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Genetically modified organisms—Follow-up petition on Canada's response to the Starlink™ corn controversy

Petition: No. 34B

Issue(s): Biological diversity, human health/environmental health, international cooperation, and science and technology

Petitioner(s): Greenpeace Canada

Date Received: 18 January 2002

Status: Completed

Summary: In this petition, which is a follow-up to petition No. 34A, the petitioner posed further questions related to Starlink™ corn. 

Federal Departments Responsible for Reply: Agriculture and Agri-Food Canada, Canada Customs and Revenue Agency [1996-2003], Environment Canada, Foreign Affairs and International Trade—Department of [1996-2003], Health Canada

Petition

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

January 15, 2002

Dear Johanne Gélinas,

Petition pursuant to Section 22 of the Auditor General Act

Following our petition (dated July 19, 2001), we acknowledge the government's response entitled StarLinkþ Corn and Canada's Feeds, Seeds, Food Supply, and Ecosystems made public on December 10, 2001 (available on the Canadian Food Inspection Agency's (CFIA's) website: http://www.inspection.gc.ca/english/ppc/biotech/tech/greenstare.shtml).

Unfortunately, the government's response raises additional questions and further concerns. Therefore, Greenpeace would like to file a supplementary petition to the Minister of Agriculture and Agri-Food, the Minister of the Environment, the Minister of Health, the Minister of International Trade, the Minister of National Revenue, the Minister of Industry, the Canadian Food Inspection Agency, the Canadian Grain Commission and any other government organizations involved in responding directly or indirectly to the genetic contamination of Canada's food supply, seeds and ecosystems by StarLinkþ, a transgenic corn illegal in Canada.

Preamble

  1. Greenpeace is opposed to the release of GMOs (genetically modified organisms) in the environment based on the precautionary principle;
  2. Greenpeace demands an immediate ban on GMOs including those already approved. Our demand is based, among other things, on the findings of the Expert Panel Report of the Royal Society of Canada commissioned by the Federal government and released in February 2001, on the position paper of the Ontario Public Health Association, Protecting our Food Supply: Public Health Implications of Food Biotechnology (November 2001) and on the document from the Institut national de santé publique du Québec, Aliments génétiquement modifiés et santé publique (October 2001) (www.inspq.qc.ca)
  3. Greenpeace supports the Biosafety Protocol as a good initial framework to regulate the international commerce and movement of GMOs. Greenpeace welcomed the fact that Canada signed the Biosafety Protocol on April 19, 2001; however, we see no reason for the delay in ratifying and implementing the BP as a sign of goodwill and avoid genetic contamination such as the one caused by illegal StarLink corn entering Canada from the United States;
  4. Greenpeace is extremely concerned about the risks of genetic pollution caused by GMOs to non-GMO crops and their seeds, wild species and surrounding ecosystems. A particular concern for Greenpeace are the risks of GMOs for organic agriculture and non-GMO agriculture in general;
  5. Greenpeace's concerns have, unfortunately, been substantiated by the genetic contamination of Mexican maize by imported US genetically engineered (GE) corn, as confirmed officially by the Mexican government in September 2001 (see attached Greenpeace International Background Information, Maize Under Threat ? Mexico, center of diversity for maize, has been contaminated, September 2001, 5 pages). Greenpeace is concerned that what has happened in Mexico could also happen in Canada.
  6. Greenpeace is extremely concerned about the policies and practices of the Canadian government to promote food biotechnology despite clearly identified risks. We are also concerned about the corresponding failure of the Canadian government to adequately promote non-GE alternatives such as organic agriculture and to ensure that non-GE crops such as wheat are protected from the commercialization of GE wheat in Canada.
  7. Greenpeace is also extremely concerned about the risks of contamination of the food chain by authorised or illegal GMOs resulting from inadequate or non-existent compulsory and effective testing, traceability and identity preservation systems.

Questions relating to StarLink contamination and the government's response published on December 10, 2001 and entitled StarLinkþ Corn and Canada's Feeds, Seeds, Food Supply, and Ecosystems.

Question 1: [relating to the government's replies 36, 37, 68 & Table 2 (pp. 15-18)]

Considering the fact that the Ministers admit that it took the CFIA two months (after the StarLink corn contamination was made public in the US) to publish a short and vague 'discussion paper for a national import control strategy and draft import control policy', would the Ministers recognise that the government was not prepared for the prevention of the occurrence of genetic contamination such as StarLink? Would the Ministers explain why it took them six months after the StarLink contamination was made public in the US and six years after the first authorisation of GMOs to send a Memorandum to all Seed Importers (dated March 2001, 2001) (reply 68) to establish proper requirements for 'adequate documentation'?

Question 2: [relating to the government's replies 37 and 46]

In view of the belated 'discussion paper for a national import control strategy' which commits the government to a 'risk analysis framework', could the Ministers make public the full details of any studies, analysis and results of such 'risk analysis framework' as it relates directly to the StarLink contamination or any other similar type of genetic contamination, in order to substantiate the basis for the government's confidence that its 'regulatory system is strong and has made every reasonable effort?to protect against the illegal?use of non-approved biotechnology-derived products in or into Canada' (reply 46)?

Question 3: [relating to Table 2, page 18, replies 53, 58, 97 and 99]

In view of the government's reassurance that in October 2000, there were no 'reports of human illnesses relating' to StarLink, would the Ministers give details of any epidemiology studies and/or specific warnings given to health professional and the public about the possible health hazards resulting from StarLink? (when? to how many health professionals? by what media? etc.). Would the Ministers give an up-date on reports of human illnesses relating to StarLink after October 2000 and what has been done pro-actively by the government to make sure that the public and medical professionals are aware of the symptoms relating to illnesses associated with StarLink and more specifically to the protein Cry9C contained in StarLink? In view of the fact that the US government has not authorised StarLink for human consumption based on risks to human health due to its potential allergenic properties, would the Ministers not agree that this alone should be grounds for Health Canada to 'establish a study to examine the health effects of the Cry9C protein contained in StarLink corn'? Would the Ministers agree that continuing to refuse to 'require a study to examine the human health effects of the Cry9C protein contained in StarLink' (reply 97) will lead Canadians to believe that their government has a 'don't-look too much-don't find too much' policy when it comes to safety of GMOs? Finally, considering the obvious need illustrated by the illegal presence of StarLink corn in Canada, would the Ministers explain how they can justify the government's continued refusal to implement mandatory labeling of GE food if, for no other reason, to allow the health effects of consuming GMOs to be studied, especially those, such as StarLink, that have been identified as potential allergens?

Question 4: [relating to replies 58, 53 & 97]

In view of the statement made by the Minister of Health regarding the health risks from StarLink that 'it [is] not possible to prove that Cry9C protein is unlikely to be an allergen' (53), how can the Minister then subsequently deny that he 'has not identified any basis on which to require a study to examine the long term human effects of the Cry9C' protein (97) while announcing the establishment of a much needed' surveillance strategy which will permit the identification of potentially undesirable impacts of [GMOs]' (99)? Would the Minister of Health give details about the promised 'surveillance strategy'? Wouldn't the Ministers agree that such a 'surveillance strategy' should be in place PRIOR to the authorisation and release, and the continuation of the release of GMOs in the environment and into the food chain?

Question 5: [relating to Table 2, page 19]

In view of the fact that the CFIA recognised that 3% of the sample of food and feed tested positive for StarLink (four recalls of food imported from the US out of 135 samples) in a period stretching for up to 6 months after the initial reporting of the contamination in the US (a product has about a five-week shelf life), would the Ministers give a month by month detailed report of the sample testings (Fall/Winter 2000/2001) and their detailed results?

Question 6: [relating to replies 72 and 79]

In view of the fact that the government acknowledged that it has identified about 25,000 metric tonnes of US corn imported into Canada contaminated by StarLink despite the belated and tiny numbers of sampling (65 seed samples done by the CFIA = one sample for every 38,000 tonnes of corn imported from the US!), wouldn't the Ministers agree that StarLink contamination in Canada has probably been grossly underestimated and that the StarLink contamination figures officially reported illustrate the wide ranging possible consequences following the environmental release of StarLink and any biotechnological products in general? What will the Ministers do to make sure that there are adequate, sufficient and meaningful tests, enforcement and control to prevent the entry of illegal GMOs in Canada in the future?

