Vol. 136, No. 39 — September 28, 2002

Living Modified Organisms Regulations

Statutory Authority

Canadian Environmental Protection Act, 1999

Sponsoring Departments

Department of the Environment

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

Description

The Living Modified Organisms Regulations will allow Canada to implement the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (the Protocol). The Protocol provides a framework for the assessment and management of the risks to the conservation and sustainable use of biodiversity from the transboundary movement of living modified organisms (LMOs). The full texts of the Protocol and Convention can be found at: www.biodiv.org/biosafety/protocol.asp and www.biodiv.org/convention/articles.asp.

Pursuant to subsection 115(1) of the Canadian Environmental Protection Act, 1999 (CEPA 1999) these Regulations will establish requirements that apply to the transboundary movement of living modified organisms.

Cartagena Protocol on Biosafety

Although Canada has signed, it has not yet ratified the Protocol. The Protocol will enter into force 90 days after 50 States have deposited instruments of ratification. There are indications that the Protocol is likely to enter into force by early 2003. A series of cross-Canada consultations on whether or not the Government of Canada should ratify the Protocol are planned for this September, where stakeholders will have further opportunity to comment on the proposed regulations. More information about the planned consultation can be obtained from www.bco.ec.gc.ca/Protocol/.

Intentional Introduction into the Environment:

Advanced Informed Agreement (AIA) and Documentation

The Protocol obliges Parties, either directly, or indirectly through exporters to provide advance notice including accurate information to the authority in an importing country which provides the basis for risk assessment prior to the first time transboundary movement of an LMO for intentional introduction into the environment. Exporters are also required to provide specified documentation to accompany all shipments of LMOs intended for intentional introduction into the environment.

Importing countries, whether a Party or a non-Party, may rely on domestic regulations to conduct risk assessments which may exceed the Protocol's requirements to conduct these risk assessments. Canadian exporters therefore may have to fulfil obligations above and beyond those of the Protocol when dealing with these Parties or non-Parties.

The AIA procedure is only required for the first intentional transboundary movement of a particular LMO for introduction into the environment. If the import were approved, subsequent imports of the same LMO from other Parties would not have to undergo the AIA procedure.

The Protocol does not specifically require an exporter to receive approval from a Party of import before the LMO leaves Canada. However, if an LMO is exported prior to receiving approval from the Party of import without AIA, it could risk having the entry of the LMO refused.

The AIA procedure does not apply to LMOs that the Parties have agreed are not likely to have adverse effects, LMOs intended for direct use as food or feed or for processing, LMOs destined for contained use and LMOs that are in transit. Parties may also exempt imports from AIA and choose instead to rely on their own regulatory procedures.

Food Feed and Processing (FFP): Documentation

The Protocol requires exporters to provide documentation accompanying each movement of LMOs intended for food, feed or processing, that specifies that it "may contain" LMOs, contains a declaration that the LMOs are not intended for intentional introduction into the environment, and provides a contact point for further information. A group of international experts on the Protocol has recommended that the "may contain" provision does not apply to the presence of adventitious material unintentionally present in the shipment.

Contained Use: Documentation

Transboundary movements of LMOs for contained use must be accompanied by documentation identifying them as LMOs, any specific requirements for safe handling, storage, transport and use, as well as contact information, including the consignee. Contained use, for example, could include operations in barns, greenhouses, containment pens, laboratories, industrial facilities, growth chambers or large-scale bioreactors.

Unintentional Transboundary Movements

A Party must notify another state if it is aware of an occurrence under its jurisdiction that has led to or is likely to lead to an unintentional transboundary movement of an LMO that is likely to have significant adverse effect on the other state's biodiversity. An unintentional transboundary movement could include events such as an accidental release, spill or the escape of LMO fish from containment pens.

Illegal Transboundary Movements

If a Party has received an illegal transboundary movement of an LMO, it may request the Party of export to repatriate or destroy the LMO.

The Regulations

Living modified organisms are defined in the proposed regulations. They are living organisms that possess a novel combination of genetic material obtained through the use of modern biotechnology (e.g. recombinant DNA or cell fusion across taxonomic families). LMOs that are pharmaceuticals for human use are excluded from the Regulations.

The proposed Regulations will implement the export notification, documentation, unintentional and illegal transboundary movement requirements of the Protocol. Canada's obligations with respect to imports will be met through existing regulations.

Exporters will be required to notify the Party of import prior to the first transboundary movement of a LMO for intentional introduction into the environment, provide them with certain specified information and certify that the information they have provided is accurate. They will have to provide the Minister with a subset of the above information (including name and address of the exporter and importer, identification of the LMO, intended date of transboundary movement, methods for safe handling, storage, transport and use and a declaration that the information is accurate and complete) when they provide notification to the importing Party. Exporters will also be required to keep a copy of all documents provided to the Party of import and received during the notification process for a period of five years.

