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CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 1
BIOSAFETY AND BIOSECURITY (BSS) Series Catalog CITI Program’s BSS series consists of courses that cover a variety of biosafety and biosecurity topics. These courses address basic information for multiple regulations, standards, and guidelines, and are meant to complement the hands on training and experience that those handling biohazards obtain from their principal investigators, laboratory managers, and fellow researchers. The Biosafety Training series of modules was designed for both BSL1 and BSL2 laboratorians and researches. This catalog provides a listing, description, and language availability for each module within the BSS series, as well as information on how to access the series. Subscription Information The BSS series is available to subscribing organizations starting at $500 USD/year, which is in addition to the base subscription fee. Independent Learner registration is available for $110 USD/course. For more information on subscriptions, click here. In order to meet the needs of subscribing organizations, the CITI Program can assist administrators in creating courses that best meet their organizational needs, including combining modules from across the CITI Program. To discuss course recommendations that combine modules from different CITI Program offerings, please contact the CITI Program Help Desk at [email protected] or (888) 529-5929.
CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 2
Table of Contents Basic Courses Basic Introduction to Biosafety 3 Biosafety Officer Training – Basic/Initial 4 Initial Biosafety Training 10 Biosafety Retraining 13 Animal Biosafety 15 Shipping and Transport of Regulated Biological Materials 16 OSHA Boodborne Pathogens 18 Select Agents, Biosecurity, and Bioterrorism 19 Emergency and Incident Response to Biohazard Spills and Releases 20 NIH Recombinant DNA Guidelines 21 Personal Protective Equipment 22 Human Gene Transfer 23 Nanotechnology 23
Institutional Biosafety Committee Member Training 24
Dual Use Research of Concern (DURC) 26 USDA Permits 27
CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 3
Basic Courses
For a basic course in the BSS series, organizations may use any of the available BSS modules. This catalog provides a listing of recommended courses. For more information, see the Using CITI Program Content: Biosafety and Biosecurity (BSS) document.
Basic Introduction to Biosafety This course provides an introduction to biosafety for researchers handling Risk Group 1 agents working only at Biosafety Level 1 containment. Module Title
Recommended Use
ID (Language)
Biosafety and Biosecurity (BSS) Introduction Required 13987 (English)
Biosafety Course Overview Required 13314 (English)
Risk Management: Work Practices Required 13898 (English)
Biosafety and Biosecurity (BSS) Introduction This module serves as an introduction to the BSS series.
Biosafety Course Overview This module provides an introduction to biosafety and training for researchers handling Risk Group 1 agents or working only at Biosafety Level 1 containment.
Risk Management: Work Practices This module serves as initial training targeted at researchers handling or who will handle biohazards in a research or clinical laboratory. It addresses an awareness of biohazards, risk assessment, and key risk management work practice principles.
CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 4
Biosafety Officer Training – Basic/Initial This course provides new biosafety officers and other environmental health and safety professionals with a comprehensive introduction to biosafety. It includes all modules within the BSS series.
Module Title
Recommended Use
ID (Language)
Biosafety and Biosecurity (BSS) Introduction Required 13987 (English)
Biosafety Course Overview Required 13314 (English)
Laboratory-Acquired Infections Required 13454 (English)
Biohazard Risk Assessment Required 13455 (English)
Medical Surveillance Required 13456 (English)
Risk Management: Work Practices Required 13898 (English)
Risk Management: Personal Protective Equipment Required 13458 (English)
Risk Management: Emergency and Spill Response Required 13459 (English)
Risk Management: Engineering Controls Required 13929 (English)
Risk Management: Laboratory Design Required 13484 (English)
Work Safely with Sharp Instruments Required 13899 (English)
Disinfection and Sterilization Required 13900 (English)
Safe Sharps Devices Required 13946 (English)
Centrifuge Precautions Required 13945 (English)
Engineering Controls and Containment Devices Required 13497 (English)
OSHA Bloodborne Pathogens Standard Required 13902 (English)
Hepatitis B Virus (HBV) Vaccination Required 13903 (English)
CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 5
Labels and Engineering Controls Required 13904 (English)
Universal Precautions and Work Practices Required 13913 (English)
Emergency Response Procedures Required 13914 (English)
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules Required 13493 (English)
Human Gene Transfer Research Required 13494 (English)
Select Agents Required 13951 (English)
Biosecurity Required 13857 (English)
Bioterrorism Required 13524 (English)
Shipping Regulated Biological Materials: Overview Required 13486 (English)
Shipping Regulated Biological Materials: Classifications Required 13487 (English)
Shipping Regulated Biological Materials: Packaging Requirements Required 13488 (English)
Shipping Regulated Biological Materials: Shipping Papers Required 13655 (English)
Shipping Regulated Biological Materials: Permits for Restricted Shipments and Transfers Required 13656 (English)
Shipping Regulated Biological Materials: Security Awareness Required 13657 (English)
Shipping Regulated Biological Materials: Emergency Response Information Required 13658 (English)
Shipping Regulated Biological Materials: Refrigerants Required 13659 (English)
Shipping Regulated Biological Materials: Appendix Required 13660 (English)
Animal Biosafety Required 13654 (English)
Understanding Nanotechnology and Its Implications Required 14044 (English)
Dual Use Research of Concern (DURC) Required 16263 (English)
CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 6
Biosafety and Biosecurity (BSS) Introduction This module serves as an introduction to the BSS series.
