q-2, r. 12 - Regulation respecting biomedical waste

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Updated to 18 July 2013
This document has official status.
chapter Q-2, r. 12
Regulation respecting biomedical waste
Environment Quality Act
(chapter Q-2, ss. 31, 46, 70, 115.27, 115.34 and 124.1).
DIVISION I
SCOPE
1. This Regulation applies to the following types of biomedical waste:
(1)  human anatomical waste consisting of body parts or organs, but excluding teeth, hair, nails, blood and biological liquids;
(2)  animal anatomical waste consisting of carcasses, body parts or organs, but excluding teeth, hair, claws, feathers, blood and biological liquids;
(3)  non-anatomical waste consisting of any of the following:
(a)  a sharp or breakable object having been in contact with blood or with a biological liquid or tissue and having been used in medical, dental or veterinary care or in a medical or veterinary biology laboratory, or such an object used in thanatopraxy;
(b)  biological tissue, cell culture, microbial culture, or material in contact with such tissue or culture, used in a medical or veterinary biology laboratory;
(c)  live vaccine;
(d)  a blood container or material that has been saturated with blood and used in medical care, in a medical biology laboratory or in thanatopraxy;
(4)  biomedical waste from outside Québec, including any of the types of biomedical waste referred to in paragraphs 1 to 3.
O.C. 583-92, s. 1.
2. This Regulation does not apply to:
(1)  a human corpse or a part of the human body governed by sections 58 to 63 or 69 to 71 of the Regulation respecting the Act respecting medical laboratories, organ and tissue conservation and the disposal of human bodies (chapter L-0.2, r. 1) or by section 3 of the Burial Act (chapter I-11);
(2)  animal anatomical waste governed by section 3 of the Animal Health Protection Act (chapter P-42), by sections 47 to 49 of the Health of Animals Act (S.C. 1990, c. 21), by section 33.8 or 33.9 of the Food Products Act (chapter P-29) or by sections 6.4.1.16, 7.1.1 to 7.1.9, 7.3.1 to 7.4.14 or 9.3.1.14 of the Regulation respecting food (chapter P-29, r. 1);
(3)  animal anatomical waste from hunting, fishing or trapping activities;
(4)  non-anatomical biomedical waste referred to in subparagraphs b and d of paragraph 3 of section 1, from home medical care;
(5)  non-anatomical biomedical waste from domestic activities.
O.C. 583-92, s. 2.
3. Section 14, the second paragraph of section 15 and sections 25, 37 to 39, 45 to 51, 63 and 64 do not apply to an operator of a system that transports less than 50 kg of biomedical waste per month.
The operator is not required to keep the biomedical waste at a temperature less than 4 ºC.
O.C. 583-92, s. 3; O.C. 787-96, s. 1; O.C. 492-2000, s. 4.
4. This Regulation applies in a reserved area or an agricultural zone established under the Act respecting the preservation of agricultural land and agricultural activities (chapter P-41.1).
O.C. 583-92, s. 4.
DIVISION II
MANAGEMENT OF BIOMEDICAL WASTE
§ 1.  — General
5. Anatomical biomedical waste shall be treated by incineration.
O.C. 583-92, s. 5.
6. Non-anatomical biomedical waste shall be treated by disinfection or incineration.
O.C. 583-92, s. 6.
7. Biomedical waste from outside Québec shall be treated by incineration.
O.C. 583-92, s. 7.
8. Equipment used to treat, store or transport biomedical waste, as well as the equipment referred to in section 29, shall be kept in good working order.
O.C. 583-92, s. 8.
9. Ash from the incineration of biomedical waste shall be put into rigid, sealed, airtight containers after being extinguished and cooled.
O.C. 583-92, s. 9.
10. Biomedical waste shall not be mechanically compressed.
O.C. 583-92, s. 10.
11. Biomedical waste shall not be discharged into a sewer system.
O.C. 583-92, s. 11.
12. The operator of a biomedical waste generation site shall keep an up-to-date register in which he shall enter each week the type and quantity of biomedical waste generated.
O.C. 583-92, s. 12.
13. The operator of a facility that treats biomedical waste by disinfection or incineration or that stores biomedical waste shall keep a daily register of the following information:
(1)  the type of biomedical waste treated or stored;
(2)  the address of the place of origin of the waste;
(3)  the quantity of waste treated or stored;
(4)  the storage time;
(5)  the name of the persons authorized to have access to the site referred to in section 17;
(6)  the operating instructions for the disinfection equipment;
(7)  the number of hours for which each piece of equipment used for disinfection and incineration has been used and any operating irregularities.
O.C. 583-92, s. 13; O.C. 492-2000, s. 4.
