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Order Amending Schedule 4 to the Canadian Environmental Protection Act, 1999, Number 2 Statutory Authority Canadian Environmental Protection Act, 1999 Sponsoring Department Department of the Environment REGULATORY IMPACT ANALYSIS STATEMENT Description This Regulatory Impact Analysis Statement (RIAS) describes the listing of the Seeds Act (SA) in Schedule 4 of the Canadian Environmental Protection Act, 1999 (CEPA 99). Listing the SA in Schedule 4 of the CEPA 99 exempts plants with novel traits that are new biotechnology products under the SA from additional notification and assessment for toxicity under the CEPA 99. The CEPA 99 allows for substances regulated for uses under other Acts of Parliament and Regulations to be exempt from the CEPA 99 notification and toxicity assessment requirements if those Acts and Regulations provide for notification and assessment of "toxicity." More specifically, the other Acts and Regulations must provide for "notice to be given before manufacture, import or sale of the substance and for an assessment of whether it is toxic or capable of becoming toxic" (subsections 81(6) and 106(6) CEPA 99). The CEPA 99 differs from its predecessor (CEPA, 1988) in subsections 81(7) and 106(7). These subsections grant the Governor in Council with exclusive responsibility to determine whether the CEPA 99 criteria (subsections 81(6) and 106(6)) are met. If the other Act and Regulations meet these criteria to the satisfaction of the Governor in Council, they can be listed in Schedule 2 or 4 of the Act. The listing of an Act and Regulations in Schedule 2 or 4 of the CEPA 99 is considered proof that the criteria have been met. The listing of the Seeds Act under the CEPA 99 Schedule 4 will avoid a potential regulatory redundancy since both the CEPA 99 and the Seeds Regulations, Part V provide authority to carry out assessments of new substances for risks to human and environmental health. The listing of the Seeds Act under the CEPA 99 Schedule 4 means the seeds sector will continue to interact with the Canadian Food Inspection Agency (CFIA) and will not require a second assessment by Environment Canada and Health Canada. The following discussion shows that environmental and health protection dimensions of the Seeds Regulations, Part V are consistent with the CEPA 99 criteria in subsection 106(6) with respect to the confined or unconfined release of plants with novel traits (PNTs). The Seeds Regulations were promulgated to allow for the testing of seeds (plants) with novel traits in field trials under controlled (confined) conditions and to provide a mechanism for a thorough science-based assessment of the PNTs prior to unconfined release with respect to their safety in the environment prior to a complete environmental risk assessment being conducted by the Canadian Food Inspection Agency (CFIA). Under the existing Seeds Regulations, Part V, both confined and unconfined release of PNTs into the environment are regulated. The biotechnology industry (researchers in private companies, universities and other public institutions) use the "confined release system" to conduct scientific research on their PNTs by using field trials under conditions which are intended to minimize the risk of their PNTs from escaping into the environment and requiring an environmental risk assessment based on these conditions prior to "unconfined" release which requires a more complete environmental risk assessment being conducted by the CFIA. Notification Requirements under the CEPA 99 and the Seeds Regulations, Part V The New Substances Notification Regulations of the CEPA 99 are an integral part of the federal Government's national pollution prevention strategy. The notification regime serves to ensure that no new substances are introduced into the Canadian environment before an assessment of whether they are potentially toxic has been completed, and any appropriate or required control measures have been taken. The CEPA 99 approach to the control of new substances is both proactive and preventative, employing a pre-import or pre-manufacture notification and assessment process that considers the manufacture, use and disposal of the substance. When this process identifies a new substance that may pose a risk to health or the environment, the Act empowers the Minister of the Environment to intervene prior to or during the earliest stages of its introduction into Canada. This ability to act early makes the new substances program an essential component of the federal Government's approach to the management of toxic substances. Part II.1 (New Substances that are Organisms) of the New Substances Notification Regulations implements sections 104 to 114 of the CEPA 99. The Regulations require notification and assessment of new substances prior to their manufacture in Canada or import into Canada in order to determine whether the substance when entering into the environment would be "toxic" or be