Registration document for the Use of Infectious Agents and...

RCDC 002.11 Registration Document for the Use of Infectious Agents and Biological Toxins

Rev. 08/09/2010 USF Institutional Biosafety Committee

Division of Research Integrity &Compliance Institutional Biosafety Committee

Registration Document for the Use of Infectious

Agents and Biological Toxins

USF requires that all projects involving the use of infectious agents or biological toxins conducted at or

supported by this university be registered with and approved by the Institutional Biosafety Committee

(IBC) prior to initiation of the project.

If you are using infectious agents / biological toxins requiring BSL-3 containment, contact Farah Moulvi,

Institutional Biosafety Officer, at (813) 974-0954 for further instructions. The use of infectious

agents/biological toxins requiring BSL-4 containment is prohibited on the USF campus.

Instructions:

1. Provide complete information for every item. Blank or incomplete items may delay the processing of

your application.

2. Consult the following reference materials prior to filling out this form. These can be accessed

through our website at: http://www.research.usf.edu/cs/biosafety.htm

a. Biosafety in Microbiological and Biomedical Laboratories, 5th Edition, J. Y. Richmond and R.

McKinney, Editors (on reserve at the Tampa campus library and Health Sciences Center library)

b. Material Safety Data Sheets (MSDS) for Infectious Agents

c. Risk Group Classification for Infectious Agents

d. USF Institutional Biosafety Manual:

3. Completed forms may be submitted by:

E-mail to [email protected] and follow with mailed hard copies of signature pages

bearing original signatures.

Mail to 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 [email protected] or (813) 974-5091 or

(813) 974-5110.

4. For more information, contact at (813) 974-0954 or Debbie King at (813) 974-5091.

Section 1 Part A – Basic Information

1.A.1 Principal Investigator: Robert HillDepartment: CMMB Campus Mail: BSF218

Building: BSF Office Room#: 114 E-mail: [email protected] Fax: 813-974-2011

Office Phone: 813-428-4210 Lab Phone: 813-428-4210 PI’s Study Coordinator: Coordinator Phone: Coordinator E-mail:

http://www.research.usf.edu/cs/biosafety.htm

http://www.cdc.gov/biosafety/publications/bmbl5/index.htm

http://www.phac-aspc.gc.ca/msds-ftss/index-eng.php

http://www.absa.org/riskgroups/index.html

http://www.research.usf.edu/cs/biosafety_docs/biosafety_manual.pdf

mailto:[email protected]




1.A.2 Type of Registration:

Single Project Multi-Project

1.A.3 Please check one:

New Registration

3rd Year Renewal Registration Replacing Previous IBC Study #

1.A.4 Project Title(s) (if multi-project, list titles of each project and assign a number to each):

Evaluation of the antiviral efficacy of plastics containing silver and copper ions

1.A.5 Sponsor(s)-List intramural and/or extramural sources:

Part B – Project Information

1.B.1 Describe your research objectives in lay terminology (1 to 2 paragraphs):

Surface contamination with pathogens is a leading cause for the spread of human disease. As such, the production of surfaces, most especially plastics that harbor antiviral properties could be effective in attenuating the spread of disease. This study evaluates the antimicrobial and antiviral efficacy of plastics containing silver and copper. This study does not in any way evaluate the safety of this product. Product safety has already been determined by

1.B.2 Provide below or attach a one-page description of the research project including in vitro

and/or in vivo specific laboratory procedures (e.g., culturing, vortexing, incubating, etc)

that will be performed during the study. Detail the actual physical manipulations with

special attention towards the safe handling of the infectious agent(s) and/or toxins and

include any animal and/or animal tissue handling procedures during the experiment. (For

example: "All pipeting will be performed in a BSC will non-aerosolizing tips." Or

"Centrifugation will be performed only on tightly-capped sample vials in a rotor equipped

with safety centrifuge caps.")