14. The operator of a system that transports biomedical waste shall keep a daily register indicating:
(1)  the type of biomedical waste transported;
(2)  the quantity of biomedical waste transported;
(3)  the address of the place of origin and of the destination of the biomedical waste.
O.C. 583-92, s. 14; O.C. 492-2000, s. 4.
15. On 1 April of each year, the operator of a biomedical waste generation site shall prepare a report in the form in Schedule I.
The operator of a facility that treats biomedical waste by disinfection or incineration off its generation site, of a facility that stores biomedical waste off its generation site or of a system that transports biomedical waste shall, on that date, prepare a report in the form in Schedule II.
O.C. 583-92, s. 15; O.C. 492-2000, s. 4.
16. Every person required to keep the registers or prepare the reports provided for in sections 12 to 15 shall keep them for at least 3 years from the date of the last entry.
O.C. 583-92, s. 16.
17. A site at which biomedical waste is stored or treated by disinfection or incineration shall be padlocked or bolted and access to the site shall be prohibited, except to duly authorized persons identified in the register provided for in section 13.
O.C. 583-92, s. 17.
18. The operator of a facility that treats biomedical waste by disinfection or incineration in a vehicle equipped for that purpose shall, on the 15th day of each month, send in writing to the Minister of Sustainable Development, Environment and Parks a schedule and an itinerary of the disinfection or incineration operations planned for the following month.
O.C. 583-92, s. 18; O.C. 492-2000, s. 4.
§ 2.  — Management of biomedical waste on its generation site
§§ 1.  — Scope
19. This Subdivision applies to the operator of a biomedical waste generation site.
O.C. 583-92, s. 19.
§§ 2.  — Storage of biomedical waste on its generation site
20. Sections 55 and 66 of the Environment Quality Act (chapter Q-2) do not apply to biomedical waste stored on its generation site.
O.C. 583-92, s. 20; O.C. 492-2000, s. 4.
21. Biomedical waste shall not be in contact with other types of residual materials.
O.C. 583-92, s. 21; O.C. 492-2000, s. 4.
§§ 3.  — Removal of biomedical waste from its generation site
22. Biomedical waste destined for shipment from its generation site shall be put into rigid, sealed, airtight containers, which shall be perforation resistant if they contain biomedical waste referred to in subparagraph a of paragraph 3 of section 1.
The biomedical waste shall be kept refrigerated at less than 4ºC.
O.C. 583-92, s. 22.
23. An identification label conforming to Schedule III shall be duly filled out and affixed by the shipper to the outside of each biomedical waste container.
The label shall measure at least 20 cm by 20 cm.
O.C. 583-92, s. 23.
24. Anatomical biomedical waste shall be shipped to a holder of a certificate of authorization for the operation of a facility that treats biomedical waste by incineration or that stores biomedical waste.
Non-anatomical biomedical waste shall be shipped to a holder of a certificate of authorization for the operation of a facility that treats biomedical waste by disinfection or incineration or that stores biomedical waste.
This section does not apply to waste destined for treatment outside Québec.
O.C. 583-92, s. 24; O.C. 492-2000, s. 4.
25. Biomedical waste shall be consigned only to a holder of a certificate of authorization for the operation of a system that transports biomedical waste.
O.C. 583-92, s. 25; O.C. 492-2000, s. 4.
26. (Revoked).
O.C. 583-92, s. 26; O.C. 787-96, s. 2.
§ 3.  — Management of biomedical waste off its generation site
§§ 1.  — Scope
27. This Subdivision applies to any person or municipality that establishes, modifies or operates a facility that treats biomedical waste by disinfection or incineration off its generation site or that stores biomedical waste off its generation or treatment site.
O.C. 583-92, s. 27; O.C. 492-2000, s. 4.
§§ 2.  — Site requirements
28. A building intended for storing or treating biomedical waste by disinfection or incineration shall be designed in such manner that waste is loaded and unloaded directly from inside the building to the vehicle and from the vehicle to inside the building.
O.C. 583-92, s. 28.
29. Equipment for cleaning containers and vehicles used to transport biomedical waste shall be set up on the operation site of a facility that stores or treats biomedical waste.
O.C. 583-92, s. 29; O.C. 492-2000, s. 4.
§§ 3.  — Receiving of biomedical waste
30. (Revoked).
O.C. 583-92, s. 30; O.C. 787-96, s. 2.
31. Biomedical waste shall be unloaded from the transportation vehicle directly into the building in which it is to be stored or treated.
O.C. 583-92, s. 31.
32. The operator of a facility that treats or stores biomedical waste shall refuse delivery of biomedical waste if the conditions provided for in sections 10, 22 and 23 have not been complied with.
O.C. 583-92, s. 32; O.C. 492-2000, s. 4.
33. Biomedical waste shall be kept at a temperature less than 4 ºC.
O.C. 583-92, s. 33.