capable of becoming "toxic." This assessment considers all stages in the development of the substance from manufacture/import to disposal. Both the CEPA 1999 and the Seeds Regulations define biotechnology as the application of science and engineering to the direct or indirect use of living organisms or parts or products of living organisms in their natural or modified forms. Under the Seeds Regulations, Part V, "seeds" include seeds derived from biotechnology. Hence, PNTs are new substances, covered by both CEPA 1999 and under the Seeds Regulations, Part V. Under the Seeds Regulations, Part V, the release in Canada's environment of a PNT is prohibited without prior notification, assessment and approval. Section 109 stipulates that no person shall undertake either confined release or unconfined release of a PNT seed unless the person a) provides notification of the proposed release to the Minister of Agriculture and Agri-Food with appropriate information set out in section 110; and b) receives authorization from the Minister of Agriculture and Agri-Food for the release pursuant to section 111. Risk Assessment under the CEPA and the Seeds Regulations, Part V The CEPA 99 defines "toxic" as follows: "64. For the purposes of this Part and Part 6, except where the expression "inherently toxic" appears, a substance is toxic if it is entering or may enter the environment in a quantity or concentration or under conditions that (a) have or may have an immediate or long-term harmful effect on the environment or its biological diversity; (b) constitute or may constitute a danger to the environment on which life depends; or (c) constitute or may constitute a danger in Canada to human life or health." The New Substances assessment conducted under the CEPA 99 takes into account: - the identity of the organism, - if modified, details of the modification, - biological and ecological characteristics, - details respecting how the organism will be imported or manufactured, including equipment, locations, and disposal, - use information, - environmental fate information, - ecological effects information, including data from tests to determine whether the organism is capable of adverse effects on other organisms, and - human health effects information. The data requirements prescribed by the CFIA to assess risks to the environment are equivalent to those prescribed under the CEPA 1999. They are designed to generate a comprehensive set of information on potential hazards of the release of the PNT. Evaluation of extensive data makes it possible to determine the implications of the release of the seed to the environment, including the potential of the plant to become a weed of agriculture or to be invasive of natural habitats, the potential for gene-flow to wild relatives, the potential for the plant to become a plant pest, the potential impact of the plant or its gene products on non-target species (including humans), and the potential impact on biodiversity. The Seeds Regulations, Part V take a proactive approach similar to that of CEPA in that the PNT will be authorized for environmental release only if there is sufficient scientific evidence to show that a product does not pose unacceptable health or environmental risks and that it is not toxic, as defined in section 64 of the CEPA 1999. The listing of the Seeds Regulations, Part V under Schedule 4 of the CEPA 99 is appropriate and will prevent duplication between the two Acts. Alternatives The Minister of Agriculture and Agri-Food, under the Seeds Act, has the responsibility for assessing the release of seeds for environmental safety, including risks to animal and human health. If the Seeds Act were not listed in the CEPA 99 Schedule 4, there would be a duplication of effort because PNTs would be subject to assessment under the CEPA 99 in addition to being assessed under the Seeds Act. Therefore, it is proposed that the Seeds Act be listed under Schedule 4 of the CEPA 99. Benefits and Costs The proposed amendment to the CEPA 99 Schedule 4 is not anticipated to incur any additional costs to industry. The benefits of the proposed amendment to industry, the public and the environment is that clarity is provided and the Government demonstrates that the federal regulatory regime for new substances with respect to environmental and human health assessment is consistently applied, without duplication. Consultation Consultation of the relationship of the CEPA 99 to other Acts with respect to the assessment of new substances did not commence with the coming into force of the CEPA 99. However, it does mark the beginning of a more public and open process to explain and analyse how other Acts and Regulations meet the CEPA 99's criteria for exemption. In 1986, the Environmental Contaminants Act Amendments Consultative Committee (ECAACC) was the stakeholder forum for consultation on designing the program for notification and assessment of "new substances" that would later be incorporated into the CEPA, 1988. In