Virus will be cultured in HeLa cells growing in 3mls DMEM supplemented with 10% FBS and 1% Glutamine. Cells will be grown for 72 hours at 37°C with 5% CO2 and 95% humidity after being infected with 30µl of virus stock (from a -80°C stored aliquot, or from an initial sample acquired from the American Type Culture Collection that has been thawed to room temperature) added to HeLa cells at ~10% of maximum density in 6-well plates. After the 72 hour incubation the conditioned media will be removed with a pipette, filtered through a 0.45µ nitrocellulose syringe filter and 1ml aliquots of virus stock will be stored at -80°C for subsequent experiments. The number of viral particles in the stocks is determined by assaying conditioned medium set to 1ml serial dilutions of 10E-7, 10E-8 and 10E-9 in D/E neutralizing broth. Following, the 1ml serial dilutions are analyzed by a plaque forming assay as described below.



Plastic strips (5 cm x 5 cm) containing 3.5% Ag and 6.5% Cu ions incorporated into the plastic during manufacturing (prior to molding) will be used in this set of experiments. The plastic coupons will be sanitized with 70% ethanol, allowed to air dry, and then evenly inoculated with 100ul frozen virus stock using a sterile glass rod. To determine the original virus titer recovered, three control strips will be sampled (virus removed from plastic strip) immediately using a sterile polyester swab dipped in 1.0 ml of D/E neutralizing broth (Remel, Lenexa, KS, USA). Remaining virus from the coupons is scraped into the 1ml of D/E neutralizing broth accomplished via consistantly scraping 3 times with the same left/right forward/backward motion. The remaining strips will then be placed in humidity chambers (~95% humidity) at room temperature kept within a certified Biological Safety Cabinet (BSC). At 1, 4, and 24 hours, the coupons will be sampled as done with the control and added to the 1ml of D/E neutralizing broth. Samples in D/E broth will be filtered using a 0.22µ pore size Acrodisc syringe filter (Pall, Ann Arbor, MI, USA) pre-wetted with 3% beef extract (pH 7.0) to remove any contaminating bacteria/fungi. Recovered virus is then tittered utilizing a plaque assay explained as follows: Recovered virus in D/E neutralizing broth from the plastic coupons will be set to 1ml serial dilutions of 10E-4, 10E-5, 10E-6 and 10E-7 in D/E broth. HeLa cells will then be diluted to a density of 0.5x10E6/ml and 3 ml of this cell suspension will be added to each well in a 6-well culture dish. Cells are then incubated for 16-24 hours at 37°C to allow attachment. Media is then replaced with the 1ml dilutions of recovered virus and the plate is allowed to rock slowly for 1 hour in the BSC at room temperature. 1 part 2x Grace's Medium supplemented with 20% Fetal Calf Serum and 0.002% Neutral Red is slowly added to 1 part melted 3% low melting temp SeaPlaque Agarose in ddH2O and the mixture is incubated in a 37°C water bath for 30 minutes. Diluted virus in then removed by pipetting from the 6-well plates and replaced carefully with 3mls of the agarose / Grace’s Medium mixture. Plates are incubated for 30 minutes in the BSC followed by a 72 hour incubation at 37°C with 5% CO2 and 95% humidity. After the 72 hour incubation, clear zones (plaques) will be visible within the agarose. Plaques for each dilution of recovered virus can then be counted using a dissecting microscope within the BSC and used to calculate the number of infectious viral particles that remained on the plastic coupons. Samples whenever exposed to the air directly (i.e. Not in tightly capped tubes) will be manipulated only in a certified Biological Safety Cabinet (BSC). All pipetting will utilize filtered, non-aerosolizing tips. No aspirate suction will be utilized for any procedures mentioned; all waste fluids will be removed from culture vessels via pipetting and added to bleach to a final concentration of 10%. All waste fluids will be provided at least a 1 hour contact time in 10% bleach and disposed of down the drain followed by copious amounts of water. All work surfaces and pipettes will be decontaminated with exposure to 10% bleach for 30 min followed by U.V. exposure after use of any mentioned biological agents. U.V. exposure to surfaces will strictly be used as a secondary method of decontamination. All centrifugation will occur only on tightly capped samples within rotors equipped with safety caps. Excluding centrifugation, 37°C incubation and -80°C storage, all steps will be performed within the BSC including cell culturing, plaque forming assay, viral dilution and the inoculation of plastics. All glass and plastics including pipette tips, plastic coupons and culture vessels exposed to any potential biohazard will be submerged into a solution of 10% bleach for 1 hour within the Biological Safety Cabinet. After exposure to bleach, plastics will be discarded as hazardous waste in accordance with USF policy.



