# Biological Safety

Biological Safety requirements are outlined in the Biological Safety Manual. The Biological Safety Manual is reviewed by the Institutional Biosafety Committee (IBC) periodically. Work with human cells and other human derived materials is safely conducted using the guidance provided in the Bloodborne Pathogens and Exposure Control Plan.   
  
The management of biological waste is also a part of biological safety. Some biological waste, such as sharps containers, is managed by using the Biological Waste Pickup Request. Waste that is managed in the lab (by autoclaving or bleaching) may need to be recorded on a log. The Biological Safety Manual gives more details and training is available to explain the different types of biological waste.

# Biological Safety Manual

The purpose of this manual is to provide guidance for personnel on how to perform work with biological   
materials safely. All research and teaching laboratories that use biological materials are expected to be   
in compliance with this manual in the areas where it applies. Where the guidance provided in this   
manual is not used, written documentation should be given showing that the procedure or arrangement   
used in lieu of the guidance given in this manual will provide a situation that is either as safe or safer   
than the guidance given in this manual.   
  
The primary sources for the regulations and guidelines that apply to biological safety are the US Center   
for Disease Control’s (CDC) Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition   
and the National Institute of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic   
Nucleic Acid Molecules. There is also limited application of both the United States Department of   
Agriculture (USDA) and the Food and Drug Administration (FDA) regulations. These authorities are cited   
where appropriate.   
  
Arkansas State University is required by NIH guidelines to have an Institutional Biosafety Committee   
(IBC). The IBC is composed of faculty and staff from various departments at the university. The IBC   
oversees all research projects that involve recombinant DNA and all research projects where pathogenic   
microorganisms are used. The IBC has also reviewed and approved this manual; any changes to the   
manual are made available to the IBC for review prior to their implementation.

# Contents

Chapter 1 Guidance, Regulations and Roles of Key Personnel   
1.1 Introduction  
1.2 Guidance  
1.3 Regulations  
1.4 Roles of Key Personnel  
1.4.1 Institutional Biosafety Committee (IBC)  
1.4.2 Biological Safety Officer  
1.4.3 Principal Investigator   
Chapter 2 Biological Risk Assessment  
2.1 Introduction  
2.2 Hazardous Characteristics of Agents   
2.2.1 Principal Hazardous Characteristics  
2.2.2 Risk Groups   
2.2.3 Resources   
2.3 Risk Assessment for Human Cell Lines and Human-Derived Materials   
2.4 Risk Assessment for Other Agents   
Chapter 3- Principles of Biosafety   
3.1 Introduction  
3.2 Engineering Controls   
3.3 Personal Protective Equipment   
3.4 Facility Construction and Design   
Chapter 4- Laboratory Biosafety Level Criteria   
4.1 Introduction   
4.2 Biosafety Level 1   
4.3 Biosafety Level 2   
4.4 Biosafety Level 3   
4.5 Biosafety Level 4   
4.6 Multi-User Research Labs   
Chapter 5- Vertebrate Animal Biosafety Level Criteria for Vivarium Research Facilities  
Chapter 6- Select Agents/ Toxins and Principles of Laboratory Biosecurity   
Chapter 7- Medical Surveillance   
Chapter 8 Emergencies and Reporting   
8.1 Spills   
8.1.1 General   
8.1.2 Spills outside of a containment device   
8.1.3 Spills inside of a Biological Safety Cabinet (BSC)   
8.1.4 Spills in a centrifuge   
8.1.5 Biological/Radioactive emergencies/spills  
8.2 Exposure to Biohazardous Agents or Material   
8.3 Security incidents   
Chapter 9 Biohazardous Waste Management  
9.1 Scope   
9.2 Biohazardous Waste Definition   
9.3 Responsibilities  
9.3.1 Principal Investigator or Faculty in Charge of Lab  
9.3.2 Biological Safety Officer (BSO)   
9.3.3 Environmental Health and Safety (EHS)   
9.4 Disinfection   
9.5 Treatment, Storage and Disposal   
9.5.1 General Storage and Disposal Methods for Different Types of Waste   
9.5.2 Chemical Treatment Standards   
9.5.3 Autoclave Standards   
9.5.4 Logging   
Appendix A Biological Safety Cabinets   
Appendix B Shipping of Biohazardous Materials   
Appendix C Transport of Biohazardous Material   
Appendix D Use of Human, Non-human Primate and other Mammalian Cells and Tissues   
Appendix E Guidelines for Work with Toxins of Biological Origin  
Appendix F NIH Oversight of Research Involving Recombinant DNA   
Appendix G Recombinant DNA Experiments Involving Plants   
Appendix H Autoclaves

# Chapter 1 Guidance, Regulations and Roles of Key Personnel

1.1 Introduction

This Biosafety Manual (BSM) provides a review of pertinent federal guidance and regulations, state   
regulations, information about safe work practices, safety equipment and personal protective   
equipment, and specific guidance for research with recombinant DNA (rDNA). Arkansas State’s Biological   
Safety Program is based on the premise that every member of the research community shares the   
responsibility for safety.

1.2 Guidance

US Center for Disease Control’s (CDC) Biosafety in Microbiological and Biomedical Laboratories (BMBL)   
5th Edition is the key guidance document for Biosafety. Although BMBL5 only recommends practices   
(“We wish to emphasize that the 5th edition of the BMBL remains an advisory document recommending   
best practices for the safe conduct of work in biomedical and clinical laboratories from a biosafety   
perspective, and is not intended as a regulatory document though we recognize that it will be used that   
way by some.” BMBL5 Forward), unless otherwise specifically stated herein, compliance with all BMBL5   
recommendations is mandatory for all laboratory biological activities (research, teaching, public   
service).

[Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition | CDC Laboratories](https://www.cdc.gov/labs/bmbl/index.html)

NIH Guidelines is also a key guidance document for this manual. Whereas BMBL5 recommends   
practices, NIH Guidelines specifies practices; “The purpose of the NIH Guidelines is to specify   
practices….” (NIH Guidelines Section I-A. Purpose). Although these NIH Guidelines closely follow the   
recommendations of BMBL6, in some cases the guidelines are more restrictive. In certain cases, this   
manual will adopt the more restrictive practices of the Guidelines, regardless of whether rDNA is   
involved. The advent of multi-PI labs precludes separate consideration of BMBL6 and the Guidelines. In   
such cases, the specific guideline will be referenced and explained.

[NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)](https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.pdf)

1.3 Regulations

Ark. Code Ann. § 20-7-109 and Ark. Code Ann. §§ 20-32-101 - 112 Rules and Regulations Pertaining to   
the Management of Medical Waste from Generators and Health Care Related Facilities governs   
management of biological waste.

  
[Medical\_Waste\_Regs\_2016\_FINAL.pdf](https://healthy.arkansas.gov/wp-content/uploads/Medical_Waste_Regs_2016_FINAL.pdf)

US Department of Transportation’s 49CFR Subchapter C Hazardous Materials Regulations governs   
shipment of infectious (biohazardous) materials.

[eCFR :: 49 CFR Chapter I Subchapter C -- Hazardous Materials Regulations](https://www.ecfr.gov/current/title-49/subtitle-B/chapter-I/subchapter-C)

1.4 Roles of Key Personnel

1.4.1 Institutional Biosafety Committee (IBC)

- Review, approve and oversee rDNA research to ensure compliance with the NIH Guidelines.
- Determines necessity of health surveillance of personnel
- Set biosafety containment levels as required by the Guidelines
- Ensure proper training for IBC members, staff, PIs, and laboratory staff and
- Report any significant problems, violations or significant research-related accidents or illnesses to NIH within 30 days. See Appendix F.
- Provide expert advice to the BSO in helping ensure safe research with hazardous biological materials

1.4.2 Biological Safety Officer

The Biological Safety Officer (BSO) should:

- Conduct lab inspections
- Develop emergency and reporting procedures
- Investigate lab accidents
- Report recombinant DNA incidents, violations of the Guidelines to the IBC
- Provide general biosafety training and
- Serve on the IBC as a voting member
- Ensure safe research with all hazardous biological materials

1.4.3 Principal Investigator

The Principal Investigator (PI) should:

- Be proficient in good microbiological techniques
- Supervise staff to ensure safety practices are followed
- Develop lab-specific SOPs for spills, exposures and/or loss of containment
- Report research-related accidents and illnesses
- Correct unsafe work practices
- Ensure biological containment is maintained and
- Instruct laboratory staff on: 
    - The risk of agents used in the lab
    - Safe work practices
    - Emergency procedures for spills and exposures
    - The reasons for vaccinations and serum collection, when applicable The PI must ensure   
        that: proper biosafety, biological waste, and shipping/ transport procedures are   
        followed by staff; lab-specific SOPs are developed and followed for spills, exposure, loss   
        of containment, and reporting research-related accidents and illnesses; biological   
        containment is maintained; unsafe work errors are corrected.

# Chapter 2 Biological Risk Assessment

2.1 Introduction

Risk assessment is a process used to identify the hazardous characteristics of a known infectious or potentially infectious agent or material, the activities that can result in a person’s exposure to an agent, the likelihood that such exposure will cause a laboratory acquired infection (LAI), and the probable consequences of such an infection. The information identified by risk assessment will provide a guide for the selection of appropriate biosafety levels and microbiological practices, safety equipment, and facility   
safeguards that can prevent LAIs. The primary factors to consider in risk assessment and selection of precautions fall into two broad categories: agent hazards and laboratory procedure hazards. The agent summary statements contained in BMBL6 identify the primary agent and procedure hazards for specific pathogens and recommend precautions for their control. A review of the summary statement for a specific pathogen is the starting point for assessment of the risks of working with that agent and those   
for a similar agent.

[Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition | CDC Laboratories](https://www.cdc.gov/labs/bmbl/index.html)

2.2 Hazardous Characteristics of Agents

2.2.1 Principal Hazardous Characteristics

The principal hazardous characteristics of an agent are:

- Its capability to infect and cause disease in a susceptible human or animal host,
- Its virulence as measured by the severity of disease, and
- The availability of preventive measures and effective treatments for the disease

2.2.2 Risk Groups

The NIH Guidelines assigns human etiological agents into four risk groups on the basis of hazard. Agents are classified into four Risk Groups (RGs) according to their relative pathogenicity for healthy adult humans by the following criteria:

- Risk Group 1 (RG1) agents are not associated with disease in healthy adult humans.
- Risk Group 2 (RG2) agents are associated with human disease which is rarely serious and for which   
    preventive or therapeutic interventions are often available.
- Risk Group 3 (RG3) agents are associated with serious or lethal human disease for which preventive or   
    therapeutic interventions may be available.
- Risk Group 4 (RG4) agents are likely to cause serious or lethal human disease for which preventive or   
    therapeutic interventions are not usually available.