their final report, the Committee recommended that substances regulated under other Acts that were subject to environmental and/or health hazard assessment be exempt from the CEPA notification requirements. In 1997, the New Substance Notification Regulations were amended. As part of the amendment, subsection 3(1), which applies to chemicals, polymers and products of biotechnology, was added to clarify that duplication of regulatory efforts should be avoided when possible, specifically: 3. (1) For greater certainty, these Regulations do not apply in respect of a substance that is manufactured or imported for a use that is regulated under any other Act of Parliament that provides for notice to be given prior to the manufacture, import or sale of the substance and for an assessment of whether it is toxic, including, without limiting the generality of the foregoing, the Feeds Act, Fertilizers Act, Health of Animals Act, Pest Control Products Act and Seeds Act. These Regulations were pre-published for public comment in the Canada Gazette, Part I (August 17, 1996). Final regulations appeared in the Canada Gazette, Part II, in March 1997, and included the following text in the RIAS for that amendment: "Following pre-publication, various stakeholders submitted comments to the Department of the Environment. The main issue that emerged from the comments was an interpretation of subsection 3(1) of the amendment, that products regulated under the Seeds Act, Fertilizers Act, Feeds Act, Health of Animals Act, and Pest Control Products Act are exempted from notification under the NSN Regulations. Stakeholders were concerned that this subsection could be misinterpreted as an exemption provision in and of itself and could undermine the legal test for equivalency established by the CEPA. After consideration and discussion with other federal government departments, the Department of the Environment decided to retain this subsection of the Regulations because (a) subsection 3(1) is only meant to clarify, not to determine an exemption; (b) the exemption is determined only by paragraph 26(3)(a) of CEPA [1988]; and (c) the determination of exemption is the sole responsibility of the Minister responsible for the other Act." The Seeds Regulations were also pre-published for public comment in the Canada Gazette, Part I (August 17, 1996). In the alternatives section of the Regulatory Impact Analysis Statement, the regulation of PNTs was proposed under the Seeds Regulations or under the CEPA. The Seeds Regulations were the alternative chosen. The provisions provided in CEPA 99 for listing other Acts in Schedule 4, which is the purpose of this Order, are intended to provide clarity to the application of the exemption clause which will aid in addressing the above concerns. Compliance and Enforcement There are no compliance and enforcement actions relevant to the CEPA 99 resulting from listing of the Seeds Act and Regulations on Schedule 4 of the CEPA 99. Compliance with the Acts that are listed will continue to be conducted by the responsible departments. Contacts Cynthia Wright, Director General, Strategic Priorities Directorate, Environment Canada, Place Vincent Massey, 16th Floor, 351 Saint-Joseph Boulevard, Hull, Quebec K1A 0H3, (819) 953-6830; and Arthur Sheffield, Team Leader, Regulatory and Economic Analysis Branch, Policy and Communications Environment Canada, Les Terrasses de la Chaudière, 22nd Floor, 10 Wellington Street, Hull, Quebec K1A 0H3, (819) 953-1172. PROPOSED REGULATORY TEXT Notice is hereby given, pursuant to subsection 332(1) of the Canadian Environmental Protection Act, 1999 ( S.C. 1999, c. 33), that the Governor in Council proposes, pursuant to paragraph 106(7)(a) of that Act, to make the annexed Order Amending Schedule 4 to the Canadian Environmental Protection Act, 1999, Number 2. Any person may, within 60 days after the publication of this notice, file with the Minister of the Environment comments with respect to the proposed Order or a notice of objection requesting that a board of review be established under section 333 of that Act and stating the reasons for the objection. All comments and notices must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to the Director General of Strategic Priorities, Environmental Protection Service, Department of the Environment, Ottawa, Ontario K1A 0H3. A person who provides information to the Minister of the Environment may submit with the information a request for confidentiality under section 313 of that Act. Ottawa, January 30, 2001 MARC O'SULLIVAN Assistant Clerk of the Privy Council ORDER AMENDING SCHEDULE 4 TO THE CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999, NUMBER 2 AMENDMENT 1. Schedule 4 to the Canadian Environmental Protection Act, 1999 ( S.C. 1999, c. 33) is amended by adding the following after item 1: *** TABLE EXTRACTED *** COMING INTO FORCE 2. This Order comes into force on the day on which it is registered.
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