2. Infectious Agents and Biological Toxins

2.1 Provide all requested information for each agent/toxin that will be used in this project in table below:

1 P=parasite, F=fungus, B=bacteria, R=Rickettsia, V=virus (not arbovirus), A=Arbovirus, T=toxin, PR=prions, VR=viroids, O=other.

2 If agent, list genus & species. If toxin, include agent (genus & species) it is derived from. 3 Specify the type and name of source (e.g., vendor – ATCC; off-campus collection – Univ. of CA; clinical specimen - human)

4 Refer to the NIH Guidelines, and the BMBL for RG and BSL designation.

Item

#

Type1

Name of

Material2

Strain of

Agent (if

applicable)

Source3 Risk

Group4

(RG)

Biosafety

Level4

(BSL)

Locations

of Use

Locations

of Storage

(if

different)

Maximum

amount possessed

(volume or

weight)

Maximum

concentration

to be used

(e.g pfu/ml)

1 V Rhinovirus HGP ATCC BSL2 2 BSF114 BSF 149 20mls 5.0 9 105 TCID50/m

2 V Influenza B B/Maryland/1/59

ATCC BSL2 2 BSF114 BSF 149 20mls 5.0 9 105 TCID50/m

3 V Human Rotavirus

WA T/C adapted

ATCC BSL2 2 BSF114 BSF 149 20mls 5.0 9 105 TCID50/m

4

5

6

7

8

9

10

http://oba.od.nih.gov/rdna/nih_guidelines_oba.html




2.2 Indicate the Biosafety Containment Level (BSL) if different than the BSL specified in

Table 1.1:

BSL-1 BSL-2 BSL-3

Provide justification for the difference:

3. Regulated Agents

3.1 Are any of the infectious agents / biological toxins (virulent or attenuated) in this

application listed in Appendix B - Regulated Agents?

No. Go to Section 4. Yes. Notify the Institutional Biosafety Officer immediately at (813) 974-0954 to

insure compliance with all federal mandates.

3.2 Have you registered the agents/toxins as select agents with the CDC/USDA?

No. Explain the exemption/exclusion criteria.

Yes. Explain the status of the CDC/USDA select agent registration/certificate for

this project: Submit a copy of CDC/USDA registration:

A. Describe the specific security procedures that you will use to ensure secure

(a) access, (b) use, (c) storage, and (d) disposal:

B. Describe the inventory control system for the agents/toxins you plan to use

(e.g., procedures used to account for the agents and to detect missing

material):

4. Recombinant DNA Technology

4.1 Do you plan to use an infectious agents generated by recombinant DNA technology?

Note this registration application is required for mutant infectious agents. For infectious

agents that are replication impaired used as a viral vector use the recombinant DNA

registration.

No. Go to Section 5. Yes. Describe the recombinant infectious agent including an assessment of the

expected phenotype below



4.2 Will the recombinant infectious agent be generated as part of this study?

No. It will be obtained from the following source below.

Yes. If yes, also complete the applicable rDNA registration application

5. Human Use

5.1 Will human subjects and/or human clinical specimens be used in any aspect of the

experiment?

No. Go to Section 6. Yes.

