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Biotechnology and "Pharming Crops"

Petition: No. 94

Issue(s): Biological diversity and science and technology

Petitioner(s): Greenpeace Canada

Date Received: 8 September 2003

Status: Completed

Summary: This petition, as with other petitions submitted by Greenpeace Canada, deals with biotechnology. In this instance, the petition concerns genetically engineered (GE) crops designed for pharmaceutical applications and/or industrial production ("pharming crops"). It also contains questions that deal with GE animals and/or other living organisms.

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

Petition

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

September 5, 2003

Dear Johanne Gélinas,

Petition pursuant to Section 22 of the Auditor General Act
Genetically Engineeed Pharmaceutical Crops in Canada:
Biosafety and Food Safety Implications.
Prescription Drugs and Industrial Chemicals with your cornflakes?

We would like to ask the following questions to Agriculture and Agri-food Canada, Environment Canada, Health Canada, Industry Canada, Foreign Affairs and International Trade, Fisheries and Ocean Canada, and any other departments involved directly or undirectly in either (1) the authorisation, regulation, monitoring, detection, enforcement and/or prevention of genetic contamination from legal, illegal or non-authorised genetically engineered pharmeceutical crops (thereafter referred as 'pharming') in Canada generally; and/or (2) making decisions that have or might have an impact on Canada international environmental obligations; and/or (3) economic development policy or public financing that might promote pharming research, development, authorisation and commercialisation in Canada.

Preamble

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 scientific evidence.
There is enormous scientific uncertainity 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, such as Roundup Ready (RR) wheat or any future GE pharming crops
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 Expert Panel Report of the Royal Society of Canada commissioned by the Federal governmentⁱ; the position paper of the Ontario Public Health Associationⁱⁱ; and a report produced by the Québec Institut national de santé publiqueⁱⁱⁱ.
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, especially considering its imminent entry into force on September 11, 2003. Canada should immediately ratify the Biosafety Protocol and contribute positively to its effective implementation in order to avoid genetic contamination outside and inside Canada.
Greenpeace is an independent, global campaigning environmental organisation. Founded in 1971 in Vancouver, Greenpeace has a presence in 40 countries or regions with a global membership of 2.8 million. Greenpeace Canada (GPC) has over 84,000 Canadian supporters.

Background

Between 1994 and 2002, 55 field trials of genetically engineered pharmaceutical crops took place in Canada. No details seem to be available for the 19 pharming crop tests that took place prior 1997. Since 1998, 36 pharming trials took place in the following provinces: British Columbia (15), Alberta (8), Ontario (7), Saskatchewan (3), Manitoba (2) and Québec (1) (see attached one page summary table).
Between 1998 and 2002, GE pharming were tested on the following crops: canola (14), tabacco (8), safflower (7), flax (4), white mustard (2) and white clover (1). Out of the 36 GE pharming test, 6 were conducted by Agriculture Canada (London, Ontario), 9 by the private sector and 21 by public research institutions. A variety of proteins can be produced in these GE plants including: avidin, aprotinin, laccase, trypsin, ß-glucuronidase for use as laboratory chemicals; hepatitis B subunit, gp120, rabies, Norwalk virus, E. coli, TGEV for vaccines for humans or animals; dog gastric lipase, anti-sperm antibodies, hirudin, and antithrombin III for use as human drugs.
Financial hardship on the farms might led some farmers to accept to grow — legally or not, knowingly or not- pharming crops. Nature reported the case of at least one company making offer to farmers on the internet to plant GE pharming crops (Vol. 421, 20 February 2003, page 776). The Nebraska based company Stauffer has placed ads to recruit American farmers to plant industrial or drug-protein pharm crops.
Despite all the alleged safety measures by the USDA, there has at least two publicly reported case of contamination of a food crop (corn) and food (soja) by a GE pharming crop in Iowa. The USDA revealed that 500,000 bushels of soja for human consumption had been contaminated by GE corn (harvested in 2001) designed to produce transmissible gastroenterisits virus (TGEV). Probably some volunteers from the pharm corn grew in the following season (2002), which then pollinated and contaminated the neighbouring corn fields. Despite the fact that the USDA forced ProdiGene to pull up and incinerate a 155 acre corn field in September 2002, it very likely that the volunteers from the GE pharm corn were able to contaminate the surrounding corn and the environment (in Iowa, corn pollination starts at the end of June).
There are other examples of GE contamination. In the North Dakota State University's Foundation Seedstocks Program non-GE natto soybeans had been contaminated with transgenic material, apparently in Chile during the production of seed. The EPA has also fined Pioneer Hi-Bred and Dow Agro Sciences for violating regulations to assure isolation of the experimental pharming crop and prevent pollen drift. Considering that, in 2002, about 300 acres of US cropland was planted with experimental pharm crop, the level of reported genetic contamination and violation is quite staggering. However, some biotech promoters anticipate that 10% of US corn production will be devoted to pharming by 2010 (Anthony Laos, CEO of ProdiGene quoted in The Nation, 'The Three Mile Island of Biotech?' 30 December 2002). Some 20 US corporations and universities conducted more than 315 open-air field trials in secret locations.

Questions to the Federal government regarding
Genetically Engineeed Pharmaceutical Crops in Canada:
Biosafety and Food Safety Implications.
Prescription Drugs and Industrial Chemicals with your cornflakes?

Could the Ministers provide full information about past, current and forthcoming open-air field trials in Canada of genetically engineered (GE) crops designed for pharmaceutical and/or industrial production (hereafter 'pharming') including acreage, location, crop used, purpose, applicant(s) details, and so on?

Could the Ministers provide full details (e.g. by year, by type of pharming crops or animals, by products, by province, by private and public partners, by Federal government funding programs) about the past, current and planned direct public funding made available specifically for the research, development and promotion of pharming crops, animals and/or living organisms including any tax reduction, exemption, delays granted for that purpose in Canada and/or abroad (international trade promotion and/or international development)?

As 14 canola pharming fields were cultivated in open-field in Canada between 1998 and 2002, could the Ministers gives details information about containments measures to prevent any genetic contamination of the nearby canola fields for human and animal feed purposed as well as the food chain? In particular, could the Ministers give details on exact locations (provinces, etc.) of the 14 canola open-air pharming fields (1998-2002) and any canola open-air pharming fields in 2003 and/or planned in future year?

Could the Ministers give details of the other crops planted in a 2 km radius of any of the open-air pharming fields (name of the crop, purpose eg. human food chain, seed reproduction, organic certified crops, quantities of production, etc.)?

Could the Ministers give details of the crops planted in a 2 km radius, at least 2 years after the planting of any open-air pharming fields (name of the crop, purpose eg. human food chain, seed reproduction, organic certified crops, quantities of production, etc.)?

Could the Ministers give details about the measures in place for preventing genetic contamination from any open-air pharming fields including (a) numbers, types and frequency of tests of nearby crops (up to what distance?), (b) results of these tests, (c) who did the tests and interpreted the results, (d) are the data publicly available and verifiable by counter-experts?

Could the Ministers provides details about the measures in place for preventing genetic contamination from any open-air pharming fields to surrounding ecosystems including (a) numbers, types and frequency of tests of nearby ecosystems, (b) results of these tests, (c) who did the tests and interpreted the results, (d) are the data publicly available and verifiable by counter-experts? Have the Ministers put in place a comprehensive and independently verifiable traceability system to assure not genetic contamination from pharming open-air fields?

Considering that seeds and relict plants can persist for up to 10 years (e.g. canola, Eastham & Sweet, 2002, Genetically modified organisms (GMOs): the significance of gene flow through pollen transfer. Expert's Corner Series, European Environment Agency, Copenhagen), could the Ministers provide details about the measures currently in place (or planned) to monitor GE pharm crop volunteers in subsequent years in and around the fields where they were planted initially? If in place, could the Ministers say how many years the monitoring for GE pharm crop volunteers last and offer a detailed justification? If they exist, could the Ministers give details about the full results of the monitoring for GE pharm crops volunteers in Canada and any decisions taken by Ministers as a consequence?

Could the Ministers provide full details (e.g. by year, by type of pharm crops or animals, by products, by province, by private and public partners, by Federal government funding programs) about the past, current and planned direct public funding made available specifically for the research and the prevention of contamination (genetic or otherwise) of pharm crops and/or animals?

Did the ministers inform the nearby farmers, farmers' organizations, residents, municipalities, regional and/or provincial governments of the existence of such pharming crops in their area? If not, please could the Ministers offer a full justification?

As it is available in other countries, would the Ministers consider establishing a public register for all planned, current and past pharm crops in Canada including a public consultation process? If not, please could the Ministers justify their answers. If yes, when such public register and public consultation will be introduced and will it be retroactive to past open-air pharm crops?

Could the Ministers explain how the liability regime in place would work should a genetic contamination from an open-air pharm crop occurred given the level of secrecy around open-air pharm crops? Would the public prosecutor and all the parties have access to information (including the full or partial sequences of the DNA constructs used in GE pharm crops) regarding the pharming open-air fields suspected as the possible cause of a genetic contamination? And how could a public prosecutor or an alleged contamination victim get access to that information?

Could the Ministers give details of all regulatory, legal and/or contractual breaches of the conditions for open-air pharm crops in Canada (e.g. dates, duration of the breach, name of the company and parties involved, type of breach, and legal, administrative and financial actions undertaken by the Ministers following a breach, etc.)?

Could the Ministers provides details about the level of rigorousness of government measures in place for preventing genetic contamination from any open-air pharm crops Canada, and in particular numbers of full-time equivalents government positions devoted to these measures and budget of these measures?

Could the Ministers provides details about specific measures in place in Canada to detect and prevent any contamination from pharming crops materials resulting from the importation in Canada of human food, animal feed, seeds from countries producing pharm crop in open-air fields?

Could the Ministers provide any details on any breach of imports regulations of pharming crops or produced from pharm crops?

Could the Ministers provide information on the steps they are taking to ensure that any suspected GE contamination of crops can be tested by independent scientists, e.g. by making available either full or partial sequences of the DNA constructs used in GE pharm crops to ensure their traceability?

Considering that the US National Research Council concluded that "(I)t [was] possible that crops transformed to produce pharmaceutical of other industrial compounds might mate with plantations grown for human consumption, with the unanticipated result of novel chemicals in the human food supply" (Environmental Effects of Transgenic Plants: The scope and adequacy of regulation, Washington, D.C. 2002) and considering the cases of genetic contamination in the US involving among other the biopharming company ProdiGene, could the Ministers explains the measures that they specifically adopted in responses to these facts and events to present contamination from open-air pharming fields?

In advance, thank you for your reply that we wait with great anticipation.

