OEH&S Biosafety Manual Chapter 4

THE BIOLOGICAL USE AUTHORIZATION (BUA) APPLICATION PROCESS

A. NEW APPLICATIONS

Principal Investigators (PIs) who meet the criteria outlined in Chapter 3 for submitting a Biological Use Authorization (BUA) should submit a completed application form (including a separate Principal Investigator Form) to the Biosafety Committee Coordinator for administrative screening and subsequent forwarding to the Biosafety Committee (BSC) or the Biosafety Officer (BSO) for review. All applicants must complete all pages of the form and any additional forms or narratives requested.

1. INFORMATION TO INCLUDE IN YOUR BUA:

a. A clear statement of the goal of the experiments.

b. A description of the actual experiments; sufficient detail should be provided so that the BSC can understand what procedural steps are involved in your experiments.

c. Your estimate of the biohazards associated with your experiments or project and the required Biosafety Level; if you have any questions regarding this estimation, contact the BSO at 476-2097.

d. A description of your biosafety facilities.

e. A description of your plan for biosafety; the BSC must be able to judge the adequacy of your biosafety precautions.

f. For research involving recombinant DNA (rDNA), identification of the specific hosts, vectors, genes and sources of DNA; when using new or uncommon hosts, vectors, genes or DNA molecules, describe them briefly.

g. For research using experimental animals, completion of the form called Animal Involvement in the Animal Care Facility after discussing arrangements with your consulting Aninal Care Facility (ACF) veterinarian.

h. For research using sheep or Old World primates (genus Macaca) or their tissue or cell lines, indication that all personnel have had the appropriate training provided by the Office of Environmental Health and Safety (EH&S).

i. A description of your health surveillance plan. If you are drawing human blood or collecting human body fluids or tissue and processing, transporting or storing these samples, you must have a medical surveillance program in accordance with the Cal-OSHA Bloodborne

Pathogens (BBP) Standard. As part of the medical surveillance plan, specify that hepatitis B immunization and post-exposure follow-up and treatment will be provided to laboratory personnel free of charge and that records of immunization or declination will be retained. Indicate that laboratory personnel will attend initial BBP training and annual retraining offered by EH&S.

j. A description of the biosafety training that you provide (i.e., informing personnel of the hazards associated with the research, training in the safe conduct of specific experimental procedures, initial training and periodic retraining in laboratory and BUA-specific hazards.)

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2. BUAs EXEMPT FROM FULL COMMITTEE REVIEW

Studies in which the research involves:

1. only the use of Risk Group 1 or otherwise unclassified biological materials and procedures or
   
2. Biosafety Level 2 containment requirements solely because of the use of a human cell line will be reviewed and approved by the BSO rather than the full BSC. An Approval Letter signed by the BSO will be forwarded to the PI. Such BUAs must be renewed after three years if the study will be continuing.

   Note: If a study meets the criteria for exemption from BSC review, a BUA must be completed for review and approval by the BSO.

3. BUAs SENT TO FULL COMMITTEE

If the applicant is required to submit an application for BSC review, the BUA must include sufficient information and details on the experimental procedures to assist the BSC in determining the appropriateness of the proposed facilities and safety procedures. As part of the review process, the assigned Department Safety Advisor (DSA) will conduct a laboratory site visit to review the information on the application and to determine the appropriate biosafety level, training, medical surveillance, personal protective equipment and other relevant safety requirements for the study. All of the information provided by the PI in the BUA, such as the biosafety training status of personnel, will be confirmed by the DSA during the site visit to the laboratory, which occurs prior to BSC review.

The BSC meets monthly to review BUA applications.The Committee’s approval options include:

• Approval - approved as submitted;

• Contingent Approval - approved when contingencies levied by the BSC are met. Often, contingencies are met by the submission of additional information;

• Return for additional information - not approved; when an application is very incomplete or seriously flawed, the BSC may return it to the PI for additional work;

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B. RENEWALS

C. MODIFICATION OF AN APPROVED BUA

D. TERMINATION OF A BUA

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