Research Policy Analysis and Coordination
Chapter 3: Environmental Health and Safety
Revised November 2011
3-100 Introduction
3-200 University Policy on Health, Safety and the Environment
- 3-210 Compliance with Applicable Government Regulations
- 3-220 Responsibility for Compliance
- 3-230 Contracts and Grants Officers' General Responsibilities
3-300 The California Environmental Quality Act (CEQA)
- 3-310 University Implementation of CEQA
- 3-320 Applicability of University Procedures for Implementation of CEQA
- 3-330 Compliance with University Procedures for Implementation of CEQA
3-400 University Policy and Responsibilities for Biohazards and Recombinant DNA
- 3-410 Responsibilities of the Environmental Health and Safety Office for Recombinant DNA, Biohazards and Carcinogens
- 3-420 Role of the Contracts and Grants Office
- 3-430 Responsibilities of Purchasing/Materiel Management
- 3-440 Biohazards
- 3-450 Recombinant DNA Research
- 3-451 NIH Guidelines
- 3-452 Responsibilities of the University under the NIH Guidelines
- 3-453 California Environmental Quality Act of 1970 (CEQA) Applicability to Recombinant DNA Research Activities
- 3-460 Etiologic Agents, Oncogenic Viruses, Select Agents and Toxins
- 3-461 Center for Disease Control Biosafety Levels
- 3-470 Carcinogens
3-500 Radiation
- 3-510 Responsibilities of EH&S and the Radiation Safety Committee
- 3-511 Nuclear Reactor Supervision
- 3-520 Role of the Contracts and Grants Office
3-600 Controlled Substances Drugs and Narcotics
- 3-610 University Procedures for Controlled Substances Business and Finance Bulletin Bus-50
- 3-620 Responsibilities of Principal Investigators
- 3-630 Requirements of Other Federal and State Agencies
3-700 Human Health and Safety
- 3-710 Responsibilities of Environmental Health and Safety Offices
- 3-720 Responsibilities of Risk Services
- 3-730 Role of Department Chairpersons
- 3-740 Applicable State and Federal Regulations
3-800 Certifications for Clean Air and Water
- 3-810 Responsibilities of Materiel Management - Business and Finance Bulletin Bus-56
- 3-820 Role of Contracts and Grants Officers
3-999 Related University References
Chapter 3-100: Introduction
This Chapter describes the University's environmental health and safety policies and procedures as they relate to the University's contract and grant administration. The University has established administrative procedures to comply with applicable State and federal environmental health and safety regulations. Most of these University procedures are in response to external requirements. These external requirements are outlined in the back of this Chapter (3-999).
Chapter 3-200: University Policy on Health, Safety and the Environment
The University Policy on Management of Health, Safety and the Environment sets forth the University’s policy, standards, and guiding principles on health, safety and the environment. It provides a description of the University’s integrated health, safety and environmental management system and states the University’s commitment to comply with all applicable federal and State environmental health and safety rules and regulations.
3-210 Compliance with Applicable Government Regulations
The University must consider all applicable State and federal laws and regulations as well as other pertinent information concerned with the health and safety of employees and the protection of the environment. Specifically, the University Policy states:
The University of California is committed to achieving excellence in providing a healthy and safe working environment, and to supporting environmentally sound practices in the conduct of University activities. It is University policy to comply with all applicable health, safety, and environmental protection laws, regulations and requirements.
In complying with these various regulations, the University may issue its own policies and procedures and set up internal University committees to oversee their implementation.
3-220 Responsibility for Compliance
As required by Title 8, California Code of Regulations, Section 3203, and in support of the University Policy on Management of Heath, Safety, and the Environment, each campus is required to have a written Injury and Illness Prevention Program (IIPP) which identifies the person or persons with authority and responsibility for implementing the campus’ health, safety, and environmental program. In most cases the Chancellor is identified as the person responsible for ensuring that the policy is implemented; however, those in management positions, including Principal Investigators, are responsible for implementing the IIPP in their facilities within their respective jurisdiction. This responsibility includes ensuring that appropriate health and safety training is provided to employees within their facility.
The Guiding Principles to Implement the University of California Policy on Health, Safety and the Environment states that:
2. Management Responsibility for Safety and the Environment
University employees who direct the activities of other individuals are responsible for protecting faculty, staff, students, visitors, the public and the environment, and for adhering to this policy. Accountability should be addressed in job descriptions and performance evaluations, and in contracts.
6. Identification of Safety and Environmental Standards and Requirements
Before a member of the University community conducts an activity which has potential adverse implications for health, safety or the environment, a responsible party must evaluate the associated hazards and environmental impacts and identify the appropriate set of protective safety and environmental requirements to assure that faculty, staff, students, visitors, members of the public, and the environment are protected from adverse affects. The principal responsibility for such an evaluation resides with employees and supervisors. The campus Environmental Health and Safety Office (EH&S) will provide assistance and consultation to identify requirements, controls, and their implementation.
Appendix A of Academic Personnel Manual, APM-245, Department Chairs, reiterates this administrative duty of Department Chairs (or equivalent officers) "to be responsible for departmental observance of proper health and safety regulations, in coordination with the campus health and safety officer."
EH&S Offices support this policy implementation by assisting managers/supervisors and Principal Investigators in identifying hazards and providing employee safety training programs. However, while EH&S Offices do support their campus's departments, they do not have the line authority to manage the safety programs within each department.
With regard to extramurally sponsored projects, Chancellors and Vice Presidents are responsible for ensuring that all matters of environmental health and safety have been considered and agency requirements are met before approving or recommending solicitations for contract or grant research, training or public service and that provisions for safe operation under the proposed programs have been or will be made.
Several offices at each University are responsible for the review and implementation of environmental health and safety regulations and procedures. They advise faculty and staff regarding compliance with these procedures. These offices include: EH&S, Facilities Management, Risk Management, and Materiel Management. The role of each of these offices is discussed in further detail below in the sections which cover their respective areas.
3-230 Contracts and Grants Officers' General Responsibilities
The general responsibility of Contracts and Grants Officers concerning environmental health and safety is to coordinate the reviews of proposals or awards with the campus EH&S or other campus offices as applicable. Contracts and Grants Officers also sign clean air and water certifications (See Section 3-820).
Chapter 3-300: The California Environmental Quality Act (CEQA)
The quality of the environment in California is protected by the California Environmental Quality Act (CEQA) (See External Requirements 3-S01). This Act was patterned after the National Environmental Policy Act (NEPA) (See External Requirements 3-F01).
CEQA requires that all State and public agencies, including the University, regulate their activities in a manner that gives major consideration to preventing environmental damage. The Act further requires that all State agencies prepare and certify the completion of an Environmental Impact Report (EIR) on any proposed project which may have a significant effect on the environment and that they adopt procedures which implement this Act and are consistent with the State CEQA Guidelines.