2.2.3 Resources

- NIH Risk groups: [NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)](https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.pdf)
- NIH guidance for lentiviral vectors: [Major RAC concerns](https://osp.od.nih.gov/wp-content/uploads/Lenti_Containment_Guidance.pdf)
- ABSA risk database: [Riskgroups | my.ABSA.org - For the Biosafety and Biosecurity Professional](https://my.absa.org/tiki-index.php?page=Riskgroups&default%5Bcontent%5D=ascaris)
- The Public Health Agency of Canada Pathogen Safety Data Sheets database: [Pathogen Safety Data Sheets - Canada.ca](https://www.canada.ca/en/public-health/services/laboratory-biosafety-biosecurity/pathogen-safety-data-sheets-risk-assessment.html)

2.4 Risk Assessment of Other Agents

The end product of risk assessment is the assignment of an appropriate biosafety level (BSL) for an experiment. BSLs will be discussed in detail in Chapter 4. The initial risk assessment from the preceding resources should be followed by a thorough consideration of how the agent is to be manipulated. Agent factors to be considered in determining the BSL include:

- Virulence,
- Pathogenicity,
- Infectious dose,
- Environmental stability
- Route of transmission
- Communicability, operations, quantity,
- Availability of vaccine or treatment
- Gene product effects such as:
- Toxicity
- Physiological activity and
- Allergenicity

Any strain that is known to be more hazardous than the parent (wild-type) strain should be considered for handling at a higher BSL. Certain attenuated strains or strains that have been demonstrated to have irreversibly lost known virulence factors may qualify for a reduction of the containment level compared to the RG assigned to the parent strain.

# Chapter 3 - Principles of Biosafety

3.1 Introduction   
A fundamental objective of any biosafety program is the containment of potentially harmful   
biological agents. The term “containment” is used in describing safe methods, facilities and   
equipment for managing infectious materials in the laboratory environment where they are being   
handled or maintained. The purpose of containment is to reduce or eliminate exposure of   
laboratory workers, other persons, and the outside environment to potentially hazardous agents.   
The most important element of containment is strict adherence to standard microbiological   
practices and techniques. Knowledge of standard microbiological practices and techniques is gained   
through a combination of training and experience.

3.2 Engineering Controls   
Engineering controls eliminate or reduce the exposure of individuals to hazards in the laboratory   
through the use of specialized equipment. In most cases, engineering controls will be the primary barrier   
between hazardous materials and the individual. Engineering controls include:   
 Biological safety cabinets (BSCs) (discussed in Appendix A)  
 Other enclosures  
 Safety centrifuge cups  
 Retractable needles  
3.3 Personal Protective Equipment   
Personal protective equipment (PPE) is equipment that the individual wears to protect them from   
exposure to hazards in the laboratory. PPE is generally intended to be a secondary barrier meaning that   
it is to be used in conjunction with engineering controls to protect the user. PPE may be used a primarybarrier when engineering controls are not possible or feasible.PPE worn should be based on the hazard   
present and can include:  
 Gloves  
 Safety glasses or splash goggles  
 Lab coat  
 Gown  
 Shoe covers  
 Boots  
 Respirator (includes dust masks)  
 Face shield  
3.4 Facility Construction and Design   
The design and construction of the facility provides a secondary barrier to protect persons outside the   
laboratory. PI’s are responsible for providing facilities commensurate with the laboratory’s function and   
the recommended biosafety level for the agents being manipulated. The recommended secondary   
barrier(s) will depend upon the risk of transmission of specific agents. For example, the exposure risks   
for most laboratory work in BSL-1 and BSL-2 facilities will be direct contact with the agents, or   
inadvertent contact exposures through contaminated work environments. Secondary barriers in these   
laboratories may include separation of the laboratory work area from public access, availability of a   
decontamination facility (e.g., autoclave) and hand washing facilities.

# Chapter 4 - Laboratory Biosafety Level Criteria

4.1 Introduction   
Four biosafety levels (BSLs) are described in BMBL5; each consists of a combination of laboratory   
practices and techniques, safety equipment, and laboratory facilities. Each combination is specifically   
appropriate for the operations being performed, the documented or suspected routes of transmission of   
the infectious agents, and the laboratory function or activity.   
The BSLs described in BMBL5 should be differentiated from Risk Groups, as described in the NIH   
Guidelines and the World Health Organization Laboratory Biosafety Manual. Risk groups are the result   
of a classification of microbiological agents based on their association with, and resulting severity of,   
disease in humans. The risk group of an agent should be one factor considered in association with mode   
of transmission, procedural protocols, experience of staff, and other factors in determining the BSL in   
which the work will be conducted.   
The recommended biosafety level(s) for the organisms in BMBL5 Section VIII (Agent Summary   
Statements) represent those conditions under which the agent ordinarily can be safely handled. Not all   
of the organisms capable of causing disease are included in Section VIII; the other resources listed in   
Chapter 2 of this manual must be utilized to perform risk assessments for agents not listed in SectionVIII. Generally, work with known agents should be conducted at the biosafety level recommended in   
Section VIII.   
When information is available to suggest that virulence, pathogenicity, antibiotic resistance patterns,   
vaccine and treatment availability, or other factors are significantly altered, more (or less) stringent   
practices may be specified. Often an increased volume or a high concentration of agent may require   
additional containment practices.  
4.2 Biosafety Level 1   
Biosafety level 1 practices, safety equipment, and facility design and construction are appropriate for   
undergraduate training and teaching laboratories, and for other laboratories in which work is done with   
defined and characterized strains of viable microorganisms not known to consistently cause disease in   
healthy adult humans.   
Bacillus subtilis, Nigeria gruberi, infectious canine hepatitis virus, and exempt organisms under the NIH   
Guidelines are representative of microorganisms meeting these criteria. Many agents not ordinarily   
associated with disease processes in humans are, however, opportunistic pathogens and may cause   
infection in the young, the aged, and immunodeficient or immunosuppressed individuals. Vaccine   
strains that have undergone multiple in vivo passages should not be considered avirulent simply   
because they are vaccine strains.   
BSL-1 represents a basic level of containment that relies on standard microbiological practices with no   
special primary or secondary barriers recommended, other than a sink for hand washing.  
4.3 Biosafety Level 2   
Biosafety level 2 practices, equipment, and facility design and construction are applicable to clinical,   
diagnostic, teaching, and other laboratories in which work is done with the broad spectrum of   
indigenous moderate-risk agents that are present in the community and associated with human disease   
of varying severity. With good microbiological techniques, these agents can be used safely in activities   
conducted on the open bench, provided the potential for producing splashes or aerosols is low.   
Hepatitis B virus, HIV, Salmonella, and Toxoplasma are representative of microorganisms assigned to   
this containment level. BSL-2 is appropriate when work is done with any human-derived blood, body   
fluids, tissues, or primary human cell lines where the presence of an infectious agent may be unknown.   
(Laboratory personnel working with human- derived materials should refer to the OSHA Bloodborne   
Pathogen Standard for specific required precautions).   
Primary hazards to personnel working with these agents relate to accidental percutaneous or mucous   
membrane exposures, or ingestion of infectious materials. Extreme caution should be taken with   
contaminated needles or sharp instruments. Even though organisms routinely manipulated at BSL-2 are   
not known to be transmissible by the aerosol route, procedures with aerosol or high splash potential   
that may increase the risk of such personnel exposure must be conducted in primary containment   
equipment, or in devices such as a BSC or safety centrifuge cups.

Personal protective equipment should be used as appropriate, such as splash shields, face protection,   
gowns, and gloves. Secondary barriers, such as hand washing sinks and waste decontamination facilities,   
must be available to reduce potential environmental contamination.  
4.4 Biosafety Level 3   
Biosafety level 3 practices, safety equipment, and facility design and construction are applicable to   
clinical, diagnostic, teaching, research, or production facilities in which work is done with indigenous or   
exotic agents with a potential for respiratory transmission, and which may cause serious and potentially   
lethal infection.  
Mycobacterium tuberculosis, St. Louis encephalitis virus, and Coxiella burnetii are representative of the   
microorganisms assigned to this level. Primary hazards to personnel working with these agents relate   
to autoinoculation, ingestion, and exposure to infectious aerosols.   
At BSL-3, more emphasis is placed on primary and secondary barriers to protect personnel in contiguous   
areas, the community, and the environment from exposure to potentially infectious aerosols. For   
example, all laboratory manipulations should be performed in a BSC or other enclosed equipment, such   
as a gas-tight aerosol generation chamber. Secondary barriers for this level include controlled access to   
the laboratory and ventilation requirements that minimize the release of infectious aerosols from the   
laboratory.   
There are currently no BSL-3 activities occurring at Arkansas State University.  
4.5 Biosafety Level 4   
Biosafety level 4 is beyond the scope of this manual. There are currently no BSL-4 activities occurring at   
Arkansas State University.  
4.6 Multi-User Research Labs   
The advent of large open labs and lab suites creates problems for separation of BSL1 and BSL2 areas and   
activities. The following NIH Guidelines, which shall apply to all biological activities at Arkansas State,   
make a multi-PI lab problematic.  
For BSL1, Access to the laboratory is limited or restricted at the discretion of the Principal Investigator   
when experiments are in progress \[Appendix G-II-A-1-a\]. For BSL2, Access to the laboratory is limited or   
restricted by the Principal Investigator when experiments are in progress \[Appendix G-II-B-1-a\]. For   
BSL2, Experiments of lesser biohazard potential can be conducted concurrently in carefully demarcated   
areas of the same laboratory \[Appendix G-II-B-1-h\].  
Any research group working with agents that are known or potential biohazards shall have an   
emergency plan that describes the procedures to be followed if an accident contaminates personnel or   
the environment. The Principal Investigator shall ensure that everyone in the laboratory is familiar with   
both the potential hazards of the work and the emergency plan” \[Appendix G-I. Standard Practices and   
Training\].  
The Principal Investigator establishes policies and procedures whereby only persons who have been   
advised of the potential hazard and meet any specific entry requirements (e.g., immunization) may enter the laboratory or animal rooms \[Appendix G-II-B-2-c\].  
For BSL2, Laboratory coats, gowns, smocks, or uniforms are worn while in the laboratory. Before exiting   
the laboratory for non-laboratory areas (e.g., cafeteria, library, administrative offices), this protective   
clothing is removed and left in the laboratory or covered with a clean coat not used in the laboratory   
\[Appendix G-II-B-2f\].  
The BSO shall work with the occupants of each multi-PI lab to determine the most effective way of   
complying with the cited Guidelines for each lab. The default solution is to designate the entire lab BSL2,   
with clearly demarcated BSL1 section(s) as required. Note that BSL2 waste must be kept in the BSL2 area   
until decontaminated. Also, all Risk Group 2 agents must remain secure (under the control of the   
researcher using the agent only). The highlighted training requirement above will be met by maintaining   
a notebook containing a Pathogen Safety Data Sheet (PSDS) for each RG2 agent in use.

