Division of Research Integrity & Compliance
Institutional Biosafety Committee
Registration Document for the Use of
Non-Exempt Recombinant DNA
USF requires that all recombinant DNA work conducted at or supported by this university be registered
with and approved by the Institutional Biosafety Committee (IBC) prior to initiation of the project.
Instructions:
1. If your recombinant DNA experiment meets the definition of any of the Non-Exempt categories
referenced in NIH guidelines (Section III-D) to complete this registration form.
2. Please provide complete information for every item. Blank or incomplete items may delay the
processing of your application.
3. Completed forms may be submitted by:
 E-mail to biosafety@research.usf.edu and followed with mailed hard copies of signature pages
bearing original signatures.
 Mail to Farah Moulvi, Institutional Biosafety Officer, Division of Research Integrity &
Compliance, MDC 35
 BSL-2 or BSL-3 laboratories must pass inspection before initial approval for research activities can
be granted for this proposed study. The Principal Investigator is responsible for scheduling an
inspection by contacting the Biosafety Staff at biosafety@research.usf.edu or (813) 974-5091 or
(813) 974-5110.
4. Please consult the NIH Guidelines for Research Involving Recombinant DNA Molecules and the USF
Institutional Biosafety Manual for information needed to complete this registration form.
5. For more information, contact Farah Moulvi at (813) 974-0954 or Debbie Howeth at (813) 974-5091.
Part A – Basic Information
A.1
A.2
A.3
A.4
Principal Investigator: Name]
Department:
Building:
E-mail:
Office Phone(s):
PI’s Study Coordinator: [Name]
Coordinator’s E-mail:
Location(s) of Experiments – Building/Room (indicate all):
Type of Registration (see Appendix A for definitions):
Campus Mail:
Office Room#:
Fax:
Lab Phone:
Coordinator Phone:
Single Project
Multi-Project
New Registration
3rd Year Renewal Registration Replacing Previous IBC Study #
Project Title(s) (if multi-project, list titles of each project and assign a number to each):
RCDC 001.11
Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments
Rev. 04/25/2011
USF Institutional Biosafety Committee
Page 1
A.5
Sponsor(s) List intramural and/or extramural sources:
Part B - Recombinant DNA Project Information
B.1
Briefly describe your research objectives in lay terms:
B.2
Provide below or attach a one-page (maximum) description of the specific laboratory
procedures (e.g., culturing, vortexing, incubating, etc.) and specific safety precautions
regarding these procedures for handling the recombinant DNA molecules and/or
organisms and viruses containing recombinant DNA molecules. Describe the
procedures by detailing the specific physical manipulations (not “why” the
manipulations are being done). Include the animal and animal tissue(s) handling
procedures that will be used during the experiment, if applicable.
RCDC 001.11
Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments
Rev. 04/25/2011
USF Institutional Biosafety Committee
Page 2
2.
Vector Information
2.1
Provide all requested information for each rDNA vector that will be used in this project in the table below.
Item
#
Type1
Vector Name
(including Serotype
or strain if
applicable)
Source2
Risk
Group3
(RG)
Biosafety
Level3
(BSL)
Locations
of Use
Locations of
Storage (if
different)
1
2
3
4
5
6
7
8
9
10
1
A=adenovirus, R=retrovirus (including lentivirus), N=non-viral, O=other viral vector (please specify)
Specify the type and name of source (e.g., vendor – Clontech, Invitrogen; off-campus collection – Univ. of CA).
3
Refer to the NIH Guidelines, and the BMBL for RG and BSL designation.
2
RCDC 001.11
Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments
Rev. 04/25/2011
USF Institutional Biosafety Committee
Page 3
2.2
Are you using a replication competent virus? If so provide justification for its use.
2.3 If using a replication –deficient virus, the possibility of homologous recombination with
endogenous viruses may exist. Indicate the reversion rate and describe recombination event
for such a possibility for each of the viral vectors identified in Table 2.1.
2.4 Are assay systems used to measure the titer of replication competent viruses that may
be present?
No. How will you ensure that replication competent viruses are excluded?
Yes. Describe the assay system and action plan if revertants are detected.