Question 7: [relating to reply 73 & Table 2, page 17 & 20]

In view of the fact (a) that the Ministers acknowledged the StarLink contamination cost Canadian taxpayers at least $900,000, and (b) that the government had close contact with Aventis CropScience (the company producing StarLinkþ corn), would the Ministers give details about any agreement or understanding reached with Aventis CropScience regarding the reimbursement of these additional direct costs to the Canadian government? Would the Ministers give details of any agreement, understanding and/or promise reached with or made by Aventis CropScience about adequate compensation for any Canadian food manufacturers, Canadian importers and/or Canadian farmers to monitor and enforce Canada's prohibition policy on StarLink? If not, would the Ministers offer the rationale for not recovering from Aventis CropScience, all the past, current and subsequent costs resulting directly or indirectly from the StarLink contamination in Canada? What steps have the Ministers taken to establish a liability framework that legally enshrines the principle that liability for contamination from GMOs rests mainly with the developer of the technology?

Question 8: [relating to replies 16, 76 and 81]

In view of the Ministers' admissions that 'seed corn is not currently subject to variety registration under the Seeds Regulations and, therefore, the degree of information required to support its importation is not as high as is required for other registered plant products', and that 'there are currently no regulation requirements applicable specifically to exports of products of biotechnology', will the Ministers make the appropriate corrections?. If not, why not? Will the Ministers also establish a policy to make sure that the additional cost for such measures or any other enforcement and monitoring measures will be born by the biotech company which is the original source of the contamination (Aventis CropScience) and not by Canadian taxpayers, Canadian consumers, Canadian manufacturers, Canadian farmers or by overseas Canadian clients? As in question 7, will the Ministers commit to establishing a liability framework that legally enshrines the principle that liability for contamination from GMOs rests mainly with the developer of the technology? In view of the Ministers' statement that 'the Government of Canada takes violations of the Seeds Act, Feeds Act, and Food and Drugs Act very seriously' (reply 16), would the Ministers give details of any evidence of 'serious' action (legal, compensation, etc.) taken against Aventis CropScience, the original source of the illegal genetic pollution in Canada?

Question 9: [relating to replies 46, 92 and 95]

In view of the fact that the CFIA admitted that there was no government 'intention to establish a federal program of compulsory buy back' (92), despite the commitment by CFIA, Health Canada and Environment Canada to make the regulatory system evolve in 'anticipation' to 'challenges' (95), wouldn't the Ministers agree that the absence of a compulsory buy-back program as a matter of general policy fails to adequately protect Canadian farmers from possible economic harm caused by present and subsequent illegal genetic contamination from StarLink or any other illegal GMOs?

Question 10: [relating to replies 46 and 95]

Notwithstanding the Ministers' statement that Canada's 'regulatory system is strong?and enforcement mechanisms serve to protect against the illegal?use of non-approved' GMOs (46), considering the obvious fact that the regulatory system failed to prevent StarLink contamination in Canada, wouldn't the Ministers agree that the release of GMOs into the environment and the food chain should be halted immediately? Would the Ministers give a detailed breakdown on how the $30 million/year budget (Feb 2000) to 'increase the capacities and capabilities of the regulatory system for biotechnology' has and will be used generally and specifically to prevent any subsequent genetic contamination?

Question 11: [relating to replies 105 and 106]

In view of the fact that the Minister for the Environment admitted that his Department has not currently 'established a program to monitor the potential introduction of StarLink corn nor any other crop derived from biotechnology', wouldn't the Ministers agree that such a program should be in place PRIOR to the authorisation and release of legal or illegal GMOs into the environment? In view of the fact that the Minister for the Environment admitted that an environmental monitoring program would be established only 'when resources are identified', wouldn't the Ministers agree that the precautionary principle should be applied and that the release of GMOs into the environment should be stopped in the meanwhile?

Question 12: [relating to replies 85 and 90; indirectly to replies 82, 83 and 84]

In view of the fact that the CFIA admitted working with the Canadian seed growing industry to 'develop quality assurance systems and analytical techniques that will contribute to the necessary advancement in crop and seed certification systems', would the Ministers confirm when they will offer and guaranty (through mandatory labelling) Canadian consumers secure access to non-GMO products resulting from 'crop and seed certification systems' that seem currently to be reserved for exports markets?

In advance, thank you very much for your reply which we are waiting for with great anticipation as always.

[Original signed by Éric Darier]

Éric Darier, Ph.D.
GMO Campaigner

Greenpeace
2444 Notre-Dame ouest
Montréal, Québec
J3J 1N5

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Joint Response: Agriculture and Agri-Food Canada, Canada Customs and Revenue Agency [1996-2003], Environment Canada, Foreign Affairs and International Trade—Department of [1996-2003], Health Canada

RESPONSE OF THE FEDERAL DEPARTMENTS AND
AGENCIES TO THE PETITION FILED
January 18, 2002, BY GREENPEACE CANADA
UNDER THE AUDITOR GENERAL ACT:


Supplemental Petition on StarLink™ Corn and Canada's Feeds, Seeds,
Food Supply, and Ecosystems


June 4, 2002

 

Minister of Agriculture and Agri-Food

Minister of the Environment

Minister of Foreign Affairs

Minister of Health

Minister for International Trade

Minister of National Revenue



Foreword

In responding to this petition, which is the second submitted under the Auditor General Act by Greenpeace Canada in respect of StarLink corn and Canada's feeds, seeds, food supply, and ecosystems, federal departments and agencies have worked together and contributed their collective knowledge and expertise. This effort has been made so as to provide a considered, integrated response that would be relevant to all Canadians who are interested in biotechnology-derived products, specifically as this topic relates to StarLink corn and the environment.

The Government of Canada's response builds on previous responses to petitions submitted under the Auditor General Act, which provided an in-depth look at the existing regulatory system for biotechnology?aspects covering health, the environment, trade and socio-economic questions, as they pertain to regulation and sustainable development in this country. Those responses provided an overview of the comprehensive manner in which Canada regulates developers' products. They also describe the "checks and balances" in the system as well as such forward-looking developments as the Cartagena Protocol on Biosafety to the Convention on Biological Diversity. The specific questions related to StarLink corn presented in the supplemental petition are addressed in this response. The reader is invited to review previous responses, which are publicly available on Government of Canada Web sites, for information on the overall regulatory framework.

Canada has one of the safest and most effective regulatory systems for biotechnology products in the world. In its renewal of the Canadian Biotechnology Strategy, which followed extensive public consultations, the Government of Canada expressed its goal of being a world leader in the responsible development of biotechnology. This means that the Government must apply rigorous standards to the manner in which it regulates and monitors biotechnology-derived products, particularly as they relate to human and animal health and the environment. The Government must continue to assure Canadians that the products and processes of biotechnology are subject to the highest standards of scientific testing for health, safety and environmental impact.

Internationally, Canada has a long and prestigious record for its science-based regulatory system—a system that is in line with principles laid out by organizations such as the World Health Organization (WHO), the Organisation for Economic Cooperation and Development (OECD), United Nations Environment Program (UNEP), the Food and Agriculture Organization (FAO), the International Plant Protection Convention (IPPC), the Codex Alimentarius Commission, and the Office Internationale des Épizooties (OIE). Canada is a world leader in helping to shape international policy directions in areas such as the labelling of biotechnology-derived foods.

One of the fundamental principles of the 1993 Federal Regulatory Framework for Biotechnology is that the development of Canadian biotechnology regulations be open and include consultation with Canadian citizens. Canadian values must be at the heart of the public discussion on biotechnology. It is in this light that the Government of Canada welcomes and values a transparent dialogue with Canadians as we move forward.