3-310 University Implementation of CEQA
The Regents’ Policy 8103: Policy on Capital Project Matters states that “All significant Capital Project Matters are reserved to the Committee and Board under Bylaw 22.2 (d). However, in the interest of operational efficiency of the University, the authority to approve or act on certain Capital Project Matters is deemed best exercised by the President of the University and designees rather than the Board or its Committees. As provided by the California Environmental Quality Act (CEQA), the certification or adoption of environmental documents is undertaken at the level of the associated project approval.” This authority has been delegated. The Capital Programs, Energy and Sustainability Office within UCOP Finance oversee the Capital Planning, Design and Construction, Facilities and Assets Management, Physical and Environmental Planning, Real Estate, Sustainability, and Energy programs. Assets Management and Physical Planning publishes CEQA Compliance, including a UC CEQA Checklist.
The Physical and Environmental Planning unit provides systemwide guidance on land use planning, physical development, and CEQA compliance. They also provide CEQA guidance on Long Range Development Plans, Capital Projects, Real Estate transactions, and other activities. The campus Facilities Management or Planning Office is responsible for completing the Initial Study or the Environmental Impact Report required by CEQA for a project which is not exempt or categorically exempt from CEQA (See Section 3-330 below).
3-320 Applicability of University Procedures for Implementation of CEQA
As a constitutionally created entity of the State of California, The Regents of the University of California (UC or University) is subject to CEQA. Additionally, UC has adopted the state’s “CEQA Guidelines” (Cal. Code Regs., Title 14, Chapter 3); thus, these Guidelines in their entirety and any subsequent updates are automatically applicable to University projects.
A Long Range Development Plan (LRDP) is defined as a physical development and land use plan to meet the academic and institutional objectives for a particular campus or medical center of public higher education. LRDPs have been prepared for all main campuses and medical centers, but not all UC-owned property is included in an LRDP. LRDP approval is subject to CEQA and requires the preparation of an environmental impact report (EIR).
CEQA applies to “discretionary projects.” The term discretionary refers to situations in which a governmental agency can exercise its judgment in deciding whether and how to approve or carry out a project. The term project refers to the whole of an action and underlying activity that has the potential, directly or ultimately, to result in a physical change to the environment.
For the University of California, typical projects that could have a significant effect on the environment include capital construction projects, LRDPs and LRDP amendments, leases, acquisition of property, substantial changes in the use of facilities, and series of actions such as seismic renovation or asbestos removal. Real estate transactions such as leases, licenses, and acquisitions of property may be considered projects under CEQA and could have a significant effect on the environment.
CEQA does not apply to:
Projects which have Statutory or Categorical Exemptions (as described in Cal. Code Regs., Title 14, § 15260-15333 (Articles 18 and 19)) such as anything specifically exempted by State law including but not limited to emergency projects, rejected projects, feasibility and planning studies, and ministerial projects.
Continuing administrative or maintenance activities, such as purchases for supplies, personnel-related actions, emergency repairs to public service facilities, general policy and procedure making (except as they are applied to specific instances covered above).
Basic research projects handled by Contracts and Grants Offices rarely require any action under CEQA. As they usually have no significant impact on the environment, they are considered "Categorically Exempt" under the CEQA procedures (See Section 3-330 below).
3-330 Compliance with University Procedures for Implementation of CEQA
Any University project, as defined in Section 3-320, which has "the potential for resulting in a physical change in the environment" must be classified as to its environmental impact. Projects requiring Office of the President consideration must be classified by the responsible administrative unit, usually the campus Facilities Management or Planning Office, at the time they are first proposed to the Office of the President for concurrence in funding, planning, development, or construction. The campus administrative unit submits an Environmental Impact Classification Form to the Office of the President for concurrence. For projects not requiring Office of the President consideration, such as minor capital projects funded from sources available to the responsible campus administrative unit, and all basic research projects which may need to be approved by the responsible campus administrative unit, the administrative unit must classify them before it grants final project approval.
The following classifications are used:
- Exempt from CEQA - if it can be seen with certainty that there is no possibility that the project may have a significant effect on the environment.
- Categorically Exempt - if the project is included within the list of classes which have been determined to have no significant effect on the environment.
- Initial Study - if the project is not exempt from CEQA or categorically exempt, and may have a significant effect on the environment.
- Environmental Impact Report - if the project may, is likely to, or clearly will have a significant effect on the environment.
Basic research projects are usually considered to be Categorically Exempt, under Class 6 of that classification (Cal. Code Regs., Title 14, § 15306). Class 6, Information Collection, is defined as follows:
Class 6 consists of basic data collection, research, experimental management, and resource evaluation activities which do not result in a serious or major disturbance to an environment. These may be strictly for information-gathering purposes or as part of a study leading to an action which a public agency has not yet approved, adopted, or funded.
However, a research project is not Categorically Exempt if there is a reasonable possibility that it may have a significant effect on the environment. Contracts and Grants Officers may contact their campus Facilities Management or Planning Office if there is a question about a research project being Categorically Exempt.
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).
3-420 Role of the Contracts and Grants Office
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.
3-430 Responsibilities of Purchasing/Materiel Management
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.
3-440 Biohazards
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.
3-450 Recombinant or Synthetic Nucleic Acid Research
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.”
3-451 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.
3-452 Responsibilities of the University under the NIH Guidelines
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.
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 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.
3-461 Center for Disease Control Biosafety Levels
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.
3-470 Carcinogens
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.
Chapter 3-500: Radiation
The use of radiation is the responsibility of the Radiation Safety Unit of the campus's Environmental Health and Safety (EH&S) Office and Radiation Safety Committee. Campuses with nuclear reactors also have Reactor Supervisors and Reactor Operations Committees responsible for use of their reactors.
In California, the State Health and Safety Code governing use of radiation supersedes federal regulations except when such use involves nuclear reactors, Department of Energy contracts, or the use of radioactive material on federal property. In these cases, the Nuclear Regulatory Commission regulations (10 CFR Chapter 1) govern the licensing and use of radioactive materials and radiation-producing machines (See External Requirements 3-F11). In addition, the Food and Drug Administration issues regulations (21 CFR Chapter 1) which govern radiation emissions from electronic products (See External Requirements 3-F12).
The California Code governing radiation control is set forth in CCR Title 17, Public Health Section 30100. It is based on an agreement with the Nuclear Regulatory Commission, subject to the provisions of 10 CFR Part 150. In general, these regulations require the licensing or registration of anyone possessing or using radioactive materials or radiation-producing machines. The California State Department of Public Health, Radiologic Health Branch, licenses each campus for possession and use of radioactive materials and radiation-producing machines (See External Requirements 3-S04).
Use of radiation at Lawrence Berkeley National Laboratory (LBNL) follows DOE Order 440.1B.
3-510 Responsibilities of EH&S and the Radiation Safety Committee
The campus Radiation Safety Committees establish policies which implement federal and State regulations and statutes pertaining to the use of radioactive materials and ionizing radiation-producing machines. It authorizes the use of ionizing radiation on campus. Each campus with a radioactive materials license must have a Radiation Safety Officer (RSO) who, in addition to advising on regulatory requirements, provides technical support to the Radiation Safety Committee.
