Carcinogen Program

CONTENTS

1.0         PURPOSE

2.0         APPLICABILITY AND SCOPE

3.0         APPLICABLE REGULATIONS AND STANDARDS

4.0         DEFINITIONS

5.0         RESPONSIBILITIES

             5.1      Employee Responsibilities

             5.2      Manager/Supervisor and Principal Investigator Responsibilities

             5.3      Career and Protective Services Responsibilities

6.0         ACCESS TO THE WRITTEN PROGRAM

7.0         SAFETY GUIDANCE FOR CARCINOGEN USE

8.0         TRAINING AND COMMUNICATION

9.0         RECORD KEEPING

10.0       PROGRAM APPROVAL AND REVIEW

Appendix A      USC-Regulated Carcinogen List  

Appendix B      Institutional Biosafety Committee Protocol Submission Form

Appendix C      Institutional Biosafety Committee Modification Form

Appendix D      Carcinogen Usage Registration Form

Appendix E       Safety Guidance for Carcinogen Use

1.0      PURPOSE

The purpose of this Program is to minimize exposure of university personnel to carcinogens, and to meet regulatory requirements regarding carcinogens. This document provides guidelines for carcinogen use and storage throughout the University.

2.0      APPLICABILITY AND SCOPE

This program covers and controls the use of USC-Regulated Carcinogens other than radioactive materials. This program applies to all university employees and students whose responsibilities expose them to USC-Regulated Carcinogens.

3.0      APPLICABLE REGULATIONS AND STANDARDS

California:         Title 8, General Industry Safety Orders, Section 5991. Occupational Exposure to Hazardous Substances in Laboratories

                        Title 8, General Industry Safety Orders, Section 5209. Carcinogens-Laboratory Activities (c) (6)

                        Title 8, General Industry Safety Orders, Section 5200, Regulated Carcinogens 

4.0      DEFINITIONS

Carcinogen:  a substance or agent capable of causing cancer, i.e., abnormal or uncontrolled growth of new cells in any part of the body in humans or animals. Carcinogens are chronic toxins with long latency periods that can cause damage after repeated or long duration exposures and often do not have immediate apparent harmful effects.

Human Carcinogen: agents that are confirmed as cancer threats in human population through statistics and epidemiological studies.  These substances are listed under the category “known to be carcinogens” in the National Toxicology Program (NTP) “Annual Report on Carcinogens” (latest edition) or listed under Group 1 (“carcinogenic to humans”) by the International Agency for Research on Cancer (IARC).

Regulated Carcinogen: cancer causing agents that are adopted and regulated by a Cal/OSHA.

Suspected Carcinogen: agents that are speculated as cancer threats only through animal studies. These substances are listed by NTP as Reasonably Anticipated to be Human Carcinogens and IARC as Probably Carcinogenic to humans or Possibly Carcinogenic to human.

Action Level:  the concentration of a specific airborne substance, calculated as an eight-hour time weighted average, which initiates certain required activities such as exposure monitoring and medical surveillance.

Designated Area: a specified and demarcated area where work may be conducted with “select carcinogens,” reproductive toxins or substances that have high acute toxicity. A designated area may be an entire laboratory, a defined area within the laboratory, or a device such as a laboratory hood.

Short Term Exposure Limit (STEL):  the Cal/OSHA 15-minute time weighted average concentration of a specific airborne substance that may not be exceeded at any time during a workday.

5.0      RESPONSIBILITIES

Environmental Health and Safety will oversee the administration of the Carcinogen Program, but ultimate responsibility for implementation rests with each department.

The Institutional Biosafety Committee (IBC) is responsible for oversight of all university research activities involving carcinogens. Researchers who use a USC Campus-Regulated Carcinogen are required to complete and submit either an IBC Protocol Submission Form or a Carcinogen Use Registration Form to Environmental Health and Safety.