Biosafety Course Overview This module provides an introduction to biosafety and training for researchers handling Risk Group 1 agents or working only at Biosafety Level 1 containment.
Laboratory-Acquired Infections This module sets the foundation for the importance of biosafety by briefly reviewing seminal laboratory-acquired infections that have occurred in the research and clinical laboratory settings. A learner may explore supplemental cases for further study and increased awareness of how the breakdown of good microbiological practices can lead to infections and death (in rare cases).
Biohazard Risk Assessment This module outlines the steps involved in identifying risk factors for experiments or procedures involving biohazards. The three P’s of risk assessment (Pathogen, Procedures, and Personnel) are reviewed to provide a basic foundation in this important building block to biosafety.
Medical Surveillance This module reviews basic medical surveillance and occupational health program recommendations for laboratory or clinical researchers handling biohazards.
Risk Management: Work Practices This module serves as initial training targeted at researchers handling or who will handle biohazards in a research or clinical laboratory. It addresses an awareness of biohazards, risk assessment, and key risk management work practice principles.
Risk Management: Personal Protective Equipment This module discusses U.S. Occupational Safety and Health Administration (OSHA) personal protective equipment (PPE) training requirements for researchers handling biohazards. A supplemental PPE Training Record Form and PPE Training and Use Table are available at the end of the module to facilitate the documentation of training.
Risk Management: Emergency and Spill Response This module provides biohazard emergency response training for employees who are designated as hazardous materials responders and address the biohazard component of their annual training.
Risk Management: Engineering Controls This module examines the engineering controls, devices, and barriers that can be utilized to protect researchers when handling biohazards in the laboratory. It describes the fundamental engineering controls utilized to safely handle biohazards and the concomitant work practices for their safe use.
Risk Management: Laboratory Design This module describes the safety features of laboratories designed to protect researchers at each of the first three Biosafety Levels (1, 2, and 3). It provides a comprehensive description of the safety factors associated with the design of a Biosafety Level 3 laboratory.
Work Safely with Sharp Instruments This module reviews how to safely handle sharp instruments when working with biohazards. It outlines safe work practices with disposable and reusable sharps.
Disinfection and Sterilization This module discusses the decontamination of items contaminated by biohazards after an experiment, prior to reuse, or before disposal. It provides information on methods of sterilization and disinfection, along with good decontamination work practices.
(continued)
CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 7
Safe Sharps Devices This module provides an overview of safe sharps devices and other engineering controls designed to minimize exposure to biohazards when handling sharp instruments. This module also supports training on a sharps safety program.
Centrifuge Precautions This module discusses risks involved in centrifugation along with the control devices and work practices that will help ensure the safe use of centrifuges.
Engineering Controls and Containment Devices This module describes a variety of engineering controls or the protective tools and devices used in the laboratory setting that help protect workers from exposure to biohazards.
OSHA Bloodborne Pathogens Standard This module is directed at researchers, employees, and students who handle or have contact with human blood, tissues, bodily fluids, or other potentially infectious materials. It is designed as initial bloodborne pathogens training to be provided at the start time of work with these materials. It can be used to fulfill annual retraining requirements from the U.S. Occupational Safety and Health Administration (OSHA), when selected in combination with the following modules: Hepatitis B Virus (HBV) Vaccination, Labels and Engineering Controls, Universal Precautions and Work Practices, and Emergency Response Procedures. Retraining must be completed within 365 days (1 year) of the previous training.
Hepatitis B Virus (HBV) Vaccination This module provides an introduction to the Hepatitis B vaccine and the requirements of offering occupationally exposed employees the vaccine. It provides information on routes of exposure to bloodborne pathogens and other biohazards, as well as routes of transmission for infectious agents in the laboratory.
Labels and Engineering Controls This module discusses the use of signs, labels, and color-coding, as well as engineering controls (mechanical barriers) used to prevent exposure to bloodborne pathogens in research and clinical laboratories.