[Original signed by Éric Darier]

Éric Darier, Ph.D.
GE Campaign
Greenpeace
2444 Notre-Dame ouest, Montréal, Qc, H3J 1N5

Statements on pharming

"A voluntary industry commitment to keep crops intended for drug or industrial use out of the conventional food and feed stream channels using containment protocols without federal oversight and external auditing to assure compliance, is a flawed approach. … It cannot be assumed that trace contamination of non-target is avoidable and the possibility cannot be ignored that an active ingredient could be expressed so highly concentrated that a single kernel might exceed food safe exposure limits. Therefore, the major world food and feed staple crops should not be used for transgenic modifications for the purpose of expressing pharmaceutical ingredients and industrial chemicals, unless they can meet food safety requirements."
Maier, D. 2002. Concerns over pharmaceutical traits in grains and oilseeds. Purdue University Grain Quality Task Force. Fact Sheet #47. July 2.

"(I)t is possible that crops transformed to produce pharmaceutical of other industrial compounds might mate with plantations grown for human consumption, with the unanticipated result of novel chemicals in the human food supply."
National Research Council. 2002. Environmental effects of transgenic plants: The scope and adequacy of regulation. Washington, D.C.: National Academy Press.

"(U)ntil the science and federal regulations can guarantee the separation of PMPs from the food and feed supply, we strongly urge the biotech industry to direct its substantial research capabilities into investigating the use of non-food crops for the development of pharmaceuticals."
Grocery Manufacturers of America. 2002. GMA urges the use of non-food crops for biotech drugs. GMA press release, November 14.

"(S)erious thought should be given to alternative plant varieties that are neither food nor feed crops for use in development of plant-made pharmaceutical and industrial compounds."
National Food Processors Association. 2002. NFPA says pharma-corn incident validates food industry concerns. NFPA media release, November 13.

Pharming and effects in humans

"Edible vaccines delivered in plant tissues … show great potential for efficacy in target organisms. … Presumably, this is because the antigen (engineered protein) is protected from degradation in the gut, and it augurs well for the development of plant-based edible vaccines."
Daniell, H., S.J. Streatfield, and K. Wycoff. 2001. Medical molecular farming: production of antibodies, biopharmaceuticals and edible vaccines in plants. Trends in Plant Science 6(5): 219-226.

"It is not entirely suprising that antigens delivered in plant foods survive the trip through the stomach well enough to reach and activate the immune system. The tough outer wall of plant cells apparently serves as temporary armor for the antigens, keeping them relatively safe from gastric secretions. When the wall finally begins to break up in the intestines, the cells gradually release their antigenic cargo."
Langridge, W.H.R. 2000. Edible vaccines. Scientific American (September): 66-71.

"Biopharmaceuticals usually elicit responses at low concentrations and may be toxic at higher ones. Many have physiochemical properties that might cause them to persist in the environment or bioaccumulate in living organisms, possibly damaging nontarget organisms (they are environmentally persistent, lipophilic molecules that can pass through cellular membranes)."
Giddings, G., G. Allison, D. Brooks, and A. Carter. 2000. Transgenic plants as factories for biopharmaceuticals. Nature Biotechnology 18: 1151-1155.

FDA study on allergenicity and digestion

Fu, T.-J., U.R. Abbott, and C. Hatzos. 2002. Digestibility of food allergens and nonallergenic proteins in simulated gastric fluid and simulated intestinal fluid ? a comparative study. Journal of Agricultural and Food Chemistry 50: 7154-7160.

Pharm Crops in Canada, 1994- 2002

Year	*Company*	Plant (number of trials)	*Trait*	*Province*
2002 (6)	SemBioSys Alberta Research Council	Safflower (4) Tobacco (2)	HT/Industrial Enzyme Precursor (3) HT/ Pharma. Precursor (1) Novel Pharmaceutical /Anti-biotic Resistance (2)	Alberta (3) British Columbia (1) Alberta (2)
2001 (3)	University of Guelph SemBioSys	White Clover Safflower (2)	Pharmaceutical Protein Pharmaceutical Protein/Herbicide Resistance	Ontario (1) Alberta (2)
2000 (6)	Ag Canada (London) SemBioSys	Tobacco (3) Flax (2) Safflower (1)	Pharmaceutical Production/ Anti-biotic Resistance Pharmaceutical Protein/HR	Ontario (3) Manitoba (2) Alberta (1)
1999 (8)	Ag Canada (London) University of Calgary	Tobacco (3) Canola (4) Flax (1)	Pharmaceutical Production/ Anti-biotic Resistance HT/Pharmaceutical Protein	Ontario (3) BC (3) PQ (1) BC (1)
1998 (13)	University of Calgary	Canola (10) White Mustard (2) Flax (1)	Pharmaceutical Production/Anti-biotic Resistance 4) HT/Pharmaceutical Protein (3) HT/Pharmaceutical Protein/Enzyme Protein (1) Enzyme Production/Anti-biotic Resistance (2) HT/Pharmaceutical Protein (2) HT/Pharmaceutical Protein (1)	BC (2) Sask. (2) BC (3) BC (1) Sask. (1) BC (1) BC BC
1997 (5)	Unknown	Unknown	Unknown	Unknown
1996 (11)	Unknown	Unknown	Unknown	Unknown
1995 (2)	Unknown	Unknown	Unknown	Unknown
1994 (1)	Unknown	Unknown	Unknown	Unknown

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Minister's Response: Canada Customs and Revenue Agency [1996-2003]

February 12, 2004

Dr. Éric Darier
Greenpeace Montréal
2444 Notre-Dame Street West
Montréal QC
H3J 1N5

Dear Dr. Darier:

I am writing in response to the petition you sent to Ms. Johanne Gélinas, Commissioner of the Environment and Sustainable Development, with respect to the impacts of biotechnology-derived crops that are used for pharmaceutical and industrial purposes. As you know, Ms. Gélinas forwarded your petition to my predecessor, the Honourable Elinor Caplan, as well as to my colleagues, the ministers of Agriculture and Agri-Food, Environment, Finance, Foreign Affairs, Health, Industry, and International Cooperation.

I am informed that the overall Government response, which included an issue related to the Canada Revenue Agency, was sent to you on January 28, 2004. I would like to confirm my support of this response.

I appreciate being made aware of your views on this matter.

Sincerely,

[Original signed by Stan Keyes, Minister of National Revenue]

Hon. Stan Keyes, P.C., M.P.

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Minister's Response: Canadian International Development Agency

February 17, 2004

Éric Darier, PhD
GE Campaign
Greenpeace
454 Laurier Avenue East
Montreal, Quebec
H2J 1E7

Dear Dr. Darier:

I am writing in response to the petition you sent to Ms. Johanne Gélinas, Commissioner of the Environment and Sustainable Development, regarding the impacts of biotechnology-derived crops that are used for pharmaceutical and industrial purposes. Ms. Gélinas has forwarded copies of your petition to my predecessor as well as to the Ministers of the Environment, Finance, Health, Industry, International Trade, Agriculture and Agri-Food, and National Revenue.

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

Yours sincerely,

[Original signed by M. Aileen Carroll, Minister for International Cooperation]

The Honourable M. Aileen Carroll, P.C., M.P.

*[See the joint response submitted by Agriculture and Agri-Food Canada, Environment Canada, Finance Canada, Industry Canada and International Trade Canada. At the time of minister sign-off, the Minister for International Cooperation was unavailable to sign the joint petition response; however, the Canadian International Development Agency did contribute to the joint response.]

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Minister's Response: Health Canada

January 30, 2004

Dr. Eric Darier
Greenpeace Montreal
454 Laurier Avenue East
Montreal, Quebec
H2J 1E7

Dear Dr. Darier:

Thank you for your petition dated September 25, 2003, addressed to myself and my colleagues, the Ministers of Agriculture and Agri-Food, Canadian Heritage, Environment, Finance, Foreign Affairs, Industry, International Trade, Natural Resources, Transport and the Secretary of State for Western Economic Diversification. In your petition, you pose questions under the Auditor General Act with respect to the topic of molecular farming.

I appreciate being made aware of your views on this matter and am pleased to provide you with the Government of Canada's response* to your petition.

Sincerely,

[Original signed by Pierre S. Pettigrew, Minister of Health, Minister of Intergovernmental Affairs and Minister responsible for Official Languages]

Pierre S. Pettigrew

*[See the joint response submitted by Agriculture and Agri-Food Canada, Environment Canada, Finance Canada, Industry Canada and International Trade Canada. At the time of minister sign-off, the Minister of Health was unavailable to sign the joint petition response; however, Health Canada did contribute to the joint response.]

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Joint Response: Agriculture and Agri-Food Canada, Environment Canada, Finance Canada—Department of, Foreign Affairs and International Trade—Department of [1996-2003], Industry Canada

RESPONSE OF THE FEDERAL DEPARTMENTS AND
AGENCIES TO THE PETITION FILED
SEPTEMBER 30, 2003, BY GREENPEACE CANADA
UNDER THE AUDITOR GENERAL ACT:

Genetically Engineered Pharmaceutical Crops in Canada:
Bio safety and Food Safety Implications.

January 28, 2004

Minister of Agriculture and Agri-Food	Minister of Industry
Minister of the Environment	Minister of International Trade
Minister of Finance

Foreword

In responding to this petition on the impact of biotechnology-derived crops in Canada that are used for pharmaceutical and industrial purposes, federal departments and agencies have worked together, contributing their collective knowledge and expertise. The result is a considered, integrated response relevant to all Canadians who are interested in biotechnology-derived products and, specifically, in the topic of plant molecular farming.

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

Canada has one of the safest, most effective regulatory systems for biotechnology products in the world. In the renewed Canadian Biotechnology Strategy, which was developed following 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 will 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 prestigious record for its science-based regulatory system-a system in line with principles laid out by organizations such as the World Health Organization, the Organisation for Economic Co-operation and Development, the United Nations Environment Programme, the Food and Agriculture Organization, the International Plant Protection Convention, the Codex Alimentarius Commission, and the Office Internationale des Épizooties.

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 it moves forward.

Contents

Foreword

Table of Contents

Acronyms

Background

Introduction

Response to Questions

Question 1
Question 2
Question 3
Questions 4 & 5
Questions 6 & 7
Question 8
Question 9
Question 10
Question 11
Question 12
Question 13
Question 14
Question 15
Question 16
Question 17
Question 18

Concluding Remarks

Annex I

Annex II

Acronyms

AAFC	Agriculture and Agri-Food Canada
CBI	Confidential Business Information
CFIA	Canadian Food Inspection Agency (the Agency)
ETD	Enabling Technologies Directorate (Industry Canada)
FTE	Full Time Equivalent
HC	Health Canada
ICAR	Inventory of Canadian Agri-Food Research
LSB	Life Science Branch (Industry Canada)
NGO	non-governmental organization
NSERC	Natural Sciences and Engineering Research Council
OCA	Office of Consumer Affairs (Industry Canada)

Background

On September 8, 2003, 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 about plant molecular farming.

