Biosafety Program

Announcements

Biosafety Program-Laboratory Close-out Procedure

September 21, 2018
All laboratory rooms, where biohazardous materials and equipment are used/stored, needs to be cleaned up/decontamination, cleared with safe final disposition of biohazardous materials before being vacated, whether due to a principal Investigator leaving the institution, relocating or terminating laboratory research activities, or a renovation project.

The PI and/or the PI's department are responsible for ensuring that the space, including shared space, is cleared of all biohazards belonging to the PI prior to the transfer to the next occupant, and that all biological materials are removed/disposed prior to vacating the space. All remaining equipment, including biosafety cabinets freezers, incubators, must be properly decontaminated, as well as all surfaces, such as counters/bench tops. PIs/Departments must document the decontamination process for closeout of labs using biohazards using the following form Decontamination of Equipment Prior to Relocation and/or Lab Closeout.

Biosafety program staff should be notified of pending moves/closures in advance, preferably at least one month. Once notified, biosafety program staff will provide additional guidance and assistance during the process to facilitate transfer/removal of biohazardous material from the laboratory and leaving these facilities in a safe condition.

Review and follow general closeout guidance/procedures.

As a team, we will jointly help you to safely and efficiently vacate your lab spaces.

Questions or concerns regarding Lab closeout, please email Biosafety staff at Biosafety@usf.edu

October 2017 is National Biosafety Month

Institutional Biosafety Committee (IBC) and the Research Integrity and Compliance would like you to know that October is National Biosafety Month.

National Biosafety Month #NBM2017 is a time to provide awareness for Biosafety here at #USF labs and promote opportunities to take steps to improve Biosafety protocols and procedures, minimize the risk of potential exposures, and ensure personnel are properly trained in safe laboratory biosafety practices.

We encourage USF researchers to review, share, and participate as part of an already ongoing effort.

  • Share this new resource with researchers/staff for # NB2017 Guiding Principles for Biosafety Governance (PDF) 
  • Review emergency plans, accidental spills/ personal contamination SOPs, and ensure that biological spill kits are available
  • Reinforce attention to biosafety policies, practices, and procedures for those all who work with biohazardous materials
  • Encourage staff to report any incidents, exposures, and near misses promptly to help provide lessons learned regarding optimal responses to incidents and identification of strategies to minimize risk
  • Submit renewals of IBC protocols for the use of infectious/biological agents via the new web-based electronic BiosafetyNet https://arc.research.usf.edu/Safety/
  • Complete annual biosafety training via a live in person training session or online web-based initiatives– information available at Biosafety Program website
  • Visit the USF Biosafety webpage and Follow us @USFResearch #USFBiosafety

If you need assistance in assessing your lab's compliance with biosafety practices and procedures, training or Institutional Biosafety Committee registration and approval, our department is always available to assist you. Email biosafety@usf.edu.


References and Resources:

BiosafetyNet Launches

USF Research & Innovation is excited to announce that it is transitioning to a new secure information system BiosafetyNet. BiosafetyNet is now available for USF faculty and staff to submit their Institutional Biosafety Committee (IBC) protocols electronically. BiosafetyNet will enable the transition from paper‐based submissions to a more streamlined electronic IBC submission process.

BiosafetyNet will allow you and your staff to submit new protocols, protocol change requests, study team updates, annual reviews and protocol renewals, all online. Full implementation will occur on January 1, 2018, at which time paper submissions of new research protocols will no longer be accepted.

BiosafetyNet is located within RIC's Applications for Research Compliance (ARC). The new system will guide users through customized menus so they can take appropriate action specific to the documents at hand. BiosafetyNet generates automated email notifications as well as organizing and storing all study-related communications and records pertinent to both active and inactive protocols.

We are excited that the IBC is going electronic with BiosafetyNet.

Publication of final rule for Bacillus cereus Biovar anthracis

Effective 04/12/2017 - HHS/CDC adopts the interim final rule adding B. cereus Biovar anthracis to the list of HHS select agents and toxins, to be regulated as a Tier 1 agent, as final without change.

The final rule was published April 12, 2017, in the Federal Register, along with a response to public comments. CDC received two comments, both of which supported the rule change.

In accordance with the interim final rule, any individual or entity that is in possession of B. cereus Biovar anthracis is required to either register in accordance with 42 CFR Part 73 or amend their current registration in accordance with 42 CFR § 73.7(h) and meet all of the requirements of the select agent regulations (42 CFR Part 73).

