SAINT LOUIS UNIVERSITY
INSTITUTIONAL BIOSAFETY
COMMITTEE
RESEARCH PROTOCOL
APPLICATION FORM
(VERSION: August 2015)
FOR IBC USE ONLY
Date Received:
IBC #:
NIH Guidelines recombinant experiment class determination:
III-A
RAC review, IBC & NIH Director approval before initiation
III-B
Requires NIH/OBA and IBC approval before initiation
III-C
Requires IBC and IRB approvals and RAC review before research
participant enrollment
III-D
Requires IBC approval before initiation
III-E
Requires IBC notice simultaneous with initiation
III-F
Exempt from NIH Guidelines
N/A
Does not involve recombinant materials
Biosafety Level (BSL) Required:
Approved
Disapproved
IBC #:
Date Approved:
IBC Chair Signature:
_______________________________
INSTRUCTIONS: Investigators must complete all questions of Section I (NEW SUBMISSION) and Section IV (DESCRIPTION
OF RESEARCH USE). Investigators must also complete sections II and III if these sections apply to the research being
conducted. All research at Saint Louis University, an NIH funded institution, must be conducted in accordance with the NIH
Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines). Compliance with the NIH Guidelines is a
condition of funding for institutions receiving NIH funds.
NOTE: Double-click on the checkbox to insert a checkmark.
SECTION II – BIOLOGICAL AGENT(s) (Includes human cells, toxins, bacteria, fungi, prions, viruses, etc.)
SECTION III – RECOMBINANT OR SYNTHETIC NUCLEIC ACID (rsNA)
SECTION I – NEW SUBMISSION Complete this section for all new protocol submissions. If amending a
previous application, please complete and submit a Form for Amendment of an IBC Approved Project.
Only typewritten submissions are considered. Handwritten submissions will be rejected.
1.
Principal Investigator (PI) name:
a. Position Title:
b. Department/Division:
2.
Application Title:
3.
Grant Start Date (if applicable):
CERTIFICATION AND SIGNATURE
The following information in this protocol is accurate and complete. As Principal Investigator, I agree to comply with federal, state and
university requirements pertaining to handling, shipment and transfer of biological materials. I agree to accept responsibility for the training of
all workers involved in this project.
By typing in your name as the Principal Investigator below, this document is electronically signed. A written signature will be needed upon
IBC approval.
Principal Investigator signature:
Date:
Co-Investigator/Faculty Mentor signature (if applicable):
Date:
Please send this form to the Saint Louis University IBC Office, Caroline C305.
Application Current as of 2/12/2016
1
4.
By my electronic signature below I, an employee in the laboratory in which a biological agent is to be used, affirm that I have
read and have been trained in the techniques presented in the following pages of this document along with the procedure for
handling biological spills in this laboratory. I have had the opportunity to ask questions, and have received answers to all of my
questions. My signature further indicates that I understand the importance of following carefully all of the provisions of this
Protocol so that my fellow employees, visitors to the University, the environment, and I will be adequately protected from the
possibility of contact with this biological agent. I have been informed of the symptoms that would occur if I become infected
with or exposed to any biological agent specified within this application. I will promptly report any spill or other release of the
biological agent to my supervisor and to the Office of Environmental Safety (977-6888), as stated by Appendix C: Emergency
Spill Procedures.
Name of P.I. and Employees.
Signature
(copy and paste lines if needed)
5.
Phone Number
Date of Last Lab. Annual
Training (In Banner)
Banner ID
Identify all laboratories, culture rooms, cold rooms, common equipment rooms, clinic areas or other areas in which the biological
agent(s) or toxins will be stored or manipulated:
Building Name
Room Number
Type of Room/Functions Performed
Application Current as of 2/12/2016
2
SECTION II – BIOLOGICAL MATERIALS, INCLUDING TOXINS
Complete section if work entails manipulations with human and animal cells, bacteria, fungi, prions, viruses,
toxins and/or plasmids
6.
Does this section apply for the research protocol? If not, Select “No” and continue to Section III.
7.
Identify microorganisms you are proposing to use by listing them in the table below (Include all strains/variants):
Full name of biological materials
(rsNA, toxins, bacteria, viruses,
fungi, Protozoa, human-derived
Materials (including human cell
Lines)).
Identify the Risk Group
(RG 1, 2, or 3) of the
biological agent.
(BMBL 5th Ed.)
(See Sect II,
Table 1)
Specify the Proposed
Containment Level
(BSL 1, 2, or 3) of the
biological agent.
(BMBL 5th Ed.)
Yes
No
N/A
Identify the common name
of the biological material
(if applicable)
A.
B.
C.
D.
E.
F.
G.
H.
I.
J.
K.
L.
M.
8.
List the total liquid volumes of the biological agents that will be manipulated at a single
time or in a single experiment:
9.
List the maximum concentrations or titers of the biological agents that will be manipulated:
10. If viral, is the virus replication-competent?
Or: Is the virus replication-incompetent?
If competent, is the virus replication attenuated?
Describe the mutation(s) that make the virus attenuated or incapable of replication:
Yes
Yes
Yes
No
No
No
N/A
N/A
N/A
11. Does the experiment involve or does a microorganism used in the experiment synthesize a
toxic molecule?
Yes
No
N/A
12. Does the experiment involve a Select Agent?
If yes:
a. Indicate which agent using Appendix B: Select Agent List:
b. TIER 1 Screening: Is the agent specified in 12a. included among the agents listed below?
c. DURC Screening: Is the agent specified in 12a. included among agents listed below?
Yes
No
N/A
Yes
Yes
No
No
Application Current as of 2/12/2016
3








Avian influenza virus (highly
pathogenic)
Bacillus anthracis
Botulinum neurotoxin
(any quantity)
Burkholderia mallei
Burkholderia pseudomallei
Ebola virus
Foot-and-mouth disease virus
Francisella tularensis







Marburg virus
Reconstructed 1918 influenza virus
Rinderpest virus
Toxin-producing strains of Clostridium
Botulinum
Variola major virus
Variola minor virus
Yersinia pestis
13. Type of funding source(s) for the Select Agent Work? Select all that applies.
Department/Institutional funds
Foundation
Federal funds
Business/Industry
Other
a.
If project is supported with Federal funds, list the name of the funding agency and grant or contract number:
14. Gain of Function Screening: The PI is required to assess whether any research directly involving any agents listed in 12a. of
this application produces, aims to produce, or is reasonably anticipated to produce 1 or more of the experimental effects listed
below.
a. Answer the following for gain-of-function surveillance. If checked Yes, please explain below– Does the experiment:
i.
Enhance the harmful consequences of the agent or toxin?
Yes
No
ii.
Disrupt immunity or the effectiveness of an immunization against
Yes
No
Yes
No
, transmissibility, or ability to be disseminated?
Yes
No
Alter the host range or tropism of the agent or toxin?
