Last Revised: 2/23/2004

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Ames Health and Safety Procedural Requirements

Chapter 38 - OSHA Regulated
Carcinogen Control Program

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38.1 Purpose

This chapter establishes the minimum requirements of the Ames Research Center OSHA Regulated Carcinogen Control Program. The Carcinogen Control Program involves identifying, evaluating and controlling occupational exposures to OSHA-regulated carcinogens. Carcinogens may only be used when it is not possible to use a non-carcinogenic material. Any use of carcinogens requires stringent controls to be in place to prevent exposures to workers, the public, and the environment. The Carcinogen Control Program is designed to meet the requirements of the Occupational Safety and Health Administration's (OSHA) chemical specific standards.

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38.2 Applicability

This chapter is applicable to:

For Ames contractors, it is applicable through contract clauses in conformance with NASA Procurement Regulation (Part 1, Subpart 52 and Part 14, Subpart 6.) All other personnel will follow the provisions of this chapter while at Ames facilities.

This program provides Ames Research Center policies and procedures for handling the OSHA regulated carcinogens listed in Table 1.

Table 1
Chemical Name CAS Number OSHA Regulation Other Requirements
2-Acetylaminoflourene 53-96-3 1910.1003-13 Carcinogens 1910.1014
Acrylonitrile 107-13-1 1910.1045
4-Aminodiphenyl 92-67-1 1910.1003-13 Carcinogens 1910.1011
Inorganic Arsenic and compounds 7440-38-2 1910.1018
Asbestos 1332-21-4 1910.1001 AGP 1700.1 Chapter 30
Benzene 71-43-2 1910.1028
Benzidine 92-87-5 1910.1003 - 13 Carcinogens 1910.1010
1,3-Butadiene 106-99-0 1910.1051
Cadmium and compounds 7440-43-9 1910.1027
bis-Chloromethyl ether 542-88-1 1910.1003 - 13 Carcinogens 1910.1008
Chloromethyl methyl ether 107-30-2 1910.1003 - 13 Carcinogens 1910.1006
1,2-Dibromo-3-chloropropane 96-12-8 1910.1044
3',3'-Dichlorobenzidine 91-94-1 1910.1003 - 13 Carcinogens 1910.1007
4-Dimethylaminoazobenzene 60-11-7 1910.1003 - 13 Carcinogens 1910.1015
Ethyleneimine 151-56-4 1910.1003 - 13 Carcinogens 1910.1012
Ethylene oxide 75-21-8 1910.1047
Formaldehyde (and formalin) 50-00-0 1910.1048
Methylene chloride 75-09-2 1910.1052
4,4'-Methylenedianiline 101-77-9 1910.1050
a-Naphthylamine 134-32-7 1910.1003 - 13 Carcinogens 1910.1004
b-Naphthylamine 91-59-8 1910.1003 - 13 Carcinogens 1910.1009
4-Nitrobiphenyl 92-93-3 1910.1003 - 13 Carcinogens
N-Nitrosodimethylamine 65-75-9 1910.1003 - 13 Carcinogens 1910-1016
b-Propiolactone 57-57-8 1910.1003-13 Carcinogens 1910.1013
Vinyl chloride 75-01-4 1910.1017
Additional sources of information.
Asbestos: http://www.osha.gov/SLTC/asbestos/index.html
Benzene: http://www.osha.gov/SLTC/benzene/index.html
1,3-Butadiene: http://www.osha.gov/SLTC/butadiene/index.html
Cadmium: http://www.osha.gov/SLTC/cadmium/index.html
Carcinogens: http://www.osha.gov/SLTC/carcinogens/index.html
Ethylene Oxide: http://www.osha.gov/SLTC/ethyleneoxide/index.html
Formaldehyde: http://www.osha.gov/SLTC/formaldehyde/index.html
Methylene Chloride: http://www.osha.gov/SLTC/methylenechloride/index.html
General information on occupational cancer:
http://www.cdc.gov/niosh/occancer.html

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38.3 Authority

NPR 1800.3 NASA Environmental Health
NHB 2710.1 NASA Occupational Safety and Health Handbook
29 CFR 1960 Basic Program Elements for Occupational Safety and Health Programs
Executive Order 12196 Occupational Safety and Health Programs for Federal Employees
OSHA Publication 2014 Occupational Safety and Health Programs for Federal Agencies

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38.4 Background

There are two basic types of chemical-handling operations at Ames: laboratory and non-laboratory. Laboratory use means:

People who work in laboratories often use small quantities of many chemicals, including carcinogens. The OSHA Laboratory Standard applies to research laboratories, and exempts them from the OSHA substance-specific standards. The Ames Chemical Hygiene Plan (Chapter 13) addresses the OSHA Laboratory Standard. Controls that apply only to laboratories are addressed in the Ames Chemical Hygiene Plan.

