UC Davis Biosafety Authorization for

Laboratory Course and

Facility Standard Operating Procedures

Application type:

/

This submission involves:

/ Date received: / ABSO Reviewer: / BSL/RG:

Recombinant DNA

/ NIH Guidelines:
/

New SOP #

/ / Exempt under NIH Guidelines section: IIIF: App. C:
Renew SOP # /

Infectious Agents (Human, animal, or plant)

/ IBC review dates
Terminate SOP # /

First review:

/ Action:
Major change
amendment, SOP # /

Bloodborne pathogens, human & nonhuman primate materials

/ Second review: / Action:
Third review: / Action:

Storage only

/ Third review: / Action:
Storage only, SOP # / Approval date:
Course Title or Facility Name:
Course Instructor or
Facility Manager: / Title:
Department: / Building: / Room:
Phone: / Fax: / E-mail address:
Faculty Director/Supervisor: / Title:
Department: / Building: / Room:
Phone: / Fax: / E-mail address:
Check here if you have listed additional shared space owners or co-investigators on a separate sheet
Course/Facility Administrator: / Title:
Department: / Building: / Room:
Phone: / Fax: / E-mail address:
General conditions for approval
The course instructor or facility manger agrees to the following (please check boxes on the left):
Ensure that course attendees and facility users listed have received or will receive appropriate documented training in safe laboratory practices and procedures for this protocol before work commences and at least annually thereafter
Follow the health surveillance practices as approved for this laboratory course or facility and inform those working on the protocol about appropriate emergency assistance information for their location(s).
Inform EH&S (530 752 1493) and the occupational medicine physician (530 752 6051) of any accident or potential laboratory-acquired illness as soon as possible after its occurrence.
Comply with UC Davis biosafety procedures, with UC Davis and UC systemwide biosafety policy and procedure, with the NIH Guidelines for Research Involving Recombinant DNA Molecules, and with all other applicable laws and regulations.
Submit in writing (by SOP Amendment) a request for pre-approval from the Institutional Biosafety Committee (530 752 1493) for any significant deviations from the biohazard containment or personnel protection provisions of the approved SOP, or any modifications to the study or additions or deletions of personnel, facilities, recombinant or infectious agents, or procedures.

By signing below, I certify that I have reviewed the above conditions and agree that all laboratory course or facility personnel will abide by those requirements and adhere to all UC Davis policies and procedures governing the use of recombinant DNA and infectious agents.

Course instructor or facility manager signature: / Date: /
Faculty Director/Supervisor: / Date: /
Department chair (required): / Date: /
IBC chair: / Date: /
Biological Safety Officer (Final Approval for previous Conditional Approvals ): / Date: /
Project Abstract:
Please supply a brief description of your course or facility operations that specifies the agents or recombinant constructs to be used, the animal or plant species (if applicable) to be used, and the types of potentially hazardous manipulations involved (e.g., aerosol generating, use of sharps, medical waste generation). If doing recombinant DNA work, briefly discuss the involvement and function (if known) of the genes of interest in the project objectives (including markers such as GFP, which are covered under the NIH Guidelines). Specify if your work involves gene discovery. Justify in detail any large-scale work (>10L culture). Specify any issued or pending agency permits (e.g., USDA) that cover your work. Provide a brief overview of the tests, processes, and components as applicable and their uses (e.g. for sequencing facilities specify the technology and analyzers in use, for diagnostic laboratories specify the types of embedding and sectioning to be conducted, for courses involving genetic transformation specify the gene(s) of interest, the vectors, the hosts, and the transformation methods). Please attach any SOPs that are established for the course or facility.
Biological safety cabinet information (use additional sheets if necessary)
I do not plan to use a biological safety cabinet in this project
Cabinet 1 / Date of most recent certification / Cabinet 2 / Date of most recent certification
Brand / Class / Type / Brand / Class / Type
Model / Width ft / Model / Width ft
Serial number / UC No. / Serial number / UC No.
Exhaust type (recirculating, canopy, or hard ducted) / Exhaust type (recirculating, canopy, or hard ducted)
Location (building and room) / Location (building and room)
Shared use? / With PI: / Shared use? / With PI:

Check here if you have listed additional biological safety cabinets on a separate sheet.

Work and equipment locations (use additional sheets if necessary)
Specific use / Lab biosafety level / Building / Room No. / Shared space
Facility/Teaching laboratory location / BSL 1 2 3
Facility/Teaching laboratory location / BSL 1 2 3
Laboratory or insectary location / BSL 1 2 3
Laboratory or greenhouse location / BSL 1 2 3
Laboratory or field planting location / BSL 1 2 3
Housed animals / ABSL 1 2 3
Autoclave for non-medical waste
Medical waste accumulation site or approved autoclave
Storage: RT 4 º -20º -80 º LN2 / Locked? / Yes No
Storage: RT 4 º -20º -80 º LN2 / Locked? / Yes No

Check here if you have listed additional locations on a separate sheet

List of attachments to this application
Laboratory Course or Core Facility Standard Operating Procedures (SOPs)
Course syllabus or course description
Animal Care and Use protocol Room/lab Safety Sheet and Personnel Roster (MANDATORY if vertebrate animals are used)
Agency permits (e.g. USDA/APHIS, CDFA)
Letter from off-campus facility director authorizing permanent transfer of biohazardous materials to the off-campus site
Bloodborne Pathogen Exposure Control Plan (Cal OSHA Title 8, Section 5193)
Medical Waste Management Plan (required for human pathogens, human, and non-human primate source material)
Aerosol Transmissible Disease Biosafety Plan (Cal OSHA Title 8, Section 5199)
Other documents:

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This page is not subject to F.O.I.A.* requests

Authorized users (use additional sheets if necessary)

Note: Complete this page for all employees involved with the laboratory course or core facility who have a potential for exposure to the biohazardous materials. If the project includes vertebrate animal use, attach the list of authorized personnel from your Animal Care and Use protocol to this application. The Biosafety Office and the IBC will keep the information on this page and on the animal care protocol page confidential.

Documented training
Name / UCD ID / Telephone / e-mail address
(text will wrap) / Bio- safety1 / BSC2 / BBP3
and MW4 / Date hepatitis B vaccine was offered for BBP ECP / DGR5 / Plant
Biosafety6 / Greenhouse Safety Operations
Principal Investigator
Laboratory contact

Check here if additional users are listed on a separate sheet

1Biosafety=Formal EH&S-provided or approved training in the principles and practices of biological safety, mandatory before beginning work; approved annual refresher training required.
2BSC=Biological Safety Cabinet training (mandatory for users of Biological Safety Cabinets)
3BBP=Bloodborne pathogen exposure control training (if applicable, mandatory before beginning work, must be repeated annually)
4MW=Medical Waste management training (if applicable, mandatory before beginning work, must be repeated annually)
5DGR=Dangerous Goods Regulations (Federal law [Title 49 of the Code of Federal Regulations, Subtitle III, Chapter 51] requires personnel training on the transportation of hazardous materials)
6Plant Biosafety=Training in the principles and practices of plant biological safety, mandatory before beginning work; annual refresher training required
Please note that the BBP and MW are given initially with the Biosafety class offered by EH&S. Annual refreshers should provide training for the BBP and MW in tandem.

*F.O.I.A.=Freedom of Information Act

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