Yes
No
Yes
No
Yes
No
the agent or toxin without clinical or agricultural justification?
iii. Confer to the agent or toxin resistance to clinically or agriculturally
useful prophylactic or therapeutic interventions against that agent or
toxin or facilitates their ability to evade detection methodologies?
iv. Alters properties of the agent or toxin in a manner that would enhance its stability
v.
vi. Enhances the susceptibility of a host population to the agent or toxin?
vii. Generate or reconstitute an eradicated or extinct agent or toxin
listed in Appendix B below?
As a reminder, if there is a change in this research with respect to the applicability of any of the above seven experimental
effects, or if the PI, for any reason, thinks the research needs to be reconsidered by the IBC for Gain of Function potential,
the PI should submit this form again to the IBC with his/her revised assessment.
For guidance on assessing the risk of the above experiment types, visit:
http://oba.od.nih.gov/biosecurity/pdf/Framework%20for%20transmittal%200807_Sept07.pdf
Application Current as of 2/12/2016
4
15 – 18 For Toxins Only:
15. Is there a therapeutic agent (e.g., antidote) available for persons exposed to the toxin?
a. If yes: Is therapeutic agent stored within the laboratoryor with Employee Health 16. Is the toxin on the Select Agent List?
a. If yes: Please check the appropriate box below.
Abrin
Botulinum neurotoxin
Conotoxins designated as short, paralytic alpha
conotoxins containing the amino acid sequence
X1CCX2PACGX3X4X5X6CX7
Diacetoxyscirpenol
Ricin
?
Yes
Yes
No
No
Yes
No
N/A
N/A
Saxitoxin
Shiga-like ribosome inactivating proteins
Shigatoxin
Staphylococcal enterotoxins
Tetrodotoxin
T-2 toxin
17. What is the LD50 of the toxin? See Appendix D for a listing of known LD 50 values:
18. What is the maximum quantity of toxin that will be on hand at any one time?
____________________________________________________________________________________________________________
19. Is there a vaccine available for persons handling this biological material?
Yes
No
a. If yes: list the vaccine and check the applicable statement below:
b.
i. All laboratory personnel working directly with the agent are required to have a valid
vaccination before working in the laboratory
ii. All laboratory personnel working within the laboratory where agent is being
manipulated will be offered vaccination but declination to vaccination will NOT
preclude working in the laboratory.
Does this project involve human cell lines, human blood, amniotic fluid,
cerebrospinal fluid, pericardial fluid, peritoneal fluid, pleural fluid, semen,
synovial fluid, tissue, vaginal secretions, or other body fluids?
REQUIRED
RECOMMENDED
Yes
No
N/A
20. A. Will any biological agents specified in item 7 be used in humans?
a. Yes: Has a protocol been submitted to the Institutional Review Board (IRB)?
b. What is the common route of inoculation?
Yes
Yes
No
No
N/A
B. Are any biological agents specified in item 7 derived from humans?
Yes: Has a protocol been submitted to the Institutional Review Board (IRB)?
Yes
Yes
No
No
N/A
N/A
Yes
Yes
No
No
N/A
N/A
Yes
Yes
No
No
N/A
N/A
If yes: All listed personnel must complete requirements to comply with 29 CFR
1910.1030 Occupational Safety and Health Standard – Toxic and Hazardous
Substances – Bloodborne Pathogens This involves completing the Hepatitis B
vaccination/refusal process through Employee Health. In addition, because there is
ongoing risk, these same individuals must complete annual mandatory bloodborne
pathogen training.
21. Will any of the biological agents specified in item 7 be used in animals? No: skip to question 22.
a. Yes: Has a protocol been submitted to the Animal Care Committee (IACUC)?
b. What is the planned route of inoculation?
c. Is the agent zoonotic?
Unknown
d. Will the agent be shed in urine and/or feces of the animals?
Unknown
e. What is the common route of infection (e.g., Blood borne, fecal/oral, respiratory)?
Application Current as of 2/12/2016
5
22. Will radioactive materials be used in conjunction with this protocol?
a. Yes: Has the approval been obtained from the Radiation Safety Committee (RSC)?
b. Yes: Specify the name of the “Permit Holder”:
c. Yes: Specify radionuclides being used with this agent”:
Yes
Yes
No
No
N/A
N/A
23. Will ionizing radiation, e.g., x-rays, be used in conjunction with this protocol?
Will non-ionizing radiation, e.g., lasers, be used in conjunction with this protocol?
Yes
Yes
No
No
N/A
N/A
Yes
No
N/A
SECTION III – RECOMBINANT or SYNTHETIC NUCLEIC ACID (rsNA)
Complete if the project involves the use of rsNA
This section applies to both bacterial plasmids and microorganisms used as vectors.
24. Does this section apply for the research protocol? If not, select “No” and continue to Section IV.
25. Biological sources of DNA/RNA whose product will be expressed (i.e., human, animal, plant, microorganism). If biological
source is a viable intact microorganism, also complete Section II – Microorganism Usage:
If rsNA is a plasmid, answer questions 26-28. If rsNA is a microorganism, answer questions 29-31.
26 – 28 For Plasmids Only:
26. List the total volume of bacterial cell culture containing rDNA grown at one time:
27. What will the plasmid express?
28. Vector(s) used:
29 – 31 For Microorganisms Only:
29. Do experiments involve the use of defective viruses in the presence of helper viruses?
Yes: Identify recipient host [microorganism - give genus, species and strain if applicable,
animal species, tissue culture/cell line (specify), plant name]:
Yes
No
N/A
Yes
No
N/A
30. What viral sequences will be expressed?
31. Will the recombinant DNA molecule contain a portion of the genome from a virus that infects
eukaryotic cells?
Yes: Indicate the fraction of viral genome:
<1/2
1/2-2/3
>2/3
32. Will rsNA material be administered or transferred to human subjects?
Yes
No
N/A
33. Will rsNA material be administered or transferred to animals?
Yes
No
N/A
34. Will rsNA be used to cause permanent expression in animal or cell lines?
Yes
No
N/A
35. Do experiments involve the creation of transgenic/knockout animals or plants? NIH Guidelines link
Yes
No
36 – 42 For Plants Only:
36. Will recombinant/synthetic nucleic acid material be administered or transferred into plants?
37. Will experiments involve exotic infectious agents with potential for serious detrimental impact
on managed or natural ecosystems?
Yes
No
Yes
No
Application Current as of 2/12/2016
N/A
6
38. Will experiments involve plants containing cloned genomes of readily-transmissible exotic infectious
agents with recognized potential for serious detrimental effects on managed or natural ecosystems?
39. Will experiments involve readily-transmissible exotic infectious agents (such as the soybean rust
fungus) or other viruses in the presence of their specific arthropod vectors, that have the potential of
being serious pathogens of major U.S. crops?
40. Will experiments involve sequences encoding potent vertebrate toxins introduced into plants or
associated organisms?