# Chapter 5 - Vertebrate Animal Biosafety Level Criteria for Vivarium Research Facilities

BMBL5 provides guidance for the use of experimentally infected animals housed in indoor research   
facilities (e.g., vivaria), and is also useful in the maintenance of laboratory animals that may naturally   
harbor zoonotic infectious agents. Laboratory animal facilities are a special type of laboratory. As a   
general principle, the biosafety level (facilities, practices, and operational requirements) recommended   
for working with infectious agents in vivo and in vitro are comparable.  
The animal room can present unique problems. In the animal room, the activities of the animals   
themselves can present unique hazards not found in standard microbiological laboratories. Animals may   
generate aerosols, they may bite and scratch, and they may be infected with a zoonotic agent. The coapplication of Biosafety Levels and the Animal Biosafety Levels are determined by a protocol-driven risk   
assessment.  
Facilities for laboratory animals used in studies of infectious or non-infectious disease should be   
physically separate from other activities such as animal production and quarantine, clinical laboratories,   
and especially from facilities providing patient care. Traffic flow that will minimize the risk of cross   
contamination should be incorporated into the facility design.  
The recommendations detailed in BMBL5 Section V describe four combinations of practices, safety   
equipment, and facilities for experiments with animals involved in infectious disease research and other   
studies that may require containment. These four combinations, designated Animal Biosafety Levels   
(ABSL) 1-4, provide increasing levels of protection to personnel and to the environment, and are   
recommended as minimal standards for activities involving infected laboratory animals. The four ABSLs   
describe animal facilities and practices applicable to work with animals infected with agents assigned to   
Biosafety Levels 1-4, respectively. Investigators that are inexperienced in conducting these types of   
experiments should seek help in designing their experiments from individuals who are experienced in   
this special work.  
In addition to the animal biosafety levels described in Section V, the USDA has developed facility   
parameters and work practices for handling agents of agricultural significance. Appendix D of BMBL5   
includes a discussion on Animal Biosafety Level 3 Agriculture (BSL-3-Ag). USDA requirements are unique   
to agriculture because of the necessity to protect the environment from pathogens of economic or environmental impact. Appendix D also describes some of the enhancements beyond BSL/ABSL-3 that   
may be required by USDA-APHIS when working in the laboratory or vivarium with certain veterinary   
agents of concern.   
Care of research animals is the responsibility of the [Institutional Animal Care and Use Committee](https://kb.astate.edu/books/research-compliance/page/institutional-animal-care-use-iacuc).

# Chapter 6 - Select Agents/toxins and Principles of laboratory Biosecurity

Select Agents are federally regulated agents that have potential use in biological warfare. Health and   
Human Services (HHS) regulates select agents targeting humans, the United States Department of   
Agriculture (USDA) regulates select agents targeting animals, and the USDA Plant Protection and   
Quarantine (PPQ) regulates select agents targeting plants. Before possessing, using, sending, or   
receiving select agents, the institution and Principal Investigator must register with CDC, APHIS, and/or   
USDA to receive official authorization for each individual requesting access to select agents.   
Requirements include background checks on those authorized to access select agents, security plans and   
inventories. Immediately notify EHS if you discover select agents in your laboratory that have not been   
registered. View the Select Agent/Toxin List here:   
https://www.selectagents.gov/SelectAgentsandToxinsList.html. Anyone desiring to work with these   
materials must have security clearance to do so and have special security procedures in place for their   
labs. Investigators wishing to work with any of these agents MUST contact Melissa Dooley, the EHS   
Director, prior to doing so, and all security clearances and procedures must be in place prior to   
requesting the Select Agents (note that requests for Select Agents MUST be placed by the Responsible   
Official). Contact Melissa Dooley Phone: 870-972-3644 E-mail: mdooley@astate.edu for assistance   
with Select Agent requirements.  
The term “biosecurity” has multiple definitions. In the animal industry, the term biosecurity relates to   
the protection of an animal colony from microbial contamination. In some countries, the term   
biosecurity is used in place of the term biosafety. For the purposes of this section the term “biosecurity”   
will refer to the protection of microbial agents from loss, theft, diversion or intentional misuse. This is   
consistent with current WHO and American Biological Safety Association (ABSA) usage of this term.  
Biosafety and biosecurity programs share common components. Both are based upon risk assessment   
and management methodology; personnel expertise and responsibility; control and accountability for   
research materials including microorganisms and culture stocks; access control elements; material   
transfer documentation; training; emergency planning; and program management. Biosafety and   
biosecurity program risk assessments are performed to determine the appropriate levels of controls   
within each program. Biosafety looks at appropriate laboratory procedures and practices necessary to   
prevent exposures and occupationally-acquired infections, while biosecurity addresses procedures and   
practices to ensure that biological materials and relevant sensitive information remain secure.

# Chapter 7 - Medical Surveillance

According to the BMBL, “Laboratory personnel must be provided medical surveillance, as appropriate,   
and offered immunization for agents handled or potential present in the laboratory.” Medical surveillance and vaccinations should be considered when infectious agents are present in the lab at the   
recommendation of the IBC. Work with human cells requires offer of vaccination to lab workers. For   
more details, consult the Arkansas State University Exposure Control Plan.

# Chapter 8 - Emergencies and Reporting

8.1 Spills   
8.1.1 General   
In general, most spills can be effectively handled by researchers and a spill kit should be available in any   
laboratory area where biohazardous materials are used or stored. The following are recommended   
procedures for evaluating and handling a spill:  
 An appropriate disinfectant that works against the BSL-2 agents of concern must be used.  
 Allow sufficient contact time for the disinfectant to work. Follow manufacturer’s directions.  
 Procedures vary with location depending upon if inside or outside of a containment device.  
 Cleaning spills requires personal protective equipment (PPE) including a lab coat or gown, and   
gloves. A face shield, shoe covers or a respirator may be required.  
 All spills must be reported to the Laboratory Supervisor and/or Principal Investigator. Contact   
the Biosafety Safety Officer (mdooley@astate.edu) for any questions about spill cleanup   
procedures.  
8.1.2 Spills outside of a containment device   
If the spill is not inside of a Biological Safety Cabinet (BSC), Centrifuge, Refrigerator, Incubator, Freezer,   
Lab instrument etc. follow this procedure:  
 Close off spill area to traffic, and notify coworkers.  
 If the spill may involve an aerosol, (e.g. event involving dropping material onto floor, high   
mechanical force, a forceful expulsion of liquid) leave the room for 30 minutes to allow aerosols   
to settle.  
 Remove contaminated lab coat or clothing and wash exposed skin and put on clean gloves and   
lab coat.  
 Prepare enough volume of a 1:9 dilution of chlorine bleach or other approved disinfectant to   
saturate the contaminated area. If dilution is not possible, undiluted household bleach can be   
used. However, eye protection must be worn and care taken not to splash the bleach onto skin   
or clothing.  
 Contain the spill with paper towels or other absorbent material e.g. "bench kote", blue "diaper   
pads"  
 Flood the spill area with disinfectant. Leave on for 10 minutes.  
 Push the absorbent material at the edge of the spill into the spill's center. Add more paper   
towels as needed. If glass is present, do not use bare hands! Use tongs (large pieces) forceps(small pieces) followed by a dustpan to remove pieces. Place the paper towels and gloves in a   
Zip-lock bag and discard bag in biohazard box (see Chapter 9). If contact with bleach occurs with   
skin, mucous membranes or eyes, flush area with copious amounts of water.  
 Wash hands thoroughly. Autoclave an overtly contaminated lab coat to prior to placing into   
laboratory laundry bag.  
 Report incident to supervisor and Principal Investigator.  
8.1.3 Spills inside of a Biological Safety Cabinet (BSC)   
If the spill is inside a biological safety cabinet, follow the following procedure:  
 Leave BSC on.  
 Put on gloves and lab coat and gather paper towels for cleaning.  
 Prepare a fresh dilution of 1:9 bleach or approved disinfectant. Prepare enough solution to   
cover the entire contaminated area. Always follow manufacturer’s directions. Do not use 70%   
ethanol as it evaporates too quickly to allow adequate surface contact time.  
 Flood the area with disinfectant solution and allow to remain in contact for required time:  
 10% Bleach for 10 minutes; or, Cavicide (full strength) for 3 minutes; or, Beaucoup (diluted   
according to manufacturer’s directions) for 10 minutes.  
 Spray and or wipe down the cabinet interior and any items inside the BSC with a towel   
dampened with disinfectant.  
 Place the paper towels and gloves in a Zip-lock bag and discard bag in biohazard box (see   
Chapter 9).   
 Spills large enough to result in liquids flowing through the front or rear grilles require more   
extensive decontamination; consult BSO immediately at (mdooley@astate.edu), for guidance. If   
a spill such as this has occurred, do not turn the BSC off.   
 Report incident to supervisor and Principal Investigator.  
8.1.4 Spills in a centrifuge   
Biohazardous spills in centrifuges can be quite difficult to disinfect. Some but not all centrifuges have   
closed rotors, buckets or other carriers with leak proof lids, designed to contain spills and allow efficient,   
safe emptying and decontamination. However, not all centrifuges are equipped with these containment   
devices. A spill resulting from primary container breakage requires immediate suspension of use, PI   
notification and assistance from the Biological Safety Officer.   
If unusual sounds from a centrifuge suggest that breakage and a spill has occurred, or, if breakage and a   
spill is discovered after the machine has stopped, wait at least 30 minutes after centrifuge has stopped   
before opening. This will allow hazardous aerosols to settle in the centrifuge. Then, follow this   
procedure:   
 Don lab coat, gloves, and face shield prior to opening centrifuge and then open carefully to   
assess the situation. Use of a respirator is recommended and double gloving is advisable if glass   
tubes were used and broken.  
 Attempt to determine if the spill is contained in a closed cup, bucket or tray carrier, or within a   
closed rotor. If the spill is contained as described in (2), spray the exterior with disinfect and allow adequate   
contact time. Take the carrier to the nearest BSC approved for use with this agent. NOTE: If a   
BSC is not available or if the rotor cannot be removed, the centrifuge should remain closed. Post   
a sign indicating "contaminated-do not use". Notify lab director and or PI and contact BSO at   
(mdooley@astate.edu), for assistance.  
 Obtain and place into the BSC containers suitable for holding tubes, broken glass or other   
containers while cleaning centrifuge components.  
 Carefully retrieve unbroken tubes, wipe outside with disinfectant, and place them into the other   
empty container in the BSC, out of the way. The broken glass tube(s) must be removed with a   
forceps or other instrument and immersed in a beaker of disinfectant solution for a time   
appropriate to achieve disinfection. The pieces can then be disposed of in a sharps container.  
 After proper decontamination, carriers, rotors etc. can be washed with a mild detergent   
according to the manufacturer’s instructions.  
 Thoroughly wipe the inside of the centrifuge chamber with disinfectant saturated towels. Allow   
for adequate contact time before wiping up excess liquid. Place the paper towels and gloves in a   
ziplock bag (if you do not have any on hand, contact EHS) and request pickup of the bag using   
the EHS waste pickup form (See chapter 9).  
8.1.5 Biological/Radioactive emergencies/spills   
EHS must be notified and will assist in the cleanup of a biological/radioactive spill. Determine if anyone   
has been contaminated, remove contaminated clothing and wash contaminated skin with soap and   
water. Proceed with clean up as instructed by the Radiation Safety Officer (EHS). The infectious agent   
will be neutralized first, taking care in choosing a disinfecting agent to avoid chemical incompatibility.   
Chlorine compounds such as bleach must NOT be used to disinfect anything containing I-125 because   
the chlorine will cause the volatilization of radioactive iodine.   
8.2 Exposure to Biohazardous Agents or Material   
An exposure is defined as: BSL-2 agent contact with broken skin, eyes, nose, mouth, other mucous   
membranes, a percutaneous injury with a contaminated sharp, or contact with an infectious agent over   
a large area of apparently intact skin. Individuals are encouraged to report any conditions that may   
increase risk or consequences of a laboratory acquired infection (e.g. pregnancy, a medical condition   
which compromises immunity) to their PI. In the event of exposure:  
 If the exposure creates a medical emergency, go to the closest emergency medical center or call   
911\.  
 Wash the area with soap and water or flush eyes, nose or mouth with large amounts of water for   
15 minutes.  
 Students not employed by the university must report to the Student Health Center during   
business hours for personal exposures. During off hours, an outpatient facility may be used if   
necessary.  
 All exposures must be reported to the immediate supervisor and Principal Investigator. The   
Principle Investigator is responsible for helping the employee in beginning the Workman’s   
Compensation process and reporting the exposure. EHS personnel will instruct the supervisor and   
the employee on what to do.  
 Principal Investigators are responsible for reporting exposure incidents to Biosafety Officer. The Biosafety Officer will perform a follow-up investigation of the incident and report findings to   
the Institutional Biosafety Committee (IBC).  
8.3 Security incidents   
Security incidents such as suspicious visitors, missing chemicals, or missing biological agents must be   
promptly reported to the Principal Investigator. University Police should be notified. Principal   
Investigators are responsible for reporting incidents to EHS.

