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Draft Living Modified Organisms Regulations

Overview of the Regulatory Proposal

Interpretation

1.

The definitions in this section apply in these regulations:

"Biosafety Clearing-House"
means the Biosafety Clearing-House established under Article 20 of the Protocol. (Centre d'échange pour la prévention des risques biotechnologiques)
"competent national authority"
means the competent national authority or authorities designated under Article 19 of the Protocol. (autorité nationale compétente)
"contained use"
has the same meaning as in Article 3(b) of the Protocol. (utilisation en milieu confiné)
"exporter"
means any person in Canada who exports or who arranges for a living modified organism to be exported from Canada. (exportateur)
"living modified organism"
means any living organism that possesses a novel combination of genetic material obtained through the use of:
  1. in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or
  2. fusion of cells beyond the taxonomic family,
that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection. (organisme vivant modifié)
"Party"
means a Party to the Protocol. (Partie)
"Protocol"
means the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, signed by Canada on April 19, 2001, as amended from time to time. (Protocole)
"transboundary movement"
means a movement of a living modified organism from one Party to another Party and extends to a movement between a Party and a non-Party for the purposes of Section 11. (mouvement transfrontière)

Application

2.

  1. These regulations do not apply to a living modified organism which is a pharmaceutical for humans.
  2. Sections 3 to 10 do not apply to a living modified organism if the organism is an agricultural product within the meaning of section 2 of the Canada Agricultural Products Act

Notification of First Intentional Transboundary Movement

3.

  1. Subject to subsections (2) to (5), with respect to the first intentional transboundary movement of a living modified organism for intentional introduction into the environment of the Party of import, the exporter shall notify the competent national authority of the Party of import in writing with the information set out in Schedule 1, prior to the transboundary movement.
  2. The exporter may notify the competent national authority of the Party of import of the transboundary movement of a living modified organism at the same time as the movement takes place, if the Party of import has in advance of the transboundary movement so specified to the Biosafety Clearing House or in writing to the exporter.
  3. If in advance of a transboundary movement, the Party of import has specified to the Biosafety Clearing House or in writing to the exporter that imports of particular living modified organisms to it are not subject to the requirements of subsection (1), the exporter shall not be subject to subsection (1) but shall provide to the Party of import the information that the Party of import has specified to the Biosafety Clearing House or in writing to the exporter.
  4. The intentional transboundary movement of a living modified organism identified in a decision of the Conference of the Parties serving as the meeting of the Parties to the Protocol as being not likely to have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health is not subject to subsection (1).
  5. The intentional transboundary movement of a living modified organism is not subject to subsection (1) if the organism is in transit in Canada.
  6. For greater certainty, the first transboundary movement of a particular living modified organism accepted for intentional introduction into the environment of a particular Party of import is considered to be an acceptance of that living modified organism in respect of that Party of import for all Parties.
  7. The notification or information referred to in subsections (1) and (3) shall be accompanied by a declaration in the form set out in Part 1 of Schedule 2 signed by the exporter certifying that the information provided under subsections (1) or (3) is accurate.

4. At the same time as the exporter complies with section 3, the exporter shall send to the Minister by registered mail a copy of the information provided in items (a) to (d) and (l) of Schedule 1 and a copy of the declaration provided under subsection 3(7) which were sent to the competent national authority of the Party of import.

Declaration - Additional Information

5. If additional information is provided by the exporter referred to in subsections 3(1) or (3) in response to a request for additional information from the Party of import, the exporter shall provide a declaration to accompany the information in the form set out in Part 1 of Schedule 2 signed by the exporter certifying that the additional information is accurate.

Records

6. The exporter referred to in subsections 3(1) or (3) shall keep at its principal place of business in Canada for a period of 5 years:

(a) a copy of the documents provided under sections 3 and 5 to the Party of import; and

(b) any acknowledgement of receipt of notification and decision provided to the exporter by the Party of import in writing.

Documentation - Direct Use as Food or Feed, or for Processing

7. An exporter shall include with every intentional transboundary movement of a living modified organism intended for direct use as food or feed, or for processing, documentation identifying the following information:

(a) the statement "may contain living modified organisms intended for direct use as a food or feed, or for processing, that are not intended for intentional introduction into the environment"; and

(b) name, address and telephone number of the person or organization in possession of further information regarding the living modified organism.

Documentation - Contained Use

8. An exporter shall include with every intentional transboundary movement of a living modified organism intended for contained use, documentation stipulating the following information:

(a) the statement "contains living modified organisms destined for contained use";

(b) requirements for the safe handling, storage, transport and use of the living modified organism;

(c) name, address and telephone number of the person or organization in possession of further information regarding the living modified organism; and

(d) name and address of the person or institution to whom the living modified organism is consigned.

Documentation - General

9.

(1) An exporter shall have documentation accompanying every intentional transboundary movement of a living modified organism, including those for intentional release in the environment, other than an organism intended for direct use as food or feed or for processing or for contained use, indicating the following information:

(a) the statement "contains living modified organisms";

(b) identity of the living modified organism including

(i) the common name of the living modified organism , and

(ii) the taxonomic identity to the genus, species and, if known, to the subspecies level;

(c) a description of the living modified organism including the traits and characteristics of the living modified organism resulting from the modifications made to the parent organism;

(d) requirements for the safe handling, storage, transport and use of the living modified organism;

(e) name, address and telephone number of the person or organization in possession of further information regarding the living modified organism;

(f) name and address of the importer; and

(g) name and address of the exporter.

(2) The exporter shall also have a declaration in the form set out in Part 2 of Schedule 2 accompanying every intentional transboundary movement of a living modified organism certifying that the movement is in conformity with the requirements of these regulations.

Required Disposal of a Living Modified Organisms

10. Should a Party of import request that Canada dispose of a living modified organism under Article 25(2) of the Protocol, the Minister may require the exporter of the living modified organism to dispose of the organism.

Unintentional Transboundary Movements

11. Where there occurs a release of a living modified organism that leads to or may lead to an unintentional transboundary movement of the organism, any person who owns or has the charge, management or control of the organism immediately before its release into the environment or causes or contributes to the release or increases the likelihood of the release, shall advise the Minister in writing of the release without delay, including the following information in the notice:

  1. location, date and time of the release;
  2. the quantity of the living modified organism released in the environment;
  3. characteristics and traits of the living modified organism relevant to risks on the conservation and sustainable use of biological diversity, taking into account risks to human health;
  4. taxonomic identity of the living modified organism, if known;
  5. circumstances of the release;
  6. use of the living modified organism in Canada;
  7. any information about the possible adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health;
  8. possible risk management measures, if available;
  9. (i) name, address and telephone number of the contact point for further information; and
  10. (j) any other information with respect to the living modified organism or its release that the person may have.

Coming Into Force

12. These regulations come into force on the later of

  1. the day of the coming into force of the Protocol, or
  2. the 90th day after the date of deposit of the instrument of ratification by Canada.

SCHEDULE 1

(subsection 3(1) and section 4)

As in the Protocol

SCHEDULE 2

(subsection 3(7), section 5 and subsection 9(2))

PART 1

DECLARATION

I hereby certify that the information provided to (Party of import) with respect to the living modified organism (brief description) is true, accurate and complete.

__________________________________

Signature of the exporter

Please print name _________________________________

Title _________________________________

Date _________________________________

PART 2

DECLARATION

I hereby certify that the transboundary movement of the living modified organism (brief description) to (the Party of import) is in conformity with the Living Modified Organisms Regulations.

_________________________________

Signature of the exporter

Please print name _________________________________

Title _________________________________

Date _________________________________

Overview of the Regulatory Proposal

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