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, biodiversity, and the environment is of priority to the federal decision-making framework for biotechnology.

The Petition 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 Finance
Minister of Industry
Minister of International Trade

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 Agency) and Agriculture and Agri-Food Canada (AAFC) in the context of this matter.

The main focus of the Petition concerns plant molecular farming. Questions pertain to open-air field trials of biotechnology-derived crops used for pharmaceutical and industrial purposes and to funding supporting this technology. Each question is addressed in the body of this document.

The petition was received by the Auditor General's office on September 8, 2003. It was sent to the Ministers on September 30, 2003. For this reason, the 120 days allowed for the government to respond to the petition began on September 30, 2003.

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

Introduction

1.	The Ministers of Agriculture and Agri-Food, Environment, Finance, Industry, and International Trade are providing this document as a joint response to the Petitioner.
2.	Providing a joint response reflects the federal government's commitment to improve the management and co-ordination of matters related to biotechnology and the environment as reflected in several previous petition responses, as well as other joint work described in those responses.
3.	Overall, the Ministers believe that Canada's existing regulatory system provides for the risk assessment and management of biotechnology-derived products, from the perspective of sustainable development. In previous petition responses, the Government of Canada has already provided information regarding: 1993 Federal Regulatory Framework for Biotechnology the federal development of Sustainable Development Strategies
4.	As a result, Ministers have structured this document to focus on responses to the Petitioner's questions (Paragraphs 5-62). Readers may refer to previous petition responses for extensive background information about the regulation of biotechnology-derived products in Canada.

Response to Questions of the Petition

Question 1:

Response to Question 1:

5.	As described on the Web site of the Canadian Food Inspection Agency (CFIA), plant molecular farming is the use of plants in agriculture to manufacture products other than food or animal feed. Products produced through molecular farming can be pharmaceuticals, diagnostic tools, industrial chemicals, plastics, etc. Plants used for plant molecular farming are plants with novel traits (PNTs)-plants that have had a specific trait added to them through genetic engineering or other techniques. All PNTs in Canada are subject to the same strict science-based regulations.
6.	Table 1 lists all confined research field trials of PNTs intended for plant molecular farming conducted in Canada. The first trial took place in 1994. Please note that the exact location of the trial is considered confidential business information (CBI) and is protected from disclosure by laws governing access to information and privacy. Disclosing exact trial locations could also lead to illegitimate removal of plant material from the trial site by objectors or by individuals with commercial interests. Removal of trial material from the site without adequate precautions may compromise environmental, human, or livestock safety.
7.	The acreage of the trials is also considered CBI. However, the maximum area of a confined research field trial is normally 1 hectare, and many plant molecular farming trials have been considerably less than 1 hectare in size. In addition, any given PNT can be field tested at no more than 10 sites per province in a given year, with a total area of no more than 5 hectares per province. The restrictions in size and number of confined research field trials are part of the mitigation of potential environmental impacts of PNTs.
8.	There were no confined research field trials of canola intended for plant molecular farming in 2000, 2001, 2002, or 2003. The CFIA has not received any future-year applications for confined research field trials of canola intended for plant molecular farming.

Table 1: Confined Research Field Trials of PNTs for Molecular Farming in Canada


Year	#of Trials	Crop	Province	Applicant	Trait

1994	1	canola	AB	University of Calgary	precursor of a pharmaceutical protein
1995	1	canola	AB	University of Calgary	precursor of a pharmaceutical protein
1995	2	canola	AB, BC	University of Calgary	precursor of a pharmaceutical protein
1996	2	ethiopian mustard	BC	University of Calgary	precursor of a pharmaceutical protein
1996	3	canola	AB (1) BC (2)	University of Calgary	precursor of a pharmaceutical protein
1996	3	canola	AB (1) BC (2)	University of Calgary	precursor of a pharmaceutical protein
1996	3	canola	AB (1) BC (2)	University of Calgary	precursor of an aquaculture feed additive
1997	2	canola	BC, SK	University of Calgary	precursor of an aquaculture feed additive
1997	2	canola	BC, SK	University of Calgary	precursor of a pharmaceutical protein
1997	1	alfalfa	QC	AAFC (Ste. Foy)	diagnostic antibody
1998	2	canola	BC, SK	University of Calgary	precursor of an aquaculture feed additive
1998	6	canola	BC (5) SK (1)	University of Calgary	precursor of an industrial enzyme
1998	2	canola	BC, SK	University of Calgary	precursor of an industrial enzyme
1998	1	flax	BC	University of Calgary	precursor of an industrial enzyme
1998	1	white mustard	BC	University of Calgary	precursor of an industrial enzyme
1999	3	tobacco	ON	AAFC (Delhi)	pharmaceutical protein
1999	4	canola	BC (3) QC (1)	University of Calgary	precursor of an industrial enzyme
1999	1	flax	BC	University of Calgary	precursor of an industrial enzyme
2000	1	tobacco	ON	AAFC (Delhi)	pharmaceutical protein
2000	1	tobacco	ON	AAFC (Delhi)	pharmaceutical protein / diagnostic agent
2000	1	tobacco	ON	AAFC (Delhi)	therapeutic antibody
2000	2	flax	MB	University of Calgary	precursor of an industrial enzyme
2000	1	safflower	AB	University of Calgary	precursor of an industrial enzyme
2001	1	white clover	ON	University of Guelph	pharmaceutical protein
2001	1	safflower	AB	SemBioSys Genetics	precursor of a compound with industrial and pharmaceutical applications
2001	1	safflower	AB	SemBioSys Genetics	precursor of an industrial enzyme
2002	2	tobacco	AB	Alberta Research Council	pharmaceutical protein
2002	1	safflower	AB	SemBioSys Genetics	precursor of a compound with industrial and pharmaceutical applications
2002	5	safflower	AB (4) BC (1)	SemBioSys Genetics	precursor of an industrial enzyme
2003	1	safflower	AB	SemBioSys Genetics	precursor of a diagnostic protein
2003	2	safflower	AB, SK	SemBioSys Genetics	precursor of an aquaculture feed additive
2003	5	safflower	AB	SemBioSys Genetics	precursor of an industrial enzyme
2003	1	safflower	SK	SemBioSys Genetics	precursor of an industrial protein
2003	3	tobacco	AB	Alberta Research Council	pharmaceutical protein
2003	4	tobacco	ON	AAFC (Delhi)	industrial protein

Question 2:

Could the Ministers provide full details (e.g. by year, by type of pharming crops or animals, by products, by province, by private and public partners, by Federal government funding programs) about the past, current and planned direct public funding made available specifically for the research, development and promotion of pharming crops, animals and/or living organisms including any tax reduction, exemption, delays granted for that purpose in Canada and/or abroad (international trade promotion and/or international development)?

Response to Question 2:

9.	The Canada Customs and Revenue Agency's Scientific Research and Experimental Development (SR&ED) program is a federal tax incentive program that encourages Canadian businesses of all sizes to conduct research and development that will lead to new or improved technologically advanced products or processes. It is the largest single source of federal government support for industrial research and development in Canada, and is widely recognized as among the most favourable in the world. The SR&ED tax incentives provide support for all types of SR&ED performed in every industrial sector in Canada, including farming crops, animals, and/or living organisms. Approximately $1.6 billion in investment tax credits is provided annually to about 11,000 claimants.
10.	AAFC is exploring potential options to designate certain plants developed using conventional or unconventional breeding methodologies, as platforms for "pharma" use that would not be part of the food or feed chain. Some of these are listed in Table 2.
11.	The Enabling Technologies Directorate (ETD) of Technology Partnerships Canada (TPC) does consider projects in the biotechnology sector. TPC, a Special Operating Agency of Industry Canada, has been approving and supporting research projects through conditionally repayable contributions since the program's inception in 1997.
12.	The mandate of Industry Canada's Life Sciences Branch (LSB) is to foster the growth of competitive life sciences industries in Canada. LSB undertakes a variety of activities to support the development of the life sciences industries through activities in trade promotion, investment attraction and industry development, and through activities to promote the development and adoption of appropriate marketplace policies, laws, and regulations within the federal government.
13.	Industry Canada's Office of Consumer Affairs (OCA) offers financial assistance to non-governmental consumer organizations (NGOs) through its Grants and Contributions program. This assistance provides NGOs the opportunity to conduct research in areas of importance to Canadian consumers.
14.	The Natural Sciences and Engineering Research Council (NSERC), part of the Industry Canada portfolio, has provided substantial funding for research in the natural sciences and engineering areas of biotechnology since 1998. These are listed in Annex I.
15.	The Industry Canada Portfolio has funded many projects on research, development, and promotion of PNTs used to produce pharmaceuticals or industrial chemicals. Health Canada has also funded various research projects aimed at the development of plant expressed vaccines and biologicals and the development of knowledge on plant expressed pharmaceuticals. Table 2, below, lists expenditures on the research, development, and promotion of plant molecular farming crops by these government organizations.

Table 2: Expenditures on the research, development, and promotion of farming crops.


