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Full access to information used for decisions on genetically modified organisms

Petition

July 7, 2005

Johanne Gélinas
Commissioner of the Environment and Sustainable Development
Office of the Auditor General of Canada
240 Sparks Street
Ottawa, ON
K1A 0G6

Dear Johanne Gélinas,

Petition pursuant to Section 22 of the Auditor General Act
Citizens' Right to Full Access to Environmental Assessment
of Genetically Engineered Organisms
Transparency, Good Science and Trust in Government

This petition under section 22 of the Auditor General Act is addressed to the Right Honorable Ministers of: Agriculture and Agri-Food, Environment Canada, Fisheries and Oceans, Foreign Affairs, Health Canada, Industry, Justice, Department of Natural Resources, Parks Canada, Public Safety and Emergency Preparedness Canada, Public Works and Government Services, and the Treasury Board of Canada Secretariat.

In view of the importance of the issue raised in this petition we would like also this petition to be submitted to the Prime Minister, the Right Honorable Paul Martin.

Preamble

1. Greenpeace is opposed to the environmental release of genetically modified organisms (GMOs) due to concerns about harmful environmental impacts. Our position is based both on the precautionary principle and independent scientific evidence.
2. There is ample scientific uncertainty surrounding both the ecological and human health effects of GMOs. Because of the lack of independent and peer-reviewed scientific knowledge about those impacts, it is incumbent on government regulators to follow the precautionary principle and ban the introduction of GMOs into the environment. Such a ban should be applied both to currently approved GMOs (e.g., GE canola, soy and corn) and those for which approval has been made.
3. Supporting our demand for an immediate ban on GMOs is a proliferation of scientific research and expert analysis. Noteworthy in Canada are the findings of the 2001 Expert Panel Report of the Royal Society of Canada commissioned by the Federal government; the position paper of the Ontario Public Health Association; and a report produced by the Québec Institut national de santé publique.
4. Greenpeace supports the Cartagena Protocol on Biosafety ("Biosafety Protocol") as a good initial framework to regulate the international movement of GMOs. Although Greenpeace welcomed Canada's signing of the Biosafety Protocol on April 19, 2001, we regret that the Canadian government has failed to ratify the Protocol. Canada should immediately ratify the Biosafety Protocol and contribute positively to its effective implementation in order to avoid genetic contamination outside and inside Canada.
5. Greenpeace is an independent, global campaigning environmental organization. Founded in 1971 in Vancouver, Greenpeace has a presence in at least 40 countries or regions with a global membership of 2.8 million. Greenpeace Canada (GPC) has over 84,000 Canadian supporters.

Background

Our petition is motivated by the recent saga around the Monsanto GE corn MON 863 authorized in Canada since 2003. The public and full release of a rat-feeding study ordered by a German court has raised the issue of the importance of transparency in government decision regarding the authorization of GMOs. Please find attached a 3-page short briefing* that gives more details.

Questions:

1. Would the Prime Minister and Ministers agree that, like European citizens (under Art. 25 of the European Directive 2001/18/EC as confirmed by a German court in June 2005 regarding the Monsanto rat-feeding study MSL-18175 of genetically engineered corn MON 863 – see attached Greenpeace 3-page briefing document*), Canadians have the right to have access to the full details of studies that are the basis for federal government's decisions regarding genetically engineered organisms in the context of Canada's commitment to sustainable development and as stipulated under the United Nations Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters – known as the Aarhus Convention that came into force on October 31, 2001?
2. Would the Prime Minister and Ministers agree that the adoption by Canada of a European-type of right to access to full environmental assessment studies (like under Art. 25 of the European Directive 2001/18/EC as confirmed by a German court in June 2005 regarding the Monsanto rat-feeding study MSL-18175 of genetically engineered corn MON 863 and as stipulated under the United Nations Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters – known as the Aarhus Convention that came into force on October 31, 2001), would simultaneously continue to protect genuine confidential business information while promoting full transparency, good science and enhanced trust in governmental decisions in the context of sustainable development?
3. Will the Prime Minister and Ministers introduce and adopt legislative amendments in Canada similar to Art. 25 of the European Directive to 2001/18/EC and as stipulated under the United Nations Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters – known as the Aarhus Convention that came into force on October 31, 2001, before the next general election to give Canadian citizens the right to access to full environmental assessment studies? If not, please supply detailed rationale. If yes, please give the detailed plan and timeframe.

We hope to receive a reply by the end of October 2005 at the latest (and within the 120 days limit) in order to share it with Canadians prior to a general election.

