Biological Safety Program
The primary objective of the UTRGV Biological Safety Program is to ensure a safe working environment for faculty, staff and students working with biological agents in a research environment. Biohazardous materials or hazardous biological agents include all infectious agents or biologically derived infectious materials that present either a risk or a potential risk to the health of humans, animals or the environment. The risk can be direct through infection or indirect through damage to the environment. Biohazardous materials include certain types of recombinant DNA; organisms and viruses infectious to humans, animals or plants (e.g. parasites, viruses, bacteria, fungi, prions, rickettsia); and biologically active agents (i.e. toxins, allergens, venoms) that may cause disease in other living organisms or cause significant impact to the environment or community.
The Biological Safety Program is comprised of two primarily organizations - the Institutional Biosafety Committee and the department of Environmental Health, Safety and Risk Management.
In pursuit of this objective, our office ensures that laboratory facilities and operations conform to the regulatory requirements established by the Institutional Biosafety Committee (IBC), state agencies such as the Texas Department of State Health Services, and federal agencies such as the National Institutes of Health (NIH) and the Occupational Safety and Health Administration (OSHA). This is conducted through training, auditing, and consulting with researchers, laboratory personnel and teaching staff concerning compliance with the federal and state laws and regulations in these areas.
Institutional Biosafety Committee
The UTRGV Institutional Biosafety Committee (IBC) is responsible for reviewing research activities utilizing recombinant DNA (rDNA) and other Hazardous Biological Agents (HBAs) to ensure that UTRGV principal investigators and lab personnel utilize appropriate best practices when performing this type of work.
UTRGV Institutional Biosafety Committee reports to the Executive Vice President for Research, Graduate Studies, & New Program Development.
All research by UTRGV investigators that involves the following biological agents, regardless of funding source, must be reviewed and approved by the Institutional Biosafety (IBC) prior to initiation of work:
- Recombinant DNA is defined in the NIH Guidelines as; (1) nucleic acid molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, and (2) DNA molecules that result from the replication of these molecules.
- Hazardous Biological Agents (HBA’s) these include infectious organisms classified as BSL-2 or above agents by the NIH (CDC) such as pathogenic bacteria, protozoans, fungi, viruses, etc., including attenuated lab & vaccine strains. Human and other vertebrate biological products (cells, fluids, etc.), applicable primary and immortal cell lines, organotypic and tissue cultures involved in research that require universal precautions are also included.
Environmental Health, Safety and Risk Management
The primary role of the Department of Environmental Health, Safety and Risk Management is to ensure that laboratory facilities and operations conform to the regulatory requirements established by the Institutional Biosafety Committee (IBC), state agencies such as the Texas Department of State Health Services, Centers for Disease Control and federal agencies such as the National Institutes of Health (NIH) and the Occupational Safety and Health Administration (OSHA).
This is accomplished through a comprehensive program comprised of training, routine audits to ensure compliance with mandated regulations and consulting with researchers, laboratory personnel and teaching staff concerning compliance with the federal and state laws and regulations in these areas.
The Biological Safety Officer for the UTRGV is the following
Dr. Richard Costello, DrPH, CSP, CHMM,RPT
1201 West University Dr. EHSB Bldg.
Edinburg, Texas 78539
(956) 665-2903 (956) 457-2357 (cell)
UTRGV Program Documents
- UTRGV Laboratory Safety Manual
- UTRGV Biological Safety Level 1 Manual
- UTRGV Biological Safety Level 2 Manual
- UTRGV Biological Safety Level 3 Manual
- Bloodborne Pathogen Exposure Control Plan
- Do I Need an IBC Protocol?
- Immunization/Surveillance Schedule
- Bloodborne Pathogen Exposure Response Procedure
Relevant Forms
Training Requirements
Training is a key requisite to guarantee the fundamental objective of biological safety programs which is to provide a safe and healthy environment for the campus community. There are two general training classes required for personnel to take prior to working with biological agents in either a research, teaching or clinical laboratory environment. All classes are offered online and periodically in person. Information can be obtained at the following website:
www.utrgv.edu/ehsrm/programs/training/
The following training classes are required to do research with infectious agents or rDNA.
Basic Laboratory Safety Hazard Communication Training – The training covers the Hazard Communication (Chemical Safety) aspect of the training.
CITI Program Training
CITI training is required for all personnel who work with infectious agents or rDNA. The CITI training can be accessed at about.citiprogram.org/en/homepage/. Select the Biosafety/Biosecurity course and complete the applicable modules.
Required Modules
And if applicable
Once initial training is conducted, the following refresher training is required on an annual basis prior to the protocol being reissued.
And any of the following classes depending on the nature of the research:
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- Clinical Safety Training – This training is required for those personnel who through their routine job duties are potentially exposed to a blood borne pathogen in a clinical environment where there is patient contact. Clinical Safety training is required on an annual basis.
- Research/Agent Specific Training - Research/Agent specific training is required to be conducted by the Principal Investigator for all research staff manipulating infectious agents.
- Shipping of Biological Substances and Dry Ice: In order to comply with U.S. Department of Transportation (DOT) and International Air Transportation Association (IATA) Dangerous Goods Regulations, persons who prepare hazardous materials for shipment (including shipping papers) or who transport hazardous materials in commerce must complete training in accordance with the requirements of these transportation safety authorities. Biological Materials and Dry Ice Shipping is required if an employee performs any of the following functions:
- Package or ship human or animal clinical specimens or tissues
- Package or ship any human or animal clinical specimens as part of a study where the sponsor has designated these materials as Category B biological substances (or prepare paperwork for such packages)
- Package or ship any materials that may contain an agent infectious to humans or animals (i.e., microbiological cultures).
Once initial training is completed, the person must complete refresher training at least once every 24 months or when significant regulatory changes occur. Training is online and is available by accessing the Shipping and Transporting Biological Materials website.
Training Schedule
The training schedule is referenced at the following link UTRGV Training Schedule. In addition to the scheduled training classes, the EHSRM provides training to groups of three or more to accommodate your schedule.
Training Guide
Other Related Links
- American Biological Safety Association (ABSA)
- Biosafety Material Safety Data Sheets (MSDS)
- Bloodborne Pathogens 29 CFR 1910.1030 (OSHA)
- Center for Disease Control and Prevention (CDC)
- CDC Select Agent Program
- NIH - Biosafety in Microbiological and Biomedical Laboratories,(BMBL), 5th edition
- NIH - Recombinant DNA Guidelines
- Pathogen Safety Data Sheet and Risk Assessment
- Risk Group Classification for Infectious Agents (ABSA)
- Texas – Bloodborne Pathogen Control