Registration of Pathogens, Select Agents and Human Cells/Tissues, at UMDNJ-RWJMS
Index
- General Instructions
- Frequently Asked Questions
- RWJMS Registration Form For Pathogens, Select Agents and
Human Cells/Tissue
- IBC Renewal/Amendment/Termination Form
General Instructions (top)
The RWJMS Institutional Biosafety Committee, in conjunction with the Office of the Associate Dean for Research, maintains a registry of all research laboratories and research personnel working with human and animal pathogens. This registration is intended for all research laboratories growing, processing, handling or characterizing biological materials capable of causing disease in humans.
The purpose of this registration is 1) to maintain a listing of laboratories and individuals working with human and animal pathogens, 2) to provide a system for checking that containment practices and facilities are appropriate and adequate for the health and safety of workers in the laboratory and immediate environment and 3) to comply with the requirement of certain funding agencies for registration of biohazardous materials.
The Responsible Investigator (the faculty member who has been asigned the laboratory space) is responsible for completing and updating the appropriate parts of this registration document. Registration form are to be completed by all registrants (one copy for each pathogen), and should be forwarded to EOHSS within one week of initiation of work. However, prior approval is required for any new organisms, that require a higher biosafety level (BL) than that which is required for organisms currently in use in the laboratory.
The RWJMS Registration Form for Pathogens, Select Agents and Human Cells/Tissues, and/or the Renewal/Amendment/Termination Form should be completed and mailed to:
Tracy Pfromm (pfrommtr@umdnj.edu) , MPH, Biosafety Officer, EOHSS
Liberty Plaza , suite 2250
335 George Street
New Brunswick, NJ 08901
(732) 235-8376
The RWJMS Institutional Biosafety Committee (IBC), chaired by Debabrata Banerjee, Ph.D., will review each registration document with respect to level of biological containment proposed by the investigator, and return a copy to the Principal Investigator indicating the committee action. The IBC will also advise registrants on containment levels when necessary.
Frequently Asked Questions(top)
1. How will the registry be kept up-to-date? After the initial inventory form is completed, you should update the information as necessary when using or storing human cells/tissues, BSL-2 or higher pathogens, or select agents that were not listed on the original form. Use the Renewal/Amendment/Termination Form to renew your protocols every 3 years, as well as to notify the IBC of termination, changes to personnel and/or agents at any time during the protocol.
2. Should Recombinant DNA protocols be registered with this form? No. The Recombinant DNA registration form is at: http://www.umdnj.edu/eohssweb/pisc/pisc_rdna.htm.
3. What is meant by biosafety level (BSL)? The CDC-NIH has designated four different biosafety levels, BSL-1 to BSL-4. Microorganisms are categorized into a biosafety level. In addition, each biosafety level requires a different combination of laboratory practices and techniques, safety equipment, and laboratory facilities as recommended by the Centers for Disease Control and the National Institutes of Health in the publication "Biosafety in Microbiological and Biomedical Laboratories, CDC, NIH, 5th Ed." (BMBL). These combinations of equipment and work practices are designed to minimize the risk of infectious disease when microorganisms are worked with. Definitions and information on organism classification and proper handling procedures can be found in this publication. Links to sources that describe the biosafety level of specific organisms are available at: http://www.umdnj.edu/eohssweb/publications/external.htm#Microbiological. EOHSS has developed safety checklists for BSL-2 and BSL-3 laboratories.
4. Why must human cells/tissues be registered? Human and other primate cells should be handled using Biosafety Level 2 (BSL-2) practices and containment. All work should be performed in a biosafety cabinet, and all material should be decontaminated by autoclaving or disinfection before discarding. All employees working with human cells and tissues are covered under the RWJMS Bloodborne Pathogen Plan and must receive training and must be up-to-date in their hepatitis B vaccination.
5. What are select agents/toxins? Select agents are specific pathogens and toxins that have the potential to pose a severe threat to public health and safety as defined by the USA PATRIOT Act and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. There is a list in section C of the registry form. This section is included on the registry form to remind researchers about what the agents are so that they will not be used inadvertently. The institution must be registered with the CDC or USDA before these materials are obtained, used or stored.
6. Must I fill out a separate "section A" for each strain of a specific pathogen? No. As long as the strains of that pathogen have the same designated biosafety level they can be included on the same form. However, submit a separate part A for each biological agent.
7. What should I do if I have questions about completing the form? Questions related to the registration process, or whether a particular organism or agent should be registered, or when a completed registration form will be reviewed by the Institutional Biosafety Committee, may be directed to the EOHSS Biological Safety Officer, Tracy Pfromm, at pfrommtr@umdnj.edu, 732-235-8376. (top)
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