All other chemical handling operations are defined as non-laboratory use. The OSHA substance-specific standards were designed for these operations. Controls that apply to both laboratories and non-laboratories or only to non-laboratories are addressed in this chapter.

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38.5 Definitions

38.5.1 Acronyms/Abbreviations

ACGIH American Conference of Governmental Industrial Hygienists
ARC Ames Research Center
CAS Chemical Abstract Number
CFR Code of Federal Regulations
CHP Chemical Hygiene Plan
HAZCOM    Hazard Communication
IARC International Agency for Research on Cancer
MSDS Material Safety Data Sheet
NFPA National Fire Protection Association
NTP National Toxicology Program
OEL Occupational Exposure Limit
OSHA Occupational Safety and Health Administration
PEL Permissible Exposure Limit
PPE Personal Protective Equipment
SOP Standard Operating Procedure
TLV® Threshold Limit Value
TWA Time-Weighted Average

Action level--an exposure level, calculated as an eight-hour time-weighted average, which initiates certain required activities, such as exposure monitoring, medical surveillance, training and record keeping.

Chemical Inventory--a written or electronic record of chemicals used in a laboratory, by container, which includes the chemical name of all ingredients, CAS number(s), manufacturer, size of container, owner, and location. See Chapter 24, Chemical Hazard Communication (Ames HAZCOM), for specific information on the Ames inventory procedures.

Hazardous Chemical--Any material that, because of its quantity, concentration, or physical or chemical characteristics, poses a significant present or potential hazard to human health and safety or to the environment if released into the workplace or the environment. If a hazardous chemical comprises 1% (0.1% for carcinogens) or greater of a compound or mixture, the compound or mixture must be treated as a hazardous chemical.

Laboratory--A facility in which research or analytical chemical procedures are performed, where hazardous materials are stored and used in quantities that may easily be handled by one person (container sizes do not exceed five gallons); a workplace where relatively small quantities of hazardous chemicals are used on a non-production basis.

Material Safety Data Sheet (MSDS)--Written, printed or electronically transmitted information on the hazards and properties of a particular material, including instructions for its safe use. See the Code Q website for several links (Code Q)

OSHA-regulated Carcinogen--Those compounds, listed in Table 1, that have been identified by the Occupational Safety and Health Administration as carcinogens. Mixtures containing 0.1% or 1000 parts per million of an OSHA-regulated carcinogen are covered by this chapter.

Note: Under the Ames CHP, OSHA-regulated carcinogens are included in the definition of "select carcinogens." The "select carcinogen" list is more comprehensive and includes more chemicals. See the Ames Chemical Hygiene Plan, Chapter 13 for more information.

Permissible Exposure Limit (PEL)--Limit established by OSHA, usually expressed as an 8-hour Time Weighted Average (TWA), meaning an airborne contaminant concentration that shall not be exceeded for any 8-hour work shift of a 40-hour workweek. Exposure limits for many hazardous materials are listed in 29 CFR 1910.1000. (OHSA PELs)

Personal Protective Equipment (PPE)--Devices and clothing designed to be worn or used for the protection or safety of an individual while in potentially hazardous areas or performing potentially hazardous operations. Includes chemical and thermal resistant gloves, safety glasses, goggles and face shields, aprons, respirators, earplugs and muffs, etc.

Regulated Area--Limited access work area for substance regulated by a specific OSHA standard.

Short-term exposure limit--a limit usually defined as a 15-minute time-weighted average.

Threshold Limit Value (TLV-TWA)--the exposure limit (established by American Conference of Governmental Industrial Hygienists), expressed as a time-weighted average airborne "concentration for a normal 8-hr workday and a 40-hr work week, to which nearly all workers may be repeatedly exposed, day after day, without adverse effect."

Toxic--The ability of a material to injure biological tissue. Training - A documented, organized presentation of information fulfilling educational objectives and regulatory requirements.