2.5 Indicate the Biosafety Containment Level (BSL) if different than the BSL specified in
Table 2.1.
BSL-1
3.
BSL-2
BSL-3
DNA Source
3.1
Indicate the original source(s) of DNA you intend to use (check all that apply).
Bacterial
Protozoan
Viral
Fungal
Human
Mammalian
Parasitic
Synthetic
Other: [Please specify]
3.2
Provide the species or strain of the source for the rDNA and, if applicable, the
vendor/investigator from which the DNA was acquired.
3.3
If a protein is expressed, what is the biological function of the gene product or sequence
that will be inserted?
3.4
Can the expression of your gene product be harmful (e.g., toxic) to humans, animals or
plants?
No.
Yes. Do you anticipate a local or systemic expression?
RCDC 001.11
Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments
Rev. 04/25/2011
USF Institutional Biosafety Committee
Page 4
4.
3.5
Will a deliberate attempt be made to obtain expression of a foreign gene(s) (a foreign
gene is one which is originally exogenous to the host-vector system used)?
No. Go to Section 4
Yes. Indicate what protein(s) the gene produces.
3.6
Is this gene involved in cell growth control (i.e., oncogene, tumor suppressor, growth
factor, cytokine, apoptosis inducer or inhibitor)?
No.
Yes.
3.7
Could exposure to the gene(s) result in tumor induction in humans, animals, or plants?
No.
Yes. Specify the type of tumor that may develop:
3.8
Indicate the host (target recipient) of the vector-recombinant DNA combination by
checking all that apply.
Animals
Human
E. coli
Cell culture
Plants
Other: [Please specify]
Recombinant DNA that Encode for Toxins or Toxic Materials
4.1
Does the gene that you are cloning produce a toxin (e.g., microbial toxins such as the
botulinum toxin, tetanus toxin, diphtheria toxin and Shigella dysenteriae neuro toxin) or
is the toxin a select agent (See Select Agent list )?
No. Go to Section 5.
Yes. Specify the toxin below. (Note: This project may require review and approval
by NIH/OBA. Contact the USF Institutional Biosafety Officer at (813) 974-0954.
5.
Drug Resistance Trait
5.1
Will there be transfer of a drug-resistance trait to microorganisms that are not known
to acquire that trait naturally, when such acquisition could compromise the use of a
drug to control disease agents in humans, animals, or plants?
No. Go to Section 6.
Yes. Please do A and B:
A. Contact the USF Institutional Biosafety Officer at (813) 974-0954.
B. Prior approval from the NIH/OBA Recombinant Advisory Committee (RAC) is
required. Attach a copy of the letter of approval from NIH/OBA.
RCDC 001.11
Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments
Rev. 04/25/2011
USF Institutional Biosafety Committee
Page 5
6.
7.
Plants, Insects, Protozoans
6.1
Do you intend to transfer recombinant DNA into a germ line (permanent change) in
order to establish a transgenic plant line, insect, and/or protozoan?
No. Go to section 7.
Yes. What are the anticipated or known immediate/long-term adverse events
associated with the deliberate/accidental release of the transgenic plant, insect,
and/or protozoa to the environment?
6.2
What safety practices, safety equipment, and engineering control(s) are in place to
prevent the accidental and/or deliberate release of the transgenic plant, insect
and/or protozoa to the environment?
6.3
Will the project at any time require the release of an organism containing rDNA
molecules into the environment?
No. Go to Section 7.
Yes. (Note: This project may require review and approval by NIH/OBA. Contact
the USF Institutional Biosafety Officer at (813) 974-0954.
rDNA Cloning
7.1
Will rDNA cloning be done using human or animal pathogens as host-vector systems
No.
Yes. Please describe the host-vector system.
7.2
Will cloning be done using source DNA from human or animal pathogens that have
been classified as Risk Group 3, Risk Group 4, and/or Select Agents?
No. Go to Section 8.
Yes. (Note: This project may require review and approval by NIH/OBA. Contact
the USF Institutional Biosafety Officer at (813) 974-0954.)
8.
Human Use
8.1
Will human subjects and/or human clinical specimens be used in any aspect of the
experiment?
No. Go to Section 9.
Yes.
