Contract and Grant Manual

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.

3-200 UNIVERSITY POLICY ON ENVIRONMENTAL HEALTH AND SAFETY

The University Policy on Environmental Health and Safety was issued by the President on October 22, 1986. This policy states:

A. It is the policy of the University of California to maintain a reasonably safe environment for its students, academic appointees, staff, and visitors.

B. University operations shall be conducted in compliance with applicable regulations, and when appropriate, with accepted health and safety standards.

3-210 COMPLIANCE WITH APPLICABLE GOVERNMENT REGULATIONS

The University must consider all applicable State and Federal laws and regulations and other pertinent information concerned with the health and safety of employees and the protection of the environment. Specifically, the University Policy states:

Chancellors and Vice Presidents shall establish programs for environmental health and safety. Applicable health and safety standards promulgated by Federal and State Agencies shall be followed in establishing such programs. In the absence of appropriate statutes and governmental regulations, the published standards of nationally recognized professional health and safety organizations shall serve as guides.

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

With regard to responsibility, the University Policy on Environmental Health and Safety states:

A. Chancellors are responsible for the implementation of the University's Environmental Health and Safety policy at all facilities under campus control.

B. Vice Presidents are responsible for implementation of Environmental Health and Safety policy in all facilities within their respective jurisdictions. When appropriate, Vice Presidents are authorized to make arrangements with individual Chancellors for surveillance and services as necessary to achieve compliance with this policy.

C. Department heads, principal investigators, supervisors, and all employees are responsible for compliance with this policy as it relates to operations under their control.

The Academic Personnel Manual reiterates this responsibility for Department chairpersons (or equivalent officers) for "departmental observance of proper health and safety regulations in coordination with the campus environmental health and safety officer." (APM-245, Appendix A.)

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 University offices are responsible for review and implementation of environmental health and safety regulations and procedures. They advise faculty and staff regarding compliance with these procedures. These offices include: Environmental Health and Safety, Facilities Management, Risk Management, and Materiel Management. The role of each of these offices is discussed in further detail under the appropriate 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 proposal review with the campus Environmental Health and Safety Office (EH& S) or other campus offices as necessary. Contracts and Grants Officers also sign clean air and water certifications. (See Section 3-820.)

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 AMENDED UNIVERSITY PROCEDURES FOR IMPLEMENTATION OF CEQA

In compliance with CEQA, The Regents adopted procedures implementing the Act on June 15, 1973. The procedures have been amended several times since their adoption. Current procedures are available from the campus Facilities Management or Planning Office.

3-320 DELEGATION OF AUTHORITY AND THE ROLE OF FACILITIES MANAGEMENT

The Vice President for Budget and University Relations has been delegated the authority for implementing the Amended University CEQA Procedures. Within the Office of Budget and University Relations, the Facilities Management Office handles these procedures.

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 3-340.)

3-330 APPLICABILITY OF UNIVERSITY PROCEDURES FOR IMPLEMENTATION OF CEQA

The Amended University Procedures state that CEQA applies to any:

...action undertaken by or on behalf of The Regents which has the potential for resulting in a physical change in the environment, directly, or ultimately, including any of the following:

(a) An activity directly undertaken by The Regents including but not limited to public works construction and related activities, clearing or grading of land, adoption of Long Range Development Plans, and improvements to existing structures.

(b) An activity which is supported in whole or in part through The Regents' contracts, grants, subsidies, loans, or other forms of assistance.

(c) An activity involving the issuance by The Regents to a person of a lease, permit, license, certificate, easement or other entitlement for use.

CEQA does not apply to:

(a) Anything specifically exempted by State law including but not limited to emergency projects, rejected projects, feasibility and planning studies, and ministerial projects.

(b) Proposals for legislation to be enacted by the State Legislature.

(c) 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.)

(d) Closing of a public school and the transfer of students to another school where the only physical changes involved are categorically exempt.

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 3-340.)

3-340 COMPLIANCE WITH UNIVERSITY PROCEDURES FOR IMPLEMENTATION OF CEQA

Any University project, as defined in Section 3-330, 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 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 administrative unit and all basic research projects which may be approved by the administrative unit and all basic research projects which may be approved by the administrative unit, the administrative unit must classify them before it grants final project approval.

The following classifications are used:

1. 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.

2. Categorically Exempt - if the project is included within the list of classes which have been determined to have no significant effect on the environment. [The list of classes is printed in the Amended University CEQA Procedures.]

