Vol. 133, No. 27 — July 3, 1999

Regulations Amending the Migratory Birds Regulations

Statutory Authority

Migratory Birds Convention Act, 1994

Sponsoring Department

Department of the Environment

REGULATORY IMPACT ANALYSIS STATEMENT

Description

Corporations organized for the purpose of training dogs as retrievers have proposed an amendment to the migratory game bird possession provision in the Migratory Birds Regulations. Presently, these organizations may possess no more than 125 carcasses of lawfully killed migratory game birds. This amendment would increase to 200 the number of carcasses of migratory game birds that a corporation that trains dogs as retrievers may have in its possession for training purposes.

Retriever dogs are specially bred and trained to find and bring in game (such as waterfowl) that are killed or wounded during the hunt.

Alternatives

Retriever clubs advise that the present limit of 125 carcasses (an arbitrary number arrived at in 1961) is insufficient for the purpose of training dogs as retrievers. That limit was sufficient until recently, when the Canadian Kennel Club introduced a new hunt test, necessitating the use of more carcasses. As a result, retaining the present carcass limit is not satisfactory.

The alternative of using "call" ducks and dummies has been examined. Call ducks (domestic ducks that have been raised commercially and are killed before use in competitions) are used by retriever clubs in some areas of Canada. However, these ducks are not available in all areas of the country. Dummies are made of plastic or canvas materials, and resemble boat fenders or bumpers. While these devices are suitable for the basic training of retrievers, they are not optimal for retriever trials or competitions, as the objective is to make them as realistic as possible by using the carcasses of ducks. Duck trained dogs are better retrievers.

The best alternative therefore is a modest increase in the present carcass limit to 200.

Benefits and Costs

The proposed increase in the carcass limit is moderate, and will not pose a threat to the conservation of wild game bird populations. The use of retrievers in waterfowl hunting is considered an excellent conservation technique because fewer birds are lost after being shot. Efforts that promote the training and use of retrievers, such as retriever competitions, ultimately benefit migratory game bird populations.

Consultation

The Canadian Wildlife Service, Environment Canada, has developed a formalized consultation process to consult annually with stakeholders on proposed hunting regulations. Discussion of the need for this regulatory amendment was developed and consulted on in the December Reports on Migratory Game Birds in Canada: Proposals for Hunting Regulations (1995, 1996, and 1998 editions). These reports are widely distributed to approximately 600 government, aboriginal and non-government organizations, including hunting and other conservation groups such as the World Wildlife Fund, Canadian Nature Federation, Nature Conservancy of Canada and Ducks Unlimited. No objections to this proposed amendment have been received.

Compliance and Enforcement

This amendment will not result in additional enforcement requirements.

Under the Migratory Birds Convention Act, 1994, and considering case law, the average penalty for a summary conviction of an individual under the Act is estimated to be approximately $300. Minor offences will be dealt with under a ticketing system. There are provisions for increasing fines for a continuing or subsequent offence.

Environment Canada's game officers, members of the Royal Canadian Mounted Police and provincial and territorial conservation officers enforce the Migratory Birds Regulations by, for example, examining hunting areas, inspecting hunters for hunting permits and equipment, and inspecting the number of migratory game birds taken and possessed.

Contact

Terry Mueller, Regulatory Analyst, Program, Analysis and Coordination Division, Canadian Wildlife Service, Department of the Environment, Ottawa, Ontario K1A 0H3, (819) 997-1272, or John Sullivan, Enforcement Coordinator, Ontario Region, Canadian Wildlife Service, Department of the Environment, 465 Gideon Drive, P.O. Box 490, Lambeth Station, London, Ontario N6P 1R1, (519) 472-3745.

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to section 12 of the Migratory Birds Convention Act, 1994 (see footnote a), proposes to make the annexed Regulations Amending the Migratory Birds Regulations.

Interested persons may make representations concerning the proposed Regulations to the Minister of the Environment within 30 days of the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be sent to the Director, Migratory Birds Conservation, Canadian Wildlife Service, Department of the Environment, Ottawa, Ontario K1A 0H3.

Ottawa, June 22, 1999

MARC O'SULLIVAN
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE MIGRATORY BIRDS REGULATIONS

AMENDMENT

1. (1) Subsection 10(4) of the Migratory Birds Regulations (see footnote 1) is replaced by the following:

(4) Notwithstanding subsections (1) and (2), a corporation that trains dogs as retrievers may, for the purpose of that training, have in its possession not more than 200 carcasses of migratory game birds.

