Carcinogen Safety Manual

Last update: 08/02/2010

Carcinogen list - Registration/Authorization form - Chemical Agent Use in Animals form

  1. Policy & Procedures
    • Policy
    • Control of Use
    • Manual Distribution
    • Categories
    • Responsibilities

  2. General Requirements
    • Decontamination and Disposal
    • Animal Facilities
    • Physical Facilities
    • Personal Protection
    • Notification of EH&S
    • Medical Surveillance
    • Report of Incident
    • Chemical Inventory
  • EXTREME Hazard Carcinogens
    • Use Authorization
    • Physical Facilities
    • Storage and Labeling
    • Transportation
    • Vacuum Line Protection
    • Housekeeping
    • Personal Protection
    • Medical Surveillance
    • Inspections
    • EmergencyProcedures
  • HIGH Hazard Carcinogens
    • Use Registration
    • Physical Facilities
    • Storage and Labeling
    • Transportation
    • Personal Protection
    • Inspections
    • Emergency Procedures
  • Definitions


  • Appendices
  • Labels

    Policy & Responsibilities

    SECTION 1 - Policy and Responsibilities

    Policy

    It is the policy of Oregon State University to maintain, insofar as is reasonably within the control of the university, an environment that will not adversely affect:

    1. The health, safety, and well-being of students, staff, visitors, and neighboring human populations; and
    2. The animals maintained on the campus of the university or in the contiguous area.

    All research and teaching activities involving the use of chemical carcinogens, as defined in this manual, in facilities controlled by Oregon State University, shall be conducted in compliance with OSHA regulations, with granting agency guidelines, with the provisions of this manual, and as approved by the Chemical Safety Committee.

    Control of Chemical Carcinogen Use

    The purpose of the Chemical Carcinogen Safety Program is to

    Program components to reach this goal:

    Chemical Carcinogen Manual

    This Chemical Carcinogen Manual is intended to provide a system for assuring safety in the use of known or suspected chemical carcinogens. It is to be accessible in those campus facilities in which chemical carcinogens are stored or used. All campus personnel working with chemical carcinogens are required to have an understanding of the contents of the manual.

    Categories of Chemical Carcinogens

    The hazard categorization scheme is intended to reflect the net potential hazard associated with the conditions for use of each carcinogen. Specifically, it considers not only the apparent biological potency of a compound, but the total quantity or concentration in use. For instance, dilution of an EXTREME hazard carcinogen may reduce its hazard to the HIGH category. Classifications are listed in the Guide for Chemical Carcinogen Classification (Appendix 2). Ranking of chemicals by OSHA, the US NTP, and IARC are the primary basis for listing.

    EXTREME Hazard Carcinogens

    1. Chemicals regulated by law.
    2. Chemicals not regulated by law but considered to be highly hazardous by the Chemical Safety Committee.

    HIGH Hazard Carcinogens

    1. EXTREME carcinogens diluted to defined concentration ranges. Chemicals identified in IARC or NTP guidelines which do not exceed the hazardous category in any concentration.
    2. Other chemicals when used in research and teaching activities that could, on the basis of new information, require the restrictions listed for this category.

    MODERATE Hazard Carcinogens

    OSU Guide for Chemical Carcinogen Classification

    Regulations and scientific evidence pertaining to the carcinogenic properties of chemicals change frequently. A categorized listing can be found in Appendix 2 . EH&S, in consultation with the University Chemical Safety Committee, will post an updated list when necessary.

    Responsibilities

    Project Leader and/or Laboratory Supervisor. Each person in charge of a research project, teaching laboratory, or other activity using chemical carcinogens will be responsible for:

    1. Development of written protocols to assure the safe use of these agents.
    2. Completion of an application/registration form for the use of all EXTREME and HIGH hazard carcinogens (Appendix 1).
    3. Completion of Chemical Agent Use in Animals form when required.
    4. Obtaining the department chairperson's approval of the project.
    5. Strict compliance with the authorized protocol and the requirements of this manual.
    6. Training of employees regarding the nature of the hazards involved, safety practices, and the correction of procedures and conditions that may result in exposure and possible injury.
    7. Maintenance of required records and inventory as defined in this manual.

