Biohazard Agent Registration (BAR) Form For Infectious

======= biohazard agent registration (bar) form ======================================= for infectious agents/materials, rec

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Biohazard Agent Registration (BAR) Form
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for
Infectious Agents/Materials, Recombinant DNA & Biological Toxin
Registration
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Instructions:
*
Complete all pertinent Parts of the NKU Biohazard Agent
Registration (BAR) Form.
*
Print a copy, sign, and date the signature page. Do not return
these cover pages.
*
To facilitate future project updates, save an electronic copy of
the completed form.
*
Submit:
*
the completed and signed BAR Form
*
a curriculum vitae for the Principal Investigator or Course
Coordinator,
to [email protected]
*
Upon receipt and review of the BAR Form, the IBC will send a memo
indicating the status of the Form as “Accepted As Is” or
“Additional Comments/Changes Requested” to the Research Grants &
Contracts office.
*
Upon final review and approval, the Principal Investigator or
Course Coordinator will receive a memo indicating that the project
has been approved. Projects must be approved by the IBC before the
beginning of the work.
*
If you have any questions, please contact Anita Southwick at
859-572-5168 or [email protected].
Every Principal Investigator or Course Coordinator either performing
research with recombinant DNA or biological hazards or
coordinating/teaching courses involving recombinant DNA or biological
hazards must complete the following BAR Form Parts:
Part 1. General Information;
Part 2. Laboratory Information;
Part 3. Project or Course Description; and
Part 7. Certification and Signatures.
Only if appropriate, every Principal Investigator or Course
Coordinator must also complete the following BAR Parts for
biohazardous materials currently in use and/or in storage:
Part 4. If your project or course involves recombinant DNA.
Part 5. If your project or course involves the use of infectious
agents, potentially infectious materials, tissues, or cell culture.
Part 6. If your project or course involves biological toxins.
References useful when completing the BAR Form:
NIH Guidelines for Research Involving Recombinant DNA Molecules:
http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html
Risk Group (RG) Chart:
http://www.absa.org/resriskgroup.html
CDC BioSafety Guide
Biosafety in Microbiological and Biomedical Laboratories (BMBL) 4th
Edition (CDC-NIH)
“Select Agents” that require CDC or USDA registration BEFORE acquiring
the agent or toxin:
http://www.cdc.gov/od/sap/
World Health Organization Laboratory Biosafety Manual:
http://www.who.int/csr/resources/publications/biosafety/who_cds_csr_lyo_20034/en/
USDA/APHIS Biotech regulations and permits:
http://www.aphis.usda.gov/brs/index.html
USDA/APHIS Plant protection quarantine information and permits:
http://www.aphis.usda.gov/ppq/
CDC Import Permits:
http://www.cdc.gov/od/ohs/biosfty/imprtper.htm
Disinfection Resources: Consult your site Biosafety Officer.
Biosafety level information to be used when completing Parts 2, 4E and
5F of the BAR Form:
Research Biosafety Levels:
Biosafety Level 1 (BSL-1) – For agents not known to consistently cause
disease in healthy human adults.
Biosafety Level 2 (BSL-2) – For agents associated with human disease
or equivalent theoretical risk (i.e., human-derived agents,
adenovirus, trypanosome, retroviruses, non-human primate materials,
certain cell lines such as COS cells).
Biosafety Level 2 Plus (BSL-2+) – For agents associated with serious
human disease or equivalent theoretical risk and not transmissible via
the aerosol route (i.e., lentivirus). A hybrid biosafety level
utilizing BSL-3 practices and procedures in a BSL-2 laboratory. NOTE:
requires additional documentation, review, and notification.
Biosafety Level 3 (BSL-3) – For agents indigenous or exotic with
potential for aerosol transmission may have serious health effects or
equivalent theoretical risk (i.e., Mycobacterium tuberculosis). NOTE:
requires additional documentation, review, notification, and facility
design. Please notify the site Biosafety Officer well in advance of
your projected start date.
Animal Biosafety Levels:
Animal Biosafety Level 1 (BSL-1-N) – Risk Group 1 (RG1) materials
being administered to animals.
Animal Biosafety Level 2 (BSL-2-N) – Risk Group 2 (RG2) materials
being administered to animals.
Animal Biosafety Level 3 (BSL-3-N) – Risk Group 3 (RG3) materials
being administered to animals.
Part 1. General Information
===========================
A. BAR Project No.:_________ (Leave blank, to be assigned by the
Biosafety Committee)
Project Type: New Revision: No:   Continuation: IBC No:  
Research (Funded Grant #  ) Teaching (Course #   )
B. Project / Course Title:
C. Principal Investigator / Instructor: email:
Department/Group: Campus Addr:
Office Phone: Lab Phone:
D. List all project personnel: (Provide Principal Investigator /
Instructor curriculum vitae.)