(2) Subsection 10(4.1) (see footnote 2) of the French version of the Regulations is replaced by the following:

(4.1) Le paragraphe (3) ne s'applique pas à la personne morale visée au paragraphe (4).

COMING INTO FORCE

2. These Regulations come into force on the day on which they are registered.

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Environmental Assessment Regulations (Department of Health)

Statutory Authority

Food and Drugs Act

Sponsoring Department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

Description

It is proposed that regulations entitled Environmental Assessment Regulations, be added to the Food and Drugs Act (the Act). These regulations will provide for the environmental assessment of new substances from biotechnology that are foods, drugs or cosmetics.

The proposed regulations will provide for both health and environmental assessments to be carried out by Health Canada for products of biotechnology, regulated under this Act. These regulations will apply to foods, drugs and cosmetics that are microorganisms, cultured cells or transgenic animals, or products derived from microorganisms, cultured cells, transgenic animals or plants.

The proposed regulations will provide a flexible regulatory framework for this rapidly evolving technology while protecting the health and safety of Canadians. They also fulfill the Government's commitment to develop environmental assessment regulations under the Act to provide a single window for product review. The environmental assessment requirements outlined in these regulations complement the notification and human health assessments in the Food and Drug Regulations and the Cosmetic Regulations.

Health Canada will be working in close cooperation with the Canadian Food Inspection Agency (CFIA) for all environmental assessments of products from transgenic animals and plants. In such instances, it is proposed that CFIA will carry out the environmental assessment of the animal or the plant, while at the same time, Health Canada will assess the products, thus eliminating duplication.

Requirement for an Environmental Assessment

Biotechnology is defined under the federal framework for regulating biotechnology products as "the application of science and engineering in the direct or indirect use of living organisms or parts or products of living organisms in their natural or modified forms." This broad definition covers all organisms, their parts and products. Both traditionally developed products and those developed through the newer molecular techniques such as genetic engineering are included. Biotechnology is a series of techniques, not a product. In consequence, biotechnology is applied in many sectors to develop goods and services of value to the economy.

In response to the concerns of the public regarding environmental and human health and safety issues and the requests from the biotechnology industry for a consistent and efficient review, a government-wide approach is being taken. This approach will ensure that appropriate regulations are applied to organisms, their parts and their products and will also address Canada's international commitments under the United Nations Commission on Sustainable Development and the United Nations Convention on Biological Diversity.

Federal Framework for the Regulation of Biotechnology

The government-wide approach resulted in Cabinet approval of a Federal Framework for the Regulation of biotechnology products in Canada. This federal framework resulted from an agreement among federal regulatory departments on principles for an efficient and effective approach for regulating biotechnology products. These principles would ensure that the practical benefits of biotechnology products and processes are balanced with the need to protect the environment, human health and safety and are the basis of the present regulatory framework that:

A key principle in the regulation of biotechnology products is to maintain Canada's high standards for the protection of human health and the environment. This principle means that all new biotechnology products will be assessed, based on the established procedures for identification of safety concerns.

Another key principle of the federal framework is the use of existing legislation and institutions to clarify responsibilities and avoid duplication. This principle means that departments now regulating products developed by using traditional techniques and processes will be responsible for regulating products developed by using newer biotechnology techniques and processes. Regulatory departments such as the Canadian Food Inspection Agency, Health Canada and Environment Canada have developed considerable expertise over a period of many years in addressing safety questions related to a variety of products including biotechnology products.

Adoption of regulations under the framework will establish clear guidance to the public, industry, international agencies and other governmental departments, the requirements for regulatory approval by the federal government, the legislative basis for the approval process, and the responsible department. Implementation of regulations under the framework will provide for a government-wide regulatory process that addresses the needs of the Canadian public and industry and the requirements under Canada's international commitments.

Canadian Environmental Protection Act

A key part of the federal framework described above, is the Canadian Environmental Protection Act (CEPA). This Act, which was enacted in 1988, requires that all substances, new to Canada, manufactured in, sold in or imported into Canada, be assessed to determine whether the substance is toxic. According to CEPA, a substance is toxic if it may enter the environment in a quantity or concentration or under conditions that may have an immediate or long-term harmful effect on the environment, may constitute a danger to the environment on which human life depends or may constitute a danger to human life or health.