Universal Precautions and Work Practices This module discusses the universal precautions concept where all blood and other potentially infectious materials are treated as if infectious for HIV, HBV, and HCV. This concept also extends to all sharps and patients. It reviews best practices, guidelines, and precautions to be used in a laboratory setting.
Emergency Response Procedures This module describes the recommended guidelines for dealing with an unplanned release of bloodborne pathogens and other potentially infectious materials in the laboratory or workplace.
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules This module provides principal investigators and others responsible for the conduct of recombinant and synthetic nucleic acid research experiments, and institutional biosafety committee (IBC) members who review these experiments, with training on the requirements of the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. It is designed as initial training but can also be used as periodic refresher training for principal investigators and IBC members as required by the NIH guidelines.
Human Gene Transfer Research This module is designed for principal investigators, clinicians, and institutional biosafety committee (IBC) members participating in the conduct or review of a human gene transfer clinical study. It reviews the National Institutes of Health (NIH) and IBC requirements for human gene transfer clinical trials.
(continued)
CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 8
Select Agents This module is designed for researchers who handle or have access to select agents. It is part of the “Select Agents, Biosecurity, and Bioterrorism” training, which provides initial and annual retraining options in select agents and laboratory biosecurity as required by U.S. select agent regulations.
Biosecurity This module is designed for researchers who handle or have access to potential biowarfare agents or other potentially valuable biological materials. It is part of the “Select Agents, Biosecurity, and Bioterrorism” training, which provides initial and annual retraining options in select agents and laboratory biosecurity as required by U.S. select agent regulations.
Bioterrorism This module is designed for researchers who handle or have access to potential biowarfare agents or other potentially valuable biological materials. It is part of the “Select Agents, Biosecurity, and Bioterrorism” training, which provides initial and annual retraining options in select agents and laboratory biosecurity as required by U.S. select agent regulations. It can also be used by emergency responders who deal with potential bioterrorism incidents.
Shipping Regulated Biological Materials: Overview This module provides an overview of the applicable regulations on the transportation of hazardous materials, which help to ensure the safety of the public and workers in the transportation chain. It is intended for those researchers and technicians who package and ship diagnostic or clinical human and animal specimens, human and animal pathogens, and related regulated biohazards.
Shipping Regulated Biological Materials: Classifications This module presents the different classes of dangerous goods and provides a description and examples of infectious substances, and exempt human or animal specimens. It also discusses medical transport exceptions.
Shipping Regulated Biological Materials: Packaging Requirements This module discusses the packaging criteria to ensure compliance with the major requirements of the U.S. Department of Transportation (DOT), International Air Transport Association (IATA), and the U.S. Postal Service.
Shipping Regulated Biological Materials: Shipping Papers This module discusses the Shipper’s Declaration for Dangerous Goods (Shipper’s Declaration) that is required when shipping infectious substances, toxic substances, or genetically modified microorganisms. It lists the various requirements for completing the Shipper’s Declaration Form.
Shipping Regulated Biological Materials: Permits for Restricted Shipments and Transfers This module discusses the need to obtain an import or export permit prior to the shipment of infectious substances and related biological substances, and/or materials that may contain infectious substances into or out of the country. It presents information on the agencies that regulate the import and export of these substances.
Shipping Regulated Biological Materials: Security Awareness This module discusses the need for general security awareness training for all employees handling hazardous materials in the transport chain.
Shipping Regulated Biological Materials: Emergency Response Information This module discusses the need for all employees involved in the hazardous materials transport chain to be aware of the initial emergency response procedures and whom to notify in the event of an incident.
Shipping Regulated Biological Materials: Refrigerants This module discusses safety factors, guidelines, and shipping requirements to take into consideration when dealing with refrigerants.
(continued)
CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 9
Shipping Regulated Biological Materials: Appendix This module provides several lists of regulated biological materials including an example list of Category A Infectious Substances, a list of select agents, and the U.S. Department of Commerce (DOC) Commerce Control List (CCL).
Animal Biosafety This module is designed as initial training for researchers and animal handlers working with small or conventional animals used in biohazard experiments. It can also be used as periodic refresher training based on the schedule outlined by the host institution. Additional CITI Program content for persons involved in the conduct of research using animals can be found in the Animal Care and Use (ACU) series.
Understanding Nanotechnology and Its Implications This module provides basic awareness and understanding of nanoparticles, and the unique safety issues associated with their handling.
Dual Use Research of Concern (DURC) This module provides a detailed training on the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern. It is based on the 2014 United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern, which is required for all National Institutes of Health (NIH) funded entities. It describes the agents and types of experiments that require oversight, individual and organizational responsibilities, and risk mitigation strategies.
CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 10
Initial Biosafety Training This course provides initial training for researchers handling biohazards in a research or clinical laboratory. It addresses awareness of biohazards, risk assessment, and key risk management principles including work practices, personal protective equipment, engineering controls, and emergency response. The Biosafety Training series of modules was designed for both BSL1 and BSL2 laboratorians and researches.
Module Title
Recommended Use
ID (Language)
Biosafety Course Overview Required 13314 (English)
Laboratory-Acquired Infections Required 13454 (English)
Biohazard Risk Assessment Required 13455 (English)
Medical Surveillance Required 13456 (English)
Risk Management: Work Practices Required 13898 (English)
Risk Management: Personal Protective Equipment Required 13458 (English)
Risk Management: Emergency and Spill Response Required 13459 (English)
Risk Management: Engineering Controls Required 13929 (English)
Risk Management: Laboratory Design Required 13484 (English)
Work Safely with Sharp Instruments Required 13899 (English)
Disinfection and Sterilization Required 13900 (English)
Safe Sharps Devices Required 13946 (English)
Centrifuge Precautions Required 13945 (English)
Engineering Controls and Containment Devices Required 13497 (English)
Biosafety and Biosecurity (BSS) Introduction Supplemental 13987 (English)
Dual Use Research of Concern (DURC) Supplemental 16263 (English)
CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 11
Biosafety Course Overview This module provides an introduction to biosafety and training for researchers handling Risk Group 1 agents or working only at Biosafety Level 1 containment.
Laboratory-Acquired Infections This module sets the foundation for the importance of biosafety by briefly reviewing seminal laboratory-acquired infections that have occurred in the research and clinical laboratory settings. A learner may explore supplemental cases for further study and increased awareness of how the breakdown of good microbiological practices can lead to infections and death (in rare cases).
Biohazard Risk Assessment This module outlines the steps involved in identifying risk factors for experiments or procedures involving biohazards. The three P’s of risk assessment (Pathogen, Procedures, and Personnel) are reviewed to provide a basic foundation in this important building block to biosafety.
Medical Surveillance This module reviews basic medical surveillance and occupational health program recommendations for laboratory or clinical researchers handling biohazards.
Risk Management: Work Practices This module serves as initial training targeted at researchers handling or who will handle biohazards in a research or clinical laboratory. It addresses an awareness of biohazards, risk assessment, and key risk management work practice principles.
Risk Management: Personal Protective Equipment This module discusses U.S. Occupational Safety and Health Administration (OSHA) personal protective equipment (PPE) training requirements for researchers handling biohazards. A supplemental PPE Training Record Form and PPE Training and Use Table are available at the end of the module to facilitate the documentation of training.
Risk Management: Emergency and Spill Response This module provides biohazard emergency response training for employees who are designated as hazardous materials responders and address the biohazard component of their annual training.
Risk Management: Engineering Controls This module examines the engineering controls, devices, and barriers that can be utilized to protect researchers when handling biohazards in the laboratory. It describes the fundamental engineering controls utilized to safely handle biohazards and the concomitant work practices for their safe use.
Risk Management: Laboratory Design This module describes the safety features of laboratories designed to protect researchers at each of the first three Biosafety Levels (1, 2, and 3). It provides a comprehensive description of the safety factors associated with the design of a Biosafety Level 3 laboratory.
Work Safely with Sharp Instruments This module reviews how to safely handle sharp instruments when working with biohazards. It outlines safe work practices with disposable and reusable sharps.
Disinfection and Sterilization This module discusses the decontamination of items contaminated by biohazards after an experiment, prior to reuse, or before disposal. It provides information on methods of sterilization and disinfection, along with good decontamination work practices.
Safe Sharps Devices This module provides an overview of safe sharps devices and other engineering controls designed to minimize exposure to biohazards when handling sharp instruments. This module also supports training on a sharps safety program.
(continued)
CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 12
Centrifuge Precautions This module discusses risks involved in centrifugation along with the control devices and work practices that will help ensure the safe use of centrifuges.
Engineering Controls and Containment Devices This module describes a variety of engineering controls or the protective tools and devices used in the laboratory setting that help protect workers from exposure to biohazards.
Biosafety and Biosecurity (BSS) Introduction This module serves as an introduction to the BSS series.
Dual Use Research of Concern (DURC) This module provides a detailed training on the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern. It is based on the 2014 United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern, which is required for all National Institutes of Health (NIH) funded entities. It describes the agents and types of experiments that require oversight, individual and organizational responsibilities, and risk mitigation strategies.
CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 13
Biosafety Retraining This course provides a refresher for researchers handling biohazards and should be scheduled by the organization periodically to reinforce biocontainment practices to control biohazards.
