................................................................... 27 Mechanical Pipetting Devices ................................................................................................................................................................ 27 Lyophilizers .................................................................................................................................................................................................... 27 Cryostats .......................................................................................................................................................................................................... 27 Miscellaneous Equipment (Waterbaths, Shakers, Cold Storage) .......................................................................................... 27

Work Practice Controls ................................................................................................................... 29 Universal (Standard) Precautions ....................................................................................................................................................... 29 Use of Engineering Controls ................................................................................................................................................................... 29 General Work Practices ............................................................................................................................................................................ 29 Hand Washing .............................................................................................................................................................................................. 29 Handling Disposable Needles and Syringes .................................................................................................................................... 29 Reusable Sharps ........................................................................................................................................................................................... 30 Footwear ......................................................................................................................................................................................................... 30 Slash and Aerosol Control ....................................................................................................................................................................... 30 Housekeeping for Laboratory Workers ............................................................................................................................................ 30 Chemical Sterilization and Disinfection ........................................................................................................................................... 31

Personal Protective Equipment (PPE) .............................................................................................. 32 Laboratory Clothing................................................................................................................................................................................... 32 Hand Protection ........................................................................................................................................................................................... 32 Face and Eye Protection........................................................................................................................................................................... 33 Respiratory Protection ............................................................................................................................................................................. 34 Disposable Booties and Shoe Covers................................................................................................................................................... 34

Decontamination ............................................................................................................................ 35 Liquid Disinfection ...................................................................................................................................................................................... 35 Heat ................................................................................................................................................................................................................... 35 Vapors and Gases ......................................................................................................................................................................................... 36 Radiation ......................................................................................................................................................................................................... 36

Regulated Medical Waste /Biological Waste ................................................................................... 37

Select Agents and Toxins ................................................................................................................ 38

Shipping, Receiving and Transportation of Biological Materials ....................................................... 39 On Campus Transport of Biological Materials .............................................................................................................................. 39 Federal Permits for Transport and Use ............................................................................................................................................ 39

Biosecurity ..................................................................................................................................... 41 Inventory ......................................................................................................................................................................................................... 41

Biological Exposure and Spill Response Procedures ......................................................................... 42 Steps to Consider with a Biohazard Exposure ............................................................................................................................... 42 Basic Biological Spill Clean-up Procedures ..................................................................................................................................... 42

Reporting Incidents ........................................................................................................................ 43

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Fire and Fire Related Emergencies .................................................................................................. 44 In Laboratories ............................................................................................................................................................................................. 44 Animal Areas ................................................................................................................................................................................................. 44 Evacuation ...................................................................................................................................................................................................... 44

Appendices .................................................................................................................................... 46

Appendix A: Disinfectants and Sterilization Methods ...................................................................... 47

Appendix B: Spill Response Cue Cards ............................................................................................. 48

Appendix C: Supplemental Supportive Documents .......................................................................... 44

Appendix D: External Resources ..................................................................................................... 45

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Definitions

Antiseptic is a chemical germicide formulated to be used on skin or tissue. Biological Agents: This Manual uses the Environmental Agency (EPA) originated definition of biological agents as preparations made from living organisms and their products. Biological agents include: all microorganisms and their toxins, viruses and sub-viral particles (including prions), recombinant products (plant, animal, microbial), parasites (microscopic, as well as, macroscopic), Cultured human and animal cells and the potentially infectious agents that these cells may contain, clinical specimens (human or animal blood, body fluids, cells, tissues, bone), whole animals and tissues from experimentally infected animals, allergens (such as molds, microbial spores, and animal allergens. Biohazards (Biological Hazards): Biohazardous materials will include any of the following requiring IBC oversight: recombinant or synthetic nucleic acid materials, biological agents and toxins, bacteria and their phages and plasmids, viruses, fungi, mycoplasmas, prions, and parasites; human and non-human primate tissues, body fluids, blood, blood byproducts, and cell lines, animal remains and insects that may harbor zoonotic pathogens. Biological Select Agent or Toxin: Specifically regulated pathogens and toxins as defined in Titles 42 CFR Part 73, 7 CFR Part 331, and 9 CFR Part 121, Possession, Use, and Transfer of Biological Agents and Toxins regulated by both DHHS and USDA (i.e., overlapping agents or toxins) and plant pathogens regulated by USDA alone. Decontamination refers to any procedure that eliminates or reduces microbial contamination to a safe or acceptable level with respect to the transmission of infection. Disinfection is the irreversibly inactivation of specific viruses, bacteria, or pathogenic fungi (but not necessarily spores) on inanimate surfaces. Exposure: Any eye, nose, other mucous membrane, skin, or parenteral contact with any biohazardous material. Laboratory Personnel: refers to anyone, including students of any kind, conducting research on or otherwise handling biohazard material. Recombinant and synthetic nucleic acid molecules: as defined by the NIH Guidelines, molecules that (a) are constructed by joining nucleic acid molecules and (b) that can replicate in a living cell, i.e., recombinant nucleic acids; nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e., synthetic nucleic acids, or molecules that result from the replication of those described in (i) or (ii) above. Sterilization is the destruction of all microorganisms on inanimate surfaces.

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Forward The NYU Biosafety Program is administered by the NYU Department of Environmental Health and Safety (EHS), which has primary responsibility for its content, implementation, and enforcement. Working with principal investigators, laboratory personnel, supervisors, and administrators, EHS, through this Program, seeks to minimize the health risks of laboratory personnel and the community at large and reduce environmental impacts while meet regulatory requirements.

The purpose of the Manual is to provide general reference, guideline, policies and procedures to be followed in teaching, research, and clinical laboratories and for other activities that use biological agents. This Manual, in conjunction with NYU Safety Policies and training modules, forms the basis for the Biological Safety Program, which has the commitment to obtain the following goals:

Protect laboratory personnel and visitors from exposure to infectious agents Prevent environmental contamination Provide an environment for research excellence while maintaining a safe work place Comply with applicable federal, state and local requirements

In general, the handling and manipulation of biological agents and toxins, as well as recombinant or synthetic nucleic acid molecules, requires the use of a variety of precautionary measures depending on the material involved. The Manual provides assistance in the evaluation/assessment, containment and control of biological hazards. However, it is expected that all parties working with these materials will seek additional information and advice if necessary. All research personnel should be familiar with this manual.

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Incidents, Exposures and Emergencies

Emergency Numbers

NYU DIAL 911 from a campus phone

NYU Washington Square Public Safety DIAL 8-2222 from a campus phone

NYU College of Dentistry Public Safety DIAL 8-9828 from a campus phone NYU Tandon School of Engineering DIAL 646-977-3537 or 8-2222 for after hour

emergencies

Student Health Center DIAL 212-443-1000

On-Campus Medical Emergencies Requiring an Ambulance

1. Do not move a seriously injured person unless they are in further danger. 2. Dial 9-911(from campus phone) then X82222 or 212-998-2222. Tell the dispatcher the location and nature of

the emergency. 3. Public Safety will coordinate the ambulance or transportation to either the Student Health Center or a local

Hospital. 4. Employees and students must immediately notify their supervisor or instructor of all illnesses and injuries

possibly related to an exposure of an infectious material. 5. The PI or Laboratory Supervisor is responsible for contacting EHS once you have received medical attention. 6. The PI or Laboratory Supervisors must complete an Incident Reporting form and submit it to Biosafety

within 5 days of an exposure incident and within 7 days of an accidental spill. Accidents, injuries and exposures must also be reported on the Work Related Incident-Injury Form for anyone employed by the University. Non-employee students will complete an additional form at Student Health Services.

7. Spills resulting in an overt exposure must be reported immediately and the reporting form must be completed within 24 hours.

https://goo.gl/forms/pNmSDrF5yJ1Pd1b93

http://www.nyu.edu/employees/resources-and-services/financelink/insurance-and-risk/available-coverage/workers-compensation.html

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Rules, Regulations and Guidelines Governing the Use of Biological Agents National Institute of Health (NIH) Guidelines for research involving Recombinant or Synthetic Nucleic Acid Molecules: The NIH Guidelines address the safe conduct of research and/or teaching activities that involve construction and handling of recombinant or synthetic nucleic acid molecules and organisms containing them. The 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 environment. The RAC published the initial version of the NIH Guidelines in 1976. The current NIH Guidelines include practices/procedures for research involving recombinant or synthetic nucleic acid molecules. Principal Investigators who are responsible for research and/or teaching activities that involve recombinant or synthetic nucleic acid molecules must include them on IBC registration forms.

Centers for Disease Control and Prevention (CDC) and the NIH In 1984, the CDC and NIH published Biosafety in Microbiological and Biomedical Laboratories (BMBL). The BMBL describes combinations of standard and special microbiological practices, safety equipment and facilities that constitute four levels of biological containment (BSL 1-4) which are recommended for working with a variety of infectious (biological) agents in various laboratory settings. The BMBL also outlines requirements for four levels of animal biological safety containment (ABSL 1-4). The BMBL serves as the basis for NYU’s biosafety manual. The CDC also issues permits for the importation of infectious agents, materials and host animals into the United States.

Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard (BBP): The 1991 Bloodborne Pathogens regulations were originally created to address healthcare workers concerns regarding occupational health risks caused by exposure to human blood and other potentially infectious materials of human origin. While originally focused on healthcare workers, this standard applies to any personnel who may be exposed to human blood or other potentially infectious materials of human origin, including human cell lines. Refer to the BBP section of the Manual for specific information

regarding the BBP standard and how it applies to “occupationally exposed” personnel. The Select Agent Rule Federal regulations regarding the use, storage and transfer of certain select biological agents and toxins were published starting in 1996. At the federal level, registration and approval of select agents is the responsibility of the USDA-APHIS/CDC National Select Agent Registry (NSAR). Additional information can be found in the Select Agent section of this Manual.

United States Department of Agriculture (USDA) USDA issues permits for the possession, use and transport of biological agents and materials important to agriculture and at times, human health. Conditions of these permits vary for each type of agent or material. These conditions often include requirements for containment, handling and disposal of permitted materials. Additional information can be found in the Shipping, Receiving and Transportation section of this Manual.

New York Department of Health Users of hypodermic syringes and needles must comply with the applicable New York State Department of Health regulations, and are responsible for appropriate certification, procurement, storage, and distribution.

http://www.rpi.edu/dept/hr/forms/EHS%20Programs/Appendix%20G-%20Title%2010%20Section%2080.133.pdf

http://www.rpi.edu/dept/hr/forms/EHS%20Programs/Appendix%20G-%20Title%2010%20Section%2080.133.pdf

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Non-medical and non-veterinary use of syringes and needles (e.g. teaching, research) require a Department of Health Certificate of Need.

