Site Map

Manuals

1.0 Introduction

Laboratories handling biohazardous agents are special, often unique, environments that may pose an infectious disease risk to persons in or near them.  Fewer than 20 percent of all cases of laboratory-acquired infections are associated with a known incident.  Exposure to infectious aerosols is a plausible, but usually unconfirmed, source of infection.  The knowledge, techniques and equipment needed to prevent most laboratory-acquired infections are readily available.  This publication was prepared as an aid to researchers to prevent the infection of laboratory workers and ancillary personnel.  It serves as the written Biological Safety Program for facilities at The University of Iowa.  All personnel engaged in the use of infectious or hazardous biological (biohazardous) agents must participate in this program. 

The goal of the University's Biological Safety Program is to protect staff, students and the environment from exposure to biohazardous agents, as well as the protection of experimental materials.  Prior to removal from the clinical or research laboratory area, biohazardous/infectious wastes must be properly packaged and labeled for subsequent decontamination and disposal.  The responsibility for identifying and disposing of biohazardous materials rests with the PI’s (principal investigators) or laboratory supervisors.  This responsibility cannot be shifted to inexperienced or untrained personnel. 

Principal investigators or laboratory supervisors should call the Biological Safety Section of EHS (Environmental Health & Safety Office) at 335-8501, if there is uncertainty about categorizing, handling, storing, treating, or discarding biologically derived material. 

 

10.0 Select Agents and Toxins

As required by the Public Health Security and Bioterrorism Act of 2002, the DHHS (Department of Health and Human Services) and USDA (United States Department of Agriculture) have set forth rules regarding the possession, use and transfer of select agents and toxins.  The biological agents and toxins subject to these rules have the potential to pose a severe threat to public health and safety, to animal health or to animal products.  These rules, defined as the Select Agent Program, are outlined in the CFR (Code of Federal Regulations), Title 42, part 73, Possession, Use and Transfer of Select Agents and Toxins.  The initial program took effect in 2002; the interim Final Rule has since been replaced with the Final Rule on March 18, 2005.  

In this section an overview of the Select Agent Program will be presented.  The Select Agent Program requires that any facilities, including government agencies, universities, research institutions and commercial entities, that possess, use or transfer select agents or toxins register with the CDC (Center for Disease Control and Prevention) or USDA (United States Department of Agriculture), depending on the agents involved.  For a more detailed description, please visit the CDC’s or USDA’s Select Agent Homepage where a full account of the Final Rule is published.

11.0 Shipping Regulations

IATA (International Air Transport Association) and DOT (Department of Transportation) regulate the shipping of infectious substances and diagnostic specimens.  Specific requirements regarding the classification of agents, package preparation, package marking/identification and shippers declaration have been established.  It is the shipper’s responsibility to be aware and to adhere to applicable laws, regulations and requirements.  

12.0 Safety Training

Departments must provide employees with information and training in order to ensure that they are apprised of biohazards in their work area.  Training may take the form of individual instruction, group seminars, audiovisual presentations, handout material or any combination of the above.  Training should include the specific hazards associated with agents in the work area when generic training is insufficient to address specific hazards. 

Training should be provided at the time of an employee's initial assignment to a work area where biohazardous agents are present and prior to assignment involving new exposure situations.  Employees should receive periodic refresher information and training.  All training must be documented (see below). 

Information and training provided by departments should include: 

  • the location and availability of the written Biological Safety Manual; 
  • the health hazards, signs and symptoms associated with exposures and infections from biohazardous agents used in the work area;
  • the measures employees can take to protect themselves from these hazards, including specific procedures the University or department has implemented such as appropriate work practices, emergency procedures and personal protective equipment; and
  • the location and availability of reference material on the hazards, safe handling, storage and disposal of biohazardous agents. 

Although students are not covered under IOSH (Iowa’s Occupational Safety and Health Administration), they should be aware of biohazards in teaching situations and be provided information and equipment to protect themselves from those hazards.  Departments should provide student training at the beginning of each course in which biohazardous agents are used, with specific safety instructions provided at the beginning of each class period. 