Module Title
Recommended Use
ID (Language)
Risk Management: Work Practices Required 13898 (English)
Risk Management: Personal Protective Equipment Required 13458 (English)
Risk Management: Emergency and Spill Response Required 13459 (English)
Risk Management: Engineering Controls Required 13929 (English)
Risk Management: Laboratory Design Required 13484 (English)
Work Safely with Sharp Instruments Required 13899 (English)
Disinfection and Sterilization Required 13900 (English)
Safe Sharps Devices Required 13946 (English)
Centrifuge Precautions Required 13945 (English)
Engineering Controls and Containment Devices Required 13497 (English)
Biosafety and Biosecurity (BSS) Introduction Supplemental 13987 (English)
Dual Use Research of Concern (DURC) Supplemental 16263 (English)
Risk Management: Work Practices This module serves as initial training targeted at researchers handling or who will handle biohazards in a research or clinical laboratory. It addresses an awareness of biohazards, risk assessment, and key risk management work practice principles.
Risk Management: Personal Protective Equipment This module discusses U.S. Occupational Safety and Health Administration (OSHA) personal protective equipment (PPE) training requirements for researchers handling biohazards. A supplemental PPE Training Record Form and PPE Training and Use Table are available at the end of the module to facilitate the documentation of training.
(continued)
CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 14
Risk Management: Emergency and Spill Response This module provides biohazard emergency response training for employees who are designated as hazardous materials responders and address the biohazard component of their annual training.
Risk Management: Engineering Controls This module examines the engineering controls, devices, and barriers that can be utilized to protect researchers when handling biohazards in the laboratory. It describes the fundamental engineering controls utilized to safely handle biohazards and the concomitant work practices for their safe use.
Risk Management: Laboratory Design This module describes the safety features of laboratories designed to protect researchers at each of the first three Biosafety Levels (1, 2, and 3). It provides a comprehensive description of the safety factors associated with the design of a Biosafety Level 3 laboratory.
Work Safely with Sharp Instruments This module reviews how to safely handle sharp instruments when working with biohazards. It outlines safe work practices with disposable and reusable sharps.
Disinfection and Sterilization This module discusses the decontamination of items contaminated by biohazards after an experiment, prior to reuse, or before disposal. It provides information on methods of sterilization and disinfection, along with good decontamination work practices.
Safe Sharps Devices This module provides an overview of safe sharps devices and other engineering controls designed to minimize exposure to biohazards when handling sharp instruments. This module also supports training on a sharps safety program.
Centrifuge Precautions This module discusses risks involved in centrifugation along with the control devices and work practices that will help ensure the safe use of centrifuges.
Engineering Controls and Containment Devices This module describes a variety of engineering controls or the protective tools and devices used in the laboratory setting that help protect workers from exposure to biohazards.
Biosafety and Biosecurity (BSS) Introduction This module serves as an introduction to the BSS series.
Dual Use Research of Concern (DURC) This module provides a detailed training on the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern. It is based on the 2014 United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern, which is required for all National Institutes of Health (NIH) funded entities. It describes the agents and types of experiments that require oversight, individual and organizational responsibilities, and risk mitigation strategies.
CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 15
Animal Biosafety This course is designed for researchers and animal handlers working with small or conventional animals used in experiments involving biohazards. Module Title
Recommended Use
ID (Language)
Animal Biosafety Required 13654 (English)
Biosafety and Biosecurity (BSS) Introduction Supplemental 13987 (English)
Animal Biosafety This module is designed as initial training for researchers and animal handlers working with small or conventional animals used in biohazard experiments. It can also be used as periodic refresher training based on the schedule outlined by the host institution. Additional CITI Program content for persons involved in the conduct of research using animals can be found in the Animal Care and Use (ACU) series.
Biosafety and Biosecurity (BSS) Introduction This module serves as an introduction to the BSS series.
CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 16
Shipping and Transport of Regulated Biological Materials This course is designed as initial training and periodic retraining for employees who package or ship diagnostic and clinical human or animal specimens, human or animal pathogens, and other regulated biohazards. It is designed to meet requirements of the International Air Transport Association (IATA) and the U.S. Department of Transportation (DOT).
Module Title
Recommended Use
ID (Language)
Shipping Regulated Biological Materials: Overview Required 13486 (English)
Shipping Regulated Biological Materials: Classifications Required 13487 (English)
Shipping Regulated Biological Materials: Packaging Requirements Required 13488 (English)
Shipping Regulated Biological Materials: Shipping Papers Required 13655 (English)
Shipping Regulated Biological Materials: Permits for Restricted Shipments and Transfers Required 13656 (English)
Shipping Regulated Biological Materials: Security Awareness Required 13657 (English)
Shipping Regulated Biological Materials: Emergency Response Information Required 13658 (English)
Shipping Regulated Biological Materials: Refrigerants Required 13659 (English)
Shipping Regulated Biological Materials: Appendix Required 13660 (English)
Shipping Regulated Biological Materials: Overview This module provides an overview of the applicable regulations on the transportation of hazardous materials, which help to ensure the safety of the public and workers in the transportation chain. It is intended for those researchers and technicians who package and ship diagnostic or clinical human and animal specimens, human and animal pathogens, and related regulated biohazards.