8.2
Will there be transfer of DNA, recombinant DNA, or RNA derived from recombinant
DNA to human subject(s) (i.e., gene therapy)?
No.
Yes. If yes, submit these five documents:
A. Informed Consent form
B. Copy of the IRB application
C. Sponsor’s investigational brochure
D. Protocol
E. A copy of the letter of review from NIH/OBA
RCDC 001.11
Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments
Rev. 04/25/2011
USF Institutional Biosafety Committee
Page 6
8.3
Does the study involve the use of human cells and/or human clinical samples?
No.
Yes. List the type(s) of human clinical specimens you intend to use.
8.4 Has this research protocol been reviewed and approved by the IRB?
No. Date of Intended Submission to IRB: ________________
Yes. IRB study #: ________________ Date approved: ________________
Approval Pending - Date Submitted to IRB: ________________
9.
Animal Use
9.1
Will you administer recombinant DNA to animals or use animal tissue?
No. Go to Section 10.
Yes. Specify the animal species: ________________
9.2
Indicate the Animal Biosafety Containment Level (ABSL) at which the project will be
conducted in the vivarium:
ABSL-1
ABSL-2
The animals will be housed at ABSL-2 for
days or
entire study.
NOTE: Research activities requiring an Animal Biosafety Level 3 (ABSL-3)
containment facility are prohibited due to the lack of facilities.
9.3
Will you insert recombinant DNA into a germ line (permanent change) in order to
establish a transgenic or gene-targeted animal?
No.
Yes. What are the anticipated or known immediate/long-term adverse effects or
changes in phenotype/or genotype (e.g., early disease onset/resistance,
immunodeficiency) of such a change on the animal?
9.4
Does the study involve creation of transgenic or gene-targeted mice through the
Moffitt Small Animal Modeling and Imaging – SAMI Core Facility?
No.
Yes. Please have the SAMI Staff Scientist initial the following assurance:
The creation of transgenic mice by pronuclear DNA injection of ES cells into blastocysts will be
done at the Moffitt SAMI Core Facility in accordance with standard safety procedures described
and approved in corresponding SAMI Core Facility IACUC application.
Name
Please Initial
Date
RCDC 001.11
Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments
Rev. 04/25/2011
USF Institutional Biosafety Committee
Page 7
9.5
List the animal facility (e.g., College of Medicine, VA Hospital, College of Public
Health, LSA, SRB) and the area/room number(s) where the animals will be housed or
used.
9.6
What kind of expression do you expect the recombinant DNA to exhibit in the
animal?
Transient in vivo expression (e.g., injection of plasmids or transfected cell line in
animal).
Permanent expression (e.g., creation of transgenic animal).
9.7
Route of agent administration.
Intravenous
Intraperitoneal
Other: [Please specify]
Subcutaneous
Intramuscular
9.8
Has this research protocol received approval from the USF Institutional Animal Care
and Use Committee (IACUC)?
No. Date of Intended Submission to IACUC: ________________
Yes. IACUC study #: ________________ Date approved: ________________
Approval Pending - Date Submitted to IACUC: ________________
9.9
Will the rDNA molecule and/or the organism containing the rDNA molecule present
any risk of exposure to animal care staff?
No. Go to Section 10.
Yes. Answer A, B, C, and D.
A. What animal sources/routes (e.g., urine, feces, blood, bite/scratch), that may
contain the rDNA microorganism or the product of the gene expressed,
present a potential risk of exposure to the animal care staff?
B. What Personnel Protective Equipment is required to be worn by the animal
care staff to protect them from potential risk of exposure from the animal
source(s) mentioned in 4.9.A?
Face masks:
N 95 (HEPA)
N 100 (HEPA)
Face Shield
Head covers
Safety Glasses/Goggles
Double gloves
Lab gown
Gloves
Tyvek/Disposable Suits
Shoe covers
Lab coats
Other: [Please specify]
Surgical Mask
C. What safety practices are in place to protect the animal care staff from
potential risk of exposure from the animal source(s) mentioned in part A?
RCDC 001.11
Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments
Rev. 04/25/2011
USF Institutional Biosafety Committee
Page 8
D. The IBC requires a minimum concentration of 10% bleach solution as the
primary disinfectant. If using 10% bleach solution as the primary disinfectant
check this box.
