Bill C-494: An Act to amend the Canadian Environmental Protection Act, 1999 (nanotechnology)

C-494 Third Session, Fortieth Parliament, 59 Elizabeth II, 2010 HOUSE OF COMMONS OF CANADA BILL C-494 An Act to amend the Canadian Environmental Protection Act, 1999 (nanotechnology) first reading, March 10, 2010 Mr. Julian 402351 SUMMARY This enactment amends the Canadian Environmental Protection Act, 1999 and adds a new Part 6.1 primarily to implement procedures for the investigation and assessment of nanomaterials. Also available on the Parliament of Canada Web Site at the following address:http://www.parl.gc.ca 3rd Session, 40th Parliament, 59 Elizabeth II, 2010 house of commons of canada BILL C-494 An Act to amend the Canadian Environmental Protection Act, 1999 (nanotechnology) Her Majesty, by and with the advice and consent of the Senate and House of Commons of Canada, enacts as follows: 1. The second to last paragraph of the preamble of the Canadian Environmental Protection Act, 1999 is replaced by the following: Whereas the Government of Canada recognizes the need to protect the environment, including its biological diversity, and human health, by ensuring the safe and effective use of biotechnology and nanotechnology; 2. Paragraph 2(1)(j.1) of the Act is replaced by the following: (j.1) protect the environment, including its biological diversity, and human health, by ensuring the safe and effective use of biotechnology and nanotechnology; 3. Subsection 3(1) of the Act is amended by adding the following in alphabetical order: “nanomaterial”« nanomaté­riau » “nanomaterial” has the same meaning as in section 115.1. “nanotechnology”« nanotechnologie » “nanotechnology” means the application of science and engineering in the design, characterization, production and application of structures, devices and systems by controlled manipulation of size and shape at the nanometer (atomic, molecular and macromolecular) scale that produces structures, devices and systems with at least one novel/superior characteristic or property. 4. Section 44 of the Act is amended by adding the following after subsection (4): Nanotechnology (5) The Ministers shall conduct research or studies relating to nanotechnology, including on nanomaterials, nanoparticles and the following subjects: (a) identifying sources, environmental fate, transport, and exposure; (b) understanding human health and ecolog- ical effects to inform risk assessments and test methods; (c) developing risk assessment approaches; and (d) preventing and mitigating risks. 5. Section 48 of the Act is renumbered as subsection 48(1) and is amended by adding the following: National inventory – nanotechnology (2) The Ministers shall establish a national inventory respecting nanotechnology, including nanomaterials and nanoparticles, using the information collected under sections 46 and 71 and any other information to which the Ministers have access, and may use any information to which the Ministers have access to establish any other inventory of information. 6. Section 50 of the Act is replaced by the following: Publication of inventory 50. Subject to subsection 53(4), the Minister shall publish the national inventory of releases of pollutants and the national inventory of nanotechnology, nanomaterials and nanoparticles in any manner that the Minister considers appropriate and may publish or give notice of the availability of any other inventory of information established under section 48, in any manner that the Minister considers appropriate. 7. The Act is amended by adding the following after section 115: PART 6.1 NANOTECHNOLOGY Definitions 115.1 The definitions in this section apply in this Part. “nanomaterial”« nanomaté- riau » “nanomaterial” means a substance that is a product of nanotechnology and includes nanoparticles. “significant new activity”« nouvelle activité » “significant new activity” includes, in respect of a nanomaterial, any activity that results or may result in (a) the entry or release of the nanomaterial into the environment in a quantity or concentration that, in the Ministers’ opinion, is significantly greater than the quantity or concentration of the nanomaterial that previously entered or was released into the environment; or (b) the entry or release of the nanomaterial into the environment or the exposure or potential exposure of the environment to the nanomaterial in a manner and circumstances that, in the Ministers’ opinion, are significantly different from the manner and circumstances in which the nanomaterial previously entered or was released into the environment or of any previous exposure or potential exposure of the environment to the nanomaterial. Adding nanomaterials to Domestic Substances List 115.2 (1) The Minister shall, for the purposes of sections 74 and 115.3, add to the Domestic Substances List maintained under section 66 any nanomaterial if the Minister is satisfied that it (a) was manufactured in or imported into Canada by any person; and (b) entered or was released into the environment without being subject to conditions under this or any other Act of Parliament or of the legislature of a province. Amendment of List (2) Where the Minister includes a nanomaterial on the Domestic Substances List and subsequently learns that the requirements set out in paragraphs (1)(a) and (b) were not met, the Minister shall delete the substance from the List. Publication of List (3) The Minister shall publish in the Canada Gazette the Domestic Substances List and any amendment to the List. Designation (4) The Minister may, by order, designate any person or class of persons to exercise the powers and perform the duties and functions set out in this section. Manufacture or import of nanomaterials 115.3 (1) Where a nanomaterial is not spec- ified on the Domestic Substances List, no person shall manufacture or import the nanomaterial unless (a) the prescribed information with respect to the nanomaterial, accompanied by the prescribed fee, has been provided by that person to the Minister on or before the prescribed date; and (b) the period for assessing the information under section 115.5 has expired. Notification of significant new activity in respect of nanomaterial on List (2) Where a nanomaterial is specified on the Domestic Substances List with an indication that this subsection applies with respect to the nanomaterial, no person shall use, manufacture or import the nanomaterial for a significant new activity that is indicated on the List with respect to the nanomaterial unless (a) the person has provided the Minister with the prescribed information, on or before the date that is specified by the Minister or prescribed, accompanied by the prescribed fee; and (b) the period for assessing the information specified by the Minister or provided under section 115.5 has expired. Notification of significant new activity in respect of nanomaterial not on List (3) Where a nanomaterial is not specified on the Domestic Substances List and the Minister publishes a notice in the Canada Gazette indicating that this subsection applies with respect to the nanomaterial, no person shall use the nanomaterial for a significant new activity that is indicated in the notice unless (a) the person has provided the Minister with the prescribed information, on or before the date that is specified by the Minister or prescribed, accompanied by the prescribed fee; and (b) the period for assessing the information specified by the Minister or provided under section 115.5 has expired. Transfer of rights in respect of substance (4) Where prescribed information with respect to a nanomaterial has been provided under subsection (1), (2) or (3) by a person who subsequently transfers the right or privilege in relation to the nanomaterial for which the information was provided, the information is, subject to any conditions that may be prescribed, deemed to have been provided by the transferee of that right or privilege. Application (5) Subsections (1) to (3) do not apply to (a) a nanomaterial that is manufactured or imported for a use that is regulated under any other Act of Parliament that provides for notice to be given before the manufacture, import or sale of the nanomaterial and for an assessment of whether it is toxic or capable of becoming toxic; (b) a nanomaterial that is manufactured, used or imported under the conditions and in the circumstances prescribed as exempt from this section; or (c) impurities and contaminants related to the preparation of a nanomaterial. Governor in Council may amend Schedule 4.1 (6) For the purposes of the administration of this section, the Governor in Council has the exclusive responsibility for determining whether or not the requirements referred to in paragraph (5)(a) are met by or under an Act of Parliament referred to in that paragraph, or regulations made under that Act, and (a) if the Governor in Council determines that the requirements referred to in paragraph (5)(a) are met by or under an Act of Parliament referred to in that paragraph, or regulations made under that Act, the Govern- or in Council may by order add to Schedule 4.1 the name of that Act or those regulations, as the case may be, and the fact that an Act or regulations are listed in Schedule 4.1 is conclusive proof that the requirements referred to in paragraph (5)(a) are met; and (b) if the Governor in Council determines that the requirements referred to in paragraph (5)(a) are no longer met by or under an Act of Parliament, or regulations, listed in Schedule 4.1, the Governor in Council may by order delete from Schedule 4.1 the name of that Act or those regulations, as the case may be. Waiver of information requirements (7) On the request of any person to whom subsection (1), (2) or (3) applies, the Minister may waive any of the requirements to provide information under that subsection if (a) in the opinion of the Ministers, the information is not needed in order to determine whether the