§§ 4.  — Removal of biomedical waste
34. Sections 24 and 25 apply, with the necessary modifications, to the removal of biomedical waste from a storage site and to its shipment to a treatment site.
O.C. 583-92, s. 34.
§§ 5.  — Temporary or permanent shutdown of a facility that treats biomedical waste by disinfection or incineration or that stores biomedical waste
35. The operator of a facility that treats biomedical waste by disinfection or incineration or that stores biomedical waste who permanently ceases operations or suspends operations for at least 4 days shall not take delivery of biomedical waste for the duration of the cessation or suspension of operations.
O.C. 583-92, s. 35; O.C. 492.2000, s. 4.
36. The operator of a facility that treats biomedical waste by disinfection or incineration or that stores biomedical waste shall, prior to permanently ceasing operations,
(1)  notify the Minister in writing of the date on which operations will shut down and file a timetable with the Minister at least 30 days prior to the beginning of shutdown operations;
(2)  remove all remaining biomedical waste and other residual materials, including ash, from the ground, from buildings and from equipment, in accordance with sections 24 and 25 of the Regulation respecting the landfilling and incineration of residual materials (chapter Q-2, r. 19) and, to the extent that that Regulation maintains their application, with the Regulation respecting solid waste (chapter Q-2, r. 13) as well as, where applicable, hazardous materials, in accordance with the Regulation respecting hazardous materials (chapter Q-2, r. 32);
(3)  clean the inside of the equipment and buildings using a disinfectant; and
(4)  inform the Minister in writing of the completion of the work.
O.C. 583-92, s. 36; O.C. 1310-97, s. 151; O.C. 492-2000, s. 4; O.C. 451-2005, s. 174.
§ 4.  —  Systems that transport biomedical waste
O.C. 583-92, Sd. 4; O.C. 492-2000, s. 4.
37. The operator of a system that transports biomedical waste shall ensure that vehicles or containers used to transport biomedical waste serve only for that purpose.
O.C. 583-92, s. 37; O.C. 492-2000, s. 4.
38. The operator shall affix, to the sides and to the rear of the vehicle used, a sign conforming to Schedule IV, showing the international symbol.
The sign shall be permanent, shall be visible at all times and shall measure at least 50 cm by 50 cm.
O.C. 583-92, s. 38; O.C. 492-2000, s. 4.
39. The operator shall equip the vehicle with:
(1)  a refrigeration system capable of keeping the biomedical waste contained in the vehicle at less than 4 ºC at all times;
(2)  a collecting basin to contain leakage from the waste;
(3)  compartments made of a non-porous material designed in such manner as to facilitate cleaning operations.
O.C. 583-92, s. 39.
40. An operator shall refuse to transport biomedical waste if the requirements of sections 10, 22, 23 and 33 have not been complied with.
Section 24 applies, with the necessary modifications, in respect of the removal of biomedical waste from its generation, treatment or storage site.
The compartment containing the biomedical waste shall be padlocked or bolted and the biomedical waste shall be kept refrigerated at less than 4 ºC until unloaded.
O.C. 583-92, s. 40.
41. (Revoked).
O.C. 583-92, s. 41; O.C. 787-96, s. 2.
42. (Revoked).
O.C. 583-92, s. 42; O.C. 787-96, s. 2.
43. An operator shall not transfer biomedical waste from one vehicle to another during transport.
Notwithstanding the foregoing, the operator shall transfer the waste in the event of a breakdown liable to result in a spill of biomedical waste or of a substance discharged therefrom.
O.C. 583-92, s. 43.
44. Where biomedical waste or a substance discharged therefrom is released into the environment during transport, the operator shall, without delay:
(1)  stop the spill;
(2)  recover the waste and remove any contaminated matter that cannot be cleaned up on site; and
(3)  notify the Minister.
O.C. 583-92, s. 44.
45. After biomedical waste has been unloaded, the operator shall clean, using a disinfectant, the collecting basin, the inside of the compartment and the containers used to transport the waste.
Cleaning shall be carried out using the equipment referred to in section 29.
O.C. 583-92, s. 45.
DIVISION III
CERTIFICATE OF AUTHORIZATION
O.C. 583-92, Div. III; O.C. 492-2000, s. 4.
46. An applicant for a certificate of authorization for the setting up or modifying of a facility that stores or treats biomedical waste by incineration or a system that transports biomedical waste shall:
(1)  file a written application with the Minister;
(2)  furnish, in addition to the information and documents required under other provisions of the Act or its regulations, the information and documents required under section 47 or 48;
(2.1)  provide an attestation approved by an engineer within the meaning of section 1 of the Engineers Act (chapter I-9), according to which the planned design and operation of the equipment does not contravene the Act or its regulations;
(3)  (paragraph revoked).