5.2 Has this research protocol been approved by the IRB?

No. Date of Intended Submission to IRB: ________________

Yes. IRB study #: ________________ Date approved: ________________

Approval Pending; Date Submitted to IRB: ________________

5.3 Will you administer infectious agents/biological toxins to humans?

No.

Yes. Submit copies of the following documents:

A. Informed Consent form

B. USF Institutional Review Board (IRB) application or IRB approval of

exemption

C. Sponsor’s investigational brochure

D. Protocol

5.4 Does the study involve the use of human cells and/or human clinical samples?

No.

Yes. List the type of human clinical sample(s) you plan to use:

6. Animal Use

6.1 Will you administer infectious agents/biological toxins to animals or animal tissue in

the vivarium?

No. Go to Section 7. Yes. Specify the animal species: ________________.

6.2 Indicate the Animal Biosafety Containment Level (ABSL) at which the project will be

conducted in the vivarium:

ABSL-1 ABSL-2 ABSL-3

6.3 Has this research protocol received USF Institutional Animal Care & Use Committee

(IACUC) approval?

No. Date of Intended Submission to IACUC ________________

Yes. IACUC study #: ________________ Date approved: ________________ Approval Pending; Date Submitted to IACUC: ________________



6.4 List the animal facility (e.g., College of Medicine, Moffitt Cancer Research, VA

Hospital, College of Public Health, LSA, SCA, SRB, ACH, IDRB) and the area/room

number (s), if known, where the animals will be housed or used:

6.5 Will the animals exposed to the infectious agents/biological toxins be transported

within the animal facility or to other areas within USF:

No.

Yes. Describe how and where the animals will be transported.

6.6 Route of agent administration:

Intravenous Intraperitoneal Subcutaneous Intramuscular

Other: [Specify]

6.7 Will the infectious agents/toxins present any risk of exposure to animal care staff?

No. Go to Section 7.

Yes. Answer parts A, B, C and D.

A. What animal sources/routes (e.g., urine, feces, blood, bite/scratch), 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 part A? Check all that apply.

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: [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?

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 above 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.

7. Medical Information

7.1 Are there any risks of disease and/or adverse effects (Ex. - Altered immune response/

immunosuppression/allergenicity/toxicity) to humans, animals, and/or plants that

might result from exposure to these organisms/toxins?

No.

Yes. Describe the potential adverse effects to humans, animals, plants, and/or the

environment for each infectious agent/biological toxin, including:

a. The infectious dose and/or the LD50;

b. Availability of treatment or prophylaxis/vaccine (licensed or IND)

c. Known drug/vaccine resistance or prophylaxis failure rate (Please note the

specific antimicrobial or other agent to which there is resistance); None

d. The symptoms/disease(s) which may result from exposure.

Rhinovirus o INFECTIOUS DOSE: Ranges from 0.032 to 0.4 TCID50 when given as nasal spray. o IMMUNIZATION: None o PROPHYLAXIS: Antiviral agents have proven effective in vitro, but with little effect in clinical

trials. Rest, hydration, nasal decongestant and saline gargles constituted standard treatment.

o PATHOGENICITY: Most frequent cause of the common cold responsible for 30-50% of cases; acute infection of the upper respiratory tract; characterized by coryza, sneezing, lacrimation, irritated nasopharynx, headache, sore throat, chilliness and malaise lasting 2-7 days; little or no fever; can be accompanied by laryngitis, tracheitis and bronchitis; secondary bacterial infection may produce acute otis media, sinusitis or pneumonitis

Rotavirus o GENERAL INFORMATION: Rotavirus is the most common cause of severe diarrhea among

infants and young children, and is one of several viruses that cause infections often called stomach flu, despite having no relation to influenza. It is a genus of double-stranded RNA virus in the family Reoviridae. By the age of five, nearly every child in the world has been infected with rotavirus at least once. However, with each infection, immunity develops, and subsequent infections are less severe,] adults are rarely affected. There are five species of this virus, referred to as A, B, C, D, and E. Rotavirus A, the most common, causes more than 90% of infections in humans. This species will be evaluated in this study. Our lab will include signage strictly forbidding entry to persons under the age of 16 during the course of and up to one month following this study.