The proposed Regulations specify the documentation that must accompany every intentional transboundary movement of a living modified organism to another Party. The content of the documentation will vary depending on whether the living modified organism is intended for direct use as food or feed, or for processing or for contained use or for intentional introduction into the environment. The information required may be inserted with the existing documentation that currently accompanies transboundary movements.

The proposed Regulations enable the Minister to require exporters to dispose of LMOs that have undergone an illegal transboundary movement.

Any person, responsible for the release of a LMO that may lead to an unintentional transboundary movement must provide the Minister with specified information without delay. The proposed Regulations provide a means by which the Minister may learn of such an event and satisfy Canada's obligation to notify the affected State.

Alternatives

Many of the provisions of the Protocol have to be implemented through regulations. Should Canada decide to ratify the Protocol, the Government of Canada intends to meet its obligations under two different Acts:

1. The Canada Agricultural Products Act (CAP Act), which is administered by the Canadian Food Inspection Agency (CFIA). The planned CFIA regulations will be made pursuant to section 32 of the CAP Act and could cover living modified organisms that are agricultural products such as seeds or seeds used for food or feed (grain commodities).
2. The Canadian Environmental Protection Act, 1999 (CEPA 1999), which is jointly administered by the Ministers of Environment and of Health Canada. The proposed Living Modified Organisms Regulations are made pursuant to subsection 115(1) of CEPA 1999 and regulate all living modified organisms that fall within the scope of the Protocol. The CEPA 1999 Regulations exempt LMOs from the notification and documentation provisions if they are regulated by equivalent provisions under the Canada Agricultural Products Act (CAP Act). For example, the proposed CEPA 1999 regulations would cover LMOs including transgenic fish and animals, and bio-pesticides.

Benefits and Costs

Canadians support the conservation and sustainable use of biodiversity at home and abroad. The proposed Regulations will not alter Canada's existing domestic regime for the protection of biodiversity, but will contribute to protecting global biodiversity. Canadians value and share in the benefits of global biodiversity. Environment Canada is seeking independent expert opinion about the magnitude of the potential global biodiversity benefits that may arise from the implementation of the Protocol. Since Canadians value the protection of global biodiversity, this may be an indirect benefit.

The costs of notification incurred by Canadian exporters are unlikely to change much. Developers and exporters claim that they already provide most of the required information when they are seeking approvals for LMOs in new markets. The regulatory regimes of many importing countries may already be consistent with the risk assessment requirements of the Protocol. These costs are normal costs of doing business. Regardless of whether Canada ratifies the Protocol or not, Canadian exporters will still have to provide the information required by countries of import. If anything, AIA and the establishment of a Biosafety Clearing-House may facilitate the exchange of the information required for notification, reducing the exporters' overall cost of doing business in new markets.

The documentation requirements can be met through minor modifications to existing exporter-generated documentation. The cost to exporters of complying with these documentation provisions is expected to be minimal to non-existent.

Existing regulations, standards, and codes of good laboratory practice will continue to apply to the handling, packaging, identification, transportation, and use of LMOs. The proposed Regulations will change current requirements minimally.

Trade with non-Parties is unlikely to be affected if they have a regulatory regime in place that is consistent with the objectives of the Protocol.

The incremental costs of compliance incurred by exporters are expected to be minimal and may decrease through time as result of a learning curve. By harmonising requirements to some extent between different jurisdictions, over time the Protocol may also level cost differences between different regulatory regimes, and reduce the delays encountered.

Currently, the majority of LMOs exported from Canada are plant LMOs. When the CAP Act regulations are in place, transboundary movements of plant LMOs will be covered under them. There are relatively few transboundary movements of other LMOs. At the present time Environment Canada has conducted risk assessments on less than a dozen LMOs. It is aware of research and development of several transgenic animals and fish. The Pest Management Regulatory Agency (PMRA) has approved one field trial of a LMO bio-pesticide. Environment Canada anticipates that each year for the foreseeable future there could be at least one LMO subject to the notification requirements and up to 100 LMOs for contained use, including between laboratories, subject to the documentation requirements of these Regulations.

Environment Canada and Health Canada will incur costs to build capacity (training and communication), to administer and enforce the Regulations, and to participate in the Biosafety Clearing-House. Preliminary estimates place the annual cost of implementing these Regulations at between $240 and $270 thousand (in current year dollars using a 5 percent and 10 percent discount rate) over the next five years. Environment Canada has also identified the need to develop the capacity to handle reports on accidental releases of living modified organisms that may result in unintentional transboundary movement. These cost estimates will be subject to further refinement as Environment Canada is able to reduce the amount of uncertainty about the scope and volume of transboundary movements that will be subject to these Regulations.