Departments are responsible for insuring that their employees and students receive the proper training as stipulated in the Biosafety Manual.  Online, web-based courses are currently available for all training courses through EHS’s Web site.  EHS provides training courses in the following areas:

  • Biological Safety
  • Chemical Safety
  • Ergonomics
  • General Safety
  • Hazardous Waste Management
  • Industrial Hygiene
  • Radiation Safety including Laser Safety

2.0 Abbreviations

Presented below is a listing of the abbreviations found throughout this manual.

ABSA

American Biological Safety Association

ABSL

Animal Biosafety Level

APHIS

Animal and Plant Health Inspection Service

ARO

Alternate Responsible Official

BBP

Bloodborne Pathogens

BMBL

Biosafety in Microbiological and Biomedical Laboratories

BSC

Biological Safety Cabinet (aka Tissue Culture Hood/Cabinet)

BSL

Biosafety Level

BSO

Biological Safety Officer

CDC

Centers for Disease Control and Prevention

CFR

Code of Federal Regulations

DHHS

Department of Health and Human Services

DNR  

Department of Natural Resources

DOT 

Department of Transportation

DPS   

Department of Public Safety (UI Police Department)

EHS  

Environmental Health & Safety Office

ETC 

Emergency Treatment Center

FBI 

Federal Bureau of Investigation

FM 

 Facilities Management

GMT 

Good Microbiological Techniques

HEPA

High Efficiency Particulate Air

HHMI

Howard Hughes Medical Institute

IACUC

Institutional Animal Care and Use Committee

IATA

International Air Transport Association

IBC 

Institutional Biosafety Committee

IRB

Institutional Review Board

IOSH

Iowa Occupational Safety and Health Administration

MSDS

Material Safety Data Sheet

NCI 

National Cancer Institute

NIH  

National Institutes of Health

NSF   

National Sanitation Foundation

OBA    

Office of Biotechnology Activities

OSHA  

Occupational Safety and Health Administration

OPIM

Other Potentially Infectious Materials

PI 

Principal Investigator

PPE   

Personal Protective Equipment

ppm  

parts per million

RAC  

Recombinant DNA Advisory Committee

rDNA  

Recombinant DNA

RG

Risk Group

RO   

Responsible Official

SOP

Standard Operating Procedure

UEHC

University Employee Health Clinic

UIHC   

University of Iowa Hospitals and Clinics

UIRIS   

University of Iowa Research Information System

USDA   

United States Department of Agriculture

USPS  

United States Postal Service

UV 

Ultra-violet

WHO  

World Health Organization

 

6.0 Biosafety Level Criteria

Four biosafety levels have been defined that consist of specified lab practices and techniques, safety equipment and lab facilities.  These are commensurate with the operations performed and with the hazard potential posed by the biohazardous agents with which the laboratory works. 

The reference for this section is the BMBL (Biosafety in Microbiological and Biomedical Laboratories), 5th Edition, 2007, U.S. Department of Health and Human Services.  Described below are Biosafety Levels 1 through 3.  Biosafety level 4, the maximum containment lab, described in the BMBL is not included in this manual, as facilities do not presently exist at the University that would accommodate the safety regulations involved with Level 4 work.   Table 4 presents a summary of the different biosafety level requirements.

7.0 Animal Biosafety Level Criteria

These guidelines describe three combinations of practices, safety equipment and facilities for experiments on animals infected with agents that produce or may produce human infection.  They provide increasing levels of protection to personnel and the environment and are recommended as minimal standards for activities involving infected laboratory mammals.  These three combinations are designated in each of the ABSL (Animal Biosafety Levels) 1 through 3 and describe animal facilities and practices applicable to work on animals infected with agents assigned to corresponding BSL1 through 3. 

The reference for this section is the BMBL, 5th Edition, 2007, U.S. Department of Health and Human Services.  See Appendix Q of the NIH Guidelines for additional requirements specific to large animals involved in research with rDNA.

8.0 Disinfection and Sterilization

Routine cleaning of the laboratory is required to maintain a sanitary, safe working environment.  Several different means of decontamination exist and the method you choose will depend on the type of experimental work and the nature of the infectious agent(s) present.  Of note, prions are highly resistant to inactivation by most physical and chemical agents; decontamination of prions will be addressed separately in this chapter.  Standard procedures should be established for each laboratory, designed to meet the needs of the various levels of biohazards found in your particular lab.