10% Bleach Solution (1:10 dilution bleach to water)
If using an alternative disinfectant, specify in box below, the name, active
ingredient, concentration and an exemption for use of this disinfectant.
NOTE: Unless noted on this application with an explanation and approved by the
IBC, all other disinfectants (e.g., 70% alcohol) are secondary
disinfectants to be used after the 10% bleach.
10.
Medical Information
10.1 Are there any risks of disease and/or adverse effects (e.g. – altered immune
response/immunosuppression/allergenicity/toxicity) to humans, animals, and/or plants
that might result from exposure to the organisms or viruses containing recombinant
DNA molecules?
No.
Yes. Describe the potential adverse effects to humans, animals, plants and/or the
environment for each rDNA molecule:
10.2
By checking this box, I affirm that in the case of an exposure incident my
laboratory personnel (Faculty, staff, students and visitors) have been instructed to
follow the Exposure Management Plan as described below:
USF Personnel:
1.
Contact OptaComp at 1-877-518-2583 (24 hours a day/7 days per week) --During working hours (M-F, 8 – 5 PM) the USF Worker’s Compensation
Insurance Specialist Meica Elridge should also be contacted at (813) 9745775, or (melridge@admin.usf.edu).
2. In the event that follow-up is necessary following initial care from the USF
Workers’ Compensation Provider, please contact the USF Medical Health
Administration (Employee Health) office at (813) 974-3163, or pager (813) 2160153.
Moffitt Personnel:
Moffitt Incidents Website per Moffitt Work Related Injury policy EH-13
If you have a protocol specific exposure management plan which is different than
above, describe in the space provided below.
RCDC 001.11
Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments
Rev. 04/25/2011
USF Institutional Biosafety Committee
Page 9
10.3 Describe the process to inform the personnel working with organisms or viruses
containing recombinant DNA molecules of the potential hazards, including an
immunocological condition which may increase the risk of infection (e.g., signage on
door, specific training, read and initial this application).
Occupational Health Requirements
10.4 Indicate the Occupational Health Requirements for personnel who will actively be
taking part in this research project (check all that apply).
Not Applicable.
Baseline Serum Banking – This is suggested for any disease process potentially
found in the community that is most effectively treated by monitoring a rise in
serum antibody titer.
Baseline Status Testing – This is suggested for any disease process potentially
found in the general community and is also the focus of this research. The current,
appropriate exposure/infected/immune status of the individual(s) will be
determined.
General Vaccine(s) (Hepatitis B, Influenza, etc) – Hepatatis B vaccination is
recommended for any individual working with human tissue. Additional,
appropriate vaccines may be available, depending on the research.
Agent Specific Vaccine – specify in box
Respiratory Health Evaluation and Respirator Fit-Testing – Respirator (N-95, N100, etc) use is recommended when there is the possibility for infectious aerosol
exposure and/or potentially toxic chemical inhalation exposure during the conduct
of this research.
Other [specify]
11.
Experimental Procedures
11.1 A. What is the greatest volume/weight (e.g., ml) and working concentration (e.g.
units/ml, cfu/unit of volume) of the organisms and/or viruses containing
recombinant DNA molecules that you expect to have in use at any one time?
11.2 A. Will you culture an organism/virus containing recombinant DNA?
No.
Yes.
B. Does the study involve the generation or use of more than 10 liters of culture?
No.
Yes. (Note: This project may require review and approval by NIH/OBA.
Contact the USF Institutional Biosafety Officer at (813) 974-0954.)
11.3 A. Indicate the types of experimental manipulations which you will use that have the
potential to generate aerosols/splashes (check all that apply).
Homogenization
Centrifugation
Sonication
Dissection
Pipetting
Other: [Please specify]
Cell sorter and/or flow cytometry
None. Go to Question 11.4
RCDC 001.11
Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments
Rev. 04/25/2011
USF Institutional Biosafety Committee
Page 10
B. What special practices/procedures will you use for containment of aerosols/splashes
for the above-mentioned experimental manipulations in Question 11.3.A?