3. Initial Study - if the project is not exempt from CEQA or categorically exempt, and may have a significant effect on the environment.

4. 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 in classification 2. Categorically Exempt, under Class 6 of that classification. 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 have a significant effect on the environment. These may be for strictly information-gathering purposes or as part of a study leading to an action which has not yet been 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.

The Amended University CEQA Procedures contain a description of these classifications and their sub-classes.

3-400 UNIVERSITY POLICY ON BIOHAZARDS AND RECOMBINANT DNA

The University has not issued a university-wide policy on the use of biohazards and carcinogens. However, according to the University Policy on Environmental Health and Safety (Section 3-210), the University follows applicable State and federal guidelines and regulations covering biohazards and carcinogens. These guidelines and regulations are implemented by the campus or Laboratory Environmental Health and Safety Office and biosafety committees.

3-410 RESPONSIBILITIES OF THE ENVIRONMENTAL HEALTH AND SAFETY OFFICE FOR 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 recombinant DNA (rDNA) research (Section 3-441 and 3-442) and other guidelines (Sections 3-450 to 3-470) for research using biohazardous and carcinogenic materials and for advising researchers and students regarding compliance with these guidelines. In cases where the Department of Energy (DOE) has issued Orders covering any of these areas, the University DOE Laboratories generally follow these DOE Orders. Where there are no DOE Orders, the DOE Laboratories follow applicable federal regulations.

EH& S inspects laboratories where proposed research using biohazards or carcinogens would take place. In response to the Contracts and Grants Office proposal cover sheets which indicate laboratories that may be used for research with biohazards or carcinogens, EH& S staff reviews and approves the facilities for the proposed research. It advises the Principal Investigator on safe laboratory procedures and materials required. On some campuses, EH& S reviews the entire proposal to assure that laboratory protocols and materials are in accordance with applicable guidelines and regulations.

The campus Institutional Biosafety Committee, required by the NIH Guidelines, approves EH& S policies and reviews higher risk research proposals. The Biological Safety Officer described in the NIH Guidelines is an administrative staff member of EH& S. (See Section 3-442.) Proposals for higher biosafety level research are presented to the campus Institutional Biosafety Committee via EH& S for review and approval. (See Section 3-442.)

3-420 ROLE OF THE CONTRACTS AND GRANTS OFFICE

Generally, the Contracts and Grants Office receives a proposal with a cover sheet which indicates if biohazards, carcinogens or recombinant DNA (rDNA) would be involved in the research. If the Principal Investigator (PI) indicates they would be, this cover sheet is forwarded to the Environmental Health and Safety Office. (On some campuses, EH& S reviews the entire proposal.)

The Principal Investigator generally submits a proposal requiring the campus Institutional Biosafety Committee review and approval directly to that committee through EH& S prior to sending it to the Contracts and Grants Office.

When the Office of Environmental Health and Safety receives the proposal or the C& G proposal cover sheet, it can begin the review and approval procedures necessary. However, if a laboratory needs modifications, safety instruments, or other requirements to be approved for the proposed research, the Principal Investigator should be aware of the costs incurred by such required renovations and modifications when determining the proposed research budget. If the PI does not know whether a proposed laboratory will meet EH& S requirements, consulting with EH& S staff before determining the proposal budget would let the PI know if the proposed research would involve laboratory renovation or modification expenditures.

If a proposal using recombinant DNA contains proprietary data and potentially patentable concepts, a Proprietary Data legend should be included by the Principal Investigator. This legend would specify the paragraphs and pages which contain potentially patentable concepts and proprietary data. Supplemental information on this subject is disseminated via Contract and Grant Memo 33-79, April 10, 1979.

3-430 BIOHAZARDS

Biohazards, as the term is used in the context of scientific research, are microorganisms, including recombinant DNA (rDNA) molecules, which are commonly accepted as posing a hazard to human health or the environment. Biohazards used in research include pathogenic bacteria, fungi, parasites, protozoans, viruses, oncogenic viruses, rDNA, and plant and animal toxins. University practices regarding these biohazards are discussed in the following sections 3-440 through 3-470.

3-440 RECOMBINANT DNA

The University follows the National Institutes of Health (NIH) Guidelines for all research involving recombinant DNA molecules (rDNA) for which the University is responsible, and not just for research funded by NIH. These Guidelines are published in the Federal Register and are periodically updated. The most recent Guidelines are available from the Contracts and Grants Office, Office of the President.