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38.6 Responsibilities

38.6.1 Safety Division

Responsibilities include:

  1. Oversee development and implementation of the Ames Carcinogen Program and applicable procedures.
  2. Review the Ames chemical inventory annually to identify the locations and operations where OSHA-regulated carcinogens are used.
  3. Provide advice, oversight, and consultation, when requested, to Ames line management to ensure compliance with relevant regulations and policies for procurement, use, and disposal of carcinogens.
  4. Review proposed use, as requested by a supervisor or chemical user, of carcinogenic chemicals and the proposed precautions used to protect employees, including specific designated work areas and PPE.
  5. Provide direction and oversight of Ames chemical monitoring programs, ensuring that exposure assessments are conducted as needed and that exposure monitoring records are maintained.
  6. Notify employees of the results of exposure monitoring, and provide copies of such records to the Ames Health Unit for retention in the individual's medical record.
  7. Provide for periodic review and update, as needed, of this program.
  8. Provide an annual report to the Executive Safety Committee describing the extent of carcinogen use at ARC, the methods in place to ensure safe handling of carcinogens and a summary of the exposure monitoring performed.

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38.6.2 Line Management

Line management is responsible for operations within the organization, and for compliance with all relevant regulations, policies, and procedures. Supervisors hold the primary responsibility for safe operations. Prudent and thorough planning for experiments and contingencies are paramount. Specific measures and responsibilities that ensure a safe working environment include:

  1. Implement the carcinogen program in areas under their control.
  • Help provide the necessary resources to ensure that the facilities meet the established health and safety requirements for the material being handled.
  • Remain current on the potential hazards associated with the use of carcinogens. Acquire the knowledge and information needed to control chemical carcinogens.
  1. Identify and assess the hazards present.
  • Ensure that a complete and up-to-date inventory of all carcinogenic chemicals used under the manager's oversight is maintained as part of the ARC inventory (maintained by Code QE).
  • Identify employees who in the course of their work may be exposed to carcinogens. Ensure that the potential for employee exposure is considered prior to the use of chemical carcinogens.
  • Review, with the Ames Safety Division, the proposed uses of carcinogenic chemicals, and the proposed precautions used to protect employees, including engineering controls, specific designated work areas and PPE, prior to initiating operations with a new hazard (new hazardous material or new/significantly modified operation with previously used material). Complete Job Hazard Analyses for these operations.
  • Request, when needed, technical advice on exposure assessments, chemical hazards, less hazardous substitutes, containment, decontamination, neutralization, personal protective equipment, engineering controls and emergency procedures.
  • Ensure (in coordination with the Ames Safety Division) that hazard/exposure assessments are conducted for all operations where hazardous chemicals are handled. Identify required control measures for each operation.
  • Ensure (in coordination with the Ames Safety Division) that exposure monitoring is conducted whenever required by a chemical specific standard. Maintain copies of exposure monitoring records.
  • Ensure that medical attention is provided to any employee whenever signs and symptoms develop that may be associated with exposure to a hazardous chemical or whenever monitoring reveals exposure levels in excess of the action level. Provide relevant information (identity of the materials and amounts, if known, and circumstances of the exposure, employee's symptoms) to the attending medical professional.
  1. Provide information and training on hazards.
  • Verify that employees have been given training on the various requirements of the OSHA chemical specific standard (see Table 1).
  • Identify task-specific training requirements.
  • Provide or arrange for task-specific training.
  • Inform employees of the hazards associated with the chemicals to which they may be exposed. Verify that they know and follow the guidelines for working with hazardous chemicals.
  • Ensure that toxicity/hazard information is available for all carcinogens used. List the location of this information in the Laboratory Safety Plan or JHA. Material Safety Data Sheets (MSDS) are a primary source of this information. MSDSs received from the chemical supplier must be readily available to employees. Provide applicable supplemental information to employees about potential health hazards, safe handling procedures, chemical storage, and emergency response. Provide access to copies of the applicable OSHA regulation (Table 1).
  • Ensure that labels on incoming containers are not removed or defaced. Label containers in accordance with the applicable OSHA regulation (Table 1).
  1. Provide the means to control hazards.
  • Prepare a PPE assessment for operations (PPE). Ensure that each worker has access to PPE in good condition, and uses it correctly.
  • Provide for routine, formal inspections, including regular inspections of emergency equipment, and provide for corrective actions when needed. (See Safety Division Web site for standard inspection checklists.)
  • Ensure that facilities, storage areas, and equipment are adequate for procedures being conducted.
  • Ensure (in coordination with the Safety Division) that monitoring is conducted to evaluate the proper functioning of fume hoods and other engineering controls, and prohibit the use of fume hoods that do not meet performance standards.
  • Ensure that sufficient coordination is employed so that regulatory requirements relating to procurement, storage, use, collection, transportation, and disposal of chemicals used are followed.