Going forward when a request to use B. cereus is submitted, the PI will need to provide assurance that the requested strain is not Bacillus cereus Biovar anthracis.

Institutional Biosafety Committee (IBC) Launch of BiosafetyNet

USF Research & Innovation is pleased to announce that USF faculty and staff will soon be able to submit their Institutional Biosafety Committee (IBC) protocols electronically. BiosafetyNet, USF's implementation of Huron Consulting Group's Click™ Safety product, will enable the transition from paper-based submissions to a more streamlined electronic IBC submission process.

BiosafetyNet will allow faculty and staff to submit new protocols, protocol change requests, study team updates, annual reviews and protocol renewals, all online. Members of USF Research Integrity & Compliance and Research Technologies are currently in the development phase of this initiative. Several research faculty and staff have also joined the effort as Project Champions to provide feedback and input.

BiosafetyNet's pilot phase will begin in summer 2017, followed by a full transition to electronic submissions for all new IBC studies.

October 2016 is National Biosafety Month

The NIH Office of Science Policy has announced the 3rd annual National Biosafety Month, October 2016. The theme of this year's National Biosafety Month is: Evaluation, Collaboration, and Commitment.

National Biosafety Month is an opportunity to raise awareness about the importance of Biosafety and seek input from investigators on ways to strengthen institutional biosafety programs. Focusing on biosafety awareness during October gives researchers the opportunity to take steps to improve protocols and procedures, minimize the risk of potential exposures, and ensure personnel are properly trained in safe laboratory practices. Efforts should be made to highlight the proper ways to report accidents, exposures, near misses and other potential problems to supervisors and biosafety professionals.

USF researchers are strongly encouraged to participate by:

  • Fulfilling your annual Biosafety Training module—this can be completed online or live—information available at Biosafety Program website
  • Reviewing and updating SOPs for use of work involving infectious agents and/or recombinant or synthetic nucleic acid molecules to ensure that all personnel are familiar with them.
  • Spending some time during October to conduct inventories for infectious agents. Check all your refrigerators, freezers, and cabinets for forgotten or abandoned agents or samples. Assure these are safely removed and properly disposed.
  • Ensuring all materials, even within communal storage spaces, are well-labeled.
  • Updating IBC protocols to reflect all infectious agents and all use and storage locations.
  • Reviewing the training of all laboratory members and ensuring correct documentation including General Biosafety and laboratory-specific training.
  • Reviewing emergency plans, accidental spills/ personal contamination SOPs and ensure that biological spill; kits are available.
  • Encouraging staff to report any incidents, exposure and near misses promptly to help provide lessons learned regarding optimal responses to incidents and identification of strategies to minimize risk.
  • Providing feedback to biosafety staff for ways to strengthen institutional biosafety program.

Let's work together this month to promote biosafety and conscientious research practices that will strengthen the Culture of Safety at University of South Florida. If you need assistance in assessing your lab's compliance with biosafety practices and procedures, training or Institutional Biosafety Committee registration and approval our office is always available to assist you. Visit the USF Biosafety webpage or email us at biosafety@usf.edu.

Also follow us at #USFBiosafety.

References and Resources:

Revised IBC Non-Exempt rDNA Registration Application Form - Rev 8/16

The Institutional Biosafety Committee (IBC) periodically updates the USF Biosafety Registration Application forms. The updates incorporate changes in federal guidelines, university policies/procedures and improvements in the IBC review process. Our Non-Exempt rDNA application has been updated. The newly updated version of the IBC registration form has been posted on the Biosafety Program website.

Please begin using the new forms for your submissions as soon as possible. We will continue to accept submissions on the previous version of the form until the November IBC Meeting. After the November IBC meeting, the IBC will require that Principal Investigators use forms dated "Rev. 08/2016." Earlier versions will not be accepted and/or processed—applications submitted on earlier versions will be returned for re-submission on the current forms.

IBC Policy Manual Update - July 2016

8.7.4 Animals that are infected with lentiviral/retroviral vectors, must utilize an Animal BSL-2 (ABSL-2) containment area for the procedure(s). ABSL-2 housing is required due to the replication-defective virus may revert or recombine in vivo thereby causing the vector to become replication competent. In turn this live virus may be shed from the animal and pose a potential exposure to those handling animals, animal bedding, feces, etc.