Part 2. Laboratory Information
==============================
List all laboratories and facilities where work with biohazardous
agents and toxins is to be conducted. Indicate the corresponding
biosafety level, if applicable (refer to the list of biosafety levels
on page 2). Include cold rooms, animal workrooms and housing, as
appropriate. Also indicate rooms where biosafety cabinets (BSCs) are
located.
Check Box if Applicable
Building and Room Number
Biosafety Level of Room
Research Lab
Teaching Lab
BSC
Equip-
ment
Room
Cold Room
Animal Work and/or Housing
Other, please describe
Indicate all equipment used to manipulate the biohazardous materials
in this project:
Centrifuge (note type: tabletop, floor, and or microfuge):
Sonicator
Plate Washer
Syringes/Needles
Other (list):
Specify protective clothing and equipment utilized in this project:
Specify disinfectant(s) utilized to decontaminate surfaces and
equipment:
Part 3. Project Description
===========================
Briefly, outline the overall goal(s), or scope of the project or
course and the activities to be conducted. Provide sufficient
information about the techniques used, and purpose of the work for the
reviewers to understand what you have planned. Please use clearly
understood and reasonably non-technical (laymen’s) terms. Do not
insert research protocols. Please limit your description to 1-2
paragraphs.
Part 4. Use of Recombinant DNA
==============================
Please complete this section if you use or generate recombinant
microorganisms.
A. Source of Gene, Insert, or Clone:
1.
Specify DNA/RNA source, nature of insert, any a protein expressed,
and the percent of any viral genome in the construct:
2. If any sequences code for toxins, list the toxin and corresponding
LD50 (if known).
3. If the DNA source is from a regulated plant or animal (e.g., USDA)
and the regulated organism is grown or stored on site, indicate the
regulatory agency monitoring its use and please include a copy of the
regulatory permit. Consult references listed on cover page if you are
not certain that the material is regulated.
4. Will experiments result in acquisition of new characteristics such
as enhanced virulence, infectivity, drug resistance, or change in host
range of the organism that is being manipulated? If so, explain:
B. Vectors and Host Cells:
1. Identify general forms of cloning/expression/transfection vectors
used (e.g. bacterial plasmids, phage), recipient bacterial strains
(e.g. Eschericia coli K-12), and recipient host cell lines (human,
mouse, plant, etc.). Describe the location and type of promoters and
other control sequences and percent of any viral genome in each
construct.
2. If using viral vectors, indicate packaging cell lines and assay
system used to measure helper virus titer or titer of replication
competent virus (background) generated. Include host range of packaged
viral vector.
C. Biosafety Level covering Part 4 (circle one): BSL-1 BSL-2 BSL-2a
BSL-3
Part 5. Infectious Agents and Human/NHP/Animal Materials
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A.
Name the infectious microbial agent(s) in use or in storage, and
corresponding risk group (RG). Consult references listed on cover
page if you are not certain of the risk group and whether or not
the agent is regulated under HHS/USDA or Commerce Department.
Risk Group 1 (RG1) – not associated with disease in healthy adults.
Risk Group 2 (RG2) – associated with human disease, a preventative or
therapeutic intervention may be available.
Risk Group 3 (RG3) – associated with serious or lethal human disease,
a preventive or therapeutic intervention may be available.
List Agent(s):
(eg., Adenovirus Type 5, Helicobacter pylori, E. coli 0157)
Risk Group
(i.e., 1, 2 or 3)
HHS or USDA Select Agent? (yes/no)
Commerce Controlled Agent? (yes/no)
Room Number for Use and/or Storage
1. What is the host range (human, plant, animal) for each microbial
agent listed? If animals are within the host range, specify each
species potentially affected.
2. Describe the disease pathology and mode of transmission. Provide a
copy of the most relevant publication(s), if available.
3. Is a vaccine available? If yes, will project personnel be
vaccinated before project initiation?
B.
Human and Non-Human Primate Materials, and Materials from
Non-Living Animals Exempt from IACUC Review (sheep shoulder,
bovine brain, for example):
List Material(s): (e.g., blood/serum, blood components, cell lines,
unfixed tissues, organs, etc.)
Note: Use of human source material requires the Principal Investigator
to comply with all applicable facets of the Bloodborne Pathogen
requirements.
C. Source(s) of materials listed above in items A & B: (e.g., new
isolate from human tissue, blood, animal, tissue culture, another
laboratory or company, ATCC)
Do any of the materials listed in A & B require an import permit?