41. Will experiments involve work with microbial pathogens of insects or small animals?
42. Will recombinant/synthetic nucleic acid material be used to cause permanent expression in plants?
Yes
No
Yes
No
Yes
Yes
Yes
No
No
No
*Note: All plant work must have a “Greenhouse/Plant Facility Biosafety Inspection Form” associated with it.
43. Do the DNA clones contain genes for the biosynthesis of toxic molecules lethal for vertebrates at an:
a. LD50 of <100 nanograms/kilogram body weight
d.
LD50 >100 micrograms/kilogram body weight
b. LD50 of 100-1000 nanograms/kilogram body weight
e.
Genes for biosynthesis of toxic molecules not involved
c. LD50 of 1-100 micrograms/kilogram body weight
If a-d is checked, complete Section IV – Biological Toxin Usage
44. Do the proposed studies involve a deliberate transfer of a drug resistance trait to a microorganism?
If yes, does such acquisition compromise the use of the drug to control disease agents in humans,
veterinary medicine, or agriculture?
Yes
Yes
No
No
N/A
N/A
45. Do experiments involve the release of an organism outside of the facility containing rsNA?
If yes: Has approval for this release been filed with a state or federal regulating agency?
If yes: Identify the regulatory agency and date filed, and send a copy of approval to the SLU OESS, C305:
Yes
Yes
No
No
N/A
N/A
Agency:
Date filed:
46. NIH experiment class determination (check one). NIH Class descriptions. See Appendix E for SLU Class determinations at the end
of this packet.
III-A Requires IBC approval, RAC review, and NIH
Director approval before initiation
III-B Requires NIH/OBA and IBC approval before start
III-C Requires IBC and IRB approvals and RAC review
Before research participant enrollment
III-D Requires IBC approval before initiation (including
animal work)
III-E Requires IBC notice simultaneous with initiation
III-F Exempt
SECTION IV – FACILITY, SECURITY, TRAINING AND A DESCRIPTION OF THE USE OF
BIOLOGICAL MATERIALS – Section required for all applications
47. By checking “Yes”, the investigator affirms he/she has read Appendix A: General Practices and
agrees to abide by the rules established for protection and safety in the laboratory. If there is any
variance from Appendix A, please state below and justify.
Yes
No
N/A
48. Protocol Summary: Summarize the general purpose of the experiments. List the types of laboratory procedures or assays to
be performed with the materials/agents listed in Section II, Item 7 of this application. Please provide concise details related to
handling and manipulating of the biological agents or toxins to allow reviewers an understanding of the potential of exposure. If
no risk of transmission exists or the biological agent is non-pathogenic when transmitted, please state so and justify. Be sure to
include background information relating to the organism(s) to be used. Type or Insert additional page(s) as necessary for a
thorough description of the proposed work:
Application Current as of 2/12/2016
7
49.
Splash and Exposure Procedure
a. In the event of an accidental splash to skin or eye, flush for a full (timed) 15 minutes with running water/eye wash and
seek medical attention.
b. In the event of an accidental exposure or injection with the biological agent, recombinant DNA, or toxin, the exposed
skin or injection site will be washed with anti-microbial soap and water, and/or an approved alcohol base rub (containing
>60% alcohol) will be applied to the site of injection or contact.
c. The supervising PI and Biological Safety Officer will be notified.
d. The SLU employee will complete and Employee Report of Injury form.
e. The SLU employee will report to Employee Health during regular business hours. The SLU employee should report to
Saint Louis University Hospital Emergency Department if injury is life threatening/severe or if acute treatment is
required after business hours. If initial treatment is provided in the Emergency Room, the employee is to follow up with
Employee Health on the next business day.
Describe signs and symptoms of infection with, or exposure to, the biological material:
50. For non-SLU personnel, has your Occupation Health Program (OHP) been submitted
to Employee Health?
Yes
No
N/A
By checking yes, the PI agrees to uphold their laboratory staff to the above statements for an accidental splash or exposure
incident. Please check:
Yes
No
N/A
A. FACILITIES:
51. Please provide a diagram of each laboratory and other areas with specific areas of biological or toxin agent use and/or storage
identified. Attach the diagram to the application and label as Appendix F.
52. All work with biological agent(s) or toxin(s) will be done in a HEPA-filtered (Class II)
Yes
No
N/A
biological safety cabinet?
No: Please explain what barrier system will be employed and justify its adequacy for the work performed (attach additional
material if necessary):
53. Autoclaves used for sterilization of biological waste are spore tested weekly and
documented by a designated area individual.
a.
b.
c.
Yes
No
N/A
Identify the room number of the autoclave being utilized:
Identify the individual responsible for documentation:
Identify where documentation will be located:
54. Identify the disinfectant(s) you will use in conjunction with this work. PI’s are allowed to choose more than one disinfectant:
10% (1 part stock bleach: 9 parts water-dilution) bleach solution prepared fresh daily
Envirocide; used according to product label (Product information sheet showing efficacy and MSDS attached)
Sporklenz; used according to product label (Product information sheet showing efficacy and MSDS attached)
Virex; used according to product label (Product information sheet showing efficacy and MSDS attached)
70% alcohol (70 parts stock alcohol: 30 parts water-dilution) – Not appropriate by itself.
Other (Please attach product information sheet showing efficacy of product for killing or denaturing biological material.
Attach MSDS):
B. WASTE:
55. Biological waste will be disposed of using one of the following methods:
Solids-NO SHARPS:
Segregated in laboratory or clinic by placing in red biohazard bags, within specification packaging (boxes or plastic tubs) in
accordance with Department of Transportation (DOT) requirements. The boxes are sealed in accordance with box
Application Current as of 2/12/2016
8
manufacturer instructions and delivered to licensed medical waste vendor (Stericycle). The solid biological waste is then
rendered non-infectious by autoclaving. The waste is compacted and placed in a segregated landfill by the waste vendor.
Segregated in laboratory or clinic by placing in red biohazard bags and rendered non-infectious by autoclaving (using
departmental autoclave). The autoclaved waste is placed inside a black trash bag and disposed of as regular trash.
(Please note: Autoclave must be validated weekly using spore test procedure and this must be documented.)
Solids-SHARPS:
All sharps including needles, razor blades, scalpels or any other contaminated material capable of puncturing DOT approved
specification packaging will be placed in an OSHA approved “Sharps” container. The container is labeled with a biohazard
label, is sealable, and puncture and leak resistant. Full Sharps containers will be disposed of as solid waste by placing in red
bags, within specification packaging (boxes or plastic tubs) and delivered to licensed medical waste vendor and treated as
solid medical waste. The sharps containers are rendered non-infectious by being autoclaved. The waste is compacted, and
placed in a segregated landfill by the waste vendor.
Liquids:
Rendered non-infectious by making 10% (1:9 dilution) with respect to bleach, held overnight and disposed in laboratory sink
with running water.