3-441 The NIH Guidelines

On May 5, 1976, the Director of NIH established the Office of Recombinant DNA Activities (ORDA) in the National Institute of General Medical Sciences to coordinate the administration of NIH policies and procedures pertaining to the utilization of recombinant DNA technology in research.

On June 23, 1976, NIH issued its first "Guidelines for Research Involving Recombinant DNA Molecules". The Guidelines are periodically revised and reissued in the Federal Register. The Guidelines govern the conduct of NIH supported research in recombinant DNA molecules, and they establish carefully controlled conditions for the conduct of experiments involving the production of such molecules and their insertion into organisms such as bacteria.

The NIH Guidelines assign rDNA research to one of four levels of biosafety, or levels of physical containment, BL1 through BL4, based on the potential hazard posed by each experiment. Each rDNA experiment is subject to a review and approval procedure, depending on its determined biosafety level.

3-442 Responsibilities of the University Under the NIH Guidelines

The University is responsible for ensuring that all recombinant DNA research is carried out in full conformity with the provisions of the NIH Guidelines as published in the Federal Register. (See External Requirements 3-F02.) In order to fulfill this responsibility, the University shall:

1. Establish and Implement Policies

Establish and implement policies that provide for the safe conduct of recombinant DNA research and that ensure compliance with the Guidelines. The University may establish additional procedures, as deemed necessary.

2. Establish an Institutional Biosafety Committee (IBC)

Establish an Institutional Biosafety Committee (IBC) that meets the membership and procedure requirements listed in the NIH Guidelines and carries out the functions of reviewing rDNA research proposals and activities.

3. Appoint a Biological Safety Officer (BSO)

If the University is engaged in recombinant DNA research at the BL3 or BL4 containment level, it shall appoint a BSO who shall be a member of the IBC and carry out the duties specified in NIH Guidelines.

3-443 California Environmental Quality Act (CEQA Applicability to Recombinant DNA Research Activities

Contract and Grant Memo 12-77, February 22, 1977, issued the University General Counsel's decision (set forth in a February 1, 1977 letter) which states that since recombinant DNA research has a potential for resulting in a physical change to the environment, CEQA applies to any such research carried out by the University.

CEQA requires the preparation of an Environmental Impact Report (EIR) on any project which may have a significant effect on the environment. The decision as to whether an EIR is required for a research project involving recombinant DNA can only be made after an analysis of the proposed experiment and the facility in which the experiment is to take place. For example, DNA research conducted under approved contained laboratory conditions may not require an EIR, while any proposed rDNA research outside the laboratory setting would have to be reviewed under the University Procedures for Implemen tation of CEQA. (See Sections 3-310 through 3-340.)

3-450 ETIOLOGIC AGENTS

Etiologic agents are infectious agents such as viruses, bacteria, or fungi which cause diseases. Research using these agents should be conducted under proper laboratory biosafety practices. The Centers for Disease Control (CDC) has published voluntary guidelines for working with infectious agents in various laboratory settings, and requirements for importation and interstate shipment of human pathogens and related materials. (Biosafety in Microbiological and Biomedical Laboratories, Centers for Disease Control, U.S. Public Health Service, 1st Edition, March, 1984.) The importation, possession, use or interstate shipment of animal pathogens may also be subject to Department of Agriculture regulations.

3-451 Centers for Disease Control Biosafety Levels

The four CDC biosafety levels for research using etiologic agents 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-FO3.)

3-460 ONCOGENIC VIRUSES

Research using oncogenic (tumor-causing) viruses is classified by the National Cancer Institute into three risk categories: low, moderate and high. (Safety Standards for Research Involving Oncogenic Viruses, DHEW Publication No. 78-790.) Campus and Laboratory Environmental Health and Safety Offices review laboratory facilities and procedures proposed for use in experiments with oncogenic viruses in order to approve them for the risk level which the research poses. (See External Requirements 3-FO4.)

3-470 CARCINOGENS

The uses of certain chemical carcinogens are regulated in Title 8 of the California Administrative Code. The campus EH& S Office which oversees the use of carcinogens may add other hazardous, toxic or carcinogenic chemicals to this list as it deems necessary. (See External Requirements 3-SO3.) The DOE Laboratories follow DOE Order 5480.10, Industrial Hygiene Program, when dealing with carcinogens.