# Chapter 9 - Biohazardous Waste Management

9.1 Scope   
While this protocol is included as a part of the Biosafety Manual, it applies to all generator of medical   
waste as defined by the regulation and this protocol at this university. The applicability is defined by the   
Arkansas Department of Health (ADH) Rules and Regulations Pertaining to the Management of Medical   
Waste from Generators and Health Care Related Facilities promulgated under the authority of Ark. Code   
Ann. § 20-7-109 and Ark. Code Ann. § § 20-32-101 – 112.   
9.2 Biohazardous Waste Definition   
Medical waste (also known as biohazardous waste or infectious waste) is waste that requires   
inactivation of the biological material in an approved manner prior to final disposal. It includes the   
following:   
 Pathological waste - all human unfixed tissues, organs and anatomical parts, other than intact   
skin, which emanate from surgeries, obstetrical procedures, dental procedures, autopsies and   
laboratories, including embalming waste Such waste shall be exclusive of bulk formaldehyde and   
other preservative agents.   
 Liquid or semi-liquid blood such as human blood, human blood components and/or products   
made from human blood (e.g., serum, plasma) and other potentially infectious materials, to   
include regulated human body fluids such as semen, vaginal secretions, cerebrospinal fluid,   
pleural fluid, pericardial fluid, synovial fluid, peritoneal fluid, amniotic fluid, saliva in dental   
procedures, any body fluid that is visibly contaminated with blood, and all body fluids where it is   
difficult or impossible to differentiate between body fluids, can be discharged into the collection   
system of a publicly owned treatment works (POTW) within the generating facility. Breast milk,   
urine, and feces are not considered medical waste and can also be discharged into the (POTW).   
 Contaminated items to include dressings, bandages, packing, gauze, sponges, wipes, personal   
protective equipment, cotton rolls and balls, etc., which cannot be laundered or disinfected and from which blood, blood components, or regulated body fluids drip freely, or that would release   
blood or regulated body fluids in a liquid or semi-liquid state if compressed or are caked with   
dried blood or regulated body fluids and all capable of releasing these materials during handling,   
not to include feminine products, enema bags, used condoms, or diapers.   
 Contaminated disposable, single-use gloves such as surgical or examination gloves   
shall not be washed or decontaminated for reuse and are to be handled as a   
contaminated item.   
 Protective coverings such as plastic wrap and aluminum foil used to cover   
equipment and environmental surfaces when removed following their   
contamination are considered a contaminated item.   
 All patient care items from hospital isolation rooms and end-stage renal dialysis   
units, or from patients with communicable diseases, which cannot be laundered   
and which are contaminated with regulated body fluids or blood or potential   
infectious material, must be considered a contaminated item.   
 Biological waste and discarded materials contaminated with blood, excretion,   
exudates, or secretions from isolated animals known, or suspected, to be infected   
with communicable diseases.   
 Microbiological waste which includes, but is not limited to, cells and tissue cultures, culture   
medium or other solutions and stocks of infectious agents, organ cultures, culture dishes,   
devices used to transfer, inoculate and mix cultures, paper and cloth that has come in contact   
with specimens or cultures and discarded live or attenuated vaccines.   
 Contaminated sharps which include, but is not limited to, any contaminated object that can   
penetrate the skin, e.g., hypodermic needles, intravenous tubing with needles attached,   
syringes with attached needles, razor blades used in surgery, scalpel blades, Pasteur pipettes,   
capillary tubes, broken glass from laboratories, and dental wires. Potentially breakable   
container(s) of blood, regulated body fluid, microbiological waste, or infectious material must be   
treated as contaminated sharps when disposed of. Sharps that have been used in human or   
animal patient care, treatment or for other medical procedures are included. Any waste   
produced in the course of physically altering a human being or animal including tattooing, ear   
piercing, or any other process where a foreign object is used to cut or pierce the skin. All waste   
generated in this manner meeting the definition of sharps must be handled accordingly.   
 Veterinary waste to include any and all animal related waste (carcasses, body parts, bulk blood   
and blood products, bedding of animals, etc.) which meets the definition of any of the five   
categories delineated above and has been or is suspected to have been exposed to a zoonotic   
disease or pathogens known to cause human disease, or which has been exposed to human   
pathogens in research or the production of biological, must be handled as medical waste. All   
contaminated sharps and microbiological waste must be handled as medical waste.   
 Trace contaminated chemotherapy waste that can be treated as medical/infectious waste. Bulk   
wastes such as full expired vials of chemotherapy drugs are considered to be chemical waste   
NOT biological waste and should be managed accordingly. Trace contaminated chemotherapy   
waste includes: Masks  
 Empty drug vials  
 Gloves   
 Gowns   
 IV tubing  
 Empty IV bags/bottles and   
 Spill clean-up materials.   
 Spill/clean-up material collected during or resulting from the clean-up of a spill of regulated   
medical waste.   
 Crime scene/accident/trauma clean-up waste generated by individuals or commercial entities   
hired to clean crime scenes or accidents that are saturated with human blood, sharps, or sharp   
objects contaminated with human blood.  
 Recombinant DNA. All contaminated liquid, solid, carcasses, and animal wastes from research   
activities involving RG-2 agents requiring BSL-2 and ABSL-2 containment. All contaminated   
liquid, solid, carcasses, and animal wastes from research activities involving RG-3 agents   
requiring BSL-3 and ABSL-3 containment. NOTE: Although RG1-associated DNA is not included   
in the definition of medical waste; all materials that have been in contact with recombinant   
DNA must be decontaminated prior to disposal in the sewer or trash. These items are not   
subject to the logging requirements described for autoclaves and chemical disinfection but   
they must still be rendered biologically inactive. This includes recombinant plants.   
 Additional wastes may be added at the discretion of the Institutional Biosafety Committee (IBC)   
and the EHS director.  
9.3 Responsibilities   
9.3.1 Principal Investigator or Faculty in Charge of Lab   
The principal investigator or faculty in charge of the lab is responsible for:   
 Identifying the biohazardous waste generated by their activity   
 Segregating biohazardous waste into the appropriate waste stream   
 Managing biohazardous waste in accordance with this protocol and   
 Providing appropriate training to personnel under their supervision.   
9.3.2 Biological Safety Officer (BSO)   
The biological safety officer is responsible for:   
 Providing training upon request for management of biohazardous waste and  Inspecting laboratories to ensure compliance with this protocol.   
9.3.3 Environmental Health and Safety (EHS)   
EHS is responsible for:   
 Picking up those biohazardous wastes requiring offsite treatment from laboratories in a timely   
manner   
 Final packaging, manifesting and shipping them for disposal and   
 Recordkeeping for wastes shipped off-site in compliance with ADH regulations.  
9.4 Disinfection   
Arkansas Department of Health requires that any material or surface that comes in contact with an   
infectious substance must be disinfected prior to reuse. Disinfection is accomplished by appropriate use   
of an EPA registered disinfectant used according to the label instructions for the agent being inactivated.   
The most familiar disinfectants that are registered with the EPA are bleach (active ingredient sodium   
hypochlorite) at a concentration of 10% (1 part household bleach mixed with 9 parts water, hitherto   
called 10% bleach), Cavicide, and 70% isopropyl alcohol. However, the disinfectant chosen must be   
effective against the agent that is being inactivated. If assistance is needed with this, contact EHS.   
9.5 Treatment, Storage and Disposal   
Arkansas Department of Health requires that biohazardous (medical) waste be treated by chemical   
disinfection, incineration or steam sterilization before disposal. Arkansas State University requires that   
all biohazardous waste be treated with 10% bleach (liquids only), sterilized by autoclave or packaged for   
offsite contract incineration.  
9.5.1 General Storage and Disposal Methods for Different Types of Waste   
 Disposable sharps are deposited in a sharps container. All disposable sharps waste are treated   
offsite. Re-usable sharps are safely segregated and contained in leak-proof, rigid, punctureresistant containers while awaiting cleaning, decontamination, and sterilization before re-use.  
 Liquid biohazardous waste is chemically treated with bleach and disposed via sanitary sewer or   
autoclaved and disposed via sanitary sewer or contained in a biohazard bottle which is placed in   
a biohazard bin. Biohazard bins are treated offsite by incineration; disposal is by the University’s   
Infectious Waste Contractor.   
 Solid biohazardous waste is either autoclaved in a clear autoclave bag lacking the biohazard   
symbol then disposed of as ordinary trash or placed in a biohazard bin. Biohazard bins are   
treated offsite by incineration; disposal is by the University’s Infectious Waste Contractor. Red   
or orange bags, or bags marked as biohazard cannot be disposed as ordinary trash, regardless of   
whether they were autoclaved.  
 Infectious animal body parts or carcasses are contained in biohazard bags, kept in designated   
freezers or refrigerators until pickup by EHS. They are placed in a biohazard bin before removal   
from the lab. Biohazard bins are treated offsite by incineration; disposal is by the University’s   
Infectious Waste Contractor. 9.5.2 Chemical Treatment Standards   
 Household bleach is 5.5 - 10 % sodium hypochlorite. The appropriate concentration of sodium   
hypochlorite for disinfecting liquid waste, e.g. supernatants from cell culture, is 5000 ppm,   
approximately 0.5%. A 1:10 (v/v) dilution of bleach to liquid biological waste is required.  
 A minimum contact time of sodium hypochlorite with liquid waste is 20 minutes. After 20   
minutes of contact, disinfected liquid waste is poured into the sanitary sewer.   
 Bleach should be stored between 50 and 75°F. Undiluted household bleach has a shelf life of six   
months to one year from the date of manufacture, after which bleach degrades at a rate of 20%   
each year until totally degraded to salt and water (exposure to sunlight or additional heat   
increases the degradation rate substantially).  
 Any dilution of bleach has a shelf life of 5 days.  
9.5.3 Autoclave Standards   
All steam sterilizers must:   
 Use the biological indicator Bacillus stearothermophillus placed at the center of a load   
processed under standard operating conditions to confirm the attainment of adequate   
sterilization conditions. Indicator organisms must be used monthly at a generator facility in each   
steam sterilizer;  
 Record the temperature and time during each complete cycle to ensure the attainment of a   
temperature of 121 degrees Centigrade (250 degrees Fahrenheit) for 30 minutes or longer (refer   
to Appendix I of the Biosafety Manual for large quantities) at fifteen (15) pounds pressure,   
depending on quantity and density of the load, in order to achieve sterilization of the entire   
load; (Thermometers shall be checked for calibration at least annually.)  
 Have a gauge that indicates the pressure of each cycle.  
 Use heat sensitive tape that is lead-free or other device for each container that is processed to   
indicate that the steam sterilization temperature has been reached. The waste will not be   
considered appropriately treated if the indicator fails.  
 Maintain records of the procedures specified in (b) above for a period of not less than three (3)   
years.  
 Assure that treatment residues are disposed of in accordance with applicable State and Federal   
Requirements.  
9.5.4 Logging   
All wastes that meet the definition of biohazardous waste and are treated chemically or by steam   
sterilization must be logged before disposal. The date and amount of waste treated and disposed must   
be included. A monthly log must be sent to the EHS at the beginning of each month for the previous   
month. A template of the log can be obtained by contacting EHS