Department	Partner(s)	Project / Product	Year(s)	Province	Amount

AAFC	Robarts Research Institute	Production of interleukin-4 in tobacco and the evaluation of its functionality in the NOD mouse	1996-1998	ON	$150,000
AAFC	University of Guelph, Crop Science, Ontario Veterinary College (OVC), OREP	Production of an oral vaccine for PRRS virus of swine in a non-food crop bioreactor system	1998-1999	ON	$229,000
AAFC	London Health Sciences Center	Production of IL-10 in a non-food crop bioreactor for the treatment of inflammatory bowel disease	1998-2001	ON	$160,000
AAFC	Veterinary Infectious Diseases Organization (VIDO)	Oral vaccine for PPV of swine produced in transgenic plants	1998-2001	ON	$45,000
AAFC	Fraunhofer Institute	Field testing transgenic tobacco expressing the gene for human serum albumin and for tumour diagnostic antibodies	1999	ON
AAFC	Rutgers University	Evaluation of chloroplast expression as a means of producing recombinant proteins in plants	1999	ON
AAFC	London Health Sciences Centre	2^nd International Molecular Farming Conference	1999	ON	$50,000
AAFC	London Health Sciences Centre, Ontario Ministry of Agriculture, Food and Rural Affairs (OMAFRA)	Targeting of human IL-10 to non-food bioreactor organelles	1999-2002	ON	$75,000
AAFC	Canadian Department of Defence	Plant cell expression and processing of influenza and encephalitis vaccines	1999-2004	ON	$240,000
AAFC	Child Psychiatric Research Institute	Production of arylsulfatase A in transgenic tobacco non-food bioreactor, a potential therapy for metachromatic leukodystrophy	2000	ON
AAFC	London Health Sciences Centre	Optimizing recombinant protein production in transgenic non-food bioreactor	2001-2003	ON	$162,000
AAFC	Nexia Biotechnologies	Production of recombinant spider silk in the non-food bioreactor	2001-2003	ON	$110,000
AAFC	University of Guelph	Production of diagnostic antibodies for food borne pathogens in plants	2001-2003	ON	$120,000
AAFC	Agrisoma Ltd.	Evaluation of the Use of Mammalian Artificial Chromosomes (MAC) as a Recombinant Pharmaceutical Protein Production Platform in Crops	2003-2005	ON	$414,000
AAFC	London Health Sciences Centre	Plant recombinant antibodies for Pseudomonas aeruginosa: A model for the topical prevention of hospital-acquired infections	2003-2005	ON	$100,000
Health Canada (LCDC)		Plant-derived bio-farming of oral vaccines	1999-2002	MB	$429,000
Health Canada (BGTD)		Safety and efficacy of plant-made biotherapeutics using cytomegalovirus and blood cell cytokines as model proteins	1999-2002	ON	$429,000
Health Canada (BGTD)	Prairie Plant Systems Inc.	Cultivation of transgenic tobacco plants expressing the glycoprotein B of cytomegalovirus	2001-2002	SK	$26,000
Health Canada (OBS)	IC, NRC, CIHR, TPC	Regulatory session at conference on Plant-Made Pharmaceuticals	2003	QC	$10,000
TPC (ETD)		SemBioSys (TPC)		AB	$5,522,607
TPC	IC, NRC, CIHR, HC	Conference on Plant-Made Pharmaceuticals	2003	QC	$12,000
Industry Canada (LSB)	HC, NRC, TPC, CIHR	Conference on Plant-Made Pharmaceuticals	2003	QC	$12,000
Industry Canada (LSB)	CFIA, HC, EC, AAFC	Situation Paper & Roadmap: Canadian Novel Protein Production Systems (NPPS)	2003	ON	$21,400
Industry Canada (OCA)	Option Consommateurs' production	Plant Molecular Farming: Issues and Challenges for Canadian Regulators	2002-2003	QC	$45,100

Question 3:

As 14 canola pharming fields were cultivated in open-field in Canada between 1998 and 2002, could the Ministers gives details [sic] information about containments [sic] measures to prevent any genetic contamination of the nearby canola fields for human and animal feed purposed [sic] as well as the food chain? In particular, could the Ministers give details on exact locations (provinces, etc.) of the 14 canola open-air pharming fields (1998-2002) and any canola open air pharming fields in 2003 and/or planned in future year?

Response to Question 3:

16.	The CFIA approves and regulates confined research field trials and determines appropriate protocols for planting, growing, and harvesting, as well as for site monitoring and record keeping. As described in the updated Regulatory Directive 2000-07, which can be found at http://www.inspection.gc.ca/english/plaveg/bio/dir/dir0007ie.shtml, a confined field trial is the release of a PNT, for research purposes, under terms and conditions of confinement designed to minimize any impact the PNT may have on the environment. These terms and conditions include, but are not limited to, reproductive isolation, site monitoring, and post-harvest land use restrictions. The specific terms and conditions for the 10 confined research field trials of novel canola intended for plant molecular farming in 1998, and for the 4 such trials in 1999, can be found in Annex II. There were no confined research field trials of canola intended for plant molecular farming in 2000, 2001, 2002, or 2003. The CFIA has not received any future-year applications for confined research field trials of canola intended for plant molecular farming.
17.	The CFIA is developing regulatory directives to cover field testing and commercial cultivation of PNTs for molecular farming. Such regulatory directives are designed to assist the Agency in the protection of human, livestock, and environmental health. As part of its development of new regulatory directives, the CFIA hosted a multi-stakeholder consultation on plant molecular farming in fall 2001. The consultation focussed on the particular concerns associated with confined research field trials of PNTs for pharmaceutical production. As well, the CFIA invited comments from interested Canadians through a questionnaire that was posted on the Agency's Web site.
18.	Following these consultations, the CFIA proposed increased requirements for confined research field trials of PNTs for molecular farming. For example, the proposals included more stringent requirements to ensure isolation from related species or other food or feed crops, increased assessments of the potential toxicity and allergenicity where food or feed crop species are used, and increased inspections of field trials of PNTs for molecular farming. These additional requirements have now been incorporated in the amendments to regulatory directive Dir 2000-07 mentioned above.

Question 4:	Could the Ministers give details of the other crops planted in a 2 km radius of any of the open-air pharming fields (name of the crop, purpose e.g. human food chain, seed reproduction, organic certified crops, quantities of production, etc...)?
Question 5:	Could the Ministers give details of the crops planted in a 2 km radius, at least 2 years after planting any open-air pharming fields (name of the crop, purpose e.g. human food chain, seed reproduction, organic certified crops, quantities of production, etc...)?

Response to Questions 4 & 5:

19.

The CFIA does not keep records of crops planted outside a confined research field trial site within a 2-km radius either during or after the trial, nor does the Agency require the proponents of confined research field trials to report this information. The terms and conditions of authorization of the trials are designed to limit environmental, human, or livestock exposure resulting from gene flow from, or unintentional mixing of, plant molecular farming material (see Paragraphs 49-56 and Annex II). The terms and conditions require that after the trial is harvested, the applicant must control trial volunteers and report land use and crops planted on the trial site, and within a 10-m border, for a given number of years, which is assigned based on the biology of the plant. The terms and conditions are regularly updated according to the best available scientific knowledge and are enforced by CFIA inspectors. As measures implemented for reproductive and physical isolation of the trial and trial material are based on current science, there is no scientific justification for collecting data to an arbitrary distance of 2 km.

Question 6:

Could the Ministers give details about the measures in place for preventing genetic contamination from any open-air pharming fields including (a) numbers, types and frequency of tests of nearby crops (up to what distance?), (b) results of these tests, (c) who did the tests and interpreted the results, (d) are the data publicly available and verifiable by counter-experts?

Question 7:

Could the Ministers provides [sic] details about the measures in place for preventing genetic contamination from any open-air pharming fields to surrounding ecosystems including (a) numbers, types and frequency of tests of nearby ecosystems, (b) results of these tests, (c) who did the tests and interpreted the results, (d) are the data publicly available and verifiable by counter-experts? Have the Ministers put in place a comprehensive and independly [sic] verifiable traceability system to assure not [sic] genetic contamination from pharming open-air fields?

Response to Questions 6 & 7:

20.

The CFIA takes proactive measures so that any environmental exposure resulting from gene flow or unintentional mixing of material from confined research field trials will be minimal. The terms and conditions of authorization of confined research field trials are designed to mitigate the flow of genes and/or plant material from the trial to surrounding crops and ecosystems, and are regularly updated based on current agricultural practices and on the best available scientific knowledge specific to the biology of the crop species (see Paragraphs 49-56 and Annex II). In setting the terms and conditions of authorization of a confined research field trial, the CFIA considers both the known biology of the plant and the anticipated environmental impacts of the novel trait. Trial sites and records are subject to inspection by the CFIA both during the trial and in post-harvest years. These inspections are mandatory for all confined research field trials of PNTs. Confined research field trials are also subject to restrictions in size and number to further mitigate environmental impacts. Any given PNT can be field-tested at no more than 10 sites per province in a given year, with a total area of no more than 5 hectares per province and no more than 1 hectare per site.

21.

The CFIA also notes that it was a Government of Canada decision, made following extensive consultations with Canadian stakeholders, to allow confined research field trials of PNTs to take place before full environmental, food, and feed safety assessments are done. This is reflected in the 1993 Federal Regulatory Framework for Biotechnology which provides for the protection of the environment and health and safety without unduly hindering innovation. This decision recognizes that the enforcement of terms and conditions of authorization, which are based on the best available scientific knowledge, will mitigate environmental impacts and allow for the collection of environmental safety data of PNTs under controlled conditions.

Question 8:

Considering that seeds and relict plants can persist for up to 10 years (e.g. canola, Eastham & Sweet, 2002, Genetically modified organisms (GMOs): the significance of gene flow through pollen transfer. Expert's Corner Series, European Environment Agency, Copenhagen), could the Ministers provide details about the measures currently in place (or planned) to monitor GE pharm crop volunteers in subsequent years in and around the fields where they were planted initially? If in place, could the Ministers say how many years the monitoring for GE pharm crop volunteers last and offer a detailed justification? If they exist, could the Ministers give details about the full results of the monitoring for GE pharm crops volunteers in Canada and any decisions taken by Ministers as a consequence?

Response to Question 8:

22.	All confined research field trial sites are subject to post-harvest restrictions. These include requirements to monitor the trial site (plus a 10-m border) for volunteers from the trial and to remove and destroy any such plant prior to flowering, for a number of years after the trial depending on the biology of the species. The proponent of the trial is required to maintain written records of post-harvest monitoring and compliance activities. Both the trial site and the monitoring and compliance records are subject to inspection by the CFIA.
23.	For confined research field trials of PNTs intended for plant molecular farming, additional post-harvest land use restrictions may be imposed case by case for anticipated environmental impacts of the novel trait or particular geographic conditions. These may include restrictions on food or feed production, including grazing of livestock, on the trial site in post-harvest years.
24.	The number of years that post-harvest restrictions are in place is the maximum period in which volunteers can be expected to appear. This is based on scientific knowledge of the species and is regularly updated through expert consultations. Seed dispersal, pod shattering, seed dormancy, agricultural practices, and any annual post-harvest control of volunteers are factors all considered.
25.	The number of years of post-harvest restrictions imposed by the CFIA is in accordance with the international standards articulated by the Organisation for Economic Co-operation and Development seed schemes, as well as the Canadian Seed Growers Association's seed production guidelines. Of the species that have been used in plant molecular farming confined research field trials in Canada, the post-harvest restrictions apply for 3 years for canola (Brassica napus), 3 years for Ethiopian mustard (Brassica carinata), 3 years for alfalfa (Medicago sativa), 3 years for flax (Linum usitatissimum), 5 years for white mustard (Sinapis alba), 1 year for tobacco (Nicotiana tabacum), 3 years for white clover (Trifolium repens), and 2 years for safflower (Carthamus tinctorius).
26.	Since receiving special funding for biotechnology regulation in 2000, the CFIA has inspected 100% of sites of confined research field trials of PNTs for plant molecular farming for compliance with post-harvest land use restrictions and monitoring requirements. If compliance problems are discovered, the CFIA will issue a letter to the proponent. The letter will stipulate that the trial must immediately be brought back into compliance and that the proponent must respond in writing that compliance actions have been taken. The trial will then be re-inspected to verify compliance.