Other Agencies and Entities Shipping of regulated biological materials must comply with the US Department of Transportation (DOT) and the International Civil Aviation Organization and the International Air Transport Association (IATA) regulations. Personnel packaging and shipping regulated biological materials must be trained every two years. See Shipping, Receiving and Transportation of Biological Materials section of this Manual. Information Systems for Biotechnology’s (Virginia Tech) “A Practical Guide to Containment: Plant Biosafety in Research Greenhouses” and The American Committee of Medical Entomology of the American Society of Tropical Medicine and Hygiene’s “Arthropod Containment Guidelines” are examples of independent entities whose work has become Biosafety best practices.

https://www.health.ny.gov/professionals/narcotic/licensing_and_certification/

https://www.health.ny.gov/professionals/narcotic/licensing_and_certification/

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Responsibilities and Administration

Senior Biosafety Specialist The Senior Biosafety Specialist is responsible for the implementation and the administration of the biosafety program. The Senior Biosafety Specialist identifies potential areas of concern and suggests to the EHS Director safety objectives to be achieved.

Ensures the department head, principal investigators, and managers are complying with the biosafety program,

Coordinate the University biosafety program by enforcing applicable standards governing the safe use, storage, and disposal of biohazards,

Conduct annual inspections of laboratories, Report to the IBC any problems, violations, and accidents or illnesses from activities that involve the use

of biohazardous materials, Assist with the development of emergency plans for handling accidental spills and personnel

contamination and investigate laboratory accidents involving biohazard materials, Review and approve the use of biohazard materials, Provide advice on lab security, Provide technical advice to PIs, lab personnel, and the IBC on biosafety procedures.

Institutional Biosafety Committee (IBC) It is the IBC’s responsibility to review and approve the use of recombinant and synthetic nucleic acid molecules (r-sNA) and select agent materials as defined in this Manual. The IBC must assure that all University community members engaged in teaching and/or research activities follow the safety guidelines and requirements of the NIH Guidelines and the CDC/NIH publication Biosafety in Microbiological and Biomedical Laboratories. Teaching or research laboratory experiments that involve the use of r-sNA molecule technology and/or biohazard material must be registered as described in this Manual research or teaching activities conducted at or sponsored by New York University (NYU) that use of the described materials through the review of registrations.

Academic Chairs, Department Heads Academic departments have a responsibility to instill good scientific practices in their students and to assure that employees use and enforce safe work practices. Department Heads have overall responsibility for the teaching and research conduct of their faculty. This responsibility includes the maintenance of safe work practices/procedures in the handling of hazardous and potentially hazardous materials.

Principal Investigator (PI) The role of Principal Investigator (PI) may be fulfilled by a Faculty member, Laboratory Director/Manager or course Instructor. The following are responsibilities of every PI:

Complete the training required by EHS and other appropriate compliance committees, Assist in implementing the University’s health and safety policy, use of the biosafety manual and all

other university safety practices, Complete a biological laboratory survey for their laboratory, Register with the IBC for the use of r-sNA or select agent materials, Prepare a risk assessment for all biological materials (see Risk Assessment),

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Implement the guidelines, policies and procedures outlined in this Manual, Institute appropriate safe work practices, Instruct laboratory personnel, (students and staff) on a continuing basis, of potential health hazards in

the workplace, Assure all laboratory personnel receive required safety training,

Provide appropriate training resources, Document and report accidents, injuries and exposures involving biological agents, Develop practices and procedures that serve to protect employees and students, Maintain workplaces and equipment under your direction in a safe, well maintained manner, Identify and meet the safety needs for personnel they relate to appropriate engineering controls,

training, personal protective equipment and corrective measures for non-compliant issues, Conduct periodic self-audits to identify operational gaps in work practices and/or facilities.

Laboratory Personnel It is the laboratory personnel's responsibility to:

Complete the training required by EHS and other appropriate compliance committees, Know and adhere to all laboratory biosafety policies and emergency procedures, Receive an overview of the Laboratory Specific Biosafety Manual from the PI or Laboratory Supervisor

and follow all laboratory practices established, Inform the PI of any personal health requirements that may require implementation of safety

precautions, Report to the PI or the lab supervisor all problems, deviations in procedure, spills involving biohazardous

materials, exposures, and/or safety/security concerns (e.g., suspicious persons or activities).

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Biosafety Requirements The following information describes the requirements for NYU researchers as defined by EHS. It is the responsibility of each PI to ensure the laboratory is in compliance.

Biological Laboratory Survey Institutions with research and teaching activities are obligated by federal and/or state regulations to know which biological agents are used or stored in their buildings. The identification of the biohazard materials present in an institution is a crucial step in the development of an effective biological safety program.

The Principal Investigators (PI) are required to complete a biological laboratory survey. It is used to identify laboratories and personnel who are handling biological materials. The information provided will be reviewed by the Senior Biosafety Specialist. The Biosafety review will:

Determine appropriate risk groups and biological safety containment levels (BSL), Identify recombinant or synthetic nucleic acid molecule activities, Determine the adequacy of the laboratory for the research activities, Determine and establish appropriate biosecurity measures, Determine bloodborne pathogens exposure risk, Determine and develop necessary and appropriate training/training tools, Determine medical surveillance needs, Comply with all applicable regulations, Determine appropriate shipping and transport procedures, Identify related environmental issues (waste handling, facility ventilation), and Assist emergency response planning.

The Survey must be updated for the following reasons:

New agents and materials are brought in the laboratory Location of laboratory changes Removal or addition of personnel

Registration of Recombinant and Synthetic Nucleic Acid Molecule (r-sNA) Experiments PIs are required to register all r-sNA activities with NYU Medical Center’s Institutional Biosafety Committee. Committee approval is required prior to the initiation of all r-sNA activities. The r-sNA registration form is available on NYU School of Medicine’s IBC webpage through the Kerberos Research Portal System.

Human Blood, Body Fluids, Tissues and Other Potentially Infectious Materials The Occupational Safety and Health Administration (OSHA) created the Occupational Exposure to Bloodborne Pathogens Standard, 29 CFR Part 1910.1030 (the Standard) to minimize or eliminate exposure to infectious agents that may be present in human blood, tissues or certain body fluids (bloodborne pathogens.) The Standard applies to all employers having employees that may be “occupationally exposed” to human blood or other potentially infectious materials. An employee is considered occupationally exposed if there is “reasonably anticipated skin, eye, mucous membrane, or parenteral contact with human blood or other potentially infectious materials (OPIM) in the performance of an employee’s duties.” Other potentially infectious materials include:

http://www.med.nyu.edu/research/ibc

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Human cell/tissue cultures, including embryonic stem cells, Organ cultures, Any unfixed tissue or organ, other than intact skin, from a human being (living or dead), HIV- or HBV-containing culture media or other solutions, Human body fluids, except urine, feces, saliva or tears unless visibly contaminated with blood, Blood, organs or other tissues from experimental animals infected with HIV or HBV or other

bloodborne pathogens,

An individual is also considered occupationally exposed if they do not have direct contact with blood or other potentially infectious material, but operate equipment that is used to process or store blood or OPIMs.

The BMBL recommends that human and non-human primate (NHP) cells, tissues, and bodily fluids be handled using Biosafety Level 2 (BSL-2) practices and containment. Human and NHP materials, even in the absence of overt contamination, may contain adventitious viruses and/or other opportunistic pathogens or zoonotic agents. Since it is extremely difficult to screen for every pathogen, all human and NHP materials must be handled with standard precautions (e.g. treated as though they are contaminated with infectious agents) and utilize BSL-2 practices.

Moreover, all cell lines and tissue cultures of human and NHP origin, including established cell lines and bodily fluids will be handled in accordance with the OSHA Bloodborne Pathogens Standard and under Biosafety Level 2 (BSL-2) containment. Other mammalian cell lines used to propagate viruses will also require BSL-2 practices. Laboratory personnel working with these cultures must maintain a written record of their annual training as required by OSHA Bloodborne Pathogens Standard. Contact EHS at 212-998-1450 for a training schedule. NYU’s Exposure Control Program is located at the following website policy #110, Bloodborne Pathogens Exposure Control Program.

Animal Use All research involving animals must be conducted in accordance with an approved University Animal Welfare Committee (UAWC) protocol. Additionally, animal research that contains biohazards must receive approval from the IBC prior to the conduct of research. Contact the UAWC for additional information. The UAWC is charged with responsibility for reviewing New York University’s program for the humane care and use of animals in research and teaching labs. The Biosafety Officer works with the UAWC when protocols involve the use of biohazard materials and the IBC when materials are of an r-sNA nature. Contact Biosafety if there are any questions or concerns regarding biohazards and animal use.

Biological Safety Cabinets (BSC), Laminar Flow Benches (LFB) and Chemical Fume Hoods Clean air devices are equipment that use one or more HEPA filters to deliver clean, nearly particulate free, air to a work surface. BSC are designed to protect the user and the environment from contamination, most protect the product as well. Laminar flow benches (LFB) only protect the product from contamination. The efficacy of BSCs and LFBs depends upon the behavior of the operator, the unit’s orientation in the facility, and the movement of personnel in the laboratory.

Chemical fume hoods and other capture devices must be used for operations that might result in the release of toxic chemical vapors, fumes, or dusts. Benchtop use of chemicals that present an inhalation hazard is not permitted. Fume hoods must be used when conducting new experiments with unknown consequences from reactions or when the potential for a fire exists.

http://www.nyu.edu/ehs/safety.policies/

http://www.nyu.edu/ehs/safety.policies/

mailto:[email protected]

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EHS has implemented and Inspection Program, designated to ensure the health and safety of NYU’s laboratory personnel and prevent environmental release of infectious materials or the inhalation of chemical vapors, fumes, or dust. This is done through annual certification of all BSCs, LFBs and fume hoods to ensure the unit’s ability to perform the intended function. All clean air devices and fume hoods must be placed on the NYU service contract and be certified at least annually. Biosafety coordinates the certification with a contracted vendor. Units that are not certified annually will be rendered non-functional until such time as a certification is performed. The Office of Environmental Health and Safety will contact you to schedule the required annual certification.

Notify Biosafety in advance when you plan to have BSCs or LFBs moved, placed in storage, transferred to a new owner, discarded, removed from NYU or obtained from another institution or manufacturer. Contact Biosafety if service or repairs (e.g., replacing fluorescent lamps) are needed for your unit. BSCs must be professionally decontaminated with formaldehyde, by a certified technician, before a unit is relocated, stored, serviced (interior) or discarded.

Training Successful completion of certain EHS training may be required prior to the conduct of research or work assignment. The training program was developed and is offered by EHS via classroom and online (NYU Classes). A schedule of trainings is provided to the NYU community at the start of each semester. If a specific training is required for work in the laboratory, health center or clinic, please contact Environmental Health and Safety at x81450 or [email protected] to schedule a training time.

EHS maintains a list of individuals who have completed various training modules. Please contact EHS if you require proof of training. Principal investigators are responsible for providing laboratory personnel with information regarding specific hazards or situations not covered in EHS trainings. This may include information about health hazards, location and use of PPE, spill clean-up materials, and the presence of any particularly hazardous materials in the laboratory. Additional training, provided by the principal investigator, should be specific to the activities conducted in the laboratory. It should include:

Health risks (biological, chemical and physical) posed by the experimental procedures conducted in their

lab, Regulated Medical Waste (RMW) training and proper disposal methods for biological, chemical and

hazardous materials, The existence and location of all designated areas in the laboratory, The selection and use of personal protective equipment appropriate for laboratory tasks.