Shipping Regulated Biological Materials: Classifications This module presents the different classes of dangerous goods and provides a description and examples of infectious substances, and exempt human or animal specimens. It also discusses medical transport exceptions.
(continued)
CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 17
Shipping Regulated Biological Materials: Packaging Requirements This module discusses the packaging criteria to ensure compliance with the major requirements of the U.S. Department of Transportation (DOT), International Air Transport Association (IATA), and the U.S. Postal Service.
Shipping Regulated Biological Materials: Shipping Papers This module discusses the Shipper’s Declaration for Dangerous Goods (Shipper’s Declaration) that is required when shipping infectious substances, toxic substances, or genetically modified microorganisms. It lists the various requirements for completing the Shipper’s Declaration Form.
Shipping Regulated Biological Materials: Permits for Restricted Shipments and Transfers This module discusses the need to obtain an import or export permit prior to the shipment of infectious substances and related biological substances, and/or materials that may contain infectious substances into or out of the country. It presents information on the agencies that regulate the import and export of these substances.
Shipping Regulated Biological Materials: Security Awareness This module discusses the need for general security awareness training for all employees handling hazardous materials in the transport chain.
Shipping Regulated Biological Materials: Emergency Response Information This module discusses the need for all employees involved in the hazardous materials transport chain to be aware of the initial emergency response procedures and whom to notify in the event of an incident.
Shipping Regulated Biological Materials: Refrigerants This module discusses safety factors, guidelines, and shipping requirements to take into consideration when dealing with refrigerants.
Shipping Regulated Biological Materials: Appendix This module provides several lists of regulated biological materials including an example list of Category A Infectious Substances, a list of select agents, and the U.S. Department of Commerce (DOC) Commerce Control List (CCL).
CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 18
OSHA Bloodborne Pathogens This course is intended for researchers who handle human blood, tissues, bodily fluids, or other potentially infectious materials. It is designed as initial training or annual retraining to meet the requirements of the U.S. Occupational Safety and Health Administration’s (OSHA) Bloodborne Pathogen Standard. To fulfill the OSHA Bloodborne Pathogen Standard, a learner must complete all of the modules within this section. This requirement includes module ID: 13902, 13903, 13904, 13913, and 13914.
OSHA Bloodborne Pathogens Standard This module is directed at researchers, employees, and students who handle or have contact with human blood, tissues, bodily fluids, or other potentially infectious materials. It is designed as initial bloodborne pathogens training to be provided at the start time of work with these materials. It can be used to fulfill annual retraining requirements from the U.S. Occupational Safety and Health Administration (OSHA), when selected in combination with the following modules: Hepatitis B Virus (HBV) Vaccination, Labels and Engineering Controls, Universal Precautions and Work Practices, and Emergency Response Procedures. Retraining must be completed within 365 days (1 year) of the previous training.
Hepatitis B Virus (HBV) Vaccination This module provides an introduction to the Hepatitis B vaccine and the requirements of offering occupationally exposed employees the vaccine. It provides information on routes of exposure to bloodborne pathogens and other biohazards, as well as routes of transmission for infectious agents in the laboratory.
Labels and Engineering Controls This module discusses the use of signs, labels, and color-coding, as well as engineering controls (mechanical barriers) used to prevent exposure to bloodborne pathogens in research and clinical laboratories.
Universal Precautions and Work Practices This module discusses the universal precautions concept where all blood and other potentially infectious materials are treated as if infectious for HIV, HBV, and HCV. This concept also extends to all sharps and patients. It reviews best practices, guidelines, and precautions to be used in a laboratory setting.
Emergency Response Procedures This module describes the recommended guidelines for dealing with an unplanned release of bloodborne pathogens and other potentially infectious materials in the laboratory or workplace.
Module Title
Recommended Use
ID (Language)
OSHA Bloodborne Pathogens Standard Required 13902 (English)
Hepatitis B Virus (HBV) Vaccination Required 13903 (English)
Labels and Engineering Controls Required 13904 (English)
Universal Precautions and Work Practices Required 13913 (English)
Emergency Response Procedures Required 13914 (English)
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Select Agents, Biosecurity, and Bioterrorism This course is intended for researchers who handle or have access to select agents, potential biowarfare agents or other potentially dangerous biological materials. It is designed to provide initial biosecurity awareness training, but must be augmented with site-specific biosecurity information as required by the select agent regulations. Module Title
Recommended Use
ID (Language)
Select Agents Required 13951 (English)
Biosecurity Required 13857 (English)
Bioterrorism Required 13524 (English)
Select Agents This module is designed for researchers who handle or have access to select agents. It is part of the “Select Agents, Biosecurity, and Bioterrorism” training, which provides initial and annual retraining options in select agents and laboratory biosecurity as required by U.S. select agent regulations.