Table of Contents

Foreword

Table of Contents

Acronyms

Background

Response of the Departments and Agencies to the Petition

Introduction

Update on the Status of StarLink Corn in Canada

The Response to Questions of the Petition

Question 1
Question 2
Question 3
Question 4
Question 5
Question 6
Question 7
Question 8
Question 9
Question 10
Question 11
Question 12

Concluding Remarks

Annex A

The December 10, 2001, Response of the Federal Departments and Agencies to the Petition on StarLink Corn and Canada's Feeds, Seeds, Food Supply, and Ecosystems

Annex B

The Industry Advisories of the Canadian Food Inspection Agency and the Trade Memoranda of the Canadian Grain Commission Regarding StarLinkCorn



Acronyms

AAFC

Agriculture and Agri-Food Canada

CEPA

Canadian Environmental Protection Act

CFIA

Canadian Food Inspection Agency

CGC

Canadian Grain Commission

CCRA

Canada Customs and Revenue Agency

DFAIT

Department of Foreign Affairs and International Trade

USEPA

U.S. Environmental Protection Agency

FAO

Food and Agriculture Organization

GIPSA

U.S. Grain Inspection, Packers and Stockyards Administration

OECD

Organisation for Economic Cooperation and Development

SD/SDS

Sustainable Development/Sustainable Development Strategy

WHO

World Health Organization

WTO

World Trade Organization

USDA

U.S. Department of Agriculture

USFDA

U.S. Food and Drug Administration



Background

  1. On January 18, 2002, Greenpeace Canada (hereafter referred to as the Petitioner) filed a petition (hereafter 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 asks questions further to a previous petition on the topic of StarLink Corn and Canada's feeds, seeds, food supply, and ecosystems.

  2. The petition process set out in Section 22 of the Auditor General Act is a means by which Canadians can express their views and seek 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 their fellow Canadians that responsible stewardship of human health, biodiversity, and the environment is a central priority to the federal decision-making framework for biotechnology.

  3. The Petition deals with follow-up questions regarding the December 10, 2001, Government of Canada response to the original petition on the topic of StarLink Corn and was specifically directed to the petitioned Ministers on behalf of their departments (hereafter referred to as the Ministers) for response:

    • Minister of Agriculture and Agri-Food
    • Minister of the Environment
    • Minister of Foreign Affairs
    • Minister of Health
    • Minister for International Trade
    • Minister of National Revenue

  4. It should be noted that where the Petitioner refers to "Agriculture Canada," a response is provided that reflects the roles and responsibilities of the Canadian Food Inspection Agency (CFIA), the Canadian Grain Commission (CGC), and Agriculture and Agri-Food Canada in the context of this matter.

  5. The main focus of the Petition concerns the role of the federal government as it relates to the potential Canada-U.S. trans-boundary movement of StarLink corn, a corn plant product not approved in Canada for environmental release or for use as either food or feed.

  6. The Petition asks 12 supplemental questions, further to information provided in the response of December 10, 2001, to a previous petition about the regulatory system for biotechnology (policies and programs related to regulations, enforcement, compliance, and institutional arrangements) and the federal response to the potential presence of StarLink corn in Canada. The Petitioner's questions are annotated with numerical references to specified paragraphs in the original December 2001 Government of Canada response that is provided as Annex A to this supplemental response. Specifically, the Petitioner's questions were:

    Question 1:

    [relating to the government's replies 36, 37, 68, & Table 2 (pp. 15-18)] Considering the fact that the Ministers admit it took the CFIA two months (after the StarLink corn contamination was made public in the U.S.) to publish a short and vague 'discussion paper for the national import control strategy and draft import control policy,' would the Ministers recognise that the government was not prepared for the prevention of the occurrence of genetic contamination such as StarLink? Would the Ministers explain why it took them six months after the StarLink contamination was made public in the US and six years after the first authorisation of GMOs to send a Memorandum to all Seed Importers (dated March 2001) (reply 68) to establish proper requirements for 'adequate documentation'?

    Question 2:

    [relating to the government's replies 37 and 46] In view of the belated 'discussion paper for a national import control strategy,' which commits the government to a 'risk analysis framework,' could the Ministers make public the full details of any studies, analysis and results of such 'risk analysis framework' as it relates directly to the StarLink contamination or any other similar type of genetic contamination, in order to substantiate the basis for the government's confidence that its 'regulatory system is strong and has made every reasonable effort . . . to protect against the illegal . . . use of non-approved biotechnology-derived products in or into Canada' (reply 46)?

    Question 3:

    [relating to Table 2, page 18, replies 53, 58, 97, and 99] In view of the government's reassurance that in October 2000, there were no 'reports of human illnesses relating' to StarLink, would the Ministers give details of any epidemiology studies and/or specific warnings given to health professionals and the public about the possible health hazards resulting from StarLink? (When? To how many health professionals? By what media? etc.). Would the Ministers give an update on reports of human illnesses relating to StarLink after October 2000 and what has been done proactively by the government to make sure that the public and medical professionals are aware of the symptoms relating to illnesses associated with StarLink and more specifically to the protein Cry9C contained in StarLink? In view of the fact that the U.S. government has not authorised StarLink for human consumption based on risks to human health due to its potential allergenic properties, would the Ministers not agree that this alone should be grounds for Health Canada to 'establish a study to examine the health effects of the Cry9C protein contained in StarLink corn'? Would the Ministers agree that continuing to refuse to require a study to examine the human health effects of the Cry9C protein contained in StarLink (reply 97) will lead Canadians to believe that their government has a 'don't look too much-don't find too much' policy when it comes to safety of GMOs? Finally, considering the obvious need illustrated by the illegal presence of StarLink corn in Canada, would the Ministers explain how they can justify the government's continued refusal to implement mandatory labelling of GE food if, for no other reason, to allow the health effects of consuming GMOs to be studied, especially those, such as StarLink, that have been identified as potential allergens?

    Question 4:

    [relating to replies 58, 53, and 97] In view of the statement made by the Minister of Health regarding the health risks from StarLink that 'it [is] not possible to prove that Cry9C protein is unlikely to be an allergen' (53), how can the Minister then subsequently deny that he 'has not identified any basis on which to require a study to examine the long term human effects of the Cry9C protein' (97) while announcing the establishment of a much needed 'surveillance strategy which will permit the identification of potentially undesirable impacts of [GMOs]' (99)? Would the Minister of Health give details about the promised 'surveillance strategy'? Wouldn't the Ministers agree that such a surveillance strategy should be in place PRIOR to the authorisation and release and the continuation of the release of GMOs in the environment and into the food chain?

    Question 5:

    [relating to Table 2, page 19] In view of the fact that the CFIA recognised that 3 percent of the sample of food and feed tested positive for StarLink (four recalls of food imported from the U.S. out of 135 samples) in a period stretching for up to 6 months after the initial reporting of the contamination in the U.S. (a product has about a five-week shelf life), would the Ministers give a month by month detailed report of the sample testings (Fall/Winter 2000-2001) and their detailed results?

    Question 6:

    [relating to replies 72 and 79] In view of the fact that government acknowledged that it has identified about 25,000 metric tonnes of U.S. corn imported into Canada contaminated by StarLink despite the belated and tiny numbers of sampling (65 seed samples done by the CFIA = one sample for every 38,000 tonnes of corn imported from the U.S.!), wouldn't the Ministers agree that StarLink contamination in Canada has probably been grossly underestimated and that the StarLink contamination officially reported illustrates the wide ranging possible consequences following the environmental release of StarLink and any biotechnological products in general?

    Question 7:

    [relating to reply 73 & Table 2 (page 17 &20)] In view of the fact (a) that the Ministers acknowledged the StarLink contamination cost Canadian taxpayers at least $900,000, and (b) that the government had close contact with Aventis CropScience (the company producing StarLink corn), would the Ministers give details about any agreement or understanding reached with Aventis CropScience regarding the reimbursement of these additional direct costs to the Canadian government? Would the Ministers give details of any agreement, understanding and/or promise reached with or made by Aventis CropScience about adequate compensation for any Canadian food manufacturers Canadian importers and/or Canadian farmers to monitor and enforce Canada's prohibition policy on StarLink? If not, would the Ministers offer the rationale for not recovering from Aventis CropScience, all the past, current, and subsequent costs regulating directly or indirectly from the StarLink contamination in Canada? What steps have the Ministers taken to establish a liability framework that legally enshrines the principle that liability for contamination from GMOs rests mainly with the developer of the technology?