PI’s can work with EHS to schedule laboratory or department specific trainings. For more information on training requirements visit the Training webpage.

mailto:[email protected]

http://www.nyu.edu/life/safety-health-wellness/be-safe/environmental-health-and-safety/training.html

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Work Involves Required Training Delivery Method

Working in a lab Laboratory Safety In- person

Working with chemicals

Hazardous Waste (initial) In- person

Annual Refresher On-line

Human or NHP blood, other potentially infectious materials including human, NHP cell lines (e.g. HeLa, HEK 293, Vero), infectious (capable of causing disease in healthy adults) microorganisms; or viral vectors

Bloodborne Pathogens (initial) Training In-person

Annual Refresher In-person or On-line

Animal subjects Laboratory Animal Care and Use Contact UAWC

Shipping biological materials

IATA/DOT Shipping Training In-person

2 year refresher In-person

Biohazard work that may generate aerosols Respirator Training In-person

Working with recombinant-synthetic nucleic acid materials

r-sNA training On-line PPT slides

3 year Refresher On-line PPT slides

Table 1: EHS Laboratory Science Trainings

Standard Operating Procedures Standard operating procedures (SOPs) are intended to provide individuals with general guidance on how to safely work with a specific class of biological agent or hazard. While SOPs provide only general guidance, observance of all the safety practices listed in them is mandatory. If compliance with all the requirements of a specific standard operating procedure is not possible, the principal investigator must develop a written procedure that will be used in its place. This alternate procedure must provide the same level of protection as the SOP it replaces. Biosafety is available to provide guidance during the development of alternate procedures.

SOPs, at minimum, should include step-by-step instructions of the tasks emphasizing safety controls, (i.e. Personal Protective equipment, use of fume hoods). They should also state the type of personnel authorized to perform the task.

In order to provide flexibility, standard operating procedures are generic in nature. They address the use and handling of substances by hazard class only. In some instances, multiple SOPs may be applicable for a specific biological agent. All SOPs should be incorporated into a Laboratory Specific Biosafety Manual and be accessible to all laboratory personnel. If you have questions concerning the applicability of any item listed in an SOP, contact the Principal Investigator of your laboratory or Biosafety at 212-998-1440.

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Risk Assessment and Exposure Sources Risk Assessment Risk is the probability that harm, injury, or, in the context of this document, an occupationally acquired infection will occur. The foundation of any safety program is the use of control measures appropriate for the risk posed by the activities and the agents in use. To characterize the risk and facilitate control measures, microorganisms and clinical materials are assigned to one of four Biosafety Levels (BSL). For each BSL there is a unique set of safety equipment, facility design features, and practices that will reduce the risk of laboratory-acquired infections. Biosafety Level classifications are appropriate for typical laboratory operations. The PI or laboratory supervisor is responsible for implementing more (or less) stringent practices based on laboratory specific conditions. Such a decision is ultimately the result of a risk assessment process that accounts for the following:

Biological Agent Hazards Virulence - the severity of disease Capacity to infect and cause disease in a susceptible host Infectious dose - the dose required causing infection in humans or animals Stability in the environment Host range Endemic nature Agent origin Reports of laboratory acquired infections Availability of treatment and prophylaxis Probable routes of transmission in laboratory

All of the above factors are inherent to a particular microbe. The use of r-sNA materials may alter any of the risk factors and investigators should take these modifications into consideration when working with r-sNA microorganisms.

Exposure Sources

Exposure sources in the laboratory are hazards that could result in the infection of researchers or the public through work with biological agents. Some of the more common hazard considerations include the following:

Aerosol generation (e.g. pipetting, mixing, sonicating, centrifuging, vortexing) Animal handling (e.g. bites and scratches) Manipulation with sharps Contact with blood, bodily fluids, or other potential infectious materials Spills and splashes into the mucous membranes

When performing a risk assessment of laboratory procedures, all potential routes of exposure should be addressed. Most laboratory-acquired infections have resulted from inhalation of aerosols, splashes or sprays, and needlesticks. It is good practice to look for potential exposures via ingestion, inoculation, inhalation, and contamination of skin and mucous membranes. It is up to the Principal Investigator (PI) to determine which controls will be implemented. During periodic biosafety audit, Biosafety works with the PI/facility personnel to provide improvements to procedures, as necessary. It is recommended that the PI or his designee perform regular self-audits of their laboratory areas and related facilities. Biosafety safety checklists can be found on the Biosafety website for this purpose.

https://www.nyu.edu/life/safety-health-wellness/be-safe/environmental-health-and-safety/programs/biosafety.html

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Risk Groups The NIH Risk Group and World Health Organization (WHO) classifications should be used when a risk assessment for a microorganism is being conducted. The classification system assigns organisms to one of four categories of risk based on the agent hazard criteria listed above.

Visit

the Risk Group webpage for a comparison of international risk group classifications. A complete description of work practices, safety equipment, and facility design features for BSL-1 through BSL-4 is available in the CDC/NIH publication Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition, specifically, Section IV. The NIH’s Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) also provides additional guidance for risk assessment of microorganisms and materials containing r-sNA molecules, which may alter the risk of the activities.

Risk Group 1 (RG1)

Agents that are not associated with disease in healthy adult humans

Risk Group 2 (RG2)

Agents that are associated with human disease which is rarely serious and for which preventative or therapeutic interventions are often available

Risk Group 3 (RG3)

Agents that are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available (high individual risk but low community risk)

Risk Group 4 (RG4)

Agents that are likely to cause serious or lethal human disease for which preventative or therapeutic interventions are not usually available (high individual risk and high community risk)

https://my.absa.org/tiki-index.php?page=Riskgroups

http://www.cdc.gov/biosafety/publications/bmbl5/

http://www4.od.nih.gov/oba/IBC/IBCnihguidelines.htm

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Routes of Exposure There are four exposure routes that must be addressed when working with biological materials and many work practices can be viewed in the context of eliminating a particular exposure pathway.

Percutaneous Exposure (through the skin) Percutaneous injuries can result from needle sticks and cuts or abrasions from contaminated items. These exposures are particularly serious because of the potential for immediate entry of the agent into the circulation. Sharps must be handled and disposed as noted in the Regulated Medical Waste Disposal section.

Inhalation of Aerosols Many laboratory procedures can cause the aerosolization of infectious agents. Some of these procedures include the use of vortexes, blenders and sonicators. Proper work practices must be implemented to minimize the aerosolization of all materials, especially whose main route of exposure is through inhalation (e.g., Mycobacterium tuberculosis, SARS.). Please see the Laboratory Practice and Technique section for more information on how to minimize and contain aerosols.

Mucous Membrane Compared to intact skin, infectious agents can more readily enter the body through contact with the eyes, nose, mouth, or by inadvertent inoculation of these areas via contaminated hands. Eye and face protection should always be used if there is a potential of splash or splatter.

Ingestion Accidental ingestion of biohazardous materials can result from improper personal hygiene in the laboratory. Food and drink are prohibited in all areas of the laboratory. Hands must be washed immediately if visible contamination occurs, after removing gloves and always before leaving the laboratory.

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Biosafety Levels Although the most important aspect of biohazard control is the awareness and care taken by personnel in handling infectious materials, certain features of laboratory design, ventilation, and safety equipment can prevent dissemination of pathogens should accidental release occur. The CDC/NIH publication, Biosafety in Microbiological and Biomedical Laboratories (BMBL) defines four levels of containment based on the risks assigned to the agents and procedures. Each biosafety levels describes the standard microbiological and safety practices, safety equipment (primary barriers and personal protective equipment), and laboratory facilities recommended to protect personnel and the environment from exposure and contamination. Special microbiological practices enhance worker safety, environmental protection, and address the risk of handling agents requiring increasing levels of containment. During your initial or annual laboratory inspection a biosafety level will be assigned depending upon the risks associated in each lab space.

Biosafety Level 1 Biosafety Level 1 is appropriate for laboratories, and for other facilities in which work is done with well-characterized agents not known to cause disease in healthy adult humans. Work in a BSL 1 laboratory is typically conducted on an open bench top using standard microbial practices and universal precautions.

Agents: defined and characterized strains of microorganisms not known to consistently cause disease in healthy adults (e.g., B. subtilis, S. cerevesiae, non-pathogenic E. coli.) Includes recombinant DNA activities using such non-pathogenic organisms as hosts for the expression of genes incorporated into bacterial plasmids or low risk viral vectors such as baculovirus or Adeno Associated Virus.

Work practices: standard microbiological practices/aseptic technique. Safety equipment: none required-gloves, lab coats and eye protection recommended. Facilities: bench top sink available for hand washing.

Biosafety Level 2 Biosafety Level 2 is applicable to work done with a broad spectrum of indigenous agents present in the community and associated with moderate-risk to humans.

Agents: associated with human diseases of varying severity (e.g., Hepatitis B and C, HIV, S. typhi, human retroviruses, S. aureus. Includes r-sNA activities using viral vector systems such as Adenoviruses and some Retroviral vectors, particularly Lentiviral vectors, and expression of recombinant DNA in BSL-2 organisms.)

Transmission: inoculation and other percutaneous injuries, ingestion, mucous membrane exposure Work practices: BSL-1 practices, with the addition of: limited access, Biohazard signs, sharps

precautions, defined procedures for Regulated Medical Waste (RMW) disposal and medical surveillance (as needed).

Safety equipment: Class II Biological Safety Cabinet (BSC) or equivalent containment for manipulations with potential for aerosolization or splashing; lab coats, gloves, eye/face protection.

Facilities: BSL-1 facilities, with the addition of: available autoclave, directional airflow, no air recirculation, disinfection/decontamination procedures are in place.

Please note: Biosafety level 3 and 4 work requires specially engineered laboratory facilities.


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These facilities are not available at New York University. No work may be conducted with agents requiring BSL-3 or BSL-4 containment at NYU Washington Square, Tandon School of Engineering, or the College of Dentistry.

Biosafety Level 3 Biosafety Level 3 is applicable to work done using indigenous or exotic agents with a potential for respiratory transmission and which may cause serious and potentially lethal infection.

Agents: serious or lethal diseases transmissible via aerosols (e.g., M. tuberculosis, SARS. RecombinantDNA activities using genetic material from BSL-3 organisms or such organisms as host cells.)

Transmission: aerosol inhalation, inoculation and other percutaneous injuries, ingestion, mucousmembrane exposure

Work practices: BSL-2 practices, with the addition of: respiratory protection training and policy;individualized proof of competency, controlled access, on-site decontamination of all waste and labclothing, medical surveillance.

Safety equipment: Class II Biological Safety Cabinet (BSC) or equivalent containment for all openmanipulations of agents; lab coats, gloves, eye/face, and respiratory protection (as needed).

Facilities: BSL-2 facilities, with the addition of: physical separation from access corridors, double-doorentry, directional air flow into lab, no recirculation of exhaust air, back-up ventilation and filtrationsystems, in-lab autoclave.

No work is conducted on BSL-3 organisms at New York University, and no facilities currently exist here for BSL-4 work.