    Department Chairperson. The department chairperson is responsible for:

    1. Protecting the health and safety of departmental employees, visitors, and students.
    2. Approving all protocols and purchase orders for research or teaching involving EXTREME carcinogens in the department.
    3. Providing the Chemical Safety Committee, through EH&S, with copies of all protocols and/or forms requiring departmental approval.
    4. Providing EH&S with copies of all purchase orders of EXTREME carcinogens for inventory records.

    Environmental Health & Safety. EH&S will:

    1. Forward the protocols prepared by the project leader for work involving chemical carcinogens to the Chemical Safety Committee.
    2. Provide consultation, upon request, in the development of protocols.
    3. Maintain the following records:
      1. Copies of Application/Registration for Use of Chemical Carcinogens.
      2. The names and employee ID numbers of personnel authorized to work with these materials.
      3. Electronic inventory of carciongens based on PI input.
    4. Investigate all accidents which could or did result in the exposure of personnel to chemical carcinogens.
    5. Periodically inspect, as defined in Section 5, all EXTREME and HIGH chemical carcinogen work areas, and notify the principal researcher and the department chairperson of the results.
    6. Issue periodic updates of classification of chemical carcinogens.

    Campus Veterinarian. The campus veterinarian shall be responsible for reviewing all procedures involving animal experiments with EXTREME and HIGH carcinogens.

    Chemical Safety Committee. The Chemical Safety Committee is responsible to:

    1. Approve or reject all applications and protocols for the use of EXTREME carcinogens.
    2. Review protocols for the use of HIGH and MODERATE chemical carcinogens when requested by the principal investigator.
    3. Determine appropriate hazards categorization of newly identified chemical carcinogens.
    4. Instruct EH&S to initiate revision or termination of projects when, in the opinion of the committee, a project entails an unacceptable risk to the health and safety of the personnel involved.
    5. Participate in periodic inspections of projects involving the use of chemical carcinogens.

    General Requirements

    SECTION 2 - GENERAL REQUIREMENTS

    Decontamination and Disposalof Chemical Carcinogens

    Decontamination.

    Reporting.

    Disposal.

    Facilities for Housing Animals Exposed to Chemical Carcinogens

    Nonvolatile Carcinogens

    Volatile Carcinogens.

    Alternative Facilities

    Physical Facilities

    Personal Protection

    All standard laboratory safety practices, such as the wearing of eye protection, shall be observed.

    Prohibited Activities in Laboratories Where Carcinogens are Used

    Decontamination.

    Training Responsibilities Of Project Leaders.

    Prior to working with chemical carcinogens, each employee shall receive training including, but not limited to:

    1. The nature of the hazards, including local and systemic toxicity.
    2. The specific nature of operations which could result in exposure.
    3. The purpose for, the nature of, the application of decontamination procedures.
    4. The employee's specific role in prescribed emergency procedures.
    5. Specific information to aid the employee in recognition and evaluation of conditions and situations which may result in the release of a carcinogen.
    6. The employee shall be trained in the prescribed emergency procedures and rehearsed in their application.

    Supplementary Training.

    Storage and labeling

    Notification of EH&S

    Medical Surveillance

    Report of Incidents

    Chemical Inventory

    Extreme Hazard Carcinogens

    SECTION 3 - EXTREME HAZARD CARCINOGENS

    Authorization for Use

    Designation of Person in Charge.

    Content of Protocols.

    The individual in charge of a project involving the use of Extreme carcinogens shall prepare a written protocol in consultation with EH&S to include, but not be limited to, the following information:

    1. Name of principal investigator and/or project supervisor. First time applicants attach C.V.
    2. Names of all other laboratory personnel associated with the project.
    3. Names, amounts, and concentrations of chemical carcinogens involved.
    4. Description of experimental procedures, including:
      • Overall nature of the study.
      • Concentrations and amounts of stock and working solutions, and methods for routine decontamination and disposal.
      • Techniques and equipment to assure containment.
      • Emergency procedures including deactivation and/or decontamination.
      • Personal protective measures to be employed and/or equipment to be used.
      • Description of physical facilities where proposed study will be done.