    Question 8:

    [relating to replies 46, 92, and 95] In view of the Minister's admissions that 'seed corn is not subject to variety registration under the Seeds Regulations and, therefore, the required degree of information required to support its importation is not as high as is required for other registered plant products' and that 'there are currently no regulation requirements applicable specifically to exports of products of biotechnology,' will the Ministers make the appropriate corrections? If not, why not? Will the Ministers also establish a policy to make sure that the additional cost for such measures or any other enforcement and monitoring measures will be borne by the biotech company which is the original source of the contamination (Aventis CropScience) and not by Canadian taxpayers, Canadian consumers, Canadian manufacturers, Canadian farmers or by overseas Canadian clients? As in question 7, will the Ministers commit to establishing a liability framework that legally enshrines the principle that liability for contamination from GMOs rests mainly with the developer of the technology? In view of the Ministers' statement that 'the Government of Canada takes violations of the Seeds Act, Feeds Act, and Food and Drugs Act very seriously' (reply 16), would the Ministers give details of any evidence of serious action (legal compensation, etc.) taken against Aventis CropScience, original source of the illegal genetic pollution in Canada?

    Question 9:

    [relating to replies 46, 92, and 95] In view of the fact that the CFIA admitted that there was no government 'intention to establish a federal program of compulsory buy back' (92), despite the commitment by CFIA, Health Canada and Environment Canada to make the regulatory system evolve in 'anticipation' to 'challenges' (95), wouldn't the Ministers agree that the absence of a compulsory buy-back program as a matter of general policy fails to adequately protect Canadian farmers from possible economic harm caused by present and subsequent illegal genetic contamination from StarLink or any other illegal GMOs?

    Question 10:

    [relating to replies 46 and 95] Notwithstanding the Minister's statement that Canada's 'regulatory system is strong ... and enforcement mechanisms serve to protect against the illegal ... use of non-approved' GMOs (46), considering the obvious fact that the regulatory system failed to prevent StarLink contamination in Canada, wouldn't the Ministers agree that the release of GMOs into the environment and the food chain should be halted immediately? Would the Ministers give a detailed breakdown on how the $30 million/year budget (Feb. 2000) to 'increase the capacities and capabilities of the regulatory system for biotechnology' has and will be used generally and specifically to prevent any subsequent genetic contamination.

    Question 11:

    [relating to replies 105 and 106] In view of the fact that the Minister for the Environment admitted that his Department has not currently 'established a program to monitor the potential introduction of StarLink corn nor any other crop derived from biotechnology,' wouldn't the Ministers agree that such a program should be in place PRIOR to the authorisation and release of legal or illegal GMOs into the environment? In view of the fact that the Minister for the Environment admitted that an environmental monitoring program would be established only 'when resources are identified,' wouldn't the Ministers agree that the precautionary principle should be applied and that the release of GMOs into the environment should be stopped in the meanwhile?

    Question 12:

    [relating to replies 85, and 90; indirectly to replies to 82, 83, and 84] In view of the fact that the CFIA admitted working with the Canadian seed growing industry to 'develop quality assurance systems and analytical techniques that will contribute to the necessary advancement in crop and seed certification systems,' would the Ministers confirm when they will offer and guarantee (through mandatory labelling) Canadian consumers secure access to non-GMO products resulting from 'crop and seed certification systems' that seem currently to be reserved for export markets?



The Response of the Federal Departments and Agencies to the Greenpeace Petition

Introduction

  1. The Ministers of Agriculture and Agri-Food, Environment, Foreign Affairs, Health, International Trade, and National Revenue have provided this document as a joint response to the Petitioner.

  2. The provision of a joint response is consistent with the federal government's commitment to improve its management and coordination of matters related to biotechnology and the environment as reflected in:

    • the 1996 joint response to the Third Report of the Standing Committee on Environment and Sustainable Development entitled Biotechnology Regulation in Canada: A Matter of Public Confidence;
    • the 1998 renewed Canadian Biotechnology Strategy, which identified a federal management structure for cross-cutting matters such as the regulation of products of biotechnology;
    • the joint departmental and agency responses to previous petitions regarding the regulation of agri-food biotechnology;
    • the November 2001 release of the Action Plan of the Government of Canada in response to the Royal Society of Canada Expert Panel Report entitled: Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada and the subsequent Progress Reports for this Action Plan, including the latest update as released in May 2002.

  3. Overall, the Ministers believe that Canada's existing regulatory system provides for the risk assessment and management of biotechnology-derived products from a sustainable development perspective. In the response of December 10, 2001, (Annex A), to the original petition about StarLink corn, Government of Canada information has already been provided to the Petitioner regarding:

    • the status of StarLink corn in the U.S. and Canada;
    • the 1993 federal regulatory framework for biotechnology; and
    • the federal development of Sustainable Development Strategies

  4. As a result, Ministers have structured this response document to focus upon:

    • an update to the status of StarLink corn in Canada (paragraphs 11-23);
    • responses to the Petitioner's questions (paragraphs 24-62); and
    • copies of the latest notifications about StarLink corn to industry as jointly issued by the CFIA and the CGC (Annex B)

Update on the Status of StarLink Corn in Canada

  1. In Canada, the regulatory status of StarLink corn has not changed; this product remains unauthorized for feed use and environmental release and for use as food, by the CFIA and Health Canada, respectively. The presence of this corn in the Canadian environment or in our feed and food supply systems would constitute evidence of a contravention of the Seeds Act and Regulations, the Feeds Act and Regulations, the Food and Drugs Act and Regulations, and the Canada Grain Act and Regulations.

  2. Approval of a biotechnology-derived product by the U.S., or by other countries, does not relieve any seed developer, food, or feed processor, grocery distributor, or other type of manufacturing or production company from their obligation to comply with the regulations of importing countries, including Canada.

  3. It was determined, in September 2000, from the testing of certain food products in the U.S., that StarLink corn had entered the U.S. food supply, a use that is not approved by the U.S. Environmental Protection Agency (USEPA). Since that time, Aventis CropScience and authorities from the USEPA, the U.S. Food and Drug Administration (USFDA), and the U.S. Department of Agriculture (USDA) have taken rigorous measures to assess and address this situation. These measures include the establishment of a StarLink corn recovery and diversion program.

  4. Immediately, as events unfolded in the U.S., the Government of Canada undertook a series of actions regarding recalls of imported U.S. food products potentially containing StarLink corn, and broader initiatives to prevent the commingling of StarLink corn in imported U.S. products for use as grain corn, feed, food, and seed for planting in Canada. These actions and requirements for industry responsiveness to these situations were described through industry advisories and trade memoranda issued by the CFIA and the CGC, respectively.

  5. The Government of Canada's monitoring and surveillance program for StarLink corn has been in place throughout the past two years. In fall 2001, the Government focussed more of its monitoring program on U.S. shipments of whole-grain corn to effectively prevent the entry of StarLink corn at points of entry into Canada. On October 10, 2001, the CFIA and the CGC issued an updated joint industry advisory notifying stakeholders that all whole-grain corn imported from the U.S. for seed, feed, food, or other purposes requires adequate documentation indicating that the corn has been tested to demonstrate that StarLink corn has not been detected. Failure to provide this documentation will result in shipments being refused entry into Canada. Corn destined for a licensed grain elevator in Canada must meet the requirements outlined in the CGC's Memorandum No. 2001-10, which can be found on the CGC Web site at: http://www.cgc.ca/views/Tradenotices/2001/2001-10-e.htm.

