Guidelines for the reduction of ethylene oxide releases from sterilization applications

Interpretation

1. In these guidelines,

  • "aeration" means the part of the sterilization process during which residual ethylene oxide or its reaction products dissipate until predetermined levels are reached, whether under forced air flow, natural or mechanically assisted convection, or other means, from previously sterilized materials after the sterilization cycle is complete;

  • "aerator" means any piece of equipment or space in which materials previously sterilized with ethylene oxide are placed or remain for the purpose of aeration;

  • "aerator exhaust stream" means all ethylene oxide-contaminated air which is intentionally released from an aerator during aeration;

  • "animal care facility" means any facility that provides veterinarian care, food, water, or shelter to an animal;

  • "commercial facility" means any facility that
    1. sterilizes products or equipment manufactured elsewhere as its principal business;
    2. sterilizes products or equipment it manufactures; or
    3. sterilizes materials used in conducting its business, other than a health care or animal care facility;

  • "control efficiency" means the efficiency of an emission control system in reducing the mass flow of ethylene oxide in an exhaust stream;

  • "emission control system" means an article, machine, piece of equipment, or contrivance which reduces the amount of ethylene oxide between the inlet and outlet of the system. It includes catalytic oxidation devices, thermal oxidation devices and acid-water scrubbers;

  • "facility" means all buildings, equipment, structures and stationary items that are located on a single site or on contiguous or adjacent sites and that are owned or operated by the same person and that function as a single integrated site;

  • "health care facility" means any facility that provides diagnostic services and general and specialized medical care to human beings. It includes acute care facilities, nursing homes, long term care facilities, community health centres, medical and dental offices, professional's private treatment facilities, and health units in industry;

  • "owner or operator" means any person who holds a right in, has possession, control or custody of, is responsible for the operation of, or has the power to dispose of a sterilizer or aerator;

  • "sterilization cycle" means the process which begins when ethylene oxide is introduced into the sterilizer, that includes the initial purge or evacuation after sterilization, and subsequent air, steam or other washes, and ends after evacuation of the final air wash;

  • "sterilizer" means any piece of equipment in which ethylene oxide is used as a biocide;

  • "sterilizer exhaust stream" means all ethylene oxide-contaminated air which is intentionally released from the sterilizer during the sterilization cycle;

  • "year" means a consecutive 12-month period.

Application

2. Effective January 1, 2007, subject to section 3, these Guidelines apply with respect to facilities that purchase or use a total of 10 kg or more of ethylene oxide per year for sterilization purposes.

3. (1) Subject to subsection (2), these Guidelines do not apply with respect to sterilizers that use ethylene oxide exclusively as a control product as defined in the Pest Control Products Act.

(2) These Guidelines apply with respect to uses of ethylene oxide as a control product that are exempt from the Pest Control Products Act according to section 3 of the Pest Control Products Regulations.

(3) These Guidelines do not apply with respect to aerators that exclusively receive materials from a sterilizer referred to in subsection (1).

(4) These Guidelines do not apply with respect to emission control systems that exclusively receive exhaust streams from a sterilizer referred to in subsection (1) or an aerator referred to in subsection (3).

Performance criteria

4. An owner or operator should operate a sterilizer in accordance with the following:

  1. the sterilizer exhaust stream is ducted to an operating emission control system that has a control efficiency of at least 99 percent; and
  2. there is no liquid discharge from the sterilizer during the sterilization cycle.

5. An owner or operator should operate an aerator in accordance with the following:

  1. subject to section 6, during the first two hours following the start of aeration, the aerator exhaust stream is ducted to an operating emission control system that has a control efficiency of at least 95 percent; and
  2. there is no liquid discharge from the aerator during aeration.

6. An owner or operator should operate an aerator in a commercial facility in accordance with one of the following:

  1. the aerator exhaust stream is ducted to an operating emission control system that has a control efficiency of at least 99 percent; or
  2. the concentration of ethylene oxide released to the atmosphere from the aerator exhaust stream is below one part per million.

7. The owner or operator of a sterilizer or aerator used in a health care facility should conform to the standard Installation, Ventilation, and Safe Use of Ethylene Oxide Sterilizers in Health Care Facilities, CAN/CSA-Z314.9, as amended from time to time, by CSA International.

8. An owner or operator should ensure that an emission control system is installed, operated and maintained in accordance with the instructions of the manufacturer.

Compliance provisions

9. Notwithstanding section 2, by June 30, 2006, an authorized senior administrator of a facility should provide to the Minister of the Environment the information outlined in items 1 through 6 of the Annex, and indicate, in writing, his commitment to comply with these Guidelines.

Testing provisions

10. Every year, an owner or operator should test all emission control systems referred to in paragraph 4(a) to determine their control efficiency.

11. Every year, an owner or operator should

  1. test all emission control systems referred to in paragraph 5(a) or 6(a) to determine their control efficiency, unless an emission control system has been tested under section 10 for the same year; or
  2. test the aerator exhaust stream of at least one aerator to determine the concentration of ethylene oxide released to the atmosphere.

12. All testing should be conducted under normal operating conditions and maximum ethylene oxide mass flow in the sterilizer or aerator exhaust stream, as the case may be.

Reporting provisions

13. Unless an owner or operator is subject to the reporting requirements of the National Pollutant Release Inventory, the owner or operator should provide to the Minister of the Environment, with the form provided by the Minister, information specified in the Annex by June 30th of every year.

Annex

Information to be provided

  1. The facility name and address.
  2. The technical contact, telephone and fax numbers, and e-mail address.
  3. The quantity of ethylene oxide purchased or used during the previous calendar year.
  4. The number of sterilizers subject to these Guidelines and volume of each sterilizer.
  5. The number of sterilization cycles performed in the previous calendar year.
  6. The number and type of emission control systems subject to these Guidelines.
  7. The results of latest testing referred to in sections 10 and 11, and the date of testing.
  8. The quantity of ethylene oxide released to the atmosphere during the previous calendar year.
  9. The occurrence and duration of each malfunction of each emission control system subject to these Guidelines.
  10. The number of sterilization cycles performed during each malfunction of each emission control system subject to these Guidelines.
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