    Review and Approval of Protocols.

    1. Departmental Review:
      • In addition to the protocol, the principal investigator must complete an Application/Registration for Use of Chemical Carcinogens (Appendix 1).
      • If animals are to be used in the experiment, a Chemical Agent Use in Animals form must be completed.
      • The completed forms and protocol must be reviewed and approved by the department chairperson.
      • The completed forms and the approved protocol will be forwarded through EH&S to the Chemical Safety Committee.
    2. Chemical Safety Committee Review:
      • After departmental approval, the completed forms and the accompanying protocols will be reviewed by the Chemical Safety Committee in consultation with EH&S, the consulting physician, and if animals are to be used, by the campus veterinarian.
      • Final approval by the Chemical Safety Committee must precede initiation of proposed projects or laboratory teaching exercises.
    3. EH&S Review:
      • Following approval by the Chemical Safety Committee, the submitted forms and accompanying protocols will be placed on file in the EH&S office.

    Notification To Add or Delete Personnel.

    Amendments To Approved Protocols.

    Duration of Authorization.

    1. Initial Period of Authorization: Authorization for the use of Extreme carcinogens by the Chemical Safety Committee are approved for three years. Substantive changes in use or procedures will require re-authorization
    2. Period of Review of Authorization: All authorizations will be updated by the investigator and reviewed by the Chemical Safety Committee at 3-year intervals to assure that protocols, procedures and usage comply with the initial authorization.

    Physical Facilities

    Isolated Systems

    1. Physical facilities for use of Extreme carcinogens shall be capable of providing either an isolated system or a totally controlled access facility with an independent ventilation system. For most uses, the most practical alternative is a glove box with an appropriately treated exhaust system approved by EH&S.
    2. Laboratory must be under negative pressure with respect to general access areas such as hallways and offices.
    3. The following criteria are required of all laboratories in which Extreme carcinogens are used or stored:
      • Isolated systems must be provided with an approved exhaust treatment system.
      • Isolated systems and approved storage cabinets must be labeled "Caution - Select Carcinogen."

    Working Outside Isolated Systems.

    If the procedures involved in the use of Extreme carcinogens cannot be contained in an approved isolated system, the following features must be provided in the laboratory:

    1. Laboratory must be under negative pressure with respect to general access areas such as hallways and offices.
    2. Entrances must be posted with "Cancer Suspect Agent."
    3. Vacuum lines must be appropriately protected to prevent entry of the carcinogens used into the lines.
    4. Prior to commencing work with chemical carcinogens, the laboratory ventilation system must be approved by EH&S.
    5. Laboratory work surfaces shall be protected from contamination by the use of disposable, absorbent paper with moisture-proof backing.
    6. Authorized entry into the laboratory must be regulated by a system approved by the Chemical Safety Committee.
    7. The laboratory shall be equipped with an approved air exhaust system that is independently ducted, under negative pressure in interior spaces, and does not recirculate air.
    8. General room exhausts, glove boxes, laboratory hoods, or biological safety cabinets shall be equipped with approved exhaust treatment systems. (The appropriate exhaust for any carcinogen is dependent upon the nature of the compound and will be determined in the protocol phase of the experiment. Recommended equipment for treatment includes, but is not limited to, HEPA filters, activated charcoal filters, exhaust incinerators, and/or chemical scrubbers.)
    9. Provision shall be made for shower facilities and the management of protective clothing in the regulated area.
    10. The regulated area must contain a roster of persons who enter the facility.

    Animal Care Facilities.

    Storage and Labeling

    Labeling of Containers.

    Storage.

    Inventory.

    1. A complete, current inventory of each Extreme chemical carcinogen shall be maintained in the secured storage area. The inventory record shall include:
      • The quantity of chemical carcinogen originally acquired.
      • The name of the authorized individual removing the material, the date, and amount removed.
      • The date and final disposition of the remaining material.
    2. Inventory records shall be kept up to date in the university's on-line inventory program.