  1. Animals exposed to replication incompetent lentiviral/retroviral vector(s) as a part of the research protocol, must be housed under Animal BSL-2 (ABSL-2) containment practices for:
    • The life of the study for direct administration of other viral vectors (e.g. Lentivirus, retrovirus) that are co-administered with human cells to the animals
    • Seven days for direct administration of other viral vectors (e.g. Lentivirus, retrovirus) that are not co-administered with human cells to the animals
  2. Precautions must be taken to minimize aerosol creation (e.g., emptying animal waste material, washing down cages, cleaning the room with water hoses).

14.3 Biosafety containment practices, facilities, and equipment are assessed as part of the registration approval process but prior to the initiation of the project. Biosafety laboratory audits will be conducted for materials requiring BSL-2 and/or BSL-3 containment:

  1. As part of the IBC approval process of a research/teaching registration study
  2. Submission of new application unless an inspection of the lab space has occurred within a year
  3. Modification to a protocol for addition of lab spaces

The biosafety audits will be scheduled in advance whenever possible. However, unannounced and follow-up inspections may also be conducted.

14.5 Lab Inspections are not required for the following applications:

  1. Human Gene Transfer studies that occur in a clinical setting. Standard precautions which are the clinical equivalent of BSL-2 are used in these settings. The Biosafety office will not inspect these facilities as they defer to the inspections performed by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) as acceptable standard precautions inspections in lieu of BSL-2 at the current time for these clinical areas.
  2. Exempt recombinant DNA application
  3. Storage applications

Association of Public and Land-grant Universities' (APLU) releases A Guide to Implementing a Safety Culture in Our Universities

Seeking to provide a roadmap for university-wide efforts to renew and strengthen a culture of research safety, the Association of Public and Land-grant Universities' (APLU) Task Force on Laboratory Safety today released its Guide to Implementing a Safety Culture in Our Universities. The task force also released a companion website, www.aplu.org/researchsafety intended to make the guide more accessible and allow for the continued sharing of best practices and other information to improve safety at research universities nationwide. We would like to thank Raymond Hackney, DrPH, CBSP of Duke University for representing ABSA International on this task force.

Revisions to the NIH RAC Review Process for Gene Transfer Protocols

On March 22, 2016, the National Institutes of Health (NIH) announced a streamlined review process for human gene transfer protocols subject to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). These changes are described in detail in a notice published in the Federal Register (PDF) and will go into effect on April 27, 2016.

As background, the changes to the human gene transfer protocol review process are being made after NIH, in consultation with the Institute of Medicine, determined that the NIH Recombinant DNA Advisory Committee's (RAC) review of individual human gene transfer trials should be limited to cases in which an oversight body (such as an Institutional Biosafety Committee or an Institutional Review Board) determines that a protocol would significantly benefit from RAC review, and has been determined to meet one or more of the following criteria:

  • The protocol uses a new vector, genetic material, or delivery methodology that represents a first-in-human experience, thus presenting an unknown risk; or
  • The protocol relies on preclinical safety data that were obtained using a new preclinical model system of unknown and unconfirmed value; or
  • The proposed vector, gene construct, or method of delivery is associated with possible toxicities that are not widely known and that may render it difficult for oversight bodies involved to evaluate the protocol rigorously.

Human gene transfer protocols may also be reviewed by the RAC if the NIH Director determines a protocol presents significant scientific, societal, or ethical concerns.

As before, all human gene transfer protocols subject to the NIH Guidelines will continue to be registered with the NIH and be reviewed and approved by institutional oversight bodies such as the IBCs and IRBs. However, to accommodate the new registration and review process described in the amended NIH Guidelines, several changes are being implemented. The principal investigator will remain responsible for submitting documentation regarding a proposed human gene transfer protocol to local oversight bodies and to the NIH as outlined in the NIH Guidelines, but documentation submitted to the NIH shall also include written assessments originating from all oversight bodies involved in the review at an initial site(s) as to whether RAC review is warranted. Also, in an effort to reduce administrative burden associated with the protocol registration process, the NIH is reducing the document submission requirements as outlined in Appendix M-I-A.

For more detailed information on the revised review process, please see the notice published in the Federal Register on specifying the changes to the NIH Guidelines. Additionally, a set of FAQs will be posted to the Office of Science Policy Website in the upcoming weeks.

A summary of the changes can be found in the following RAC Revisions Factsheet (PDF).