Best wishes,

[Original signed by Éric Darier]

Éric Darier, Ph.D.
Genetic Engineering Campaigner
Greenpeace

*[attachment not posted]

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Joint Response: Agriculture and Agri-Food Canada, Environment Canada, Fisheries and Oceans Canada, Foreign Affairs and International Trade—Department of [1996-2003], Health Canada, Industry Canada, Justice Canada—Department of, Natural Resources Canada, Treasury Board of Canada Secretariat

3 November 2005

Dr. Éric Darier
Genetically Engineering Campaigner
Greenpeace
454 Laurier Avenue East, 3rd Floor
Montréal, Quebec
H2J 1E7

Dear Dr. Darier:

I am responding to your Environmental Petition No. 152, to the Commissioner of the Environment and Sustainable Development, in which you pose questions under the Auditor General Act with respect to Canadians' right to access information regarding the environmental assessments of novel products of biotechnology, including the studies on which regulatory decisions are based. Your Petition was received in Environment Canada on July 22, 2005.

Due to the nature of the issues raised in the petition, we are providing a joint response from Agriculture and Agri-Food Canada, Environment Canada, Health Canada, Fisheries and Oceans Canada, Industry Canada, Foreign Affairs Canada, Justice Canada, Natural Resources Canada, the Treasury Board Secretariat, and the Canadian Wheat Board.

The Government of Canada appreciates being made aware of your views on this matter, and I am pleased to provide you with the enclosed response to your petition.

I trust that the information provided is helpful.

Yours sincerely,

[Original signed by Stéphane Dion, Minister of the Environment]

Stéphane Dion

RESPONSE OF THE FEDERAL DEPARTMENTS AND
AGENCIES TO ENVIRONMENTAL PETITION 152 FILED
BY GREENPEACE CANADA UNDER THE AUDITOR GENERAL
ACT (RECEIVED JULY 22, 2005):

Canadians' Right to Access Information Regarding the
Environmental Assessments of Novel Products of Biotechnology

November 18, 2005

Minister of Agriculture and Agri-Food
Minister of the Environment
Minister of Fisheries and Oceans
Minister of Health
Minister of Industry
Minister of Foreign Affairs
Minister of Justice and Attorney General of Canada
Minister of Natural Resources
President of the Treasury Board and Minister
responsible for the Canadian Wheat Board

Foreword

The Government of Canada defines biotechnology broadly as the application of science and engineering to the direct or indirect use of living organisms or parts or products of living organisms in their natural and modified forms. Canada has a unique regulatory approach for biotechnology products which considers the novelty of an organism (or product) as the primary trigger for regulatory review (e.g. the introduction of new genetic trait(s), change in an existing genetic trait(s) or a new use), instead of the process by which the product was developed. However, the criteria for novelty are specific to the organism or product (e.g. plants, livestock feeds, fertilizers and supplements, micro-organisms, foods, biologics, pest controls, drugs, etc) and are defined in the appropriate Acts and Regulations. Novel products of biotechnology can be developed through various genetic modification techniques (e.g. traditional breeding, genetic engineering, mutagenesis, cell fusion, etc). In Canada-regardless of their method of production-the resulting novel products of biotechnology are thoroughly assessed for their safety as well as their potential environmental, animal health, and human health risks before they are permitted to be imported, manufactured, released into the environment or allowed to be sold in the marketplace. Although the questions within the Petition refer to genetically engineered (GE) organisms specifically, the text within this Petition response refers to novel products of biotechnology as this term more accurately describes the Canadian regulatory system for biotechnology. That is to say, the Government of Canada regulates novel products of biotechnology which include, but are not limited to, GE organisms.

In 1993, the Government of Canada established the Federal Regulatory Framework for Biotechnology. This federal framework resulted from an agreement among federal regulatory departments on principles for an efficient, effective approach for regulating novel products of biotechnology. The following six principles were approved on the basis that they would assure that the practical benefits of novel products and processes of biotechnology would be balanced with the need to protect human health, animal health and the environment. The framework:

• maintains Canada's high standards for the protection of the health of workers, the general public and the environment
• uses existing legislation and regulatory institutions to clarify responsibilities and avoid duplication
• continues to develop clear guidelines for evaluating products of biotechnology which are in harmony with national priorities and international standards
• provides a sound scientific database on which to assess risk and evaluate products
• assures that both the development and enforcement of Canadian biotechnology regulations are open and include consultation
• contributes to the prosperity and well-being of Canadians by fostering a favourable climate for investment, development, innovation and adoption of sustainable Canadian
• biotechnology products and processes

Canada has one of the safest, most effective regulatory systems for novel products of biotechnology in the world. In the Canadian Biotechnology Strategy, which was developed following extensive public consultation, the Government of Canada expressed its goal of being a world leader in the responsible development of novel products of biotechnology. This means that the Government of Canada must apply rigorous standards to the manner in which it regulates and monitors novel products of biotechnology, particularly as they relate to human health, animal health, and the environment. Internationally, Canada has a long record for its science-based regulatory system that is consistent with principles laid out by organizations such as the World Health Organization (WHO), the Organisation for Economic Co-operation and Development (OECD), the United Nations Environment Programme (UNEP), the Food and Agriculture Organization (FAO), the International Plant Protection Convention (IPPC), the Codex Alimentarius Commission, and the Office International des Épizooties (OIE).