Biosafety Level 4 Biosafety Level 4 is for work using dangerous and exotic agents, which pose a high individual risk of life-threatening disease, which may be transmitted via the inhalation route and for which there is no available vaccine or therapy. No work is conducted on BSL-4 organisms at New York University, and no facilities currently exist here for BSL-4 work.

Biosafety Level 2 Plus There are no standard criteria for this intermediate biosafety level. The enhancements or additions to the standard BSL-2 are dependent on the risk assessment. It is preferred that the BSL2+ laboratory be self-contained with the equipment required for the experiment located in the laboratory. Additions also include mandatory use of personal protective equipment such as a surgical mask, safety glasses, a class II biological safety cabinet, and secondary containment is utilized for centrifugation and other potential aerosol generating procedures. Respiratory protection may be recommended especially in animal facilities.

Please follow the link to Section IV of the BMBL Laboratory Biosafety Level Criteria for more complete details. A table summarizing the laboratory recommendation is provided on the next page.

The BMBL also provides guidance for the use of experimentally infected animals housed in indoor research facilities (e.g., vivaria), and also in the maintenance of laboratory animals that may naturally harbor zoonotic infectious agents. The four animal biosafety levels provide increasing levels of protection to personnel and to the environment, and are recommended as minimal standards for activities involving infected laboratory animals. The four ABSLs describe animal facilities and practices applicable to work with animals infected with agents assigned to Biosafety Levels 1-4, respectively. Information on Vertebrate Animal Biosafety Level Criteria can be found in Section V of the BMBL.

http://www.cdc.gov/biosafety/publications/bmbl5/BMBL5_sect_IV.pdf

http://www.cdc.gov/biosafety/publications/bmbl5/BMBL5_sect_V.pdf

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Table 2: Summary of Recommended Biosafety Levels for Infectious Agents

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Signs and Labels All persons entering a laboratory must be advised of the actual or potential hazards present and must be informed of any specific entry/exit requirements. This may be accomplished by the use of signs posted at the entrances to the laboratory. Biosafety will post a biosafety level 2 sign incorporating the biohazard symbol and the words biohazard authorized personnel only. The sign can also be downloaded by accessing the Biosafety website. The lab must also post the NYU Emergency Contact Card.

Warning labels must be affixed to containers of regulated waste, refrigerators, freezers, incubators and other devices used to store, transport or ship infectious or potentially infectious materials. Biosafety will provide adhesive labels for equipment. The labels shall be fluorescent orange or orange-red with lettering and symbols in a contrasting color (black).

https://www.nyu.edu/content/dam/nyu/environmentalHealthSafety/documents/DOORSIGN.PDF

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Laboratory Practices Microbiological Standard Practices The most important element of containment is strict adherence to standard microbiological practices and techniques. Persons working with biological materials must be aware of potential hazards, and must be trained and proficient in the practices and techniques required for handling them safely. Standard microbiological practices are the basis for biosafety practices. This list highlights some of these practices. Following sections of the manual will provide more details.

Never mouth pipette. Avoid hand to mouth or hand to eye contact in the laboratory. Never smoke, eat, drink, take medication or apply cosmetics in the laboratory. Use aseptic technique. Thorough hand washing is essential after handling microorganisms, cells, mammalian tissues or body

fluids and prior to exiting the laboratory. Wear laboratory garments, gloves and other recommended personnel protective equipment that

protect street clothing from contamination in Biosafety Level-2 laboratories. It is strongly recommended that similar precautions be taken in Biosafety Level-1 labs as well. Discard laboratory gloves and remove lab coats upon leaving the laboratory area. Autoclave lab coats if working with cultured human pathogens before sending them to the laundry.

Use great care and caution when handling syringes and needles, sharps or glassware in the microbiological laboratory. Never attempt to recap a used needle prior to disposal. Dispose of syringe needle assemblies in sharp-proof, autoclavable containers.

Handle human pathogens or infectious materials containing pathogens in certified biosafety cabinets. Use the cabinets wisely, free of clutter and materials that block airflow and vent rids.

Never leave pathogenic materials or contaminated labware open to the environment outside the biosafety cabinet. Store all biohazardous materials securely in clearly labeled, sealed containers. Storage units, incubators, freezers or refrigerators should be labeled with the Universal Biohazard sign when they house infectious material.

Biosafety Level-2 laboratories must be posted with the Universal Biohazard symbol and must list infectious agent(s) in use.

Avoid aerosol-generating procedures when working with pathogenic materials. Needle clipping, pipette mixing, sonication, centrifugation and other seemingly innocuous procedures can produce substantial aerosols. Use safety equipment when aerosol generation is unavoidable.

Always close the laboratory doors when working with pathogenic materials. Know the laboratory biosafety plan for handling and the most suitable disinfectant for decontaminating

the pathogens you use. Be familiar with the laboratory plan for managing an accidental spill of pathogenic materials. Always keep an appropriate spill kit available in the lab.

Clean up the laboratory work surfaces thoroughly with a proven disinfectant after using pathogenic materials. The containment laboratory must not be cluttered in order to permit proper floor and work area cleaning.

Never allow contaminated, infectious waste materials to leave the laboratory non-sterilized as normal trash or to be put in the sanitary sewer without being decontaminated. Use incineration or autoclaving at adequate temperature (121°), pressure (18 psi) and time (based on the size of the waste load) and always use a sterile indicator tag to denote sterilization. Expose all materials being sterilized to the flowing steam principle.

When shipping or moving pathogenic materials to another laboratory, always use DOT approved, leak-proof, sealed and properly packed containers (primary and secondary containers).

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Report all accidents, occurrences and unexplained illnesses to your work supervisor. Understand the pathogenesis of the biohazards with which you work. Protect your fellow workers and the public from the pathogens you use. Think safety at all times during laboratory operations. The greater the hazard, the greater care that must

be exercised. If you do not understand the proper safety procedures or the use of the appropriate safety equipment, do not work with the biohazard until you receive proper instruction. Seek the advice of the appropriate individuals.

Hazard Controls Hazard controls are the steps necessary to protect workers from exposure to a substance. Steps to control a hazard include:

Elimination (including substitution) - removing the hazard from the workplace, or substituting hazardous materials with less hazardous ones.

Administrative controls- controls that alter the way the work is done, including policies, timing of work, training and work practices such as standard operating procedures.

Engineering controls- methods that are built into the design of a lab, equipment or process to minimize the hazard.

Personnel Protective Equipment The most effective hazard control is elimination, although this may not be practical when it comes to biological agents. This is because to eliminate the hazard the agent must be dead. An alternative to elimination is substitution. Substitution occurs when a substance (in this case biological agent) that is less hazardous is used instead of another. When conducting activities with biohazardous materials, this may be possible if a less hazardous species or strain of a biological agent exists or has been engineered in such a way that it does not cause any harmful effects. If the hazards cannot be eliminated or diminished then a way to contain the hazard and shield the worker from exposure must be explored in the form of engineering controls. Administrative Controls should be in place before addressing Engineering Controls, Work Practices and Personal Protection. These controls include the elimination and/or substitution of hazardous agents and procedures, creation of standard operating procedures (SOP), laboratory and agent specific training and appropriate supervision of workers during hazardous or potentially hazardous procedures.

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Engineering Controls Engineering Controls include equipment, devices or supplies that reduce the risk of occupational exposure by removing the hazard or isolating the worker from the exposure. Biological safety cabinets, autoclaves, safety centrifuges, medical sharps containers, splashguards, mechanical pipetting devices, and self-sheathing needles/needle devices are examples of engineering controls. Supervisors are responsible for providing the necessary engineering controls in the workplace. Utilize appropriate engineering controls whenever possible. Engineering controls are most effective when they are combined with good work practices. Equipment will require preventive maintenance or periodic replacement to provide worker protection. It is the direct responsibility of the supervisor to insure these controls operate properly. Equipment such as biological safety cabinets, safety centrifuges and mechanical pipetting devices are to be decontaminated immediately (or as soon as feasible) when overtly contaminated, or after a spill of biological agents, blood or other potentially infectious materials. Engineering controls should also be routinely decontaminated at the end of the work shift.

Biological Safety Cabinets Biological Safety Cabinets (BSCs) offer personal, product and environmental protection. They prevent biohazards from contaminating the worker by confining contaminants within the operating cabinet and removing them through High Efficiency Particulate Air (HEPA) or Ultra High Efficiency Particulate Air (ULPA) filters. The intake air must pass through the filter before flowing into the BSC work area. The exhaust air is also filtered by a HEPA or ULPA filter. Any aerosols generated within the cabinetwork area are contained within the BSC. Proper airflow is essential to the containment nature of BSCs and other CADs. BSCs must be certified by a qualified and reputable certifier after installation, and before use, after being relocated and at least annually thereafter. BSCs in use or with uncertain or undetermined usage are to be professionally decontaminated before relocation, storage or service to the interior of the unit. Contact EHS Biosafety to coordinate a BSC certification and/or repair services. Additional considerations for BSC use include the following: Small table-top centrifuges, sonicators, stirrers and shakers may be operated within a biological safety cabinet to protect workers from any aerosols generated during their operation and when opening pressurized containers. Biological safety cabinets with microscope modifications are available when the use of a microscope in a clean environment is necessary.

Centrifugation Centrifuge safety cups or buckets are designed to retain the contents of the centrifuge tube in the event of breakage or leakage. When centrifuging biological agents, use sealed tubes and safety buckets that seal with O-rings. Open these inside a BSC to contain the release of any potential aerosols. The contents may be under pressure.

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Centrifuge Safety Cup

The left suction flask (A) is used to collect contaminated fluids into a suitable decontamination solution; the right flask (B), serves as a fluid overflow collection vessel. An in-line HEPA filter (C) is used to protect the vacuum system (D) from aerosolized microorganisms. Use flask(s) large enough to collect a day’s worth of aspirate, nothing larger. Keep flasks in the BSC, not on the floor, to avoid accidental breakage or spilling. Filters may be obtained through VWR, Fisher, and other lab supply companies. Empty flasks daily.

Safety Centrifuges (Centrifuges with automatic locking mechanisms or solid lids) prevent the centrifuge lid from being opened while the rotor is still in motion or prevent aerosol release while the centrifuge is in operation. The locking device releases after the centrifuge head has stopped revolving.

Vacuum Line Chemical Traps and Filters Vacuum line chemical traps and filters prevent suction of human blood and other potentially infectious materials into the vacuum lines. The trap systems also prevent vacuum lines from clogging with non-infectious material. Laboratory workers protect maintenance personnel and vacuum line by installing and maintaining vacuum line traps and filter systems. PLEASE NOTE: Filters are to be placed between the chemical traps and the vacuum line. Do not allow Erlenmeyer flasks to overfill. Filters are to be examined and replaced if clogged or if liquid makes contact with the filter. Insure all connections or seals are tight to assure the vacuum is adequate. Spent filters are to be discarded in the regulated medical waste stream. There are now a variety of inexpensive HEPA in-line filter traps on the market. Contact the EHS –Biosafety for information regarding vacuum line filters.