 

October is National Biosafety Stewardship Month October 2015

National Institutes of Health (NIH) has designated this year, October as National Biosafety Stewardship Month for the NIH

The month-long campaign serves as a reminder to all to be vigilant in ensuring constant attention to biosafety standards.

Focusing on biosafety stewardship during October gives researchers the opportunity to take steps to improve protocols and procedures, minimize the risk of potential exposures, and ensure personnel are properly trained in safe laboratory practices. Efforts should be made to highlight the proper ways to report accidents, injuries and other potential problems to supervisors and biosafety professionals.

USF researchers are strongly encouraged to participate by:

  • Fulfilling your annual Biosafety Training module—this can be completed online or live—information available at Biosafety Program website.
  • Reviewing and updating SOPs for use of work involving infectious agents and or rDNA to ensure that all personnel are familiar with them.
  • Spending some time during the remaining weeks of October to conduct inventories for infectious agents. Check all your refrigerators, freezers, and cabinets for forgotten or abandoned agents or samples. Assure these are safely removed and properly disposed.
  • Ensuring all materials, even within communal storage spaces, are well-labeled.
  • Updating IBC protocols to reflect all infectious agents and all use and storage locations.
  • Reviewing the training of all laboratory members and ensuring correct documentation including General Biosafety and laboratory-specific training.
  • Reviewing emergency plans, accidental spills/ personal contamination Sops and ensure that biological spill; kits are available.
  • Encouraging staff to report any incidents promptly to help provide lessons learned regarding optimal responses to incidents and identification of strategies to minimize risk.

Let's work together this month to promote biosafety and conscientious research practices that will strengthen the Culture of Safety at University of South Florida.

If you need assistance in assessing your lab's compliance with biosafety practices and procedures, training or Institutional Biosafety Committee registration and approval our department is always available to assist you. Email biosafety@usf.edu.

References and Resources:

Multiagency webinar: The Importation and Exportation of Infectious Biological Agents, Infectious Substances and Vectors; Public Webcast

September 16, 2015 - 11:00 am to 4 pm

This public webcast will address import and export regulations for infectious biological agents, infectious substances, and vectors, and import and export exemptions. The purpose of this notice is to inform all interested parties, including those individuals and entities already possessing an import or export permit (or license) of the webcast.

If you are interested in attending the live webinar please RSVP for a head count at biosafety@usf.edu

News from the NIH Program on Biosecurity and Biosafety Policy

August 28, 2014

NIH Announces the launch of "National Biosafety Stewardship Month" — Recent reports of lapses in biosafety practices involving Federal laboratories have served to remind us of the importance of constant vigilance over implementation of biosafety standards. These events potentially put individuals at risk, undermine public confidence in the research enterprise, and must be addressed to prevent their reoccurrence. Efforts to strengthen biosafety oversight and practice must be supported and carried out by organizational leadership, biosafety programs, and individual laboratories.

As a measure toward preventing future lapses as well as promoting stewardship of the life sciences and biosafety awareness across Federal entities, Federal laboratories will reinforce their attention to safe practices in biomedical research. In that regard, the NIH and other HHS agencies will be instituting National Biosafety Stewardship Month. NIH grantee institutions are also encouraged to participate in this important initiative. The NIH Director, Dr. Francis Collins, recently sent a memo to IBC chairs, IBC contacts, and biological safety officers urging their participation in the National Biosafety Stewardship Month. Additional information for grantees on this initiative can also be found in the NIH Guide Notice for Grants and Contracts.

During the month of September, NIH laboratories will, and NIH grantee institutions are encouraged to reexamine current policies and procedures for biosafety practices, conduct inventories of infectious agents and toxins in all laboratories, and reinforce biosafety training of investigators, laboratory staff, and members of IBCs.

New OBA Brochure:
Investigator Responsibilities Under the NIH Guidelines for Research Involving Recombinant DNA Molecules

OBA has developed a brochure that describes "Investigator Responsibilities Under the NIH Guidelines for Research Involving Recombinant DNA Molecules." The brochure is intended to educate investigators and others about the NIH Guidelines and the specific biosafety, educational, and reporting tasks that investigators are expected to fulfill when conducting recombinant DNA research. Institutional officials may wish to disseminate this brochure as part of biosafety training, faculty orientation, courses on the responsible conduct of research for trainees and fellows, and other activities in which faculty and staff are discussing research practices.