11.4 Indicate the Safety Equipment you will use (check all that apply)
Stomachers
Safety Blender (e.g. shatter proof jar-double walled: blender rotors leak proof)
Low aerosolization pipette tips
Mechanical or electronic pipettors
Chemical fume hood (for chemical use)
Centrifuge with safety cups or sealed rotor heads
Other: [Please specify]
Use of Sharps
11.5 Indicate the Safety Practices to be used with Sharps (needles, scalpels, etc.)
Substitute glassware with plastic ware, when possible
Do not bend, break or recap needles
Do not bend, break or recap scalpels
Dispose of sharps in red sharps containers
Use of safer sharp devices/engineered sharps
Not Applicable
NOTE: An engineered sharp has a physical attribute built into the sharp device that
effectively reduces the risk of an exposure incident. Examples of such devices include
retractable needles, hinged needle shields, needleless IV connectors, sliding sheath/sleeve
and needle guards.
11.6 Indicate the Personnel Protective Equipment that will be used (check all that apply).
Particulate respirators:
N 95 (HEPA)
N 100 (HEPA)
Face Shield
Lab Coats (front buttoned)
Safety Glasses/Goggles
Double gloves
Lab gown (Tie backs)
Gloves
Disposable Suits/coveralls with attached hood and boots
Other: [Please specify]
NOTE: The use of particulate masks, such as N-95, requires medical evaluation, fit
testing, and training prior to their use per OSHA regulations.
11.7 Have all personnel working with organisms containing rDNA been instructed and
trained in lab-specific clean up procedures for biohazardous spills and PI provided
laboratory specific training?
No.
Yes
NOTE: For general biohazard spill procedures access the following website
http://www3.research.usf.edu/dric/biosafety/resources.asp . Print and post the
Biological spill response in the laboratory.
RCDC 001.11
Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments
Rev. 04/25/2011
USF Institutional Biosafety Committee
Page 11
11.8 Do you intend to use a Biological Safety Cabinet (BSC)?
No. Explain what safety procedures you will use instead of the BSC to eliminate
the risk of aerosol exposure:
Yes. Answer A:
A. BSC should be certified annually. What was the date of the last certification?
Decontamination and Disposal
11.9 The IBC requires a minimum concentration of 10% bleach solution as the primary
disinfectant. If using 10% bleach solution as the primary disinfectant check this box.
10% Bleach Solution (1:10 dilution bleach to water)
If using an alternative disinfectant, specify in box below, the name, active
ingredient, concentration and an exemption for use of this disinfectant.
NOTE: Unless noted on this application with an explanation and approved by the
IBC, all other disinfectants (e.g., 70% alcohol) are secondary
disinfectants to be used after the 10% bleach.
11.11 Indicate how biohazardous solid waste will be decontaminated and disposed.
Autoclaved Time:
minutes
Temp:
Celsius
Chemically inactivated: [Please specify]
Packaged as biohazardous waste per USF policy
Other: [Please specify]
11.12 Indicate how biohazardous liquid waste will be decontaminated and disposed.
Autoclaved Time:
minutes
Temp:
Celsius
Chemically inactivated: [Please specify]
Packaged as biohazardous waste per USF policy
Other: [Please specify]
Storage and Transport
11.13 Will the organism harboring the rDNA used/generated in these experiments be
transported or transferred outside of the room in which they are stored?
No.
Yes. Answer A and B below.
A. To what location(s) outside of your laboratory will you transport/transfer these
recombined biological materials?
RCDC 001.11
Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments
Rev. 04/25/2011
USF Institutional Biosafety Committee
Page 12
B. When transporting/transferring materials, the materials must be placed inside
a watertight primary container, which is then placed into a watertight, leak proof
and durable secondary container for transportation, with absorbent material
placed between the two containers to absorb contents of the container in case of
possible spill.
I will transport material in accordance with the above described procedure.
11.14 Will any of these organisms and/or viruses containing recombinant DNA be shipped
via commercial carrier (e.g., Federal Express)?
No.
Yes. Identify the person(s) that will be preparing the recombinant DNA molecules
for shipping and provide their Transportation of Dangerous Goods training dates.
11.15 Will any of these materials be imported from or exported to one or more foreign
countries?
No.