EH&S reviews proposals involving radiation and, after approval by the Radiation Safety Committee, issues Radiation Use Authorizations (RUA) to the Principal Investigators. A valid RUA must be in effect prior to ordering radioactive material. Radioactive material shipments are routed through EH&S. EH&S is responsible for the transportation and disposal of radioactive wastes and the training of employees in all aspects of radiation safety. It inspects and monitors radiation uses and electronic product radiation safety to assure compliance with appropriate State and federal codes and regulations.
3-511 Nuclear Reactor Supervision
The campus Reactor Operations Committee and Reactor Supervisor are responsible for establishing policies which implement federal regulations governing the use of a nuclear reactor. They must review and approve proposed experiments which would involve the use of the reactor.
3-520 Role of the Contracts and Grants Office
The cover sheet or approval form which accompanies a proposal from a Principal Investigator to the Contracts and Grants Office asks for the RUA application or RUA number of the Investigator if radiation is involved in the proposed research. If such an authorization has not been obtained or applied for, the Investigator is referred to EH&S. Generally, Principal Investigators apply for or have an RUA before submitting a proposal to their Contracts and Grants Office.
Chapter 3-600: Controlled Substances & Drugs and Narcotics
The federal (21 CFR Part 1300 et seq.) and State of California (Health and Safety Code 11100 et seq.) Uniform Controlled Substances Acts require the University to have specific procedures for the acquisition and use of controlled substances, as defined in these Acts.
3-610 University Procedures for Controlled Substances – Business and Finance Bulletin BUS-50
The University procedures for the acquisition and use of controlled substances are established in Business and Finance Bulletin BUS-50, Controlled Substances Program. The purpose of this Bulletin is to implement the requirements of the federal and State Uniform Controlled Substances Acts. It sets forth the roles and responsibilities for establishing and maintaining University’s Controlled Substances Program.
In accordance with BUS-50, the Chancellor or Laboratory Director is responsible for designating, in writing, a Responsible Official to establish and oversee the campus or Laboratory Controlled Substances Program. The Responsible Official’s designee (such as personnel from Environmental, Health & Safety) is charged with implementing and managing the Controlled Substances Program on a day-to-day basis.
Campus and LBNL Material Managers or Purchasing Officers are responsible for the procurement of controlled substances, including completing DEA registration, order forms, and reporting requirements, in compliance with the federal and State Uniform Controlled Substances Acts (See External Requirements 3-F04 and 3-S05). BUS-50 sets forth the procedures for the campus Material Management and the Laboratory Purchasing Office to follow in order to register for the appropriate research classifications and to apply for the acquisition and use of controlled substances. BUS-50 also sets forth the procedures for issuing orders for controlled substances, for establishing controls against theft and diversion, and for maintaining records and inventories.
3-620 Responsibilities of Principal Investigators
The Principal Investigator (PI) or Department Chair initiates and signs requisitions for controlled substances. For any Schedule I controlled substance, as defined by the Controlled Substances Acts (see External Requirements 3-F05), the research protocol describing the project must be submitted to Materiel Management with the application. At the same time, a research proposal must be submitted to the State Research Advisory Panel (See External Requirements 3-S05). BUS-50 outlines the applicable Controlled Substances laws, the definitions of the five Schedules of Controlled Substances and the procedures for PIs to follow to apply to the State Research Advisory Panel and to acquire controlled substances.
If funds to support research are being sought from any federal, State or local granting agency, the PI should submit the proposal prior to or with the application to the State Research Advisory Panel (See External Requirements 3-S05 for further information on requirements of the State Research Advisory Panel). In addition, if approval is needed from any other federal or State agency (see Section 3-630), the PI must apply for such approval and show evidence of it to the Materiel Manager.
PIs or laboratory employees (e.g., staff and/or students) who are authorized to possess or use Controlled Substances by the University or LBNL are responsible for complying with federal and State regulations, program requirements, and University/Laboratory policy governing the acquisition, use, storage, and disposition of controlled substances.
3-630 Requirements of Other Federal and State Agencies
Approval is required from the federal Food and Drug Administration for interstate commerce of controlled substances and for human subject studies (See C&G Manual Chapter 18, Protection of Research Subjects). The California Department of Justice, Office of the Attorney General, is the cognizant office if intrastate commerce is involved.
Chapter 3-700: Human Health and Safety
As required by Title 8, Industrial Relations, California Code of Regulations Section 3203, “Injury and Illness Prevention Program,” and in support of the University Policy on Management of Health, Safety, and the Environment, each campus is required to have a written Injury and Illness Prevention Program (IIPP) which identifies the person or persons with authority and responsibility for implementing the campus’ health, safety, and environmental program. In most cases, the Chancellor is identified as being responsible for ensuring that the policy is implemented. However, those in management positions, including Principal Investigators, are responsible for implementing the IIPP in their facilities within their respective jurisdiction. This responsibility includes ensuring that appropriate health and safety training is provided to employees within their facility.
3-710 Responsibilities of Environmental Health and Safety (EH&S) Offices
EH&S staff evaluate potential hazards and coordinate campus programs to prevent work-related injuries and illnesses at the University. They work with academic departments and administrative services to develop training and monitoring processes for accident prevention programs.
EH&S Offices support the mission of the University by providing comprehensive environmental protection, occupational health, and industrial safety expertise to the entire University community. EH&S supports the research and educational processes through training and consultation, facilitating loss prevention programs, and providing a framework for workplace hazard analysis and control.
In addition to the areas discussed in Sections 3-410 and 3-510, EH&S concerns include: emergency planning; seismic, fire, office and industrial safety; asbestos; PCBs; pest management; sanitation; hazardous waste management; and diving safety.
3-720 Responsibilities of Risk Services
The President is assigned the authority and responsibility for coordination of the University Risk Management Program. The UCOP Risk Services Office is responsible for implementing the Risk Management Policy. In relation to environmental health and safety issues, the Risk Management Policies aim to "eliminate or modify conditions and practices, whenever practical, which may cause loss."
The campuses' Risk Management Offices are responsible for analyzing causes of personal injury and property damage. Risk Management staff collaborates with EH&S staff in developing insurance, security and prevention programs in such areas as industrial, seismic and fire safety. Such programs are aimed at minimizing risks and losses for the campus. Risk Services is also concerned with indemnity issues in regard to disposal of hazardous wastes (See C&G Manual Chapter 21, Risk Management).
3-730 Role of Department Chairpersons
The Department Chairperson or equivalent officer is responsible for "departmental observance of proper health and safety regulations, in coordination with the campus Health and Safety Officer" (APM-245). EH&S acts in an advisory capacity to Departmental Chairpersons and Principal Investigators, providing guidance on the implementation of regulations and the use of hazardous materials.
3-740 Applicable State and Federal Regulations
The two major laws which cover the health and safety of workers are the Federal (29 CFR Chapter XVII) and State (Labor Code Section 6300) Occupational Safety and Health Acts (See External Requirements 3-F05 and 3-S02).