CEPA also provides that new substances regulated under other Acts of Parliament may be exempt from the requirements of section 26 of CEPA — if they are subject to:

— notification prior to manufacture, import, or sale; and

— an assessment for health and environmental effects.

Food and Drugs Act

Presently, the Food and Drugs Act requires that novel foods, food additives, drugs, cosmetics, and medical devices, be assessed for their effects on human health, prior to sale in Canada. It does not currently provide for environmental assessments of these products. In the absence of an environmental assessment under the Food and Drugs Act, these products would become subject to an assessment for both environmental effects and human health effects from the environment under CEPA and an assessment for human health under the Food and Drugs Act.

Authority

Paragraph 30(1)(l) of the Act provides regulation making authority with respect to foods, drugs and cosmetics. It does not provide for any authority for medical devices. Consequently, the proposed regulations will not apply to medical devices.

A consequential amendment in Bill C-32, An act respecting pollution prevention and the protection of the environment and human health in order to contribute to sustainable development, presently before Parliament, is intended to modify the Food and Drugs Act and provide regulation making authority with respect to medical devices.

Cooperation with Other Government Departments

Environmental assessment regulations for seeds, feeds, fertilizers and veterinary biologics were promulgated in 1997 by the CFIA. These regulations also apply to seeds used to produce foods, drugs, and cosmetics. The proposed regulations under the Food and Drugs Act will apply to the actual products of those seeds if they are foods, drugs or cosmetics. Health Canada and CFIA are working together so that biotechnology products will be subject to joint assessments under the existing legislative authority, drawing on the strengths of both organizations.

Regulations for other biotechnology products under the Canadian Environmental Protection Act were also promulgated in 1997. With the promulgation of the Environmental Assessment Regulations under the Food and Drugs Act, biotechnology drugs, foods and cosmetics will be exempt from the New Substance Notification Regulations under the Canadian Environmental Protection Act. Health Canada is working with Environment Canada to ensure a smooth transition on promulgation of these regulations.

The legislative authority for the environmental assessment of medical devices will remain under CEPA until the consequential amendments are made to the regulatory authority of the Food and Drugs Act.

Cost Recovery

Environmental assessments by Health Canada will be subject to cost recovery. Fees for this assessment will be discussed in the future with the regulated industry.

Alternatives

The federal government is committed to protecting the Canadian public with respect to human health and environmental effects. In order to accomplish this goal, all new products from biotechnology will require an assessment of their environmental and health effects under the Canadian Environmental Protection Act or another federal statute. Consequently, there are two possible options:

1. Environmental assessment under the Canadian Environmental Protection Act

This option results in a product from biotechnology undergoing two evaluations:

— an assessment of environmental effects and the effect on human health from the effect on the environment by Environment Canada; and

— an assessment of human health effects by Health Canada.

Under this option, industry would be required to develop two submissions, one for health effects and one for environmental effects, submit them for review to two departments and await a decision from two reviews. In addition, the assessment could be subject to cost recovery by both Health Canada and Environment Canada.

This alternative is not consistent with the regulatory approach laid out in the Federal Framework for Regulating Biotechnology (1993), nor with the Government's commitment in the 1994 document entitled Jobs, Growth, Building a More Innovative Economy.

2. Environmental assessment under the Food and Drugs Act

This option results in industry being provided with a single contact for product review. Health Canada would assess both the human health and environmental effects of products from biotechnology regulated under the Food and Drugs Act.

Industry would prepare only one submission and present it for review by one department, a "single window approach".

Only one department, Health Canada, would be charging fees for the review.

This option is consistent with the regulatory approach laid out in the Federal Framework for Biotechnology, and the Government's commitment in the document entitled Jobs, Growth, Building a More Innovative Economy.

Recommendation

Alternative 2 is recommended.

Benefits and Costs

Pre-market review of biotechnology products using combined review strategies for human health risk assessment and environmental impact will result in an efficacious review process. This process will best take into account the manufacturing process, intended usage, potential exposure and all data, including clinical data, that can demonstrate strength and toxicity of the product. Incorporating the human health and environmental effects into a single review by one department could reduce the time needed for new and useful products to be made available to Canadians.