Consultation

Copies of the proposed Regulations have been circulated for comment to all provincial and territorial governments. Other federal government departments were consulted in developing the proposed Regulations, including Health Canada, the Canadian Food Inspection Agency, Agriculture and Agri-food Canada, the Department of Fisheries and Oceans, the Pest Management Regulatory Agency, Natural Resources Canada, Industry Canada, the Department of Foreign Affairs and International Trade, and the Canadian International Development Agency. The proposed Regulations have been sent to stakeholders through electronic mail-out and were available on the CEPA registry (www. ec.gc.ca/ceparegistry).

Compliance and Enforcement

The CEPA 1999 Enforcement and Compliance Policy describes a range of possible responses to violations: warnings, directions, environmental protection compliance orders, ticketing, ministerial orders, injunctions, prosecution, and environmental protection alternative measures, which are an alternative to a court trial after the laying of charges for a CEPA 1999 offence. In addition, the policy explains when the Government of Canada will resort to civil suits by the Crown for cost recovery.

When, following an inspection, investigation or following the report of a suspected violation, an enforcement officer confirms that a violation has been committed, the enforcement officer will select the appropriate response based on the following criteria:

1. Nature of the alleged violation: This includes consideration of the damage, the intent of the alleged violator, whether it is a repeat violation, and whether an attempt has been made to conceal information or otherwise subvert the objectives and requirements of the Act.
2. Effectiveness in achieving the desired result with the alleged violator: The desired result is compliance within the shortest possible time and with no further repetition of the violation. Factors to be considered include the violator's history of compliance with the Act, willingness to co-operate with enforcement officials, and evidence of corrective action already taken.
3. Consistency: Enforcement officers will consider how similar situations have been handled when determining the measures to be taken to enforce the Act.

Contacts

David McBain, New Substances Branch, Environment Canada, 351 Saint-Joseph Boulevard, 14th Floor, Hull, Quebec K1A 0H3, (819) 997-4336 (Telephone), (819) 953-7155 (Facsimile), biosafety.regulations@ec.gc.ca (Electronic mail); or Céline Labossière, Regulatory and Economic Analysis Branch, Environment Canada, 10 Wellington Street, 24th Floor, Hull, Quebec K1A 0H3, (819) 997-2377 (Telephone), (819) 997-2769 (Facsimile), celine.labossiere@ec.gc.ca (Electronic mail).

PROPOSED REGULATORY TEXT

Notice is hereby given, pursuant to subsection 332(1) of the Canadian Environmental Protection Act, 1999 (see footnote a) , that the Governor in Council proposes, pursuant to subsection 115(1) of that Act, to make the annexed Living Modified Organisms Regulations.

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 Regulations 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, Toxics Pollution Prevention Directorate, 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, September 24, 2002

EILEEN BOYD
Assistant Clerk of the Privy Council

LIVING MODIFIED ORGANISMS REGULATIONS

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 a living modified organism from Canada or who arranges for one 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

(a) in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles; or
(b) techniques involving the 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 the movement of a living modified organism from one Party to another Party and for purposes of Section 11 extends to the transboundary movement between Parties and Non-Parties. (mouvement transfrontière)

APPLICATION

2. (1) These Regulations do not apply to a living modified organism that is a pharmaceutical for humans.

(2) Sections 3 to 9 do not apply to a living modified organism that is an agricultural product within the meaning of section 2 of the Canada Agricultural Products Act if regulated under that Act with provisions equivalent to sections 3 to 9.

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 of the living modified organism shall notify the competent national authority of the Party of import in writing of the information set out in Schedule 1, prior to the transboundary movement.

(2) The exporter may notify the Party of import's competent national authority of the intentional transboundary movement of a living modified organism at the same time as the movement takes place, if under the Protocol the Party of import has in advance of the transboundary movement so specified to the Biosafety Clearing-House or to the exporter in writing.

(3) If in advance of an intentional transboundary movement the Party of import has specified to the Biosafety Clearing-House or in writing to the exporter that imports of a particular living modified organism to it are not subject to the requirements of subsection (1), the exporter is not subject to that subsection but shall provide to the Party of import the information that the Party of import has specified under the Protocol to the Biosafety Clearing-House or to the exporter in writing.

(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 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, an acceptance of the first intentional transboundary movement of a particular living modified organism 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 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 subsection (1) or (3) is accurate and complete.

