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 Recombinant 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 or Synthetic Nucleic Acid 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. EH&S is also responsible 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 ensure that laboratory protocols and materials are in accordance with applicable guidelines and regulations.
The Biological Safety Officer described in the NIH Guidelines is an administrative staff member of EH&S. Each campus's Institutional Biosafety Committee (required by the NIH Guidelines) approves EH&S policies and reviews research proposals with biohazardous risks. 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).
Generally, a campus Contracts and Grants (C&G) Office receives a proposal with a cover sheet which indicates if biohazards, carcinogens, or recombinant or synthetic nucleic acids would be involved in the research. If the Principal Investigator (PI) indicates that there would be, this cover sheet is forwarded to their campus's EH&S. 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 EH&S receives the proposal or the C&G proposal cover sheet, it can begin the review process. However, if a Principal Investigator (PI) needs to renovate their laboratory space, acquire safety equipment, or meet other requirements to conduct the proposed research, the PI should be aware of these costs when creating the proposed research budget. If the PI does not know whether their laboratory or equipment will meet EH&S requirements for the proposed research, it is recommended that the PI consult with campus EH&S staff before creating the proposal budget.
If a proposal using recombinant or synthetic nucleic acids contains proprietary data and potentially patentable concepts, the PI should include a Proprietary Data legend in the proposal. This legend would specify which paragraphs and pages contain potentially patentable concepts and proprietary data. Supplemental information on this subject is disseminated via Contract and Grant Memo 79-33.
Each campus has developed its own purchasing policies and guidelines for procuring regulated materials. These campus policies are governed by the campus Biosafety Committee. For specific requirements, PIs should contact their campus's Biosafety Officer in the EH&S Office.
Biohazards, as the term is used in the context of scientific research, are biological substances, including recombinant or synthetic nucleic acid 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, recombinant or synthetic nucleic acid molecules, and plant and animal toxins. University practices regarding these biohazards are discussed in the following sections 3-450 through 3-480.
The University follows the National Institute of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules for all research involving recombinant or synthetic nucleic acid molecules for which the University is responsible, not just for research funded by NIH. As Section I-D-2 of the Guidelines states: “All non-NIH funded projects involving recombinant or synthetic nucleic acid molecules conducted at or sponsored by an institution that receives NIH funds for projects involving such techniques must comply with the NIH Guidelines.”
The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules govern the conduct of all research involving recombinant or synthetic nucleic acid molecules, regardless of the funding source(s). In the context of the NIH Guidelines, recombinant and synthetic nucleic acids are defined as:
- molecules that a) are constructed by joining nucleic acid molecules and b) can replicate in a living cell (i.e., recombinant nucleic acids);
- nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, (i.e., synthetic nucleic acids); or
- molecules that result from the replication of those described in (i) or (ii) above.
The NIH Guidelines assign recombinant or synthetic nucleic acid research to one of four levels of biosafety (BSL-1 through BSL-4), or levels of physical containment, based on the potential hazards imposed by the agents used and for the laboratory function and activity, with BSL-4 requiring the highest level of containment. Each experiment involving recombinant or synthetic nucleic acid molecules is subject to an IBC review and approval procedure, depending on its determined biosafety level.
The University is responsible for ensuring that all recombinant or synthetic nucleic acid 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 or synthetic nucleic acid research and ensure compliance with the Guidelines. The University may establish additional policies, as deemed necessary.
- Establish an Institutional Biosafety Committee (IBC)
Establish an IBC that meets the membership and procedure requirements listed in the NIH Guidelines and carries out the functions of reviewing recombinant or synthetic nucleic acid research proposals and activities.
- Appoint a Biological Safety Officer (BSO)
If the University is engaged in recombinant or synthetic nucleic acid research at the BSL-3 or BSL-4 containment levels, 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 recombinant DNA research outside of a laboratory setting may need review under the University Procedures for Implementation of CEQA.
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 Import Permit Program (IPP). This website includes links to regulations and guidance on:
- International shipment of 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 - Animal and Plant Health Inspection Service (USDA-APHIS) permits that are 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 USDA-APHIS 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 Federal Select Agent Program in accordance with 42 CFR 73 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 Federal Select Agent Program website.
The four CDC biosafety levels for research using etiologic agents and oncogenic viruses, as 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 Offices, which oversees the use of carcinogens, may add other hazardous, toxic or carcinogenic chemicals to the list of cancer-causing substances, as described in 8 CCR 5203 et seq. and 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.