Seeds Regulations (C.R.C., c. 1400)

103 A suspension of a licence shall remain in effect until

• (a) an inspector verifies that the operator has taken corrective measures; and

• (b) the Registrar notifies the operator in writing that the suspension is lifted.

• 104 (1) The Registrar shall not renew the licence of an operator whose licence has been suspended three times, unless, after the third suspension, the operator has successfully completed the applicable evaluations referred to in section 95.

• (2) [Repealed, SOR/2001-93, s. 15]

105 If an individual’s operator’s licence has been cancelled for a reason set out in any of paragraphs 100(b) to (e), the Registrar shall not issue an operator’s licence to the individual again unless 24 months have gone by since the cancellation and the individual satisfies the conditions referred to in sections 95 and 96.

106 [Repealed, SOR/97-534, s. 4]

PART VRelease of Seed

Interpretation

• 107 (1) In this Part,

  confined release

  confined release means release under conditions intended to minimize the establishment and spread, in the environment, of seed or of genetic material from plants derived from the seed, and the interaction of the seed or genetic material with the environment; (dissémination en milieu confiné)

  environment

  environment means the components of the Earth and includes

  • (a) air, land and water,

  • (b) all layers of the atmosphere,

  • (c) all organic and inorganic matter and living organisms, and

  • (d) the interacting natural systems that include components referred to in paragraphs (a) to (c); (environnement)

  novel trait

  novel trait, in respect of seed, means a characteristic of the seed that

  • (a) has been intentionally selected, created or introduced into a distinct, stable population of cultivated seed of the same species through a specific genetic change, and

  • (b) based on valid scientific rationale, is not substantially equivalent, in terms of its specific use and safety both for the environment and for human health, to any characteristic of a distinct, stable population of cultivated seed of the same species in Canada, having regard to weediness potential, gene flow, plant pest potential, impact on non-target organisms and impact on biodiversity; (caractère nouveau)

  release

  release means any discharge or emission of seed into the environment or exposure of seed to the environment and includes the growing and field testing of plants; (dissémination)

  unconfined release

  unconfined release means release on an unrestricted basis. (dissémination en milieu ouvert)

• (2) For the purposes of this Part, seed 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.

Exemptions

108 The following seed is exempt from the operation of this Part:

• (a) seed grown in Canada outside of containment before the coming into force of this Part in such a manner that the seed constitutes a distinct, stable population in the Canadian environment;

• (b) seed grown in containment in such a manner that there is no release into the environment of any genetic material from the plants derived from the seed; and

• (c) seed that is derived from seed referred to in paragraph (a), or from seed in respect of which an unconfined release has been authorized under paragraph 111(1)(b), and that is substantially equivalent, in terms of its specific use and safety both for the environment and for human health, to seed of the same species, having regard to weediness potential, gene flow, plant pest potential, impact on non-target organisms and impact on biodiversity.

Notification and Authorization

• 109 (1) Subject to subsections (2) to (4), no person shall undertake either the confined release or unconfined release of seed unless

  • (a) notification of the proposed release has been provided in writing to the Minister, accompanied by the information set out in section 110; and

  • (b) the Minister has authorized the release under section 111.

• (2) Subsection (1) does not apply in respect of seed of a variety that is registered under Part III.

• (3) Subsection (1) does not apply in respect of an unconfined release that was authorized by the Minister before the coming into force of this Part.

• (4) Where the accompanying information that is required to be provided to the Minister pursuant to paragraph (1)(a) in respect of a proposed confined release is the same as information that has already been provided to the Minister before the coming into force of this Part, or that is provided on or after the coming into force of this Part in relation to another notification or authorization, the information is not required to be provided again.

Information Requirements

• 110 (1) Subject to subsection (4), the accompanying information that is required to be provided to the Minister by a person pursuant to paragraph 109(1)(a) is the following:

  • (a) the name of the person or body responsible for the proposed release and the name of the person who will be in charge of carrying out the release;

  • (b) the purpose and objectives of the proposed release;

  • (c) the plants derived from the unmodified host seed;

  • (d) in the case of seed with a novel trait,

    • (i) the novel trait expressed by the plants derived from the modified seed and, where the novel trait was introduced from another species, details of the donor organism and of the methods of incorporation of the novel trait into the host seed, where applicable, and

    • (ii) the plants derived from the modified seed resulting from the introduction of the novel trait, including details relating to expression of the novel trait and the stability of the incorporation of the novel trait into the plants derived from the modified seed, and a comparison of the characteristics of the plants derived from the modified seed with those derived from the unmodified host seed;

  • (e) all other information and test data in respect of the plants referred to in paragraph (d) that are relevant to identifying the risk to the environment, including the risk to human health, and that are in the person’s possession or to which the person ought reasonably to have access;

  • (f) other government agencies, either Canadian or foreign, that have been provided with information in respect of the plants referred to in subparagraph (d)(ii), and the purpose for which the information was provided; and

  • (g) a description of the analytical methodologies followed in generating any submitted data, including quality control and quality assurance procedures.