Syringes and Needles

Needle-sticks may occur in situations where needles require manipulation or disassembly. Devices or systems such as Catheter Safety Systems, I.V. Access Safety Systems, Needle Protection Devices, Air Bubble Removal Devices, Syringe and Needle Shields reduce the need to use needles and lessens the danger of accidental needle-sticks. There are also safety sharps devices such as retractable lancets and disposable scalpels with safety features. Contact EHS for information about safer sharps devices. Sharps contaminated with biological agents, human blood, or other potentially infectious material and capable of puncturing the skin must be disposed of in sharps containers. Waste items that can puncture or tear plastic bags are considered sharps and should also be disposed of in sharps containers. Sharps disposal containers are to be used to contain and discard used and unused sharps waste. Containers for sharps disposal should be easily accessible and located as close as possible to the immediate area where sharps are used or found. Sharps containers should be puncture-resistant, closeable and leak-proof on the sides and

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bottom. Proper use of sharps containers eliminates the need to recap, bend, break or manipulate sharps waste by hand. Specific examples of sharps include: needles, scalpel blades, hypodermic needles, syringes (with or without attached needles), Pasteur pipettes, disposable pipettes, razor blades, blood vials, test tubes, needles with attached tubing, pipet tips, broken plastic culture dishes, unbroken glass culture dishes regardless of the presence of infectious agents, and other types of broken and unbroken glass waste materials including microscope slides and coverslips. Waste items that can puncture or tear plastic bags are considered sharps. PLEASE NOTE: Sharps containers that are in use are to be kept in an upright position and closed before removal from the laboratory to prevent spillage or protrusion of contents during handling, storage or transport.

Safety Blenders, Sonicators, and Mixers Safety Blenders, Sonicators and Mixers are designed to contain aerosols during operation. Open them inside a BSC to prevent the release of any aerosols. Contents may be under pressure allow time for aerosols to settle before opening.

Mechanical Pipetting Devices Mechanical pipetting devices are to be used in place of mouth pipetting or mouth aspirations. Pipetting of all biohazardous agents must be confined to a BSC. Infectious materials should never be forcefully expelled from a pipette. The proper use of a mechanical pipetting device eliminates or reduces the risk of contamination of the mouth, hand and work environment. All pipettes contaminated with biohazardous agents should be decontaminated with a suitable disinfectant, such as 10% bleach before be discarded as regulated medical waste. ,

Lyophilizers Lyophilizers produce a dry solid that is very easily dispersed. They should be fitted with a HEPA filter or vented to a BSC when used for drying suspensions of infectious material. Ampoules of lyophilized solids should be opened only in a BSC; place a disinfectant-moistened pad over the scored line when opening the ampoule. Disinfect chamber surfaces and any material collected in the vapor trap.

Cryostats Cryostats should be regularly decontaminated with a tuberculocidal hospital disinfectant. Trimmings and tissue sections should be treated as potentially infectious. Never attempt to clear debris from a blade with your finger; always use a brush or other mechanical device to prevent contact with the blade. When changing blades use protective gloves and handle the blades with forceps or tongs. Pre-soaking blades in a disinfectant solution prior to cleaning (removal of debris) will reduce the number of viable microorganisms. Due to the very sharp blade and the nature of the materials used with the cryostat, training is essential in the use of the equipment and in the hazards of the materials used with the equipment. Users should be informed of the need to prevent cuts and scrapes as well as protect the eyes, nose, mouth and skin from exposure to the materials being used. New personnel must be trained in the proper use and maintenance of the equipment, and demonstrate proficiency prior to use.

Miscellaneous Equipment (Waterbaths, Shakers, Cold Storage) Waterbaths and waterbath sonicators used for inactivating, incubating or testing of infectious substances should contain a disinfectant or other microstatic agent to minimize bacterial, fungal or algal growth. Iodine-

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based or phenolic disinfectants are recommended for intermediate temperature baths. A 1:10 dilution of household bleach is also effective but may corrode water bath components. Sodium azide should never be used as a bacteriostatic, it is toxic and drain disposal is illegal and may result in the formation of explosive metal azides. Consult the manufacturer to determine the recommended disinfectant. Water should be periodically changes to prevent the growth of microorganisms. Do not leave water baths on overnight or when they will be unattended for an extended period of time. Shaking machines should be examined carefully for potential breakage of flasks or other containers being shaken. Screw-capped durable plastic or heavy walled glass flasks should be used. These should be securely fastened to the shaker platform. An additional precaution would be to enclose the flask in a plastic bag with or without an absorbent material. Deep freeze, liquid nitrogen, and dry ice chests as well as refrigerators should be checked and cleaned out periodically to remove any broken ampoules, tubes, etc. containing infectious materials. Samples should be decontaminated and disposed of as regulated medical waste. Use proper personnel protection equipment during this cleaning. All infectious or toxic material stored in refrigerators or deep freezers should always be properly labeled. Security measures should commensurate with the hazards.

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Work Practice Controls Work practice controls are procedures that reduce the likelihood of exposure to an infectious agent by altering the way in which a task is performed. The protection provided by Work Practice Controls is dependent upon an employee’s behavior. It is necessary to exercise good work practices to ensure the effective use of Engineering Controls and Personal Protective Equipment. Work Practice Controls include:

Universal (Standard) Precautions At our institution, we observe the practice of “Universal Precautions” to reduce the occurrence of an exposure incident in the workplace; this incorporates the use of Engineering Controls, Work Practice Controls and Personal Protective Equipment.

Use of Engineering Controls

It is important for all laboratory personnel to understand how to properly use and maintain the integrity of engineering controls in your facility. Engineering controls must be maintained and examined in all laboratories. They should be examined before and after use, maintained or replaced on a regular schedule. If you supervise other workers, it is your responsibility to assure they understand which engineering controls to use and how to effectively use them.

General Work Practices Organize and plan work procedures and keep an uncluttered workspace. Always make sure all necessary materials are at hand. Keep the appropriate disinfectant, such as 10% household chlorine bleach and paper towels nearby in case of a spill. Remove and leave laboratory coats, gowns or smocks in the clinical or laboratory areas before going to general access areas such as lunchrooms/cafeterias, libraries and administrative offices. Eating, drinking, smoking, applying cosmetics and lip balm and handling contact lenses are prohibited in potentially contaminated work sites. Hand creams and lotions are permitted because they are not applied to the face. Use non-petroleum based hand creams only. Petroleum based hand creams compromise glove integrity at the microscopic level. Food and drink shall not be stored in refrigerators, freezers, cabinets or bench tops where biological agents may be present or in equipment labeled with a biohazard symbol.

Hand Washing Hands should be washed immediately upon coming into contact with potentially infectious materials and when gloves are removed. Hands should also be washed before exiting the laboratory. Slowly singing the alphabet to yourself is a good way to ensure that hands are scrubbed for an appropriate length of time. Alcohol-based hand sanitizers are at least as effective as soap in terms of biocidal activity but they should not be used if hands are visibly soiled or in place of soap and water when leaving the rest room.

Handling Disposable Needles and Syringes Hypodermic needle and syringe should only be used for parenteral injection and aspiration of fluids from humans, laboratory animals and diaphragm bottles. Use extreme caution when handling needles and syringes. Use needle-locking syringes or disposable syringe-needle units (i.e. the needle is integral to the syringe) as much as possible. Avoid autoinoculation and aerosol generation during use and disposal.

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Contaminated needles are not to be sheared, bent, recapped or removed unless the supervisor can demonstrate to EHS that no alternative is feasible or that such action is required by a specific research procedure. Exemption from recapping prohibition must be done in writing to the EHS. If recapping exemption is approved, then such recapping or removal of a needle must be accomplished through the use of a mechanical device or a one handed technique. Finger/hand shields offer full protection of the hand holding the needle sheath from accidental puncture. The one hand scoop method with the hand holding the sharp is used to scoop up the cap from a flat surface. All needles and syringes are to be discarded promptly into appropriate sharps containers after use.

Reusable Sharps Reusable sharps contaminated or not, shall be disposed of in a puncture-resistant hard sided labeled sharps container. They should be disposed of as soon as possible after use and stored or processed in a ways that does not require workers to reach in to the repossessing container by hand and risk a needlestick injury.

Footwear Wear close-toed shoes at all times. Close-toe shoes completely cover your feet, not just your toes. Sandals or open-toed shoes do not provide adequate foot protection and are inappropriate in laboratory or animal care areas. A dedicated pair of work shoes may reduce the amount and type of contamination introduced into the workplace by street shoes. This practice can also minimize the possibility of bringing microbial contamination from the workplace into the home.

Slash and Aerosol Control All procedures involving infectious or potentially infectious materials are to be performed in a manner that minimizes splashing, spraying, spattering and generation of droplets. This precaution decreases the chances of direct personal exposure and reduces the contamination of bench tops, instruments or other surfaces in the work area. Liquid cultures of infectious material, sealed ampoules and vacutainers are best opened in a biological safety cabinet (BSC).

Housekeeping for Laboratory Workers Good housekeeping in laboratories can reduce the risk of accidents occurring. Workbenches should be kept as clutter-free as possible and aisles should always be free of trip hazards. Benches should be wiped down with an approved disinfectant at least once a day and immediately after any spill. Other areas within the lab that should be addressed include hoods, refrigerators, cabinets, chemical storage cabinets, sinks, trashcans, etc. Additionally housekeeping refers to the general condition and appearance of a laboratory and also includes:

Cleaning up all chemicals spills immediately, regardless if the chemical is hazardous or not. When cleaning up a chemical spill, look for any splashes that may have resulted on nearby equipment,

cabinets, doors, and counter tops. For more information on cleaning up spills, see Biological Exposure and Spill Response Procedures.

Keeping areas around emergency equipment clean and free of clutter. This includes items such as eye-wash/emergency showers, electric power panels, fire extinguishers, and spill cleanup supplies.

Keeping a minimum of three feet of clearance (as required by fire codes) between benches and equipment. Exits must be clear of obstacles and tripping hazards such as bottles, boxes, equipment, electric cords, etc.

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When storing items overhead, keep heavier and bulkier items closer to the floor. New York State (NYS) Building Code prohibits the storage of combustible material (such as paper, boxes, plastics, etc.) within two feet of the ceiling in unsprinklered rooms and within 18 of the crown of a sprinkler head in sprinklered rooms.