Biosecurity This module is designed for researchers who handle or have access to potential biowarfare agents or other potentially valuable biological materials. It is part of the “Select Agents, Biosecurity, and Bioterrorism” training, which provides initial and annual retraining options in select agents and laboratory biosecurity as required by U.S. select agent regulations.
Bioterrorism This module is designed for researchers who handle or have access to potential biowarfare agents or other potentially valuable biological materials. It is part of the “Select Agents, Biosecurity, and Bioterrorism” training, which provides initial and annual retraining options in select agents and laboratory biosecurity as required by U.S. select agent regulations. It can also be used by emergency responders who deal with potential bioterrorism incidents.
CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 20
Emergency and Incident Response to Biohazard Spills and Releases This course provides biohazard emergency response training for employees who are designated as hazardous materials responders and address the biohazard component of their annual training. Module Title
Recommended Use
ID (Language)
Risk Management: Emergency and Spill Response Required 13459 (English)
Biosafety and Biosecurity (BSS) Introduction Supplemental 13987 (English)
Risk Management: Emergency and Spill Response This module provides biohazard emergency response training for employees who are designated as hazardous materials responders and address the biohazard component of their annual training.
Biosafety and Biosecurity (BSS) Introduction This module serves as an introduction to the BSS series.
CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 21
NIH Recombinant DNA Guidelines This course provides principal investigators and those responsible for the conduct of recombinant and synthetic nucleic acid research experiments with basic training and an overview of the requirements established by the National Institutes of Health (NIH).
Module Title
Recommended Use
ID (Language)
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules Required 13493 (English)
Biosafety and Biosecurity (BSS) Introduction Supplemental 13987 (English)
Dual Use Research of Concern (DURC) Supplemental 16263 (English)
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules This module provides principal investigators and others responsible for the conduct of recombinant and synthetic nucleic acid research experiments, and institutional biosafety committee (IBC) members who review these experiments, with training on the requirements of the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. It is designed as initial training but can also be used as periodic refresher training for principal investigators and IBC members as required by the NIH guidelines.
Biosafety and Biosecurity (BSS) Introduction This module serves as an introduction to the BSS series.
Dual Use Research of Concern (DURC) This module provides a detailed training on the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern. It is based on the 2014 United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern, which is required for all National Institutes of Health (NIH) funded entities. It describes the agents and types of experiments that require oversight, individual and organizational responsibilities, and risk mitigation strategies.
CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 22
Personal Protective Equipment This course discusses U.S. Occupational Safety and Health Administration (OSHA) personal protective equipment (PPE) training requirements for researchers handling biohazards. A supplemental PPE Training Record Form and PPE Training and Use Table are available at the end of the module to facilitate the documentation of training. Module Title
Recommended Use
ID (Language)
Risk Management: Personal Protective Equipment Required 13458 (English)
Biosafety and Biosecurity (BSS) Introduction Supplemental 13987 (English)
Risk Management: Personal Protective Equipment This module discusses U.S. Occupational Safety and Health Administration (OSHA) personal protective equipment (PPE) training requirements for researchers handling biohazards. A supplemental PPE Training Record Form and PPE Training and Use Table are available at the end of the module to facilitate the documentation of training.
Biosafety and Biosecurity (BSS) Introduction This module serves as an introduction to the BSS series.
CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 23
Human Gene Transfer This course is designed for principal investigators, clinicians, and institutional biosafety committee (IBC) members participating in the conduct or review of a human gene transfer clinical study. It reviews the National Institutes of Health (NIH) and IBC requirements for human gene transfer clinical trials. Module Title
Recommended Use
ID (Language)
Human Gene Transfer Research Required 13494 (English)
Biosafety and Biosecurity (BSS) Introduction Supplemental 13987 (English)
Human Gene Transfer Research This module is designed for principal investigators, clinicians, and institutional biosafety committee (IBC) members participating in the conduct or review of a human gene transfer clinical study. It reviews the National Institutes of Health (NIH) and IBC requirements for human gene transfer clinical trials.
Biosafety and Biosecurity (BSS) Introduction This module serves as an introduction to the BSS series.