Rendered non-infectious by autoclaving (using departmental autoclave) and disposed in laboratory sink with running water.
(Please note: Autoclave must be validated weekly using spore test procedure and this must be documented.)
Mixed (radioactive) Waste:
Liquid radioactive infectious waste: This waste will be rendered non-pathogenic by adding fresh bleach until the resulting
solution is 10% bleach. The solution will then be disposed of in accordance with Saint Louis University procedures for liquid
radioactive waste.
Solid radioactive infectious waste materials: If these materials are contaminated with radionuclides with half-lives of less
than 120 days, they will be held for decay for a minimum of 10 half-lives. They will then be re-surveyed to ensure that all
radioactivity has decayed, and autoclaved. If these materials are contaminated with radionuclides with half-lives of more than
120 days, they will be submerged in solution made up of 10% (1:9 dilution) fresh bleach overnight to render them nonpathogenic. After overnight submersion, the solid waste will be removed from the solution and will be disposed of in
accordance with Saint Louis University procedures for solid radioactive waste. Any remaining liquid bleach solution will be
disposed of in accordance with Saint Louis University procedures for liquid radioactive waste.
(Please note: Autoclave must be validated weekly using spore test procedure and this must be documented.)
C. PERSONAL PROTECTIVE EQUIPMENT (PPE) Checkmark and/or add the appropriate protective gear (as described in Item
#48, Protocol Summary), which must be worn by a person working with the agent:
56.
a. BSL-2: (if ABSL-2, SPECIFY ACCORDINGLY)
Single Gloves
Respirator (e.g. N95)-must
Disposable Lab Coat/Gown
Leggings
be medically cleared and fittested for this application
Double Gloves
Eye Protection
Double disposable wrap-around Lab
Cap
Coat/Gown-with liquid impermeable
outermost layer
Face Shield
Bench Shield
Booties
Loose-fitting maskLab Coat
Double booties with liquid
Other (list)
Does not provide
impermeable outmost layer
aerosol protection;
for anticipated
splashes only
b.
BSL-3: (if ABSL-3, SPECIFY ACCORDINGLY)
Single Gloves
Double Gloves
Respirator (e.g. N95)-must
be medically cleared and fittested for this application
Eye Protection
Disposable Lab Coat/Gown
Double disposable wrap-around Lab
Coat/Gown-with liquid impermeable
outermost layer
Application Current as of 2/12/2016
Leggings
Cap
9
Face Shield
Loose-fitting maskDoes not provide
aerosol protection; for
anticipated splashes
only
Bench Shield
Lab Coat
Booties
Double booties with liquid
impermeable outmost layer
57. By checking yes, the PI agrees to use the above PPE and enforce for staff.
Other (list)
Yes
No
D. SECURITY
58. Access to the laboratory or clinic areas is restricted to authorized personnel while work with the biological agent or toxin is in
progress. Note: Open labs are restricted with proximity card access in the DRC. The following measures are in place to restrict
access:
Signage
Laboratory doors are closed
Laboratory doors are closed and locked
The biological agent or toxin is stored in a locked freezer (only accessible by authorized personnel) to
reduce the likelihood of unauthorized access.
Yes
No
N/A
Yes
No
N/A
Yes
Yes
No
No
N/A
N/A
Yes
No
N/A
63. Have all employees received BSL-3 Awareness training?
Yes
If yes: please identify the individual(s) with BSL-3 Awareness training and attached training diploma:
No
N/A
64. Have all employees received ABSL-3 Awareness training?
Yes
If yes: please identify the individual(s) with ABSL-3 Awareness training and attached training diploma:
No
N/A
65.
Have all employees received Select Agent Awareness training?
Yes
If yes: please identify the individual(s) with Select Agent Awareness training and attached training diploma:
No
N/A
F.
SUPPLEMENTAL DOCUMENTATION
E. SHIPPING, TRANSPORT AND TRAINING
59. Source of the biological agent(s) if from a source outside the University
(if applicable, attach ATCC or other appropriate documentation).
60. Will materials containing, or contaminated by the biological agent or toxin be transported via
a corridor or other thoroughfare which is used by persons not directly working with the agent?
If yes: Please describe the precautions that will be employed to minimize breakage of containers
and release of biological agents or toxins during transport:
61. Have all employees received the following training:
a. General Laboratory Safety and Compliance Training within the last year?
b. Have all shippers received IATA function specific training within the last 2 years?
If yes: please identify the individual(s) with shippers training and attach training diploma(s):
(The U.S. Department of Transportation requires that all individuals responsible for shipping hazardous
materials be trained and certified in the proper packaging of these materials. Saint Louis University
offers this training. Contact (314) 977-6795 or e-mail at npiercec@slu.edu for training information.)
62. Have all employees received Bloodborne Pathogen training?
If yes: please identify the individual(s) with BBP training and attached training diploma:
Application Current as of 2/12/2016
10
66. The following documents have been attached to the IBC application:
a. Curriculum Vitae
b. A recent (annual) Biosafety Inspection. If needed, call OESS at 977-8608 to schedule.
c. A recent (annual) Greenhouse/Plant Facility Biosafety Inspection Form
d. Floor diagrams that are legible and describe the location of major equipment,
Eye-washing station(s), & sink location(s)
e. Clinical protocol – if biological agents are being used in humans
f. IRB approved (or draft) application – if submitting a clinical protocol
g. Investigator Brochure – if submitting a clinical protocol
h. Correspondence from NIH/OBA regarding NIH review (e.g., Appendix M of
NIH Guidelines, letter indicating in-depth review not required, etc.)
i. IACUC approved (or draft) application – if biological agents are being used in animals
j. Product information sheet describing cell lines (if applicable)
k. Product information sheet describing disinfectant – other than 10% bleach
l. MSDS information sheet describing disinfectant – other than 10% bleach
m. RSC approved (or draft) application – if working with radioactive materials
Yes
Yes
Yes
No
No
No
N/A
Yes
Yes
Yes
Yes
No
No
No
No
N/A
N/A
N/A
N/A
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
N/A
Note: If changes in funding source, project title, or project location occurs, an IBC Amendment must be submitted. If changes in
any other item(s) occur(s), such as an organism used, Biosafety level or NIH classification, a new IBC Research Protocol Application
Form must be completed and submitted for IBC Approval. I agree:
Yes
No
APPENDIX A: GENERAL PRACTICES
General Practices: It is to be understood that the following general practices are the minimum precautions to be observed in
any laboratory or other research facility in which biological agents or toxins pathogenic to human beings are stored, cultured,
manipulated or treated (additional precautions may be required - see later items in this document):
A.
The universal biohazard sign shall be posted on all doors providing access to a facility listed in Item 10 above.
B.
All work surfaces on which the agents are used, or which could possibly have become contaminated by the agent, shall be
cleaned thoroughly, immediately after use and at the end of each day, with a disinfectant known to be effective against the
biological agent or toxin.