O.C. 583-92, s. 46; O.C. 492-2000, s. 4; O.C. 441-2008, s. 6.
47. An application for a certificate of authorization for the setting up or modifying of a facility that stores or treats biomedical waste by incineration shall contain:
(1)  in the case of a natural person, his name, address and telephone number;
(2)  in the case of a partnership or a legal person, its name, its head office, the position of the person who signed the application, and a certified copy of a document from the board of directors or from the partners authorizing the filing of the application;
(3)  in the case of a partnership, the name, domicile and address of the partners or the name of a legal person associated therewith, as well as the head office of the legal person;
(4)  in the case of a legal person, the name, domicile and address of the directors and officers;
(5)  in the case of a municipality, a certified copy of a municipal resolution authorizing the filing of the application;
(6)  the cadastral designation of the lots on which the facility is to be set up or modified;
(7)  a certified copy of the document giving the applicant a right of ownership or use of the equipment to be used in the operations planned;
(8)  an up-to-date geographic map or aerial photograph, with the scale indicated, of the territory within a 2-km radius of the lots referred to in paragraph 6 and showing the following:
(a)  the limits of the lots in question;
(b)  the current use and zoning of the territory in question;
(9)  a plan showing the following, where applicable;
(a)  the dimensions and area of the lots in question;
(b)  the location of existing and planned equipment and buildings;
(c)  the location of waste loading and unloading areas and of areas for parking the vehicles used for those purposes;
(d)  the location of areas for cleaning vehicles and containers;
(e)  the location and capacity of waste storage areas;
(10)  the plans and specifications of the equipment and buildings and of any device or works to control, contain or prevent environmental contamination;
(11)  a description of the project, comprising a description of the technical characteristics of the project or activity for which the application is filed, the extent of the region served by the project and an evaluation of atmospheric emissions, of anticipated liquid discharge, of the quantity of biomedical waste covered by the application and of other waste, including ash, to be generated by the activity for which the application is filed;
(12)  a description of the method of operating the facility for which the application is filed, of the method of operating the equipment and of the manner of disposing of the biomedical waste and other residual materials, including ash and liquid discharge, to be generated by that operation;
(13)  an emergency prevention and procedures plan containing the following information:
(a)  the points within the biomedical waste storage or treatment site at which a contaminant within the meaning of section 1 of the Act may be emitted into the environment;
(b)  measures to be taken to prevent spills of biomedical waste, contaminant emissions, fires, or accidents liable to affect the environment;
(c)  measures to be taken to stop environmental contamination at its source, to eliminate environmental effects and to repair environmental damage;
(d)  the name, address and telephone number of a natural person residing less than 30 km from the installations and responsible for giving emergency access to the site to the Minister’s representatives and to the fire department of the municipality in which the equipment and buildings are located;
(14)  measures to be taken in the event that operations are cut back or ceased for longer than 4 days; and
(15)  plans and specifications for the equipment used to clean vehicles and biomedical waste containers.
In addition, where the application for a certificate of authorization made by a person concerns a facility that treats biomedical waste by incineration off its generation site, it must include the guarantee referred to in section 56.
O.C. 583-92, s. 47; O.C. 492-2000, s. 4.
48. An application for a certificate of authorization for the setting up or modifying of a system that transports biomedical waste shall contain the following information and documents:
(1)  the information and documents mentioned in paragraphs 1 to 5, 7, 11 and 12 and in subparagraphs b and c of paragraph 13 of section 47;
(2)  the type of biomedical waste to be transported;
(3)  the type and number of vehicles and containers that the applicant plans to use;
(4)  a copy of the registration certificate and the serial number of each vehicle used to transport biomedical waste;
(5)  the capacity of each vehicle and each container, by weight and volume;
(6)  the type of refrigeration equipment in each vehicle;
(7)  the materials of which the inside of each vehicle compartment is made and a description of the collecting basin for leaks; and
(8)  the address at which the vehicles used to transport biomedical waste are to be stored.
O.C. 583-92, s. 48; O.C. 492-2000, s. 4.
49. (Revoked).
O.C. 583-92, s. 49; O.C. 492-2000, s. 4; O.C. 441-2008, s. 7.
50. The certificate of authorization indicates that it was issued under section 55 of the Act, shows the date of its issue and the name of its holder, and describes the type of activity planned, the property used for that activity and the location of the property.
O.C. 583-92, s. 50; O.C. 492-2000, s. 4.
51. Paragraphs 1 and 3 of section 46, paragraphs 1 to 7, 9 to 11 and 13 to 15 of section 47 and section 50 apply with the necessary modifications to an application for a certificate of authorization issued under section 55 of the Act for the setting up, modifying or operating of a facility that treats biomedical waste by disinfection.