9.0 Research Involving Recombinant DNA

As a condition for NIH funding, all rDNA research conducted at or sponsored by the University, irrespective of the source of funding, must comply with the NIH Guidelines.  The NIH Guidelines defines rDNA as either (1) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell or (2) molecules that result from the replication of those described in (1) above.  Non-compliance by a PI may result in (1) suspension, limitation or termination of financial assistance for the noncompliant NIH-funded research project and of NIH funds for other rDNA research at the institution or (2) a requirement for prior NIH approval of any or all recombinant DNA projects at the University.  In order to assure compliance, all PIs working with rDNA need to be familiar with the latest edition of the NIH Guidelines; an online course, NIH Guidelines for Research Involving Recombinant DNA, offered through EHS, has been developed to assist PIs in meeting this obligation. 

Appendix A

CATEGORY A INFECTIOUS SUBSTANCES*

UN 2814: Infectious substance, affecting humans

Bacillus anthracis (cultures only)

Brucella abortus (cultures only)

Brucella melitensis (cultures only)

Brucella suis (cultures only)

Burkholderia mallei-Pseudomonas mallei - Glanders (cultures only)

Burkholderia pseudomallei-Pseudomonas pseudomallei (cultures only)

Chlamydia psittaci-avain strains (cultures only)

Clostridium botulinum (cultures only)

Coccidioides immitis (cultures only)

Coxiella burnetii (cultures only)

Crimean-Congo hemorrhagic fever virus

Dengue virus (cultures only)

Eastern equine encephalitis virus (cultures only)

Escherichia coli, verotoxigenic (cultures only)

Ebola virus

Flexal virus

Francisella tularensis (cultures only)

Guanarito virus

Hantaan virus

Hantaviruses causing haemorrhagic fever with renal syndrome

Hendra virus

Hepatitis B virus (cultures only)

Herpes B virus (cultures only)

Human immunodeficiency virus (cultures only)

Highly pathogenic avian influenza virus (cultures only)

Japanese Encephalitis virus (cultures only)

Junin virus

Kyasanur Forest disease virus

Lassa virus

Machupo virus

Marburg virus

Monkeypox virus

Mycobacterium tuberculosis (cultures only)

Nipah virus

Omsk hemorrhagic fever virus

Poliovirus (cultures only)

Rabies virus

Rickettsia prowazekii (cultures only)

Rickettsia rickettsii (cultures only) 

Rift Valley fever virus

Russian spring-summer encephalitis virus (cultures only)

Sabia virus

Shigella dysenteriae type 1 (cultures only)

Tick-borne encephalitis virus (cultures only)

Variola virus

Venequelan equine encephalitis virus (cultures only)

West Nile virus (cultures only)

Yellow fever virus (cultures only)

Yersinia pestis (cultures only)

UN 2900: Infectious substance, affecting animals

African swine fever virus (cultures only)

Avian paramyxovirus Type 1- Newcastle disease virus (cultures only)

Classical swine fever virus (cultures only)

Foot and mouth disease virus (cultures only)

Lumpy skin disease virus (cultures only)

Mycoplasma mycoides – Contagious bovine pleuropneumonia (cultures only)

Peste des petits ruminants virus (cultures only)

Rinderpest virus (cultures only)

Sheep-pox virus (cultures only)

Goatpox virus (cultures only)

Swine vesicular disease virus (cultures only)

Vesicular stomatitis virus (cultures only)

*This list is not exhaustive.

Appendix B

RESOURCES

Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5th Edition, February 2007, U.S. Department of Health and Human Services Center for Disease Control and Prevention and National Institutes of Health

Bloodborne Pathogens, 29 CFR 1910.1030

Centers for Disease Control and Prevention, Department of Health and Human Services

Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines), National Institutes of Health NIH Guidelines

Laboratory Biosafety Manual, 3rd Edition, 2004, World Health Organization

National Institutes of Health

Occupational Safety and Health Administration (OSHA), United States Department of Labor

Select Agent Program, Department of Health and Human Services, Centers for Disease Control and Prevention

Select Agent Program, United States Department of Agriculture, Animal and Plant Health Inspection Service