3-500 RADIATION

The use of radiation is the responsibility of the Radiation Safety Unit of the Environmental Health and Safety Office and the campus Radiation Safety Committee. Campuses with nuclear reactors also have a Reactor Supervisor and a Reactor Operations Committee responsible for use of the reactor.

In California, the state codes governing use of radiation supersede the 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 govern the licensing and use of radioactive materials and radiation-producing machines. These regulations are printed in Chapter 1 of Title 10, the Code of Federal Regulations. (See External Requirements 3-F11.) In addition, the Food and Drug Administration issues regulations which govern radiation emissions from electronic products. (See External Requirements 3-F12.)

The California radiation control codes are set forth in Title 17 of the California Administrative Code. They are based on an agreement with the Nuclear Regulatory Commission, subject to the provisions of Part 150 of Title 10 of the Code of Federal Regulations. 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 Health Services, Radiologic Health Branch, licenses each campus for possession and use of radioactive materials and radiation-producing machines. (See External Requirements 3-SO4.)

In the use of radiation, the DOE Laboratories follow DOE Order 5480.1A, Chapter XI, Requirements for Radiation Protection.

3-510 RESPONSIBILITIES OF EH& S AND THE RADIATION SAFETY COMMITTEE

The Radiation Safety Committee establishes 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 staff 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 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 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 application or RUA number of the investigator if radiation is involved in the research proposed. If such 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 the Contracts and Grants Office.

3-600 CONTROLLED SUBSTANCES - DRUGS AND NARCOTICS

The federal and State of California Uniform Controlled Substances Acts require the University to have specific procedures for the acquisition and use of controlled substances, as defined in these Acts.

Campus material managers or Laboratory purchasing officers are responsible for registration, order forms, and reporting requirements under the Federal and State Uniform Controlled Substances Acts. (See External Requirements 3-FO5 and 3-SO5.)

3-610 UNIVERSITY PROCEDURES FOR CONTROLLED SUBSTANCES - BUSINESS AND FINANCE BULLETIN BUS-50

The University procedures for the acquuisition and use of controlled substances are established in Business and Finance Bulletin BUS-50, Materiel Management: Acquisition and Use of Narcotics and Dangerous Drugs. The purpose of this Bulletin is to implement the requirements of the Federal and State Uniform Controlled Substances Acts.

This Bulletin states the procedures for the campus Material Management and Laboratory Purchasing Offices to follow in order to register the campus for the appropriate research classifications and to apply for the acquisition and use of controlled substances. It outlines the applicable laws and gives the definitions of the five Schedules of Controlled Substances and procedures for Principal Investigators to follow to apply to the State Research Advisory Panel and to acquire controlled substances.

BUS-50 also sets forth the procedures for issuing orders for controlled substances, for effective controls against theft and diversion, and for maintaining records and inventories.

3-611 Delegation of Authority and the Role of Material Management

Authority for the purchasing of controlled substances under the Federal and State of California Uniform Controlled Substances Acts was delegated by then Vice President McCorkle to the Chancellors and Laboratory Directors, August 14, 1972. This authority may be redelegated to campus Material Managers and Laboratory Purchasing officers.

Materiel Managers and Purchasing Officers are responsible for authorizing applications for registration, official order forms, and reporting required under these Acts. Business and Finance Bulletin BUS-50 sets forth these procedures.

3-620 RESPONSIBILITIES OF PRINCIPAL INVESTIGATORS

The Principal Investigator or Department Chair initiates and signs requisitions for controlled substances. For any controlled substance on Schedule I, as defined by the Controlled Substances Acts (see External Requirements 3-FO5), 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-SO5.)

If funds to support research are being sought from any federal, state or local granting agency, the investigator 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 investigator must apply for such approval and show evidence of it to the Materiel Manager.

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 State Department of Health, Food and Drug Section is the cognizant office if intrastate commerce is involved.

3-700 HUMAN HEALTH AND SAFETY

Under the University Policy for Environmental Health and Safety, each Chancellor was delegated responsibility for implementing the University's environmental health and safety

3-710 RESPONSIBILITIES OF EH& S

EH& S staff evaluate potential hazards and coordinate campus programs to prevent injuries and work-related illnesses at the University. They work with academic departments and administrative services to develop training, monitoring, and accident prevention programs. 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 MANAGEMENT OFFICE

The President is assigned the authority and responsibility for coordination of the University Risk Management Program. The University Risk Management and Safety Office is responsible for implementing the Risk Management Policy. In relation to environmental health and safety issues, the Risk Management Policy is to "eliminate or modify conditions and practices, whenever practical, which may cause loss".