For the treatment of biomedical waste by disinfection in a vehicle equipped for that purpose, paragraphs 1 to 5, 7, 10 and 11 and subparagraphs a to c of paragraph 13 of section 47 and paragraphs 3, 4 and 8 of section 48 apply with the necessary modifications to the application.
In addition to the information and documents required by this section, the application shall include a description of the method of operating the facility and the equipment, a description of the methods to be used to determine the optimal operating conditions for the equipment and to verify the effectiveness of the treatment, as well as a description of the manner of disposing of the biomedical waste, of the other residual materials and of the liquid discharge from the operation.
O.C. 583-92, s. 51; O.C. 492-2000, s. 4; O.C. 441-2008, s. 8.
DIVISION III.1
GUARANTEE
O.C. 583-92, Sd. 2; O.C. 492-2000, s. 4.
52. (Revoked).
O.C. 583-92, s. 52; O.C. 492-2000, s. 4.
53. (Revoked).
O.C. 583-92, s. 53; O.C. 492-2000, s. 4.
54. (Revoked).
O.C. 583-92, s. 54; O.C. 492-2000, s. 4.
55. (Revoked).
O.C. 583-92, s. 55; O.C. 492-2000, s. 4.
56. The operation by a person of a facility that treats biomedical waste by incineration off its generation site is subject to the setting up of a guarantee complying with sections 57 to 61. The guarantee shall be kept in force for all the duration of the operation.
The amount of the guarantee is calculated on the basis of hourly incineration capacity, at the rate of $300,000 per metric ton.
This section does not apply where a guarantee is required under Chapter V of the Regulation respecting the landfilling and incineration of residual materials (chapter Q-2, r. 19) or, to the extent that that Regulation maintains its application, under section 17 of the Regulation respecting solid waste (chapter Q-2, r. 13).
O.C. 583-92, s. 56; O.C. 492-2000, s. 4; O.C. 451-2005, s. 175.
57. The guarantee shall ensure:
(1)  that the operator intends to incinerate biomedical waste in accordance with the Act and with the Regulations made thereunder;
(2)  that the Minister will be reimbursed for the cost of work that he carries out or causes to be carried out in the cases referred to in section 113, 115 or 115.1 of the Act.
O.C. 583-92, s. 57; O.C. 492-2000, s. 4.
58. The guarantee shall be provided by the operator, or by a third person on the operator’s behalf, in the form of:
(1)  cash or a certified cheque made out to the Minister of Finance;
(2)  bearer bonds, cashable at any time, issued or guaranteed by the Government of Canada, of Québec or of the person’s province of origin, or by a municipality, and having a market value at least equal to the amount of the guarantee required;
(3)  a solidary deed in the form of security or of a guarantee policy, with a waiver of the benefits of discussion and of division, issued by a banking institution, a savings and credit union or an insurer holding a permit issued under Chapter I of Title IV of the Act respecting insurance (chapter A-32); or
(4)  an irrevocable letter of credit issued by a banking institution or a savings and credit union.
O.C. 583-92, s. 58; O.C. 492-2000, s. 4.
59. Where a guarantee is provided in cash, by certified cheque or in the form of bearer bonds, the sum of money or the securities shall remain on deposit with the Minister of Finance for the duration of the operation and for not more than 12 months following the final termination of the operation, to ensure that the obligations provided for in section 36 are complied with.
O.C. 583-92, s. 59; O.C. 492-2000, s. 4.
60. Where a guarantee is provided in the form of security, a guarantee policy or a letter of credit, it shall have a term of at least 12 months.
The guarantee shall include a clause fixing at not less than 6 months following the expiry of the guarantee the time period for filing a claim relative to failure, prior to the expiry of the guarantee, of the operator to perform a secured action or a claim relative to failure of the operator to comply with the provisions of section 36.
At least 15 days prior to the expiry of the guarantee, the operator shall forward a renewed guarantee for a term of at least 12 months. In the absence of a renewed guarantee, the operator shall provide an equivalent guarantee in one of the forms described in section 58.
O.C. 583-92, s. 60; O.C. 492-2000, s. 4.
61. Where a guarantee contract contains a revocation or cancellation clause, it shall also contain a provision to the effect that the guarantor will inform the Minister of a revocation or cancellation at least 2 months prior to the day on which that clause is to take effect.
O.C. 583-92, s. 61.
62. (Revoked).
O.C. 583-92, s. 62; O.C. 492-2000, s. 4.
63. (Revoked).
O.C. 583-92, s. 63; O.C. 492-2000, s. 4.
64. Within 30 days following any change in the information or documents furnished for the issue of a certificate of authorization, or any change in the guarantee required under sections 57 to 61, an operator shall notify the Minister in writing of that change.