With regard to the environment, the Government of Canada agrees that novel products of biotechnology need to be regulated from a sustainable development perspective before they are introduced into Canada. It is important that their potential immediate and long-term impacts be understood. As such, the existing Canadian regulatory system clearly provides for the assessment and management of novel products of biotechnology from this perspective.

As stated above, one of the fundamental principles of the 1993 Federal Regulatory Framework for Biotechnology was that the development of regulations be open and include consultation with Canadian citizens. Canadian values must be at the heart of the public discussion on novel products of biotechnology. It is in this light that the Government of Canada welcomes and values a transparent dialogue with Canadians; this principle is embodied in the Auditor General Act and the process for petitioning the Government on matters pertaining to the environment and sustainable development.

In responding to this Petition, the federal departments and agencies have worked together to contribute their collective knowledge and expertise. The result is a considered, integrated response relevant to all Canadians who are interested in the topic of Canadians' right to access information regarding the environmental assessments of novel products of biotechnology, including the studies on which regulatory decisions are based.

The Government of Canada's response builds on previous responses to petitions submitted under the Auditor General Act, which provide an in-depth look at the existing regulatory framework for novel products of biotechnology in aspects covering health, environment, trade, and socioeconomic questions, as they pertain to sustainable development in Canada. Previous biotechnology-related petitions are publicly available on Government of Canada Internet sites at: <www.oag-vg.gc.ca/domino/cesd_cedd.nsf/html/menu8_e.html> and <www.inspection.gc.ca/ english/sci/biotech/trans/petitionse.shtml>.

In regard to the current Petition, the questions posed relate to Canadians' right to access information regarding the environmental assessments of novel products of biotechnology, including the studies on which regulatory decisions are based. These questions are addressed in this Petition response.

Acronyms

Background

On July 7, 2005, Greenpeace Canada (hereinafter referred to as the Petitioner) filed a Petition (hereinafter referred to as the Petition) with the Commissioner of the Environment and Sustainable Development, pursuant to Section 22 of the Auditor General Act. The Petition contains questions relating to Canadians' right to access information regarding the environmental assessments of novel products of biotechnology, including the studies on which regulatory decisions are based. These questions are addressed in this Petition response. The Petition was received by the Auditor General's Office on July 7, 2005. It was sent to the petitioned Ministers on behalf of their departments (hereafter referred to as the Ministers) on July 22, 2005. For this reason, the 120 days allowed for the Government of Canada to respond to the Petition, as expressed in the Auditor General Act, began on July 22, 2005.

The Petition process set out in Section 22 of the Auditor General Act is a means by which Canadians can express their views while seeking more information on matters of federal policy in the context of the environment and sustainable development. The Government of Canada wishes to assure the Petitioner and other Canadians that responsible stewardship of human health, animal health, biodiversity, and the environment is of priority to the Government of Canada.

The Commissioner of the Environment and Sustainable Development forwarded the Petition to the following Ministers for response:

• Minister of Agriculture and Agri-Food
• Minister of the Environment
• Minister of Fisheries and Oceans
• Minister of Health
• Minister of Industry
• Minister of Foreign Affairs
• Minister of Justice and Attorney General of Canada
• Minister of Natural Resources
• President of the Treasury Board and Minister responsible for the Canadian Wheat Board

A copy of this Petition was also forwarded to the Deputy Prime Minister and Minister of Public Safety and Emergency Preparedness; the Minister of Public Works and Government Services; and the Minister of the Environment in his capacity as the Minister responsible for Parks Canada Agency for information purposes only. It should also be noted that content provided by the Minister of Agriculture and Agri-Food reflects the roles and responsibilities of the Canadian Food Inspection Agency (CFIA) and Agriculture and Agri-Food Canada (AAFC) in the context of this matter. It should be further noted that content provided by the Minister of Health reflects the roles and responsibilities of Health Canada and the Pest Management Regulatory Agency (PMRA) in the context of this matter.