5.1      Employee Responsibilities

Each employee affected by this program is responsible for:

• Being familiar with this Carcinogen Program and follow the strict requirements in the Safety Guidance for Carcinogen Use.
• Obtaining medical surveillance for regulated carcinogen exposure above the action level or STEL upon determination of exposure at such levels, or upon development of signs or symptoms of overexposure, and annually thereafter;
• Attending training that covers the potential hazards of the carcinogen(s) used in your work area, prior to use and annually (provided by your department or principal Investigator);
• Leaving the exposure area in the event of unsafe conditions;
• Immediately notifying a supervisor of any new or changed workplace hazards, questions, problems or any significant change in medical condition;

5.2      Manager/Supervisor and Principal Investigator Responsibilities

Each manager, supervisor, and principal investigator affected by this program is responsible for implementing this program and ensuring compliance within their department. This responsibility includes:

• Being familiar with this Carcinogen Program;
• Informing EH&S of the use or storage of a USC-Regulated Carcinogen, and a list of carcinogen users under their supervision;
• Establishing a designated area for use and/or storage of any USC-Campus Regulated Carcinogens;
• Annually updating the USC On-line Chemical Inventory for all workplace locations under your purview;
• Submitting to EH&S either an IBC Protocol Submission Form, or a completed Carcinogen Use Registration Form for all USC Campus-Regulated Carcinogen Use in workplace locations under your control;
• Submitting an IBC Modifcation Form to EH&S for (a) any minor changes in research protocol that uses a USC-Regulated carcinogen and (b) any changes in personnel who work with USC-Regulated Carcinogens (deletions or additions). Note: The Carcinogen Use Registration form may be used to document changes in personnel as well;
• Re-submitting the IBC Protocol Submission Form for significant changes in research protocol including new use of USC-Regulated Carcinogens;
• Assuring that each employee who has a USC Campus-Regulated Carcinogen workplace exposure that exceeds the action level or STEL, or who develops signs or symptoms of overexposure, receives medical surveillance before such work commences, upon determination of such exposure levels, or upon developing symptoms, and annually thereafter.
• Providing employees handling hazardous chemicals including carcinogen Personal Protective Equipment.
• Ensuring that all employees who work with USC Campus-Regulated Carcinogens receive training on the potential hazards of all such substances and protective measures they can take, before initial use and annually thereafter, or more often if required by regulation;
• Notifying Environmental Health and Safety of changes in work practices, chemicals or other hazardous materials, so that a current exposure assessment can be made; and
• Referring to Environmental Health and Safety questions or problems regarding carcinogens.

5.3      Career and Protective Services Responsibilities

Career and Protective Services is responsible for:

• Reviewing carcinogen users usage and procedures, type of carcinogen, amounts, and concentration to determine the necessity of further review by the IBC;
• Providing assessments of carcinogen exposure within the University;
• Assisting employees and supervisors in obtaining medical clearance;
• Providing training on carcinogens;
• Recommending appropriate protective measures, including engineering control, personal protective equipment, and work practices;
• Periodically inspecting work areas for hazards;
• Periodically monitoring Program records including Chemical Inventory, List of Department Carcinogen Users, Medical Clearance, and Training Record documents; and; Accident Investigation.
• Maintaining this written Carcinogen Program.

6.0      ACCESS TO THE WRITTEN PROGRAM

This written Carcinogen Program is available to all USC employees and their representatives. Copies of this program are available from EH&S (323) 442-2200, and can also be accessed from the EH&S web site at http://capsnet.usc.edu/EHS/Index.cfm.

7.0       SAFETY GUIDANCE FOR CARCINOGEN USE

Any activities that require the use and storage of carcinogens should follow this strict Safety Guidance for Carcinogen Use.

8.0      TRAINING AND COMMUNICATION

Training is required at least annually for all carcinogen users, and is provided through Professional Development initially and/or Annual Refresher Training should be provided through the individual Departments, Principal Investigator, or Laboratory Manager. The following components are included in Carcinogen Training:

• The nature of carcinogen hazards and consequences that may occur from hazard exposure without adequate protection. Note: Health hazard guidelines are contained in applicable Material Safety Data Sheets and in the USC Chemical Hygiene Plan;
• What characterizes a designated area;

• Selection of appropriate control measures;
• Medical clearance requirements;
• Proper storage, use and disposal, including standard operating procedures for USC Campus-Regulated Carcinogen use; and
• Employee responsibilities to follow Safety Guidance for Carcinogen Use. 

9.0      RECORD KEEPING

Manager/Supervisor and Principal Investigator will be required to maintain the following documents:

• Copies of Carcinogen Use Registration form submittals;
• Copies of IBC-approved protocols, modifications, and addenda; and
• A current list of carcinogen users. 

Career and Protective Services will maintain the following documents:

• Chemical Inventory;
• Training records;
• Assessment of Air Contaminants;
• Medical Clearance records; and
• Protocol submission forms and other records related to protocol review.

The medical facility that conducts the medical clearance assessment will maintain the following documents for each potential respirator user:

• Health History Questionnaires, and
• Medical Assessment records.

10.0       PROGRAM APPROVAL AND REVIEW