o Signs and Symptoms: Rotavirus A infections can occur throughout life: the first usually produces symptoms, but subsequent infections are typically asymptomatic, as the immune system provides some protection. Consequently, symptomatic infection rates are highest in children under two years of age and decrease progressively towards 45 years of age. Infection in newborn children, although common, is often associated with mild or asymptomatic disease; he most severe symptoms tend to occur in children six months to two years of age, the elderly, and those with compromised or absent immune system functions. Due to immunity acquired in childhood, most adults are not susceptible to rotavirus; gastroenteritis in adults usually has a cause other than rotavirus, but



asymptomatic infections in adults may maintain the transmission of infection in the community. Symptomatic reinfections are often due to a different rotavirus A serotype.

o TREATMENT AND PROGNOSIS: Treatment of acute rotavirus infection is nonspecific and involves management of symptoms and, most importantly, maintenance of hydration. If untreated, children can die from the resulting severe dehydration. Depending on the severity of diarrhea, treatment consists of oral rehydration, during which the child is given extra water to drink that contains small amounts of salt and sugar. Some infections are serious enough to warrant hospitalization where fluids are given by intravenous drip or nasogastric tube, and the child's electrolytes and blood sugar are monitored. Rotavirus infections rarely cause other complications and for a well-managed child the prognosis is excellent. There are rare reports of complications involving the, and recent studies have confirmed that rotavirus infection is not always confined to the gut, but can cause viremia.

o TRANSMISSION: Rotavirus is transmitted by the fecal-oral route, via contact with contaminated hands, surfaces and objects, and possibly by the respiratory route. The feces of an infected person can contain more than 10 trillion infectious particles per gram; only 10–100 of these are required to transmit infection to another person. Rotaviruses are relatively unstable in the environment but have been found in estuary samples at levels as high as 1–5 infectious particles per US gallon. Sanitary measures adequate for eliminating bacteria and parasites seem to be ineffective in control of rotavirus, as the incidence of rotavirus infection in countries with high and low health standards is similar

o References for Rotavirus Information Bishop RF (1996). "Natural history of human rotavirus infection". Arch.

Virol. Suppl. 12: 119–28. PMID 9015109 Flewett TH, Woode GN (1978). "The rotaviruses". Arch. Virol. 57 (1): 1–23..

PMID 77663 Koopman JS, Monto AS (1989). "The Tecumseh Study. XV: Rotavirus

infection and pathogenicity". Am. J. Epidemiol. 130 (4): 750–9. PMID 2549788.

Diggle L (2007). "Rotavirus diarrhoea and future prospects for prevention". Br. J. Nurs. . 16 (16): 970–4. PMID 18026034

Influenza B Virus o INFECTIOUS DOSE: the HID50 measured when inoculation was performed by intranasal drops

was 127–320 TCID50 o IMMUNIZATION: FDA approved seasonal flu vaccine. o PROPHYLAXIS: FDA approved antiviral drugs, Peramivir and interferon. o PATHOGENICITY: An infectious disease caused by RNA viruses. The most common symptoms

of the disease are chills, fever, sore throat, muscle pains, severe headache, coughing,

weakness/fatigue and generating discomfort lasting 3-14 days.

Note: The information needed can be found in the MSDS available at the

following website http://www.phac-aspc.gc.ca/msds-ftss/index-eng.php

7.2 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:

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) 974-

5775, or ([email protected]).

2. In the event that follow-up is necessary following initial care from the USF

http://en.wikipedia.org/wiki/Infectious_disease

http://en.wikipedia.org/wiki/Chills

http://en.wikipedia.org/wiki/Fever

http://en.wikipedia.org/wiki/Sore_throat

http://en.wikipedia.org/wiki/Myalgia

http://en.wikipedia.org/wiki/Headache

http://en.wikipedia.org/wiki/Cough

http://en.wikipedia.org/wiki/Fatigue_(medical)

http://en.wikipedia.org/wiki/Malaise





Workers’ Compensation Provider, please contact the USF Medical Health

Administration (Employee Health) office at (813) 974-3163, or pager (813)

216-0153.

