BIOSAFETY AND BIOSECURITY (BSS) Series Catalog

Transcription

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 support@citiprogram.org or (888) CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 1

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 Research of Concern (DURC) 26 USDA Permits 27 CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 2

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. Biosafety and Biosecurity (BSS) Introduction (English) Biosafety Course Overview (English) Risk Management: Work Practices (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 3

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. Biosafety and Biosecurity (BSS) Introduction (English) Biosafety Course Overview (English) Laboratory-Acquired Infections (English) Biohazard Risk Assessment (English) Medical Surveillance (English) Risk Management: Work Practices (English) Risk Management: Personal Protective Equipment (English) Risk Management: Emergency and Spill Response (English) Risk Management: Engineering Controls (English) Risk Management: Laboratory Design (English) Work Safely with Sharp Instruments (English) Disinfection and Sterilization (English) Safe Sharps Devices (English) Centrifuge Precautions (English) Engineering Controls and Containment Devices (English) OSHA Bloodborne Pathogens Standard (English) Hepatitis B Virus (HBV) Vaccination (English) CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 4

5 Labels and Engineering Controls (English) Universal Precautions and Work Practices (English) Emergency Response Procedures (English) NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (English) Human Gene Transfer Research (English) Select Agents (English) Biosecurity (English) Bioterrorism (English) Overview (English) Classifications Packaging Requirements Shipping Papers Permits for Restricted Shipments and Transfers Security Awareness Emergency Response Information (English) (English) (English) (English) (English) (English) Refrigerants (English) Appendix (English) Animal Biosafety (English) Understanding Nanotechnology and Its Implications (English) Dual Research of Concern (DURC) (English) CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 5

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 laboratoryacquired 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 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 6

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 colorcoding, 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 7

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. 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. 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. 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 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. 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. Security Awareness This module discusses the need for general security awareness training for all employees handling hazardous materials in the transport chain. 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. 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 8

9 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 (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 Research of Concern (DURC) This module provides a detailed training on the United States Government Policy for Institutional Oversight of Life Sciences Dual Research of Concern. It is based on the 2014 United States Government Policy for Oversight of Life Sciences Dual 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 9

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. Biosafety Course Overview (English) Laboratory-Acquired Infections (English) Biohazard Risk Assessment (English) Medical Surveillance (English) Risk Management: Work Practices (English) Risk Management: Personal Protective Equipment (English) Risk Management: Emergency and Spill Response (English) Risk Management: Engineering Controls (English) Risk Management: Laboratory Design (English) Work Safely with Sharp Instruments (English) Disinfection and Sterilization (English) Safe Sharps Devices (English) Centrifuge Precautions (English) Engineering Controls and Containment Devices (English) Biosafety and Biosecurity (BSS) Introduction Supplemental (English) Dual Research of Concern (DURC) Supplemental (English) CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 10

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 laboratoryacquired 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 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 11

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 Research of Concern (DURC) This module provides a detailed training on the United States Government Policy for Institutional Oversight of Life Sciences Dual Research of Concern. It is based on the 2014 United States Government Policy for Oversight of Life Sciences Dual 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 12

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. Risk Management: Work Practices (English) Risk Management: Personal Protective Equipment (English) Risk Management: Emergency and Spill Response (English) Risk Management: Engineering Controls (English) Risk Management: Laboratory Design (English) Work Safely with Sharp Instruments (English) Disinfection and Sterilization (English) Safe Sharps Devices (English) Centrifuge Precautions (English) Engineering Controls and Containment Devices (English) Biosafety and Biosecurity (BSS) Introduction Supplemental (English) Dual Research of Concern (DURC) Supplemental (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 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 13

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 Research of Concern (DURC) This module provides a detailed training on the United States Government Policy for Institutional Oversight of Life Sciences Dual Research of Concern. It is based on the 2014 United States Government Policy for Oversight of Life Sciences Dual 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 14

15 Animal Biosafety This course is designed for researchers and animal handlers working with small or conventional animals used in experiments involving biohazards. Animal Biosafety (English) Biosafety and Biosecurity (BSS) Introduction Supplemental (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 (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 15

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). Overview (English) Classifications Packaging Requirements Shipping Papers Permits for Restricted Shipments and Transfers Security Awareness Emergency Response Information (English) (English) (English) (English) (English) (English) Refrigerants (English) Appendix (English) 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. 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 16

17 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 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. 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. Security Awareness This module discusses the need for general security awareness training for all employees handling hazardous materials in the transport chain. 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. Refrigerants This module discusses safety factors, guidelines, and shipping requirements to take into consideration when dealing with refrigerants. 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 17

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 OSHA Bloodborne Pathogens Standard (English) Hepatitis B Virus (HBV) Vaccination (English) Labels and Engineering Controls (English) Universal Precautions and Work Practices (English) Emergency Response Procedures (English) 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. CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 18

19 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. Select Agents (English) Biosecurity (English) Bioterrorism (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 19

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. Risk Management: Emergency and Spill Response (English) Biosafety and Biosecurity (BSS) Introduction Supplemental (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 20

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). NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (English) Biosafety and Biosecurity (BSS) Introduction Supplemental (English) Dual Research of Concern (DURC) Supplemental (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 Research of Concern (DURC) This module provides a detailed training on the United States Government Policy for Institutional Oversight of Life Sciences Dual Research of Concern. It is based on the 2014 United States Government Policy for Oversight of Life Sciences Dual 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 21

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 Table are available at the end of the module to facilitate the documentation of training. Risk Management: Personal Protective Equipment (English) Biosafety and Biosecurity (BSS) Introduction Supplemental (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 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 22

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. Human Gene Transfer Research (English) Biosafety and Biosecurity (BSS) Introduction Supplemental (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. Understanding Nanotechnology and Its Implications (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 23

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. Biosafety Course Overview (English) Laboratory-Acquired Infections (English) Biohazard Risk Assessment (English) Medical Surveillance (English) NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (English) Human Gene Transfer Research (English) Dual Research of Concern (DURC) (English) Biosafety and Biosecurity (BSS) Introduction Supplemental (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 laboratoryacquired 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 24

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 Research of Concern (DURC) This module provides a detailed training on the United States Government Policy for Institutional Oversight of Life Sciences Dual Research of Concern. It is based on the 2014 United States Government Policy for Oversight of Life Sciences Dual 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 25

26 Dual Research of Concern (DURC) This course is based on the U.S. Government Policy for Institutional Oversight of Life Sciences Dual Research of Concern (DURC). Dual Research of Concern (DURC) (English) Biosafety and Biosecurity (BSS) Introduction Supplemental (English) Dual Research of Concern (DURC) This module provides a detailed training on the United States Government Policy for Institutional Oversight of Life Sciences Dual Research of Concern. It is based on the 2014 United States Government Policy for Oversight of Life Sciences Dual 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. This module serves as an introduction to the BSS series. Biosafety and Biosecurity (BSS) Introduction CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 26

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). USDA Permits: Plant Pest (English) USDA Permits: Soils (English) USDA Permits: Veterinary Services (VS) (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: 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. 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. CITI Program: Biosafety and Biosecurity (Updated: January 2017) citiprogram.org 27