Without the promulgation of these regulations, companies that manufacture or import products from biotechnology will be required to notify both Environment Canada and Health Canada, submit information to both departments and wait for their decisions with respect to an assessment of both environmental and human health effects in order to comply with statutory requirements.

These regulations will also reduce the possibility of duplication of environmental assessments with other federal legislation such as the Feeds Act, Seeds Act, Fertilizers Act, and the Health of Animals Act. This supports the overall governmental objective of eliminating duplication and will also put less of a burden on the parties being regulated.

By providing a single window, the cost to industry of preparing a submission can be minimized, thus reducing the cost of product development which ultimately should result in lower costs when Canadians buy these products.

As the costs of carrying out environmental assessments is intended to be recovered from industry, the efficiency gained by a single review by Health Canada could result in lower costs to the industry, which ultimately could result in lower costs to consumers.

Cosmetics

Cosmetics are the one exception to products regulated under the Food and Drugs Act. Consultation with the cosmetic industry has shown that very few "new" cosmetics will fall solely within the scope of these regulations. Most of the raw ingredients or "new ingredients" are used both in cosmetics and in other products not regulated under the Food and Drugs Act.

If cosmetics are included in these regulations, it is not anticipated that studies that are required to obtain data on which an environmental assessment can be based will add significantly to the time and cost of producing and developing the ingredient for use in cosmetics and determining its effect on human health.

Health Canada is conscious that including these products under the proposed Regulations would result in the majority of such "new" biotechnology cosmetics requiring two reviews. Health Canada is prepared to withdraw cosmetics from the scope of these regulations based on comments from the Canada Gazette, Part I. If so, these products will continue to be regulated under the CEPA.

Impact Analysis

The Government of Canada is committed to providing an environmental assessment for all new products from biotechnology being manufactured, imported or sold in Canada. As mandated in the Federal Regulatory Framework for Biotechnology, all regulations in this area are to build on existing legislation and institutions, clarify jurisdictional responsibilities and avoid duplication. Additionally, all regulations for this area are to promote development and enforcement of Canadian regulations in an open and consultative manner, in harmony with national priorities and international approaches. The CEPA requires an environmental assessment for all products that will be released to the environment.

Based on the policies articulated in the Federal Regulatory Framework for Biotechnology, Health Canada is the most logical choice to carry out the environmental assessments on products regulated under the Food and Drugs Act. Health Canada already does full human health assessments for all the products that will need an environmental assessment and therefore can provide the single window approach that will both reduce duplication and increase efficiency.

These regulations will be tailored to the products regulated under the Act, thus allowing Health Canada to harmonize the information requirements for environmental assessments with those of our major trading partners. This will increase the ability of the regulated industry to compete internationally by reducing non-tariff trade barriers, and increase the possibility of joint reviews of these products.

Consultation

In December 1996, Information Letter (IL) 818 was distributed to biotechnology companies across Canada, including Apotex, Novopharm; biotechnology associations including the Industry Biotechnology Advisory Committee, Agri-West; and environmental groups including the Canadian Environmental Law Policy.

Health Canada received only four written responses to Information Letter 818. The written responses commended Health Canada on this initiative, raised some concerns and made some suggestions. The concerns and suggestions have been considered in the development of the Regulations. Some examples of those are:

The Industrial Biotechnology Association of Canada raised the necessity of reducing any possible duplication with other Federal legislation (such as the Seeds Act) and the Environmental Assessment Regulations. Minimizing duplication has always been one of Health Canada's objectives in the process of creating these Regulations. The Industrial Biotechnology Association of Canada's comments effectively highlighted possible duplication. Through these regulations and on-going negotiations with other government departments, including the Canadian Food Inspection Agency and Environment Canada, the duplication will be eliminated.

One manufacturer raised the issue that while standard size fermentation containers for low risk organisms are typically only filled with 10 000 L of fermentation material, the contents during the process of fermentation typically expands in volume. The final volume would exceed the original proposed regulation. The section in the IL dealing with this has undergone much revision and the limit of 10 000 L has been eliminated.

The Canadian Institute for Environmental Law and Policy both welcomed the proposed regulations and highlighted some concerns. A concern was for the potential invasive environmental effects of some novel foods which could enter the environment. Health Canada consulted with the Canadian Food Inspection Agency, to ensure that the novel foods are adequately assessed. Health Canada regulations cover the effects of the food itself on the environment while the Agency regulates the seeds, including any invasive effects, from which the food would be grown.