Chemical Sterilization and Disinfection Always clean surfaces and equipment before using a chemical disinfectant or sterilant. PLEASE NOTE: If you use chemical agents to disinfect/decontaminate/sanitize surface, equipment, microbial/cell culture or skin surfaces, you should be familiar with the difference between disinfectants, antiseptics and sanitizers in order to use the products correctly and effectively. OSHA requires tuberculocidal disinfectants or 10% household chlorine bleach to disinfect surfaces contaminated with human blood or other potentially infectious human materials. Household chlorine bleach sold commercially has a concentration of 5.25% w/v (100,000 ppm) sodium hypochlorite. A 10% solution results in greater than a 0.5% w/v sodium hypochlorite, which inactivates bloodborne pathogens. Read the label on your disinfectant, antiseptic or sanitizer container to determine the appropriate dilution necessary to decontaminate environmental and body surfaces against bloodborne pathogens. Visit the EPA website for a list of registered products.

http://www.epa.gov/oppad001/chemregindex.htm

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Personal Protective Equipment (PPE) Personal Protective Equipment is to be used to provide additional protection when an occupational exposure remains after Engineering and Work Practice Controls are in place. The purpose of PPE is to act as a barrier to minimize the risk of exposure to aerosols, splashes and accidental inoculation. Exposure may occur via apparent or unapparent skin lesions or through the membranes of the eye, nose or mouth. PPE is often used in combination with BSCs and other equipment that contain the agents or animals being handled. PPE should be worn only while working in the laboratory; all PPE should be removed and hands should be washed before exiting the laboratory. Supervisors are responsible to discuss with their employees and students the type and proper use of PPE needed to perform job tasks safely General Guidelines for Personal Protective Equipment:

Individuals who supervise occupationally exposed workers are required to provide all appropriate PPE at no charge to the laboratory personnel and are responsible for cleaning, repairing, disposing and replacing all PPE. PPE should be easily accessible to all laboratory personnel. Supervisors should provide a variety of sizes, brands or types (e.g. nitrile gloves, latex glove) to meet individual needs.

PPE worn within the laboratory should not be worn outside the laboratory into common areas, such as cafeterias, offices, break rooms, etc. PPE should be placed in an appropriately designated area or container for storage, washing, decontamination or disposal.

PPE should never be taken home for laundering; such garments should be discarded or laundered using a commercial laundry service.

Change PPE as soon as feasible whenever biological agents, blood, or other potentially infectious materials penetrate it. PPE that is worn or torn should be discarded immediately.

Wash hands whenever PPE is removed. Do not touch door handles, elevator buttons, telephones, computers or other clean surfaces or items with gloved hands.

Wear closed-toe shoes and long pants to guard against skin contamination or chemical exposure. Do not wear sandals or shorts in the laboratory.

Laboratory Clothing Protective clothing such as laboratory coats, gowns and jumpsuits are used to protect the user against biological or chemical spills, and should be worn when working in the laboratory. The specific hazard and the desired level of protection will dictate the type of clothing needed. Wear coats that are resistant to liquid penetration for activities with splash potential or use a plasticized apron. For high-risk activities, a rear-fastening lab coat should be utilized. Provision, laundering, and replacement of lab coats are the responsibility of the Principal Investigator, or Department; employees must not launder contaminated lab coats at their home. Protective clothing is to be removed as soon as feasible, if contaminated or penetrated by biological agents, blood or other potentially infectious materials, and autoclaved or otherwise disinfected before being discarded or laundered. Lab coats must not be worn outside of the laboratory if they were used during work with infectious materials.

Hand Protection Disposable single-use gloves should fit properly, be comfortable and prevent exposure to the wrist and forearms. They are to be inspected before use. Gloves must be worn whenever handling biological materials or chemicals and should be inspected prior to use. Gloves must be selected based on the hazards involved and the

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activity to be conducted. Additionally, you should consider alterative materials (e.g. nitrile, vinyl) if sensitive to latex. Corrosives and organic solvents may penetrate gloves or diminish their protective ability; it may be necessary to stock more than one type of glove for the full range of a laboratory's activities. Glove compatibility information is available from glove manufacturers or contact EHS. When using any gloves consider these factors:

Check for visible tears and other defects. Remove rings and other jewelry that may rip gloves. Protective ability diminishes as gloves are worn due to stretching and abrasion; change gloves regularly

or as soon as possible if they are overtly contaminated. Disposable gloves do not protect against needle stick and animal bites. Specialty reusable gloves such as Kevlar or DYNEEMA are cut-resistant and needle-stick resistant Gloves should be long enough to cover the cuff or lower sleeve of laboratory clothing and protect

exposed skin. Do not wash or reuse disposable gloves. Remove gloves when leaving the laboratory. Even if they are "clean", their presence in an elevator or

other common area justifiably causes misgivings among other building occupants. Proper decontamination of the exterior surfaces of containers used to transport biological materials is required and will eliminate the perceived need to wear gloves during transport on campus.

Wash hands immediately after removing gloves.

Face and Eye Protection Eye injuries are among the most preventable types of laboratory accidents. Glasses routinely worn for vision correction do not provide the appropriate level of protection for work with hazardous materials. Contacts lenses do not provide protection in the laboratory and should not be substituted for eye protection. Contact lenses may increase the risk of eye damage because biological materials may become trapped between the lens and the cornea. Goggles face shields, safety glasses with side shields or masks should to be worn whenever there is potential for the generation of splashes, spray, splatter or droplets of biological agents, blood or other potentially infectious material in the eyes, nose, mouth or other facial areas. Factors to consider when using facial or eye protection:

Safety glasses with side shields provide the minimum level of protection for handling any hazardous material.

Goggles, which unlike safety glasses fit tightly all around the eyes are required for activities with a moderate-to-high splash hazard or work with organisms transmissible through mucous membrane exposure.

Face shields, worn over goggles, are appropriate when an elevated risk of large quantity splashes exists or when working with highly toxic, corrosive, or infectious materials. Face shields must also be used for protection against UV radiation (be sure that the face shield carries the manufacturer’s validation of UV protection) and when handling liquid nitrogen.

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Surgical mask are generally protective against droplets, splashes and sprays. Some surgical masks are available with attached eye shields. Masks should cover both the nose and the mouth and shall be positioned and secured on the face to minimize gaps or spaces between the face and mask.

Respiratory Protection When engineering controls and work practices cannot provide adequate protection against aerosolized agents or when mandated by federal regulations, respirators shall be worn. The Respiratory Protection Program requires that employees be medically cleared, fit-tested, and trained on proper usage and care before being allowed to wear a respirator. For more information please visit the EHS website learn about the Respirator Protection Program. Please contact EHS at 212-998-1450 for Respirator training and fit testing.

Disposable Booties and Shoe Covers When significant splash and splatter are anticipated, booties or shoe-covers should be considered. Prior to exiting the laboratory, these must be removed and disposed of properly.

http://www.nyu.edu/content/dam/nyu/environmentalHealthSafety/documents/resp.pdf

http://www.nyu.edu/content/dam/nyu/environmentalHealthSafety/documents/resp.pdf

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Decontamination The purpose of decontamination is to make a hazardous material safe for further handling. A decontamination procedure can range from sterilization to simple cleaning with soap and water. The best general-purpose disinfectant solution is household bleach (5.25% sodium hypochlorite) diluted 1:10 in water. There are many commercially available disinfectants. They should be selected carefully based on their known activity against the agents used in the particular laboratory. The following includes a description of the four main categories of physical and chemical means of decontamination.

Liquid Disinfection Chemical disinfectants destroy disease-causing agents on inanimate surfaces. Chemicals proven to kill Mycobacterium tuberculosis on surfaces, called tuberculocidal disinfectants are considered to be broad spectrum disinfectants. A 10% solution of standard household bleach, 2% Lysol (commercial) and Wescodyne 75ppm (18 ml concentrate/gallon water) are examples of tuberculocidal disinfectants. Tuberculocidal disinfectants are required in labs using human materials. Some materials of human origin and any materials that may contain prions such as Creutzfeldt-Jakob (CJ) infectious agent, require multiple decontamination steps to achieve inactivation. Prions are resistant to common disinfectants.

Ethanol or isopropyl alcohol (70%) have limited effect as disinfectants, and are not generally considered to be disinfectants. These alcohols are effective cleaners or sanitizers and may be used after an appropriate disinfectant. The following criteria will help in the selection of a disinfectant or sterilant: The product must be effective against all organisms present in the laboratory,

The product must be compatible with surfaces/materials being decontaminated,

The product must be able to maintain sufficient contact time to inactivate the organisms,

The product must have sufficient stability in its diluted form to achieve inactivation. See Appendix A for additional information about disinfectants. Contact EHS-Biosafety section with questions about the selection of disinfectants. NOTE: When bleach is used for the decontamination, a fresh solution (10% bleach) must be prepared daily. Each solution container must be labeled with either a make-up or an expiration date. However, bleach products with additives that extend the shelf life are available from commercial vendors.

Heat Moist heat is the most dependable method of sterilization. Steam autoclaving is the most convenient method available to the laboratories for decontaminating biological waste and sterilizing glassware and media. Autoclaves provide the most efficient and reliable method of sterilization for most laboratory applications. The critical process factors are temperature, exposure time, and ensuring that materials are packaged to allow the steam to penetrate throughout the load. Sterilization time will vary in relation to the size

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of the load and the packing density of the chamber. Typical laboratory autoclaves operate at 121°C. All users must review the operating manual periodically. Instructions should be prominently posted. Use heat resistant gloves and face protection, particularly when removing processed material; crack the

door slowly and wait a few minutes before fully opening it. For dry loads, add 250-500 ml. of water to the load pan to aid in steam generation. Autoclave bags should

be closed loosely to allow steam to penetrate; do not tightly cap bottles and test tubes. Autoclave tape is not a fail-safe indicator of sterilization; it blackens after only brief exposure to a

temperature of 121°C. When used for sterilizing infectious waste, autoclave performance must be periodically confirmed by using B. stearothermophilus spore vials. Place a vial in a hard-to-reach area of a mock load and attach a string to facilitate removal after autoclaving. Incubate as directed; a lack of turbidity indicates that the autoclave is achieving sterilizing conditions.

Some autoclave tapes contain lead, which makes it necessary to dispose of these tapes as Hazardous Waste. Laboratories must use lead-free autoclave tape to eliminate this hazardous waste stream Information concerning lead-free autoclave tape contact EHS.

Vapors and Gases The use of vapors and gases as decontamination methods usually involve the decontamination of biological safety cabinets, but they can also be used for whole building or room decontaminations. Agents used in this category include ethylene oxide, formaldehyde gas, hydrogen peroxide and peracetic acid. Biological Safety Cabinet decontaminations may not be performed using formaldehyde; rather, hydrogen peroxide must be used. Before arranging for gas decontamination methods, contact EHS.

Radiation Ultraviolet radiation (UV) is sometimes used in biological safety cabinets for surface decontamination, but because of the low penetrating power of UV light, dusty or soiled areas limit its usefulness. UV creates excess amounts of ozone, which can result in symptoms of dry throat and dryness in the eyes. Because UV can cause serious burns to eyes and skin, it must not be used when work areas are occupied. EHS along with the CDC and NIH strongly discourage the use of UV as means of decontamination.

