Environmental Health & Safety Chemical Carcinogen Safety Manual

Last update 07/07/2008

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 a EXTREME hazard carcinogen may reduce its hazard to the HIGH category. Classifications are listed in the OSU Guide for Chemical Carcinogen Classification, Appendix 2 . Ranking of chemicals by the US National Toxicology Program (NTP) or International Agency for Research on Cancer (IARC) are also considered.

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.

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.

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.

Decontamination. Contaminated materials shall either be decontaminated by procedures that decompose the chemical carcinogen to produce a safe product or be removed for subsequent disposal. Chemical carcinogens that have spilled out of a primary container so as to constitute a hazard shall be inactivated in-situ or shall be absorbed by appropriate means for subsequent disposal by authorized procedures. A means for assuring adequacy of cleanup shall be employed, for instance, wipe tests or fluorescence tests.

Reporting. All incidents involving contamination of personnel or spills of EXTREME and HIGH carcinogens shall be reported immediately to EH&S during normal working hours. At all other times, contact the Campus Police and Security, 7-3010, or 911.

Disposal. Residual carcinogens and solutions should be deactivated in the laboratory prior to disposal, when appropriate procedures are available which do not increase the hazard to research personnel or make the resultant solution more difficult and costly to dispose. Acceptable procedures for various structural classes of carcinogens are available from EH&S. Consult EH&S for further instructions and information, especially about appropriate techniques and what disposal challenges might result.

Nonvolatile Carcinogens. When nonvolatile carcinogens are used, a cage with solid sides and bottom in conjunction with a filter top is recommended.

Volatile Carcinogens. When volatile carcinogens are used, the cage must be used in conjunction with an approved ventilation system.

Alternative Facilities. Alternative facilities must be approved by EH&S prior to commencement of the project.

Procedures involving volatile chemical carcinogens and those involving solid or liquid chemical carcinogens that may result in the generation of aerosols are not to be conducted on the open bench; depending on the carcinogen category, they should be conducted in suitable containment equipment as described below. Use of ductless filtered devices for protection from volatile chemicals is not permitted.

Examples of aerosol producing procedures are: the opening of closed vessels; transfer operations; preparation of feed mixtures; blending; open vessel centrifugation; and the application, injection or intubation of a chemical carcinogen into experimental animals.

Tissue culture and other biological procedures involving chemical carcinogens may be conducted in a Class II, type B Biological Safety Cabinet (see Section 5, Definitions). A Class II, type A Biological Safety Cabinet may also be used if the cabinet's exhaust air is discharged to the outdoors.

The principal investigator should obtain guidance from EH&S on the selection and use of a Class II Biological Safety Cabinet for procedures involving chemical carcinogens. It is expected that for a majority of situations, certain EXTREME compounds will be used in forms or dilutions which would place them in the HIGH category.

Prohibited Activities in Laboratories Where Carcinogens are Used. There shall be no eating, drinking, smoking, chewing of gum or tobacco, application of cosmetics or storage of food in areas where chemical carcinogens are used.

Decontamination. Personnel involved in cleanup of leaks or spills, maintenance or repair of contaminated systems or equipment, or any operations involving work in an area where direct contact with a carcinogen could result shall:

Pipetting. Pipetting of any chemical carcinogens by mouth is absolutely prohibited. Mechanical pipettes shall be used for pipetting.

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. The Chemical Safety Committee will be responsible for providing periodic workshops and training sessions which cover current information, procedures and equipment available for the use of chemical carcinogens in laboratories.

Designation of Person in Charge.

• A primary work area and the principal investigator or supervisor shall be identified by the department chairperson for each research project or activity in the department using Extreme carcinogens.
• The department chairperson shall designate appropriate faculty members to be responsible for courses which use Extreme carcinogens.
• Use of Extreme carcinogens is highly discouraged in course work.

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:
1. Overall nature of the study.
2. Concentrations and amounts of stock and working solutions, and methods for routine decontamination and disposal.
3. Techniques and equipment to assure containment.
4. Emergency procedures including deactivation and/or decontamination.
5. Personal protective measures to be employed and/or equipment to be used.
5. Description of physical facilities where proposed study will be done.

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. When the program of a research or teaching laboratory using Extreme carcinogens requires the addition or deletion of personnel in the approved project, EH&S shall be notified immediately.

Amendments To Approved Protocols. When the program of a research or teaching laboratory using Extreme carcinogens requires the addition of other Extreme carcinogens, or significant amendments are made to an approved protocol, the individual in charge shall obtain the department chairperson's approval to make whatever modifications in the protocol are required. Amended protocols must then be forwarded through EH&S to the Chemical Safety Committee for review.

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.

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:

Animal Care Facilities. When Extreme carcinogens are used in animal care facilities, shower facilities must be provided for employees in addition to the requirements provided in "Laboratory Use of Extreme carcinogens Outside Isolated Systems".

Labeling of Containers.

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

Storage.

• Working solutions of carcinogens shall be stored in sealed, primary containers, placed in unbreakable secondary containers, and stored in an approved, labeled storage area. The secondary container shall be sealed.
• Stock quantities of Extreme carcinogens shall be stored in a tightly sealed primary container and placed inside an unbreakable, sealed impervious outer container.
• The doubly contained material shall be stored in an approved labeled storage area that is secured at all times.

