Ethylene Oxide (EtO) Exposure Limits

Regulations/ Guidelines for Ethylene Oxide

Exposure limits and guidelines when using ethylene oxide have been set by a number of national agencies including the following:

OSHA: Occupational and Safety Health Administration
OSHA Permissible Exposure Limit (PEL) :  1.0 ppm (8 Hr TWA)
    -Duties: Employers have a duty to provide a safe work     environment and employees have a duty to work safely.
    -Hazard Communication Regulation, suppliers (labels,     safety data sheets), Employers (facilities, work practices,     training and personal protective equipment) to enable     the safe use of the chemicals

NIOSH: National Institute of Occupational Safety and Health
NIOSH Immediately Dangerous to Life and Health (IDLH) :  800 ppm

JC: Joint Commission
Joint Commission Standard EC.02.02.01

ACGIH   : American Conference of Government Industrial Hygienist
ACGIH Threshold Limit Values TLV
  :  1.0 ppm    (8 Hr TWA)
 
OSHA Hazard Communications 29 CFR 1910.1200

AAMI
  : Association for the Advancement of Medical Instrument
AAMI ST:41:1999 and ST:58:2013

UK HSE
  : United Kingdom Health & Safety Executive
UK HSE Long-Term
  : 5 ppm  

Mexico: 
1 ppm (8 Hr TWA)

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20(d)(1)(ii)

“Employee exposure records.” Each employee record shall be preserved and maintained for at least thirty (30) years…

1910.1020(c)(5)

“Employee exposure record” means a record containing any of the following kinds of information: 

1910.1020(c)(5)(i)

Environmental (workplace) monitoring or measuring of a toxic substance or harmful physical agent,… 

1910.1020(e)(1)(i)

Whenever an employee or designated representative requests access to a record, the employer shall assure that access is provided in a reasonable time, place, and manner…

1910.1020(e)(2)(i)(A)

Except as limited by paragraph (f) of this section, each employer shall, upon request, assure the access to each employee and designated representative to employee exposure records relevant to the employee. For the purpose of this section, an exposure record relevant to the employee consists of:

1910.1020(e)(2)(i)(A)(1)

A record which measures or monitors the amount of a toxic substance or harmful physical agent to which the employee is or has been exposed;

1910.1020(e)(2)(i)(A)(2)

In the absence of such directly relevant records, such records of other employees with past or present job duties or working conditions related to or similar to those of the employee to the extent necessary to reasonably indicate the amount and nature of the toxic substances or harmful physical agents to which the employee is or has been subjected, and

1910.1020(e)(2)(i)(A)(3)

Exposure records to the extent necessary to reasonably indicate the amount and nature of the toxic substances or harmful physical agents at workplaces or under working conditions to which the employee is being assigned or transferred.


Hazard Communication Standard



Legal Background

1970 Occupational Health & Safety Act created the Occupational Safety and Health Administration (OSHA) and empowered OSHA to create and enforce workplace safety standards.

29 CFR 1910.1200 Hazard Communication Standard

  • Requires chemical manufacturers or importers to classify the hazards of chemicals which they produce or import

  • Employers must provide information to their employees about the hazardous chemicals to which they are exposed, by means of a hazard communication program, labels and other forms of warning, safety data sheets, and information and training. [b(1)]

Standard Includes the following requirements:

Assess hazards

Labels and markings

  • Include Product identifier, hazard statements, pictogram, precautionary statements, name & address of manufacturer or responsible party. [f(1)]

  • The chemical manufacturer, importer, or distributor shall ensure that each container of hazardous chemicals leaving the workplace is labeled, tagged, or marked.[f(1)]

  • Labels not required for portable containers for immediate use [f(8)]

  • Labels shall be in English and optionally also in other languages if spoken by workers

Safety Data Sheets (SDSs)

  • Maintain for all chemicals in the workplace and accessible to workers [g(8)]

  • Sections include: Identification, Hazard Identification, Composition, First Aid Measures, Fire fighting Measures, Accidental Release Measures, Handling & Storage, Exposure Controls & Personal Protection, Physical & Chemical Properties, Stability and Reactivity, Toxicology, Ecological Information, Disposal, Transportation, Regulations, Other Information including date of last revision. [g(2)]

  • Suppliers will provide with first shipment and shipments after SDS revision [g(6)]

Training

  • Employers shall provide employees with effective information and training on hazardous chemicals in their work area at the time of their initial assignment, and whenever a new chemical hazard the employees have not previously been trained about is introduced into their work area. [h(1)]

  • Training shall include: [h(3)]

    • If multiple employers, then must ensure that all employees potentially exposed to chemicals are trained [(2)

    • Requirements of this standard

    • Operations using hazardous chemicals,

    • Location of written plan, SDSs and chemical list

    • Methods and observations that may be used to detect the presence or release of a hazardous chemical in the work area (such as monitoring conducted by the employer, continuous monitoring devices, visual appearance or odor of hazardous chemicals when being released, etc.);

    • The physical, health, simple asphyxiation, combustible dust, and pyrophoric gas hazards, as well as hazards not otherwise classified, of the chemicals in the work area

    • The measures employees can take to protect themselves from these hazards, including specific procedures the employer has implemented to protect employees from exposure to hazardous chemicals, such as appropriate work practices, emergency procedures, and personal protective equipment to be used; and,

    • Details of the hazard communication program developed by the employer, including an explanation of the labels received on shipped containers and the workplace labeling system used by their employer; the safety data sheet, including the order of information and how employees can obtain and use the appropriate hazard information.

Written plan [e(1)

  • List of chemicals on sit

  • The methods the employer will use to inform employees of the hazards of non-routine task

  • Chemical Inventor

  • Trade secrets – information can be kept as trade secrets so long as safety information is not withheld and composition is made available in case of emergency. [i]

Pictograms

Standard pictograms indicating chemical hazards have been developed under the Globally Harmonized System of Classification and Labeling of Chemicals (GHS);2 some of which are shown below. OSHA has adopted the GHS and updated the Hazard Communication Standard in 2012. 





Standard EC.3.10

The hospital manages its hazardous materials and waste risks.

Elements of Performance for EC.3.10

The hospital creates and maintains an inventory that identifies hazardous materials and waste used, stored, or generated using criteria consistent with applicable law and regulation (for example, the Environmental Protection Agency [EPA] and the Occupational Safety and Health Administration [OSHA]).

The hospital maintains documentation, including required permits, licenses, and adherence to other regulations.




NSI/AAMI ST:41:1999/(R)2005.8.5

Environmental and employee monitoring/Recordkeeping

Environmental and EBZ monitoring must be documented, and records maintained in the department files or another designated location.

Employees must be notified of their personal monitoring results within 15 days of when the monitoring report is available, and a copy of the monitoring records must be kept in each employee’s file.  In accordance with the OSHA standard, these records must be maintained by the health care facility for the duration of employment and for at least 30 years thereafter.  If EBX monitoring shows EtO levels exceeding the PEL or EL, corrective actions must be taken and documented, as required by OSHA.  The results of environmental monitoring should be posted in an area that is readily accessible to employees.

Rationale: Good record keeping enables the health care facility to establish a continuous history of the work environment. Also, records of monitoring results are required by OSHA.  If environmental monitoring results are posted, workers will know that potentially dangerous concentrations of PAA could exist in the workplace, and the importance of proper work practices will be reinforced.  Also, if the posted results show that all areas and occupations are below the action level, employees will be encouraged to continue the safe practices that made this possible.


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