Consult references listed on cover page if you are not certain that
the material is regulated. If so, specify:
D. Experimental Procedures:
1.
Briefly, describe general procedures used to manipulate materials
listed in A & B, above (indicate culture volume, maximum
con­cen­tration). For bacterial agents, please indicate method of
culture (agar plates or liquid), size of culture and method of
liquid culture (aerated or static). How and at what stage of the
experiment is the infectious material inactivated or lysed? If the
material is transported to another lab within NKU or outside of
NKU, specify where it is being sent to and how it will be
transported.
2.
Will experiments result in acquisition of new phenotypic
characteristics of the microorganisms being manipulated, such as
enhanced virulence, infectivity, drug resistance, or change in
host range? If so, explain:
3.
Will the material(s) listed in items a/b/c be administered to
animals? If yes, please describe the method of administration and
dose. Also provide the IACUC Protocol Number.
E. Biosafety Level for Part 5 (circle one): BSL-1 BSL-2 BSL-2a BSL-3
Part 6. Toxins of Biological Origin
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A.
Name toxins (microbial and non-microbial) in use or in storage.
Consult references listed on cover page if you are not certain
that the agent is regulated under HHS/USDA or Commerce Department.
List Toxin(s):
(eg., Ricin, Cholera Toxin, Staph. Enterotoxin B)
HHS or USDA Select Agent Toxin?
Commerce Controlled Toxin?
Room Number for Use and/or Storage
B.
Describe the general procedures requiring the use of the materials
listed above. If the material is transported to another lab within
NKU (or outside of NKU), specify where it is being sent, and how
it will be transported.
C.
If you store or use any of the following U.S. Department of Health
and Human Services (HHS) “Select Agent Toxins” define the
approximate maximum inventory (i.e. amounts) stored under your
control, in your facility, at any given time.
Toxin
Regulatory Threshold Quantity Requiring CDC or USDA
Certificate of Registration
Site Maximum
Inventory
Quantity
Abrin
100 mg
Contotoxins
100 mg
Diacetoxyscirpenol
1000 mg
Ricin
100 mg
Saxitoxin
100 mg
Tetrodotoxin
100 mg
Shiga-likribosome inactivating proteins
100 mg
Botulinum neurotoxins
0.5 mg
Clostridium perfringens epsilon toxin
100 mg
Shigatoxin
100 mg
Staphylococcal enterotoxins
5 mg
T-2 toxin
1000 mg
Part 7. Certification and Signatures
====================================
The information contained in this Biohazard Agent Registration (BAR)
Form is accurate and complete. I am familiar with and agree to abide
by the provisions of the current NIH Guidelines and other specific NIH
instructions, and/or applicable country-specific regulations
pertaining to the proposed project described above. Further, I
similarly will abide by all NKU Policies, Procedures, and Guidelines,
and all local, regional, and national regulations relevant to the
manipulation, use and storage of all biohazardous agents and toxins.
In addition, I agree to abide by the following requirements:
A.
Initiate no recombinant DNA project work subject to the NIH
Guidelines until that project has been reviewed and approved by
the Institutional Biosafety Committee. All potentially
biohazardous work will be registered with and approved by the site
Biosafety Committee.
B.
Initiate no work with human materials subject to the OSHA
Bloodborne Pathogen Standard until an Exposure Control Plan has
been written and approved by the site Biosafety Officer and
personnel have had the required documented OSHA training.
C.
Assure the compliance with all appropriate national and
international shipping requirements for recombinant DNA materials,
biohazardous, and infectious agents.
D.
Make available to all affected workers, copies of the approved
protocols that describe the potential biohazards and the
precautions to be taken.
E.
Provide for the appropriate training of affected students and
workers in good microbiological practices and techniques required
to ensure safety for this project, in procedures for accidents and
incidents, housekeeping, and waste management.
F.
Assure the appropriate supervision of all affected students and
workers, and to correct work conditions that could result in
breeches of the NIH Guidelines, NKU Policies, Procedures, and
Guidelines, and applicable local, regional or national
regulations.
G.
Immediately inform my site Institutional Biosafety Committee of
any changes or anticipated changes in risk conditions affecting
the biohazardous agents and toxins under my span of control.
H. Complete all required training pertaining this study and
biohazardous agents and toxins.
I.
Verify that all staff and students working ont his project have
completed the required training pertaining to this study and
biohazardous agents and toxins.
H.
Principal Investigator Signature
Date
Biosafety Committee Review/Approval
Date of IBC or BC Approval
NKU Institutional Biosafety Committee Biohazard Agent Registration
2008
Reference only – do not return with completed BAR Form