Question 9:

Could the Ministers provide full details (e.g. by year, by type of pharm crops or animals, by products, by province, by private and public partners, by Federal government funding programs) about the past, current and planned direct public funding made available specifically for the research and the prevention of contamination (genetic or otherwise) of pharm crops and/or animals?

Response to Question 9:

27.	Tobacco is a non-food crop that has been the subject of many years of breeding and agronomic research and can be used as a strong base for a field production system for molecular farming. AAFC has developed a production system based on hybrids between male-sterile low-alkaloid females and homozygous transgenic lines. The resultant hybrids express the transgene uniformly, and protein production is based on leaves, not seeds or tubers, which further limits the potential for escape. The plants are grown at a high density to maximize biomass yield and are harvested after 30-40 days, eliminating flower production and allowing the system to be adapted to a broad range of production environments. Tobacco does not survive over winter in Canada and wild relatives native to Canada have been reported only in a small area of southern British Columbia.
28.	Over the past several years, AAFC has applied this plant system to the production of human interleukin-10, an anti-inflammatory with potential application in the treatment of inflammatory bowel disease and other autoimmune diseases.
29.	AAFC has conducted a variety of studies investigating transgenic tobacco expressing the human interleukin-10 (IL10) gene. Tobacco hornworms and aphids were chosen as test organisms as they are the only type of animal that normally feeds on tobacco. Researchers evaluated hornworms fed both non-transgenic tobacco and transgenic interleukin-10 tobacco for 7 days and compared the size of the worms' head capsules (a measure of growth). There was no difference in hornworms fed either type of tobacco and therefore it was concluded that transgenic tobacco containing human IL10 had no acute biological activity in hornworms. When the experiment was conducted with aphids, researchers found that transgenic tobacco containing human IL10 did not affect the insects' reproductive rate.
30.	AAFC also conducted an experiment that compared interleukin-10 protein levels in soil where transgenic tobacco and non-transgenic interleukin-10 tobacco had been grown. There was no detectable interleukin-10 in the soil where either type of plant was grown, from which we concluded that interleukin-10 does not leach out of roots and remain in any stable form in potting soil. This gives us a reasonable degree of confidence that no interleukin-10 would be present in soil in field-produced transgenic tobacco with interleukin-10.
31.	The CFIA is currently using funds from the Canadian Biotechnology Strategy to contract a study on the feasibility of segregating commodities of commercial plant molecular farming from other agricultural products. These funds will also be used to contract a study to identify critical control points, to organize a technical expert consultation on this topic, and to coordinate regulatory activities on plant molecular farming with Health Canada and the U.S. Department of Agriculture.
32.	NRC's Plant Biotechnology Institute has invested $1 million over the last five years related to the research and prevention of contamination of pharmaceutical crops. The research was conducted under the project title: Development of Alternative Host Plants for Molecular Farming in Saskatchewan; the research focussed on the evaluation of the tissue culture and genetic transformation potential of species that are not grown as food crops (e.g. oilseed radish and crambe). All research was undertaken in laboratory and greenhouse conditions, and no field tests were conducted. The Canada-Saskatchewan Agri-Food Innovation Fund (AFIF) supported the research based on a funding split of 70 percent federal and 30 percent provincial. Total funding from AFIF was $600k and PBI contributed $400k. The duration of project was over 3 fiscal years commencing in 1999-2000 and ending in 2001-2002. Funding was evenly divided over these 3 years.
33.	Environment Canada has not received or planned the use of public funding made available specifically for the research and the prevention of contamination (genetic or otherwise) of crops and/or animals used to produce pharmaceutical or industrial compounds.
34.	Health Canada has not received or planned the use of public funding made available specifically for the research and the prevention of contamination (genetic or otherwise) of crops and/or animals used to produce pharmaceutical or industrial compounds.

Question 10:

Did the ministers informed [sic] the nearby farmers, farmers' organisations, residents, municipalities, regional and/or provincial governments of the existence of such pharming crops in their area? If not, please could the Ministers offer a full justification?

Response to Question 10:

35.	Plant molecular farming activity in Canada has been restricted to confined research field trials. The exact location of field trials is considered CBI. As such it is protected under access to information and privacy laws and cannot be disclosed except in accordance with these laws. Furthermore, proponents of confined research field trials are responsible for ensuring that any plant material planted or harvested in the trial is accounted for. In the interests of environmental, human, and livestock safety, trial material must not be removed from the site without adequate precautions. Disclosing exact trial locations could lead to illegitimate removal of plant material from the trial site by objectors or by individuals with commercial interests.
36.	The CFIA notifies provincial authorities of all applications for confined research field trials of PNTs in their province prior to their approval. The CFIA also encourages proponents of confined research field trials of PNTs to conduct local public consultations before beginning the trial. In addition, the regulation of confined research field trials as outlined in Regulatory Directive 2000-07 (at http://www.inspection.gc.ca/english/plaveg/bio/dir/dir0007e.shtml) has been subject to extensive consultation. This directive includes requirements relative to notification, inspection, and information; an authorization process; and specific terms and conditions for confined research field trials of PNTs in Canada. The CFIA has sought public approval on the entire regulatory process rather than on the basis of each submission.
37.	While respecting the limitations imposed by access to information and privacy laws, the CFIA is endeavouring to enhance transparency in relation to confined research field trials. All non-CBI information of all confined research field trials of PNTs conducted in Canada is provided in detailed tables on the CFIA's Plant Biosafety Office's Web site at http://www.inspection.gc.ca/english/plaveg/bio/triesse.shtml.

Question 11:

As it is available in other countries, would the Ministers consider establishing a public register for all planned, current and past pharm crops in Canada including a public consultation process? If not, please could the Ministers justify their answer. If yes, when such public register and public consultation will [sic] be introduced and will it be retroactive to past open-air pharm crops?

Response to Question 11:

38.	The CFIA has consulted extensively with experts and stakeholders in developing the terms and conditions under which confined research field trials are authorized, and again in developing the additional terms and conditions that are applied to confined research field trials of PNTs intended for plant molecular farming. This latter consultation process is described on the CFIA Web site at http://www.inspection.gc.ca/english/plaveg/bio/mf/mf_cnsle.shtml.
39.	The CFIA and Health Canada have launched a pilot project to post scientific "notices of submission" on the CFIA Web site for public access prior to the submission's review at the beginning of the safety assessment process. These notices will describe the product-new Plants with Novel Trait (PNTs), or novel feed or food derived from a PNT-and summarize the information provided for the safety assessment. Members of CropLife Canada, the trade association representing 85% of Canadian developers of biotechnology-derived plant products for use in agriculture, have volunteered to write these notices of submission to accompany their submissions to the CFIA and Health Canada.
40.	On December 1, 2003, CFIA and Health Canada received the first notice of submission from Dow AgroSciences Canada for corn (designated as Event TC6275) which has been modified to express the Cry1F protein of Bacillus thuringensis (Bt) to ward off insects.
41.	On their respective Web sites, the CFIA and Health Canada post lists of all approved PNTs, novel feeds from PNTs, and novel foods from PNTs, together with the accompanying decision documents. However, there has been limited public information available about the products while they are under review. In the past, the CFIA and Health Canada have not posted information about products that are under review.
42.	During the pilot stage of the notice of submission project, only novel foods and novel feeds derived from PNTs—not all novel foods and feeds—will be covered. All PNTs will be included, no matter how the new trait was introduced into the plant. This is a voluntary project that, for the first time in Canada, makes this information available to the public at the beginning of the safety evaluation process of biotechnology-derived products. There is no requirement for this in the legislation administered by the CFIA and Health Canada.
43.	Since 1977, AAFC has been tracking agriculture and food research programs in Canada through the Inventory of Canadian Agri-Food Research (ICAR) database. The ICAR is a comprehensive database for agriculture and food research in Canada and is a product of the Canadian Agri-Food Research Council (CARC). It contains detailed information on current research projects in agriculture, food, human nutrition, aquaculture, and related areas of biotechnology. It is a publicly available database that contains all AAFC research studies, those of other federal and provincial institutions, and, as well, university studies and some industry projects. Information can be found on the database at <www.carc-crac.ca>.

Question 12:

Could the Ministers explain how the liability regime in place would work should a genetic contamination from an open-air pharm crop occurred [sic] given the level of secrecy around open-air pharm crops? Would the public prosecutor [sic] and all the parties have access to information (including the full or partial sequences of the DNA constructs used in GE pharm crops) regarding the pharming open-air fields suspected as the possible cause of a genetic contamination? And how could a public prosecutor [sic] or a [sic] alleged contamination victim get access to that information?

Response to Question 12:

44.	Question 12 contains three separate questions that would appear to be hypothetical in nature and to raise legal issues. The Government of Canada is not in a position to provide legal advice to the Petitioner.
45.	The first sentence of the question raises the issue of potential liability in a civil context as the Ministers are apparently being asked to comment on a hypothetical private legal dispute. As litigation of this nature could be brought before the courts, it would not be appropriate for the Government of Canada to express an opinion on the legal issues that could arise.
46.	In the second sentence, the Petitioner would appear to be enquiring about applicable disclosure requirements in hypothetical criminal proceedings. As it is the Attorney General who would be responsible for the conduct of any prosecution arising out of an alleged violation of federal legislation governing plant molecular farming, the Ministers are not in a position to comment on questions respecting access to evidence that could be adduced before the court or information that could be disclosed during the course of the proceeding. The Ministers expect that the usual rules of evidence would apply.
47.	The third sentence appears to be asking for the Ministers' explanation as to how a prosecutor in a criminal prosecution or an alleged victim in a criminal or civil proceeding could obtain information regarding plant molecular farming activities that may be suspected of causing genetic contamination. The Ministers expect that the usual rules of evidence would apply in either a criminal or civil proceeding.

Question 13:

Could the Ministers give details of all regulatory, legal and/or contractual breaches of the conditions for open-air pharm crops in Canada (e.g. dates, duration of the breach, name of the company and parties involved, type of breach, and legal, administrative and financial actions undertaken by the Ministers following a breach, etc.)?

Response to Question 13:

48.

Plant molecular farming activity in Canada has been restricted to confined research field trials. As mentioned previously, confined research field trials of PNTs, including those intended for plant molecular farming, are authorized by the CFIA under strict terms and conditions. Post- harvest compliance issues were discussed in Paragraphs 22-26. Since receiving special funding for biotechnology regulation in 2000, the CFIA has inspected 100 percent of sites of confined research field trials of PNTs for plant molecular farming. If compliance problems are discovered with post-harvest restrictions, the CFIA will issue a letter to the proponent. The letter will stipulate that the trial must be immediately brought back into compliance and that the proponent must respond in writing that compliance actions have been taken. The trial will then be re-inspected to verify compliance. To date, all inspected trials have been in compliance with the terms and conditions of the authorization by the end of the trial. No environmental safety concerns have resulted from any of these trials.