1. A complete, current inventory of each Extreme chemical carcinogen shall be maintained in the secured storage area. The inventory record shall include:
   1. The quantity of chemical carcinogen originally acquired.
   2. The name of the authorized individual removing the material, the date, and amount removed.
   3. 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.

Transport On Campus. Primary containers shall be protectively packaged and placed in sealed, unbreakable, impervious outer containers.

Transport Off Campus. Packaging and shipping methods shall meet the regulations of the Department of Transportation and other state and federal regulations for transporting hazardous chemicals. Assistance in complying with these regulations is available from EH&S.

Transport Within Laboratories. Extreme carcinogens shall be transported in sealed, unbreakable, impervious secondary containers.

Personal Hygiene Requirements when using Extreme carcinogens in Facilities NOT Utilizing an Isolated System. Upon completion of work with Extreme carcinogens, employees shall be required to wash hands, forearms, and exposed areas before exiting a regulated area.

Personal Hygiene Requirements for Personnel Working with Extreme carcinogens in Animal Care Facilities. Upon completion of work involving animals, employees shall be required to shower, including washing the hair, after the last exit of the day.

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

Certification Of Laboratory Hoods And Isolated Systems. All ventilation apparatus such as hoods and glove boxes used for working with Extreme carcinogens shall be tested and approved for such use at least annually by EH&S. Immediately after modification or maintenance, the apparatus shall be reinspected.

Preassignment Examinations. An appropriate preassignment medical examination is required and shall be provided for each individual planning to work with Extreme carcinogens. The purpose of this preassignment examination is to establish a baseline value against which changes in health can be measured. A determination will be made whether there are any medical conditions that may lead to increased risk at work. The examination shall include the personal history of the employee, family and occupational background, including genetic and environmental factors.

Periodic Examinations. Periodic medical examinations may be required at intervals as determined by the consulting physician for all employees and students working with Extreme carcinogens. Evidence of accidental exposure is a clear signal for a medical examination. At termination of employment, a medical examination shall be provided.

Content. In all physical examinations, the examining physician shall consider whether there exist conditions of increased risk, including reduced immunological competence, those undergoing treatment with steroids or cytotoxic agents, pregnancy, and cigarette smoking.

Records. Complete and accurate records shall be maintained for all required medical evaluations. Such records shall be maintained for the duration of the employee's or student's work with Extreme carcinogens. Upon termination of the employee's services, including retirement or death, the records of evaluations (or copies thereof) shall be forwarded to Oregon OSHA. Student records will be maintained for 30 years in the OSU Archives. These records include dates of examinations, name of physician, and general statements; they DO NOT include diagnoses, specific lab tests, findings, etc.

Any physician who conducts a carcinogen-related medical examination will furnish to the employer a statement of the employee’s suitability for employment in the specific exposure..

Designation Of Person in Charge.

• The department chair shall identify a primary work area and a principal investigator or supervisor for each research project or activity in the department using HIGH carcinogens.
• The department chair shall designate one faculty member to be responsible for any course that uses HIGH carcinogens.

Completion Of Registration Form.

• Prior to use of HIGH hazard carcinogens, the designated person in charge must complete a Application/Registration for Use of Chemical Carcinogens form (Appendix 1).
• This form requires a demonstrated knowledge of appropriate deactivation and disposal procedures.
• If HIGH carcinogens are used in whole animal experimentation, the Chemical Agent Use in Animals form must also be completed.

Departmental Approval. Completed forms will be reviewed and approved by the department chairperson and forwarded to EH&S.

Changes in Use. All changes in locations, personnel in charge, and types of HIGH carcinogens used are to be reported to EH&S.

Duration of Registration. Registrations must be updated every three years.

HIGH 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. 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 mechanisms, or 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.
3. Vacuum lines are to be protected to prevent entry of the chemicals used into the system.
4. Prior to conducting work with the chemicals, the laboratory's ventilation system must be certified by EH&S as having an adequate number of air changes per hour under negative pressure.
5. Laboratory work surfaces shall be protected from contamination by the use of disposable, absorbent paper lined with plastic, or other equivalent impervious materials.

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

Storage.

• Working solutions of carcinogens shall be stored in sealed, primary containers, placed in unbreakable secondary containers, and stored in an approved, labeled storage area.
• Stock quantities of HIGH carcinogens shall be stored in a tightly sealed primary container and placed inside an unbreakable, sealed impervious outer container.
• The doubly-contained material shall be stored in an approved labeled storage area that is secured at all times.

Transport On Campus. Primary containers shall be protectively packaged and placed in sealed, unbreakable, impervious outer containers.

Transport Off Campus. Packaging and shipping methods shall meet the regulations of the Department of Transportation and other state and federal regulations for transporting hazardous chemicals.

Protective Clothing: When working with HIGH carcinogens, employees must wear a laboratory coat, protective gloves, and shoes that cover the entire foot.

Certification Of Laboratory Hoods And Isolated Systems.

• All ventilation apparatus such as hoods and glove boxes used for working with HIGH carcinogens shall be tested and approved for such use at least annually by EH&S.
• Immediately after modification or maintenance, the apparatus shall be re-inspected.

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.