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

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chapter Q-2, r. 12
Regulation respecting biomedical waste
Environment Quality Act
(chapter Q-2, ss. 46, 70, 95.1, 115.27, 115.34 and 124.1).
O.C. 583-92; I.N. 2019-12-01.
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 hereinafter called “sharp medical object” ;
(a.1)  a sharp object having been in contact with blood or with a biological liquid or tissue from a person or an animal, from household activities or non-medical beauty care, such as an injection, provision of care, tattooing, piercing or electrolysis, hereinafter called “sharp household object” ;
(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; O.C. 871-2020, s. 1.
2. This Regulation does not apply to:
(1)  a body governed by the Funeral Operations Act (chapter A-5.02);
(1.1)  the carcass of a companion animal within the meaning of subparagraph 2 of the second paragraph of section 1 of the Animal Welfare and Safety Act (chapter B-3.1) that is in the possession of its owner;
(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;
(3.1)  animal anatomical waste from biology laboratories in educational institutions, provided that the carcasses or animal parts were not inoculated or preserved in preserving agents;
(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, other than the waste referred to in subparagraph a.1 of paragraph 3 of section 1.
O.C. 583-92, s. 2; S.Q. 2016, c. 1, s. 148; O.C. 871-2020, s. 2.
3. Section 14, the second paragraph of section 15, sections 37 to 39 and section 45 do not apply to the operator of a system that transports biomedical waste who is exempted from the application of section 22 of the Environment Quality Act (chapter Q-2) under the Regulation respecting the regulatory scheme applying to activities on the basis of their environmental impact (chapter Q-2, r. 17.1).
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; O.C. 871-2020, s. 3.
3.1. Only sections 10, 11, 21, 24 and 25 apply to any person having generated sharp household objects.
O.C. 871-2020, s. 4.
3.2. Only sections 10, 11, 21 and 22, the first paragraph of section 23, section 34 and paragraph 2 of section 36, with the necessary modifications, apply to an operator who recovers and stores sharp household objects for non-profit purposes to be shipped to a facility that may legally accept them.
O.C. 871-2020, s. 4.
3.3. Only section 13, the first paragraph of section 15, sections 16 and 32, and paragraph 2 of section 36, with the necessary modifications, apply to an operator who treats sharp household products by disinfection with an autoclave in a biomedical waste generation site.
O.C. 871-2020, 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.
Where non-anatomical biomedical waste from outside Québec is treated by disinfection, the treatment shall be carried out under the following conditions:
(1)  the treated biomedical waste is not landfilled in Québec; and
(2)  a label conforming to section 23 and indicating that the biomedical waste is from outside Québec is placed on each biomedical waste container by the operator of the treatment or storage facility.
O.C. 583-92, s. 6; O.C. 871-2020, s. 5.
7. (Revoked).
O.C. 583-92, s. 7; O.C. 871-2020, s. 6.
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, leakproof containers after being extinguished and cooled.
O.C. 583-92, s. 9; I.N. 2020-12-31.
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.
Where the biomedical waste is from outside Québec, the operator shall indicate separately in the register the information provided for in the first paragraph and indicate the address of the recipient where the biomedical waste is to be shipped.
O.C. 583-92, s. 13; O.C. 492-2000, s. 4; O.C. 871-2020, s. 7.
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. (Revoked).
O.C. 583-92, s. 18; O.C. 492-2000, s. 4; O.C. 871-2020, s. 8.
§ 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. Section 66 of the Environment Quality Act (chapter Q-2) does not apply to biomedical waste stored on its generation site.
O.C. 583-92, s. 20; O.C. 492-2000, s. 4; I.N. 2019-12-01; O.C. 871-2020, s. 9.
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, leakproof containers, which shall be perforation resistant if they contain sharp medical objects or sharp household objects.
The biomedical waste, other than sharp medical objects or sharp household objects, shall be kept refrigerated at less than 4ºC.
O.C. 583-92, s. 22; O.C. 871-2020, s. 10; I.N. 2020-12-31.
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 an operator of a facility that treats biomedical waste by incineration or of a facility that stores biomedical waste, in accordance with the Regulation respecting the regulatory scheme applying to activities on the basis of their environmental impact (chapter Q-2, r. 17.1).
Non-anatomical biomedical waste shall be shipped to an operator of a facility that treats biomedical waste by disinfection or incineration or of a facility that stores biomedical waste, in accordance with the Regulation respecting the regulatory scheme applying to activities on the basis of their environmental impact.
This section does not apply to waste destined for treatment outside Québec.
O.C. 583-92, s. 24; O.C. 492-2000, s. 4; I.N. 2019-12-01; O.C. 871-2020, s. 11.