nanomaterial is toxic or capable of becoming toxic; (b) a nanomaterial is to be used for a prescribed purpose or manufactured at a location where, in the opinion of the Ministers, the person requesting the waiver is able to contain the nanomaterial so as to satisfactorily protect the environment and human health; or (c) it is not, in the opinion of the Ministers, practicable or feasible to obtain the test data necessary to generate the information. Publication of notice of waiver (8) The Minister shall publish in the Canada Gazette a notice stating the name of any person to whom a waiver is granted and the type of information to which it relates. Compliance with waiver (9) Where the Minister waives any of the requirements for information under paragraph (7)(b), the person to whom the waiver is granted shall not use, manufacture or import the nanomaterial unless it is for the purpose prescribed by regulations made under paragraph 115.11(1)(f) or at the location specified in the request for the waiver, as the case may be. Correction of information (10) A person who has provided information under this section, including for the purposes of a request for a waiver under subsection (7), or under section 115.4 or 115.6 shall notify the Minister of any corrections to the information as soon as possible after learning of them. Request for information previously waived (11) Where the Minister is notified of any corrections to information that was provided for the purposes of a request for a waiver under subsection (7), the Minister may, after consideration by the Ministers of those corrections, require the person to whom the waiver was granted to provide the Minister with the information to which the waiver related within the time specified by the Minister. Application of section 115.6 (12) Where the Ministers suspect, after considering (a) any corrections received under subsection (10), or (b) the information provided under subsection (11), that a nanomaterial is toxic or capable of becoming toxic, the Minister may exercise any of the powers referred to in paragraphs 115.6(1)(a) to (c). Prohibition of activity 115.4 (1) Where the Minister has reasonable grounds to believe that a person has used, manufactured or imported a nanomaterial in contravention of subsection 115.3(1), (2) or (3), the Minister may, in writing, require the person to provide the information referred to in that subsection and prohibit any activity involving the nanomaterial until the expiry of the period for assessing the information under section 115.5. Waiver of information requirements (2) On the request of any person required under subsection (1) to provide information, the Minister may waive any of the requirements for prescribed information if one of the conditions specified in paragraphs 115.3(7)(a) to (c) is met and, in that case, subsections 115.3(8) to (12) apply with respect to the waiver. Assessment of information 115.5 (1) Subject to subsection (4), the Ministers shall, within the prescribed assessment period, assess information provided under subsection 115.3(1), (2) or (3) or paragraph 115.6(1)(c) or otherwise available to them in respect of a nanomaterial in order to determine whether it is toxic or capable of becoming toxic. Assessment of information (2) Subject to subsections (3) and (4), the Ministers shall assess information provided under subsection 115.4(1) or otherwise available to them in respect of a nanomaterial in order to determine whether it is toxic or capable of becoming toxic. Time for assessment (3) An assessment of information under subsection (2) shall be made following the date on which the information is provided within a period that does not exceed the number of days in the prescribed assessment period. Extension of assessment period (4) Where the Ministers are of the opinion that further time is necessary to assess any information, the Minister may, before the expiry of the assessment period referred to in subsection (1) or (3), extend the period for assessing the information, but the extension shall not exceed the number of days in the prescribed assessment period. Notification of extension (5) Where the Minister extends the period for assessing information, the Minister shall, before the expiry of the assessment period referred to in subsection (1) or (3), notify the person who provided the information. Termination of period (6) The Minister may, before the expiry of the assessment period referred to in subsection (1) or (3), terminate the period for assessing information and, immediately before doing so, shall notify the person who provided the information. Action to be taken after assessment 115.6 (1) Where the Ministers have assessed any information under section 115.5 and they suspect that a nanomaterial is toxic or capable of becoming toxic, the Minister may, before the expiry of the period for assessing the information, (a) permit any person to manufacture or import the nanomaterial, subject to any conditions