# Appendix A Biological Safety Cabinets

Biological Safety Cabinets and other primary containment devices are an essential component of   
conducting biological research. As a primary safety barrier, the effectiveness of the BSC is limited by the   
techniques employed by the researcher (e.g. good microbiological techniques), an understanding of how   
the cabinet functions, and the location of the biological safety cabinet within the facility. As a general   
rule, keep biosafety cabinets away from doors, high traffic areas and supply diffusers. The Biosafety   
Officer can provide consultation and guidance on the selection, operation and use that meet your   
specific research needs.   
A Class II, A2 Biosafety Cabinet is recommended and the most common type of BSC in use, as it is   
appropriate for most biohazardous work applications. Class II BSC provide personnel protection from   
biohazardous materials using HEPA filtered air prior to release into the room, in addition to providing   
product protection (to maintain sterility). Information on specific classes and types of Biosafety   
Cabinets can be found at https://www.cdc.gov/labs/pdf/CDCBiosafetyMicrobiologicalBiomedicalLaboratories-2009-P.PDF  
For most applications, it is not necessary to connect a Class II A2 BSC to the building ventilation   
system. Class II A2 cabinets are designed to be “convertible” units and can be connected to the   
ventilation system using a thimble connection designed with an air gap. This is recommended only in   
certain situations that merit connection to the HVAC system.   
Biological Safety Cabinets must be certified annually and whenever moved; they must be   
decontaminated (chlorine dioxide gas or hydrogen peroxide vapor) before being moved. BSCs are   
certified (and decontaminated) by an outside contractor at the expense of the Principal Investigator. The   
Biosafety Officer will provide a list of designated, NSF-certified vendors from which to choose.   
Laboratory staff is responsible for coordinating BSC certification service directly with the vendor.   
Instructions on the proper use of the Biological Safety Cabinet (BSC)   
 Biosafety cabinets are designed to run 24 hours a day, and for frequent work with BSL-2 agents   
in the BSC, it is recommended that blowers remain on at all times.   
 If it is necessary to turn off the blower, allow sufficient time to purge airborne contaminants   
from the work area (Centers for Disease Control and the Public Health Agency of Canada   
recommend a minimum of 5 minutes before and 5 minutes after work, taking into account   
sufficient time for settling of aerosols).   
 Minimize other activities in the room (e.g., rapid movement, open/closing room doors, etc.) to   
avoid disrupting the cabinet air barrier.   
 Laboratory coats are worn buttoned over street clothing; gloves are worn to provide hand   
protection.   
 Before beginning work, the investigator must adjust the stool height so that his/her face is   
above the front opening.   
 Plastic-backed absorbent toweling can be placed on the work surface (but not on the front or rear grille openings). This toweling facilitates routine cleanup and reduces splatter and aerosol   
formation during an overt spill.   
 Closure of the drain valve under the work surface must be done prior to beginning work so that   
all contaminated materials are contained within the cabinet should a large spill occur.   
 Place necessary materials in the BSC before beginning work. This serves to minimize the number   
of arm-movement disruptions across the air barrier of the cabinet. All materials must be placed   
as far back in the cabinet as practical, toward the rear edge of the work surface and away from   
the front grille of the cabinet.   
 The front grille must not be blocked with research notes, discarded plastic wrappers, pipeting   
devices, etc.   
 Aspirator suction flasks must contain an appropriate disinfectant, and a High Efficiency   
Particulate Air (HEPA) in-line filter. This combination will provide protection to the central   
building vacuum system or vacuum pump, as well as to the personnel who service this   
equipment. Inactivation of aspirated materials can be accomplished by placing sufficient   
chemical decontamination solution such as bleach, into the flask to kill the microorganisms as   
they are collected. Once inactivation occurs, liquid materials can be disposed of as noninfectious   
waste.   
 Horizontal pipette discard trays containing an autoclave bag or an appropriate chemical   
disinfectant should be used within the cabinet. Upright pipette collection containers placed on   
the floor outside the cabinet or autoclave-safe biohazard collection bags taped to the outside of   
the cabinet should not be used. The frequent inward/outward movement needed to place   
objects in these containers is disruptive to the integrity of the cabinet air barrier and can   
compromise both personnel and product protection.   
 All operations should be performed on the work surface at least four (4) inches from the inside   
edge of the front grille.   
 Active work should flow from the clean to contaminated area across the work surface. Bulky   
items such as biohazard bags, discard pipette trays and suction collection flasks must be placed   
to one side of the interior of the cabinet.   
 Use of glass Pasteur pipettes is discouraged. Glass pipettes should be replaced with safer   
alternatives (i.e., plastic) as recommended by the U.S. Department of Health and Human   
Services, Centers for Disease Control and Prevention and National Institutes of Health in   
Biosafety in Microbiological and Biomedical Laboratories, 5th Edition Fifth Edition and by The   
World Health Organization Biosafety Manual. Contact EHS Biosafety for more information on   
safer alternatives.   
 Open flames (i.e., Bunsen burners) are rarely necessary in the near microbe-free environment   
of a biological safety cabinet and are an artifact left over from usage of A1 cabinets (e.g.,   
provided only personnel, not product protection) several decades ago. An open flame creates   
turbulence that disrupts the pattern of HEPA-filtered air supplied to the work surface. When   
deemed absolutely necessary, touch-plate micro-burners equipped with a pilot light to provide a   
flame on demand may be used. Internal cabinet air disturbance and heat buildup will be   
minimized. The burner must be turned off when work is completed. Micro-incinerators (electric)   
are the best alternative for use in the BSC.   
 Use of ultraviolet light (UV) in the BSC is strongly discouraged. UV bulbs in the BSC must be   
cleaned and monitored regularly, as dust and debris inhibit effectiveness as well as gradual   
degradation of the UV bulb over time and should never be used as a primary or sole means of   
disinfecting the unit. Therefore, chemical surface disinfection must be the primary means of decontaminating the BSC.   
 Clean Up: Upon completion of work, the final surface decontamination of the cabinet must   
include a wipe-down of the interior surfaces. Investigators must remove their gloves and gowns   
in a manner to prevent contamination of unprotected skin and aerosol generation and wash   
their hands as the final step in safe microbiological practice. Investigators must determine the   
appropriate method of decontaminating materials that will be removed from the BSC at the   
conclusion of the work.

# Appendix B Shipping of Biohazardous Materials

Biohazardous materials are considered a hazardous material by both the US Department of   
Transportation and by the International Air Transport Association (IATA, which oversees air transport of   
hazardous materials). Like all hazardous material, special training is required to safely and legally ship   
biohazardous materials. Please see the Arkansas State University Hazardous Materials Shipping plan to   
determine the type of training needed to ship biohazardous materials.   
Biohazardous materials require special shipping containers. There are several vendors that sell the   
appropriate containers; consult with EHS before shipping biohazardous materials to make sure that the   
shipping containers that will be use meet the regulatory requirements.

# Appendix C Transport of Biohazardous Material

The DOT Hazardous Material Regulations (49 CFR Parts 171-180) regulates the movement of Division 6.2   
Infectious Substances when a commercial carrier is used. This is covered in Appendix B: Shipment of   
Infectious Substances. Transport refers to movement of Arkansas State material by Arkansas State   
personnel (faculty, staff or students) in a vehicle or hand carry between buildings. Substances that meet   
the DOT definition of infectious (see Appendix B) and are being transported in a vehicle, must be   
packaged per DOT regulations by a person certified to ship infectious substances. Pay particular   
attention to the exemptions in the A-State Hazardous Materials Shipping Plan; most substances   
requiring transport at Arkansas State are exempt from the DOT definition of infectious.   
Substances not meeting the DOT definition of infectious, but requiring BSL-2 (or higher) containment or   
covered by Arkansas State’s definition of biohazardous (see Chapter 9 of this Manual) must be packaged   
as follows for transport either by vehicle or hand carry: Place material in a primary (specimen) container   
that is leak-proof and secured with a tight-fitting cap; place absorbent material (diapers, absorbent   
towels, pads) around the primary containers for transport of liquids; place the primary container(s) in a   
secondary transport container that is also sealed and labeled with a biohazard symbol.   
Arkansas State encourages the use of university-owned vehicles when transporting materials off   
campus. Accidents during movement of any of these materials can result in harm to persons and   
property. Release and spills of these materials may involve police and HAZMAT responders including   
clean-up and cost of recovery. Under NO circumstances may public transportation be used for transport of Hazardous Materials.

