BSL-3 Research
Research Requiring Biological Safety Level 3 (BSL-3) Containment

All work requiring Biosafety Level 3 (BSL-3) containment must be submitted to the Institutional Biosafety Committee (IBC) for review and approval prior to initiation of studies. 

The 5th edition of Biosafety in Microbiological & Biomedical Laboratories (BMBL) defines Biological Safety Level 3 as applicable to clinical, diagnostic, teaching, research, or production facilities where work is performed with indigenous or exotic agents that may cause serious or potentially lethal disease through the inhalation route of exposure. Laboratory personnel must receive specific training in handling pathogenic and potentially lethal agents, and must be supervised by scientists competent in handling infectious agents and associated procedures.

Working at Biosafety Level 3 (BSL-3)

BSL-3 laboratory facilities ensure safe working conditions for researchers carrying out studies requiring stringent levels of biological containment.

Work with agents or materials at BSL-3 requires registration, approvals, and training beyond that required for other basic research at Penn as set forth by federal regulations, CDC/NIH guidelines, and Penn policy.

The IBC is responsible for approving all BSL-3 research proposals and for granting access to users based upon prior proficiency and training. A BSL-3 Biosafety Manual describing all procedures that must be followed by researchers carrying out projects in the BSL-3 facility is made available during training.

Request for Access to BSL-3 Laboratories

Access to Biosafety Level 3 (BSL-3) laboratories requires mandatory, recent (within the past five years), full time, documented experience*; registration with and approval by the Institutional Biosafety Committee (IBC), and BSL-3 specific training.  Please submit a complete application consisting of all of the documentation detailed on the checklist available below to the IBC.  All applications must be reviewed and approved by the IBC before training and proficiency testing is initiated.  Request for access must be submitted and signed by the Principal Investigator.  Approved applications will require an interview with a Biosafety Officer and clearance for work in containment lab from Occupational Medicine, before initiation of training.

 

*Required experience guidelines

Virus work:
2 years, full time, tissue culture
1 year, mammalian virology

OR
Documented and verified BSL-3 experience (i.e. TB) from another institution (NOTE: HIV work does not count as BSL-3 experience)

Specimen processing:
Most specimens will not require use of BSL-3 lab
For processing specimens requiring BSL-3 containment, personnel must have >1-year, full time experience, in the proposed method of processing

 

Application Documents for Access to BSL-3 Laboratories:

BSL-3 Access Instructions

          (1) BSL-3 Form I Checklist

          (2) BSL-3 Form II Justification

          (3) BSL-3 Form III Access Request

          (4) BSL-3 Form IV Background & Experience

          (5) BSL-3 Form V Agent Registration

          (6) BSL-3 Form VI SOP TOC

 

BSL-3 Training Requirements:

The BSL-3 training program consists of didactic, hands-on training, and observation sessions under the supervision of a Biosafety Officer (BSO) or IBC-approved trainer. Training is focused on developing competency in the trainee's IBC-approved SOPs and general BSL-3 procedures including donning and doffing PPE, waste management, and emergency response. Training progression will depend on the level of prior experience and skill of the individual trainee. 

BSL-3 Training Overview

 

Arthropod Containment

The use of arthropods which are intentional carriers of pathogens presents unique containment challenges for researchers. The Arthropod Containment Guidelines (ACG), developed in part by members of the American Committee on Medical Entomology (ACME) of the American Society of Tropical Medicine and Hygiene (ASTMH), recommends biosafety measures specific for arthropods of public health importance. These guidelines address risk assessment, practices, safety equipment, and facility design to provide levels of containment for arthropod research in the laboratory. 

Arthropod Containment Guidelines (pdf)

Studies Involving Arthropods Infected with Zika Virus

From the Centers for Disease Control (CDC): "In areas where the Zika virus has not been established in the mosquito population, in order to reduce the risk of environmental establishment, Arthropod Containment Level 3 (ACL-3) should be used for all work with live, infected arthropods." 

Disposal of Transgenic Arthropods 

To comply with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acids, the IBC set the Transgenic Arthropod Containment and Disposal Standard to prevent the accidental release of transgenic arthropods into the environment. All transgenic arthropods, including but not limited to Drosophila melanogaster (Common Fruit Fly), must never be discarded in the regular trash or down the drain. Instead, after euthanasia, old stocks and vials must be disposed of as biohazardous waste. Flies caught in ethanol and/or mineral oil must be disposed of as chemical waste and picked-up by Penn's Chemical Waste Team. Any deviation of this disposal standard must be reviewed and approved by the IBC. Specific guidance will be provided to labs based on school and lab location.

Transgenic Arthropod Containment and Disposal Standard

Disposal of Transgenic Animals Fact Sheet

 


Plant Containment

Transgenic Plants

Research involving genetically modified plants and plant-associated microorganisms and small animals must comply with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. Appendix P of the NIH Guidelines specifies physical and biological containment conditions and practices suitable for this research. 

Work involving the generation and/or use of transgenic plants must be reviewed and approved by the Institutional Biosafety Committee (IBC).

Permits

Permits are required for the importation into the U.S. and transit through the U.S. of regulated plants and plant products for consumption or propagation.

APHIS Plant and Plant Product Permits

Various plant pathogens (microorganisms such as bacteria, fungi, phytoplasmas, viruses; small animals (such as nematodes, arthropods) that are injurious or cause disease in plants are subject to federal and international regulations. Permits are required for the importation, transit, domestic movement and environmental release of Organisms that impact plants, and the importation and transit of Plants and Plant Products

Plant Health Import Permits