The last written reply to the IL was by Environment Canada, which raised several issues that have been settled, including the importance of consistency between federal legislation. We share Environment Canada's desire for consistency, but also recognize that consistency does not always require exact duplication and that legislation regulating different areas needs to be tailored to best meet the goals of the regulations. This position is consistent with the Federal Framework for Biotechnology. It also meets the equivalence requirement as explained by the Government most recently in the Government Response to the Third Report of the Standing Committee on Environment and Sustainable Development.

A presentation was made to the biotechnology industry at Biotech 97. During this presentation, additional comments were solicited from participants, and the IL was made available. A full spectrum of stakeholders was present at Biotech 97 including The National Research Council, Monsanto Canada Inc., Industry Canada, Biocapital/Envirocapital Inc., Innovation Place, University of New Brunswick, Seabright Corporation Limited and Ventures West Inc.

Compliance and Enforcement

Compliance with these regulations will be monitored by Health Canada through the product review process and the inspection of facilities for licencing for good manufacturing practices.

Health Canada will consider imposing appropriate controls over the manufacturing, labelling and packaging process in order to alleviate or mitigate any potential adverse environmental effects.

Contact

Joel Weiner, Acting Director General, Policy, Planning and Coordination Directorate, Health Protection Branch, Department of Health, Ottawa, Ontario K1A 0L2, (613) 952-3665 (Telephone), (613) 954-9981 (Facsimile).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to subsection 30 (see footnote b) of the Food and Drugs Act, proposes to make the annexed Environmental Assessment Regulations (Department of Health).

Interested persons may make representations with respect to the proposed Regulations within 45 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Mr. Tim Flaherty, Acting Senior Analyst, Regulatory and Compliance Policy, Policy, Planning and Coordination Directorate, Department of Health, Health Protection Building, Address Locator 0700B4, Tunney's Pasture, Ottawa, Ontario K1A 0L2, (613) 957-3844 (Telephone), (613) 954-8637 (Facsimile), Tim_Flaherty@hc-sc.gc.ca (Electronic mail).

The representations should stipulate those parts of the representations that should not be disclosed pursuant to the Access to Information Act and, in particular, pursuant to sections 19 and 20 of that Act, the reason why those parts should not be disclosed and the period during which they should remain undisclosed. The representations should also stipulate those parts of the representations for which there is consent to disclosure pursuant to the Access to Information Act.

Ottawa, June 22, 1999

MARC O'SULLIVAN
Assistant Clerk of the Privy Council

ENVIRONMENTAL ASSESSMENT REGULATIONS (DEPARTMENT OF HEALTH)

INTERPRETATION

1. The definitions in this section apply in these Regulations.

"biotechnology" means the application of science and engineering in the direct or indirect use of living organisms or parts or products of living organisms in their natural or modified forms. (biotechnologie)

"biotechnology product" means a product of biotechnology, including its components and ingredients, that is a food, drug or cosmetic and

(a) a living or killed micro-organism, a living or killed cultured cell or a living or killed genetically-modified animal, or a product that is derived from one of those things; or

(b) a product that is derived from a living or killed genetically-modified plant. (produit biotechnologique)

"consumed" means, in respect of a biotechnology product, that the product is destroyed, or converted to another product to the point where no further conversion of the product is likely under the reaction conditions. (consommé)

"contained facility" means an enclosed building with walls, floor and ceiling or an area within such a building, where the containment is in accordance with the physical and operational requirements of a level set out in the Laboratory Biosafety Guidelines published by the Laboratory Centre for Disease Control, Health Protection Branch, Health Canada, 2nd edition, 1996, as amended from time to time, or Appendix K of the Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) dated January 1996 and established by the United States Department of Health and Human Services, as amended from time to time. (installation étanche)

"cultured cell" means a eukaryotic cell that has been cultured ex vivo or as ascites and that

(a) is not classified

(b) is not otherwise classified as a unicellular organism. (cellule cultivée)

"food additive" has the meaning assigned by section B.01.001 of the Food and Drug Regulations. (additif alimentaire)

"micro-organism" means a microscopic organism that is not a cultured cell and that is

(a) classified

(b) a virus, virus-like particle or sub-viral particle; or

(c) any culture other than a pure culture. (micro-organisme)

