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User Advisory

Advisory Title: The Use of Biological Materials at the ALS
Advisory Number: 18/Rev. 0
Issue Date: January 1, 2005
Review Date: January 1, 2007
Current Info: This Advisory is valid for two years from Issue or Review Date(s), at which time it is reviewed for relevancy and accuracy. Copies of all current user advisories are available at the ALS User Services Office, (510) 486-7745.

Overview

Small amounts of biological materials (biologicals) may be used for experiments at the ALS. The use of these materials must be reviewed and approved by ALS Environment, Health and Safety (EH&S) staff and by the Berkeley Lab Institutional Biosafety Committee (IBC) before an experiment may begin. The proper handling of biological materials, including the use of biological safety cabinets, disinfectants, personal protective equipment, and the disposal of waste products, is essential to ensure the safety of ALS personnel and visiting researchers. This advisory is intended to establish guidelines for the safe use and disposal of biological materials at the ALS.

Policy

The guidelines provided in this advisory are designed to assist ALS users and staff in meeting Berkeley Lab’s health and safety requirements for the use of biological materials in their experiments. All equipment and procedures for the use of such materials must ultimately satisfy the safety requirements detailed in Chapter 4.7 (Biohazards and Sanitation) of the Laboratory’s Health and Safety Manual, Pub-3000, and in the EH&S Biosafety Manual.

All biological materials intended for experimental use at the ALS must be registered and approved by the IBC (see next section) and be listed on the ALS General Sciences Proposal and Request for Beamtime Form (submitted by general users) or on the Experiment Form (submitted by members of a PRT)*. Based on this information, ALS staff will create an Experiment Safety Sheet (ESS) that must be reviewed and approved before an experiment may begin. If any changes or additions are made to any aspect of the proposed experiment, the Experimenter-in-Charge is responsible for notifying the ALS EH&S Program Manager (ext. 7407) or the Beamline Coordination Section Leader (ext. 5527) of the intended modifications. All changes must be approved by both the ALS and IBC before the experiment will be permitted to begin.

*These forms are available at http://alsusweb.lbl.gov/.

Institutional Biosafety Committee (IBC)

The IBC is responsible for reviewing and approving all work conducted by Berkeley Lab employees and visiting researchers that involves the use of any kind of biological material. These materials include, but are not limited to:

  • animal and human tissues*
  • recombinant DNA
  • cell lines
  • hazardous biological agents
  • nonhazardous biological materials (i.e., bacteria, plants, etc.).


Before any experiment using biologicals begins, researchers must complete a Biosafety Registration Form. See Berkeley Lab’s Biosafety Program Web site at for the Biosafety Registration Form and for extensive information about all aspects of research using biological materials at the ALS.

*Note: All experiments that include the use of human tissues, fluids, etc., must also be reviewed and approved by the Human Subjects Committee; see http://www.lbl.gov/ehs/biosafety/Biosafety_Manual/html/human_subjects.htm for more information.

Establishing Biosafety Levels for Use of Biological Materials at the ALS

Researchers intending to use biologicals must submit the Biosafety Registration Form at least four to six weeks before a planned experiment begins. This allows the IBC, and if necessary, other review committees (i.e., the Human Subjects Committee), to review all the safety requirements needed for the biologicals intended for use.

To ensure that the proper safety conditions are established for each experiment, users are required to determine a Biosafety Level (BL) for all biological materials intended for use when they submit the Biosafety Registration Form. A BL is a combination of safety control measures including specific work practices, protective equipment, barriers, etc., that is created based on the Risk Group(s) to which a biological material belongs. Both Risk Groups and BLs range from 1 (lowest biological risk or control group) to 4 (highest risk or control group). Biological materials that require BL-3 and BL-4 safety controls are not currently permitted at Berkeley Lab.

To review the classification of biologicals and their corresponding Risk Group, see the Classification Web pages in the Biosafety Manual. For additional information about the BL assigned to each Risk Group, see the chapter entitled "Containment" in the Biosafety Manual, or contact Berkeley Lab ’s Biosafety Program Manager (ext. 2768).

Biological Safety Equipment at the ALS

A safety cabinet, certified for work with Biosafety Level-2 biologicals, is available for ALS users and staff. Sharps containers, disinfectants, gloves, safety goggles, and medical waste containers with red biohazard bags are also provided. All other required biological safety equipment, including carrying boxes, lab coats, etc., is the responsibility of the user and must be provided before work begins.

Weekly pick-up and disposal of sealed medical waste bags is provided by LBNL ’s licensed medical waste contractor.

Shipping and Storage of Biologicals

All hazardous materials, including biologicals, shipped to or from the ALS, must be packaged and handled according to U.S. Department of Transportation (DOT) regulations. Biologicals shipped to the ALS must be contained in DOT-approved packaging and be clearly labeled with the user’s name, address, and local contact information. At the ALS, all biologicals must be stored in a secure location that is clearly labeled on the exterior with the universal biohazard symbol. The storage site (freezer, refrigerator, lab, etc.) must be approved by a Beamline Coordinator or the responsible Beamline Scientist. Each container must also be labeled with the name of the biological material, and the user’s name and contact information. In addition, any Risk Group 2 biological materials containers must also carry a biohazard label. Contact the Beamline Coordination Section Leader (ext. 5527) for information about storage procedures, proper labeling, and access to the appropriate storage facilities.

For More Information

For additional information about the use, storage, or disposal of biological materials at the ALS, contact the ALS EH&S Program Manager (ext. 7407) or the Beamline Coordination Section Leader (ext. 5527). Questions regarding LBNL biosafety policies, biological material classifications and corresponding biosafety levels should be directed to the Berkeley Lab Biosafety Program Manager (ext. 2768; bwking@lbl.gov)


Approved by  Signed
Georgeanna Perdue, ALS EH&S Program Manager 02/11/2005
Ben Feinberg, Division Deputy for Operations 02/11/2005