C.
Personal protective equipment prescribed by the Principal Investigator must be worn by anyone handling or working with
this agent.
D.
At no time shall protective clothing that has been used in the laboratory or contaminated street clothing be removed from a
laboratory to be laundered in a private home. Contaminated, disposable clothing shall be discarded only in approved waste
receptacles. Reusable clothing that becomes contaminated shall be autoclaved or disinfected with an agent appropriate for
the contaminating biological agent before it is sent to a commercial laundry.
E.
Protective laboratory wear, including gloves, that is likely to have been contaminated, shall not be worn outside of the
laboratory into a corridor or any facility in which the agent is not being used. Contaminated gloved hands must not touch
clean surfaces such as doorknobs, telephones or computer keyboards.
F.
Hands will be thoroughly washed with antiseptic soap solution and dried upon removing gloves. Gloves shall be removed
and discarded any time that a tear, hole or other discontinuity in the glove material is observed.
G.
House vacuum lines shall be protected from contamination by a trap of liquid disinfectant or a high-efficiency particulate air
(HEPA) filter, as appropriate for the task. This is an inline filter that is place between the house vacuum lines and the trap for
liquid disinfectant. Hypochlorite-based disinfectants must be prepared fresh each day so as to maintain adequate potency to
kill and/or inactivate biological agents. Manufacturers’ instructions shall be followed on all other types of disinfectants for
killing and/or inactivation of biological agents or toxins.
H.
Syringes with hypodermic needles, or other devices that can cause aerosolization of a pathogen, shall not be used unless no
other alternative exists. Where hypodermic needles and syringes must be used to inject or aspirate potentially infective
material (such as into or from animals or diaphragm bottles), only needle-locking syringes or one-piece syringe/needle units
shall be used. If risk of aerosolization of a pathogen exists, a biosafety cabinet must be used. If a research procedure cannot
be performed in a biosafety cabinet, the laboratory personnel must be fitted with appropriate respiratory protective equipment
(e.g., suitable masks) and laboratory doors must remain closed throughout the procedure.
Application Current as of 2/12/2016
11
I.
The use of sharps devices, such as needles or scalpels shall be limited to procedures for which no other alternative exists.
Any sharp object must be disposed of in a clearly marked, puncture-resistant container either of red color or bearing a
Biohazard Sign. Where there is no satisfactory alternative to using a reusable needle, removal of it from the syringe body
must be effected by grasping the hub of the needle with a needle holder, hemostat, or other clamping device which will not
reasonably permit the fingers of the operator to contact the sharp point of the needle. Contaminated disposable needles shall
not be sheared, bent, or removed from the syringe before being placed in the sharps container.
J.
Eating, drinking, smoking, application of cosmetics, and the insertion or removal of contact lenses are SPECIFICALLY
PROHIBITED in any laboratory in which biological agents or toxins are in use or in which biological agents or toxins have
recently been used or stored. No storage of food or beverages shall be permitted in any room in which the Universal
Biohazard symbol is displayed on the door.
K.
Any spill of a biological agent or toxin shall be promptly contained and cleaned up following procedures outlined in the
accompanying Emergency Response Procedure (See Spill Procedure of this application). Clean-ups shall be carried out by
persons knowledgeable in working with the biological agent or toxin and in no case shall the procedure involve untrained
students, employees, or housekeeping staff. Any release of a biological agent or toxin should be reported to the Office of
Environmental Safety within 24 hours.
L.
Contamination of a person or a person’s clothing is to be reported as soon as practical to the Office of Environmental Safety
so that appropriate medical treatment and consultation can be provided to the affected individual(s). The appropriate
University incident report form must be completed by the contaminated employee and his/her supervisor within the time
required by the Office of Risk Management.
M.
All employees and students working in a laboratory designated as the site of research with a biological agent or toxin, and all
future employees or students who may become associated with the laboratory, shall read this document and affix their
signatures and the date in the designated place on the second page. The signature signifies that a person has read and
understands their obligations in working with the agent and indicates their intention to abide by all of the provisions of this
document. The principal investigator shall review safety precautions in his/her laboratory at least annually with all of his/her
laboratory staff.
N.
Function of all biological safety cabinets will be certified annually by a person qualified to certify such devices.
O.
Each investigator will devise and implement an inventory tracking system for biological agents or toxins specified in this
application such that the investigator and/or his/her staff have the capability to readily assess the loss or theft of these
biological agents or toxins. The investigator and/or his/her staff will report the loss or theft of these biological agents or
toxins to the Office of Environmental Safety within one business day of the investigator’s determination that a loss or theft
has occurred.
P.
In accordance with the OSHA Bloodborne Pathogens Standard [29 CFR 1910.1030(d)(2)(xiii (A,B,C))], specimens of blood
or other potentially infectious materials shall be placed in a container which prevents leakage during collection, handling,
processing, storage, transport, or shipping. The container for storage, transport, or shipping shall be labeled or color-coded
according to paragraph (g)(1)(i)* and closed prior to being stored, transported, or shipped. When a facility utilizes Universal
Precautions in the handling of all specimens, the labeling/color-coding of specimens is not necessary provided containers are
recognizable as containing specimens. This exemption only applies while such specimens/containers remain within the
facility. Labeling or color-coding in accordance with paragraph (g)(1)(i) * is required when such specimens/containers leave
the facility.
If outside contamination of the primary container occurs, the primary container shall be placed within a second container
which prevents leakage during handling, processing, storage, transport, or shipping and is labeled or color-coded according to
the requirements of this standard. If the specimen could puncture the primary container, the primary container shall be placed
within a secondary container, which is puncture-resistant in addition to the above characteristics.
* A Biohazard label that shall be fluorescent orange, orange-red, or predominantly so, with lettering and symbols in a
contrasting color.
