Biohazardous Agents and Recombinant DNA

Establishes policy for ensuring the safe use and handling of biohazardous agents and recombinant DNA (r-DNA) at Stanford.

1. Overview

It is Stanford University policy that all PI/Laboratory Directors must assume primary responsibility for the proper use, handling, and disposal of all biohazardous agents and recombinant DNA molecules associated with their research. Stanford PIs and research personnel must comply with applicable Federal, State and local regulatory standards, as well as any administrative requirements established by applicable institutional committees. Failure to comply with this policy may result in an administrative review and a possible suspension of approval by the Administrative Panel on Biosafety (APB) to work with biohazardous agents and/or non-exempt recombinant DNA molecules.

It is Stanford University policy that:

• All activities involving the use of Biosafety level (BSL) 2 or 3 agents must have prior approval by the Administrative Panel on Biosafety (APB), who will review the scope of work and assure that the work is being performed at the appropriate biosafety level as described in the CDC/NIH Guideline, Biosafety in Microbiological, and Biomedical Laboratories
• All research personnel using BSL 2 or 3 biohazardous agents must be appropriately trained and familiar with the safety procedures in handling these materials. The PI/Laboratory Director is responsible for training and ensuring that all biohazardous agents are used at the appropriate level of biological containment
• All APB approved applications involving the use of BSL 2 agents are valid for a maximum of three years  and must be reviewed for changes annually by the Biosafety Officer; duration of BSL 3 approvals are for one year
• APB approval is not required for experiments which involve the use of BSL 1 agents exclusively (without the use of recombinant DNA molecules). However, any investigator working with human blood, clinical specimens, human tissues/tissue culture, or other potentially infectious materials must still meet the compliance requirements of the OSHA Bloodborne Pathogen Standard. (See the Stanford Biosafety Manual, Chapter 6 available below in "Related Items")
• APB approval to work with biological agents does not constitute institutional approval to work with radioactive materials, research laboratory animals, or human subjects. The use of radioactive materials, research laboratory animals, or human subjects as an adjunct to biological research is discussed in Section IIIA of this policy
• Shipping of biological goods that are classified as hazardous by Federal agencies must be done according to all regulations. Shipping of hazardous or non-hazardous biological goods that entails the use of dry ice must still follow all regulatory restrictions as dry ice is considered a dangerous good for air shipment purposes. Additional information on shipping procedures and requirements can be found at the Biosafety website (Shipping) or in the Biosafety Manual, Chapter 9, available below in "Related Items".

2. Biosafety Organization and Responsibilities

A. Administrative Panel On Biosafety (APB)

The APB reports to the President of the University through the Office of the Dean of Research and reviews all teaching and research projects involving the use of biohazardous agents and recombinant DNA that require approval (except those conducted under the jurisdiction of Stanford Health Services (SHS). An application form entitled "Request For Institutional Review /Approval For Research Involving Biohazardous Agents, Recombinant DNA and USDA-Regulated Materials" must be submitted to the APB for its review and approval. Through these reviews, the Panel assures that such activities and related facilities are in compliance with applicable University policies and external guidelines and regulations. Licensed clinical laboratories are covered by the guidelines imposed by the licensing board of the State of California.

• The APB is responsible for advising the University on all matters related to biosafety, for reviewing and approving proposed uses of biohazardous agents, and for advising and guiding the Department of Environmental Health and Safety in carrying out the biosafety program.
• The APB publishes and distributes the university's Biosafety Manual, which contains biosafety standards from the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and other applicable regulations. It also includes information about the specific hazards of each class of biohazardous agents. The Biosafety Manual must be available in every relevant laboratory on campus. Additional copies of the Biosafety Manual may be found at the website or by calling Stanford's Biosafety Officer in the Department of Environmental Health and Safety Office at 725-1473.

B. Department Of Environmental Health and Safety (EH&S)

EH&S is assigned the responsibility, subject to review and approval of the APB, for monitoring and providing services in conformity with the policy and standards set forth in the Biosafety Manual. The Associate Vice Provost of EH&S is an ex-officio member of the APB.