The Response of the Federal Departments and Agencies to the Petition

Introduction

1. The petitioned Ministers, named above, are providing this document as a joint response to the Petitioner.
2. Providing a joint response illustrates the Government of Canada's commitment to improve the management and co-ordination of matters related to novel products of biotechnology and the environment as reflected in several previous Petition responses, as well as other joint activities described in those responses.
3. Overall, the Ministers believe that the Government of Canada's existing regulatory system provides for the assessment and management of novel products of biotechnology from the perspective of sustainable development. In previous Petition responses (specifically Petitions numbered 23, 34A and B, 38A and B, 44, 84, 85, 88, 94, 108, and 125) the Government of Canada has already provided information regarding:
• the 1993 Federal Regulatory Framework for Biotechnology
• the federal development of Sustainable Development Strategies
4. The Petitioner may refer to previous biotechnology-related Petition responses that are publicly available on Government of Canada Internet sites at: <www.oag-bvg.gc.ca/ domino/cesd_cedd.nsf/html/menu8_e.html> and <www.inspection.gc.ca/english/sci/ biotech/trans/petitionse.shtml> for extensive background information about the regulation of novel products of biotechnology in Canada.
5. In addition, several Acts and Regulations related to the environmental assessments of new substances were found to provide for notification and assessment under the New Substances Notification Regulations (NSNR) of the Canadian Environmental Protection Act, 1999 (CEPA 1999). As a result, the Seeds Act, Feeds Act, Fertilizers Act, Health of Animals Act, Pest Control Products Act and Regulations are listed in Schedule 4 of the CEPA 1999 indicating the Government of Canada's finding that the provisions for notification and assessment of novel products of biotechnology in these Acts and Regulations are comparable to those contained in CEPA 1999, the benchmark regulatory authority for novel products of biotechnology.
6. As a result of the above, Ministers have structured this document to focus on responses to the Petitioner's questions (refer to paragraphs 7-30).

Preamble

7. The Petitioner makes several references to international agreements and to the regulations of the European Union (EU). In the preamble of the Petition, for example, the Government of Canada is urged to immediately ratify the Cartagena Protocol on Biosafety (the Protocol) and to contribute positively to its effective implementation. Further, the Petitioner makes reference to Article 25 of the EU Directive 2001/18 and to the United Nations (UN) Convention on Access to Information, Public Participation in Decision Making and Access to Justice in Environmental Matters (referred to as the Aarhus Convention) in each of the three questions. These references reflect, in part, the international context in which decisions on novel products of biotechnology are made by governments, depending on the nature of their regulatory regimes and their obligations under international law. The Government of Canada is mindful of this context-although not a Party to either international agreement cited-and seeks, in particular, to work constructively with other countries toward effective and practical implementation of the Protocol. However, the questions within the Petition essentially relate to management of the Canadian environment, including the regulations, studies, and environmental assessments used to support the regulatory decisions regarding novel products of biotechnology. Accordingly, it is the requirements of domestic legislation and regulation that apply and that are addressed in this Petition response. Nevertheless, these domestic requirements are consistent with the international obligations that Canada has formally undertaken.
8. Further, the Petitioner made reference to corn line MON 863, a registered product of Monsanto Inc. In March 2003, corn line MON 863-genetically engineered to be resistant to corn rootworm-was authorized for use as a food, use as a livestock feed, and for unconfined release into the Canadian environment following comprehensive assessments based upon internationally recognized principles. The results of the 90-day rat feeding study mentioned by the Petitioner did not affect the Government of Canada's authorization. It is internationally recognized¹ that whole food feeding studies are of limited value in assessing the toxicity of a food and/or feed product. There have been more established and robust methods by which Canada and other countries have conducted their assessments of novel products of biotechnology.
9. Mandatory, pre-market environmental, livestock feed, and human health assessments are required before novel products of biotechnology are made available for use in Canada. However, the questions within the Petition refer to Canadians' right to access information regarding the environmental assessments of GE organisms, including the studies on which regulatory decisions are based. Therefore, only environmental assessments of novel products of biotechnology (including the studies on which regulatory decisions are based) are addressed within this Petition response. Should the Petitioner be interested in additional information concerning other assessments required before novel products of biotechnology are made available for use, visit the Government of Canada BioPortal available at: <www.BioPortal.gc.ca>.
10. To enhance the Petitioner's understanding of the subsequent response, it is necessary to briefly describe the federal departments and agencies responsible for the environmental assessment of novel products of biotechnology. The responsibilities belong to Environment Canada (e.g. under the CEPA 1999), the CFIA (e.g., under the Feeds Act, Fertilizers Act, Seeds Act, and Health of Animals Act), the PMRA (e.g. under the Pest Control Products Act), and Health Canada (e.g. under the Food and Drugs Act). The aforementioned Acts, administered by the CFIA and PMRA, are listed in Schedule 4 of CEPA 1999 meaning that novel products of biotechnology regulated under them are exempted from environmental assessment under CEPA 1999's new substances provisions. For novel products of biotechnology not already falling within the purview of those Acts listed in Schedule 4 of CEPA 1999, Environment Canada and Health Canada assess these products under the CEPA 1999. Micro-organisms used in bioremediation and industrial enzyme production are examples of such products.
11. In May 2004, Fisheries and Oceans Canada, Environment Canada, and Health Canada signed a Memorandum of Understanding under which Fisheries and Oceans Canada agreed to assist in th e administration of the NSNR for aquatic organisms with novel traits. For example, Fisheries and Oceans Canada will conduct assessments for aquatic organisms with novel traits. Fisheries and Oceans Canada is developing aquatic organism-specific regulations, that once complete, will provide for CEPA 1999-equivalent regulatory oversight of aquatic organisms.
12. Novel products of biotechnology evaluated for human health safety under the Food and Drugs Act also undergo an environmental assessment under the authority of the CEPA 1999 and its NSNR. The NSNR prescribe the information that must be submitted to the Minister of the Environment. As part of Health Canada's shared responsibility for the protection of the environment and as a partner in CEPA 1999, Health Canada has established its own Environmental Assessment Unit (EAU) to conduct the environmental assessments of novel products of biotechnology regulated under the Food and Drugs Act in accordance with a Memo of Understanding with Environment Canada. For clarification, the environmental assessment of plants with novel traits (PNTs) conducted by Health Canada would be performed on the food, pharmaceutical or industrial substance Itself-which can be the harvested plant-but not on the plant in the field. The CFIA is responsible for assessing the environmental impact of PNTs in the field under the Seeds Act.