Application Current as of 2/12/2016
12
APPENDIX B: HHS AND USDA SELECT AGENTS AND TOXINS
7 CFR Part 331; 9 CFR Part 121; and 42 CFR Part 73
*Denotes Tier 1 Agent
Application Current as of 2/12/2016
13
HHS SELECT AGENTS AND TOXINS
o Abrin
o Botulinum neurotoxins*
o Botulinum neurotoxin producing species of
Clostridium*
o Conotoxins (Short, paralytic alpha
conotoxins containing the following amino
acid sequence X1CCX2PACGX3X4X5X6CX7)
o Coxiella burnetii
o Crimean-Congo haemorrhagic fever virus
o Diacetoxyscirpenol
o Eastern Equine Encephalitis virus
o Ebola virus*
o Francisella tularensis*
o Lassa fever virus
o Lujo virus
o Marburg virus*
o Monkeypox virus
o Reconstructed replication competent forms
of the 1918 pandemic influenza virus
containing any portion of the coding regions
of all eight gene segments (Reconstructed
1918 Influenza virus)
o Ricin
o Rickettsia prowazekii
o SARS-associated coronavirus (SARS-CoV)
o Saxitoxin
o South American Haemorrhagic Fever
viruses:
o Chapare
o Guanarito
o Junin
o Machupo
o Sabia
o Staphylococcal enterotoxins A,B,C,D,E
subtypes
o T-2 toxin
o Tetrodotoxin
o Tick-borne encephalitis complex (flavi)
viruses:
o Far Eastern subtype
o Siberian subtype
o Kyasanur Forest disease virus
o Omsk hemorrhagic fever virus
o Variola major virus (Smallpox virus)*
o Variola minor virus (Alastrim)*
o Yersinia pestis*
OVERLAP SELECT AGENTS AND TOXINS
o Bacillus anthracis *
o Bacillus anthracis Pasteur strain
o Brucella abortus
o Brucella melitensis
o Brucella suis
o Burkholderia mallei*
o Burkholderia pseudomallei*
o Hendra virus
o Nipah virus
o Rift Valley fever virus
o Venezuelan equine encephalitis virus
USDA SELECT AGENTS AND TOXINS
o African horse sickness virus
o African swine fever virus
o Avian influenza virus
o Classical swine fever virus
o Foot-and-mouth disease virus*
o Goat pox virus
o Lumpy skin disease virus
o Mycoplasma capricolum
o Mycoplasma mycoides
o Newcastle disease virus1
o Peste des petits ruminants virus
o Rinderpest virus*
o Sheep pox virus
o Swine vesicular disease virus
USDA PLANT PROTECTION AND QUARANTINE (PPQ)
SELECT AGENTS AND TOXINS
o Peronosclerospora philippinensis (Peronosclerospora
sacchari)
o Phoma glycinicola (formerly Pyrenochaeta glycines)
o Ralstonia solanacearum
o Rathayibacter toxicus
o Sclerophthora rayssiae
o Synchytrium endobioticum
o Xanthomonas oryzae
*Denotes Tier 1 Agent
APPENDIX C: Environmental Health and Safety Biological Safety Level Spill Protocol:
It is to be understood that the following general spill procedures includes the minimum guidelines to be observed in any
laboratory or other research facility in which a biological agent or toxin has been released:
Spill of BSL-2 material:



Wear gloves and lab coat. If splashing is likely, also wear goggles and surgical mask.
Use forceps to pick up broken glass and discard into SHARPS container.
Cover spilled material with paper towels.
Application Current as of 2/12/2016
14






Carefully pour diluted disinfectant (defined on following page) onto paper towels in sufficient quantity to ensure effective
microbial inactivation, making sure you work from outside of spill to inside.
Allow a contact period sufficient for kill of the microorganism.
Pick up paper towels and dispose in biohazard waste container.
Re-wipe spill area with disinfectant, diluted to working strength.
Place all contaminated materials, including Personal Protective Equipment (PPE), into biohazard waste container and autoclave.
Wash hands with soap and water.
Spill of BSL-3 material:














Stop work. Alert others to evacuate laboratory immediately. Avoid inhaling airborne material.
Close doors to affected area.
Remove contaminated clothing turning exposed area inward, place in a biohazard bag.
Wash hands and other skin contacted areas with soap and water.
Notify PI. Call the Biological Spill Emergency Response Number 977-3000 for help.
Do not re-enter laboratory for at least 30 minutes to allow aerosols to disperse.
Assemble all clean-up materials.
Put on full Personal Protective Equipment (HEPA-filtered respirator, gown, gloves, shoe covers).
Cover spill with paper towels or disposable pads. Pour diluted disinfectant onto paper towels.
Leave the room for 30 minutes to allow the disinfectant to inactivate the material.
Pick up any broken glass with forceps and dispose in SHARPS container.
Pick up paper towels and wipe the area again with an appropriate disinfectant.
Place all contaminated materials, including disposable PPE, in a biohazard bag and autoclave.
Wash hands thoroughly with soap and water.
APPENDIX D - TOXINS AND KNOWN LD50 VALUES
Toxin
Abrin
Abrin reconstituted (A+B mix)
Abrin A
Abrin B
Abrin C
Abrin D
Aflatoxin
Aflatoxin B(Aflatoxin B1)
Aflatoxin B1 mixed with G1
Aflatoxin B2/dihydro B1
Aflatoxin G1
Species (if other than Mouse)
Route (if Other than IP)
Monkey
Oral
Intramuscular
Rat
Duck
IP
Oral
Aflatoxin G2/dihydro G1
Aflatoxin M1/4-hydroxy B1
Aflatoxin M2/4-hydroxy B2
Aflatoxin P1
Aflatoxin 485 Q1, Ro, Ro’ and Aflatoxin B1
dichlorides, oxides, epoxides
β Toxin
Cholera Toxin
Clostridium botulinum (“natural product”)
C. botulinum neurotoxin
C. botulinum toxin A
C. botulinum toxin B
C. botulinum toxin C1
C. botulinum toxin C2
C. botulinum toxin D
C. botulinum toxin E
C. botulinum toxin F
Clostridium perfringens
Coagulase
Conotoxins –GI, GIIIA, GIIIB, GIVA, MI, MVILA, SIA, SVIB
Diacetoxyscirpenol
Exfoliative toxins A, B
γ Toxin
Pantovalentine leukocidin
Ricin/Ricine
Ricin A
LD50 (ng/kg)
20,000
6,000
10,000
25,000
16,000
31,000
1,750,000
2,020,000
9,500,000
680,000
1,700,000
14,900,000
785,000
2,450,000
320,000
281,000
150,000,000
No data available
No data available
250,000
0.03
0.2
MLD 1,2
1.2-2.0
1.1
1.2
0.4
1.1
2.5
MLD 100
No Data Available
12,000-30,000
7,839,000
No Data Available
No Data Available
No Data Available
2,000
5,000
Application Current as of 2/12/2016
15
Ricin A chain
Ricin B
Ricin C
Ricin D
Ricin D alanine-chain protein
Ricin D isoleucine-chain reduced
Ricin nitrogen
Ricin reduced
Ricin, total hydrolysate
Ricin toxin – Con A
Saxitoxin/Saxitoxin Hydrate
Saxitoxin dihydrochloride/hydrochloride
Saxitoxin p-bromobenzenesulfonate
Shiga toxin
Shigella shigae neurotoxin
Staphylococcus enterotoxins
T-2 toxin
T-2 toxin tetraol
T-2 hemisuccinate
Tetrodotoxin
Tetrodotoxin citrate, 2 hydroxycitrate
Tetrodotoxin 4,9-anhydro…
No Data Available
35,000
17,500
0.248
300,000
29,000
LC50 500,000
200,000
4,100
41,500,000
8,000
8,000
10,000
250
1,350
25,000-1,333,000
3,000,000
11,000,000
7,500,000
8,000
8
16,900,000
986,000
>50,000,000
26,100,000
477,000
2,700,000
41,700,000
692,000
12,700,000
322,000
2,000
20,000
Unreported
Unreported
Inhalation
Rat
IV
Oral
IV
Tetrodotoxin 4,9-anhydro, 8,9-diacetate
Tetrodotoxin 4-amino-4-deoxy
Oral
IV
Oral
IV
Deoxytrodotoxin
Ethoxytetrodotoxin
Methoxytetrodotoxin
Toxic Shock Syndrome Toxin
Oral
IV
Subcutaneous
IV
Rabbit
APPENDIX E - RECOMBINANT DNA – IBC AND OTHER REVIEW REQUIREMENTS
(For assistance, please contact OESS at (314) 977-8608, or visit our website at http://oess.slu.edu)
All recombinant DNA (rDNA) projects at Saint Louis University (SLU) must adhere to the requirements
of the NIH Guidelines for Research Involving Recombinant DNA Molecules. SLU has also adopted
policies and procedures that describe how the NIH Guidelines are implemented at this institution. In
some cases, SLU’s policies and procedures are more stringent than the NIH Guidelines. For example,
SLU requires IBC notification and review of r-DNA projects that are specifically exempt from the NIH
Guidelines, as well as projects involving pathogenic agents and bloodborne pathogens. In no case are
SLU’s policies and procedures less stringent than the NIH Guidelines. The NIH Guidelines and SLU
Biosafety Guidelines are provided on the OESS web site.
