Overview of a Regulatory Proposal under the CEPA, 1999 for the possible Implementation of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity

Draft Living Modified Organisms Regulations

Proposed Living Modified Organisms Regulations (Published: 2002-09-28)

The Cartagena Protocol on Biosafety to the Convention on Biological Diversity is a treaty under the United Nations Convention on Biological Diversity. It is designed to provide a framework within which living modified organisms could be traded in a safe and responsible manner with due regard for the protection of biodiversity.

The Protocol will enter into force 90 days after 50 States have ratified it. This could take place later this year or early next year. Canada has not yet made a decision as to whether or not it will ratify the Protocol but recognizes the need for keeping options open. There will be public consultations in September on whether or not Canada should ratify the Protocol. Draft regulations will be further discussed at that time. Should Canada choose to ratify the Protocol, regulations must be in place. In the event that Canada chooses to ratify the Protocol in time for the first meeting of the parties, regulations would have to be in force. This could be required early in 2003.

As a result, the Government is developing proposals for complementary regulations under the Canadian Environmental Protection Act, 1999 (CEPA 1999) and the Canada Agricultural Products Act (CAP Act). This document provides a brief overview of a regulatory proposal under CEPA 1999 that could apply should Canada choose to ratify the Protocol.

The Canadian Environmental Protection Act, 1999 is administered by the Ministers of the Environment and of Health. The regulations would be made under Section 115 of the Act. The attached proposal regulates certain living modified organisms and aspects of living modified organisms under the scope of the Protocol. Some examples include living modified organisms that are animals and fish, certain pest control products, a variety of micro-organisms and some foods containing living modified organisms.

Scope of the Regulatory Proposal

With regard to imports, as outlined in the Simplified Procedure provision in Article 13.1 of the Protocol, countries can opt to use their existing regulatory structure if it is consistent with the objectives of the Protocol. Because the Government of Canada believes that the domestic regulatory system meets the objectives of the Protocol, we intend to exercise this option if Canada ratifies and, therefore, the draft regulations will not address import obligations outlined in the Protocol.

The regulations would apply to living modified organisms under the scope of the Protocol only. Living modified organisms which are pharmaceuticals for human use are exempt from the draft regulations.


The definitions in Article 3 of the Protocol are reflected in these draft regulations, with necessary adjustments.

Notification of First Intentional Transboundary Movement

The exporter would be required to notify the Party of Import prior to the first transboundary movement of a living modified organism intended for intentional introduction into the environment. The notification would be required to be accompanied by a statement from the exporter certifying that the information provided is accurate. In addition to being required to keep a copy of all documents provided and received during the notification process, the exporter would be required to provide the Minister with certain specified information in relation to the notification package.


The exporter would be required to include documentation with every transboundary movement of a living modified organism from Canada to another Party to the Protocol. In accordance with the obligations of Article 18.2 of the Protocol, the content of the documentation will vary depending on whether the living modified organism is intended for :

  1. direct use as food or feed, or for processing;
  2. contained use; or
  3. intentional introduction into the environment.

Required Disposal of a Living Modified Organism

Under the Protocol, Canada could be requested by a Party of import, in certain circumstances, to repatriate or destroy living modified organisms that are the subject of an illegal transboundary movement. The draft regulations enable the Minister to require the exporter to dispose of the organisms, at the exporter’s expense, should the Minister decide this is appropriate.

Unintentional Transboundary Movements

The Protocol requires a Party to take appropriate measures to notify a potentially affected State when it knows of an occurrence that may lead to an unintentional transboundary movement that is likely to have significant adverse effects on the conservation and sustainable use of biological diversity of that State. The draft regulations provide a means by which the Minister could learn of such an occurrence and access the information required as part of the notification to the affected State.

Should Canada decide to ratify the Protocol, and these draft regulations go into force, there will be costs, benefits and other possible impacts that have to be assessed. A Regulatory Impact Assessment Statement (RIAS) must accompany every regulatory proposal submitted for Government approval. The purpose of the RIAS is to ensure that federal Government intervention is justified, that Canadians have been consulted, that regulation is the best alternative, that the proposed approach maximises the benefits and minimises the burden on Canadians, and that suitable compliance mechanisms are in place.

The RIAS in support of the draft regulations being proposed under the Canadian Environmental Protection Act, 1999 will deal only with incremental or marginal changes in benefits, costs or impacts brought about by the implementation of the Protocol and regulations. This summer Environment Canada is undertaking studies of these potential impacts. The co-operation and assistance of stakeholders that are contacted for information and their views is critical to the accuracy of the assessment. The preliminary findings of these studies will be tabled during a consultation process on ratification planned for September. (See below in Section V).

The draft regulations and RIAS will be pre-published in the Canada Gazette, Part I for a comment period of 60 days during which time stakeholders and the public will have an opportunity to comment on the proposed regulations or the RIAS. The RIAS will also be published on the Environment Canada Internet web sites. Environment Canada will then have an opportunity to review and revise the draft regulations in response to the concerns that were expressed, before the regulations are finally submitted for approval.

In addition, the possible impact of Canada’s ratification on the competitive position of Canadian exporters relative to other major exporting nations like the United States, Australia and Argentina will be assessed by Agriculture and Agri-Food Canada.

The draft regulations under CEPA 1999 are being sent to stakeholders through electronic mail-out and are also available on the Internet web sites listed below. Canadians are invited to submit their comments by July 26, 2002 on the draft regulations and their benefits, costs and other consequences to:

Dominique Dore
Environment Canada
Phone: (819) 994-4769
E-mail: biosafety.regulations@ec.gc.ca

The Internet web sites :

Biotechnology (Living Organisms)

CEPA Environmental Registry - Draft Living Modified Organisms Regulations

In addition, opportunities will exist to provide additional views throughout the summer at our e-mail address (biosafety.regulations@ec.gc.ca), and during a series of consultations on ratification and the draft regulations that are planned for September.

The Canadian Food Inspection Agency is developing a complementary proposal with respect to the products that it normally regulates. Some examples of these products would include fertilizers, veterinary biologics, animal feeds and certain plants.

July 22, 2002

Draft Living Modified Organisms Regulations

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