Responses to Petition Questions

Response to Questions 1 and 2:

13. The Government of Canada is committed to regulatory transparency as stated in the Government of Canada's Action Plan in response to the Royal Society of Canada Expert Panel Report on the Elements of Precaution: Recommendations for the Regulations of Food Biotechnology in Canada, (a copy of the Action Plan is available at: <www.hcsc.gc.ca/fn-an/gmf-agm/index_e.html>) and in the Government of Canada's Report on Actions and Plans in response to the Report of the External Advisory Committee on Smart Regulations released in September 2004 (a copy is available at: <www.regulation.gc.ca>. Therefore, the Government of Canada is committed to increasing transparency and openness in the Canadian regulatory system, specifically related to the environmental assessment process, product information and how environmental assessments are conducted. Several transparency initiatives that aim to achieve these goals are underway and are described below.
14. The CFIA, Health Canada, Environment Canada, and PMRA prepare and publish decision documents for assessments conducted on novel products of biotechnology. Decision documents explain what scientific information was reviewed to make the decision and how certain conclusions and regulatory decisions were reached. They also provide background information, describe the organism's novel traits, and discuss the results of the assessment. CFIA decision documents can be viewed at: <www.inspection.gc.ca/english/plaveg/bio/dde.shtml> while Health Canada decision documents can be viewed at: <www.hc-sc.gc.ca/fn-an/gmf-agm/index_e.html> (also available in hard copy). Joint Health Canada and Environment Canada Decision Documents ca be viewed at: <www.bch.gc.ca> while PMRA decision documents can be viewed at: <www.pmraarla. gc.ca/english/pubs/rdd-e.html>. Also, CEPA 1999 prescribes that any regulatory decisions requiring risk mitigation measures (e.g. Significant New Activity [SNAc] provisions, conditions, etc.) be published in the Canada Gazette.
15. As a member of the OECD, the Government of Canada also submits non-confidential information on the environmental release of PNTs to the OECD's publicly available Biotrack database. The database is available on the OECD Internet site at: <www.oecd.org>.
16. Further, the Biosafety Clearing-House (BCH) was established under the Cartagena Protocol on Biosafety (the Protocol) as an internet-based tool that allows users to search domestic and international biosafety information on living modified organisms (LMOs). The Protocol is a subsidiary agreement to the UN Convention on Biological Diversity. Parties are required to make any final decision regarding the importation or release of an LMO, or the domestic use of an LMO that may be subject to a subsequent transboundary movement for direct use as food or feed, or for processing, available to the BCH. Although Canada is not a Party to the Protocol, it supports the objective of the Protocol-to protect and preserve biodiversity-and recognizes that there is significant interest domestically and internationally in knowing which LMOs have been assessed and approved for use in Canada. The Government of Canada's support for the objective of the Protocol is demonstrated through the development of the Canadian portion (i.e. node) of the BCH. In addition to providing public access to biosafety information, it allows countries to exchange scientific, technical, environmental, and legislative information about LMOs produced through modern biotechnology. The Government of Canada has implemented the Canadian Node of the Biosafety Clearing-House (CNBCH) as a central portal to information on the Canadian regulatory system for LMOs and environmental assessments conducted thereunder. Once Fisheries and Oceans Canada begins conducting environmental assessments, assessment summaries for aquatic organisms with novel traits will also be available through the CNBCH. The CNBCH is available on the Internet at: <www.bch.gc.ca>.
17. The creation of the Government of Canada BioPortal (available at: <www.biotech.gc.ca>) is another example of the actions taken by the federal government to increase transparency and public communication with regards to the regulation of novel products of biotechnology. The Government of Canada BioPortal is the online gateway to the latest government information on biotechnology for consumers, industry, scientists and educators. This easy to use and fully searchable site brings together resources from all federal departments and agencies (refer to Part 1 of Annex A for a list of individual federal department and agency Internet sites), including:
• regulatory information
• government policy and research activity
• business support programs and market intelligence
• a virtual library of educational resources
• regulations on biotechnology research and applications
