Biological Safety

Biological Waste Management

Our biological waste management division schedules pickup and disposal of biomedical waste and regulated (red bag) waste and sharps.

Biological Waste Pick Up Contacts

• For Radioactive Waste pick up, call 252-744-3867 and press #1.
• For HIPAA-Compliant Clinical Confidential Document pick up, call 252-744-3867 and press #2.
• For Biological Waste pick up, call 252-744-3867 and press #3.
• For other questions, call 252-744-9092.

Biohazardous Materials Use

Biohazardous Materials include:

All individuals are required to file a registration with the Office of Prospective Health/Biological Safety, if they wish to work with a covered biohazard (biotoxins, allergens, biohazardous agents, microorganisms with an assigned biosafety level 2 or higher, human tissues, body fluids and commercially available human cell lines, any recombinant DNA or synthetic genomics work or use of viral vectors, or Select Agents). Use or breeding of knock-out or transgenic animals may require registration to meet NIH Guidelines.

NIH

• Adsat-Adenovirus-Vector-Containment
• Biosafety Considerations for Research with Lentiviral Vectors
• Experiments that are Exempt from the NIH Guidelines
• FAQs-Major Actions under NIH Guidelines
• Investigator Educational Brochure Recombinant-DNA1
• Lenti-Lenti-Virus-Containment-Guidance
• NIH Guidelines for Research Involving Recombinant DNA Molecules
• Session-III-Synthetic-Genomis-Issues
• State-of-the-Art-Lentiviral-Vectors-for-Research-Use-Risk-Assessment-and-Biosafety-Recommendations
• Transgenic-Animals-and-the-Use-of-Recombinant-DNA-in-Animals
• Transgenic-Transgenic-Plants
• Overview of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules 
• Overview of the NIH Guidelines Requirements for Institutional Biosafety Committees Under the NIH Guidelines

Biological Safety Cabinets

All biological safety cabinets at East Carolina University must be certified annually.

Basic certification includes: leak testing HEPA filters, checking air inflow and exhaust rates in the cabinet, noise and vibration tests, as well as checking light levels inside the cabinet on the work surface.

Cabinets are to be certified when they are newly installed, annually, or if moved to a different location. If your cabinet needs certification, or if you believe it may not be operating properly, contact the Biological Safety Officer (252-744-3437).

• Biological Safety Cabinet Decision
• Biological Safety Cabinets
• Biological Safety Cabinets and Laminar Flow Hood Certificate Costs
• Working in a Biosafety Cabinet (Video)

Hazardous Material Transportation General Security Awareness – Saf-T-Pak/IATA Training Requirements

Shipping Division 6.2 Dangerous Goods Compliance Training**

**New Users use this link for Hazardous Material Transportation General Security Awareness (Saf-T-Pak Training): www.apps.saftpak.com

• Hazardous Material Transportation General Security Awareness Form

• Hazardous Material Transportation General Security Awareness – Saf-T-Pak/IATA training is required every two years for anyone shipping dangerous goods through IATA. Dangerous goods are defined as articles or substances which are capable of posing risk to health, safety, property or the environment. If your position requires you to ship any dangerous goods through IATA, you need training.

• You may be exempt from this training depending on what you actually ship (See Shipping Categories below).

Shipping Categories Which Require Training

Feel free to contact our biosafety office to obtain a copy of our “Dangerous Goods Packaging, Labeling, and Declaration Checklist” available on loan as well as consultant resources with clinics and labs involved in shipping to answer your questions. Contact numbers for this information include 252-744-3437 or 252-744-2237.

• Category A substances: An infectious substance which is transported in a form that, when exposure to it occurs, is capable of causing permanent disability, life threatening or fatal disease in otherwise healthy humans or animals.
• Category B substances: An infectious substance which does not meet the criteria for inclusion into category A (example, patient samples in which it has not been determined if they contain an infectious substance or not)
• If you ship genetically modified organism or micro-organisms

You may be exempt from this training if: Exempt status can only be used for direct patient specimens. Direct patient specimens are those collected directly from the human or animal which have been determined by a professional to have minimal likelihood of containing a pathogen. If the specimen is cultured after collection, it can no longer be considered a direct patient specimen.

Please review the list of Category A substances and flow chart below to determine whether or not you need training. If you follow the flow chart and end up at any of the UN boxes at the bottom, then this training is required for you. If you have any questions please don’t hesitate to email or call Chad Spruill or John Baumgartner at 252-744-2070.

• Category A (PDF)
• Flow Chart (PDF)

Links

American Biological Safety Association

• American Biological Safety Association

American Society for Microbiology

• American Society for Microbiology

CDC Links

• Select Agent Program – CDC
• CDC – Biosafety Resource and Tools
• ABSL3 Ag Checklist 

CDC/NIH

• BMBL 5th Edition (PDF)

Information Links

• Biological Indicator Spore Testing Procedure (DOCX)
• Bloodborne Pathogen Training Information
• State-of-the-Art Lentiviral Vectors for Research Use – Risk Assessment and Biosafety Recommendations (PDF)

CDC Links

• Select Agent Program – CDC
• CDC – Biosafety Resource and Tools
• ABSL3 Ag Checklist 

CDC/NIH

• CDC/NIH: 2007 BioSafety in Microbiological and Biomedical Laboratories
• BMBL 5th Edition (PDF)

Controlled Environmental Testing Association

• Controlled Environmental Testing Association

OSHA

• Bloodborne Pathogen Standard

PHP&R

• NC PHP&R Biological Threats Response Guide (PDF)

WHO

• World Health Organization Laboratory BioSafety Manual 2nd Edition