Research Policy Analysis and Coordination
Chapter 3-400: The California Environmental Quality Act (CEQA)
The University has not issued a university-wide policy on the use of biohazards and carcinogens. However, in accordance with the University Policy on Health, Safety and the Environment (Section 3-200), the University follows applicable State and federal guidelines and regulations covering biohazards, carcinogens, select agents and toxins. These guidelines and regulations are implemented by the campus or Laboratory Environmental Health and Safety Office and Institutional Biosafety Committees.
3-410 Responsibilities of the Environmental Health and Safety Office for Recomdinant DNA, Biohazards and Carcinogens
Each campus or Laboratory Environmental Health and Safety Office (EH&S) is responsible for monitoring and assisting departments and individuals who use hazardous materials to comply with University procedures and relevant government regulations. EH&S is responsible for implementing the National Institute of Health (NIH) Guidelines for Research Involving Recombinant DNA (rDNA) Molecules, the Centers for Disease Control (CDC) Biosafety in Microbiological and Biomedical Laboratories (BMBL) and CDC regulations on “Select Agents and Toxins” at 42 CFR 73, the Department of Agriculture regulations on “Possession, Use, and Transfer of Select Agents and Toxins,” at 7 CFR 331 and 9 CFR 121, and other guidelines listed below in Sections 3-450 to 3-470 for research using biohazardous and carcinogenic materials and for advising researchers and students regarding compliance with these guidelines. In cases where the Department of Energy (DOE) has issued Orders covering any of these areas, the Lawrence Berkeley National Laboratory (LBNL) generally follows these DOE Orders. Where there are no DOE Orders, LBNL follows applicable federal regulations.
EH&S inspects laboratories where proposed research using biohazards or carcinogens would take place. In response to the Contracts and Grants Office proposal cover sheets which indicate laboratories that may be used for research with biohazards or carcinogens, EH&S staff reviews and approves the facilities for the proposed research. It advises the Principal Investigator on safe laboratory procedures and materials required. On some campuses, EH& S reviews the entire proposal to assure that laboratory protocols and materials are in accordance with applicable guidelines and regulations.
The campus Institutional Biosafety Committee, required by the NIH Guidelines, approves EH&S policies and reviews higher risk research proposals. The Biological Safety Officer described in the NIH Guidelines is an administrative staff member of EH&S. Proposals for higher biosafety level research are presented to the campus Institutional Biosafety Committee via EH&S for review and approval. (See Section 3-452.)
3-420 Role of the Contracts and Grants Office
Generally, the Contracts and Grants Office receives a proposal with a cover sheet which indicates if biohazards, carcinogens or recombinant DNA (rDNA) would be involved in the research. If the Principal Investigator (PI) indicates they would be, this cover sheet is forwarded to the Environmental Health and Safety Office. (On some campuses, EH&S reviews the entire proposal.)
The Principal Investigator generally submits a proposal requiring the campus Institutional Biosafety Committee review and approval directly to that committee through EH&S prior to sending it to the Contracts and Grants Office.
When the Office of Environmental Health and Safety receives the proposal or the C&G proposal cover sheet, it can begin the review and approval procedures necessary. However, if a laboratory needs modifications, safety instruments, or other requirements to be approved for the proposed research, the Principal Investigator should be aware of the costs incurred by such required renovations and modifications when determining the proposed research budget. If the PI does not know whether a proposed laboratory will meet EH&S requirements, consulting with campus EH&S staff before determining the proposal budget would let the PI know if the proposed research would involve laboratory renovation or modification expenditures.
If a proposal using recombinant DNA contains proprietary data and potentially patentable concepts, a Proprietary Data legend should be included by the Principal Investigator. This legend would specify the paragraphs and pages which contain potentially patentable concepts and proprietary data. Supplemental information on this subject is disseminated via Contract and Grant Memo79-33.
3-430 Responsibilities of Purchasing/Materiel Management
Each campus has developed its own purchasing policies and guidelines for procuring these regulated materials. These campus policies are governed by the campus Biosafety Committee. For specific requirements, campus investigators should contact the campus Biosafety Officer in the campus EH&S Office.
Biohazards, as the term is used in the context of scientific research, are microorganisms, including recombinant DNA (rDNA) molecules, which are commonly accepted as posing a hazard to human health or the environment. Biohazards used in research include pathogenic bacteria, fungi, parasites, protozoans, viruses, oncogenic viruses, rDNA, and plant and animal toxins. University practices regarding these biohazards are discussed in the following sections 3-450 through 3-480.
3-450 Recombinant DNA Research
The University follows the National Institute of Health (NIH) Guidelines for Research Involving Recombinant DNA (rDNA) Molecules for all research involving recombinant DNA molecules (rDNA) for which the University is responsible, not just for research funded by NIH. As the Guidelines state: “All non-NIH funded projects involving recombinant DNA techniques conducted at or sponsored by an institution that receives NIH funds for projects involving such techniques must comply with the NIH Guidelines.”