  6. On April 5, 2002, the CFIA and the CGC issued a new, joint update to the October 2001 industry advisory. This update states that the request for documentation is a continuing import requirement and reminds all parties responsible for the supply, storage, importation, transportation, and handling of corn to follow good industry and agricultural practices by identifying potential situations where StarLink could be introduced into a lot or shipment and to take the necessary steps to minimize this introduction.

  7. In its ongoing monitoring for StarLink corn, the CFIA is continuing its domestic food, feed, and seed product surveys, which include market sampling and analysis. Detection of StarLink may lead to enforcement action under the legislation administered and enforced by the CFIA. Likewise, the CGC continues to survey licensed grain facilities for compliance with its issued requirements, as noted in paragraph 15, above.

  8. On April 8, the CFIA and the CGC followed up the issuance of the latest joint industry advisory with the release of an update to be posted regularly regarding the Government of Canada's monitoring and surveillance activities for potential StarLink importations from the U.S. The CFIA has reviewed over 25 000 documents for shipments of whole-grain corn, and of these, 50 shipments have been refused entry into Canada.

  9. Furthermore, in the petition response of December 2001, the CFIA and the CGC reported on the following enforcement and compliance actions for six sources of U.S. imported corn or corn-derived products found to be commingled with StarLink corn: (1) four food recalls of U.S. imported corn-derived food products as managed by the CFIA; (2) two shipments of whole-grain corn, where one shipment underwent detention and disposal as supervised by the CGC, while the other involved a feed recall as overseen by the CFIA; and (3) one detention and disposal by CFIA inspection staff of corn seed for planting.

  10. Since December 2001, when the response to the first petition was provided, there have been no additional food recalls of corn or of corn-derived food products. The ongoing CFIA/CGC sampling and testing programs, which have included hundreds of samples, recently found trace amounts of StarLink in two shipments of imported U.S. corn that was destined for use as livestock feed. In the first instance, the CFIA determined that all the corn from a shipment found in Alberta had been used in livestock feed. Based on a Health Canada human health risk assessment, the presence of these trace amounts of StarLink protein (Cry9C) in grain that is used for animal feed is unlikely to pose a risk to human health. No further action was taken. In the second instance, trace amounts of StarLink were detected in corn in Quebec that was also to be used as livestock feed. Subsequent information on this shipment revealed the possibility that the equipment used to move the corn may have previously come into contact with StarLink corn. The CFIA tested additional samples with negative results, and the corn was released.

  11. In addition to the inspections of two shipments of corn for livestock feed, a seed company in Ontario recently informed the CFIA that seed it had been storing since 2000 was found to contain trace amounts of StarLink material. None of this seed was planted in Canada and under the supervision of CFIA inspection staff, the company disposed of all of the detained seed according to a CFIA-approved method.

  12. Thus, over the past two years, many thousands of shipments of imported U.S. whole-grain corn shipments have had documentation inspected and processed by the CFIA Import Service Centres. In conjunction with this monitoring program, the CFIA's sampling and surveillance of hundreds of corn-derived agricultural and agri-food products already in Canada has yielded a total of 10 cases found to contain unintended, trace amounts of StarLink material that required follow-up actions to be supervised by CFIA and/or CGC staff.

  13. The industry advisories on StarLink and the Web page update on StarLink monitoring activities are included with this response as Annex C and are available through the CFIA Web site at:
    http://www.inspection.gc.ca/english/bureau/inform/20020405e.shtml
    http://www.inspection.gc.ca/francais/bureau/inform/20020405f.shtml
    http://www.inspection.gc.ca/english/bureau/inform/20020405be.shtml
    http://www.inspection.gc.ca/francais/bureau/inform/20020405bf.shtml

Response to Questions of the Petition

Question 1:

[relating to the government's replies 36, 37, 68, & Table 2 (pp. 15-18)] Considering the fact that the Ministers admit it took the CFIA two months (after the StarLink corn contamination was made public in the U.S.) to publish a short and vague 'discussion paper for the national import control strategy and draft import control policy,' would the Ministers recognise that the government was not prepared for the presentation of the occurrence of genetic contamination such as StarLink? Would the Ministers explain why it took them six months after the StarLink contamination was made public in the U.S. and six years after the first authorisation of GMOs to send a Memorandum to all Seed Importers (dated March 2001) (reply 68) to establish proper requirements for 'adequate documentation'?

Response to Question 1:

  1. In the petition response of December 2001, reference was made to the CFIA's draft discussion paper dated November 2000 and entitled Towards a National Import Strategy and Policy. The paper outlined a suggested strategic approach for guiding CFIA import policy and operational activities in the longer term (i.e. over the next 10 years) and was published to stimulate further discussion with stakeholders. The paper articulated the underlying principles of the Agency's approach to import policy development and the program developments within the CFIA that are being planned to forecast and address the growing complexity of the import control environment, to define the Agency's role within this environment, and to identify new measures of accountability for the delivery of the Agency's mandate.

  2. The Government of Canada continues to believe that the existing fundamentals of Canada's system of import controls make sense and are effective. The ability of the CFIA to meet its mandated food safety, animal health, and plant protection obligations needs to be made stronger and more sustainable in the face of the following: the events of September 11, 2001; the globalization of trade; free trade agreements; electronic commerce; increased trade and travel; new and emerging hazards; new foods and agricultural products, including those derived through biotechnology; better, faster means of transportation; and government initiatives, such as cost recovery and government on-line.

  3. The first line of responsibility for meeting federal standards and requirements for agricultural and agri-food products, including biotechnology-derived products, rests with stakeholders across the whole continuum of the agriculture and agri-food supply systems, that is, developers, producers, processors, suppliers, importers, and distributors. All of these stakeholders are required to exercise due diligence in responding to, and keeping abreast of, the Government of Canada regulations and directives as related to their individual roles and responsibilities in the importation of agricultural and agri-food products, whether or not derived through biotechnology, into Canada. Furthermore, as soon as StarLink was discovered in the U.S. food supply, the CFIA and the CGC began working with importers to remind them of their responsibilities to keep such a product out of Canada.

  4. The Government of Canada is committed to informing and better educating stakeholders, including consumers, about domestic regulatory requirements for imports and for the safety assessment of products, including those derived through biotechnology, to protect Canadians, animal and plant health, and the sustainability of the environment. To achieve this objective, the CFIA, Health Canada, and Environment Canada use a range of information tools such as industry communiqués, fact sheets, guidelines, notices of product recalls, notifications of amendments to Acts, regulations or directives/guidelines, prosecution bulletins, news releases, annual reports, and various communication products.

  5. In a timely manner, these routine sources of information relay important health and safety information to consumers and industry alike. These tools can also be used to convey to many parties at one time reminders about regulatory requirements or to provide scientific and technical updates to proponents about other non-health and safety regulatory information for regulated products. Such information can provide recommendations to industry, as did the updated industry advisories about StarLink corn, on the use of appropriate methodologies for detection of this unapproved product and on the adoption of good industry and manufacturing practices to minimize the risk of the commingling of this corn with whole-grain corn destined for Canada.

Question 2:

[relating to the government's replies 37 and 46] In view of the belated 'discussion paper for a national import control strategy,' which commits the government to a 'risk analysis framework,' could the Ministers make public the full details of any studies, analysis and results of such 'risk analysis framework' as it relates directly to the StarLink contamination or any other similar type of genetic contamination, in order to substantiate the basis for the government's confidence that its 'regulatory system is strong and has made every reasonable effort . . . to protect against the illegal . . . use of non-approved biotechnology-derived products in or into Canada' (reply 46)?

Response to Question 2:

  1. The CFIA's discussion paper for a national import control strategy was not initiated in response to the StarLink situation. In October 2000, as an agency-wide initiative, the CFIA Import Control Systems Task Force Steering Committee was asked to develop a discussion paper and draft import control policy that would provide a strategic basis for the consideration of measures to enhance and guide the integration of the various import control systems within the CFIA?systems that were brought together with the Agency's creation in 1997.