In addition to these major acts and the laws and regulations previously described in this chapter, the following federal and State laws covering worker health and safety are outlined under External Requirements:
Federal
Toxic Substances Control Act (3-F06)
Federal Food, Drug and Cosmetic Act (3-F07)
Federal Insecticide, Fungicide and Rodenticide Act (3-F08)
Resource Conservation and Recovery Act (3-F12)
State
Occupational Carcinogens Control Act (3-S03)
Chapter 3-800: Certifications for Clean Air and Water
The Federal Clean Air Act (42 USC 7401 et seq.) and the Federal Water Pollution Control Act (33 USC 1251 et seq.) require federal awards to include certifications of compliance with these Acts. (See External Requirements 3-F09.) The certification states that the awardee and any facility to be used in performance of the agreement will comply with the standards of these regulations. No facility included in the Federal Excluded Parties List may be used in the performance of a federal or State contract or grant.
State of California Government Code Section 4475 et. seq. states that
No state agency shall enter into any contract for the purchase of supplies, equipment, or services from any person who is in violation of any order or resolution not subject to review promulgated by the State Air Resources Board or an air pollution control district, or is subject to a cease and desist order not subject to review issued pursuant to Section 13301 of the Water Code for violation of waste discharge requirements or discharge prohibitions, or is finally determined to be in violation of federal laws relating to air or water pollution.
The State contract or grant clause requires the contractor to certify that no portion of the work to be done will be performed at a facility which is in violation of any State or federal air or water pollution orders. (See External Requirements 3-S06.)
3-810 Responsibilities of Materiel Management - Business and Finance Bulletin Bus-56
Business and Finance Bulletin BUS-56, Materiel Management: Purchases from Entities Violating State or Federal Water or Air Pollution Laws, sets forth the procedures for the University implementation of these laws. Materiel Managers are prohibited "from entering into contracts of $10,000 or more for the purchase of supplies, equipment or services from any person entity who has been determined to be in violation of federal or State air or water pollution laws in violation of this statute.” Where subcontracts are administered by campus Contract and Grant Offices, those offices are responsible for confirming that a proposed subcontractor is not on the Federal Excluded Parties List.
3-820 Role of Contracts and Grants Officers
Contracts and Grants Officers may sign federal contracts or lists of certifications and representations which include the clean air and water certifications. The signature certifies that the University does not use any facility in the performance of this proposed award which has been listed on the Federal Excluded Parties List as an EPA violating facility.
In State contracts, clean air and water compliance clauses are incorporated in the exhibits.
Chapter 3-999: Related University References
- University Policy on Management of Health, Safety and the Environment
- Academic Personnel Manual-245, Appendix A, “Duties of Department Chairpersons (or Equivalent Officers)”
- Presidential Delegation of Authority to Senior Vice President - Administration, “Implementation of California Environmental Quality Act”
- University CEQA Handbook
- Contract and Grant Memo No. 33-79, “Proprietary Data Legend for Protection of Sensitive Data Submitted in Research Proposals”
- Business and Finance Bulletin BUS-50, “Controlled Substances Program”
- UC Regents Policy 5301, "University Risk Financing Policy"
- Presidential Delegation of Authority to Vice President - Financial and Business Management, Risk Management Program,
- Business and Finance Bulletin BUS-56, “Material Management: Purchases from Entities Violating State or Federal Water or Air Pollution Laws”
External Requirements - Federal
3-F01 National Environmental Policy Act of 1969 as Amended (PL 91-190 42 USC §4321 et seq. as amended)
IMPLEMENTING REGULATIONS
40 CFR Part 6
PURPOSE
To establish a National Environmental Policy and Council on Environmental Quality. The Declaration of National Environmental Policy calls for federal government, in cooperation with state, local, public and private organizations, to use all means to foster and promote the general welfare, to create and maintain conditions under which humans and nature can exist in productive harmony, and to fulfill responsibility of each generation as trustees of the environment for future generations.
SUMMARY
These regulations require information on and coordination of federal projects and programs impacting the environment, including environmental impact statements, initial and use planning information, and review and public involvement. Federal agencies must include appropriate and careful consideration of all environmental effects of a proposed action.
APPLICABILITY
Regulations apply to federal agencies and all federal assistance programs. Environmental assessment must be prepared by grantee for each federally assisted project if it falls within categories required.
LEAD AGENCY
Environmental Protection Agency
Council on Environmental Quality
UNIVERSITY RESPONSIBILITY
In general, the University implements the National Environmental Policy Act (NEPA) through compliance with the California Environmental Quality Act (CEQA) (see 3-S01). However, there are circumstances under which Facilities Management prepares environmental impact documents under NEPA federal awards because a research project is determined to be categorically exempt under CEQA, but not excluded under NEPA.
3-F02 National Institutes of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
IMPLEMENTING REGULATIONS
59 FR 34472 and amendments
PURPOSE
To detail safety practices and containment procedures for basic and clinical research involving recombinant or synthetic nucleic acid molecules, including the creation and use of organisms and viruses containing recombinant or synthetic nucleic acid molecules
SUMMARY
Regulations establish four biosafety levels (BSLs) or levels of physical containment for classifying recombinant or synthetic nucleic acid research, depending on the risk posed by the etiological agents to be used in the proposed research. Compliance with these biosafety levels consists of implementing combinations of laboratory practices, safety equipment, and laboratory facilities appropriate for the operations performed and the hazards posed by any proposed recombinant or synthetic nucleic acid research. Agents assigned to biosafety level 4 (BSL-4) require the most stringent containment conditions. Those assigned to BSL-1 require the least stringent.
The regulations describe the guidelines for classifying recombinant and synthetic nucleic acid experiments and their review procedures, and the membership requirements, functions and responsibilities of the Institutional Biosafety Committee (IBC), which reviews proposed recombinant or synthetic nucleic acid research.
The regulations require the institution to appoint a Biological Safety Officer (BSO) if it is engaged in recombinant or synthetic nucleic acid research at the BSL-3 or BSL-4 containment level. The officer shall be a member of their campus's Institutional Biosafety Committee (IBC).
The duties of the BSO are described in the NIH Guidelines. They also describe the responsibilities of Principal Investigators for compliance with the Guidelines and as well as the responsibilities of NIH.
APPLICABILITY
Regulations are required for institutions receiving NIH funds for recombinant or synthetic nucleic acid research and are voluntary for others.
LEAD AGENCY
National Institutes of Health
UNIVERSITY RESPONSIBILITY
Campuses appoint an Institutional Biosafety Committee (IBC) and a Biological Safety Officer (BSO) to implement the Guidelines. The BSO is a member of the IBC and a staff member of campus EH&S. EH&S is responsible for establishing and implementing policies that provide for the safe conduct of recombinant or synthetic nucleic acid research, ensuring compliance with the Guidelines, and establishing additional procedures as necessary.
3-F03 Biosafety in Microbiological and Biomedical Laboratories (BMBL)
PURPOSE
Recommends best practices for the safe conduct of work in biomedical and clinical laboratories from a biosafety perspective.
SUMMARY
This publication sets forth a code of practice for biosafety—the discipline addressing the safe handling and containment of infectious microorganisms and hazardous biological materials, including microbiological containment practices, safety equipment, and facility safeguards that protect laboratory workers, the environment, and the public from exposure to infectious microorganisms handled and stored in a laboratory that constitute biosafety levels 1-4.