The campus Risk Management Office is 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 Management 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 the departmental chairperson and principal investigator, 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 and state Oc cupational Safety and Health Acts. (See External Requirements 3-F06 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-F07)
Federal Food, Drug and Cosmetic Act (3-F08)
Federal Insecticide, Fungicide and Rodenticide Act (3-F09)
Resource Conservation and Recovery Act (3-F13)

State -

Occupational Carcinogens Control Act (3-S03)

3-800 CERTIFICATION 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 contractors with contracts exceeding $100,000 to certify compliance with these Acts. (See External Requirements 3-F10.) The certification asks if any contractor or facility to be used in performance of the agreement has been subject to conviction under the Clean Air or Water Acts or is on the Environmental Protection Agency (EPA) list of violating facilities which EPA publishes periodically in the Federal Register.

Chapter 8 (commencing with Section 4475), added to Division 5 of Title 1 of the State of California Government Code by Chapter 1812, Statutes of 1971 "prohibits state agencies from entering into contracts of $5,000 or more for the purchase of supplies, equipment or services from any person or entity who is subject to a cease and desist order not subject to review issued for violation of waste discharge requirements, 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. The State Water Resources Control Board provides lists of persons or businesses which are in violation of these pollution laws to the Director--Materiel Management.

The Director--Materiel Management sends the lists received from the State Water Resources Control Board to campus Materiel Managers. As stated on these lists, the Materiel Managers are prohibited "from entering into contracts of $5,000 or more for the purchase of supplies, equipment or services from any person ...", as quoted in 3-800.

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 certification. The signature certifies that the University does not use any facility in the performance of this proposed contract which has been listed on the EPA list of violating facilities.

In State contracts, clean air and water compliance clauses are incorporated in the exhibits.

3-999 RELATED UNIVERSITY OF CALIFORNIA REFERENCES

University Policy on Environmental Health and Safety, Office of the President, October 22, 1986.

Academic Personnel Manual (APM) Section 245, Appendix A, Duties of Department Chairpersons (or Equivalent Officers), November 18, 1985.

Presidential Delegation of Authority to Vice President - Budget and University Relations, Implementation of California Environmental Quality Act, December 4, 1984.

Amended University of California Procedures for Implementation of CEQA.

Contract and Grant Memo No. 33-79, Proprietary Data Legend for Protection of Sensitive Data Submitted in Research Proposals, April 10, 1979.

Vice Presidential Memorandum to Chancellors and Laboratory Directors, Delegation of Aluthority--Registration and Acquisition of Narcotics and Dangerous Drugs, August 14, 1972.

Business and Finance Bulletin BUS-50, Material Management: Acquisition and Use of Narcotics and Dangerous Drugs.

University of California Risk Management Policy, Approved by The Regents, January 16, 1970.

Presidential Delegation of Authority to Vice President - Financial and Business Management, Risk Management Program, December 1, 1982.

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 (PL 91-790 83 Stat. 852; 42 USC §4321 et seq. as amended)

Executive Order No. 11514, Protection and Enhancement of Environmental Quality

IMPLEMENTING REGULATIONS

40 CFR Part 6, 1500 (44 FR 71742-52)

Executive Order No. 11514 (35 FR 4247)

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 invironmental 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.

EXTERNAL REQUIREMENTS--FEDERAL

3-F02 The National Institutes of Health

Guidelines for Research Involving Recombinant DNA Molecules

IMPLEMENTING REGULATIONS

51 FR 16958, May 7, 1986

PURPOSE

To specify practices for constructing and handling recombinant DNA (rDNA) molecules and organisms and viruses containing recombinant DNA molecules.

SUMMARY

Regulations establish four biosafety levels (BL) or levels of physical containment for classifying rDNA research, depending on the risk posed by the etiological agents to be used in the proposed research. These biosafety levels consist of combinations of laboratory practices, safety equipment, and laboratory facilities appropriate for the operations performed and the hazards posed by any proposed rDNA research. Agents assigned to biosafety level 4 (BL4) require the most stringent containment conditions. Those assigned to BL1 require the least stringent.