4. The exporter shall send to the Minister by registered mail a copy of the information provided under items (a) to (d) and (1) of Schedule 1 and a copy of the declaration provided under subsection 3(7) at the same time as they are sent to the competent national authority of the Party of import.

DECLARATION — ADDITIONAL INFORMATION

5. If additional information is provided by an exporter referred to in subsection 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 and complete.

RECORDS

6. An exporter referred to in subsection 3(1) or (3) shall keep at its principal place of business in Canada for a period of five 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 any 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 setting out the following information:

(a) the statement "May contain living modified organisms intended for direct use as food or feed, or for processing, that are not intended for intentional introduction into the environment."; and
(b) the name, address and telephone number of the contact person 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 setting out the following information:

(a) the statement "Contains living modified organisms intended for contained use.";
(b) requirements for the safe handling, storage, transport and use of the living modified organism;
(c) the name, address and telephone number of the contact person in possession of further information regarding the living modified organism; and
(d) the name and address of the individual and institution to whom the living modified organism is consigned.

DOCUMENTATION — GENERAL

9. (1) An exporter, with every intentional transboundary movement of a living modified organism within the scope of the Protocol, including one for intentional release into the environment, other than an organism intended for contained use or for direct use as food or feed or for processing, shall include documentation setting out the following information:

(a) the statement "Contains living modified organisms.";
(b) identification of the living modified organism, including
(i) the common name of the living modified organism, and
(ii) its taxonomic identity, to genus, species and, if known, subspecies;
(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 parental organisms;
(d) requirements for the safe handling, storage, transport and use of the living modified organism;
(e) the name, address and telephone number of the contact person in possession of further information regarding the living modified organism;
(f) the name and address of the importer; and
(g) the name and address of the exporter.

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

DISPOSAL OF LIVING MODIFIED ORGANISMS

10. If a Party of import requests that Canada dispose of a living modified organism under Article 25, paragraph 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 who causes or contributes to the release or increases the likelihood of the release, shall notify the Minister in writing of the release without delay and include the following information in the notice:

(a) the location, date and time of the release;
(b) the quantity of the living modified organism released into the environment;
(c) the traits and characteristics of the living modified organism relevant to risks to the conservation and sustainable use of biological diversity, taking into account risks to human health;
(d) the taxonomic identity of the living modified organism, if known;
(e) the circumstances of the release;
(f) the use of the living modified organism in Canada;
(g) any information about the possible adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health;
(h) the possible risk management measures, if available;
(i) the name, address and telephone number of the contact person for further information; and
(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

(a) the day of the coming into force of the Protocol, in accordance with Article 37, paragraph 1, of the Protocol, and

(b) the 90th day after the date of deposit of the instrument of ratification by Canada in accordance with Article 37, paragraph 2, of the Protocol.

SCHEDULE 1
(Subsection 3(1) and section 4)

NOTIFICATION

The information to be in the notification with respect to the first intentional transboundary movement of a living modified organism is as follows:

(a) name, address and telephone number of the exporter;
(b) name, address and telephone number of the importer;
(c) name and identity of the living modified organism, and the domestic classification, if any, of the biosafety level of the living modified organism in Canada;
(d) intended date or dates of the transboundary movement, if known;
(e) taxonomic identity, common name, point of collection or acquisition of the recipient organism or parental organisms and the characteristics of that organism or those organisms related to biosafety;
(f) centres of origin and centres of genetic diversity of the recipient organism and the parental organisms and a description of the habitats where the living modified organism may persist or proliferate;
(g) taxonomic identity, common name, point of collection or acquisition of the donor organism or organisms and the characteristics of that organism or those organisms related to biosafety;
(h) description of the nucleic acid or the modification introduced, the technique used and the resulting characteristics of the living modified organism;
(i) intended use of the living modified organism or processed materials that are of living modified organism origin and that contain detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology;
(j) quantity or volume of the living modified organism in the transboundary movement;
(k) any previous and existing risk assessment report consistent with Annex III of the Protocol, as amended from time to time;
(l) methods for the safe handling, storage, transport and use of the living modified organism, including packaging, labelling, documentation, disposal and contingency procedures;
(m) regulatory status of the living modified organism within Canada and, if the living modified organism is banned in Canada, the reason or reasons for the ban; and
(n) result and purpose of any notification by the exporter to other States regarding the living modified organism to be exported.

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

PART 1

DECLARATION OF ACCURACY

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

Signature of the exporter _______________

Please print name ____________________

Title ______________________________

Date ______________________________

PART 2

DECLARATION OF CONFORMITY

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

Signature of the exporter _______________

Please print name ____________________

Title ______________________________

Date ______________________________

[39-1-o]

Footnote a 

S.C. 1999, c. 33