Yes. All shipments must meet federal and state transportation regulations and
USF policies. Respond to A, B, C, and D below:
A. List the materials to be imported and/or exported.
B. List the country of origin or destination for each.
C. Indicate whether this is a one-time shipment or part of a series of shipments.
D. Attach a copy of the USDA permit, CDC permit, and/or Dept. of Commerce
permit.
12.
Diagram of Laboratory Areas
Attach a clearly labeled diagram of the laboratory that shows the following:
1) Where the agent(s) will be manipulated and stored;
2) Location of biological safety cabinet(s), eye-wash, sink, and other safety equipment;
3) Room entry/exit;
4) Location of the nearest available autoclave (if autoclave is not available in
laboratory, list the location using text).
RCDC 001.11
Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments
Rev. 04/25/2011
USF Institutional Biosafety Committee
Page 13
13.
Personnel
The Institutional Biosafety Committee (IBC) must be notified of any new personnel who will be directly involved in the conduct of the
experiment and/or for whom a potential risk exists by virtue of their presence within the research environment.
13.1 List the names of all personnel involved and have each person initial the following assurance:
 I have read and understand the nature of these experiments.
 I have the knowledge and training required to safely handle the materials described.
 I agree to conduct these experiments in accordance with all USF IBC policies and the USF Biosafety Manual:
 http://www3.research.usf.edu/dric/biosafety/docs/biosafety-manual.pdf
 I have attended/will attend the annual USF biosafety training indicated.*
Name
Initial
here
Date
Biosafety
Training*
Training Date
E-mail
Occupational Health Evaluation
Completed
Yes
No
Yes
No
NA
Yes
No
Yes
No
NA
Yes
No
Yes
No
NA
Yes
No
Yes
No
NA
Yes
No
Yes
No
NA
Yes
No
Yes
No
NA
Yes
No
Yes
No
NA
Yes
No
Yes
No
NA
Yes
No
Yes
No
NA
Yes
No
Yes
No
NA
*
The following types of training classes are required:
 Core – Must be completed by those who have not completed it previously.
 Continuing Education – Must be completed annually.
 Special Topics – Required for persons involved in certain types of work.
For current Biosafety training information, please go to: http://www3.research.usf.edu/dric/biosafety/education.asp
RCDC 001.11
Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments
Rev. 04/25/2011
USF Institutional Biosafety Committee
Page 14
14.
Laboratory Inspection
BSL-2 or BSL-3 laboratories must pass inspection before initial approval for research
activities can be granted for this proposed study. The Principal Investigator is responsible for
scheduling an inspection by contacting the Biosafety Staff at biosafety@research.usf.edu or
(813) 974-5091 or (813) 974-5110.
Information on biosafety containment levels and other guidance is available in the NIH Guidelines
for Research Involving Recombinant DNA Molecules, the Biosafety in Microbiological and
Biomedical Laboratories, 5th Edition , and the USF Institutional Biosafety Manual. Investigators
are encouraged to consult these sources to ensure that their laboratories meet the required standards
for sound biosafety practices.
A Sample BSL-2 Checklist is provided to help you prepare for a laboratory inspection.
15.1 Has your laboratory been scheduled for inspection?
Yes. Please provide the date:
No. Inspection is pending due to:
Does not apply because the laboratory involved is BSL-1.
15.
Investigator Assurance
 I agree to use lab practices that meet the biosafety level (BSL) specified in Question 2.2.1
or 2.2.5 with all recombinant DNA work in this project.
 I have read the NIH Guidelines and I acknowledge my responsibility for the conduct of
this research in accordance with Section IV-B-7 of the NIH Guidelines.
 I have the knowledge and training required to safely handle the materials described.
 I acknowledge my responsibility for the conduct of this research in accordance with
University Policy, Section IV-B-7 of the NIH Guidelines and/or the recommendations of
the CDC/NIH published in Biosafety in Microbiological and Biomedical Laboratories, 5th
Edition and the USF Institutional Biosafety Manual .
 I acknowledge my responsibility to secure and control the biological agents used in this
project.
 Entry doors to the laboratory will be closed and locked when the laboratory is
unattended.