APPLICABILITY
These advisory guidelines from the Centers of Disease Control are for research facilities using infectious microorganisms, hazardous biological materials, etiologic agents, select agents and toxins.
LEAD AGENCY
Centers for Disease Control
UNIVERSITY RESPONSIBILITY
Campus EH&S Offices review proposed research procedures and laboratory facilities for compliance with biosafety level standards. Some campuses require specific authorizations from EH&S for use of infectious microorganisms, hazardous biological materials and etiologic agents.
3-F04 Comprehensive Drug Abuse Prevention and Control Act of 1970, Federal Controlled Substances Act (21 USC 801 et seq.)
IMPLEMENTING REGULATIONS
21 CFR Chapter II
PURPOSE
To provide increased research into and prevention of drug abuse and dependence, treatment, and rehabilitation. To strengthen existing law enforcement authority in the drug abuse field and to consolidate all federal marijuana, narcotics and dangerous drug laws.
This Act is designed to control the legitimate drug industry as well as to curtail the importation and distribution of illicit drugs throughout the United States.
SUMMARY
This Act provides funds for rehabilitation programs and research. The regulations set up controls, enforcement, penalties, and administration. They establish the schedules of controlled substances, restrictions, and registration classifications for their use.
Schedules of Controlled Substances - Section 202
The Act establishes five schedules of controlled substances, which classifies drugs and narcotics based on the substance's medical use, potential for abuse and safety or dependence liability, and places restrictions on obtaining and handling them. Schedule I lists those substances with the highest abuse potential and Schedule V lists those with the lowest potential. A listing of the specific items in each schedule is published annually by the Drug Enforcement Administration (DEA) in 21 CFR §§1308.11 through 1308.15. Further details about the Schedules are given in Appendix A of Business and Finance Bulletin BUS-50.
DEA Registration Classifications
The Federal Controlled Substances Act requires institutions or individuals to register with the DEA to legally obtain and use controlled substances. The DEA classifies registrations based on the business activity (e.g., manufacturing, research, teaching, etc.) an applicant requires controlled substances for (21 CFR §1301.13). The registration classification determines which schedule(s) of drugs the applicant may obtain and use. Application for the use of any scheduled substances must be in the specific registration classifications which apply to that institution.
APPLICABILITY
Any use of scheduled substances.
LEAD AGENCY
Drug Enforcement Administration (DEA)
UNIVERSITY RESPONSIBILITY
Materiel Management must submit applications to the DEA for use of any controlled substances (Schedules I through V). These applications use the specific registration classifications which apply to the University. They are:
- Teaching Institution using Schedules II through V
- Hospital/Clinic using Schedules II through V
- Research in Schedule II through V
- Research in Schedule I
- Chemical Analysis distinct from research
- Manufacturing
Each campus Materiel Management or Laboratory Purchasing Office registers its campus with the DEA for the classifications which apply to its needs (see Section 3-610). Once a campus or laboratory is registered in a classification, it can acquire controlled substances from Schedules II through V for use in that classification. Materiel Management must control the acquisition and distribution of scheduled substances.
A separate registration is required for each research project using Schedule I controlled substances. The Principal Investigator initiates this application, which includes a description of the research protocol, and submits it to Materiel Management (see Business and Finance Bulletin BUS-50 for further detail).
3-F05 Occupational Safety and Health Act (29 USC 667 et seq.)
IMPLEMENTING REGULATIONS
29 CFR 1900
PURPOSE
To establish regulations for the workplace to assure that no employee will suffer diminished health as a result of working conditions. To set forth procedures for the development of state plans, enforcement and reporting, and federal standards and penalties.
SUMMARY
This Act establishes regulations to protect the health and safety of workers. The regulations set forth state planning for development and enforcement of state standards and procedures for inspections, citations, proposed penalties, and reporting injuries and illnesses. They list occupational health and safety standards for various work sectors and industries. The Act creates the National Institutes for Occupational Safety and Health (NIOSH), which conducts workplace studies and makes recommendations. It creates a broad mechanism for protecting workers from workplace hazards and occupational exposure to hazardous chemicals in laboratories as well as blood borne pathogens.
APPLICABILITY
States and interstate commerce industries.
LEAD AGENCY
Department of Labor
UNIVERSITY RESPONSIBILITY
EH&S is responsible for appropriate implementation of applicable State OSHA regulations, which are approved by the Secretary of Labor in accordance with these federal regulations (see 3-S02).
3-F06 Toxic Substances Control Act of 1977 (15 USC §2601-2629)
IMPLEMENTING REGULATIONS
40 CFR 700
PURPOSE
To regulate commerce and protect human health and the environment by requiring testing and necessary use restrictions on certain chemical substances.
SUMMARY
Sets forth conditions to test for possible health or environmental risks. Makes rules, procedures, and regulations. Provides for data collection, record keeping, and enforcement. Fills gaps in other environmental laws by authorizing the Environmental Protection Agency (EPA) to acquire information on chemical substances in order to identify and evaluate potential hazards and then to regulate the production, use, distribution, and disposal of those substances.
APPLICABILITY
Consulting laboratories, contractors, and grantees performing studies to which these regulations apply. Applies to commodity and specialty chemicals made by biotechnology and microorganisms used in the environment.
LEAD AGENCY
EPA with rules issued by EPA and Treasury Department.
UNIVERSITY RESPONSIBILITY
Campus EH&S Offices are responsible for implementing the regulations under this law which include: proper handling, resting and storage of substances; equipment maintenance; records retention; and employee protection.
3-F07 Federal Food, Drug and Cosmetic Act (FFDCA)
Amended by Medical Devices Amendments of 1976 (21 USC 301 et seq.)
IMPLEMENTING REGULATIONS
21 CFR Chapter I
PURPOSE
To regulate drugs, biologics, food, food additives, cosmetics, and tobacco products.
SUMMARY
These regulations establish good laboratory and manufacturing practices and require premarket testing of certain products.
APPLICABILITY
Consulting laboratories, contractors, grantees, and manufacturers.
LEAD AGENCY
Food and Drug Administration
UNIVERSITY RESPONSIBILITY
The EH&S Office is responsible for implementing the safe laboratory practices required by the regulations under this law.
Principal Investigators must apply for a permit from the Food and Drug Administration for work involving an experimental use stage of any product covered by these regulations.
Under the Medical Devices Amendments, the Principal Investigator must apply to the Food and Drug Administration for an Investigational Device Exemption required to conduct clinical trials of a medical device.
3-F08 Federal Insecticide, Fungicide and Rodenticide ACT (FIFRA) (7 USC 136 et seq.)
IMPLEMENTING REGULATIONS
40 CFR 150 et seq.
PURPOSE
To regulate development, studies, manufacture, and use of biological pesticides, herbicides, microorganisms, or their chemical products.
SUMMARY
These regulations prescribe good laboratory practices and manufacturing requirements. They require studies in support of applications for research or marketing permits for pesticides products regulated by the Environmental Protection Agency (EPA) and assure the quality and integrity of data. They cover treatment of animals; handling, storage, and testing of substances; and require the EPA's review of pesticides.