18. The Government of Canada also encourages public participation. For example, the CFIA and Health Canada, in co-operation with Croplife Canada, launched a pilot Notices of Submission Project on October 21, 2003. With the launch of this project, the federal government is responding to the public's interest, along with the recommendations of expert advisory groups, such as the Royal Society of Canada and the Canadian Biotechnology Advisory Committee, in having a more transparent process of regulating PNTs, novel foods, and/or novel livestock feeds derived from plants. Previously, only lists of approved products-along with their accompanying decision documents and directives-were posted on the CFIA and Health Canada Internet sites. To complement this practice, notices of new submissions are also being posted on the CFIA Internet site. These notices describe products currently under assessment by the CFIA and Health Canada and summarize the information used as part of that assessment. As such, this new initiative allows for public input before the assessment process itself, rather than only after the assessment is complete. Also, for the first time, the public has access to a list of scientific studies conducted on these products. For more information on this pilot project, visit the CFIA Internet site at: <www.inspection.gc.ca/english/plaveg/bio/subs/ subliste.shtml>. Those wishing to receive e-mail notification of new submissions, may join the notification subscription service at: <www.inspection.gc.ca/english/tools/listserv/ listsube.shtml?biosub_biodem>.
19. Second, CEPA 1999 requires the maintenance of an Environmental Registry, a comprehensive online source of public information relating to activities under CEPA 1999. In addition to providing up-to-date copies of current CEPA 1999 instruments and activities, the primary objective of the Environmental Registry is to encourage and support public participation by facilitating access to documents arising from the administration of the Act, such as proposed Regulations and orders from their initial publication in Part I of the Canada Gazette through public consultations and their final publication in Part II of the Canada Gazette. For more information, visit the Environment Canada Internet site at: <www.ec.gc.ca/CEPARegistry/default.cfm>.
20. That being said, the Government of Canada holds many trade secrets and other types of confidential business information on behalf of third parties, such as companies or academic institutions that submit novel products of biotechnology for environmental assessments. In legal terms, this proprietary information belongs to the companies that generate it and it has traditionally been protected by intellectual property law. In Canada, intellectual property includes, in part, patents, trademarks, copyright, plant breeders' rights, and trade secrets.
21. Companies consider proprietary business information to be valuable. All persons submitting data or information to the government, for the purpose of an environmental assessment of a novel product of biotechnology, are entitled to request that the Government of Canada treat their commercially sensitive information as confidential. This entitlement is found in CEPA 1999 (e.g. Section 313) for the Minister of the Environment. The request must be made in writing to the Minister of Environment. Notwithstanding the request for confidentiality made under Section 313 of CEPA 1999, the Minister of Environment may disclose any information if the disclosure would not be prohibited under Section 20 of the ATIA or is in the interest of public health, public safety, or the protection of the environment. However, the public interest in the disclosure must clearly outweigh private interests. The private interests to be considered are the material financial loss or prejudice to the competitive position of the person who provided the information or on whose behalf it was provided, as prescribed in Section 315 of CEPA 1999. The Government of Canada is required by law to assure that such information, provided by a third party, is not given to unauthorized recipients. The confidential business information provided by third parties is protected from public disclosure, but is reviewed as part of the environmental assessment and the regulatory decision process.
22. Nevertheless, confidential business information that is used in conducting an environmental assessment is subject to the same data quality standards as all other required information. Regulators will not make a decision on the environmental release of a novel product of biotechnology, unless the submitted information is complete and fully meets the evaluation criteria. However, confidential business information is not publicly disclosed in the Government of Canada's decision documents, nor is it included in any other transparency initiatives in which Decision Documents are made available to the public.
23. The Government of Canada's decisions surrounding Canadians' right to access information regarding the environmental assessments of novel products of biotechnology (including the studies on which regulatory decisions are based) involves a balance between protecting the rights of Canadians and protecting the rights of third parties who have provided information to the Government of Canada. While the Government of Canada is committed to regulatory transparency, it would be impossible to simultaneously provide Canadians full access to all studies on which regulatory decisions regarding novel products of biotechnology are based while protecting confidential business information for the reasons outlined above. Therefore, it is the Government of Canada's view that the regulatory system for novel products of biotechnology adequately balances Canadians' right to access information regarding the environmental assessments of novel products of biotechnology (including the studies on which regulatory decisions are based) while protecting the rights of third parties who have provided information to the Government of Canada.
24. In addition to the transparency and public participation initiatives discussed above, the Access to Information Act, R.S.C. (1985) c. A-1 (ATIA) already provides a right of access to all individuals or incorporated entities present in Canada with respect to records held by government institutions listed in Schedule I to the Act. The purpose of the Act, as stated in Section 2, is to:


"extend the present laws of Canada to provide a right of access to information in records under the control of a government institution in accordance with the principles that government information should be available to the public, that necessary exceptions to the right of access should be limited and specific and that decisions on the disclosure of government information should be reviewed independently of government."

25. The right of access under the ATIA applies notwithstanding any other Acts and is subject only to limited exemptions listed in the ATIA. To view a copy of the ATIA, visit the Department of Justice Internet site at: <http://laws.justice.gc.ca/en/A-1/8.html>.
26. These limited exemptions are intended to balance freedom of information against other public interests, such as commercial confidentiality, which is protected under Section 20 of the ATIA. Subsection 20(1) of the ATIA provides that a government institution shall refuse to disclose any record requested under the Act that contains (a) trade secrets of a third party; (b) financial, commercial, scientific or technical information that is confidential information supplied to a government institution by a third party and is treated consistently in a confidential manner by the third party; (c) information the disclosure of which could reasonably be expected to result in material financial loss or gain to, or could reasonably be expected to prejudice the competitive position of, a third party; or (d) information the disclosure of which could reasonably be expected to interfere with contractual or other negotiations of a third party. The application of the limited exemptions set out in paragraphs (a) through (d) of Subsection 20(1) of the ATIA may however, in some circumstances, be affected by the operation of Subsections 20(2), (5) or (6) of the ATIA. For example, under Subsection 20(2) of the ATIA a government institution shall not, pursuant to Subsection 20(1) of the ATIA, refuse to disclose a part of a record that contains the results of product or environmental testing carried out by or on behalf of a government institution, unless the testing was done as a service to a person, a group of persons or an organization other than a government institution and for a fee. Further, Subsection 20(6) of the ATIA provides provisions for the Government of Canada to disclose confidential information as set out in Subsection 20(1) of the ATIA (trade secrets excluded) if that disclosure would be in the public interest as it relates to public health, public safety or protection of the environment and, if the public interest in disclosure clearly outweighs in importance any financial loss or prejudice.
27. In circumstances when the Government of Canada is considering the release of information which may contain confidential third party information as outlined in Section 20 of the ATIA, a consultation with the third party is conducted based on the notification provisions of Sections 27, 28 and 29 of the ATIA. The documents are reviewed on a case-by-case basis; based on a detailed, line-by-line assessment of the information while taking into account representations of the third party and the interpretation of provisions of the ATIA. The ATIA, Treasury Board of Canada Guidelines (available at: <www.tbs-sct.gc.ca/pubs_pol/gospubs/TBM_121/CHAP2_8-2_e.asp#third>) and relevant case law outline the strict criteria by which Federal Institutions must review third party information. Only the portions of the records which meet the criteria set out in the ATIA are withheld while the remaining information is released.
28. In essence, any documents or studies that are under a government institution's control and form the basis for the Government of Canada's decisions regarding novel products of biotechnology, would be accessible unless one of the limited exemptions applies. The Government of Canada considers that the overall structure of the ATIA balances Canadians' right to access information regarding the environmental assessments of novel products of biotechnology (including the studies on which regulatory decisions are based) while protecting the rights of third parties who have provided information to the Government of Canada.