    Transportation of Extreme Hazard Carcinogens

    Transport On Campus.

    Transport Off Campus.

    Transport Within Laboratories

    Vacuum Line Protection

    1. HEPA filters or other approved devices must be used to prevent entry of carcinogenic chemicals into the vacuum system is required.
    2. Vacuum line protective systems shall be approved by EH&S prior to use.
    3. When using a volatile carcinogen, a separate vacuum pump or other device vented to an approved laboratory hood shall be used.

    Housekeeping

    Personal Protection

    Extreme carcinogens NOT used in an Isolated System

    Extreme carcinogens used in Animal Care Facilities.

    Protective Clothing

    All standard laboratory safety practices, such as the wearing of eye protection, shall be observed in addition to the following:

    1. When working with Extreme chemicals, employees must wear a laboratory coat, protective gloves, and shoes which cover the entire foot.
    2. When working inside regulated Extreme carcinogen areas, employees shall be required to wear clean, protective laboratory clothing such as a surgical gown, surgical scrub suit, or fully buttoned laboratory coat and head cover, protective shoe covers, and gloves.
    3. Prior to each exit from the regulated area, employees shall be required to remove and leave protective clothing at the point of exit.
    4. At regular intervals or when overtly contaminated, used protective clothing shall be placed in impervious containers for the purpose of decontamination or disposal. The impervious container shall be labeled "Cancer Suspect Agent."
    5. Required protective clothing for employees working with animals not contained in a glove box and using Extreme carcinogens shall include coveralls, protective shoe covers, head covers, gloves, and respirators approved by EH&S.
    6. Personnel involved in maintenance or decontamination of facilities in which Extreme carcinogens are used shall be required to wear clean protective garments, including gloves, protective shoe covers, head covers, and when required, respirators.

    Certification Of Laboratory Hoods And Isolated Systems.

    Medical Surveillance

    Preassignment Examinations.

    Periodic Examinations.

    Content.

    Records.

    Physician requirements

    Inspections Required

    All projects using Extreme carcinogens are subject to periodic inspections (announced or unannounced) by EH&S or the Chemical Safety Committee in order to insure safe conditions and procedures. EH&S or the Chemical Safety Committee may also inspect any project where potentially carcinogenic chemicals are being used.Inspections of projects using Extreme carcinogens will include, in part:

    1. A review of the physical facilities to see if enclosures and other safety equipment are functioning correctly.
    2. Determination that materials required to cope with accidents are readily available and emergency procedures are displayed.
    3. Determination that all personnel involved in the project are familiar with appropriate normal and emergency procedures and are aware of the potential hazards of the work of their own group as well as those of any other group with whom the facilities are shared.
    4. Determination that appropriate procedures for biological, physical, and chemical containment are consistent with approved protocols.
    5. Review of the roster maintained at regulated areas where the Extreme carcinogens are used. (See Laboratory Use of Extreme carcinogens Outside Isolated Systems, this section).
    6. Review of the inventory of Extreme carcinogens.

    The results of inspections will be brought to the immediate attention of the principal investigator, the department chairperson, and reported to the chairperson of the Chemical Safety Committee. Inspection reports will be retained as part of the permanent files of EH&S.

    Posting of Emergency Procedures

    Approved specific emergency procedures shall be prescribed and posted in areas using Extreme carcinogens. The posted information shall include, but not be limited to:

    1. Name and phone number of principal investigator, department chairperson, EH&S, and Campus Police and Security.
    2. Decontamination procedure.
    3. Location of closest shower facility.

    High Hazard Carcinogens

    SECTION 4 - High Hazard Carcinogens

    Registration for Use

    Designation Of Person in Charge.

    Completion Of Registration Form.

    Departmental Approval.

    Changes in Use

    Duration of Registration.