APPLICABILITY
Consulting laboratory, contractor, grantee or manufacturer.
LEAD AGENCY
EPA
UNIVERSITY RESPONSIBILITY
The EH&S Office is responsible for implementing safe use of biological pesticides, herbicides, microorganisms, or their chemical products. Principal Investigators must apply to the EPA for the permits required for research involving experimental use stages.
3-F09 Clean Water Act (PL 92-500; 33 USC 1251 et seq.) and Clean Air Act (PL 88-206; 42 USC 7401 et seq.)
Clean Water Act Amendments (1977 - PL 95-217; 1987 - PL 100-4)
Clean Air Act Amendments (1970 - PL 91-604; 1977 - PL 95-95; 1990 - PL 101-549)
IMPLEMENTING REGULATIONS
40 CFR Part 25
Executive Order 11738, "Providing for Administration of the Clean Air Act and the Federal Water Pollution Control Act with Respect to Federal Contracts, Grants, or Loans" (E.O. 11738 - 38 FR 25161, September 12, 1973)
PURPOSE
The Clean Water Act (Federal Water Pollution Control Act of 1972) calls for restoration and maintenance of the chemical, physical, and biological integrity of the nation's waters.
The Clean Air Act's purpose is to protect and enhance the quality of air resources to promote health and welfare. It initiates research and development on prevention and control of air pollution.
E.O. 11738 assures that each federal agency which awards grants, contracts or loans undertakes procurements and assistance activities in a manner that will result in effective enforcement of the Clean Air and Water Acts, by implementing Section 306 of the Air Act and 508 of the Water Act (see below).
SUMMARY
The Water Act covers the elimination of discharge of pollutants, protects fish and wildlife, prohibits toxic pollutants, and assists in the construction of water treatment plants and development of research and technology.
The Clean Air Act authorizes activities of research and development programs, proposes ambient air standards, and sets forth pollution enforcement procedures. States are required to maintain standards of air quality.
Section 306 of the Clean Air Act and 508 of the Clean Water Act are virtually identical in scope and impact. Each section provides general environmental standards and administrative requirements for federal contracts and grants that are subject to the Clean Air and Clean Water Acts. Regulations issued pursuant to these sections by the Environmental Protection Agency (EPA) are set forth in a detailed code of enforcement and compliance standards. These regulations may be found at 40 CFR Part 25.
Under the EPA regulations, sanctions may be imposed upon offending facilities when they fail to comply with federal and state requirements and orders issued pursuant to the Acts. In such cases, EPA may initiate hearing procedures which may result in the placement of the facility on a "list of violating facilities". The consequence of such action is that listed facilities may not be awarded future grants or receive extensions of existing grants. In addition, existing grants may be terminated.
Grants, subgrants, and contracts issued by grantees for less than $100,000 are exempted from the Acts. Additionally, grants used to assist facilities in their compliance with environmental requirements are exempted. These exemptions do not apply to facilities whose prior violations of environmental requirements have resulted in criminal convictions under either of the above cited Acts.
APPLICABILITY
Section 306 of the Clean Air Act and Section 508 of the Clean Water Act specifically apply to federal contracts, grants, loans, and subcontracts greater than $100,000. Other sections of these Acts apply to all activities engaged in, supported, funded, licensed, permitted, or approved by any federal department or agency.
LEAD AGENCY
EPA
UNIVERSITY RESPONSIBILITY
Under BUS-56, Materiel Management: Purchases from Entities Violating State or Federal Water or Air Pollution Laws, Materiel Management is responsible for ensuring that the University does not use any federal money to subcontract with or purchase from any person or facility on the EPA's list of facilities in violation of the Clean Air Act and Clean Water Act Sections 306 and 508, respectively. Contracts and Grants Officers certify the University's compliance with these Acts. When subcontracts are administered by campus Contract and Grant Offices, those offices are responsible for confirming that a proposed subcontractor is not on the Federal Excluded Parties List.
3-F10 Atomic Energy Act of 1954, as amended (42 USC §§2011 et seq)
Energy Reorganization Act of 1974, as amended (42 USC §§5801 et seq)
IMPLEMENTING REGULATIONS
10 CFR Chapter 1
PURPOSE
To foster the research and development of atomic energy and nuclear material and to disseminate technical information and benefits of such research. To promote peaceful and defensive uses, and international cooperation, of atomic energy for common defense and security. To establish government control of possession, use, and production of atomic energy and nuclear material. To set up program administration.
SUMMARY
These regulations govern all aspects of the use of nuclear materials including licensing, procedures to access restricted data, procedures to access and control these materials, and human and environmental protection standards. They set forth reporting procedures, standards for manufacturing and transporting nuclear materials, standards for patent licenses, security approvals, and import and export procedures.
APPLICABILITY
Any person, institution, political entity, corporation, etc. which uses or manufactures nuclear materials, except for Agreement States exempted under 10 CFR Part 150. An Agreement State is a State that the Nuclear Regulatory Commission or the Atomic Energy Commission has entered into an effective agreement under subsection 274b of the Act.
LEAD AGENCY
Nuclear Regulatory Commission
UNIVERSITY RESPONSIBILITY
The EH&S Radiation Safety Officer (or the Reactor Supervisor, as appropriate) is responsible for implementing these regulations for licensing and use of nuclear material and radiation-producing machines when they involve Department of Energy contracts, nuclear reactors, or use on federal property. In other cases, the State Radiation Control Codes apply as California is an Agreement State under 10 CFR Part 150 (see External Requirements 3-S04).
LBNL follows DOE Order 458.1 Change 4, Radiation Protection of the Public and the Environment.
3-F11 Radiation Control for Health and Safety Act of 1968 (21 USC 360)
IMPLEMENTING REGULATIONS
21 CFR 1000 et seq.
PURPOSE
To provide for the protection of the public health from radiation emissions from electronic products.
SUMMARY
This Act identifies performance standards to control emissions from: ionizing electromagnetic radiation and particulate radiation products; ultraviolet, visible, infrared, microwave, and radio/low frequency emitting products; laser and maser light emitting products; and sonic, infrasonic, and ultrasonic emitting products. It supports public and private organization research and investigation into the effects and control of such emissions.
The regulations establish requirements for notification by manufacturers of defects, repairs, or replacements. They set up controls for imported products and require codes for reporting listed electronic products and electronic product radiation warnings.
APPLICABILITY
Manufacturers and users of such products.
LEAD AGENCY
Food and Drug Administration
UNIVERSITY RESPONSIBILITY
EH&S and the Radiation Safety Officer are responsible for implementing regulations regarding the safe use of these products.
3-F12 Resource Conservation and Recovery Act of 1976 as amended (42 USC 6901)
IMPLEMENTING REGULATIONS
40 CFR Part 239 et seq.
PURPOSE
To provide technical and financial assistance for the development of management plans, facilities for the recovery of energy and other resources from discarded materials, and for the safe disposal of discarded materials. To regulate the management of hazardous waste. To set up state and regional plans for solid and hazardous waste disposal management.