Nanotechnology This course provides basic awareness and understanding of nanoparticles, and the unique safety issues associated with their handling. Module Title
Recommended Use
ID (Language)
Understanding Nanotechnology and Its Implications Required 14044 (English)
Understanding Nanotechnology and its Implications This module provides basic awareness and understanding of nanoparticles, and the unique safety issues associated with their handling.
CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 24
Institutional Biosafety Committee Member Training This course provides training for members of the organization’s institutional biosafety committee (IBC), with a focus in general biosafety and the requirements of the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.
Module Title
Recommended Use
ID (Language)
Biosafety Course Overview Required 13314 (English)
Laboratory-Acquired Infections Required 13454 (English)
Biohazard Risk Assessment Required 13455 (English)
Medical Surveillance Required 13456 (English)
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules Required 13493 (English)
Human Gene Transfer Research Required 13494 (English)
Dual Use Research of Concern (DURC) Required 16263 (English)
Biosafety and Biosecurity (BSS) Introduction Supplemental 13987 (English)
Biosafety Course Overview This module provides an introduction to biosafety and training for researchers handling Risk Group 1 agents or working only at Biosafety Level 1 containment.
Laboratory-Acquired Infections This module sets the foundation for the importance of biosafety by briefly reviewing seminal laboratory-acquired infections that have occurred in the research and clinical laboratory settings. A learner may explore supplemental cases for further study and increased awareness of how the breakdown of good microbiological practices can lead to infections and death (in rare cases).
Biohazard Risk Assessment This module outlines the steps involved in identifying risk factors for experiments or procedures involving biohazards. The three P’s of risk assessment (Pathogen, Procedures, and Personnel) are reviewed to provide a basic foundation in this important building block to biosafety.
Medical Surveillance This module reviews basic medical surveillance and occupational health program recommendations for laboratory or clinical researchers handling biohazards.
(continued)
CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 25
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules This module provides principal investigators and others responsible for the conduct of recombinant and synthetic nucleic acid research experiments, and institutional biosafety committee (IBC) members who review these experiments, with training on the requirements of the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. It is designed as initial training but can also be used as periodic refresher training for principal investigators and IBC members as required by the NIH guidelines.
Human Gene Transfer Research This module is designed for principal investigators, clinicians, and institutional biosafety committee (IBC) members participating in the conduct or review of a human gene transfer clinical study. It reviews the National Institutes of Health (NIH) and IBC requirements for human gene transfer clinical trials.
Dual Use Research of Concern (DURC) This module provides a detailed training on the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern. It is based on the 2014 United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern, which is required for all National Institutes of Health (NIH) funded entities. It describes the agents and types of experiments that require oversight, individual and organizational responsibilities, and risk mitigation strategies.
Biosafety and Biosecurity (BSS) Introduction This module serves as an introduction to the BSS series.
CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 26
Dual Use Research of Concern (DURC) This course is based on the U.S. Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (DURC). Module Title
Recommended Use
ID (Language)
Dual Use Research of Concern (DURC) Required 16263 (English)
Biosafety and Biosecurity (BSS) Introduction Supplemental 13987 (English)
Dual Use Research of Concern (DURC) This module provides a detailed training on the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern. It is based on the 2014 United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern, which is required for all National Institutes of Health (NIH) funded entities. It describes the agents and types of experiments that require oversight, individual and organizational responsibilities, and risk mitigation strategies.
Biosafety and Biosecurity (BSS) Introduction
This module serves as an introduction to the BSS series.
CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 27
USDA Permits This course covers the import, transit, and release of regulated: plants pests, plant pathogens, plants, and plant products; soils; and animal pathogens, animal products, and etiologic agents. Organizations may add these modules to a basic BSS course or setup a course specific to learners working with the particular permit(s). Module Title
Recommended Use
ID (Language)
USDA Permits: Plant Pest Required 17256 (English)
USDA Permits: Soils Required 17257 (English)
USDA Permits: Veterinary Services (VS) Required 17258 (English)
USDA Permits: Plant Pest This module introduces the United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service’s (APHIS) Plant Protection and Quarantine (PPQ) plant permits. It provides basic information about PPQ import and transport permits for plant pests, plant pathogens, plants, and plant products. It also discusses the requirements and best practices to apply for a PPQ permit, as well as what to expect during a PPQ inspection.
USDA Permits: Soils This module serves as an overview of the different U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service’s (APHIS) Plant Protection and Quarantine (PPQ) soil permits. It provides learners with basic information on when and why soil permits are required for research purposes, as well as who is required to have them.
USDA Permits: Veterinary Services (VS) This module introduces the United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service’s (APHIS) Veterinary Services (VS) permits. It provides basic knowledge about VS import and transport permits for animal pathogens, animal products, and etiologic agents. It also discusses the requirements to apply for a permit.