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Regulated Medical Waste /Biological Waste Regulated Medical Waste (RMW) is material that may be contaminated with blood, bodily fluids, or other infectious materials. RMW may also be referred to as “biohazardous” or “infectious waste”. RMW must be properly handled and disposed of in order to minimize the risk of transmitting infection or endangering human health. RMW that contains BSL-2 organisms should be autoclaved or otherwise decontaminated prior to disposal. This is a requirement for BSL-3 organisms and recombinant- synthetic nucleic acid microorganisms. Untreated RMW must be carefully packaged to eliminate the chances of exposure during transport to its ultimate treatment and destruction site. RMW must be collected in rigid containers lined with red bags imprinted with the infectious waste biohazard symbol. Any sharps or materials contaminated with infectious agents that may puncture a red bag must be deposited in a sharps disposal container. RMW includes the following:

Cultures and stocks of agents infectious to humans, and associated biologicals, cultures from medical or pathological laboratories, cultures and stocks of infectious agents from research and industrial laboratories, wastes from the production of biologicals, discarded live or attenuated vaccines, or culture dishes and devices used to transfer, inoculate or mix cultures;

Human or non-human primate blood, blood products and infectious body fluids as defined by OSHA; Items saturated or caked with human blood or body fluids that would release blood/body fluid in a

liquid or semi liquid state if compressed or would flake if handled; Human or non-human primate tissue, cell lines or anatomical wastes Sharps (needles, syringes with attached needles, and scalpel blades, wires, glass pipets etc.) Disposable

sharps must be placed in an approved plastic sharps container as soon as possible after use. Sharps containers must be located close to the area where sharps are used. When the sharps container is ¾ full, it must be capped tightly and placed in a RMW container for disposal.

Animal carcasses that have been intentionally infected with organisms likely to be pathogenic to healthy humans, inoculated with human-derived materials, or are otherwise considered ABSL-2 must be put in red plastic Biohazard bags and disposed of in the vivarium cold room or designated freezer.

Any residue that results from the cleanup of a spill of infectious waste.

Principal Investigators and Supervisors are responsible for training their staff and students on proper disposal of RMW. Regulated Medical Waste disposal is only done through the University’s vetted vendor. See Regulated Medical Waste Safety Policy # 103.

http://www.nyu.edu/content/dam/nyu/environmentalHealthSafety/documents/policies_RMW.pdf

http://www.nyu.edu/content/dam/nyu/environmentalHealthSafety/documents/policies_RMW.pdf

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Select Agents and Toxins Biological select agents and toxins are regulated by the Department of Health and Human Services and the United States Department of Agriculture through regulations promulgated under the CDC and Animal and Plant Health Inspection Service (APHIS). The Federal Select Agent Program oversees the possession, use and transfer of biological select agents and toxins, which have the potential to pose a severe threat to public, animal or plant health or to animal or plant products. A full description of the program and its requirements may be found at the Federal Select Agent Program website. Institutions and entities must register with and be inspected by the Select Agent Program if they possess, use, or store any of the listed agents. Registration is not required for diagnostic laboratories that destroy or transfer specimens, which test positive for a Biological Select Agent or Toxin as long as they comply with reporting requirements. Registration is not required if individual Principal Investigators possess and use exempt quantities of Select Agent Toxins. Select Agent List Exempt Toxin Amounts The following toxins are not regulated if the amount under the control of a principal investigator, treating physician or veterinarian, or commercial manufacturer or distributor does not exceed, at any time, the amounts indicated in the table below.

HHS Toxins Amount

Abrin 100 mg

Botulinum neurotoxins 0.5 mg

Short, paralytic alpha conotoxins 100 mg

Diacetoxyscirpenol (DAS) 1000 mg

Ricin 100 mg

Saxitoxin 100 mg

Staphylococcal Enterotoxins (Subtypes A, B, C, D, and E) 5 mg

T-2 toxin 1000 mg

Tetrodotoxin 100 mg Adapted from Federal Select Agent Program: Permissible Toxin Amounts Table

Exempt quantities of Select Agent Toxins, attenuated or excluded Biological Select Agents and any genetic sequences or plasmids from Biological Select Agent must be registered with the IBC. The Biosafety Specialist must be notified when purchasing exempt select agent toxins. PIs are responsible for completing a Pathogen Risk Assessment and submitting a Select Agent Possession Declaration form to EHS-Biosafety at least 10 days prior to the contemplated purchase. Please refer to the Biosafety SOP for working with Exempt Biological Select Agents and Toxins.

http://www.selectagents.gov/

http://www.selectagents.gov/SelectAgentsandToxinsList.html

http://www.selectagents.gov/PermissibleToxinAmounts.html

https://www.nyu.edu/life/safety-health-wellness/be-safe/environmental-health-and-safety/programs/biosafety.html

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Shipping, Receiving and Transportation of Biological Materials The U.S. Department of Transportation (DOT) and the International Air Transport Association (IATA) regulate shipment of human and animal pathogens. The regulations are complex and exacting. They require that researchers who prepare infectious materials for shipment receive periodic training. In addition, packages must be marked and labeled exactly as the regulations specify, and packaging materials must have been tested and certified to withstand certain durability and pressure tests. Cardboard boxes in which supplies have been received cannot be used to ship infectious materials. Personnel packaging and shipping biological materials must comply with the requirements for training by NYU EHS to ship those materials. This training addresses:

1. Properly packaging, labeling and marking the shipment; 2. Accurately completing the paperwork; 3. Making advance arrangements as needed with the recipient and the carrier; 4. Obtaining any permits needed to import or export biological materials.

Individuals who fail to comply with the regulations may have their shipments refused by airlines or other carriers. They are also at risk for the fines and/or jail terms described below.

Up to $250,000 and up to a year jail sentence for individuals. Up to $500,000 per incident for organizations.

Note: It is illegal to carry infectious or other hazardous materials on an airplane. For example, if you visit another lab and want to bring an infectious substance back to your lab, you CANNOT take it on an airplane. You must ship it using a certified carrier such as DHL or Federal Express. Before shipping or transporting any biological material on a public road you must be certified by NYU EHS. Please contact EHS at 212-998-1450 for a training and certification schedule. To ship biological material you must be certified once every two years. EHS maintains a list of certified laboratory members and staff. During Laboratory Audits, EHS may inspect individual laboratory shipping logs and airway bills for compliance. Only those who are trained may be able to ship biological material.

On Campus Transport of Biological Materials Biological materials transported between laboratories or buildings on campus must be contained, as they would be in a laboratory, to prevent release of materials into the environment. Transported materials must be in closed leak-proof primary containers (e.g. freezer vials, tubes) secured with a tight cap. Liquid samples should be surrounded by absorbent material to contain liquids and absorb any shock during transport. They must then be placed in a sealed secondary container prior to transport. Samples must be clearly labeled. Laboratory contact information must be in or on the outer container. The secondary container must have a biohazard symbol and the word “biohazard”.

Federal Permits for Transport and Use

Many biohazardous materials require federal permits for the transport and use of those agents. These permits are required for a wide range of activities, which state many of the stipulations required to maintain approval. PIs who conduct research with biohazard materials that require federal permits must notify and send a copy of the permit(s) to Biosafety. The following are some of the regulatory agencies, which issue permits;

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1. Centers for Disease Control Etiologic Agent Import Permit The CDC regulates the transport of biological materials that could cause or suspected to cause illness in humans, including pathogens and biological toxins. Some animal hosts and vectors (i.e., snails, arthropods, bats) that play a role in transmitting infection to humans also require a CDC permit. These permits may be obtained from the Centers of Disease Control and Prevention, Office of Health and Safety, Etiologic Agent Import Permit Program for further information. Note: Domestic transport may or may not require a permit. Some microorganisms and cell lines purchased from ATCC require permits to be shipped domestically. 2. US Department of Agriculture Animal and Plant Health Inspection Service (USDA /APHIS)

Permits USDA/APHIS regulates transport of materials that could potentially harm U.S. agricultural products including livestock, poultry and crops. APHIS permits may be required for import, export, and interstate transport of animal or plant pathogens, pathogen vectors, animals, animal products, plants, plant products, and the introduction of genetically modified organisms into the environment.

a) Veterinary Services Import/Export Permits (VS) A USDA veterinary permit is generally needed for materials derived from animals or exposed to animal-source materials. Examples include: animal tissues, blood, cells or cell lines of livestock or poultry origin, RNA/DNA extracts, hormones, enzymes, monoclonal antibodies for in vivo use in non-human species, certain polyclonal antibodies, antisera, bulk shipments of test kit reagents, and microorganisms including bacteria, viruses, protozoa, and fungi.

b) Plant Protection & Quarantine Import/Export Permits (PPQ)

APHIS-PPQ safeguards agriculture and natural resources from the risks associated with the entry, establishment, or spread of animal and plant pests and noxious weeds. Plant pathogens, pests, noxious weeds, or materials that may contain these are likely to require a PPQ permit.

c) Biotechnology Regulatory Services Permits (BRS)

The Biotechnology Regulatory Services (BRS) program regulates the field-testing, movement, and importation of genetically engineered (GE) organisms that are known to be, or could be plant pests. BRS issues various types of permits for each of these activities.

http://www.cdc.gov/od/eaipp/

http://www.aphis.usda.gov/animal_health/permits/

https://www.aphis.usda.gov/aphis/ourfocus/planthealth

https://www.aphis.usda.gov/aphis/ourfocus/biotechnology

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Biosecurity Biological security or biosecurity is the protection of microbial agents and research-related information from theft, loss, diversion or intentional misuse. While biosecurity includes the physical security of items, it also includes security for information stored on computers and other electronic devices.

In general, all laboratory personnel are responsible for:

controlling access to areas where hazardous materials are used and stored, knowing who is in the laboratory and asking for identification if unsure, knowing what materials are brought into and removed from the laboratory, reporting any undocumented visitors, missing biological, chemical or radioactive materials, unusual or

threatening phone calls, etc. to the laboratory supervisor, EHS and Public Safety.

Inventory It is the PIs responsibility to assure the security of the biological agents and materials under their control. The loss or theft of some agents and materials may have consequences greater than an accidental release in the lab. The only way to know if there has been a loss or theft is to know what you have in storage. A complete inventory of recombinant materials, microorganisms, cells, cell lines, tissue samples, toxins and any other regulated biological materials is required for all long term ultralow temperature storage devices. The freezers or dewars must have access controls in place; a lock on the unit or in a locked room under your control. Units located in a shared space with public access must be locked at the freezer or dewar.

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Biological Exposure and Spill Response Procedures

Steps to Consider with a Biohazard Exposure

1. Contaminated PPE should be removed.2. Proceed to the closest sink.3. If the exposure involves broken/compromised skin, (needle sticks and/or sharps) the area should be

washed thoroughly with soap and water for 15 minutes. 4. If applicable cover the wound with a bandage.5. If the exposure involves the contamination of the mucus membrane(s), the area should be treated by

flushing with water for 15 minutes at the nearest emergency eyewash station.6. Report to the Student Health Services or the nearest hospital for post exposure follow-up. Provide the

medical provider with the following description:

Biohazardous material The route of exposure (needlestick or splash to eyes) Time and place of the incident Prior first aid provided

7. Notify the PI, Senior Biosafety Specialist and Public Safety immediately once you have received medical attention.

The PI must complete an Incident Reporting Form and submit it to the EHS within 5 days of the incident.

8. Accidents, injuries and exposures must also be reported on the Work Related Injury Form for anyone employed by the University.