SUMMARY
These regulations set forth guidelines for solid or hazardous waste disposal and management. They identify and list hazardous wastes, as well as regulate handling, storage, treatment, transportation, and disposal of solid or hazardous wastes. They provide for employee protections against firings when the employee reports violations of these regulations.
APPLICABILITY
Any user, manufacturer, or disposer of solid and hazardous wastes.
LEAD AGENCY
Environmental Protection Agency
UNIVERSITY RESPONSIBILITY
EH&S is responsible for implementing these regulations, and providing guidance to departments on the safe disposal of wastes to protect employees, facilities, and the environment.
3-F13 Agricultural Bioterrorism Protection Act of 2002 (7 USC 8401)
Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (42 USC 262a; sections 201–204, 221 and 231)
IMPLEMENTING REGULATIONS
42 CFR 73; 7 CFR 331; 9 CFR 121
PURPOSE
Implements the provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Agricultural Bioterrorism Protection Act of 2002 which require restricted access to select agents and toxins.
SUMMARY
Sets forth the requirements for possession, use, and transfer of select agents and toxins. Assesses security risks and provides security requirements for access to these agents and toxins. The biological agents and toxins listed in these parts have the potential to pose a severe threat to public health and safety, to animal health and products, or to plant health and products. Overlap select agents and toxins are subject to regulation by both CDC and APHIS.
APPLICABILITY
Applies to any government agency (Federal, State, or local), academic institution, corporation, company, partnership, society, association, firm, sole proprietorship, or other legal entity.
LEAD AGENCY
Centers for Disease Control and Protection - U.S. Department of Health and Human Services;
Animal and Plant Health Inspection Services (APHIS) – U.S. Department of Agriculture
UNIVERSITY RESPONSIBILITY
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 their campus's EH&S Office.
External Requirements - State
3-S01 California Environmental Quality Act (CEQA) (Public Resources Code §§21000 et seq.)
IMPLEMENTATION REGULATIONS
California Code of Regulations (CCR)
PURPOSE
To maintain a high quality environment for the people of the State. To require all State and public agencies to ensure that their activities are carried out in the best manner to prevent environmental damage.
SUMMARY
CEQA is patterned after the National Environmental Policy Act (NEPA). CEQA requires all State and public agencies to regulate their activities to prevent environmental damage. Regulations must be consistent with the Act and comply with the State CEQA. All State agencies prepare and certify the completion of an environmental impact report (EIR) on any proposed project which may have a significant impact on the environment.
APPLICABILITY
State and public agencies.
LEAD AGENCY
California Natural Resources Agency
UNIVERSITY RESPONSIBILITY
The policy adopted by The Regents, as required by CEQA and the University’s implementation of CEQA, is set forth in the UC CEQA Handbook. The campus Facilities Management or Planning Office is responsible for submitting environmental impact reports when required by the guidelines (see Sections 3-300 to 3-330).
3-S02 California Occupational Safety and Health Act (Labor Code §§ 6300 et seq.)
IMPLEMENTATION REGULATIONS
California Code of Regulations Title 8 Industrial Relations Section 340 et seq.
PURPOSE
To fulfill the federal Occupational Safety and Health Act requirements by establishing State standards and procedures to provide a safe and healthful place of employment (see Section 3-F05).
SUMMARY
This code sets forth State occupational health and safety standards which are approved by the California Secretary of Labor. It contains detailed regulations and safety orders for safety in employment, worker safety, safety devices, and safeguards. It sets forth health standards, inspection and investigation procedures, hazardous substances information and training requirements.
APPLICABILITY
Employers in California.
LEAD AGENCY
Division of Occupational Safety and Health (Cal/OSHA) - Department of Industrial Relations
UNIVERSITY RESPONSIBILITY
The EH&S Office interprets and assists managers/supervisors and Principal Investigators in the implementation of these health and safety codes.
3-S03 Occupational Carcinogens Control Act of 1976 (Labor Code §§ 9000 et seq.)
IMPLEMENTING REGULATIONS
California Code of Regulations Title 8 Industrial Relations Section 5203 et seq.
PURPOSE
To establish requirements for use of regulated chemicals which can be carcinogenic.
SUMMARY
This code sets forth standards for use of specific chemicals which can be carcinogenic. It establishes procedures for implementation of the code and for inspections to verify enforcement. It gives penalties for violations and lists regulated chemicals to which the code applies.
APPLICABILITY
Users of specific regulated chemicals in California.
LEAD AGENCY
Division of Occupational Safety and Health (Cal/OSHA) - Department of Industrial Relations
UNIVERSITY RESPONSIBILITY
The EH&S Office regulates the use of carcinogens on campus and in laboratories in accordance with State requirements and campus policies.
LBNL follows DOE Order 440.1B for regulating the use of carcinogens.
3-S04 California Radiation Control Law (Health and Safety Code §§ 114960 et seq.)
IMPLEMENTATION REGULATIONS
California Code of Regulations Title 17 Public Health §§30100 et seq.
PURPOSE
To control the use and disposal of radioactive material and radiation-producing machines.
SUMMARY
This code sets standards for enforcement and requirements for use, storage, transportation, and disposal of radioactive material. It requires the licensing and registration of radioactive materials and radiation-producing machines.
APPLICABILITY
Users or persons in possession of radioactive materials and radiation-producing machines in California.
LEAD AGENCY
Department of Public Health Radiologic Health Branch
UNIVERSITY RESPONSIBILITY
The EH&S Radiation Safety Officer and the Radiation Safety Committee are responsible for authorization, control, distribution, use and disposal of radioactive materials and radiation-producing machines.
LBNL follows DOE Order 458.1 on Radiation Protection of the Public and the Environment.
3-S05 Uniform Controlled Substances Act (Health and Safety Codes §§11000 et seq.)
IMPLEMENTING REGULATIONS
California Code of Regulations Title 11 Attorney General §§800 et seq.
PURPOSE
To regulate the acquisition and use of narcotics and dangerous drugs.
SUMMARY
This Act supplements the Federal Controlled Substances Act, governing the acquisition and use of controlled substances within the State. The Code sets forth regulations for human subject research with controlled substances. Health and Safety Code Section 11213 gives authority to the State Research Advisory Panel, established under Sections 11480 and 11481, to approve the use of controlled substances in research, instruction, and analysis.
State of California Research Advisory Panel
Anyone planning to conduct research in the following areas must submit a research application to the State Research Advisory Panel:
- Any research involving any Schedule I controlled substance;
- Human research utilizing any Schedule I or Schedule II controlled substance except those included in subsection d of Schedule II (see C& G Manual Chapter 18 for general information on human subjects review and approval); or
- Research for treatment of drug abuse utilizing any scheduled or unscheduled drug.
The Schedules of Controlled Substances are explained in Section 3-F04. It is unlawful to engage in any of the above-described research areas without prior authorization from the Research Advisory Panel. Application requirements and guidelines are available from their website.
APPLICABILITY
Use of scheduled substances in the State of California.
LEAD AGENCY
State Department of Justice – Office of the Attorney General
UNIVERSITY RESPONSIBILITY
The University procedures for the acquisition and use of controlled substances are established Business and Finance Bulletin BUS-50, Controlled Substances Program. Under BUS-50, Materiel Management and Purchasing Offices are responsible for authorizing applications for registration, official order forms, and reporting requirements (see Section 3-610).