that the Ministers may specify; (b) prohibit any person from manufacturing or importing the nanomaterial; or (c) request any person to provide any additional information or submit the results of any testing that the Ministers consider necessary for the purpose of assessing whether the nanomaterial is toxic or capable of becoming toxic. Additional information or testing (2) Where the Minister requests additional information or test results under paragraph (1)(c), the person to whom the request is directed shall not manufacture or import the nanomaterial unless (a) the person provides the additional information or submits the test results; and (b) the period for assessing information under section 115.5 has expired or a period of 120 days after the additional information or test results were provided has expired, whichever is later. Variation of conditions and prohibitions (3) The Minister may vary or rescind a condition or prohibition specified or imposed under paragraph (1)(a) or (b). Expiry of prohibition (4) Any prohibition on the manufacture or import of a nanomaterial imposed under paragraph (1)(b) expires two years after it is imposed unless, before the expiry of the two years, the Governor in Council publishes in the Canada Gazette a notice of proposed regulations under section 115.11 in respect of the nanomaterial, in which case the prohibition expires on the day the regulations come into force. Publication of conditions and prohibitions (5) Where the Minister specifies, imposes, varies or rescinds any condition for or prohibition on the manufacture or import of a nanomaterial, the Minister shall publish in the Canada Gazette a notice setting out the condition or prohibition and the nanomaterial in respect of which it applies. Significant new activity 115.7 (1) Where the Ministers have assessed any information under section 115.5 in respect of a nanomaterial that is not on the Domestic Substances List and they suspect that a significant new activity in relation to that nanomaterial may result in the nanomaterial becoming toxic, the Minister may, within 90 days after the expiry of the period for assessing the information, publish in the Canada Gazette and in any other manner that the Minister considers appropriate a notice indicating that subsection 115.3(3) applies with respect to the nanomaterial. Variation or revocation (2) The Minister may, by notice published in the Canada Gazette, vary the significant new activities in relation to a nanomaterial in respect of which a notice has been given under subsection (1) or indicate that subsection 115.3(3) no longer applies with respect to that nanomaterial. Contents of notice (3) A notice referred to in subsection (1) or (2) shall indicate, by inclusion or exclusion, the significant new activities in relation to the nanomaterial in respect of which subsection 115.3(3) is to apply, and where regulations in respect of those significant new activities are not made under paragraphs 115.11(1)(c), (d) and (g), specify the information to be provided to the Minister under that subsection, the date on or before which it is to be provided and the period within which it is to be assessed under section 115.5. Notification of persons required to comply 115.8 Where a notice is published in the Canada Gazette under subsection 115.7(1) in respect of a nanomaterial, every person who transfers the physical possession or control of the nanomaterial shall notify all persons to whom the possession or control is transferred of the obligation to comply with subsection 115.3(3). Amendment of List 115.9 (1) The Minister shall add a nanomaterial to the Domestic Substances List within 120 days after the following conditions are met: (a) the Minister has been provided with information in respect of the nanomaterial under section 115.3 or 115.4 and any additional information or test results required under subsection 115.6(1); (b) the Ministers are satisfied that the nanomaterial has been manufactured in or imported into Canada by the person who provided the information prescribed for the purpose of this paragraph; (c) the period for assessing the information under section 115.5 has expired; and (d) no conditions specified under paragraph 115.6(1)(a) in respect of the nanomaterial remain in effect. Amendment of List (2) Where the Minister adds a nanomaterial to the Domestic Substances List and subsequently learns that the nanomaterial was not manufactured or imported as described in subsection (1), the Minister shall delete the nanomaterial from the List. Significant new activity (3) Where a nanomaterial is on the Domestic Substances List or is to be added to the List under subsection (1), the Minister may amend the List in respect of the nanomaterial to indicate that subsection 115.3(2) applies with respect to the nanomaterial or that it no longer applies or by varying the significant new activities in relation to the nanomaterial in respect of which subsection 115.3(2) is to