If you have a protocol specific exposure management plan which is different than

above, describe in the space provided below.

7.3 Describe the process that will be used to inform the personnel working with infectious

agents/toxins of the potential hazards, including the presence of an immunological

condition that could increase the risk of infection (e.g., signage on the door, specific

training, read and initial this application, etc.).

As the sole user, the PI is aware of all the associated risks and will use appropriate PPE. Sinage on the door outside of the entry door, on the incubator and BSC, and on the North wall of the lab will indicate the following: The PI's and Ph.D.(USF CAS CMMB Chair) contact information, that this Laboratory is a BSL-2 facility and as such the possibility of infection exists and those that are or believe to be immunocompromised have a heightened risk of infection.

Occupational Health Requirements

7.4 Indicate the Occupational Health Requirements for personnel who will be actively

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(s).

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.) - Hepatitis B vaccination is

recommended for any individual working with human tissue. Additional, appropriate

vaccines may be available, depending upon the research agent.

Agent Specify Vaccine –specify in box

Respiratory Health Evaluation and Respirator Fit-Testing – Respirator (N-95, N-

100, 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 project.

Other [Specify]



8. Experimental Procedures

8.1 Will any of the procedures described in the protocol result in acquisition of a new

characteristic, such as enhanced virulence, infectivity, drug resistance, or change in

host range?

No.

Yes. Explain:

8.2 Does the study involve the generation or use of more than 10 liters of culture? No.

Yes. Explain the culture procedures, including identification of:

(a) The culture room.

(b) The types of equipment used for culture growth/handling.

(c) Any special precautions to handle such large volumes.

8.3 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: [Rocking] Cell sorter and or Flow cytometry None.

Safety Precautions

8.4 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 biological toxin use)

Centrifuge with safety cups or sealed rotors heads

Other: [BSC]

Use of Sharps

8. 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, needless IV connectors, sliding

sheath/sleeve and needle guards).



For a list of Safety-Engineered Sharp Devices and other products designed to prevent

occupational exposures

8.6 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 aerosols exposures:

Yes. Answer A:

A. BSC must be certified annually. Provide the date of the last certification:

[January 2011]

8. 7 Indicate the Personnel Protective Equipment that will be used (check all that apply):

Particulate respirators: N 95 (HEPA) N 100 (HEPA)

Face Shield Double gloves

Safety Glasses/Goggles Gloves

Lab coats (front buttoned)

Lab gown (Tie backs)

Disposable Suits/coveralls with attached hood and boots Other: [Specify]

NOTE: The use of particulate masks such as N-95 requires medical evaluation, fit

testing and training prior to its use per OSHA regulations.

8.8 Have all personnel working with infectious agent(s) been instructed and trained

in lab-specific clean up procedures for biohazardous spills (that is both USF Biosafety

Training Course and PI provided training)?

No.

Yes.

NOTE: For general biohazard spill procedures access following website

http://www.research.usf.edu/cs/biosafetyinfoguides.htm. Print and post the Biological

spill response in the laboratory.

8.9 As part of the research procedures will the organism/toxin be inactivated/lysed

before subsequent manipulation outside containment?

No.

Yes. Answer parts A, B, and C:

A. Method of inactivation (heat, chemical, other)

B. At what stage of the experiment will the agent/toxin be inactivated/lysed:

http://www.healthsystem.virginia.edu/internet/epinet/safetydevice.cfm#1

http://www.research.usf.edu/cs/biosafetyinfoguides.htm



C. Will you verify inactivation/lysing and if so how?

8.10 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 above 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.

8. 11 Indicate how biohazardous solid waste will be decontaminated and disposed.