C. Biosafety Officer

The Biosafety Officer is a member of EH&S and is responsible for facilitating the operation of the biosafety program, for assuring that the use of biohazardous agents conforms with the University policy and applicable governmental regulations, and for referring to the APB matters requiring its review and approval. The Biosafety Officer conducts periodic inspections of biological laboratories and provides biosafety training as needed. The Biosafety Officer is an ex-officio member of the APB.

D. Principal Investigator/Laboratory Director Hereafter called PI

The PI has the following responsibilities:

• Instructing and training laboratory staff in the practices and techniques required to ensure safety and proper emergency response and notification procedures in the event of an accident or injury;
• Familiarize his/her staff with the symptoms of exposure and other pertinent information about the biohazardous agent used in the experiment before allowing lab personnel to work with the agent;
• Supervising the laboratory staff's safety performance to ensure that the required safety practices and techniques are employed;
• Informing the staff of the reasons and provisions for any precautionary medical practices advised or requested, such as immunization or serum collection;
• Selecting and providing personal protective equipment to all laboratory staff members based on the experimental procedures used in the lab;
• Making available a copy of the Stanford Biosafety Manual to all laboratory staff members;
• Maintaining written documentation for all training activities, which includes instruction in laboratory safety procedures, for all laboratory staff personnel;
• Immediate investigation and verbal reporting to the Biosafety Officer, promptly followed by a written report to the Biosafety Officer and the APB, of any significant problems or incidents pertaining to the operation and implementation of containment practices and procedures;
• Correcting conditions that may result in the release of biohazardous agents;
• Having biosafety cabinets certified by the Stanford University approved contractor on an annual basis, or when moved;
• Ensuring compliance with the other procedures governing the use of biohazardous agents (see Section III below).

Further guidance in these responsibilities is available from the Biosafety Officer and from the Stanford Biosafety Manual.

3. Procedures Governing the Use of Biohazardous Agents

All application forms submitted to the Biosafety Officer are reviewed by the APB at a convened meeting with a quorum. Upon approval, an application will be reviewed on an annual basis. Upon expiration of approval, the PI must submit a new application for review and approval by the APB.

A. Experimental Applications

Research with Biohazardous Agents not Involving Recombinant DNA

PI's are not required to complete an application form when working only with BSL 1 agents. PI's are required to complete an application form and receive APB approval before working with BSL 2 and 3 agents. Currently, there are no BL4 facilities available to conduct work involving BSL 4 agents; therefore, research involving these agents cannot be approved by the APB at this time. All PI's who are considering the use of BSL 3 agents must notify the Biosafety Officer prior to applying to the APB to discuss the unique containment requirements involved with handling these agents.

Research with Recombinant DNA

Stanford categorizes experiments using recombinant DNA based on the NIH classification described in the NIH Guidelines for Research Involving Recombinant DNA Molecules. See the document in "Related Items" below for additional information regarding exempt/non-exempt work.

Research with Biohazardous Agents Involving the Use of Animal Subjects

Biological research involving any laboratory animals requires an administrative approval from the Administrative Panel on Laboratory Animal Care (A-PLAC).

Any biological research involving the introduction of BSL 2 or 3 agents or non-exempt recombinant DNA molecules into animal subjects requires both A-PLAC and APB approval. A-PLAC application forms can be obtained online.

Research with Biohazardous Agents Involving Human Subjects

Biological research involving human subjects or clinical specimens from human subjects (human blood, tissues, organs, etc.) requires an additional administrative approval, which may be obtained from the Administrative Panel on Medical Human Subjects. For information, call the Office of The Dean of Research, Human Subjects Panel Coordinator, at 723-5244. APB approval will be required if clinical specimens from human subjects who are infected with BSL 2 or 3 agents will be used for research purposes. APB approval is also required if biohazardous agents or recombinant DNA molecules will be introduced to a human subject.

Research with Biohazardous Agents Involving Radiological Hazards

Biological research involving the use of radiological materials requires an additional administrative approval, which may be obtained from the Administrative Panel on Radiological Hazards. For more information, call the Environmental Health and Safety Office, Office of Health Physics at 723-3201.