"new to Canada" means

(a) in the case of a biotechnology product that is a drug, that a notice of compliance has not been issued in respect of the drug pursuant to section C.08.004 of the Food and Drug Regulations;

(b) in the case of a biotechnology product that is a food, other than a food additive,

(c) in the case of a biotechnology product that is a food additive,

(d) in the case of a biotechnology product that is a cosmetic,

"site-limited" means, in respect of a biotechnology product, a product that is

(a) manufactured and consumed on the site of manufacture;

(b) manufactured at one site and transported to a second site where it is consumed; or

(c) imported and transported directly to a site where it is consumed. (limité à un lieu)

"toxic" means, in respect of a biotechnology product, a product that is entering or may enter the environment in a quantity or concentration or under conditions such that the product

(a) has or may have an immediate or long-term harmful effect on the environment;

(b) constitutes or may constitute a danger to the environment on which human life depends; or

(c) constitutes or may constitute a danger in Canada to human life or health. (toxique)

GENERAL

2. (1) Subject to sections 3 to 6, every manufacturer or importer of a biotechnology product that is new to Canada shall provide the Minister with an environmental assessment of that product, which shall contain

(a) an analysis of the extent to which the product will or may be released into the environment;

(b) an analysis of the potential environmental impact resulting from a release referred to in paragraph (a);

(c) an analysis of the actual environmental impact resulting from any release of the product into the environment

(d) the data on which the analyses referred to in paragraphs (a) to (c) are based;

(e) in the case of a biotechnology product that is proposed to be site-limited within a contained facility, the proposed containment level for the product, identified by reference to a biosafety guidelines document referred to in the definition "contained facility" that was used to determine the appropriate level of containment and to identify any potential environmental hazards; and

(f) in the case of a biotechnology product that is proposed to be manufactured or imported in quantities of more than 1000 kg per year by that manufacturer or importer and that is not proposed to be site-limited in a contained facility, the results of acute toxicity tests performed on indicative plant, invertebrate and vertebrate species that demonstrate adequate safety with respect to environmental impact in Canada.

(2) The manufacturer or importer shall submit the following information with the environmental assessment referred to in subsection (1):

(a) a description, in sufficient detail to allow for a comprehensive environmental assessment, of the biotechnology product and, if the product is to be manufactured in Canada, of the manufacturing process;

(b) the amount of the product to be manufactured by the manufacturer or imported by the importer in each year;

(c) the place where the product is to be manufactured or its point of entry into Canada, the means by which the product is to be transported, the type of packaging in which the product is to be packaged and the place where the product is to be stored following manufacture or importation;

(d) the nature of the risk to the environment that would result from the release of the product into the environment;

(e) the procedures that are to be used for the disposal of the product;

(f) a description of any special requirements or conditions for use, storage or disposal that would affect the nature and amount of release of the product into the environment;

(g) any environmental assessments in respect of the product that have been performed by, or submitted to, foreign or other Canadian government departments or agencies;

(h) information in respect of the environmental fate of the product and in respect of the ecological effects of any release of the product into the environment; and

(i) information in respect of the proposed use of the product, including, if applicable, information regarding its exclusive use in a laboratory, clinic, hospital or similar facility and whether the facility has in place a licensed hazardous materials waste management system.

(3) The manufacturer or importer shall, on the request of the Minister, provide the Minister with any additional information that is necessary in order for the Minister to analyze the environmental assessment pursuant to section 8.

3. (1) The manufacturer or importer of a biotechnology product that is new to Canada and that is set out below is only required to provide the Minister with a complete description of the product and to identify which of the following paragraphs describe the product:

(a) a site-limited biotechnology product that is a genetically-modified animal that is used for research and development purposes where there is no possibility of release of the product or of its genetic material into the environment;

(b) a biotechnology product that is a human or animal cell for transplantation or a cultured cell that is not infected with a micro-organism;

(c) a biotechnology product that is naturally occurring and that is

(d) a biotechnology product that is an attenuated or killed non-genetically-engineered micro-organism that is used as a therapeutic drug or vaccine and that is of a species that is substantially equivalent to species of naturally-occurring micro-organisms in terms of pathogenicity, host specificity, potential impact on non-target organisms, on biodiversity and on biogeochemical cycles, mode of action, persistence and dispersal in the environment and gene flow.