apply. Contents of amendment (4) An amendment referred to in subsection (3) shall indicate, by inclusion or exclusion, the significant new activities in relation to the nanomaterial in respect of which subsection 115.3(2) is to apply, and where regulations in respect of those significant new activities are not made under paragraphs 115.11(1)(c), (d) and (g), specify the information to be provided to the Minister under that subsection, the date on or before which it is to be provided and the period within which it is to be assessed under section 115.5. Publication of masked name 115.10 Where the publication under this Part of the name of a nanomaterial would result in the release of confidential business information in contravention of section 314, the nanomate- rial shall be identified by a name determined in the prescribed manner. Regulations 115.11 (1) The Governor in Council may, on the recommendation of the Ministers, make regulations (a) respecting nanomaterials or establishing groups of nanomaterials for the purposes of the provision of information under section 115.3 or 115.4, including those that are research and development nanomaterials and nanomaterials manufactured only for export; (b) prescribing conditions and circumstances for the purpose of paragraph 115.3(5)(b); (c) respecting the information that shall be provided to the Minister under subsection 115.3(1), (2) or (3) or section 115.4 and the form and manner in which it is to be provided; (d) prescribing dates on or before which information shall be provided under subsection 115.3(1), (2) or (3); (e) respecting the maintenance of books and records for the administration of any regulation made under this section; (f) prescribing the purpose for which a nanomaterial must be used so as to permit the waiver of information requirements under subsection 115.3(7); (g) prescribing periods within which the Ministers shall assess information under subsection 115.5(1); (h) respecting the conditions, test procedures and laboratory practices to be followed in developing test data on a nanomaterial in order to comply with the information requirements of section 115.3 or 115.4 or requests for information under paragraph 115.6(1)(c); (i) prescribing information for the purpose of paragraph 115.9(1)(b); (j) prescribing the manner of determining a name for a nanomaterial for the purpose of section 115.10; and (k) generally for carrying out the purposes and provisions of this Part. Prescribed assessment period (2) For the purposes of sections 115.3 and 115.5, where no assessment period is prescribed or specified with respect to a nanomaterial, the prescribed assessment period is 120 days after the day the Minister is provided with the prescribed information. Prescription of conditions and circumstances (3) Regulations made under paragraph (1)(b) may prescribe conditions and circumstances in respect of a nanomaterial in terms of (a) whether or not the nanomaterial is a member of a group of nanomaterials established by regulations made under paragraph (1)(a); or (b) the purposes for which the nanomaterial is manufactured or imported. Prescription of information and assessment periods (4) Regulations made under paragraph (1)(c), (d) or (g) may prescribe information, dates or periods in respect of a nanomaterial in terms of (a) whether or not the nanomaterial is a member of a group of nanomaterials established by regulations made under paragraph (1)(a); (b) the purposes for which the nanomaterial is manufactured or imported; or (c) the conditions under which and the circumstances in which the nanomaterial is manufactured or imported. Other regulations 115.12 (1) Subject to subsection (2), the Governor in Council may, on the recommendation of the Ministers, make regulations (a) for the purposes of implementing an international agreement, (i) respecting nanomaterials, whether or not they are on the Domestic Substances List, and (ii) respecting the safety of the environment or human health, including, but not limited to, the safe transfer, handling and uses of any nanomaterial that is moved across a boundary; and (b) respecting the effective and safe use of nanomaterials in pollution prevention. Nanomaterials regulated under other Acts of Parliament (2) The Governor in Council shall not make a regulation under subsection (1) in respect of any nanomaterial if the regulation regulates an aspect of the nanomaterial that is regulated by or under any other Act of Parliament in a manner that provides, in the opinion of the Governor in Council, sufficient protection to the environment and human health. 8. The Act is amended by adding, after Schedule 4, the schedule set out in the schedule to this Act. SCHEDULE (Section 8) SCHEDULE 4.1 (Subsection 115.3(6)) ACTS AND REGULATIONS Item Column 1 Acts Column 2 Regulations 1. 2. 3. 4. 5. Published under authority of the Speaker of the House of CommonsAvailable from:Publishing and Depository ServicesPublic Works and Government Services Canada