# Appendix D - Use of Human, non-human Primate, and other Mammalian Cells and Tissues

Background: In 1991, the Occupational Safety and Health Administration (OSHA) issued the Bloodborne   
Pathogens (BBP) Standard to protect employees who have occupational exposure to human blood or   
other potentially infectious materials. While human blood, most body fluids, unfixed human tissues and   
organs were clearly included within the scope and application of the standard, the inclusion of human   
cell lines was ambiguous.   
In 1994, OSHA issued an interpretation of the applicability of the BBP Standard towards human cell lines.   
According to the interpretation, human cell lines are considered to be potentially infectious and within   
the scope of the BBP Standard unless the specific cell line has been characterized to be free of hepatitis   
viruses, HIV, Epstein-Barr virus, papilloma viruses and other recognized bloodborne pathogens. In   
alignment with this interpretation, the American Type Culture Collections (ATCC) recommends that all   
human cell lines be accorded the same level of biosafety consideration as a line known to carry HIV.   
ATCC also states “However, in general, we do not test for animal viruses, therefore not all of our cell   
lines have been tested for animal viruses and should be treated accordingly”.  
ATCC assigns biosafety level (BSL) designations for the purposes of safe shipment, according to whether   
or not at the time of accessioning it is known that the cell lines is harboring any known virus or any   
portion of a virus which causes human disease. “While ATTC does provide the biosafety level for each   
ATCC culture, we do not provide information on biosafety practices. Each researcher should determine   
the appropriate BSL using a risk assessment based on the characteristics of the cell line and how the cell   
line will be used.” This includes, but is not limited to, laboratory manipulations employed during its   
handling.   
Human, primate or mammalian cell lines, even in the absence of overt contamination, may contain   
adventitious viruses and/or other opportunistic pathogens or zoonotic agents. Since it is extremely   
difficult to screen for every pathogen, all human, primate and mammalian cell lines must be handled   
with standard precautions i.e. treated as though they are contaminated with infectious agents and   
should utilize BSL2 practices.   
In addition to viral and bacterial threats, the European Union – European Medicines Agency document   
“Viral Safety Evaluation of Biotechnical Products Derived from Cells lines of Human or Animal Origins”   
also indicates the potential for the introduction of bovine spongiform encephalopathy prions (BSE)   
contamination into established cell lines via use of contaminated animal-derived products (including   
animal serum products) and/or through the use of improper work methods. “However, in contrast to   
most of the infectious agents, prions are particularly difficult to inactivate. In fact, no method can   
guarantee total inactivation of these agents. So, one should bear these considerations in mind when   
using growth media of bovine origin”.   
In consideration of the aforementioned regulatory interpretations, consensus guidelines, best practices,   
and other factors, the EHS has adopted the following guidance: All cell and organ cultures of human origin, including well established cell lines, human bodily   
fluids, non-human primate and mammalian cells and tissues should be handled in accordance   
with the OSHA Bloodborne Pathogens Standard and under Biosafety Level 2 (BSL2) containment.

# Appendix E Guidelines for work with toxins of biological origin

Biological toxins comprise a broad range of poisons, predominantly of natural origin but increasingly   
accessible by modern synthetic methods, which may cause death or severe incapacitation at relatively   
low exposure levels. Laboratory work with most toxins, in amounts routinely employed in the   
biomedical sciences, can be performed safely with minimal risk to the worker and negligible risk to the   
surrounding community. Toxins do not replicate, are not infectious, and are difficult to transmit   
mechanically or manually from person to person. Many commonly employed toxins have very low   
volatility and, especially in the case of protein toxins, are relatively unstable in the environment; these   
characteristics further limit the spread of toxins.   
Toxins can be handled using established general guidelines for toxic or highly-toxic chemicals with the   
incorporation of additional safety and security measures based upon a risk assessment for each specific   
laboratory operation. The main laboratory risks are accidental exposure by direct contamination of   
mouth, eyes or other mucous membranes; by inadvertent aerosol generation; and by needle-sticks or   
other accidents that may compromise the normal barrier of the skin.   
A risk assessment should be conducted to develop safe operating procedures before undertaking   
laboratory operations with toxins; suggested “pre-operational checklists” for working with toxins are   
available. For complex operations, it is recommended that new workers undergo supervised practice   
runs in which the exact laboratory procedures to be undertaken are rehearsed without active toxin. If   
toxins and infectious agents are used together, then both must be considered when containment   
equipment is selected and safety procedures are developed. Likewise, animal safety practices must be   
considered for toxin work involving animals.   
Detailed information and guidance is contained in BMBL 5th Edition Appendix I:   
https://www.cdc.gov/labs/pdf/CDC-BiosafetyMicrobiologicalBiomedicalLaboratories-2009-P.PDF

# Appendix F - NIH Oversight of Research Involving Recombinant DNA

The NIH Guidelines for Research Involving Recombinant DNA Molecules (https://osp.od.nih.gov/wpcontent/uploads/NIH\_Guidelines.html) contain procedures for the containment of rDNA research. The   
Guidelines apply to all institutions that receive NIH funding for rDNA. All Investigators at the institution   
must comply with the Guidelines, even if their individual research is not funded by NIH. Consequences   
of noncompliance include suspension, limitation, or termination of NIH funds for rDNA research at the   
institution, or a requirement for prior NIH approval of rDNA projects at the institution.   
The original guidelines were issued in 1976 due to public concern for safety, environmental impact, and   
ethical implications of rDNA research. The purpose of the guidelines is to specify safe handling practices   
and containment levels for rDNA molecules, organisms and viruses containing rDNA molecules, and   
transgenic animals.

Responsibilities under the Guidelines:   
 The Institution must: establish an Institutional Biosafety Committee to ensure compliance with   
the NIH Guidelines by investigators and report any significant problems, violations or significant   
research-related accidents or illnesses to NIH within 30 days.   
 The Institutional Biosafety Committee must: review, approve and oversee rDNA research to   
ensure compliance with the Guidelines, determine necessity of health surveillance of   
personnel, ensure training for IBC members, staff, PIs, and laboratory staff,   
 set biosafety containment levels as required by the Guidelines for some experiments under IIID-4-b   
 Incident Reporting to NIH   
The following incidents must be reported to NIH OBA within 30 days: any significant problems or   
violations of the NIH Guidelines, e.g. failure to adhere to the containment and biosafety practices in the   
Guidelines, any significant research-related accidents and illnesses, e.g. spill or accident leading to   
personal injury or illness or a breach in containment, e.g. escape or improper disposition of a transgenic   
animal.   
The following incidents require immediate reporting to NIH OBA: spills or accidents involving rDNA   
requiring BSL2 containment resulting in an overt exposure, e.g. needlestick; splash in eyes, nose, mouth;   
or accidental aerosolization/inhalation.

# Appendix G Recombinant DNA Experiments Involving Plants

Appendix P NIH Guidelines specifies physical and biological containment conditions and practices   
suitable to the greenhouse conduct of experiments involving recombinant DNA-containing plants, plantassociated microorganisms, and small animals. All provisions of the NIH Guidelines apply to plant   
research activities with the following modifications:   
Appendix P supersedes Appendix G NIH Guidelines (Physical Containment) when the research plants are   
of a size, number, or have growth requirements that preclude the use of containment conditions   
described in Appendix G. The plants covered in Appendix P include but are not limited to mosses,   
liverworts, macroscopic algae, and vascular plants including terrestrial crops, forest, and ornamental   
species.   
Plant-associated microorganisms include viroids, virusoids, viruses, bacteria, fungi, protozoans, certain   
small algae and microorganisms that have a benign or beneficial association with plants, such as certain   
Rhizobium species and microorganisms known to cause plant diseases. The appendix applies to   
microorganisms that are being modified with the objective of fostering an association with plants.   
Plant-associated small animals include those arthropods that: (i) are in obligate association with plants,   
(ii) are plant pests, (iii) are plant pollinators, or (iv) transmit plant disease agents, as well as other small   
animals such as nematodes for which tests of biological properties necessitate the use of   
plants. Microorganisms associated with such small animals (e.g., pathogens or symbionts) are included. For both BSL1-P and BSL2-P, experimental organisms shall be rendered biologically inactive by   
appropriate methods before disposal outside of the greenhouse facility.

# Appendix H - Autoclaves

Autoclaves are safe and highly effective when used properly. They sterilize equipment and supplies and   
they kill biologicals and denature proteins. Autoclaves do not remove chemical contamination and   
should not be used in conjunction with chemical disinfectants.   
Autoclave Cycles  
There are three basic autoclave cycles:   
1\) Gravity Cycle (aka Fast Exhaust): This cycle is used for dry items such as glassware or metal   
instruments. This cycle cannot be used for liquids because the rapid pressure release will cause   
any liquids to boil.   
2\) Liquid Cycle (aka Slow Exhaust): This cycle is used to sterilize liquids. The slow pressure release   
at the end of the cycle keeps liquids (which have been heated to 121C) from boiling. A table of   
autoclave times based on liquid volume is given below.   
3\) Pre-Vacuum Cycle: This cycle is used for porous materials, animal bedding, etc. Some of the air   
in the chamber is evacuated to create a negative pressure space. This allows the steam to   
penetrate deeper into the materials placed in the autoclave to help ensure that even the   
deepest pockets within these materials become sterile.   
When an autoclave is used to kill biologicals prior to disposal, follow the procedures set forth in the   
appropriate chapter of the Biosafety Manual.   
Safety Rules for Autoclaves  
 Hot glassware being removed from the autoclave must be handled with dry, heat-resistant   
gloves.   
 Use the liquid (slow-exhaust) cycle for liquids and let them stand for 10 minutes before removal   
from the autoclave.   
 For media bottles (glassware with a sealable cap), the cap must remain loose while the bottle is   
in the autoclave. This will prevent it from building pressure and exploding.   
 Secondary containment must be used for items being placed in the autoclave. Items should   
never be placed directly on the floor of the autoclave.   
 Not all plastics can be autoclaved. Polypropylene and polycarbonate may survive the autoclave;   
polyethylene, even high-density polyethylene will not. Be sure your item is autoclave safe before   
placing in the autoclave. If there is any doubt, use secondary containment.   
 To ensure adequate steam penetration, add 1 cup of extra water for dry loads and leave bags   
partially open.   
 Red biohazard bags must never be used in an autoclave, even if they are autoclave-safe. Clear   
autoclave bags must be used.   
 Never open an autoclave until the chamber pressure is zero.