3-451 NIH Guidelines
The NIH Guidelines for Research Involving Recombinant DNA Molecules govern the conduct of NIH supported research in recombinant DNA molecules. They establish carefully controlled conditions for the conduct of experiments involving:
- molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or
- molecules that result from the replication of those described in (i) above.
The NIH Guidelines assign rDNA research to one of four levels of biosafety, or levels of physical containment, BL1 through BL4, based on the potential hazard posed by each experiment. Each rDNA experiment is subject to a review and approval procedure, depending on its determined biosafety level.
3-452 Responsibilities of the University under the NIH Guidelines
The University is responsible for ensuring that all recombinant DNA research is carried out in full conformity with the provisions of the NIH Guidelines. (See External Requirements 3-F02.) In order to fulfill this responsibility, the University shall:
- Establish and Implement Policies
Establish and implement policies that provide for the safe conduct of recombinant DNA research and that ensure compliance with the Guidelines. The University may establish additional procedures, as deemed necessary.
- Establish an Institutional Biosafety Committee (IBC)
Establish an Institutional Biosafety Committee (IBC) that meets the membership and procedure requirements listed in the NIH Guidelines and carries out the functions of reviewing rDNA research proposals and activities.
- Appoint a Biological Safety Officer (BSO)
If the University is engaged in recombinant DNA research at the BL3 or BL4 containment level, it shall appoint a BSO who shall be a member of the IBC and carry out the duties specified in NIH Guidelines.
3-453 California Environmental Quality Act of 1970 (CEQA) Applicability to Recombinant DNA Research Activities
CEQA requires the preparation of an Environmental Impact Report (EIR) on any project which may have a significant effect on the environment. The decision as to whether an EIR is required for a research project involving recombinant DNA can only be made after an analysis of the proposed experiment and the facility in which the experiment is to take place. For example, DNA research conducted under approved contained laboratory conditions may not require an EIR, while any proposed rDNA research outside the laboratory setting may need review under the University Procedures for Implementation of CEQA.
3-460 Etiologic Agents, Oncogenic Viruses, Select Agents and Toxins
Etiologic agents are infectious agents such as viruses, bacteria, or fungi which cause diseases. Oncogenic viruses are tumor causing viruses. Research using these agents must be conducted under proper laboratory biosafety practices. The Centers for Disease Control (CDC) has published Biosafety in Microbiological and Biomedical Laboratories (BMBL) for working with infectious agents in various laboratory settings.
Requirements for importation of etiologic agents are available from the CDC Etiologic Agent Import Permit Program (EAIPP). This website includes links to regulations and guidance on:
- International shipment of human pathogens and related materials (World Health Organization Guidance on Regulations for the Transport of Infectious Substances);
- Department of Transportation regulations for interstate shipping of hazardous materials (49 CFR Part 173);
- IATA Dangerous Goods Regulations (International Air Transport Association);
- Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS) permits required for infectious agents of livestock and biological materials containing animal material; and
- Export of a wide variety of etiologic agents of human, plant, and animal diseases requiring a license from the Department of Commerce.
Additional requirements for using select agents and toxins on the CDC or USDA lists of select agents and toxins are published in the Code of Federal Regulations (CFR) at 42 CFR 73, CDC regulations on “Select Agents and Toxins,” and at 7 CFR 331 and 9 CFR 121, the Department of Agriculture regulations on “Possession, Use, and Transfer of Select Agents and Toxins.” In addition, individuals wishing to import select agents and toxins must be registered with CDC's Select Agent Program in accordance with 42 CFR Part 73 (Select Agents and Toxins) for the select agent(s) and toxin(s) listed on the import permit application. Approval to ship select agents or toxins under the import permit must be granted before shipping. Additional information can be found on the USDA APHIS/CDC National Select Agent Registry website.
3-461 Center for Disease Control Biosafety Levels
The four CDC biosafety levels for research using etiologic agents and oncogenic viruses described in the Biosafety in Microbiological and Biomedical Laboratories (BMBL) parallel those in the NIH Guidelines for research involving recombinant DNA. The CDC guidelines are advisory and do not mandate biosafety committee review of research proposals. Most campuses have, however, instituted review processes for research involving etiologic agents. (See External Requirements 3-F03.) Also see the National Research Council publication, Prudent Practices in the Laboratory: Handling and Management of Chemical Hazards.
The uses of certain chemical carcinogens are regulated in California Code of Regulations (CCR) Title 8 Industrial Relations Section 5203 et seq. The campus EH&S Office which oversees the use of carcinogens may add other hazardous, toxic or carcinogenic chemicals to the list of cancer-causing substances provided in this Code as well as in the California Labor Code, Section 9000 et. seq. as it deems necessary. (See External Requirements 3-S03.) LBNL follows DOE Order 440.1B, Worker Protection Program for DOE (Including the National Nuclear Security Administration) Federal Employees, when dealing with carcinogens.