O.C. 583-92, s. 64; O.C. 492-2000, s. 4.
DIVISION III.2
MONETARY ADMINISTRATIVE PENALTIES
O.C. 660-2013, s. 1.
64.1. A monetary administrative penalty of $250 in the case of a natural person or $1,000 in other cases may be imposed on any person who fails
(1)  to comply with the minimum measurement of a label prescribed by the second paragraph of section 23;
(2)  to inform the Minister in writing of the completion of the work in accordance with paragraph 4 of section 36;
(3)  to comply with the conditions relating to a sign prescribed by the second paragraph of section 38.
O.C. 660-2013, s. 1.
64.2. A monetary administrative penalty of $350 in the case of a natural person or $1,500 in other cases may be imposed on any person who fails
(1)  to keep the register prescribed by section 12, 13 or 14, according to the conditions and frequencies provided for therein;
(2)  to prepare a report that complies with the requirements of section 15 on the date provided for in that section;
(3)  to keep a report or register referred to in section 16 for the period provided for in that section;
(4)  to send in writing to the Minister the information prescribed by section 18 on the date provided for in that section;
(5)  to affix or to fill out an identification label that complies with the requirements of the first paragraph of section 23;
(6)  to affix a sign that complies with the requirements of the first paragraph of section 38;
(7)  to notify the Minister in writing of any change referred to in section 64 within the period provided for in that section.
O.C. 660-2013, s. 1.
64.3. A monetary administrative penalty of $500 in the case of a natural person or $2,500 in other cases may be imposed on any person who fails
(1)  to comply with the conditions prescribed by section 9 in respect of ash from the incineration of biomedical waste;
(2)  to comply with the safety conditions prescribed by section 17 as to the site at which biomedical waste is stored or treated;
(3)  to design the building intended for storing or treating biomedical waste referred to in section 28 in accordance with that section;
(4)  to set up cleaning equipment referred to in section 29 in accordance with that section;
(5)  to unload biomedical waste in accordance with the requirements of section 31;
(6)  to comply with the safety conditions of the compartments prescribed by the third paragraph of section 40;
(7)  to carry out cleaning referred to in section 45 after biomedical waste has been unloaded in accordance with that section;
(8)  to set up a guarantee or to keep it in force in accordance with section 56, or to forward a renewed guarantee or to provide an equivalent guarantee in accordance with the third paragraph of section 60.
The penalty provided for in the first paragraph may also be imposed on any person who, in contravention of section 32 or the first paragraph of section 40, delivers or transports biomedical waste where the conditions provided for in any of sections 10, 22 or 23 or, where applicable, section 33 are not complied with.
O.C. 660-2013, s. 1.
64.4. A monetary administrative penalty of $750 in the case of a natural person or $3,500 in other cases may be imposed on any person who fails
(1)  to keep in good working order the equipment referred to in section 8;
(2)  to keep biomedical waste at the temperature provided for in the second paragraph of section 22, section 33 or the third paragraph of section 40;
(3)  to ensure that vehicles or containers used to transport biomedical waste serve only for that purpose in accordance with section 37;
(4)  to equip a vehicle used to transport biomedical waste with either of the elements provided for in section 39.
The penalty provided for in the first paragraph may also be imposed on any person who
(1)  mechanically compresses biomedical waste in contravention of section 10;
(2)  stores biomedical waste in contravention of the requirements of section 21;
(3)  puts biomedical waste referred to in the first paragraph of section 22 into containers that do not comply with the conditions provided for in that section;
(4)  transfers biomedical waste from one vehicle to another during transport in contravention of section 43.
O.C. 660-2013, s. 1.
64.5. A monetary administrative penalty of $1,000 in the case of a natural person or $5,000 in other cases may be imposed on any person who fails
(1)  to notify the Minister in writing of the date on which the operations of a facility referred to in section 36 will shut down or to file a timetable with the Minister of shutdown operations within the period provided for in paragraph 1 of that section;
(2)  to carry out the removal or cleaning work prescribed by paragraph 2 or 3 of section 36 on the conditions provided for in that section;
(3)  to notify the Minister if, during transport, biomedical waste or a substance is released into the environment in accordance with paragraph 3 of section 44.
O.C. 660-2013, s. 1.
64.6. A monetary administrative penalty of $1,500 in the case of a natural person or $7,500 in other cases may be imposed on any person who fails
(1)  to treat biomedical waste in accordance with the requirements of section 5, 6 or 7 according to their nature or place of origin;
(2)  to ship or to consign biomedical waste referred to in section 24 or 25 to a holder of a certificate of authorization referred to therein.
The penalty provided for in the first paragraph may also be imposed on any person who, in contravention of section 35, receives biomedical waste where the treatment or storage operations of biomedical waste have permanently ceased or are suspended.
