UNH acknowledges its responsibility to provide a program for the safe handling, storage and disposal of biohazardous materials; to provide emergency response to incidents involving biohazardous materials; and to educate the UNH community about the safe use of these materials in research, teaching, and public service activities.

All work with biological materials must be registered with the Biological Safety Officer in the Office of Environmental Health and Safety. A one page Biological Materials Registration form can be downloaded and sent to the BSO for initial review. 

Biological Materials Registration Form

UNH established an Institutional Biosafety Committee (IBC) in compliance with the National Institutes of Health (NIH) Guidelines to develop policies and procedures which ensure the health and safety of all faculty, staff, students and visitors at UNH.  This committee also ensures compliance with all federal, state and local regulations.  The IBC reviews protocols for recombinant DNA, infectious agents, biological toxins and Select Agents. Large scale biological work (> 9.9 L) must also be approved by the IBC.

There are two levels of IBC review: Level 1 Registration requires full Committee review and approval prior to beginning work; and Level 2 Registration requires approval by the IBC Chair and BSO only, with quarterly notification to the IBC by the BSO.  Descriptions of the approval levels are below.  Forms should be submitted to the BSO and a risk assessment will be scheduled.  

Level 1 Review: Full IBC Review and Approval Prior to the Initiation of Work

rDNA Registration Form

Protocols included in the following categories of the NIH Guidelines for Research Involving Recombinant DNA Molecules must have IBC approval prior to the initiation of work. 

1. Section III-A of the NIH Guidelines: Experiments that Require Institutional Biosafety Committee Approval, RAC Review, and NIH Director Approval Before Initiation
2. Section III-B of the NIH Guidelines: Experiments That Require NIH/OBA and Institutional Biosafety Committee Approval Before Initiation
3. Section III-C of the NIH Guidelines: Experiments that Require Institutional Biosafety Committee and Institutional Review Board Approvals and RAC Review Before Research Participant Enrollment
4. Section III-D of the NIH Guidelines: Experiments that Require Institutional Biosafety Committee Approval Before Initiation
5. Section III-E of the NIH Guidelines: Experiments that Require Institutional Biosafety Committee Notice Simultaneous with Initiation
   1. Section III-E-1:  Experiments Involving the Formation of Recombinant DNA Molecules Containing No More than Two-Thirds of the Genome of any Eukaryotic Virus (those not included in other sections)
   2. Section III-E-2:  Experiments Involving Whole Plants (those not included in other sections)
   3. Section III-E-3:  Experiments Involving Transgenic Rodents  (those not included in other sections)
6. Section III-F of the NIH Guidelines: Exempt Experiments
   1. Section III-F-1: Those that are not in organisms or viruses.
   2. Section III-F-2: Those that consist entirely of DNA segments from a single nonchromosomal or viral DNA source, though one or more of the segments may be a synthetic equivalent.
   3. Section III-F-3: Those that consist entirely of DNA from a prokaryotic host including its indigenous plasmids or viruses when propagated only in that host (or a closely related strain of the same species), or when transferred to another host by well-established physiological means.
   4. Section III-F-4: Those that consist entirely of DNA from a eukaryotic host including its chloroplasts, mitochondria, or plasmids (but excluding viruses) when propagated only in that host (or a closely related strain of the same species).
   5. Section III-F-5: Those that consist entirely of DNA segments from different species that exchange DNA by known physiological processes, though one or more of the segments may be a synthetic equivalent. Appendices A-I through A-VI of the Guidelines list the natural exchangers that are exempt from the NIH Guidelines (http://oba.od.nih.gov/oba/rac/Guidelines/APPENDIX_A.html). 
   6. Section III-F-6: Those that do not present a significant risk to health or the environment, as determined by the NIH Director, with the advice of the RAC, and following appropriate notice and opportunity for public comment.  Appendix C of the Guidelines lists classes of experiments which are exempt from the NIH Guidelines (http://oba.od.nih.gov/oba/rac/Guidelines/APPENDIX_C.html).

Full text of the NIH Guidelines can be found at http://oba.od.nih.gov/rdna/nih_guidelines_oba.html, if clarification on any section is needed.  It is the Principal Investigator’s responsibility to determine what section of the Guidelines their work falls into.  The Biological Safety Officer can offer assistance in determining the section and will confirm the section when the risk assessment is completed.

Work with Risk Group 3 agents, Select Agents, Biological Toxins and all Large Scale work also requires a Level 1 Review.

Infectious Agent Registration Form

It is strongly recommended that PI’s present their proposals to the committee in person during the quarterly IBC meeting to answer any technical questions that may come up.  Following the IBC meeting, the BSO will draft an approval letter with the terms and conditions of the approval, including an expiration date of up to 3 years.  The BSO will require brief annual updates on approved level 1 projects.

Level 2 Review: Notification to the IBC

Level 2 Review Form

Protocols included in this section require notification to the IBC but full IBC approval is not necessary for the work.  Approval for projects in this category will be granted by the IBC Chair or designee and Biological Safety Officer.

1. Research, teaching and service labs using RG2 agents or materials known to harbor RG2 agents (Note: RG3 agents are prohibited in teaching labs.)
2. Research, teaching and service involving potentially infectious materials, including, but not limited to:
   1. unfixed tissue of human or animal origin
   2. animal and human cell lines
   3. all bodily fluids from animals or humans
   4. insect vectors of disease, such as ticks, fleas, mosquitoes, biting flies, etc.
   5. environmental samples that may harbor pathogenic or zoonotic agents, but are not known to harbor such agents

A summary of the registrations in this category will be given by the BSO to the IBC each quarter, when applicable. The BSO will require periodic updates on all Level 2 projects.

Applications are due by November 30, 2012 for consideration at the December 13th meeting.

If you have any questions regarding the use of biological materials and the process for registering work, please contact the Biological Safety/Security Officer.