The regulations describe the guidelines for classifying rDNA experiments and their review procedures, and the membership requirements, functions and responsibilities of the Institutional Biosafety Committee (IBC), which reviews proposed rDNA research.

They require the institution to appoint a Biological Safety Officer (BSO) if it is engaged in rDNA research at the BL3 or BL4 containment level. The officer shall be a member of the I0B0RC. The duties of the BSO are described. They describe the responsibilities of Principal Investigator for compliance with the Guidelines and as well as the responsibilities of NIH.

APPLICABILITY

Regulations are required for institutions receiving NIH funds for rDNA 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 EH& S. EH& S is responsible for establishing and implementing policies that provide for the safe conduct of rDNA research and ensure compliance with the Guidelines and establishing additional procedures as necessary.

EXTERNAL REQUIREMENTS--FEDERAL

3-F03 Biosafety in Microbiological and Biomedical Laboratories

(HHS Publication No. (CDC) 84-9305, 1st Edition March, 1984.)

PURPOSE

To describe safety practices standards for work with etiologic agents.

SUMMARY

This publication describes combinations of standard and special microbiological practices, safety equipment, and facilities that constitute biosafety levels 1-4, which are recommended for working with a variety of infectious agents in various laboratory settings.

APPLICABILITY

The guidelines are for research facilities using etiologic agents and are advisory from the Centers of Disease Control.

LEAD AGENCY

Centers for Disease Control

UNIVERSITY RESPONSIBILITY

EH& S Office reviews proposed research procedures and laboratory facilities for compliance with biosafety levels recommended. Some campuses require specific authorizations from EH& S for use of etiologic agents.

EXTERNAL REQUIREMENTS--FEDERAL

3-F04 Safety Standards for Research Involving Oncogenic Viruses

(DHEW Publication No. NIH 78-790.)

PURPOSE

To set forth laboratory safety practices for research involving oncogenic viruses.

SUMMARY

The publication describes research procedures and laboratory facilities needed for conducting safe research using oncogenic viruses. It establishes three risk categories (low, moderate and high) for classifying research involving oncogenic viruses.

APPLICABILITY

Research facilities using oncogenic viruses.

LEAD AGENCY

National Cancer Institute

UNIVERSITY RESPONSIBILITY

EH& S reviews and approves proposed research procedures and laboratory facilities. On some campuses, EH& S administers use authorizations for the use of oncogenic viruses.

EXTERNAL REQUIREMENTS--FEDERAL

3-F05 Comprehensive Drug Abuse Prevention and Control Act of 1970

(Federal Controlled Substances Act)(PL 91-513 84 Stat 1236; 21 USC 801 et seq.)

IMPLEMENTING REGULATIONS

21 CFR Chapter 11

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 classify drugs and narcotics based on abuse potential, and gives restrictions for obtaining and handling them. Schedule I lists those substances with the highest abuse potential and Schedule V names those with the lowest potential. A listing of the specific items in each schedule is published annually by the Drug Enforcement Administration under the title "Controlled Substances Inventory List". Further details about the Schedules are given in Appendix A of Business and Finance Bulletin BUS-50.

Registration Classifications

The Federal Controlled Substances Act establishes registration classifications for the use of controlled substances. 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 DEA for use of controlled substances in Schedules I through V. These applications are for use in the specific registration classifications which apply to the University. They are:

1. Teaching Institution using Schedules II through V

2. Hospital/Clinic using Schedules II through V

3. Research in Schedule II through V

4. Research in Schedule I

5. Chemical Analysis distinct from research

6. Manufacture

Each campus Materiel Management or Laboratory Purchasing Office registers its campus with the DEA for the classifications which apply to its needs. (See Section 3-611, Role of Materiel Management.) 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 schedules substances.

A separate registration is required for each research project under Classification 4, Research in Schedule I. 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.)

EXTERNAL REQUIREMENTS--FEDERAL

3-F06 Occupational Safety and Health Act (29 USC 651 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 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 conduct studies and make recommendations. It creates a broad mechanism for protecting workers from workplace hazards.

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 Secretary of Labor in accordance with these federal regulations. (See 3-S02.)

EXTERNAL REQUIREMENTS--FEDERAL

3-F07 Toxic Substances Control Act of 1977 (PL 94-469; 15 USC §2601-2629)

IMPLEMENTING REGULATIONS

40 CFR 707; 19 CFR 12, 127

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 risk. 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 speciality chemicals made by biotechnology and microorganisms used in the environment.

