JUS-96-002-01 (SOR/DORS):
Amendments to the Fertilizer Regulations -- Novel Supplements

HIS EXCELLENCY THE GOVERNOR GENERAL IN COUNCIL, on the recommendation of the Minister of Canadian Food Inspection Agency, pursuant to section 5 of the Fertilizers Act, is pleased hereby to amend the Fertilizers Regulations, C.R.C., c. 666, in accordance with the schedule hereto.

SCHEDULE

1. The heading before section 2 of the French version of the Fertilizers Regulations is replaced by the following:

definition and interpretation

2. (1) Section 2 of the Regulations is renumbered as subsection 2(1).

(2) Subsection 2(1) of the Regulations is amended by adding the following in alphabetical order:

"environment" means the components of the Earth and includes

air, land and water,
all layers of the atmosphere,
all organic and inorganic matter and living organisms, and
the interacting natural systems that include components referred to in paragraphs (a) to (c); (environnement)

"novel supplement" means

a supplement that is not registered and not exempt from registration, or
a supplement that is derived through biotechnology and has a novel trait; (supplément nouveau)

"novel trait", in respect of a supplement derived through biotechnology, means a characteristic of the supplement that

has been intentionally selected, created or introduced into a distinct, stable population [of supplements] of the same species through a specific genetic change, and
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 similar supplement that is in use as a supplement in Canada and is considered safe for use as a supplement in Canada; (caractère nouveau)

"release" means any discharge or emission of a supplement into the environment or exposure of a supplement to the environment; (dissémination)

(3) Section 2 of the Regulations is amended by adding the following after subsection (1):

(2) For the purposes of sections 23.1 to 23.4, a novel supplement is toxic if it is entering or may enter the environment in a quantity or concentration or under conditions

having or that may have an immediate or long-term harmful effect on the environment;
constituting or that may constitute a danger to the environment on which human life depends; or
constituting or that may constitute a danger in Canada to human life or health.

3. (1) Section 3 of the Regulations is renumbered as subsection 3(1).

(2) Subsection 3(1) of the Regulations is amended by adding the word "and" at the end of paragraph (e), by striking out the word "and" at the end of paragraph (f) and by repealing paragraph (g)1.

(3) Section 3 of the Regulations is amended by adding the following after subsection (1):

(2) Supplements that are imported into or manufactured in Canada for experimental purposes are exempt from the Act and all provisions of these Regulations except sections 23.1 to 23.4.

4. The Regulations are amended by adding the following after section 23:

Notification and Authorization of the release of Novel Supplements

23.1 (1) Subject to subsection (2), no person shall release a novel supplement unless the person

provides notification of the proposed release in writing to the Minister, accompanied by the information set out in section 23.2;
provides an undertaking in writing to the Minister to take responsibility for and assume the costs of the safe disposal of the novel supplement and all crops produced on the land or growing medium to which the novel supplement is applied; and
receives authorization from the Minister for the release pursuant to section 23.3.

(2) Where the accompanying information that is required to be provided to the Minister by paragraph (1)(a) in respect of the proposed release of a novel supplement is the same as information that has already been provided to the Minister before the coming into force of this section and sections 23.2 to 23.4, or that is provided on or after the coming into force of this section and sections 23.2 to 23.4 in relation to another notification or authorization, the information is not required to be provided again.

Information Requirements

23.2 (1) Subject to subsection (2), the accompanying information that is required to be provided by a person to the Minister pursuant to paragraph 23.1(1)(a) is the following:

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;
the purpose and objectives of the proposed release;
the proposed starting date, time period and site of the release;
the proposed release protocol, including
1. any confinement measures intended to mitigate the establishment and spread, in the environment, of the novel supplement and the interaction of the novel supplement with the environment,
2. the monitoring plan and procedures to be followed both during and after the release,
3. the method to be used for the safe disposal of the novel supplement and all crops produced on the land or growing medium to which the novel supplement is applied, and
4. the contingency plan to be followed to mitigate any adverse effect of an accidental release of the novel supplement on the environment, including any adverse effect on human health;
the identification and characterization of the novel supplement, including, in the case of a novel supplement that is derived through biotechnology and has a novel trait
1. the identification and characterization of the novel trait expressed by the novel supplement and, where the novel trait is introduced from another species, details of the host and donor organism and of the methods of incorporation of the novel trait into the novel supplement, where applicable, and
2. the identification and characterization of the novel supplement 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 novel supplement, and a comparison of the characteristics of the novel supplement with those of the unmodified supplement;
all other information and test data in respect of the novel supplement 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;
other government agencies, either Canadian or foreign, that have been provided with information in respect of the novel supplement, and the purpose for which the information was provided; and
a description of the analytical methodologies followed in generating any submitted data, including quality control and quality assurance procedures.

(2) The information required by paragraph (1)(e)(ii) or paragraph (1)(f) or (h) 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 23.3, and notifies the person of that determination.

Decision of the Minister

23.3 (1) On receiving the notification provided pursuant to paragraph 23.1(1)(a), the Minister shall, after considering all relevant matters, including the information provided pursuant to 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

authorize the release where there is minimal risk to the environment, and may, where necessary in order to minimize the risk, impose conditions for the management of the risk; or
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

consider such matters as
1. the effects of the proposed release on the environment, and
2. the magnitude of the exposure to the environment of the novel supplement involved in the proposed release; and
assess whether the novel supplement is toxic.

New Information Requirements

23.4 (1) Where, at any time after providing notification pursuant to paragraph 23.1(1)(a) or receiving authorization pursuant to paragraph 23.3(1)(a), a person becomes aware of any new information regarding risk to the environment, including risk to human health, that could result from the release of the novel supplement, the person shall immediately provide the new information to the Minister.

(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 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
1. where the release has already been authorized, maintain existing conditions respecting the release;
2. change the conditions respecting the release, or
3. remove any of the conditions respecting the release;
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
1. impose additional conditions respecting the release, or
2. require release under different conditions; or
an unacceptable risk, the Minister shall
1. refuse to authorize the release, or
2. 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.