• (2) In addition to the information referred to in subsection (1) and subject to subsection (4), the following accompanying information shall be provided to the Minister with any notification in respect of a proposed confined release:

  • (a) the proposed starting date, completion date and site of the confined release; and

  • (b) the proposed confined release protocol, including

    • (i) any confinement measures intended to mitigate the establishment and spread, in the environment, of the seed or of genetic material from plants derived from the seed, and the interaction of the seed or genetic material with the environment,

    • (ii) the monitoring plan and procedures to be followed both during and after the confined release,

    • (iii) the method to be used for the safe disposal of the seed and all progeny and plant material, and

    • (iv) the contingency plan to minimize any adverse effect of an accidental movement, outside of the confined release site, of the seed or genetic material from plants derived from the seed.

• (3) In addition to the information referred to in subsection (1) and subject to subsection (4), data describing potential interactions of the seed, or plants derived from the seed, with other life forms and an evaluation of the potential risk of harm posed to the environment, including the risk of harm posed to human health, as a result of those interactions shall be provided to the Minister with any notification in respect of a proposed unconfined release.

• (4) The information required by subparagraph (1)(d)(ii), paragraph (1)(e) or (g) or subsection (2) or (3) or any part of that information may be omitted if the Minister determines, on the basis of a written scientific rationale provided by the person referred to in subsection (1), that the information or part is not relevant or cannot practicably be obtained and is not required for the Minister’s decision under section 111, and notifies the person of that determination.

Decision of the Minister

• 111 (1) Subject to subsection (3), on receiving the notification provided under paragraph 109(1)(a), the Minister shall, after considering all relevant matters, including the information provided under that paragraph, and after evaluating the potential impact on and risk to the environment, including the potential impact on and risk to human health, posed by the proposed release

  • (a) authorize a confined release, where the proposed release could pose a risk to the environment, and may, where necessary in order to minimize the risk, impose conditions for the management of the risk;

  • (b) authorize an unconfined release, where the proposed release poses minimal risk to the environment, and may, where necessary in order to minimize the risk, impose conditions for the management of the risk; or

  • (c) refuse to authorize the release, where the proposed release poses an unacceptable risk to the environment.

• (2) In evaluating the risk to the environment for the purposes of subsection (1), the Minister shall

  • (a) consider such matters as

    • (i) the effects of the release on the environment, and

    • (ii) the magnitude of the exposure to the environment of the seed involved in the proposed release; and

  • (b) assess whether the seed is toxic.

• (3) The Minister may decide not to grant an authorization to a person under subsection (1) if the Minister has reasonable grounds for believing that the person may not comply with the conditions that would be imposed under that subsection in respect of the release or the requirements of section 111.1 in respect of the release.

Requirements Applying to Confined Release

• 111.1 (1) In this section, feed and livestock have the meanings assigned by section 2 of the Feeds Act.

• (2) Every person who is granted an authorization under paragraph 111(1)(a) for the confined release of seed with a novel trait, or who is in charge of carrying out the confined release,

  • (a) shall prevent the seed and any plants derived from the seed from entering into any feed for livestock, or entering into any food for humans;

  • (b) shall provide the Agency on request with copies of, or allow the Agency to examine,

    • (i) any contracts that the person enters into or has entered into with any persons in relation to the confined release, and

    • (ii) the person’s records with respect to the confined release, including records of any trials of the seed;

  • (c) shall be responsible for all costs of the actions required to remedy any situation caused by an accidental release of the seed; and

  • (d) shall be responsible for all costs of collection, storage and disposal of the seed and plants derived from the seed if the Minister requires the person to stop the confined release.

New Information Requirements

• 112 (1) Where, at any time after providing notification pursuant to paragraph 109(1)(a) or receiving authorization pursuant to subsection 111(1), a person becomes aware of any new information regarding risk to the environment, including risk to human health, that could result from the release, the person shall immediately provide the new information to the Minister.

• (1.1) For greater certainty, the new information referred to in subsection (1) includes new information with respect to the matters described in subsection 110(1) if that new information is in regard to risk to the environment, including risk to human health, that could result from the release.

• (2) Where the Minister, on the basis of the new information provided by a person pursuant to subsection (1), re-evaluates the potential impact on and risk to the environment, including the potential impact on and risk to human health, posed by the release and determines that there is

  • (a) a risk that is less than was apparent at the time of the original notification or at the time of any subsequent provision of new information since the original notification, the Minister may

    • (i) where the release has already been authorized, maintain the existing conditions respecting the release,

    • (ii) change the conditions respecting the release, or

    • (iii) remove any of the conditions respecting the release;

  • (b) a risk that is greater than was apparent at the time of the original notification or at the time of any subsequent provision of new information since the original notification, the Minister may

    • (i) impose additional conditions respecting the release, or

    • (ii) change the conditions respecting the release; or

  • (c) an unacceptable risk, the Minister shall

    • (i) refuse to authorize the release, or

    • (ii) where the release has already been authorized, cancel the authorization and require the person to stop the release and to take any appropriate action necessary to eliminate or minimize the risk.

• (3) In re-evaluating the risk to the environment on the basis of new information for the purposes of subsection (2), the Minister shall consider the matters referred to in paragraph 111(2)(a) and make the assessment referred to in paragraph 111(2)(b).