LEAD AGENCY

EPA; rules issued by EPA and Treasury Department.

UNIVERSITY RESPONSIBILITY

EH& S Office is responsible for implementing the regulations under this law which include: proper handling, resting and storage of substances; equipment maintenance; records retention; and employee protection.

EXTERNAL REQUIREMENTS--FEDERAL

3-F08 Federal Food, Drug and Cosmetic Act (FFDCA)

Amended by Medical Devices Amendments of 1976 (21 USC 301 et seq.)

IMPLEMENTING REGULATIONS

21 CFR Part 1

PURPOSE

To regulate drugs, biologics, food, food additives, cosmetics, and tobacco products.

SUMMARY

These regulations establish good laboratory and manufacturing practices and require premarketing 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.

The Principal Investigator 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.

EXTERNAL REQUIREMENTS--FEDERAL

3-F09 Federal Insecticide, Fungicide and Rodenticide ACT (FIFRA) (47 USC 136 et seq.)

IMPLEMENTING REGULATIONS

40 CFR 158

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 EPA and assure the quality and integrity of data. They cover treatment of animals, handling, storage, and testing of substances, and require EPA review of pesticides.

APPLICABILITY

Consulting laboratory, contractor, grantee or manufacturer.

LEAD AGENCY

EPA

UNIVERSITY RESPONSIBILITY

The EH& S Office is responsible for implementing safe laboratory practices. The Principal Investigator must apply to the EPA for the permits required for experimental use stages.

EXTERNAL REQUIREMENTS--FEDERAL

3-F10 Federal Water Pollution Control Act of 1972 (PL 92-500; 33 USC 1251 et seq.)

Clean Water Act as amended (PL 91-604, 84 Stat., 1707)

Clean Air Act of 1970 (PL 91-604); and Amendments (1974 - PL 93-319; 1977 95-95; 42 USC 7401 et seq.)

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"

IMPLEMENTING REGULATIONS

40 CFR Part 15

(E.O. 11738 - 38 FR 25161, September 12, 1973)

PURPOSE

The Clean Water Act 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 construction of water treatment plants and in the 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.

Sections 306 of the Air Act and 508 of the Water Act are virtually identical in scope and impact. Each section provides general environmental standards and administrative requirements for federal contracts and grants subject to the Clean Air and Federal Water Pollution Control 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 15.

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.

Exempted from the Acts; requirements are grants, subgrants, and contracts issued by grantees for less than $100,000. In addition, grants 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

Sections 306 of the Air Act and 508 of the 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

Materiel Management is responsible for assuring that the University does not subcontract federal money to any person or facility on the EPA list of facilities in violation of Sections 306-Air Act and 508-Water Act. Contracts and Grants Officers certify the University's compliance with these Acts.

EXTERNAL REQUIREMENTS--FEDERAL

3-F11 Atomic Energy Act of 1954, as amended (PL 83-703; 42 USC §§2011 et seq)

Energy Reorganization Act of 1974, as amended (PL 93-433; 42 USC §§5801 et seq)

IMPLEMENTING REGULATIONS

10 CFR Chapter 1

PURPOSE

To foster research and development of atomic energy and nuclear material; to disseminate technical information and benefits of such research; and to promote peaceful and defense uses and international cooperation for common defense and security. To establish government control of possession, use, and dproduction 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 those exempt under Part 150 as Agreement States.

LEAD AGENCY

Nuclear Regulatory Commission

UNIVERSITY RESPONSIBILITY

The EH& S Radiation Safety Officer (or the Reactor Supervisor, as appropriate) is responsible to 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 Part 150 of 10 CFR. (See External Requirements 3-S04.)

The DOE Laboratories follow DOE Order 5480.1A, Chapter XI, Requirements for Radiation Protection.

EXTERNAL REQUIREMENTS--FEDERAL

3-F12 Radiation Control for Health and Safety Act of 1968 (PL 90-602 82 Stat. 1173; 42 USC 263f)

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 develops and sets up administration for performance standards to control emissions from: ionizing radiation emitting products; microwave and radio frequency emitting products; laser light emitting products; sonic, infrasonic, and ultrasonic emitting products; and radiation 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 with regard to the safe use of these products.