Question 14:

Could the Ministers provides [sic] details about the level of rigorousness of government measures in place for preventing genetic contamination from any open-air pharm crops in Canada, and in particular [sic] number of full-time equivalents government positions devoted to these measures and budget of these measures?

Response to Question 14:

49.	Plant molecular farming activity in Canada has been restricted to confined research field trials. Terms and conditions of authorization of confined research field trials are designed to minimize any environmental, human, or livestock exposure resulting from gene flow or unintentional mixing of trial material. Confined research field trials are also subject to restrictions in size and number to further mitigate environmental impacts. For example, any given PNT can be field tested at no more than 10 sites per province in a given year, with a total area of no more than 5 hectares per province and no more than 1 hectare per site.
50.	General terms and conditions of authorization of a confined research field trial are based on the known biology of the plant according to the best available scientific knowledge. They mandate the implementation of effective reproductive isolation for that species, such as the use of isolation distances, guard rows, or cages. Terms and conditions are updated regularly; for example, the CFIA hosted a technical workshop for academics and other experts in September 2003 to review the general terms and conditions for canola confined field trials. General terms and conditions also require proponents of confined research field trials to account for all plant material harvested from the trial. Disposal and storage records are inspected by the CFIA.
51.	Specific additional terms and conditions may be imposed on a case-by-case basis for anticipated environmental impacts of the novel trait or of particular geographic conditions. For transparency, specific additional terms and conditions for confined research field trials of PNTs for molecular farming have been elaborated in the interim rules posted on the CFIA Web site at http://www.inspection.gc.ca/english/plaveg/bio/dir/dir0007e.shtml. These are summarized below: a requirement to submit additional toxicological and allergenicity data for consideration by CFIA's Feed Section and Health Canada's Novel Foods Section prior to authorization in some cases; a mandatory submission to the CFIA of current-year and post-harvest monitoring and compliance records; a two-fold increase in minimum isolation distance from other fields of the same species; a four-fold increase in minimum isolation distance from seed-production fields of the same species; a requirement to provide information on land use of the trial site and isolation area in years prior to planting; a restriction against food or feed production, including livestock grazing, within 50 m of the trial perimeter; additional restrictions on land use in post-harvest years, particularly relating to food or feed production, including grazing of livestock, on the trial site; a requirement for disposal and destruction of residual plant material following harvest of a trial of a PNT for molecular farming to be witnessed by a CFIA inspector.
52.	As described in Paragraphs 22-26, confined research field trial sites are also subject to post-harvest land use restrictions and monitoring requirements.
53.	As in any confined research field trial, mitigation of environmental exposure of the novel product to non-target organisms is required if it is feasible and appropriate. The CFIA also encourages developers of PNTs intended for plant molecular farming to consider using plants and technologies amenable to confinement and avoiding using major food or feed species or plants used by commercial honeybees.
54.	All confined research field trials are inspected by qualified CFIA inspectors a minimum of three times: one site inspection during the trial, one inspection of disposal and storage records, and one site inspection during the post-harvest period.
55.	The total CFIA budget allocation specifically relating to inspection and enforcement of modern biotechnology from an operational perspective amounts to 21.98 ($1,230,880 dollar amount) full time equivalent staff positions (FTE's) plus $274,787.50 related operating and maintenance costs. This includes measures in place for preventing genetic contamination in seed, plants, feed, fertilizers, food and veterinary biologics. The FTE allocation for open-air pharm crops in particular which also includes the above mentioned confined research field trials is outlined in Table 3.

Table 3: Allocation of CFIA resources to deliver in-field PNT plant biosafety and seed inspection


Region	Full Time Equivalent (FTE) ($ amount)	Operating & Maintenance Costs	Total Dollar Budget
Atlantic Area	0.30 (16,000)	$3,750	$19,750
Quebec Area	0.35 (19,000)	$4,375	$23,375
Ontario Area	1.00 (56,000)	$12,500	$68,500
Western Area	2.00 (112,000)	$25,000	$136,000
Total	3.65 (203,000)	$45,625	$247,625

56.	In addition, approximately 1.5 additional full-time equivalents are committed for administrative oversight, consultation activities and policy development related to environmental releases of PNTs for molecular farming.

Question 15:

Could the Ministers provides [sic] details about specific measures in place in Canada to detect and prevent any contamination from pharming crops materials resulting from the importation in Canada of human food, animal feed, seeds from countries producing pharm crops in open-air fields?

Response to Question 15:

57.

The CFIA implements measures to detect and prevent entry into Canada of unapproved PNTs when there is suspicion of illegal entry. The two incidents involving an American plant molecular farming company in the fall of 2002 did not result in the entry of any plant molecular farming material into food or feed supply chains. The CFIA confirmed with U.S. authorities that adequate containment and enforcement actions had been taken to fully prevent any compromise to food or feed supplies. Therefore, it was not necessary to implement measures to detect or prevent entry of the plant material into Canada. The CFIA continues to monitor international activities in plant molecular farming and to harmonize regulatory approaches for plant molecular farming with other governments.

Question 16:

Could the Ministers provides [sic] any details on any breach of imports regulations of pharming crops or produced from pharm crops?

Response to Question 16:

58.

The Canada Border Services Agency (CBSA) assists other government departments and agencies, such as the CFIA, Environment Canada, Agriculture and Agri-Food Canada, and Health Canada, in the administration of their acts and regulations with respect to the importation of agricultural or agri-food products (including the trans-boundary movement of genetically engineered pharmaceutical crops from the United States into Canada. Importation of unapproved PNTs or their products is subject to Regulatory Directive D-96-13, "Import Permit Requirements For Plants With Novel Traits (Including Transgenic Plants), And Their Products", which can be found at http://www.inspection.gc.ca/english/plaveg/protect/dir/d-96-13e.shtml. The CFIA is not aware of any infractions of these regulations with respect to PNTs for molecular farming.

Question 17:

Could the Ministers provide information on the steps they are taking to ensure that any suspected GE contamination of crops can be tested by independent scientists, e.g. by making available either full or partial sequences of the DNA constructs used in GE pharm crops to ensure their traceability?

Response to Question 17:

59.

Plant molecular farming activity in Canada has been restricted to confined research field trials. Confined research field trials of PNTs have been permitted in Canada under the 1993 Federal Regulatory Framework for Biotechnology following extensive stakeholder consultation. The CFIA takes measures to proactively ensure that any environmental exposure resulting from gene flow or unintentional mixing of material from confined research field trials will be minimal. Terms and conditions of authorization of confined research field trials of PNTs are designed to mitigate the flow of genes and/or plant material from the trial to surrounding crops and ecosystems and have been developed from extensive consultation with independent scientists and stakeholders. The rigorousness of these terms and conditions, their development, and enforcement is described in Paragraphs 20, 21 and 49-56.

Question 18:

Considering that the US National Research Council concluded that "(I)t [was] possible that crops transformed to produce pharmaceutical of [sic] other industrial compounds might mate with plantations grown for human consumption, with the unanticipated result of novel chemicals in the human food supply" (Environmental Effects of Transgenic Plants: The scope and adequacy of regulation, Washington, D.C. 2002) and considering the cases of genetic contamination in the US involving among other the biopharming company ProdiGene, could the Ministers explains [sic] the measures that they specifically adopted in responses to these facts and events to present contamination from open-air pharming fields?

Response to Question 18:

60.	Well before the two incidents involving the American plant molecular farming company which took place in the fall of 2002, the CFIA had in place a rigorous program overseeing confined research field trials of PNTs, including those intended for molecular farming, to ensure that environmental, human, and livestock exposure would be minimal. These measures have been described in Paragraphs 49-56.
61.	Upon request from the CFIA, Health Canada provides evidence-based opinions on the potential impact on human health of proposed confined research field trials of molecular farming crops. These opinions are intended to assist the CFIA in determining appropriate confined research field trial conditions or compliance actions to protect the food supply.
62.	The CFIA's Feed Section also provides evidence-based opinions on the potential impact on livestock health of proposed confined research field trials of molecular farming crops. These opinions are intended to assist the PBO in determining appropriate confined research field trial conditions or compliance actions to protect the livestock feed supply.

Concluding Remarks

63.

The Ministers named in this Petition remain committed to:

an effective domestic regulatory system for biotechnology-derived products that 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.

Annex I:
NSERC funds spent on the research, development, and promotion of biotechnology-derived crops designed for pharmaceutical and industrial production

Fiscal Year	Province	Type	University	Amount ($)