Response to Question 3:

29. The Petitioner refers to Article 25 of the EU Directive 2001/18/EC which provides, at paragraph 4, that environmental assessments should not be kept confidential. The Petitioner also makes reference to the Aarhus Convention. While Article 25 of the EU Directive 2001/18/EC and the Aarhus Convention do not apply in Canada, a general review of the Aarhus Convention indicates that Canada has already implemented many of the obligations provided for therein. In principle, both Article 25 of the EU Directive 2001/18/EC and the Aarhus Convention are consistent in their general approach to the issue of the right of access to information. While there are some differences with respect to the coverage and substance of Article 25 of the EU Directive 2001/18/EC and the Aarhus Convention, a general comparison of the objective clause of the Aarhus Convention (Article 1)² with the purpose clause of the ATIA (Section 2)³ highlights the strong similarity of purpose and principle between them. As such, legislative amendments would not be necessary to give Canadians the right to access the information as requested by the Petitioner given that similar obligations are already provided for in the ATIA (refer to the response to questions 1 and 2 regarding the provisions contained within the ATIA). At this time, no legislative changes are being considered as a result of this Petition, as the provisions of current legislation are clear and serve the purpose of releasing the appropriate information to Canadians.

Concluding Remarks

30. The Ministers named in this Petition remain committed to:
• delivering an effective domestic regulatory system that embodies the concept of sustainable development as it seeks to protect the health of Canadians and the environment
• supporting the broader responsibilities of global stewardship, which Canada shares with other countries, to see that practical and effective measures to protect humans, biodiversity, and the environment are achieved through the design and operation of a science-based, rules-based, and transparent, internationally-recognized regulatory framework

Annex A: Selected Internet Sources for Further Reading

Part 1—Government Departments and Agencies

• Government of Canada
  www.gc.ca
• Canadian Biotechnology Strategy
  www.biotech.gc.ca
• CFIA
  www.inspection.gc.ca
• Commission for the Environment and Sustainable Development
  www.oag-bvg.gc.ca/domino/cesd_cedd.nsf/html/menu8_e.html
• Environment Canada
  www.ec.gc.ca/substances
• Fisheries and Oceans Canada
  www.dfo-mpo.gc.ca
• Health Canada
  www.hc-sc.gc.ca
• PMRA
  www.pmra-arla.gc.ca/english/index-e.html

Part 2—Response Topics

Foreword

• Government of Canada Response to previous Petitions
  www.oag-vg.gc.ca/domino/cesd_cedd.nsf/html/menu8_e.html
• Government of Canada Responses to Biotechnology-related Petitions
  www.inspection.gc.ca/english/sci/biotech/trans/petitionse.shtml

Preamble

• Government of Canada BioPortal
  www.BioPortal.gc.ca

Response to Questions

• Access to Information Act
  http://laws.justice.gc.ca/en/A-1/index.html
• Treasury Board of Canada Guidelines
  www.tbs-sct.gc.ca/pubs_pol/gospubs/TBM_121/CHAP2_8-2_e.asp#third
• Royal Society Government of Canada Action Plan
  www.hc-sc.gc.ca/fn-an/gmf-agm/index_e.html
• Government of Canada's Report on Actions and Plans
  www.regulation.gc.ca
• CFIA Decision Documents
  www.inspection.gc.ca/english/plaveg/bio/dde.shtml
• Health Canada Decision Documents
  www.hc-sc.gc.ca/fn-an/gmf-agm/index_e.html
• PMRA Decision Documents
  www.pmra-arla.gc.ca/english/pubs/rdd-e.html
• OECD's Biotrack database:
  www.oecd.org/topic/0,2686,en_2649_34385_1_1_1_1_37437,00.html
• CNBCH
  www.bch.gc.ca.
• CFIA/Health Canada/Croplife Canada Notices of Submission Pilot Project
  www.inspection.gc.ca/english/plaveg/bio/subs/subliste.shtml
• CEPA Registry
  www.ec.gc.ca/CEPARegistry/default.cfm.

1 Hammond, Bruce, Rogers, Steve G. and Fuchs, Roy L. (1996) Limitations of whole food feeding studies in food safety assessment. Food Safety Evaluation. pp. 85-97. Organization for Economic Cooperation and Development (OECD), Paris, France.

2 "In order to contribute to the protection of the right of every person of present and future generations to live in an environment adequate to his or her health and well-being, each Party shall guarantee the rights of access to information, public participation in decision-making, and access to justice in environmental matters in accordance with the provisions of this Convention."

3 "The purpose of this Act is to extend the present laws of Canada to provide a right of access to information in records under the control of a government institution in accordance with the principles that government information should be available to the public, that necessary exceptions to the right of access should be limited and specific and that decisions on the disclosure of government information should be reviewed independently of government."