  2. The Government of Canada's confidence in the regulatory system is based on many considerations including:

    • the continued strength and effectiveness of the 1993 Federal Regulatory Framework for Biotechnology which led to the implementation of mandatory requirements for pre-market notification and safety assessments for products derived through biotechnology, as required by the CFIA, Health Canada, or Environment Canada, and as explained in Environment Canada's fact sheet, Regulatory Roadmap for New Substances in Canada, which is available on Environment Canada's Internet site at:
      http://www.ec.gc.ca/substances/nsb/eng/neo2001a_e.htm
      http://www.ec.gc.ca/substances/nsb/fra/neo2001a_f.htm;
    • the Government of Canada's continued commitment to increasing stakeholder and public awareness of the regulation of biotechnology through enhanced transparency of the regulatory policy and decision-making processes;
    • Canada's contribution to the international regulatory framework for biotechnology including, for example, the establishment of the Cartagena Protocol on Biosafety, a UN environmental agreement regarding the trans-boundary movement of living modified organisms derived through modern biotechnology and their potential impact on biodiversity and the environment; the Codex Draft Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants; as well work with other key countries to enhance bilateral regulatory cooperation.

  3. As specifically related to StarLink corn, risk assessments by Health Canada (see paragraphs 34 and 35) and by the CFIA determined that there were unlikely to be significant health and safety impacts on consumers or livestock based on the limited exposure to products that contained only trace amounts of StarLink corn commingled in food or feed products. In addition, the Government of Canada is of the view that the international efforts made by U.S. agricultural and agri-food stakeholders and regulatory agencies have been highly effective in quickly and efficiently reducing both the presence of StarLink corn in the U.S. food, feed, and seed supply and the potential for commingling in exports to other countries.

Question 3:

[relating to Table 2, page 18, replies 53, 58, 97, and 99] In view of the government's reassurance that in October 2000, there were no 'reports of human illnesses relating' to StarLink, would the Ministers give details of any epidemiology studies and/or specific warnings given to health professionals and the public about the possible health hazards resulting from StarLink? (When? to how many health professionals? by what media? etc.). Would the Ministers give an update on reports of human illnesses relating to StarLink after October 2000 and what has been done proactively by the government to make sure that the public and medical professionals are aware of the symptoms relating to illnesses associated with StarLink and more specifically to the protein Cry9C contained in StarLink? In view of the fact that the U.S. government has not authorised StarLink for human consumption based on risks to human health due to its potential allergenic properties, would the Ministers not agree that this alone should be grounds for Health Canada to 'establish a study to examine the health effects of the Cry9C protein contained in StarLink corn'? Would the Ministers agree that continuing to refuse to require a study to examine the human health effects for the Cry9C protein contained in StarLink (reply 97) will lead Canadians to believe that their government has a 'don't look too much-don't find too much' policy when it comes to safety of GMOs? Finally, considering the obvious need illustrated by the illegal presence of StarLink corn in Canada, would the Ministers explain how they can justify the government's continued refusal to implement mandatory labelling of GE food if, for no other reason, to allow the health effects of consuming GMOs to be studied, especially those, such as StarLink, that have been identified as potential allergens?

Response to Question 3:

  1. As discussed in paragraphs 97 to 100 of the December 2001 response to the first petition titled StarLink Corn and Canada's Feeds, Seeds, Food Supply, and Ecosystems, Health Canada, in its health risk assessment, has not identified any basis on which to require a study to examine the long-term human health effects of the Cry9C protein contained in StarLink corn.

  2. Furthermore, as outlined in paragraphs 11-23 of this response, the CFIA continues to manage a stringent monitoring program for StarLink corn that includes a surveillance program of sampling and testing corn-derived food, feed, or seed products. There have been no further food recalls associated with the presence of StarLink corn since the four recall actions that were supervised and reported by the CFIA as of March 2001.

  3. Given the limited degree of human exposure in Canada, Health Canada's health risk assessment of this protein indicated that any potential for human health effects is minute. It is worth noting that StarLink corn has still not been approved for any use, including food use, in Canada. In the U.S., where the potential degree of human exposure to Cry9C was much greater than in Canada, the epidemiological investigation conducted by the U.S. Centers for Disease Control and Prevention found no evidence of adverse reactions linked to the presence of StarLink corn in foods.

  4. Health Canada has a rigorous pre-market safety assessment process in place for evaluating the safety of foods derived through biotechnology. Each safety assessment looks at the potential for short- and long-term human health effects. If Health Canada's pre-market assessments indicate that post-market surveillance is required, the food will not be approved until such a strategy is developed. None of the pre-market assessments conducted to date by Health Canada has identified such a requirement.
  5. As indicated in the Action Plan released by the Government of Canada in November 2001
    (http://www.hc-sc.gc.ca/english/protection/royalsociety/), biotechnology-derived foods that are found to contain an allergen transferred from the organism that provided the DNA will not be considered for marketing approval unless they can be clearly identified in the marketplace and unless this identity would not be lost during distribution or processing. Such a strategy would consider the utility and need for rapid identification assays.

  6. Similarly, Health Canada would require special labelling for genetically modified foods where health and safety concerns, such as compositional or nutritional changes, are identified in the course of the pre-market safety assessment if, and only if, labelling can adequately mitigate the identified concern. In this situation, the special labelling would be used to alert consumers or susceptible groups in the population, otherwise the food would not be permitted to enter the marketplace.

Question 4:

[relating to replies 58, 53, and 97] In view of the statement made by the Minister of Health regarding the health risks from StarLink that 'it [is] not possible to prove that Cry9C protein is unlikely to be an allergen' (53), how can the Minister then subsequently deny that he 'has not identified any basis on which to require a study to examine the long term human effects of the Cry9C protein (97) while announcing the establishment of a much needed 'surveillance strategy which will permit the identification of potentially undesirable impacts of [GMOs] (99)? Would the Minister of Health give details about the promised 'surveillance strategy'? Wouldn't the Ministers agree that such a surveillance strategy should be in place PRIOR to the authorisation and release and the continuation of the release of GMOs in the environment and into the food chain.

Response to Question 4:

  1. As indicated in the response to Question 3, Health Canada's pre-market safety assessments consider the need for post-market surveillance and none of the assessments conducted to date has identified such a requirement.

  2. In contrast to the majority of genetically modified food products that have been approved by Health Canada to date, it is expected that some future novel foods exhibiting more complex modifications (e.g. with intentional nutritional modification) will likely require the implementation of a post-market monitoring mechanism. In anticipation of these developments, Health Canada's Centre for Surveillance Coordination, a program of the Population and Public Health Branch, has undertaken a project to establish a surveillance strategy that will permit the identification of potentially undesirable/desirable health impacts of biotechnology products, including GM foods. Further details are available at
    http://www.hc-sc.gc.ca/pphb-dgspsp/csc-ccs/biotech_e.html.

Question 5:

[relating to Table 2, page 19] In view of the fact that the CFIA recognised that 3% of the sample of food and feed tested positive for StarLink (four recalls of food imported from the U.S. out of 135 samples) in the period stretching for up to 6 months after the initial reporting of the contamination in the U.S. (a product has been about a five-week shelf life), would the Ministers give a month by month detailed report of the sample testings (Fall/Winter 2000-2001) and their detailed results?

Response to Question 5:

  1. Information about the results of the federal monitoring program for StarLink corn have been provided in the monitoring update to the status of StarLink corn in Canada (paragraphs 11-23) and Table 2 of the December 2001 response to the first petition on StarLink corn. The CFIA and CGC sampling and testing reported in that response represent samples taken in fall/winter 2000-2001. CGC sampling of corn shipments to licensed grain facilities, as well as sampling of non-corn grain shipments, have been taken throughout the nine- month period (April-December) in 2000 and 2001 when imports of bulk grain were generally transferred from the U.S. into Canada. The CFIA maintains its national sampling program which has included two rounds in fall/winter 2000-2001 and has been ongoing since the summer of 2001.

  2. It should be noted that the number of samples taken to survey food products, feeds, seeds, and grains for the presence of StarLink corn is consistent with the sampling size and frequency of surveillance used for verifying industry's compliance with regulatory requirements for other agricultural and agri-food products as administered by the CFIA and the CGC.