25. Biomedical waste shall be consigned only to an operator of a system that transports biomedical waste, in accordance with the Regulation respecting the regulatory scheme applying to activities on the basis of their environmental impact (chapter Q-2, r. 17.1).
O.C. 583-92, s. 25; O.C. 492-2000, s. 4; I.N. 2019-12-01; O.C. 871-2020, s. 12.
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.
27.1. Only sections 32 to 34 and paragraph 2 of section 36 apply to a public health and social services institution that stores or treats biomedical waste with an autoclave, where that waste is exclusively from such institutions, in a quantity of less than 100 kg each per month.
O.C. 871-2020, s. 13.
§§ 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, other than sharp medical objects or sharp household objects, shall be kept at a temperature less than 4 ºC.
O.C. 583-92, s. 33; O.C. 871-2020, s. 14.
§§ 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 this Regulation, 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; O.C. 871-2020, s. 15.
§ 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, other than sharp medical objects or sharp household objects, contained in the vehicle at less than 4 °C 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; O.C. 871-2020, s. 16.
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, other than sharp medical objects or sharp household objects, shall be kept refrigerated at less than 4 °C until unloaded.
O.C. 583-92, s. 40; O.C. 871-2020, s. 17.
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
(Revoked)
O.C. 583-92, Div. III; O.C. 492-2000, s. 4; I.N. 2019-12-01; O.C. 871-2020, s. 18.
46. (Revoked).
O.C. 583-92, s. 46; O.C. 492-2000, s. 4; O.C. 441-2008, s. 6; I.N. 2019-12-01; O.C. 871-2020, s. 18.
47. (Revoked).
O.C. 583-92, s. 47; O.C. 492-2000, s. 4; I.N. 2019-12-01; O.C. 871-2020, s. 18.
48. (Revoked).
O.C. 583-92, s. 48; O.C. 492-2000, s. 4; I.N. 2019-12-01; O.C. 871-2020, s. 18.
49. (Revoked).
O.C. 583-92, s. 49; O.C. 492-2000, s. 4; O.C. 441-2008, s. 7.
50. (Revoked).
O.C. 583-92, s. 50; O.C. 492-2000, s. 4; I.N. 2019-12-01; O.C. 871-2020, s. 18.
51. (Revoked).
O.C. 583-92, s. 51; O.C. 492-2000, s. 4; O.C. 441-2008, s. 8; I.N. 2019-12-01; O.C. 871-2020, s. 18.
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 the Insurers Act (chapter A-32.1); 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 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; I.N. 2019-12-01; O.C. 871-2020, s. 19.
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)  (paragraph revoked);
(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; O.C. 871-2020, s. 20.
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 an operator referred to in one of those sections.
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; I.N. 2019-12-01; O.C. 871-2020, s. 21.
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 17, 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; O.C. 871-2020, s. 22.
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) Authorization No. Consignee(s) Authorization 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) Authorization No. Consignee(s) Authorization 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) Authorization No. Consignee(s) Authorization No. |
| ___________________________________________ ________________________________ |
| |
| ___________________________________________ ________________________________ |
| |
| ___________________________________________ ________________________________ |
| |
| ___________________________________________ ________________________________ |
| |
| _______________________________________________________________________________ |
O.C. 583-92, Sch. I; I.N. 2019-12-01.
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: ___________|
| | | | |
| __________| | __________ | ___________|
| | | | |
| __________| | __________ | ___________|
| | | | |
| | |Authorization No.: |Authorization No.: |
| | | __________ | ___________|
|___________________|________________|______________________|____________________|
| | | | |
| | | | |
|Name: _____________| |Name: _____________ |Name: ______________|
| | | | |
|Address: __________| |Address: __________ |Address: ___________|
| | | | |
| __________| | __________ | ___________|
| | | | |
| __________| | __________ | ___________|
| | | | |
| | |Authorization No.: |Authorization No.: |
| | | __________ | ___________|
|___________________|________________|______________________|____________________|
| | | | |
| | | | |
|Name: _____________| |Name: _____________ |Name: ______________|
| | | | |
|Address: __________| |Address: __________ |Address: ___________|
| | | | |
| __________| | __________ | ___________|
| | | | |
| __________| | __________ | ___________|
| | | | |
| | |Authorization No.: |Authorization No.: |
| | | __________ | ___________|
|___________________|________________|______________________|____________________|
O.C. 583-92, Sch. II; I.N. 2019-12-01.
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
S.Q. 2016, c. 1, s. 148
S.Q. 2018, c. 23, s. 811
O.C. 871-2020, 2020 G.O. 2, 2343A
© Gouvernement du Québec