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38.6.3 Ames Health Unit

The medical staff at the Ames Health Unit responds to requests for consultation, examination and evaluation, emergency treatment, and medical monitoring for personnel who work with or may be exposed to hazardous materials. Responsibilities include:

  1. Perform medical consultations and medical examinations, as well as provide written medical opinions as specified in the OSHA regulations, as appropriate.
  2. Establish and maintain appropriate medical records covering the consultations and examinations (including tests and written opinions) and records of exposures to hazardous chemicals.
  3. Inform each employee of the results of any examination/test given.

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38.6.4 Environmental Services Division

  1. Maintain software and databases to support a center-wide inventory of chemicals.
  2. Annotate entries in the chemical inventory of all products that contain 0.1 percent or more of a OSHA-regulated carcinogen.

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38.6.5 Employees

Each employee is responsible for personal safety while conducting assigned tasks with hazardous materials. Employee responsibilities include:

  1. Follow safe, established work practices.
  2. Develop good personal chemical hygiene habits.
  3. Report any concerns or observations of unsafe or unhealthy working conditions to the supervisor or to the Safety Division.
  4. Attend initial and refresher safety classes and supervisor's task-specific training.
  5. Report to the supervisor any ill effects experienced and seek medical consultation at the ARC Health Unit if health effects are experienced during working hours.

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38.6.6 Contracting Officer's Technical Representative (COTR)

The COTR evaluates contractor performance and compliance with all contract requirements. The COTR communicates with Government management and the Safety Division, as appropriate regarding compliance issues.

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38.7 OSHA-Regulated Carcinogen Program Implementation

This section describes the policies and procedures that implement the Ames OSHA-regulated carcinogen program.

38.7.1 Requirements

  1. Identify whether the work area falls under the Laboratory Standard or not. Laboratories must follow the Ames Chemical Hygiene Plan (see Chapter 13). Non-laboratories must meet the chemical specific standard.
  1. Identify carcinogens.
  • Table 1 contains OSHA-regulated materials that have specific work practice and handling requirements. The Safety Division can provide compliance information.
  • Complete the "Regulated Carcinogen Use Questionnaire" from Appendix A and send a copy to the Safety Division.
  1. Analyze and document the hazards of the work.

The following elements must be documented, reviewed, and approved by the supervisor before work begins:

  • Establishment of a designated area. The area can be a single hood, a portion of a room or the entire laboratory. Identify the designated area in the laboratory safety plan.
  • Use of containment devices such as fume hoods or glove boxes. Specify the hood location and number in the laboratory safety plan.
  • Procedures for safe accumulation and removal of contaminated waste.
  • Decontamination procedures. Refer to the MSDS or contact the Ames Chemical Hygiene Officer for information.
  • Leak detection systems.

The provision for additional controls may require the expertise and recommendations of various groups including the Safety Division, Facilities Engineering, and technical committees. All additional provisions for work with particularly hazardous materials must be incorporated into the standard operation procedures for those materials.

  1. Mitigate the hazards and document hazard control measures.

Handling requirements

  • The Safety Division must be notified of the names of employees working with carcinogens, the chemical names and size of the chemical containers, the location of use, and the location of storage. Completion of Appendix A satisfies this requirement.
  • Workers must have received required training (as defined in the substance specific standard) and must be authorized by management to work with carcinogens.
  • A regulated area must be assigned to carcinogen work and storage. Regulated areas must have access controlled by either administrative or physical means. The requirements of the appropriate OSHA standard must be met. Contact the Safety Division for details.
  • All areas where OSHA-regulated carcinogens are used or stored must have posted warning signs. Eating, drinking, or applying of cosmetics is not allowed in these areas.
  • All materials containing 0.1% or more of a listed carcinogen must be labeled as a carcinogen hazard.
  • Employees must know accident and spill response requirements.
  • Decontamination procedures for restoring equipment and facilities to uncontrolled use must be available before new carcinogens are used. These procedures must be described in the Safety Plan.
  1. Medical Surveillance
  • Known exposure to a carcinogen, as documented by exposure sampling data obtained by the Safety Division
  • Presumed exposure until carcinogen use exposure sampling data is acquired
  • Voluntary participation

Table 2 briefly outlines the basic requirements that are common to the OSHA-regulated carcinogens. Table 3 lists records that are required.