Question 6:

[relating to replies 72 and 79] In view of the fact that government acknowledged that it has identified about 25,000 metric tonnes of U.S. corn imported into Canada contaminated by StarLink despite the belated and tiny numbers of sampling (65 seed samples done by the CFIA = one sample for every 38,000 tonnes of corn imported from the U.S.!), wouldn't the Ministers agree that StarLink contamination in Canada has probably been grossly underestimated and that the StarLink contamination officially reported illustrates the wide ranging possible consequences following the environmental release of StarLink and any biotechnological products in general?

Response to Question 6:

  1. The CFIA has not identified a rationale for carrying out measures in addition to those identified in the response to Question 2 of the first petition (refer to paragraphs 49-75 of the December 2001 response). The current series of inspection, enforcement, and compliance activities, including monitoring for the presence of StarLink corn in imported U.S. seed destined for planting in Canada, remains in effect. The potential use of StarLink corn in Canada was not of the same magnitude and scope of that which occurred in the U.S. Aventis CropScience, the U.S. food and agriculture industries, and U.S. regulatory organizations undertook immediate comprehensive actions to rectify their domestic situation, including rigorous testing and segregation to avoid the entry of StarLink corn, or any corn commingled with this product, from entering into supply channels destined for export to countries including Canada and Japan.

Question 7:

[relating to reply 73 & Table 2 (page 17 & 20) In view of the fact (a) that the Ministers acknowledged the StarLink contamination cost Canadian taxpayers at least $900,000, and (b) that the government had close contact with Aventis CropScience (the company producing StarLink corn), would the Ministers give details about any agreement or understanding reached with Aventis CropScience regarding the reimbursement of these additional direct costs to the Canadian government? Would the Ministers give details of any agreement, understanding and/or promise reached with or made by Aventis CropScience about adequate compensation for any Canadian food manufacturers, Canadian importers and/or Canadian farmers to monitor and enforce Canada's prohibition policy on StarLink? If not, would the Ministers offer the rationale for not recovering from Aventis CropScience all the past, current, and subsequent costs regulating directly or indirectly from the StarLink contamination in Canada? What steps have the Ministers taken to establish a liability framework that legally enshrines the principle that liability for contamination from GMOs rests mainly with the developer of the technology?

Response to Question 7:

  1. There have been no discussions between the Canadian government and Aventis CropScience on matters related to compensation or liability regarding the presence of StarLink corn in Canada.

  2. Appropriate Canadian-based monitoring programs are used to ascertain whether developers are complying with their legal obligations. These programs have been undertaken as preventative measures to successfully keep StarLink corn out of Canada.

Question 8:

[relating to replies 46, 92, and 95] In view of the Ministers' admissions that 'seed corn is not subject to variety registration under the Seeds Regulations and, therefore, the required degree of information required to support its importation is not as high as required for other registered plant products' and that ' there are currently no regulation requirements applicable specifically to exports of products of biotechnology,' will the Ministers make the appropriate corrections? If not, why not? Will the Ministers also establish a policy to make sure that the additional cost for such measures or any other enforcement and monitoring measures will be borne by the biotech company which is the original source of the contamination (Aventis CropScience) and not by Canadian taxpayers, Canadian consumers, Canadian manufacturers, Canadian farmers or by overseas Canadian clients? As in question 7, will the Ministers commit to establishing a liability framework that legally enshrines the principle that liability for contamination from GMOs rests mainly with the developer of the technology? In view of the Ministers' statement that 'the Government of Canada takes violations of the Seeds Act, Feeds Act and Food and Drugs Act very seriously' (reply 16), would the Ministers give details of any evidence of serious action (legal compensation, etc.) taken against Aventis CropScience, original source of the illegal genetic pollution in Canada?

Response to Question 8:

  1. Although Canada does not currently register varieties of corn and certain other plant products, there are strict import permit requirements for plant products, including those derived through biotechnology, under the Plant Protection Act and Regulations, and for the release of plants with novel traits into the environment, under the Seeds Regulations.

  2. Nevertheless, the CFIA is reviewing the entire variety registration process. One of the outcomes from the review is a proposal to require varieties of seed of any agricultural crop that is advertised or sold in Canada, including imports, to be subject to variety registration. A part of the proposal clearly places the onus on the registrant for costs of collection, storage, and disposal of seed varieties if their registration is suspended or cancelled. It should be noted that proposals to amend the registration system may be revised following discussions with stakeholders. As revisions are made, they will be posted on the CFIA Web site at:
    http://www.inspection.gc.ca/english/plaveg/variet/vartoce.shtml
    http://www.inspection.gc.ca/francais/plaveg/variet/vartocf.shtml

  3. The actions taken by the Government of Canada were appropriate to prevent the potential importation of StarLink corn seed for planting. In the reported cases where StarLink material was detected in seed for planting, the appropriate regulatory steps stopped the sale of any corn seed and required CFIA-supervised disposal by the companies in question.

Question 9:

[relating to replies 46, 92, and 95] In view of the fact that the CFIA admitted that there was no government 'intention to establish a federal program of "compulsory buy back' (92), despite the commitment by CFIA, Health Canada and Environment Canada to make the regulatory system evolve in 'anticipation' to 'challenges' (95), wouldn't the Ministers agree that the absence of a compulsory buy-back program as a matter of general policy fails to adequately protect Canadian farmers from possible economic harm caused by present and subsequent illegal genetic contamination from StarLink or any other illegal GMOs?

Response to Question 9:

  1. The U.S. approach to the StarLink situation?including the USDA-coordinated compensation program that was implemented by Aventis CropScience, the U.S. agricultural and agri-food industry sectors, and the U.S. government?is a reflection of the magnitude and scope of the breakdown in regulatory compliance experienced throughout the U.S. food, feed, and seed supply systems. The results of Canada's monitoring program indicate that stakeholders are addressing their primary responsibility to meet domestic regulatory requirements before importing agricultural and agri-food products into Canada and, over the past two years, have taken remedial actions, in the limited number of cases, when trace amounts of StarLink corn have been found in agricultural products. Given these circumstances, the Government of Canada did not consider there to be any basis for the establishment of a domestic compensation program regarding the presence of StarLink corn in Canada.

Question 10:

[relating to replies 46 and 95] Notwithstanding the Ministers' statement that Canada's 'regulatory system is strong . . . and enforcement mechanisms serve to protect against the illegal . . . use of non-approved' GMOs (46), and considering the obvious fact that the regulatory system failed to prevent StarLink contamination in Canada, wouldn't the Ministers agree that the release of GMOs into the environment and the food chain should be halted immediately? Would the Ministers give a detailed breakdown on how the $30 million/year budget (Feb. 2000) to 'increase the capacities and capabilities of the regulatory system for biotechnology' has and will be used generally and specifically to prevent any subsequent genetic contamination.

Response to Question 10:

  1. The provision of funding as announced in Budget 2000 has strengthened investment in the Government of Canada's regulatory system for biotechnology in four key areas:

    • developing government technical capacity and human resources to address the increasing number and complexity of biotechnology products and to maintain the high level of expertise and skill sets of regulatory scientists;
    • generating knowledge to support regulation (R&D), by developing and strengthening scientific capabilities (e.g. tools, methodologies, and knowledge) for risk assessment, risk management, and monitoring;
    • improving public awareness of the regulatory system and engaging consumers in regulatory policy development, by meeting their desire for clear and timely information on regulatory processes, decisions, and enforcement activities through new information products, consultation, work with opinion leaders, etc.;
    • increasing the efficiency and effectiveness of the regulatory system by developing approaches for evaluation, inspection, and enforcement in emerging areas; by strengthening international regulatory cooperation and collaboration; and by influencing international standard setting.