Basic Biological Spill Clean-up Procedures

1. Wear personal protective equipment: lab coat, gloves, face/eye protection2. Mechanically remove broken glass/sharps and place in a sharps container3. Cover spill with paper towels4. Soak paper towels with disinfectant5. Let stand at least 20 minutes*6. Remove these materials and place in bags as biological waste7. Cover the area with disinfectant and wipe up with paper towels8. Discard all materials as biological waste9. Inspect your clothing and exposed skin for contamination10. Remove gloves and other PPE and wash hands

*Refer to your laboratory’s standard operating procedures for detailed instructions for specific agents present in the lab.

For volumes that cannot be contained with paper towels, Public Safety at 8-2222, then call EHS at 8-1450.

See Appendix B for spill response cue cards.

https://goo.gl/forms/pNmSDrF5yJ1Pd1b93


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Reporting Incidents All accidents, injuries and potential exposures involving biological agents must be reported. An immediate report is necessary to insure proper care and treatment is given to those involved. A swift and appropriate response could diminish the likelihood of disease transmission. The report will also initiate an investigation. The purpose of this investigation is to review the practices leading up to the incident and will focus on ways to eliminate or diminish any future risks. Reports are made directly to the supervisor of the work area where the event occurred. Additional reports should be made directly to the individual’s supervisor, Department, EHS Biosafety and Public Safety. Spills and incidents that do not result in an exposure or injury must also be reported if:

The material is known to contain infectious agents The material is known to contain a biological toxin or is a biological toxin The material is genetically modified, recombinant or transgenic

All reports will be documented by the supervisor on the Laboratory Incident Reporting form. Accidents, injuries and exposures must also be reported on the Work Related Incident-Injury Form for anyone employed by the University. Non-employee students will complete an additional form at Student Health Services.


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Fire and Fire Related Emergencies If you discover a fire or fire-related emergency, such as abnormal heating of material, hazardous gas leaks, hazardous material spill or flammable liquid spill, smoke, or odor of burning, immediately follow these procedures: Activate the building alarm (fire pull station) and if not available or operational, verbally notify persons in the building. Call 911- from a safe location Call Public Safety - from a safe location

1. The Public Safety Department can be reached at extension 8-2222 (Washington Square), 8-9828

(Dental), 772-5808 (IFA). Public Safety personnel should be notified of the location of the smoke or fire condition, including the building, floor and/or room number and the name and call back number of the individual reporting the incident.

2. Personnel at non-campus venues such as the Midtown Center shall rely on the respective building safety plan.

3. Do not attempt to fight the fire. Only use a fire extinguisher if it is needed to safely escape.

In Laboratories

1. Pull The Nearest Fire Alarm. 2. Notify others of the fire as stated in the General Fire Emergency Instructions. 3. If possible - Shut off all gas burning equipment. Disconnect or switch off all electrical instruments and

appliances with the exception of refrigerators and incubators. Close the windows and leave the lights on. 4. Move pressurized gas cylinders to a safe area. 5. Evacuate, call 911 and then contact Public Safety.

Animal Areas

1. Pull The Nearest Fire Alarm. 2. Notify others of the fire as stated in the General Fire Emergency Instructions. 3. If possible - Be sure all animals in your area are securely caged. 4. If possible - Remove all animals from routes of transit or from hallways and place them in the nearest

room. Be sure that cages are securely fastened. 5. Evacuate, call 911 and then contact Public Safety.

Evacuation

Upon hearing the alarm, faculty members, staff, students and visitors must exit the building using the nearest exit. Follow the evacuation chart posted in every elevator lobby. Do not use the elevator.

1. Close all doors and windows to prevent the spread of fire and smoke. Leave lights on. 2. Keep low to the floor to avoid smoke and toxic gases.

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3. Once in the stairway, proceed down to the first floor and exit the building. Move away from the building, out of the way of firefighters and other emergency personnel. Do not leave the area unless you have been accounted for.

4. Do not attempt or allow students or personnel to re-enter the building for any reason, until you are authorized to do so.

5. You are requested to assist a person with disabilities. The person should either remain in the area or be relocated to an area of rescue assistance (designated rooms in the Main Building or preferably a room with an exterior window and a telephone in other University buildings). A Fire Warden should be consulted to determine the best course of action. Call 911 immediately and advise of the exact location of the person(s). If a telephone is not readily available, someone should go to the building entrance and notify the Public Safety Officer on duty of the exact location of the person(s); NYU Public Safety will inform the fire department of the location of the person(s). The fire department will determine if an evacuation is warranted. Only the fire department should attempt to evacuate the person(s) requiring assistance.

6. If you are a person requiring assistance, and you are not able to self-evacuate, move to a location/room near the exit stairway with an exterior window. Call 911 to let the fire department know your location in the building; if possible, request that someone notify fire department personnel of your location. If needed, the fire department will assist you.

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Appendices

Appendix A Disinfectants and Sterilization Methods

Appendix B Spill Response Cue Cards

Appendix C Supplemental Supportive Documents

Appendix D External Resources

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Appendix A: Disinfectants and Sterilization Methods

Toxin

Chemical Inactivation allow at least 30 mins for the chemicals to deactivate the toxin

Autoclaving

1 hr at 121°C liquid cycle

slow exhaust 2.5% NaOCl + 0.25 N NaOH

2.5% NaOCl 1% NaOCl 0.1% NaOCl

T-2 Mycotoxin Yes No No No No

Brevetoxin Yes Yes No No No

Microcystin Yes Yes Yes No No

Tetrodotoxin Yes Yes Yes No No

Saxitoxin Yes Yes Yes Yes No

Palytoxin Yes Yes Yes Yes No

Ricin Yes Yes Yes Yes Yes

Botulinum Toxin

Yes Yes Yes Yes Yes

Staphylococcal enterotoxin B

Yes (?) Yes (?) Yes (?) Yes (?) Yes(?)

Disinfectants and Sterilization Methods from the BMBL https://www.cdc.gov/biosafety/publications/bmbl5/bmbl5_appendixi.pdf

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Appendix B: Spill Response Cue Cards

SPILLS INSIDE THE BIOSAFETY CABINET 1. Make sure the cabinet continues to operate. Wait 5 min. to allow aerosols to

be pulled through the HEPA filter. 2. Decontaminate the surfaces with 10% bleach within the cabinet wearing

protective clothing. Gently cover the spill with absorbent paper towels and apply the appropriate disinfectant starting at the perimeter and working towards the center.

3. Note: Examine drain pan for contents of the spill. Disinfect if needed. 4. Discard soaked paper towels in a biohazard bag. Wipe up residual fluids. Wipe

down surfaces with 70% EtOH, discarding towels in a biohazard bag. 5. After cleanup allow cabinet blower to run for 10 minutes before resuming

work.

SPILLS OUTSIDE THE BSC 1. Alert personnel in the vicinity. 2. Check for contaminated clothing, including shoes. Decontaminate if necessary. 3. Evacuate the room. Close door. Discard potentially contaminated PPE and

remove any contaminated clothing. Wash hands thoroughly. 4. Post warning sign: “DO NOT ENTER: Biological spill!” 5. Wait 30 min. Meanwhile, notify PI, Public Safety (8-2222), and Biosafety

Specialist (8-1440). 6. If assistance is needed, discuss with Biosafety Specialist. 7. Don fresh PPE: lab coat or gown, gloves, mask, eye protection. 8. Re-enter the room, cover spill with paper towels. 9. Soak paper towels with appropriate disinfectant, from perimeter toward the

center. 10. Allow 30 min. of contact time. Work can continue during contact time. 11. Discarded towels go in biohazard bags. Pick up sharps with tongs & place in

sharps container. 12. Wipe down spill area one final time with appropriate disinfectant. 13. PI, write up a report and submit to Biosafety.

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SPILLS INSIDE AN INCUBATOR 1. Alert personnel in the vicinity. 2. Evacuate the room. Close door. Discard potentially contaminated PPE and

remove any contaminated clothing. Wash hands thoroughly. 3. Notify PI. 4. Don fresh PPE: lab coat or gown, gloves, mask, eye protection. 5. Cover spill with paper towels. 6. Soak paper towels with appropriate disinfectant, from perimeter toward the

center. 7. Allow 30 min. of contact time. 8. Discarded towels go in biohazard bags. Pick up sharps with tongs & place in

sharps container. 9. Wipe down spill area one final time with appropriate disinfectant. 10. Decontaminate water pan using the autoclave.

SPILLS INSIDE A CENTRIFUGE 1. Open lid of centrifuge slowly. 2. If there has been no breach of containment, spray rotor with appropriate disinfectant

(e.g. 10% bleach) followed by 70% EtOH to prevent corrosion. See step #8 next 3. If inside of rotor is contaminated, decontaminate in the BSC. As a precautionary measure,

decontaminate the centrifuge chamber. 4. If rotor buckets are damaged, close centrifuge lid. 5. Alert personnel in the vicinity. Evacuate room. 6. Wait 30 min. Meanwhile, notify PI, Public Safety (8-2222) and Biosafety Specialist (8-

1440). 7. If assistance is needed, discuss with Biosafety Officer. 8. Open lid slowly and add paper towels. 9. Spray walls of chamber and rotor with appropriate disinfectant (e.g.10% bleach). 10. Close centrifuge lid for 30 min. of contact time. 11. Finish centrifuge clean-up as for major spill outside the BSC. Transport rotor to BSC. 12. Open and decontaminate rotor/buckets in the BSC. 13. PI, write up a report and submit to Biosafety.

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Appendix C: Supplemental Supportive Documents

1. Bloodborne Pathogens Exposure Control Plan

2. Biological Laboratory Survey

3. Incident Reporting form

4. Institutional Biosafety Committee Policy

5. Regulated Medical Waste Safety Policy

6. Select Agent Toxin Possession Declaration

https://www.nyu.edu/content/dam/nyu/environmentalHealthSafety/documents/BBP_2005_POLICY.PDF

https://goo.gl/forms/IpokHY8cpS8kHZeE2

https://goo.gl/forms/VjedFUL0W44xF3d03

http://www.med.nyu.edu/research/ibc/policy

https://www.nyu.edu/content/dam/nyu/environmentalHealthSafety/documents/policies_RMW.pdf

https://goo.gl/forms/RbU4G6j85CNEdgIi2

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Appendix D: External Resources

1. National Institute of Health Guidelines

2. Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5TH Edition

3. OSHA Bloodborne Pathogens Standard

4. Public Health Agency of Canada- Pathogen Safety Data Sheets

5. Federal Select Agent and Toxins Program

6. Arthropod Containment Guidelines

7. CDC Import Permit Program

8. United States Department of Agriculture/ APHIS Permits and Certifications

http://osp.od.nih.gov/office-biotechnology-activities/biosafety/nih-guidelines


https://www.osha.gov/SLTC/bloodbornepathogens/bloodborne_quickref.html

http://www.phac-aspc.gc.ca/lab-bio/res/psds-ftss/index-eng.php

http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20List.html

https://www.aphis.usda.gov/plant_health/permits/downloads/arthropod_biocontrol_containment_guidelines.pdf

http://www.cdc.gov/od/eaipp/

http://www.aphis.usda.gov/wps/portal/footer/topicsofinterest/applyingforpermit