____________________________________________
Signature of Principal Investigator
___________________
Date
RCDC 001.11
Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments
Rev. 04/25/2011
USF Institutional Biosafety Committee
Page 15
Appendix A – Biosafety References






Biosafety in Microbiological and Biomedical Laboratories, 5th Edition
Material Safety Data Sheets (MSDS) for Infectious Agents
Risk Group Classification for Infectious Agents
USF Institutional Biosafety Manual
NIH Guidelines for Research Involving rDNA Molecules
Biological Spill Response
Appendix B – Response to Laboratory Personnel Bloodborne Pathogen (BBP)
Exposure
The following emergency response guidelines shall be followed when a laboratory worker has been
exposed to potentially infectious agents, including bloodborne pathogens to ensure prompt and
appropriate care. BBP Exposure is defined as “A percutaneous injury (a needlestick or cut with a sharp
object) or contact of mucous membrane or non-intact skin with blood, tissue or other body fluids that are
potentially infectious”. Some post-exposure treatments must be started within
1-2 hours of exposure, so time is critical.
If Percutaneous and/or Non-Intact Skin Accidental Exposure Occurs:
Secure sharp device in sharps container
Wash the exposed site thoroughly with soap and water
Remove contaminated clothing
Report exposure to supervisor immediately
If Mucous Membrane Accidental Exposure Occurs:
Flush eyes, nose and/or mouth with copious amounts of water at the nearest faucet or eye wash station.
Remove contaminated clothing
Report exposure to supervisor immediately
If you are exposed to a Bloodborne Pathogen:
Immediately report all possible work-related exposures to potentially infectious agents, including BBP’s
to your supervisor. Exposures are to be reported immediately by the supervisor or department designee by
telephone to OptaComp 1(877)518-2583 (24 hours a day/7 days per week). During working hours (M-F,
8-5PM) the USF Worker’s Compensation Insurance specialist Meica Elridge should also be contacted at
(813) 974-5775 or by email at melridge@admin.usf.edu. In the event that follow-up is necessary
following initial care from the USF Workers’ Compensation provider, please contact the USF Medical
Health Administration (Employee Health) office at (813) 974-3163 or by pager (813) 216-0153.
If you become ill or injured on the job:
An employee who becomes ill or is injured as the result of a job-related incident must report the incident
to the supervisor immediately no matter how minor the injury may appear to be. Effective January 1,
2009, all work-related injuries or illnesses are to be reported by the supervisor or department designee by
telephone to:
OptaComp 1(877)518-2583 (toll free). For additional information on how to report a work-related
injury or illness go to the USF Worker’s Compensation website at: http://usfweb2.usf.edu/humanresources/employee-relations/workers-comp.asp
USF Employees, Residents, and Student Assistants classified as “Volunteers”: You must report all
potential BBP exposures to your supervisor and then call OptaComp.
RCDC 001.10 Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments
Rev. 01/15/2008
USF Institutional Biosafety Committee
Page i
USF Students not on official “Volunteer” status and not employed by the University: Your care must be
paid for through your student/personal insurance or by some other means
If you are the supervisor:
When an employee reports a work-related injury or illness, take prompt action to
1. Ensure the employee receives necessary medical attention. In case of emergency, call 911 or
immediately send the employee to a hospital emergency room. Call OptaComp as soon as
practicable at 1-877-518-2583 to report the work-related injury or illness.
2. With the injured or ill employee, immediately call OptaComp at 1-877-518-2583 to report the
work-related injury or illness so the employee can receive appropriate care. Except in cases of
emergency, the injured or ill employee must be present with the supervisor when the injury or
illness is reported.
3. Complete the Accident Investigation Report for Supervisors and forward to Human Resources
within 24 hours.
4. Take action to correct any safety hazards to prevent the same or similar injury or illness from
occurring again.
For questions on how to report a work-related injury or illness or other workers’ compensation issues,
contact Workers’ Compensation Insurance Specialist Meica Elridge at (813) 974-5775 or
melridge@admin.usf.edu. Reports may be faxed to (813) 974-7535.
RCDC 001.10 Registration Document for the Non-Exempt Use of Recombinant DNA in Experiments
Rev. 01/15/2008
USF Institutional Biosafety Committee
Page ii