Autoclaved Time: [45] minutes Temp: [121] Celsius (for example greater

than equal to 121°C and greater than equal 45 minutes)

Packaged as biohazardous waste per USF policy

Other: [Specify]

8. 12 Indicate how biohazardous liquid waste will be decontaminated and disposed.

Autoclaved Time: minutes Temp: Celsius

Chemically inactivated: [20% Bleach exposure for at least 1 hour then disposed of down the drain with copious amounts of water]

Other: [Specify]

8.13 If using a toxin(s), describe how the toxin(s) will be inactivated and disposed. In

addition provide documented literature regarding the effectiveness of the inactivation

procedure.

Storage and Transport

8.14 Will any of these agents/toxins 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 agents/toxins?

Virus stocks in tightly sealed cryogenic tubes within a sealed watertight plastic container containing absorbant material, and finally within a lock box containing absorbant material will be stored in a -80C freezer in BSF149. This will require back-and-forth transport from BSF114 to BSF149 and samples will only be stored as mentioned in a primary and secondary container during transport.



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.

8.15 Will any of these agents/toxins be shipped via commercial carrier (e.g., Federal

Express)?

No.

Yes. Identify the person(s) that will be preparing the agents/toxins for shipping

and provide their Transportation of Dangerous Goods training dates.

8.16 Will any of these agents/toxins 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 agents/toxins 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.

9. Diagram of Laboratory Areas

9.1 Attach a clearly labeled diagram of the laboratory that shows the following:

1) Where the agent(s)/toxin(s) will be manipulated and stored;

2) Location of biological safety cabinets, eye-wash, sink, and other equipment (such as

centrifuge, incubators, freezers, cell sorters etc);

3) Room entry/exit;

4) Location of the nearest available autoclave (if autoclave is not available in

laboratory, list the location using text).



10. 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.

10.1 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 attended/will attend the annual USF biosafety training indicated.

*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, go to: http://www.research.usf.edu/cs/biosafetyeducation.htm

Name Initial

here

Date Biosafety

Training*

Training Date E-mail Occupational Health Evaluation

Completed

Robert Hill 12/8/10 Yes No 2/9/2011 [email protected] 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


http://www.research.usf.edu/cs/biosafetyeducation.htm



11. 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 [email protected]

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.

11.1 Has your laboratory been scheduled for inspection?

Yes. Provide the date: Feb 3, 2011

No. Inspection is pending due to:

Does not apply because the laboratory involved is BSL-1.

12. Investigator Assurance I agree to use lab practices that meet the highest biosafety level (BSL) specified in Table

1.1 with all work with infectious agents/biological toxins in this project.

I have read the Biosafety in Microbiological and Biomedical Laboratories, 5th Edition and

I acknowledge my responsibility for the conduct of this research in accordance with the

procedures described in it.

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.

__________________________________________ 2/2/11_______________

Signature of Principal Investigator Date








http://www.research.usf.edu/cs/biosafety_forms/bsl-2_checklist.pdf


http://oba.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm#_Toc7261589





RCDC 002.11 Registration Document for the Use of Infectious Agents and Biological Toxins Page i


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 needle stick 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 [email protected]. 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/human-

resources/employee-relations/workers-comp.asp



http://www.absa.org/riskgroups/index.html



http://www.research.usf.edu/cs/biosafetyinfoguides.htm


http://usfweb2.usf.edu/human-resources/employee-relations/workers-comp.asp

http://usfweb2.usf.edu/human-resources/employee-relations/workers-comp.asp

RCDC 002.11 Registration Document for the Use of Infectious Agents and Biological Toxins Page ii


USF Employees, Residents, and Student Assistants classified as “Volunteers”: You must report all

potential BBP exposures to your supervisor and then call OptaComp.

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

[email protected]. Reports may be faxed to (813) 974-7535.


Registration document for the Use of Infectious Agents and...

Documents

Transcript of Registration document for the Use of Infectious Agents and...