B. Application Review by the APB

Upon receipt of either the completed application form or renewal form at EH&S, the Biosafety Officer conducts a detailed review of the proposed experiments. Such a review may include a personal interview with the applicant and an inspection of the proposed laboratory facilities. The Biosafety Officer will present any findings to the APB for review at the APB Meeting.

Copies of the approved application or renewal form, which constitute authorization to proceed with the research, are to be maintained in the Biosafety Office at EH&S. They are also sent to the applicant and other University Administrative Panels as appropriate (e.g., Administrative Panel on Laboratory Animal Care, Administrative Panel on Human Subjects, etc.).

C. Annual Review of Approved Applications

It is the responsibility of the PI to update the approved application annually when notified by the Biosafety Officer. The Biosafety Officer will provide notification and renewal information on an annual basis.

D. Physical Control of Biohazardous Agents

A BSL 2 or 3 agent must not be transferred from one laboratory to another without written prior approval of the Biosafety Officer. These agents can only be transferred if the PI who is receiving the biohazardous agents is authorized by the APB in writing to use them. Shipment, packaging and labeling of biohazardous agents shall comply with state and federal regulations. All international transfers of export controlled biological agents and toxins as identified by the CDC must not be sent outside of the US without an export license and prior written approval of Stanford’s Export Control Office. All biohazardous agents or mixed biohazardous waste shall be disposed of according to regulatory requirements (refer to the Stanford Biosafety Manual, available below in "Related Items").

E. Medical Program

During the approval process, the APB may consult with a physician, who may recommend a program of medical surveillance, including immunizations and/or the collection of specimens from laboratory personnel engaged in a project (refer to Stanford Biosafety Manual).

F. Accidents Involving Biohazardous Agents

Biohazardous Spills

All spills involving any biohazardous agents must be promptly treated with an appropriate disinfectant agent. Any significant spill involving BSL 2 or 3 agents that occurs outside a biological safety cabinet or containment area must be reported to EH&S (3-0448) immediately. (refer to Stanford Biosafety Manual, Chapter 7).

Exposure to Biohazardous Agents

Exposure by inhalation, inoculation, ingestion, or skin contact (including cuts and wounds) to a BSL 2 or 3 agents must be referred to a physician immediately and reported to the individual's supervisor and to the Biosafety Officer (725-1473). Any injured employee should report to Occupational Health or the Stanford Emergency Department, as appropriate, during normal work hours. After hour care is available from the Emergency Department at Stanford Hospital. Students may report to Vaden Health Center.

Reporting Requirements Involving Recombinant DNA

In addition to the item above, significant problems with, or violations of, the Recombinant DNA Guidelines, and accidents involving recombinant DNA, must be reported to the Biosafety Officer (5-1473), who is the University official for reporting such matters to the Office of Biotechnology Activities (OBA). Reporting of above incidents that are covered by the rDNA Guidelines will be done within 30 days to NIH/OBA; reporting of all such incidents will be within the appropriate regulatory guidelines.

G. Termination of APB Approval

An approved user who willfully or negligently violates the University, federal, or state rules and regulations governing the use of biohazardous agents/rDNA may have his/her APB approval suspended or revoked by the Biosafety Officer pending review by the APB.

The Biosafety Officer will prepare a report which will describe the violations in detail and will discuss the matter with the Chair of the APB who will then determine the final course of action.

H. Appeals

Disputes regarding interpretation of this policy or decisions made by the APB and/or the Biosafety Officer should be referred to the Dean of Research for adjudication.

4. Appendix B: The use of recombinant DNA (rDNA) is regulated by the National Institutes of Health

The use of recombinant DNA (rDNA) is regulated by the National Institutes of Health (NIH); the guidelines can be found in the publication Guidelines for Research Involving Recombinant DNA Molecules; these guidelines are the official guide to all rDNA work done at Stanford. It is important to realize that following these guidelines is the responsibility of all investigators at Stanford University and not solely investigators that are funded by NIH.