Any University Principal Investigator intending to conduct research in the areas covered by the State Research Advisory Panel described above must submit a research application to the Panel.
3-S06 Public Works and Purchases (Government Code §§4475 et seq.)
PURPOSE
To prohibit State agencies from contracting with entities which are in violation of State or federal water or air pollution laws.
SUMMARY
No State agency can enter into any contract with any person or entity in violation of any order of the State Air Resources Board, waste discharge requirements in the Water Code or provisions of federal laws relating to air and water pollution.
APPLICABILITY
Any State agency, including the University.
LEAD AGENCY
State Air Resources Board and Water Resources Control Board
UNIVERSITY RESPONSIBILITY
Materiel Managers shall take precautions to ensure that the University does not enter into contracts with any person or entity on the list of violators, the Federal Excluded Parties List. Business and Finance Bulletin BUS-56, Materiel Management: Purchases from Entities Violating State or Federal Water or Air Pollution Laws contains more details on this subject.
Chapter 3-300: The California Environmental Quality Act (CEQA)
The quality of the environment in California is protected by the California Environmental Quality Act (CEQA) (See External Requirements 3-S01). This Act was patterned after the National Environmental Policy Act (NEPA) (See External Requirements 3-F01).
CEQA requires that all State and public agencies, including the University, regulate their activities in a manner that gives major consideration to preventing environmental damage. The Act further requires that all State agencies prepare and certify the completion of an Environmental Impact Report (EIR) on any proposed project which may have a significant effect on the environment and that they adopt procedures which implement this Act and are consistent with the State CEQA Guidelines.
3-310 University Implementation of CEQA
The Regents’ Policy 8103: Policy on Capital Project Matters states that “All significant Capital Project Matters are reserved to the Committee and Board under Bylaw 22.2 (d). However, in the interest of operational efficiency of the University, the authority to approve or act on certain Capital Project Matters is deemed best exercised by the President of the University and designees rather than the Board or its Committees. As provided by the California Environmental Quality Act (CEQA), the certification or adoption of environmental documents is undertaken at the level of the associated project approval.” This authority has been delegated. The Capital Programs, Energy and Sustainability Office within UCOP Finance oversee the Capital Planning, Design and Construction, Facilities and Assets Management, Physical and Environmental Planning, Real Estate, Sustainability, and Energy programs. Assets Management and Physical Planning publishes CEQA Compliance, including a UC CEQA Checklist.
The Physical and Environmental Planning unit provides systemwide guidance on land use planning, physical development, and CEQA compliance. They also provide CEQA guidance on Long Range Development Plans, Capital Projects, Real Estate transactions, and other activities. The campus Facilities Management or Planning Office is responsible for completing the Initial Study or the Environmental Impact Report required by CEQA for a project which is not exempt or categorically exempt from CEQA (See Section 3-330 below).
3-320 Applicability of University Procedures for Implementation of CEQA
As a constitutionally created entity of the State of California, The Regents of the University of California (UC or University) is subject to CEQA. Additionally, UC has adopted the state’s “CEQA Guidelines” (Cal. Code Regs., Title 14, Chapter 3); thus, these Guidelines in their entirety and any subsequent updates are automatically applicable to University projects.
A Long Range Development Plan (LRDP) is defined as a physical development and land use plan to meet the academic and institutional objectives for a particular campus or medical center of public higher education. LRDPs have been prepared for all main campuses and medical centers, but not all UC-owned property is included in an LRDP. LRDP approval is subject to CEQA and requires the preparation of an environmental impact report (EIR).
CEQA applies to “discretionary projects.” The term discretionary refers to situations in which a governmental agency can exercise its judgment in deciding whether and how to approve or carry out a project. The term project refers to the whole of an action and underlying activity that has the potential, directly or ultimately, to result in a physical change to the environment.
For the University of California, typical projects that could have a significant effect on the environment include capital construction projects, LRDPs and LRDP amendments, leases, acquisition of property, substantial changes in the use of facilities, and series of actions such as seismic renovation or asbestos removal. Real estate transactions such as leases, licenses, and acquisitions of property may be considered projects under CEQA and could have a significant effect on the environment.
CEQA does not apply to:
Projects which have Statutory or Categorical Exemptions (as described in Cal. Code Regs., Title 14, § 15260-15333 (Articles 18 and 19)) such as anything specifically exempted by State law including but not limited to emergency projects, rejected projects, feasibility and planning studies, and ministerial projects.
Continuing administrative or maintenance activities, such as purchases for supplies, personnel-related actions, emergency repairs to public service facilities, general policy and procedure making (except as they are applied to specific instances covered above).
Basic research projects handled by Contracts and Grants Offices rarely require any action under CEQA. As they usually have no significant impact on the environment, they are considered "Categorically Exempt" under the CEQA procedures (See Section 3-330 below).
3-330 Compliance with University Procedures for Implementation of CEQA
Any University project, as defined in Section 3-320, which has "the potential for resulting in a physical change in the environment" must be classified as to its environmental impact. Projects requiring Office of the President consideration must be classified by the responsible administrative unit, usually the campus Facilities Management or Planning Office, at the time they are first proposed to the Office of the President for concurrence in funding, planning, development, or construction. The campus administrative unit submits an Environmental Impact Classification Form to the Office of the President for concurrence. For projects not requiring Office of the President consideration, such as minor capital projects funded from sources available to the responsible campus administrative unit, and all basic research projects which may need to be approved by the responsible campus administrative unit, the administrative unit must classify them before it grants final project approval.
The following classifications are used:
- Exempt from CEQA - if it can be seen with certainty that there is no possibility that the project may have a significant effect on the environment.
- Categorically Exempt - if the project is included within the list of classes which have been determined to have no significant effect on the environment.
- Initial Study - if the project is not exempt from CEQA or categorically exempt, and may have a significant effect on the environment.
- Environmental Impact Report - if the project may, is likely to, or clearly will have a significant effect on the environment.
Basic research projects are usually considered to be Categorically Exempt, under Class 6 of that classification (Cal. Code Regs., Title 14, § 15306). Class 6, Information Collection, is defined as follows:
Class 6 consists of basic data collection, research, experimental management, and resource evaluation activities which do not result in a serious or major disturbance to an environment. These may be strictly for information-gathering purposes or as part of a study leading to an action which a public agency has not yet approved, adopted, or funded.
However, a research project is not Categorically Exempt if there is a reasonable possibility that it may have a significant effect on the environment. Contracts and Grants Officers may contact their campus Facilities Management or Planning Office if there is a question about a research project being Categorically Exempt.
Navigating the Manual
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Chapters
2: Proposal Submission and Award Acceptance/Administration
3: Environmental Health and Safety
10: Internal University Administration
11: Intellectual Property and Related Matters
13: Legal Authorities and Principles
14: Nondiscrimination/Affirmative Action
17: Records/Paperwork Access and Management
18: Protection of Research Subjects
20: Performance of Classified Research