O.C. 660-2013, s. 1.
64.7. A monetary administrative penalty of $2,000 in the case of a natural person or $10,000 in other cases may be imposed on any person who
(1)  discharges biomedical waste into a sewer system in contravention of section 11;
(2)  fails to take any of the measures prescribed by paragraph 1 or 2 of section 44 in the cases and on the conditions provided for in that section.
O.C. 660-2013, s. 1.
DIVISION IV
PENAL SANCTIONS
O.C. 583-92, div. IV; O.C. 660-2013, s. 2.
65. Every person who contravenes the second paragraph of section 23, paragraph 4 of section 36 or the second paragraph of section 38 commits an offence and is liable, in the case of a natural person, to a fine of $1,000 to $100,000 or, in other cases, to a fine of $3,000 to $600,000.
O.C. 583-92, s. 65; O.C. 787-96, s. 3; O.C. 660-2013, s. 3.
66. Every person who contravenes any of sections 12 to 18, the first paragraph of section 23 or 38 or section 64 commits an offence and is liable, in the case of a natural person, to a fine of $2,000 to $100,000 or, in other cases, to a fine of $6,000 to $600,000.
O.C. 583-92, s. 66; O.C. 787-96, s. 4; O.C. 660-2013, s. 3.
66.1. Every person who
(1)  contravenes section 9, 17, 28, 29, 31 or 32, the first paragraph of section 40, section 45 or 56 or the third paragraph of section 60,
(2)  fails to comply with the safety conditions prescribed by the third paragraph of section 40,
commits an offence and is liable, in the case of a natural person, to a fine of $2,500 to $250,000 or, in other cases, to a fine of $7,500 to $1,500,000.
O.C. 660-2013, s. 3.
66.2. Every person who
(1)  contravenes section 8, 10, 21, 22, 33, 37, 39 or 43,
(2)  fails to keep biomedical waste at the temperature provided for in the third paragraph of section 40,
commits an offence and is liable, in the case of a natural person, to a fine of $4,000 to $250,000 or, in other cases, to a fine of $12,000 to $1,500,000.
O.C. 660-2013, s. 3.
66.3. Every person who
(1)  contravenes any of paragraphs 1 to 3 of section 36 or paragraph 3 of section 44,
(2)  pursuant to this Regulation, makes a declaration, communicates information or files a document that is false or misleading,
commits an offence and is liable, in the case of a natural person, to a fine of $5,000 to $500,000 or, despite article 231 of the Code of Penal Procedure (chapter C-25.1), to a maximum term of imprisonment of 18 months, or to both the fine and imprisonment, or, in other cases, to a fine of $15,000 to $3,000,000.
O.C. 660-2013, s. 3.
66.4. Every person who contravenes any of sections 5 to 7, 24, 25 or 35 commits an offence and is liable, in the case of a natural person, to a fine of $8,000 to $500,000 or, despite article 231 of the Code of Penal Procedure (chapter C-25.1), to a maximum term of imprisonment of 18 months, or to both the fine and imprisonment, or, in other cases, to a fine of $24,000 to $3,000,000.
O.C. 660-2013, s. 3.
66.5. Every person who contravenes section 11 or paragraph 1 or 2 of section 44 commits an offence and is liable, in the case of a natural person, to a fine of $10,000 to $1,000,000 or, despite article 231 of the Code of Penal Procedure (chapter C-25.1), to a maximum term of imprisonment of 3 years, or to both the fine and imprisonment, or, in other cases, to a fine of $30,000 to $6,000,000.
O.C. 660-2013, s. 3.
66.6. Every person who contravenes any other requirement imposed by this Regulation also commits an offence and is liable, where no other penalty is provided for by this Division or the Environment Quality Act (chapter Q-2), to a fine of $1,000 to $100,000 in the case of a natural person or, in other cases, to a fine of $3,000 to $600,000.
O.C. 660-2013, s. 3.
67. (Omitted).
O.C. 583-92, s. 67; O.C. 787-96, s. 5.