 Stand back from the door upon opening to allow excess steam to be released safely.   
 And indicator, such as autoclave tape, must be used with each load to ensure the chamber has   
reached the appropriate temperature.   
Other Autoclave Operating Suggestions  
 Placing 1-2 inches of water in the bottom of the secondary container with bottles will help   
prevent bottle bottoms from breaking.   
 Autoclaving new glassware for 90 minute will partially temper is, making it stronger.   
 If there is doubt about whether or not a piece of glassware is autoclave safe, it should be   
wrapped in foil. This will capture the pieces of glass if the glassware were to crack or shatter.   
Autoclave times based on liquid volume   
These autoclave times are only given as guidance. More time may be required for certain organisms or   
other biologicals. Allow 10-20 minutes extra for crowded items.   
<500 mL 500mL – 1L 1L – 2L 2L-4L 4L  
30 minutes 40 minutes 45-55 minutes 55-60 minutes 60 minutes  
For any additional questions regarding autoclave use and safety, contact EHS at mdooley@astate.edu.

# Biological Waste Pickup Request

[Biological Waste Pickup Request • CampusOptics](https://astate.campusoptics.com/hw/biological-pickup)

# Bloodborne Pathogens and Exposure Control Plan

Bloodborne Pathogens and Exposure Control Plan  
Purpose  
The purpose of this plan is to ensure that exposure of employees to blood or other potentially infectious   
materials is controlled and that those employees are properly trained. This plan is meant to meet the   
requirements of the OSHA Bloodborne Pathogens Standard (29CFR1910.1030).  
Scope  
This plan applies to all employees that may be exposed to blood or other potentially infectious materials   
as specified below.   
Roles and Responsibilities  
Employees  
It is the responsibility of the employees covered by this plan to know how to access this plan and to   
abide by the requirements herein.  
Management/Faculty:   
It is the responsibility of management/faculty:  
• To understand how this plan applies to their employees and  
To ensure that the plan is being followed including:  
• Enrollment in medical surveillance;  
• Administration of the HBV vaccine and;  
• Completion of bloodborne pathogen training. Available in Taleo. Experienced faculty/staff may   
administer the bloodborne pathogen training in lieu of EHS training as long as the training   
covers all of the covered elements described later in this plan.  
Environmental Health and Safety  
It is the responsibility of EHS:  
• To ensure that this plan stays up to date,   
• To provide training that meets the requirements of the bloodborne pathogen standard  
• To provide the mechanism by which bloodborne pathogen exposures are reported and   
• To assist departments in complying with the requirements of this plan.  
Procedures  
Exposure determination  
The Bloodborne Pathogen Standard requires the employer to make a determination of what positions   
have the potential for exposure to blood or other potentially infectious materials (OPIM) as defined by   
the standard (including human cell culture). The two classifications are defined below  
Exposure Classification I: Job classifications where all employees may reasonably expect to be exposed   
to blood or OPIM.  
• Law Enforcement personnel   
• Physicians and Nurses  
• Employees designated to perform first aid  
Exposure Classification II: Job classifications where some employees may reasonably expect to be   
exposed to blood or OPIM (with the specific tasks given in parentheses).  
• Clinical faculty and staff (that work with blood or OPIM)  
• Research faculty and staff (that work with blood or OPIM)  
• EHS personnel (that collect waste contaminated with blood or OPIM)  
• Faculty and teaching assistants (that handle blood or OPIM)  
Exposure Classification III: Job classifications that may encounter blood or OPIM but do not do so on a   
routine basis.  
• Custodians  
• Facilities Maintenance staff  
• Building managers  
• EHS personnel (other than listed above)  
• Research faculty and staff (other than listed above)  
• Clinical faculty and staff (other than listed above)  
• Faculty and teaching assistants (other than listed above)  
Work that may result in exposure includes:  
• Drawing or processing blood  
• Processing human body fluids that are OPIM  
• Performing human cell culture  
• Picking up contaminated waste  
• Performing first aid on an individual that is bleeding  
• Cleaning areas or equipment contaminated with blood or OPIM  
• Laundering materials contaminated with blood or OPIM  
Safety Rules  
• Assume all human and animal body fluids are infectious (Universal Precautions)  
• Use engineering controls and work practices to eliminate or reduce employee exposure.   
• Use personal protective equipment (PPE) when necessary as determined by a hazard   
assessment. PPE may include gloves, lab coat or gown, facemask and face shield.  
• Keep engineering controls in good working order and under current certification whenever   
necessary. Report problems with engineering controls immediately.  
• Make handwashing facilities readily available in areas where blood or OPIMs are present.  
• Employees must wash hands immediately after PPE removal, i.e., gloves, and if there is any   
contact with blood or OPIM.   
• Needles should be used one-time only. Contaminated needles and other sharps shall not be   
bent, recapped, or removed unless there is no alternative and, in the case of recapping or   
removal, a one-handed method or mechanical device must be used.   
• Contaminated sharps must be disposed of in containers that are puncture resistant, labeled or   
color-coded properly, leak-proof on sides and bottom, and closable on top.  
• Eating, drinking, smoking, chewing, applying lip balm or cosmetics, and handling contact lenses   
are prohibited in areas where blood or OPIM are present.  
• Food and drink shall not be kept in refrigerators, freezers, shelves, cabinets or on countertops or   
bench tops where blood or other potentially infectious materials are present.  
• Splashing, spraying, spattering and droplet generation (aerosols) will be minimized by using   
centrifuge covers and other techniques designed to reduce aerosol formation.   
• Mouth pipetting is prohibited.  
• Blood specimens or OPIM are transported and stored in leak-proof containers.   
• Equipment is decontaminated with disinfectant included in Arkansas State University List of   
Approved Disinfectants for Use against Bloodborne Pathogens prior to servicing. This list is   
derived from the registered disinfectants that appear on both EPA List E and EPA List F.   
• Each work area handling bloodborne pathogens must have a written cleaning schedule including   
autoclaving, decontamination procedure using Arkansas State University List of Approved   
Disinfectants for Use against Bloodborne Pathogens, and laundry handling. The supervisor is   
responsible for this schedule. An autoclave must also be conveniently available.   
• Each supervisor is responsible for reviewing the effectiveness of the individual controls, and   
making corrections to conform to the Bloodborne Pathogens Standard.   
Personal Protective Equipment  
Required personal protective equipment shall be used in accordance with a performed hazard   
assessment. The assessment may be done by the person in charge of the area (faculty or manager) or   
the EHS director. The EHS director must approve the level of PPE used.  
• Disposable PPE should be used whenever possible.  
• Reusable PPE shall be laundered on the premises whenever contamination is suspected. No PPE   
may be taken home to be laundered.  
• PPE shall be supplied, replaced and cleaned at no cost to the employee.  
Training  
• All employees in exposure classification I, II or III must complete BBP training as early as   
practicable. Additional in-person training may be performed by a faculty or staff member   
knowledgeable on the subject or by the EHS director.   
• All the employees must take an annual refresher either in person or online.  
The training that is given must include each of the following elements:  
• Explanation of epidemiology, symptoms, and transmission modes of bloodborne diseases.   
• How to recognize bloodborne hazards.   
• How to prevent or reduce exposure.   
• How to minimize aerosol production.   
• Handling needles properly.   
• Information and instruction on Personal Protective Equipment location, selection, removal,   
decontamination, and disposal.   
• Instruction on hand washing procedures.   
• Information on biological waste handling and disposal.   
• Information on the Hepatitis B vaccine.  
In-person training, provides opportunity for interactive questions and answers with a technicallyqualified person.   
• Explanation of the contents of Standard 1910.1030.   
• Explanation of and access to the Exposure Control Plan.  
• Information on the appropriate actions to take and persons to contact in an emergency   
involving blood or other potentially infectious materials.  
• Explanation of color coding and labeling per 1910.1030(g).  
• Handling of biological waste.   
Training records should be kept by the individual giving the training and supplied upon request.  
Hepatitis B Vaccine  
Employees in exposure classification I or II or those newly assigned to either of these classifications will   
be offered the HBV vaccination within 10 working days of initial assignment.   
• The employee may decline the vaccination by signing the Hepatitis B Vaccine Status Form.   
• The cost(s) of the vaccinations will be borne by the employee’s department.   
• The employees that receive the vaccination may not work with blood or OPIM until at least 10   
days after receiving the first of the three HBV injections.  
• Employees that were born in 1995 or after may have had the HBV vaccine series as a child. This   
must be confirmed by the employee and noted in the record.  
Exposure Procedure  
IMMEDIATELY FOLLOWING EXPOSURE  
Exposure to blood or other potentially infectious materials that could result in infection with a   
bloodborne pathogen can happen by one of two routes:  
• Puncture with a contaminated needle or other sharp object or  
• Blood or OPIM entering the open wound of the exposed individual.  
If the exposure is the result of a medical emergency, the employee should be taken to the nearest   
emergency medical center. The steps following may take place after the employee has been taken for   
emergency medical care.  
• If an exposure occurs, the exposed employee must immediately report the exposure to his or   
her supervisor.   
• The supervisor should immediately call the Injury Nurse Hotline (855-339-1893) to report the   
exposure.   
• The employee should receive medical attention as soon as possible. CDC recommendations   
state that prophylaxis is most effective when initiated within two hours of the incident;   
therefore, it is imperative that the employee go to one of the below listed medical facilities   
providing services for the Workers’ Compensation program as soon as possible.  
• The supervisor and employee must complete all of the steps required by the Workman’s   
Compensation procedure after this point. For more information on this procedure view [here](https://kb.astate.edu/books/workers-compensation).  
Post-Exposure Follow-up  
The results of the medical evaluation are to be strictly confidential between the healthcare professional   
and employee. The exposed employee’s supervisor will obtain a written notice from the healthcare   
professional and provide a copy to the employee following completion of the medical evaluation. The   
notice will not contain any findings or diagnoses. The notice to the supervisor should contain the   
following:  
• A statement that the employee has been notified of the evaluation results  
• A statement that the employee has been notified of any medical conditions that may arise from   
the exposure which may require further treatment  
• All records must be kept in accordance with the Recordkeeping section of this Plan

# Laboratory Information Questionnaire

[Laboratory Information Questionnaire](https://acrobat.adobe.com/id/urn:aaid:sc:VA6C2:b47ea19b-a259-41d5-8e1a-4fb205b6c82d "Laboratory Information Questionnaire")

# Lab Inspection Cheat Sheet

[Lab inspection cheat sheet](https://astate-my.sharepoint.com/:x:/r/personal/mdooley_astate_edu/Documents/Lab%20inspection%20cheat%20sheet.xlsx?d=w455c52a5ab5d4c4593dd98b0024eae4d&csf=1&web=1&e=nD74ya&nav=MTVfezE5QkU1QzMxLTQ1NUEtNEU1RC1BMDZDLTc2NUFENzVGNDg5Mn0 "Lab inspection cheat sheet")

# CDC Training for Transporting Biological Materials

[CDC Training for Transporting Biological Materials](https://reach.cdc.gov/course/packing-and-shipping-dangerous-goods-what-laboratory-staff-must-know?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Flabtraining%2Ftraining-courses%2Fpacking-shipping-division-6.2-materials.html "CDC Training for Transporting Biological Materials")

# Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition

[Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition](https://www.cdc.gov/labs/bmbl/?CDC_AAref_Val=https://www.cdc.gov/labs/BMBL.html "Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition")

# Lab Inspection SOP

1\. PURPOSE  
The purpose of this procedure is to outline the process used for conducting laboratory inspections at   
Arkansas State University.   
2\. SCOPE  
This procedure applies to all laboratories of Arkansas State University.   
  