1998	BC	tree	British Columbia	90,725
1998	ON	general	Toronto	77,000
1998	AB	tree	Calgary	38,500
1998	QC	plants	Laval	52,800
1998	QC	general	Laval	40,700
1998	ON	animal	Guelph	86,400
1998	ON	general	Trent	39,270
1998	ON	general	Guelph	150,000
1998	SK	plants	Saskatchewan	28,200
1998	QC	plants	Montréal	69,960
1998	QC	plants	McGill	61,600
1998	MB	plants	Manitoba	24,200
1998	QC	general	Sherbrooke	41,300
1998	QC	plants	McGill	76,729
1998	QC	general	Montréal	44,000
1998	ON	general	Toronto	55,000
1998	AB	tree	Alberta	22,000
1998	ON	fish	Guelph	1,604
1998	NF	fish	Memorial Univ. of Nfld	123,750
1998	ON	fish	Ottawa	32,120
1998	BC	tree	British Columbia	74,800
1998	BC	tree	British Columbia	3,617
1998	ON	plants	Guelph	25,300
1998	ON	plants	Guelph	111,587
1998	ON	general	Guelph	20,000
1998	MB	plants	Manitoba	28,333
1998	AB	fish	Calgary	46,200
1998	SK	plants	Saskatchewan	60,470
1998	BC	tree	British Columbia	81,400
1998	AB	plants	Alberta	62,100
1998	BC	general	British Columbia	53,460
1998	QC	plants	Concordia	33,000
1998	AB	fish	Calgary	73,200
1998	BC	plants	British Columbia	104,100
1998	SK	plants	Saskatchewan	104,400
1998	ON	general	Toronto	49,500
1998	ON	plants	Guelph	28,380
1998	BC	general	Simon Fraser	33,000
1998	ON	plants	Guelph	38,500
1998	PE	pharmaceutical	Prince Edward Island	100,625
1998	SK	fish	Saskatchewan	28,600
1998	BC	general	British Columbia	54,450
1998	QC	animal	McGill	48,375
1998	QC	plants	Institut Armand-Frappier	25,300
1998	QC	plants	McGill	8,705
1998	QC	plants	Montréal	11,095
1998	ON	animal	Laurentian	22,000
1998	QC	plants	Laval	17,375
1998	NS	algae	Dalhousie	36,300
1998	ON	plants	Guelph	102,450
1998	QC	plants	Montréal	33,000
1998	ON	general	Toronto	47,520
1998	ON	plants	Toronto	40,040
1998	NS	general	Dalhousie	22,000
1998	ON	tree	Lakehead	18,700
1998	AB	tree	Alberta	24,200
1998	SK	general	Saskatchewan	41,800
1998	BC	tree	British Columbia	101,150
1998	ON	plants	Guelph	77,500
1998	ON	plants	Guelph	99,007
1998	BC	plants	British Columbia	26,400
1998	MB	plants	Manitoba	16,500
1998	SK	animal	Saskatchewan	27,500
1998	SK	animal	Saskatchewan	133,994
1998	SK	plants	Saskatchewan	78,000
1998	QC	animal	Montréal	28,600
1998	QC	animal	Montréal	135,900
1998	ON	plants	Guelph	25,300
1998	ON	plants	Guelph	16,500
1998	QC	plants	Québec à Montréal	30,360
1998	SK	plants	Saskatchewan	16,500
1998	SK	pharmaceutical	Saskatchewan	141,103
1998	ON	plants	Western Ontario	34,100
1998	ON	general	Queen's	39,124
1998	ON	general	McMaster	53,080
1998	NS	fish	Dalhousie	27,500
1998	AB	tree	Alberta	27,500
1999	BC	tree	British Columbia	85,025
1999	ON	general	Toronto	80,850
1999	AB	tree	Calgary	40,425
1999	BC	general	British Columbia	85,680
1999	QC	pharmaceutical	Sherbrooke	86,000
1999	QC	general	McGill	251,700
1999	QC	plants	Laval	55,440
1999	QC	general	Laval	42,735
1999	QC	fish	Laval	117,000
1999	ON	general	Trent	41,234
1999	ON	general	Guelph	300,000
1999	SK	plants	Saskatchewan	28,200
1999	QC	general	Laval	23,100
1999	QC	pharmaceutical	Montréal	21,000
1999	QC	plants	Montréal	73,458
1999	QC	plants	Montréal	140,600
1999	QC	plants	McGill	64,680
1999	MB	plants	Manitoba	25,410
1999	QC	general	Sherbrooke	36,300
1999	QC	general	Montréal	46,200
1999	SK	plants	Regina	17,850
1999	ON	general	Toronto	57,750
1999	AB	tree	Alberta	23,100
1999	ON	fish	Guelph	113,237
1999	BC	fish	Simon Fraser	21,194
1999	NF	fish	Memorial Univ. of Nfld	2,956
1999	BC	fish	Simon Fraser	140,250
1999	QC	general	Laval	25,200
1999	ON	fish	Windsor	19,000
1999	ON	plants	Western Ontario	46,500
1999	ON	fish	Ottawa	33,726
1999	BC	tree	British Columbia	78,540
1999	ON	plants	Guelph	18,900
1999	ON	plants	Guelph	55,280
1999	ON	general	Laurentian	26,250
1999	AB	fish	Calgary	48,510
1999	SK	plants	Saskatchewan	61,670
1999	BC	tree	British Columbia	81,400
1999	ON	general	Toronto	21,000
1999	AB	plants	Alberta	62,100
1999	QC	plants	Concordia	34,650
1999	AB	fish	Calgary	73,200
1999	ON	animal	Ottawa	44,100
1999	BC	fish	Northern British Columbia	25,200
1999	SK	plants	Saskatchewan	104,900
1999	BC	animal	Victoria	261,099
1999	ON	general	Toronto	51,975
1999	QC	pharmaceutical	Montréal	544,500
1999	BC	wine	British Columbia	3,111
1999	ON	wine	Brock	35,739
1999	AB	plants	Alberta	37,000
1999	BC	general	Simon Fraser	34,650
1999	ON	plants	Guelph	40,425
1999	PE	pharmaceutical	Prince Edward Island	104,197
1999	ON	plants	Western Ontario	43,575
1999	SK	fish	Saskatchewan	38,325
1999	BC	general	British Columbia	57,173
1999	BC	general	British Columbia	207,000
1999	QC	plants	Institut Armand-Frappier	28,245
1999	QC	plants	McGill	20,790
1999	ON	plants	Guelph	43,890
1999	ON	animal	Laurentian	23,100
1999	QC	plants	Laval	17,375
1999	BC	general	Victoria	35,000
1999	ON	plants	Guelph	114,986
1999	QC	plants	Montréal	34,650
1999	QC	plants	Montréal	154,000
1999	ON	animal	Ottawa	118,650
1999	ON	plants	Toronto	68,250
1999	ON	plants	Toronto	41,040
1999	ON	plants	Toronto	172,000
1999	NS	general	Dalhousie	23,100
1999	ON	tree	Laurentian	17,850
1999	QC	general	Laval	58,905
1999	ON	tree	Lakehead	19,635
1999	NS	fish	Dalhousie	112,000
1999	AB	tree	Alberta	25,410
1999	SK	general	Saskatchewan	43,890
1999	BC	tree	British Columbia	95,450
1999	ON	animal	McMaster	17,850
1999	QC	plants	Québec à Montréal	114,000
1999	MB	plants	Manitoba	17,325
1999	SK	animal	Saskatchewan	28,875
1999	SK	animal	Saskatchewan	18,560
1999	SK	plants	Saskatchewan	40,000
1999	ON	plants	Guelph	52,500
1999	QC	animal	Montréal	30,030
1999	QC	animal	Laval	79,800
1999	QC	animal	Laval	25,000
1999	QC	animal	Montréal	135,900
1999	ON	general	Ottawa	26,145
1999	ON	fish	Guelph	31,500
1999	ON	plants	Guelph	26,565
1999	SK	plants	Saskatchewan	17,325
1999	ON	plants	Western Ontario	35,805
1999	ON	general	Toronto	97,200
1999	ON	general	McMaster	30,000
1999	NS	fish	Dalhousie	28,875
1999	AB	tree	Alberta	15,750
2000	BC	tree	British Columbia	97,025
2000	BC	tree	British Columbia	16,000
2000	ON	fish	Ottawa	23,800
2000	AB	animal	Alberta	27,000
2000	ON	general	Toronto	80,850
2000	SK	pharmaceutical	Saskatchewan	350,000
2000	BC	plants	British Columbia	17,000
2000	MB	plants	Manitoba	30,000
2000	ON	fish	Guelph	146,350
2000	AB	tree	Calgary	40,425
2000	BC	general	British Columbia	85,680
2000	QC	pharmaceutical	Sherbrooke	108,000
2000	BC	animal	Simon Fraser	35,000
2000	QC	general	McGill	16,762
2000	QC	general	McGill	125,486
2000	QC	plants	Laval	56,000
2000	QC	general	Laval	42,735
2000	QC	general	Laval	35,000
2000	QC	fish	Laval	116,000
2000	QC	fish	Laval	65,250
2000	ON	pharmaceutical	Guelph	26,000
2000	SK	plants	Saskatchewan	28,200
2000	BC	general	Simon Fraser	54,000
2000	ON	general	Toronto	42,000
2000	QC	general	Laval	23,100
2000	QC	pharmaceutical	Montréal	21,000
2000	QC	plants	Montréal	73,458
2000	QC	plants	Montréal	137,405
2000	QC	plants	McGill	64,680
2000	QC	general	Sherbrooke	36,300
2000	QC	animal	Montréal	24,800
2000	SK	plants	Regina	17,850
2000	ON	general	Toronto	57,750
2000	AB	general	Alberta	56,000
2000	AB	tree	Alberta	20,000
2000	ON	fish	Guelph	110,737
2000	BC	fish	Simon Fraser	24,150
2000	BC	fish	Simon Fraser	109,250
2000	QC	general	Laval	25,200
2000	ON	plants	Western Ontario	47,500
2000	QC	fish	McGill	26,188
2000	ON	general	Western Ontario	20,000
2000	QC	general	McGill	34,000
2000	ON	general	Waterloo	31,000
2000	ON	fish	Ottawa	33,726
2000	BC	tree	British Columbia	78,540
2000	SK	pharmaceutical	Saskatchewan	89,000
2000	ON	plants	Guelph	18,900
2000	ON	plants	Guelph	55,280
2000	ON	plants	Wilfrid Laurier	21,000
2000	SK	plants	Saskatchewan	55,000
2000	ON	general	Laurentian	26,250
2000	SK	plants	Saskatchewan	61,670
2000	BC	tree	British Columbia	81,400
2000	ON	general	Toronto	21,000
2000	ON	plants	Guelph	40,000
2000	QC	plants	Concordia	32,000
2000	AB	fish	Calgary	73,200
2000	ON	plants	Guelph	87,500
2000	ON	plants	Guelph	32,500
2000	ON	animal	Ottawa	44,100
2000	MB	general	Manitoba	30,000
2000	BC	fish	Northern British Columbia	14,760
2000	ON	fish	Windsor	14,240
2000	BC	fish	Northern British Columbia	5,668
2000	ON	fish	Windsor	23,492
2000	QC	pharmaceutical	Montréal	28,000
2000	SK	plants	Saskatchewan	115,900
2000	BC	animal	Victoria	253,499
2000	AB	plants	Alberta	24,000
2000	ON	general	Toronto	57,850
2000	QC	pharmaceutical	Montréal	154,625
2000	BC	wine	British Columbia	38,850
2000	AB	plants	Alberta	37,000
2000	BC	general	Simon Fraser	34,650
2000	ON	plants	Guelph	40,425
2000	BC	plants	Simon Fraser	159,415