EXTERNAL REQUIREMENTS--FEDERAL

3-F13 Resource Conservation and Recovery Act of 1976 as amended (PL 94-580 90 Stat 2795; 42 USC 6901)

IMPLEMENTING REGULATIONS

40 CFR subchapter 1, Part 240 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 regulate handling, storage, treatment, transportation, and disposal of solid or hazardous wastes and facilities and identify and list 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, providing guidance to departments on the safe disposal of wastes, protecting employees, facilities, and the environment.

EXTERNAL REQUIREMENTS--STATE

3-S01 California Environmental Quality Act (CEQA) (Public Resources Code §§21000 et seq.)

IMPLEMENTATION REGULATIONS

Title 14 California Administrative Code (CAC) Natural Resources §§15000 et seq.

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. 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 CECA. All State agencies prepare and certify the completion of an environmental impact report on any proposed project which may have a significant impact on the environment.

APPLICABILITY

State and public agencies.

LEAD AGENCY

California Secretary of Resources Agency

UNIVERSITY RESPONSIBILITY

The regulations adopted by The Regents, as required by CEQA, are the Amended University of California Procedures for Implementation of CEQA. The Facilities Management or Planning Office is responsible for submitting environmental impact reports when required by the guidelines. (See Sections 3-300 to 340.)

EXTERNAL REQUIREMENTS--STATE

3-S02 California Occupational Safety and Health Act (Labor Code §§ 6300 et seq.)

IMPLEMENTATION REGULATIONS

Title 8 CAC Industrial Relations

PURPOSE

To fulfill requirements of federal Occupational Safety and Health Act by establishing state standards and procedures to provide a safe and healthful place of employment.

SUMMARY

This code sets forth State occupational health and safety standards which are approved by the 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, and hazardous substances information and training requirements.

APPLICABILITY

Employers in California.

LEAD AGENCY

Division of Occupational Safety and Health--Department of Industrial Relations

UNIVERSITY RESPONSIBILITY

The EH& S Office interprets and implements these health and safety codes.

EXTERNAL REQUIREMENTS--STATE

3-S03 Occupational Carcinogensx Control Act of 1976 (Labor Code §§ 9000 et seq.)

IMPLEMENTING REGULATIONS

Title 8 CAC Industrial Relations §§5209 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

Use of specific regulated chemicals in California.

LEAD AGENCY

Department of Health Services

UNIVERSITY RESPONSIBILITY

The EH& S Office regulates the use of carcinogens on campus and in laboratories in accordance with State requirements and campus policies.

The University DOE Laboratories follow DOE Order 5480.10, Industrial Hygiene Program, for regulating the use of carcinogens.

EXTERNAL REQUIREMENTS--STATE

3-S04 California Radiation Control Law (Health and Safety Code §§ 25800 et seq.)

IMPLEMENTATION REGULATIONS

Title 17 CAC 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

Possession and use of radioactive materials and radiation-producing machines in California.

LEAD AGENCY

Department of Health Services

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.

The DOE Laboratories follow DOE Order 5480.1A, Chapter XI, Requirements for Radiation Protection.

EXTERNAL REQUIREMENTS--STATE

3-S05 Uniform Controlled Substances Act (Health and Safety Codes §§11000 et seq.)

IMPLEMENTING REGULATIONS

11 CAC Law §§800 et seq.

PURPOSE

To regulate 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:

1. Any research involving any Schedule 1 controlled substance; or

2. 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

3. Research for treatment of drug abuse utilizing any scheduled or unscheduled drug.

The Schedules of Controlled Substances are explained in Section 3-F05.

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:

Research Advisory Panel
6000 State Building
San Francisco, CA 94102
(415) 557-1325

APPLICABILITY

Use of scheduled substances in the State of California.

UNIVERSITY RESPONSIBILITY

Materiel Management and Purchasing Offices are responsible for authorizing applications for registration, official order forms, and reporting requirements. (See Section 3-610 and 3-611.)

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.

EXTERNAL REQUIREMENTS--STATE

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 or in violation of waste discharge requirements in the Water Code or in violation of provisions of federal laws relating to air and water pollution.

APPLICABILITY

Any state agency including the University.

LEAD AGENCY

State Air Resources and Water Resources Control Boards

UNIVERSITY RESPONSIBILITY

University Materiel Management provides updated lists of violators to campus Materiel Managers and Laboratory Purchasing Officers. Materiel Managers shall take precautions to insure that the University does not enter into contracts with any person or entity on the list of violators. Business and Finance Bulletin BUS-56 contains more details on this subject.