Biological Safety: Safety for people, animals, plants BioSafety and BioHazard Training Office of Engineering Safety Texas Engineering Experiment Station (TEES) & The Dwight Look College of Engineering “A safe, healthful, and secure environment for scholarship and research.” Biological Safety Key Concepts • Hazardous Biological Substances (Biohazards) • Bloodborne Pathogens • Universal Precautions • Exposure Control Plan • Biosafety in Microbiological and Biomedical Laboratories (BMBL) • Biological Risk Assessment • BioSafety Level (BSL)Criteria • BioSecurity Criteria • Select Agents & Toxins • BioHazard Containment, Decontamination & Disinfection • TAMU Biological Safety Office 2 Why Is Biological Safety Important? Biological Safety • Use of hazardous biological materials on campus including – Biohazardous agents and bloodborne pathogens • Bloodborne Pathogens • Prevent disease in personnel • Prevent release of organisms/agents into environment 3 Biological Safety What are BioHazardous Materials? • Any biological material capable of causing harm to humans, animals, plants • BioHazardous Agents – Pathogens that can replicate & cause disease include: – Bacteria (Streptococcus pyogenes) – Fungi (Candida, Histoplasma) – Viruses (HIV, HBV) – Prions (CJD) – Parasites (Giardia, Strongyloides) • Toxins – Microbial poisons – Exotoxins – produced by bacteria • Clostridium botulinum - food poisoning, one of most deadly • Clostridium tetanii – tetanus • Corynebacterium diphtheriae – diptheria • Bioterrorism use – Endotoxins – released from cell wall when bacteria disintegrates 4 Biological Safety Classification System For Biohazardous Materials BioSafety Levels (BSL) Risk Group 1 BSL 1 Agents not associated with disease in healthy adult humans Risk Group 2 BSL 2 Agents associated with human disease; rarely serious; preventative or therapeutic resources available Risk Group 3 BSL 3 Agents associated with serious or lethal human disease; preventative or therapeutic resources available Risk Group 4 BSL 4 Agents likely to cause serious or lethal human disease; no preventative or therapeutic resources available 5 The Standard Code of Practice for BioSafety Biological Safety • • Biosafety in Microbiological and Biomedical Laboratories (BMBL) – U.S. Department of Health & Human Services – Public Health Service – Centers for Disease Control & Prevention & the National Institutes of Health – http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm Establishes criteria for: – Biological Risk Assessment – Principles of BioSafety – Laboratory BioSafety Level (BSL) Criteria – Laboratory BioSecurity Criteria – BioHazard Containment – Decontamination & Disinfection – Transportation of BioHazards & Infectious Materials – Select Agents & Toxins… 6 Biological Safety Researcher Responsibilities: Faculty or Principle Investigator (PI) • Files a Biological Usage Authorization (BUA) • Trains all personnel • Establishes emergency procedures • Reports incidents with biologicals • Posts biohazard warning signs • Cooperates with Biological Safety Officer during inspection visits • Responsibilities of TAMU PI’s – http://researchcompliance.tamu.edu/ibc/ibcpiresp 7 BioSafety Officer TAMU Office of Research Compliance Biological Safety • Dr. Bruce M. Whitney – Institutional Biological Safety Officer – Office of Biological Safety – Texas A&M University • • • • Tel: Mailstop: Email: Email: 979-458-0683 or 436-1307 1112 TAMU brucewhitney@tamu.edu bwhitney@vprmail.tamu.edu • http://biosafety.tamu.edu/institutional-biosafety-committee/ibcrevapp/ibcapprev 8 Biological Safety Institutional BioSafety Committee (IBC) TAMU Office of Research Compliance • Mandated by National Institutes of Heath (NIH) • Must review and approve all usage of Risk Group 2 or higher agents • Must review and approve rDNA usage, formation of transgenic animals, experiments involving human gene therapy • Applies to TAMU: – Employees & students conducting research involving infectious biohazrds – Research subjects, human or animal • TAMU IBC: http://researchcompliance.tamu.edu/ibc/welcome • http://biosafety.tamu.edu/institutional-biosafety-committee/ibcrevapp/ibcapprev 9 Biological Safety Biological Usage Authorization (BUA) • Describes the Principle Investigator’s Research Project • Required when biohazardous material is stored, used, or transported • Good for 3 years • Can be amended 10 Biological Safety Forbidden Agents • Cannot be brought on campus! • Mycobacterium tuberculosis • Hantavirus • Foreign Animal Pathogens • HIV 1 & 2 • Reference material can be kept in inactive state (frozen or lyophilized) • List of all references must be given to IBC 11 Biological Safety CDC Select Agents • Cannot be brought on campus without prior approval & registration • Must be registered with the University BioSafety Officer • Required under: • U.S. BioTerrorism Prevention Act • USA Patriot Act (USAPA) • TAMUS Regulations, TEES & TAMU Rules 12 Biological Safety The BioSafety Inspection! • Personal Protective Equipment • Training • Signage • Adherence to Protocol • Technique • Physical Facility • General Safety • Risk Assessment • Controls • Project Safety Analysis (PSA) 13 Biological Safety What You Must Learn to Work Safely with Bloodborne Pathogens • Cleaning • Decontamination • Regulated waste disposal • Pre and post exposure procedures • Universal Precautions (CDC) • Special hazards – HIV, HBV research 14 Biological Safety What are Bloodborne Pathogens? • Microbial agents transmitted by the blood and bodily fluids of infected individuals. • Control of Occupational Exposures to Bloodborne Pathogens • 29 CFR 1910.1030 • http://www.osha.gov/SLTC/bloodbornepathogens/index.html 15 Biological Safety Exposure Control Plan • All laboratory supervisors, faculty & principle investigators are responsible for insuring their employees and students comply with the Exposure Control Plan to reduce the risk of occupational exposures to bloodborne pathogens. • All personnel that have the potential to be exposed to bloodborne pathogens MUST be trained to this plan. • A copy of the Exposure Control Plan must be readily available in each work area or laboratory where bloodborne pathogens exposures exist. 16 Biological Safety Where to Get More Information www.osha.gov/SLTC/bloodbornepathogens/index.html • Workers in many different occupations are at risk of exposure to bloodborne pathogens, including Hepatitis B, Hepatitis C, and HIV/AIDS. • In 1991, OSHA issued the Bloodborne Pathogens Standard to protect workers from this risk. • In 2001, in response to the Needlestick Safety and Prevention Act, OSHA revised the Bloodborne Pathogens Standard, 29 CFR 1910.1030. • The revised standard clarifies the need for employers to select safer needle devices and to involve employees in identifying and choosing these devices. • The updated standard also requires employers to maintain a log of injuries from contaminated sharps. 17 Where to Get More Training labsafety.tamu.edu/bloodborne.asp Biological Safety • Prevention of Exposures to Bloodborne Pathogens (BBP): – Exposure to human blood and bodily fluids can result in transmission of several bloodborne illnesses, including HIV and Hepatitis B. – This training presentation will aid in increasing awareness of the risk of exposure to bloodborne pathogens and techniques and practices for preventing exposure and abating hazards in Engineering laboratories and facilities. 18 Biological Safety Prepared by: http://engineering.tamu.edu/safety/ 19 20 Biological Safety Biological Safety: Safety for people, animals, plants BioSafety and BioHazard Training Office of Engineering Safety Texas Engineering Experiment Station (TEES) & The Dwight Look College of Engineering “A safe, healthful, and secure environment for scholarship and research.”