Principal Investigators (PIs) submitting a protocol to the IBC must include a reference to the appropriate
section of the NIH Guidelines. The table below summarizes experiments covered by the NIH
Guidelines, including the relevant reference to the appropriate section of the Guidelines. This table also
specifies if more stringent review requirements are mandated by the SLU Biosafety Guidelines.
Type of rDNA Experiment
A. rDNA molecules that are not in organisms or viruses
B. rDNA molecules that consist entirely of DNA segments
from a single nonchromosomal or viral source, though one or
more of the segments may be a synthetic equivalent.
SLU
Biosafety
Guidelines
Requirement
Registration
with IBC
required by
SLU policy.
Status
Under NIH
Guidelines
Exempt
Application Current as of 2/12/2016
Relevant
Section(s)
of NIH
Guidelines
III-F-1
III-F-2
16
C. rDNA molecules 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.
D. rDNA molecules 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)
E. rDNA molecules 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.
F. rDNA molecules that do not present risk to health or
environment as determined by the NIH Director. E.g.,
certain rDNA molecules containing less than one-half of any
eukaryotic viral genome propagated and maintained in tissue
culture, certain Escherichia coli K-12 host-vector systems;
certain Saccharomyces host-vector systems; certain Bacillus
subtilis or Bacillus licheniformis host-vector systems; certain
rDNA molecules derived entirely from extrachromosomal
elements of listed gram positive organisms.
G. Purchase and transfer of transgenic rodents that require
BL1 containment
H. rDNA molecules containing no more than two-thirds of
the genome of any eukaryotic virus may be propagated in
maintained in cells in tissue culture using BSL-1
containment so long as it is demonstrated that the cells lack
helper virus for the specific families of defective viruses
being used.
I. Experiments involving whole plants, and/or rDNAmodified organisms associated with whole plants (unless
specified in III-A, III-B, III-D, or III-F)
J. Experiments involving the generation of rodents in which
the animal’s genome has been altered by stable introduction
of rDNA, or DNA derived there from, into the germ-line so
long as the experiment can properly be conducted at BL-1
containment.
K. Experiments involving the introduction of rDNA into risk
group 2 or higher agents [so long as the containment level
specified in this section of the NIH Guidelines is observed]
L. Experiments in which DNA from risk group 2 or higher
agents is cloned into nonpathogenic prokaryotic or lower
eukaryotic host-vector systems [certain conditions exist for
DNA from RG 4]
M. Experiments involving the use of infectious DNA or
RNA viruses or defective DNA or RNA viruses in the
presence of helper virus [so long as the containment level
specified in this section of the NIH Guidelines is observed]
N. Experiments involving whole animals in which the
animal’s genome has been altered by stable introduction of
rDNA, or DNA derived therefrom, into the germ-line; AND
experiments involving viable rDNA-modified
microorganisms tested on whole animals.
O. Experiments to genetically engineer whole plants by
rDNA methods, to use such plants for other experimental
purposes (e.g., response to stress), to propagate such plants,
or to use plants together with microorganisms or insects
III-F-3
BSL-2 or
higher
requires
registration
and approval
by IBC prior
to initiation.
BSL-1
requires IBC
notice
simultaneous
with
initiation.
III-F-4
III-F-5
III-F-5
Appendix
C-VI
Requires IBC
notice
simultaneous
with initiation
Requires
IBC notice
simultaneou
s with
initiation (all
are typically
conducted at
BSL-1)
III-E-1
III-E-2
III-E-3
Requires IBC
approval
prior to
initiation
Requires
IBC
approval
prior to
initiation
Application Current as of 2/12/2016
III-D-1
III-D-2
III-D-3
III-D-4
III-D-5
17
containing rDNA (unless otherwise specified in III-A, III-B,
III-D, or III-F)
P. Experiments involving more than 10 L of culture.
Q. Experiments involving the deliberate transfer of rDNA, or
DNA or RNA derived from rDNA, into human research
participants.
R. Experiments involving the deliberate formation of rDNA
containing genes for the biosynthesis of toxin molecules
lethal for vertebrates at an LD50 of less than 100 ng/Kg
body weight.
S. Major Actions, defined as the deliberate transfer of a drug
resistance trait to microorganisms that are not known to
acquire the trait naturally, if such acquisition could
compromise the use of the drug to control disease agents in
humans, veterinary medicine, or agriculture.
Requires
review and
approval by
the IBC, IRB,
and federal
NIH/OBARAC prior to
initiation
Requires
review and
approval by
the IBC and
federal
NIH/OBARAC prior to
initiation.
Requires
review and
approval by
the IBC,
federal
NIH/OBARAC, and
NIH Director
prior to
initiation.
Requires
review and
approval by
the IBC,
IRB, and
federal
NIH/OBARAC prior
to initiation.
Requires
review and
approval by
the IBC and
federal
NIH/OBARAC prior
to initiation.
Requires
review and
approval by
the IBC,
federal
NIH/OBARAC, and
NIH
Director
prior to
initiation.
III-D-6
III-C-1
III-B
III-A
Interpretative guidance provided by NIH/OBA relevant to the above categories of experiments is summarized
below:
Exempt Experiments (Section III-F)
 Materials derived from or produced by genetically engineered organisms (i.e., proteins) are not subject to
NIH Guidelines (other than DNA molecules resulting from replication of rDNA).
 If an experiment falls into Section III-D or III-E of the NIH Guidelines and also falls into section III-F, it
is exempt.
 Although Appendix C-1 exempts the use of rDNA in tissue culture, there are exceptions to the exemption.