ANNUAL BIOMEDICAL WASTE GENERATION REPORT

_________________________________________________________________________________
| |
| GENERATOR |
| |
| Name: _____________________________________ Province/State: ________________ |
| |
| Address: __________________________________ Country: _______________________ |
| |
| __________________________________ Postal Code: ___________________ |
| |
| __________________________________ |
| |
| PERSON IN CHARGE |
| |
| Name: _____________________________________ Signature: _____________________ |
| |
| Title: ____________________________________ Date: __________________________ |
| |
| Telephone No.: _________________ |
| |
| TREATMENT EQUIPMENT ON SITE |
| |
| □ Incineration capacity: ______kg/hr Authorized by the MDDEPQ: ____/_____|
| |
| □ Disinfection capacity: ______kg/hr Authorized by the MDDEPQ: ____/_____|
| year month |
|_________________________________________________________________________________|
| |
| CLASS 1 - HUMAN ANATOMICAL WASTE |
| |
| (a) Total quantity generated: ______kg (c) Total quantity incinerated |
| on site: ______kg |
| |
| (b) Quantity shipped out: ______kg |
| |
| Carrier(s) Permit No. Consignee(s) Permit No. |
| ___________________________________________ ________________________________ |
| |
| ___________________________________________ ________________________________ |
| |
| ___________________________________________ ________________________________ |
| |
| ___________________________________________ ________________________________ |
| |
|________________________________________________________________________________ |
| |
| CLASS 2 - ANIMAL ANATOMICAL WASTE |
| |
| (a) Total quantity generated: ______kg (c) Total quantity incinerated |
| on site: ______kg |
| |
| (b) Quantity shipped out: ______kg |
| |
| Carrier(s) Permit No. Consignee(s) Permit No. |
| __________________________________________ _________________________________|
| |
| ___________________________________________ _________________________________|
| |
| ___________________________________________ _________________________________|
| |
| ___________________________________________ _________________________________|
| |
|_________________________________________________________________________________|
| |
| CLASS 3 - NON-ANATOMICAL WASTE |
| |
| (a) Total quantity generated: ______kg (c) Total quantity incinerated |
| on site: ______kg |
| |
| (b) Quantity shipped out: ______kg (d) Total quantity disinfected |
| on site: ______kg |
| |
| Carrier(s) Permit No. Consignee(s) Permit No. |
| ___________________________________________ ________________________________ |
| |
| ___________________________________________ ________________________________ |
| |
| ___________________________________________ ________________________________ |
| |
| ___________________________________________ ________________________________ |
| |
| _______________________________________________________________________________ |
O.C. 583-92, Sch. I.
ANNUAL BIOMEDICAL WASTE MANAGEMENT REPORT

□ Transport □ Disinfection □ Storage □ Incineration

________________________________________________________________________________
| |
|OPERATOR |
| |
|Name: _______________ Municipality: ________________ Postal Code: ______________|
| |
|Address: ____________ Province/State:_______________ |
| |
| ____________ Country: _____________________ |
| |
|PERSON IN CHARGE |
| |
|Name: _______________ Signature: ___________________ Telephone No.: ____________|
| |
|Title: ______________ Date: ________________________ |
| |
|________________________________________________________________________________|
| | | | |
| GENERATOR | TOTAL | CARRIER | CONSIGNEE |
| | QUANTITY | | |
| | (Kg) | □ Same as | □ Same as |
| | | above or: | above or: |
|___________________|________________|______________________|____________________|
| | | | |
|Name: _____________| |Name: _____________ |Name: ______________|
| | | | |
|Address: __________| |Address: __________ |Address: ___________|
| | | | |
| __________| | __________ | ___________|
| | | | |
| __________| | __________ | ___________|
| | | | |
| | |Permit No.: _______ |Permit No.: _______ |
|___________________|________________|______________________|____________________|
| | | | |
| | | | |
|Name: _____________| |Name: _____________ |Name: ______________|
| | | | |
|Address: __________| |Address: __________ |Address: ___________|
| | | | |
| __________| | __________ | ___________|
| | | | |
| __________| | __________ | ___________|
| | | | |
| | |Permit No.: _______ |Permit No.: _______ |
|___________________|________________|______________________|____________________|
| | | | |
| | | | |
|Name: _____________| |Name: _____________ |Name: ______________|
| | | | |
|Address: __________| |Address: __________ |Address: ___________|
| | | | |
| __________| | __________ | ___________|
| | | | |
| __________| | __________ | ___________|
| | | | |
| | |Permit No.: _______ |Permit No.: _______ |
|___________________|________________|______________________|____________________|
O.C. 583-92, Sch. II.
IDENTIFICATION LABEL FOR A GENERATOR OF BIOMEDICAL WASTE
O.C. 583-92, Sch. III.
SIGN TO BE AFFIXED PERMANENTLY TO A VEHICLE USED TO TRANSPORT BIOMEDICAL WASTE
O.C. 583-92, Sch. IV; O.C. 492-2000, s. 4.
REFERENCES
O.C. 583-92, 1992 G.O. 2, 2503
O.C. 787-96, 1996 G.O. 2, 2931
O.C. 1310-97, 1997 G.O. 2, 5199
O.C. 492-2000, 2000 G.O. 2, 2090
O.C. 451-2005, 2005 G.O. 2, 1182
O.C. 441-2008, 2008 G.O. 2, 1331
O.C. 660-2013, 2013 G.O. 2, 1748