  2. The CFIA and Health Canada have posted on their Web sites information about their use of this funding to build capacity. These fact sheets can be found at:
    http://www.inspection.gc.ca/english/ppc/biotech/reg/capace.shtml
    http://www.hc-sc.gc.ca/english/media/releases/2001/2001_13ebk2.htm

Question 11:

[relating to replies 105 and 106] In view of the fact that the Minister for the Environment admitted that his Department has not currently 'established a program to monitor the potential introduction of StarLink corn nor any other crop derived from biotechnology,' wouldn't the Ministers agree that such a program should be in place PRIOR to the authorisation and release of legal or illegal GMOs into the environment? In view of the fact that the Minister for the Environment admitted that an environmental monitoring program would be established only 'when resources are identified,' wouldn't the Ministers agree that the precautionary principle should be applied and that the release of GMOs into the environment should be stopped in the meanwhile?

Response to Question 11:

  1. The federal government has a notification and assessment strategy for products of biotechnology which is proactive and thorough. New products of biotechnology, which includes plants with novel traits, are required to be assessed for potential effects on human health and the environment and its biological diversity, prior to import, manufacture or sale.

  2. As indicated in paragraphs 10-15 of the response to the first petition, StarLink corn is a biotechnology-derived yellow corn product developed by AgrEvo (now Aventis CropScience) to contain the Bacillus thuringiensis (Bt) Cry9C protein. StarLink corn is not approved for any use in Canada.

  3. Environmental release of biotechnology-derived crops, where these meet the definition of plants with novel traits, is regulated by the CFIA under the Seeds Act and Regulations. The Seeds Act and Regulations are defined as meeting the new substances requirements by being listed on Schedule 4 of the Canadian Environmental Protection Act (CEPA, 1999).

  4. Monitoring is not a general condition applied to plants with novel traits that are approved for unconfined release under the Seeds Regulations. While CFIA approval for environmental release is contingent upon finding no significant environmental impact, the CFIA may, on a case-by-case basis, make the authorization for release contingent on certain conditions. For example, insect-management plans are mandatory for any Bt-technology-derived plant product approved in Canada.

  5. If a product gains market approval, it is the legal responsibility of the proponent to provide the Government of Canada with additional information regarding any untoward observations or environmental effects. The Government may carry out post-market sampling, auditing, and testing, either as routine post-market surveillance for compliance with post-approval conditions or on a case-by-case basis, or may change its regulatory decisions, in response to additional information provided by the proponents, the public, or advances in scientific knowledge. Any person who has provided notification or received authorization under either the Feeds Regulations or the Seeds Regulations is required to immediately provide any new information to the CFIA for a re-evaluation of the potential impact on and risk to the environment posed by the release of a biotechnology-derived seed, livestock feed, or food.

  6. In responding to Question 8 of the first petition, the Government did note that Environment Canada is leading the development of a federal research strategy to advance the knowledge on understanding potential ecosystem effects of genetically modified organisms (GMOs), including those developed for agricultural purposes; and when resources are identified, the research strategy will further enhance knowledge on the ecosystem effects of using products of biotechnology (such as transgenic crops) on biodiversity and wildlife, and on biogeochemical cycling and other ecosystem components and processes.

  7. In responding to the recommendations of the Royal Society of Canada regarding the regulation of food biotechnology in Canada, the Government noted "we recognize the benefits of conducting long-term monitoring studies and research on the impact of GM organisms. We are taking additional measures to improve federal capacities in this area, including ecosystems effects research."

  8. Development of measures to improve federal capacities for conducting long-term monitoring studies and research, and to set out a federal research strategy to advance understanding of potential ecosystem effects, is ongoing.

  9. As indicated in paragraphs 11-23 of this response, the CFIA and the CGC have undertaken appropriate and effective measures to prevent the entry of StarLink corn into Canada and plan to systematically report to Canadians about these ongoing activities.

Question 12:

[relating to replies 85, and 90; indirectly to replies to 82, 83, and 84] In view of the fact that the CFIA admitted working with the Canadian seed growing industry to 'develop quality assurance systems and analytical techniques that will contribute to the necessary advancement in crop and seed certification systems,' would the Ministers confirm when they will offer and guarantee (through mandatory labelling) Canadian consumers secure access to non-GMO products resulting from 'crop and seed certification systems' that seem currently to be reserved for export markets?

Response to Question 12:

  1. The primary responsibility of the CFIA's Seed Section is to administer the Seeds Act and Seeds Regulations, Parts I, III, and IV, to help to ensure that seeds sold in, imported into, and exported from Canada meet established standards for quality (varietal purity, physical purity, and germination) and are labelled so that they are properly represented in the marketplace. Activities in this regard include establishment registration, grader accreditation, operator licensing, training material development, and standards development.

  2. In meeting this responsibility, the Seed Section works with the seed industry sector, including the Canadian Seed Growers' Association, the Canadian Seed Trade Association, the Commercial Seed Analysts Association of Canada, the Canadian Seed Institute, the Association of Official Seed Certifying Agencies, the Association of Official Seed Analysts, the International Seed Testing Association, the Association of American Seed Control Officials, and the Organisation for Economic Cooperation and Development (OECD Seed Schemes).

  3. Insofar as the Seed Section deals with the labelling of seed, including biotechnology-derived seed, information must be truthful and not misleading to potential users. Labelling for biotechnology-derived traits is usually done in order to identify to the potential buyer the new characteristic, such as herbicide tolerance or pest resistance. Producers do have available a range of information sources (e.g. CFIA's list of registered plant varieties, which indicates if a product is a plant with novel trait) and options regarding the availability of plant products, including those derived through biotechnology, and this reflects the supply-and-demand interest in the marketplace. In addition to label information, seed certification provides assurances to seed buyers that seed has met strict production and output standards. Though no system of seed production can fully guarantee varietal purity of 100 percent, certified crop seed (whether or not derived through biotechnology) provides users access to specified planting material to meet their needs.

Concluding Remarks

  1. The Government of Canada considers the reported results of the monitoring program for StarLink corn to have demonstrated that its initiatives are effective and efficient in preventing the entry into Canada of StarLink corn from the U.S.

  2. The Ministers named in this Petition remain committed to:

    • an effective domestic regulatory system that embodies the concept of sustainable development as it seeks to protect both the health of Canadians and the environment; and
    • 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 international regulatory framework in which the individual components are mutually reinforcing.

ANNEX A

DECEMBER 10, 2001, RESPONSE OF THE FEDERAL DEPARTMENTS AND
AGENCIES TITLED StarLink Corn and Canada's Feeds, Seeds, Food
Supply, and Ecosystems
, TO THE PETITION FILED JULY 23, 2001, BY GREENPEACE CANADA

As indicated in paragraph 6 of the current response, Greenpeace Canada had submitted a previous petition regarding StarLink corn. On December 10, 2001, a response was provided by the departments and agencies named in the petition. This response is available on the Canadian Food Inspection Agency's Web site at:
http://www.inspection.gc.ca/english/ppc/biotech/tech/greenstare.shtml
http://www.inspection.gc.ca/francais/ppc/biotech/tech/greenstarf.shtml


ANNEX B

THE INDUSTRY ADVISORIES OF THE CANADIAN FOOD INSPECTION
AGENCY AND THE TRADE MEMORANDA OF THE CANADIAN GRAIN
COMMISSION REGARDING STARLINK CORN

As referenced throughout this response, this annex provides the Canadian Food Inspection Agency Industry Advisories and Canadian Grain Commission Memoranda dated from October 2001 to the present regarding the importation of U.S. whole-grain corn and the testing/certification for StarLink corn. These advisories, including a status of monitoring activities for StarLink corn, are posted on the agencies' Web sites under:


CFIA Bureau of Food Safety and Consumer Protection ? Industry Communiques

http://www.inspection.gc.ca/english/bureau/invenq/comme.shtml
http://www.inspection.gc.ca/francais/bureau/invenq/commf.shtml

CFIA StarLink Corn Monitoring Activities - Status

http://www.inspection.gc.ca/english/bureau/inform/20020405be.shtml
http://www.inspection.gc.ca/francais/bureau/inform/20020405bf.shtml

Canadian Grain Commission - Memoranda

http://www.cgc.ca/Views/newsmenu-e.htm#memoranda
http://www.ccg.ca/views/newsmenu-f.htm