Existing tissue culture cell lines created by the introduction of rDNA are exempt from the NIH Guidelines
unless, the cell line:
o Was modified using DNA from RG 3 or 4 agents
o Contains a toxin with an LD50 of less than 100 ng/kg body weight
o Contains viral DNA in a quantity exceeding 50% of any viral genome
o Is used in conjunction with defective viruses in the presence of helper virus
o Is used in an experiment involving the deliberate transfer of the cell line into humans
o Is grown in a volume exceeding 10 liters of culture
Major Actions (III-A) [Deliberate Transfer of a Drug-Resistance Trait]
 A drug is considered to be useful for treatment even if its use is limited to the treatment of a specific
patient population (for example, children or immunocompromised individuals), or it is primarily used for
treatment outside of the US (for example chloramphenicol is not in widespread use in the US but it is a
commonly used antibiotic in many other countries).
Application Current as of 2/12/2016
18

Approval from the NIH Director is limited to the investigator that sought the approval.
Animal Experiments
 The purchase and transfer of transgenic rodents that may be maintained at BL1 is exempt under the NIH
guidelines. However, subsequent use involving rDNA or requiring BL2 or higher containment is not
exempt.
 The purchase or transfer of animals other than rodents, regardless of containment level, is not exempt.
 With respect to gene ablation studies, when recombinant techniques are used to knock out genes, the
experiments are subject to the NIH Guidelines.
Activity
Minimum BSL
Creation of Transgenic Animals
1. Rodents
BL1
2. Rodents
BL2 or higher
3. Animals other than rodents
BL1
4. Animals other than rodents
BL 2 or higher
5. rDNA modified arthropods
BL1
6. rDNA modified arthropods
BL2 or higher
7. Knock-out rodents
BL1
8. Knock-out rodents
BL2 or higher
Creation of Transgenic Animals
9. Rodents from one strain (propagation/colony maintenance)
BL1
10. Rodents from one strain (propagation/colony maintenance)
BL2 or higher
11. Rodents from two strains
BL1
12. Rodents from two strains
BL2 or higher
13. Animals other than rodents
BL1
14. Animals other than rodents
BL2 or higher
15. rDNA modified arthropods
BL1
16. rDNA modified arthropods
BL2 or higher
17. Knockouts (propagation)
BL1
18. Knockouts (propagation)
BL2 or higher
19. Knockouts from two strains
BL1
20. Knockouts from two strains
BL2 or higher
Experiments with Transgenic Animals
21. Rodents (purchase or transfer and subsequent use that does
BL1
not involve the use of rDNA)
22. Rodents (use of rDNA subsequent to purchase)
BL1
23. Rodents
BL2 or higher
24. Animals other than rodents
BL1
25. Animals other than rodents
BL2 or higher
26. rDNA modified arthropods associated with plants
BL1
27. rDNA modified arthropods associated with plants
BL2 or higher
28. rDNA modified arthropods not associated with plants
BL1
29. rDNA modified arthropods not associated with plants
BL2 or higher
Experiments with rDNA in an Animal (transgenic or otherwise)
30. rDNA modified microbes in any animal
BL1
31. RG2 rDNA modified microbes in any animal
32. RG3 rDNA modified microbes in any animal
33. RG4 rDNA modified microbes in any animal
34. rDNA modified restricted agent (e.g., pox) in an animal
35. rDNA modified animal pathogens in an animal
BL2
BL3
BL4
BL4
BL4
Application Current as of 2/12/2016
NIH Guidelines
Section
III-E-3
III-D-4-b
III-D-4-a
III-D-4-b
III-D-4-a
III-D-4-b
III-E-3
III-D-4-b
Exempt (III-F-4)
III-D-4-b
III-E-3
III-D-4-b
III-D-4
III-D-4
Exempt (III-F-4)
III-D-4-b
Exempt (III-F-4)
III-D-4-b
III-E-3
III-D-4-b
Exempt (III-F-4)
III-D-4-a
III-D-4-b
III-D-4-a
III-D-4-b
III-E-2-b-5
III-E-2
III-D-4-a
III-D-4-b
BL1 restricted to
viruses transmitted
vertically
III-D-1-a
III-D-1-b
III-D-1-c
III-D-1-d
III-D-1-d
19
36. Introduction of less than 2/3 of eukaryotic viral genome
into a non-human vertebrate or invertebrate
37. Propagation of animals containing viral vector sequences
not leading to transmissible infection
38. rDNA involving whole animals not covered by sections IIID-1 or III-D-4-a
Cloning animals
39. Cloning animals
Purchase or Transfer of Transgenic Animals
40. Rodents
BL1
III-D-4-a
BL1
III-D-4-a
Set by IBC
III-D-4-b
BL1 or higher
Not covered
BL1
Exempt (Appendix
C-6)
III-D-4
III-D-4
III-D-4
III-D-4
III-D-4
41. Rodents
BL2 or higher
42. Animals other than rodents
BL1
43. Animals other than rodents
BL2 or higher
44. rDNA modified arthropods
BL1
45. rDNA modified arthropods
BL2 or higher
Plant Experiments with Animals or Arthropods
46. Experiments with microorganisms or insects containing
BL3P or
rDNA with the potential for detrimental impact to ecosystems.
47. Experiments with exotic infectious agents in the presence
BL4-P
of arthropod vectors
48. Experiments with microbial pathogens of insects or small
BL3-P or BL2-P
animals associated with plants with the potential for
plus biological
detrimental impact to ecosystems.
containment
49. Small animals associated with recombinant DNA-modified
BL1
plants.
50. Experiments with rDNA-modified arthropods or small
BL1
animals associated with plants
III-D-5-a or –b
III-D-5-c
III-D-5-e
III-E-2
III-E-2-b-(5).
APPENDIX F: REFERENCES
Biosafety in Microbiological and Biomedical Laboratories. CDC/NIH. 5th edition, Feb 2007.
http://www.cdc.gov/od/ohs/biosfty/bmbl5/BMBL_5th_Edition.pdf
Bloodborne Pathogens: Exposure Control Plan. 2013. Saint Louis University, Office of Environmental Health and Safety.
Laboratory Standard. 1990. Department of Labor, Occupational Safety and Health Administration. 29 CFR, Part 1910.1450.
Federal Register Vol. 55, No. 21.
NIH Guidelines for Research Involving Recombinant DNA Molecules. Revised January 2001 and subsequent amendments.
National Institutes of Health. http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html
Occupational exposure to bloodborne pathogens; final rule. 1991. Department of Labor, Occupational Safety and Health
Administration. 29 CFR, Part 1910.1030. Federal Register 56(235).
Proposed Guidelines for Research Involving the Planned Introduction into the Environment of Organisms with Deliberately
Modified Hereditary Traits. 1991. USDA. Federal Register Vol. 56, No. 22.
Application Current as of 2/12/2016
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