(2) If the description of the biotechnology product referred to in subsection (1) is not sufficiently detailed, the Minister may request additional information and the manufacturer or importer shall provide it to the Minister as soon as possible.

4. The manufacturer or importer of a biotechnology product that is new to Canada and that is proposed to be manufactured and consumed on the site of manufacture that is a contained facility is only required to provide to the Minister

(a) a complete description of the product;

(b) the level of containment, identified in the manner set out in paragraph 2(1)(e), that is proposed to be used in respect of the product; and

(c) if the description of the product is not sufficiently detailed and the Minister so requests, additional information in respect of that product, to be provided as soon as possible.

5. (1) The manufacturer or importer of a biotechnology product that is new to Canada, that is a killed micro-organism or a product that is derived from a micro-organism, a cultured cell or a genetically-modified plant or animal and that is proposed to be manufactured or imported in a quantity of not more than 20 kg by that manufacturer or importer per year is only required to

(a) provide the Minister with a complete description of the product;

(b) inform the Minister of the specific quantity of the product that is to be manufactured or imported per year; and

(c) if the description of the product is not sufficiently detailed and the Minister so requests, provide to the Minister additional information in respect of that product as soon as possible.

(2) The manufacturer or importer of a biotechnology product referred to in subsection (1) that is proposed to be manufactured or imported in a quantity of more than 20 kg in a year shall, whether or not the product is still new to Canada, provide the Minister with an environmental assessment and related information in accordance with section 2 at least 90 days before the amount manufactured or imported in that year exceeds 20 kg, unless an environmental assessment and related information have previously been provided to the Minister in respect of that product.

6. (1) Except where subsection 5(2) applies, the manufacturer or importer of a biotechnology product that is a drug that is the subject of an abbreviated new drug submission under section C.08.002.1 of the Food and Drug Regulations or a supplement to a new drug submission or to an abbreviated new drug submission under section C.08.003 of those Regulations is not required to provide an environmental assessment or the information referred to in sections 2 to 4 and subsection 5(1).

(2) The manufacturer or importer of a biotechnology product that is a drug that is authorized for sale for emergency treatment pursuant to section C.08.010 of the Food and Drug Regulations is not required to provide an environmental assessment or the information referred to in sections 2 to 4 and subsection 5(1) in connection with any case where the drug is to be sold pursuant to such an authorization.

7. The environmental assessment and the information referred to in section 2, 3 or 4 or subsection 5(1), as applicable, shall be provided in writing

(a) in the case of a biotechnology product that is a drug, at the time that a new drug submission for a notice of compliance is filed pursuant to section C.08.002 of the Food and Drug Regulations;

(b) in the case of a biotechnology product that is a food, other than a food additive, at least 90 days before the sale or advertising for sale of the product;

(c) in the case of a biotechnology product that is a food additive, at the time a submission is made pursuant to section B.16.002 of the Food and Drug Regulations in connection with a request that the food additive be added to a table to section B.16.100 of those Regulations or that a change be made to such a table with respect to the food additive; and

(d) in the case of a biotechnology product that is a cosmetic, at least 90 days before the sale or advertising for sale of the product.

8. The Minister shall analyze the environmental assessment and any other information provided by the manufacturer or importer and shall advise the manufacturer or importer if the biotechnology product is toxic.

TRANSITIONAL PROVISION

9. In the case of a biotechnology product set out below that is new to Canada, the manufacturer or importer shall provide the environmental assessment and the information referred to in section 2, 3 or 4 or subsection 5(1), as applicable, within twelve months after the coming into force of these Regulations:

(a) a biotechnology product that is a drug in respect of which, before these Regulations came into force, a submission for a notice of compliance was filed pursuant to section C.08.002 of the Food and Drug Regulations; and

(b) a biotechnology product that is a food additive in respect of which, before these Regulations came into force, a submission was filed pursuant to section B.16.002 of the Food and Drug Regulations in connection with a request that the food additive be added to a table to section B.16.100 of those Regulations or that a change be made to such a table with respect to the food additive.

COMING INTO FORCE

10. These Regulations come into force on the day on which they are registered.

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Footnote a

S.C., 1994, c. 22

Footnote 1

C.R.C., c. 1035

Footnote 2

SOR/82-703

Footnote b

S.C., 1994, c. 47, s. 117

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