3\. DEFINITIONS   
3.1 Deficiency: A problem found during an inspection that must be corrected.   
  
3.2 PI: Principal Investigator   
3.3 Laboratories: All labs belonging to Arkansas State University campus including those off   
campus that contain biological, chemical, physical, or radiological hazards.   
3.4 PPE: Personal Protective Equipment   
3.5 DSL: Department Safety Liaison   
3.6 Inspection team: The person or persons inspecting a lab   
3.7 IDLH: Immediately Dangerous to Life or Health

4\. RESPONSIBILITIES   
4.1 Arkansas State University Department Heads  
4.1.1 Communicate the importance of following safety policies and procedures identified in the   
Arkansas State University Laboratory Safety Manual, Biological Safety Manual, Radiation   
Safety Manual and Hazardous Waste Management Plan.   
4.1.2 Encourage and support laboratories to conduct self-inspections using the self-inspection   
checklist and explanation key.   
4.1.3 Encourage Principal Investigators to correct deficiencies noted by the inspection team.   
4.2 Arkansas State University Principal Investigators and Lab Managers   
4.2.1 Understand and follow safety policies and procedures identified in Arkansas State   
University Laboratory Safety Manual, Biological Safety Manual, Radiation Safety Manual and   
Hazardous Waste Management Plan.   
4.2.2 Be aware of the self-inspection checklist and explanation key and use them to prepare for   
lab inspections.   
4.2.3 Ensure all deficiencies found during lab inspections are corrected by the appropriate   
deadline.   
4.3 Arkansas State University EHS   
  
4.3.1 Maintain and update the inspections webpage, self-inspection checklist and   
explanation key and other resources to assist researchers meet their safety and   
compliance responsibilities.   
4.3.2 Schedule and perform laboratory inspections according to the goals and objectives   
and this SOP.   
4.3.3 Follow-up on noted deficiencies according to this SOP.

5\. LABORATORY INSPECTION SCHEDULING   
5.1 The following steps are involved for scheduling laboratory inspections.   
1\) Send out email memo to PIs two weeks prior to the planned start date for inspections.   
Included in the email memo should be a link to the inspection template and a lab   
characterization sheet. The PI or lab representative may have to fill out and return the lab   
characterization sheet which includes a lab roster.   
2\) Send out a subsequent email memo one week prior to the initiation of inspections. This   
memo should include a list of the labs in a facility with the name of the person responsible for   
the lab attached. Request the PI or lab representative to ensure the information in the list is   
still correct.   
3\) Set schedule based on time requests by Principal Investigators or other lab representative.   
4\) Add inspection time to calendar with an invite for the appropriate DSL.   
  
5\) Complete the inspections per the schedule.   
6\) Notify PI or lab representative if critical deficiencies are found that will result in imminent   
closure of the lab (see DEFICIENCIES section below).   
7\) Give inspection results to the lab representative at the end of the inspection. A more detailed   
report may follow at a later time if further information is needed or is requested.   
5.2 While the scheduling period for a facility should be over the course of 4-6 weeks, exceptions   
should be made for labs whose PI wishes to present for inspections but whose schedule does   
not allow it during the given time period.   
6\. LABORATORY REPRESENTATION DURING INSPECTION  
6.1 The PI or his/her designee should be present during the lab inspection. The lab representative   
should be knowledgeable of the daily operations of the lab and must be employed by   
Arkansas State University.   
6.2 If the PI refuses to have lab representation for the inspection, carry out the inspection with   
the appropriate DSL present.   
6.3 If the PI refuses to have lab representation for the inspection and the appropriate DSL is not   
available, the case shall be referred to the Director of EHS.

6.4 If possible, the appropriate DSL should be present during some of the inspections.   
7\. INSPECTION  
7.1 Before the lab visit, a roster of the lab workers should be provided by the PI or other lab   
representative. Based on the lab characterization, the inspection team should check to be   
sure that all lab workers have completed all appropriate training.   
7.2 Prior to the inspection, the Principal Investigator in charge of the lab should have the lab   
users examine the inspection template to see items that will be checked. Correcting   
deficiencies prior to the inspection is allowed and encouraged.   
7.3 A representative of the lab should meet the inspection team outside of the lab to ensure that   
the inspection team is apprised of the hazards of the lab and have the appropriate PPE.   
7.4 During the inspection, the lab representative should stay with the inspection team to answer   
any question the team may have.   
7.5 The inspection should take anywhere from 20 minutes to an hour. Large labs may take longer   
than an hour. (Note: On the first round of inspections, the process may take longer due to the   
new procedure and the length of time since previous inspections).   
7.6 Only items addressed on the inspection form may be counted as deficiencies. If a critical item   
is found that is not on the checklist, it may be counted as a deficiency at the discretion of the   
Director of EHS.   
7.7 At the end of the inspection or by the end of the inspection day a copy of the inspection   
results are given to the lab representative. A more detailed report may be provided at a later   
time if necessary.   
7.8 It is the goal of EHS to visit each lab once per year. After going through the first round it may   
be determined that higher risk labs need more frequent visits while lower risk labs may only   
require biannual (every other year) inspections.   
8\. DEFICIENCIES  
8.1 Deficiencies are classified as non-compliant and critical   
8.2 Critical Deficiencies   
8.2.1 Deficiencies found that are IDLH can result in immediate closure of the lab. If such a   
deficiency is found:

8.2.1.1 Contact the PI responsible for the lab for immediate resolution.   
8.2.1.2 If the deficiency cannot be corrected immediately, the PI refuses to correct this   
deficiency or the PI or another lab representative cannot be reached:   
8.2.1.2.1 Contact the Director of EHS   
8.2.1.2.2 Once the director gives approval for closure of the lab, post signage stating   
that the lab is unsafe for entry and contact information.   
8.2.1.2.3 Contact the appropriate DSL to lock the lab   
8.2.2 If a deficiency is critical but is not IDLH, a time frame must be established for correction of   
the deficiency.   
8.3 Re-inspection on the basis of deficiencies   
8.3.1 A lab will be re-inspected if:   
8.3.1.1 A critical deficiency is found   
8.3.1.2 The number of other deficiencies is high enough to cause the total inspection   
percentage to be below 80%   
8.3.2 Re-inspection of labs will not be announced, but at least one week will be given to correct   
non IDLH deficiencies   
8.4 Correction of Deficiencies   
8.4.1 Whether or not re-inspection occurs, it is the responsibility of the PI to ensure that ALL   
deficiencies are corrected.   
8.4.2 Correction of deficiencies, can, in some cases, be evidenced to the inspection team by   
photograph.   
8.4.3 Continued failure to correct deficiencies to an acceptable level will result in an escalation   
process described in the next section   
9\. ESCALATION PROCESS

9.1 Unless the deficiencies found are sufficiently critical to the life and health of the lab workers   
or the regulatory status of the laboratory, laboratories will be given a minimum of two weeks   
to correct deficiencies.   
9.2 If upon follow-up inspection critical deficiencies remain unresolved or the laboratory   
inspection correct percentage remains below 80% an email message will be sent reminding   
the PI in charge of the lab and the appropriate DSL as to the status of the lab. An additional   
seven days will be given to bring the lab into compliance.   
9.3 If after these seven days the lab is still non-compliant (does not meet the criteria of 9.2),   
another email communication will be sent to the PI, the appropriate DSL and the Chair of the   
appropriate department. An additional seven days will be given to bring the laboratory into   
compliance.   
9.4 At this point the PI has had a minimum of 28 days to bring the lab into compliance. If the lab   
is still not in compliance, then a third email communication will be sent to the PI, the   
appropriate DSL, the Chair or the appropriate department and the Dean for the appropriate   
college.   
9.5 If the lab still fails to comply after two weeks of the dean being contacted, the Associate Vice   
Chancellor of Research or the Vice Chancellor for Academic Affairs (depending on whether   
the lab is a research lab or a teaching lab) will be contacted to inform them of the imminent   
closure of the lab due to non-compliance. Human Resources may also be contacted.   
9.6 Failure to bring a lab into compliance after the 28 days will also result in the refusal of the EHS   
to sign any safety documentation regarding grants or permits until such time as the lab is in   
compliance.   
9.7 Extensions to any of these periods may be granted at the discretion of EHS. A request for an   
extension should be requested by an email to the inspection team.   
9.8 The escalation process will NOT be used for lab inspection findings that are out of the control   
of the PI. For items outside the control of the PI a separate escalation process will be used.   
10\. REFERENCE DOCUMENTS FOR SELF-INSPECTION  
10.1 Included in the email to the PI regarding the scheduling of the inspection will be links to the   
following documents:   
10.1.1 A blank copy of the inspection form

10.1.2 An explanation of the criteria for each inspection item to achieve the highest level of   
compliance   
10.1.3 The Laboratory Safety Manual   
10.1.4 The Chemical Hygiene Plan   
10.1.5 The Biological Safety Manual   
10.1.6 The Hazardous Waste Management Plan   
10.2 Requirements to meet the minimum compliance level will be linked to the appropriate   
regulation or standard as a demonstration of why the item is being checked in the inspection.   
11\. BENEFITS FOR HIGH COMPLIANCE RATINGS  
11.1 Laboratories that have no critical deficiencies, score higher than 95% minimum compliance   
and meet the highest compliance level (currently called excellent) on 50% or more of the   
inspection items will have the advantage of the following benefits:   
11.1.1 A streamlined process for signing off on safety documentation for permits or grants   
wherever EHS has that responsibility   
11.1.2 Priority on inspection scheduling   
11.1.3 The opportunity to self-inspect in lieu of EHS inspections (high risk labs do not qualify)   
11.1.4 Other benefits TBD