    Physical Facilities

    HIGH hazard carcinogens may be used in standard chemical laboratories or approved animal care facilities with the following restrictions:

    1. All entrances shall be posted with "Cancer Suspect Agent" signs.
    2. Laboratory or other research area must be under negative pressure with respect to general access areas such as hallways and offices.
    3. All normal laboratory procedures shall be done in an approved chemical fume hood system with average face velocity of at least 100 feet per minute, or other local exhaust equipment, or by use of other methods that will effectively minimize the chance for personnel exposure to chemical carcinogens. Use of ductless filtered devices for protection from volatile chemicals is not permitted.
    4. Vacuum lines are to be protected to prevent entry of the chemicals used into the system.
    5. Prior to conducting work with registered carcinogens, the laboratory's ventilation system must be certified by EH&S as having an adequate number of air changes per hour under negative pressure.
    6. Laboratory work surfaces shall be protected from contamination by the use of disposable, absorbent paper lined with plastic, or other equivalent impervious materials.

    Storage and Labeling

    Labeling of Containers.

    All reagent bottles, stock, and working solutions shall be labeled "Cancer Suspect Agent."

    Storage.

    Transportation of HIGH Hazard Carcinogens

    Transport On Campus.

    Transport Off Campus.

    Personal Protection

    All standard laboratory safety practices, such as the wearing of eye protection, shall be observed in addition to the following:

    Protective Clothing:

    Certification of Laboratory Hoods and Isolated Systems.

    Inspections Required

    Posting of Emergency Procedures

    Approved specific emergency procedures shall be prescribed and posted in areas using HIGH hazard carcinogens. The posted information shall include, but not be limited to:

    1. Name and phone number of principal investigator, department chairperson, EH&S, and Campus Police and Security.
    2. Decontamination procedure.
    3. Location of closest shower facility.

    Definitions

    SECTION 5 - Definitions

    Biological Safety Cabinet - CLASS II TYPE A - Has a minimum inflow of 75 FPM; recirculates approximately 70% of the cabinet's air flow; exhausts the remaining air into the immediate environment through a HEPA filter or to the outside through thimble unit.

    Biological Safety Cabinet - CLASS II TYPE B1 - Minimum inflow of 100 fpm; exhaust cabinet air must pass through a dedicated duct to the outside through a HEPA filter and rooftop mounted exhaust fan.

    Biological Safety Cabinet – CLASS II TYPE B2 - Minimum inflow of 100 fpm, no recirculation; total exhaust to outside through hard-duct and HEPA filter; rooftop mounted exhaust fan required.

    Biological Safety Cabinet - CLASS II TYPE B3 - Minimum inflow of 100 fpm; plenums are under negative pressure to room; exhaust air is thimble-ducted to the outside through a HEPA filter and rooftop mounted exhaust fan.

    Campus Veterinarian - An individual with a doctorate in veterinary medicine who is assigned the duties of overseeing the care and humane treatment of animals used for research testing or teaching at Oregon State University.

    Chemical Carcinogen - EXTREME Hazard - Chemical carcinogens regulated under OSHA Occupational Health Regulations, used above exempt concentrations; and those chemicals, when used in research and teaching activities, that should in the opinion of the Chemical Safety Committee require the restrictions listed for this category.

    Chemical Carcinogen - HIGH Hazard - Chemical carcinogens regulated under OSHA Occupational Health Regulations, used at or below exempt concentrations; and those chemicals, when used in research and teaching activities, that should in the opinion of the Chemical Safety Committee require the restrictions listed for this category.

    Chemical Carcinogen - Moderate Hazard - Those chemicals, when used in research and teaching activities, that should in the opinion of the Chemical Safety Committee require the restrictions listed for this category.

    Exempt Concentration - The concentration, specified in the OSHA Occupational Health Regulations, below which certain regulated carcinogens are exempt from the provisions of that law.

    Isolated System - A fully enclosed structure, other than the vessel of containment of a carcinogen, which is impervious to the passage of the carcinogen and which would prevent the entry of the carcinogen into the surrounding external environment should leakage or breakage occur from the original vessel of containment (e.g., glove box).

    Regulated Area - An area where entry and exit is restricted and controlled.