Table 2
Requirement
Written Safety Procedure
          Exposure assessment to determine applicability of regulation.
          Establish and post regulated area
          Regulated area controls implemented
          Access to regulated area limited to authorized employees
          Decontamination and maintenance procedures
          Emergency procedures
Regulated Area Criteria
          Inspection: annually
          Fume Hood Face Velocity verified
          Local exhaust ventilation with sufficient clean make-up air for proper operation
          Work surfaces protected with absorbent paper and/or other protective material
          Storage containers labeled as required by standard
          Waste containers labeled as required by standard
          Entrances to regulated area posted with any signs as required by regulation
          Current inventory maintained
Housekeeping
          Dry sweeping of dry chemicals is prohibited
Decontamination and Disposal
          Contaminated materials disposed of by QE
Administrative Controls
          No eating, drinking, smoking, application of cosmetics, chewing tobacco, taking oral medication, or storage of consumables.
          Wash hands, forearms, face and neck upon exit from regulated area
          No pipetting by mouth
Personal Protective Equipment
          Documented PPE assessment
          Lab coat or other full body garment, safety glasses, gloves required
          PPE collected in impervious containers at end of day for decontamination or disposal
          Respiratory protection: contact the Safety Division for evaluation
Training of personnel
          Training requirements specific to the OSHA regulated carcinogen, can be incorporates into either Hazard Communication or Chemical Hygiene program training, as long as specific standard requirements are documented in the training.
          Frequency: initial, then annually or when new carcinogen introduced or operation changes significantly.
Medical Surveillance
          Requirement varies by chemical; usually depends upon potential exposure. Contact the Safety Division for assistance

Table 3

Required Documentation
Individual or Organization Shall Maintain
Immediate Supervisor
  • A current carcinogen inventory (may be in a computer database or on paper).
  • Documentation that is relevant to qualified chemical workers' job-specific training.
  • An approved, current safety plan (e.g. Job Hazard Assessment, Laboratory Safety Plan, PPE assessment, etc.) describing carcinogen use.
  • Completed carcinogen use forms (Appendix A), one for each carcinogen in use.
  • Carcinogen use sampling data results memoranda from QH, if sampling was performed.
  • Safety Division
  • This chapter and the carcinogen list.
  • Copies of completed carcinogen use forms.
  • Employee- and workplace-exposure-monitoring (sampling) records.
  • Copies of carcinogen use sampling data results memoranda sent to immediate supervisor.
  • Ames Health Unit
  • Carcinogen medical surveillance records for civil servants.
  • 38.7.2 Related Programs at ARC

    Operations involving chemical carcinogens are subject to many programs, which provide for safety in areas related to use of hazardous materials. The procedures and policies listed below complement and coordinate with implementation of the OSHA-Regulated Carcinogen Program.

    Asbestos Management APR 1700.1, Chapter 30
    Chemical Hazard Communication Plan APR 1700.1, Chapter 24 (Ames HAZCOM)
    Chemical Hygiene Plan APR 1700.1, Chapter 13
    Respiratory Protection APR 1700.1, Chapter 28 (Respiratory protection)
    Bloodborne Pathogens Protection APR 1700.1, Chapter 32 (bloodborne pathogens)
    Confined-Space Entry Program APR 1700.1, Chapter 26 (Confined space)
    Hazard Assessment and Personal, Protective Equipment APR 1700.1, Chapter 33 (PPE)
    Environmental Management Ames Environmental Procedures and Guidelines, APR 8800.3 (Code Q)

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    38.8 Review and Update

    The Safety Division will review this chapter periodically. Revisions will incorporate new regulatory requirements and substantially modified procedures initiated since the previous update.


    38.9 Appendices

    Appendix A: Regulated Carcinogen Use Questionnaire

    38.9.1 References

    ACGIH (American Conference of Governmental Industrial Hygienists). "TLVs and BEIs," Cincinnati, Ohio, most recent edition.

    California Proposition 65 (1986), "The Safe Drinking Water and Toxic Enforcement Act of 1986." http://www.oehha.org/prop65/p65.htm.

    International Agency for Research on Cancer. "Monographs," most recent editions. National Toxicology Program (NTP), "Annual Report on Carcinogens."

    OSHA (Occupational Safety and Health Administration). "Toxic and Hazardous Substances," 29 CFR. 1910.1001-1050, Subpart Z, Washington, DC.

    38.9.2 Appendix A: Regulated Carcinogen Use Questionnaire

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    End of Document