2000	PE	pharmaceutical	Prince Edward Island	108,098
2000	ON	plants	Western Ontario	43,575
2000	SK	fish	Saskatchewan	38,325
2000	BC	general	British Columbia	59,400
2000	BC	general	British Columbia	212,750
2000	BC	plants	British Columbia	73,500
2000	QC	general	Sherbrooke	32,000
2000	QC	plants	Institut national de recherche scientifique	28,245
2000	QC	plants	Institut national de recherche scientifique	85,000
2000	QC	plants	McGill	20,790
2000	QC	tree	Montréal	100,000
2000	ON	plants	Guelph	43,890
2000	ON	animal	Laurentian	23,100
2000	NS	algae	Dalhousie	44,900
2000	QC	algae	Laval	136,200
2000	BC	general	Victoria	35,000
2000	ON	plants	Guelph	114,310
2000	ON	plants	Western Ontario	18,000
2000	ON	fish	Ottawa	28,000
2000	QC	plants	McGill	168,800
2000	QC	plants	Montréal	56,000
2000	QC	plants	Montréal	154,000
2000	ON	animal	Ottawa	118,700
2000	ON	plants	Toronto	68,250
2000	ON	plants	Toronto	43,050
2000	ON	plants	Toronto	172,000
2000	NS	general	Dalhousie	23,100
2000	QC	plants	Laval	20,000
2000	ON	tree	Laurentian	17,850
2000	QC	general	Laval	58,905
2000	ON	tree	Lakehead	19,635
2000	ON	general	Guelph	55,600
2000	NS	fish	Dalhousie	112,000
2000	NS	tree	Dalhousie	25,000
2000	NS	tree	Dalhousie	138,750
2000	ON	tree	Carleton	46,900
2000	QC	animal	Montréal	28,000
2000	BC	tree	British Columbia	107,450
2000	ON	animal	McMaster	17,850
2000	QC	plants	Québec à Montréal	116,000
2000	ON	plants	Toronto	34,000
2000	SK	animal	Saskatchewan	27,937
2000	QC	animal	Montréal	30,030
2000	QC	animal	Laval	79,800
2000	QC	animal	Laval	12,800
2000	QC	animal	Montréal	135,900
2000	ON	general	Ottawa	26,145
2000	ON	animal	Guelph	75,000
2000	NF	general	Memorial Univ. of Nfld	25,000
2000	ON	fish	Guelph	31,500
2000	ON	plants	Guelph	26,565
2000	SK	plants	Saskatchewan	17,325
2000	ON	general	Toronto	42,000
2000	QC	animal	Montréal	30,000
2000	SK	pharmaceutical	Saskatchewan	131,877
2000	SK	plants	Saskatchewan	17,000
2000	ON	general	Toronto	138,150
2000	ON	plants	Guelph	82,473
2000	ON	general	McMaster	56,304
2000	AB	tree	Alberta	15,750
2001	BC	tree	British Columbia	44,677
2001	BC	tree	British Columbia	16,000
2001	ON	fish	Ottawa	23,800
2001	AB	animal	Alberta	27,000
2001	ON	plants	Ottawa	26,800
2001	ON	general	Toronto	92,600
2001	SK	pharmaceutical	Saskatchewan	350,000
2001	BC	plants	British Columbia	17,000
2001	MB	plants	Manitoba	30,000
2001	ON	fish	Guelph	128,500
2001	BC	general	British Columbia	85,680
2001	QC	pharmaceutical	Sherbrooke	41,000
2001	BC	animal	Simon Fraser	35,000
2001	QC	general	McGill	28,000
2001	QC	general	McGill	99,400
2001	QC	plants	Laval	56,000
2001	QC	general	Laval	42,735
2001	QC	general	Laval	64,500
2001	QC	fish	Laval	116,000
2001	QC	fish	Laval	132,000
2001	ON	pharmaceutical	Guelph	26,000
2001	QC	fish	Québec à Rimouski	31,800
2001	ON	general	Toronto	64,200
2001	BC	general	Simon Fraser	30,000
2001	ON	general	Toronto	42,000
2001	QC	general	Laval	23,100
2001	QC	plants	Montréal	73,458
2001	QC	plants	Montréal	142,410
2001	QC	plants	McGill	72,200
2001	QC	animal	Montréal	24,800
2001	SK	plants	Regina	17,850
2001	ON	general	Toronto	57,750
2001	ON	general	Toronto	35,002
2001	BC	general	Victoria	57,000
2001	AB	tree	Alberta	20,000
2001	ON	fish	Guelph	109,237
2001	BC	fish	Simon Fraser	24,150
2001	QC	general	McGill	17,330
2001	QC	general	Laval	25,200
2001	ON	fish	Waterloo	26,300
2001	QC	fish	McGill	26,188
2001	ON	general	Western Ontario	20,000
2001	QC	general	McGill	34,000
2001	ON	general	Waterloo	31,000
2001	ON	animal	Ottawa	47,200
2001	SK	pharmaceutical	Saskatchewan	89,000
2001	ON	plants	Guelph	18,900
2001	ON	plants	Guelph	55,280
2001	ON	algae	Toronto	60,600
2001	QC	pharmaceutical	McGill	43,500
2001	ON	fish	Guelph	88,930
2001	ON	plants	Wilfrid Laurier	21,000
2001	SK	plants	Saskatchewan	19,400
2001	ON	animal	Guelph	157,100
2001	SK	plants	Saskatchewan	55,000
2001	ON	general	Laurentian	26,250
2001	BC	tree	British Columbia	15,500
2001	ON	general	Toronto	21,000
2001	AB	plants	Alberta	30,000
2001	ON	plants	Waterloo	40,000
2001	ON	plants	Guelph	40,000
2001	QC	plants	Concordia	32,000
2001	ON	plants	Guelph	25,000
2001	ON	plants	Guelph	87,500
2001	ON	plants	Guelph	32,500
2001	ON	animal	Ottawa	44,100
2001	MB	general	Manitoba	30,000
2001	ON	fish	Windsor	29,000
2001	ON	fish	Windsor	24,080
2001	ON	fish	Windsor	39,400
2001	QC	pharmaceutical	Montréal	28,000
2001	SK	plants	Saskatchewan	115,900
2001	BC	animal	Victoria	253,499
2001	AB	plants	Alberta	24,000
2001	ON	general	Toronto	57,850
2001	QC	pharmaceutical	Montréal	642,750
2001	BC	wine	British Columbia	38,850
2001	BC	wine	British Columbia	23,900
2001	ON	animal	Guelph	20,500
2001	ON	animal	Guelph	94,865
2001	ON	plants	Ottawa	15,000
2001	BC	general	Simon Fraser	28,000
2001	ON	plants	Guelph	40,425
2001	BC	plants	Simon Fraser	167,915
2001	ON	plants	Toronto	69,600
2001	ON	plants	Western Ontario	43,575
2001	SK	fish	Saskatchewan	38,325
2001	BC	general	British Columbia	59,400
2001	BC	general	British Columbia	187,587
2001	BC	plants	British Columbia	105,500
2001	QC	general	Sherbrooke	32,000
2001	QC	plants	Institut national de recherche scientifique	28,245
2001	QC	plants	Institut national de recherche scientifique	85,000
2001	QC	tree	Montréal	100,000
2001	ON	plants	Guelph	43,890
2001	ON	animal	Laurentian	23,100
2001	NS	algae	Dalhousie	44,900
2001	QC	algae	Laval	136,200
2001	ON	animal	Guelph	28,650
2001	ON	plants	Western Ontario	18,000
2001	ON	fish	Ottawa	28,000
2001	BC	tree	Northern British Columbia	30,000
2001	QC	plants	McGill	36,600
2001	QC	plants	McGill	168,800
2001	QC	plants	Montréal	56,000
2001	QC	plants	Montréal	155,000
2001	ON	animal	Ottawa	119,210
2001	ON	plants	Toronto	68,250
2001	ON	plants	Toronto	180,000
2001	QC	plants	Laval	32,000
2001	BC	tree	Victoria	30,000
2001	QC	animal	Montréal	145,525
2001	NS	general	Dalhousie	23,100
2001	SK	general	Saskatchewan	25,000
2001	QC	plants	Laval	20,000
2001	ON	tree	Laurentian	17,850
2001	QC	general	Laval	58,905
2001	ON	tree	Lakehead	19,635
2001	ON	general	Guelph	55,600
2001	NS	fish	Dalhousie	112,000
2001	AB	animal	Lethbridge	30,000
2001	NS	tree	Dalhousie	32,600
2001	NS	tree	Dalhousie	138,250
2001	ON	tree	Carleton	46,900
2001	QC	animal	Montréal	28,000
2001	BC	tree	British Columbia	48,271
2001	ON	animal	McMaster	17,850
2001	BC	plants	British Columbia	32,600
2001	QC	plants	Québec à Montréal	116,000
2001	ON	plants	Toronto	34,000
2001	QC	general	Laval	140,500
2001	QC	animal	Laval	79,800
2001	QC	animal	Laval	32,000
2001	BC	general	Simon Fraser	52,000
2001	ON	general	Ottawa	26,145
2001	ON	animal	Guelph	75,000
2001	NF	general	Memorial Univ. of Nfld	25,000
2001	ON	fish	Guelph	31,500
2001	ON	plants	Guelph	15,000
2001	ON	wine	Guelph	18,000
2001	ON	general	Toronto	42,000
2001	QC	tree	Concordia	76,250
2001	QC	animal	Montréal	30,000
2001	SK	pharmaceutical	Saskatchewan	141,634
2001	ON	general	Carleton	30,000
2001	SK	plants	Saskatchewan	17,000
2001	ON	general	Toronto	30,750
2001	ON	plants	Guelph	147,903
2001	SK	general	Saskatchewan	40,000
2001	AB	tree	Alberta	15,750
2002	BC	tree	British Columbia	37,231
2002	BC	tree	British Columbia	16,000
2002	ON	fish	Ottawa	23,800
2002	AB	animal	Alberta	27,000
2002	ON	plants	Ottawa	26,800
2002	ON	general	Toronto	92,600
2002	SK	pharmaceutical	Saskatchewan	350,000
2002	BC	plants	British Columbia	17,000
2002	MB	plants	Manitoba	30,000
2002	ON	fish	Guelph	87,600
2002	BC	general	British Columbia	85,680
2002	BC	animal	Simon Fraser	35,000
2002	QC	general	McGill	28,000
2002	QC	general	McGill	37,000
2002	QC	plants	Laval	10,000
2002	NS	fish	Dalhousie	35,000
2002	QC	fish	Laval	134,650
2002	QC	animal	Montréal	38,000
2002	ON	animal	Guelph	35,000
2002	ON	general	Brock	42,000
2002	ON	pharmaceutical	Guelph	26,000
2002	QC	fish	Québec à Rimouski	31,800
2002	ON	general	Toronto	64,200
2002	BC	general	Simon Fraser	30,000
2002	ON	general	Toronto	42,000
2002	QC	general	Laval	23,100
2002	QC	plants	Montréal	73,458
2002	QC	plants	McGill	72,200
2002	QC	animal	Montréal	24,800
2002	SK	plants	Regina	17,850
2002	ON	plants	Toronto	63,780
2002	ON	general	Toronto	35,002
2002	BC	general	Victoria	57,000
2002	ON	general	Windsor	33,000
2002	QC	general	Institut national de recherche scientifique	33,200
2002	AB	tree	Alberta	20,000
2002	ON	fish	Guelph	50,000
2002	BC	fish	Simon Fraser	24,150
2002	QC	general	Laval	25,200
2002	ON	general	Toronto	118,000
2002	ON	fish	Waterloo	18,800
2002	BC	general	British Columbia	73,347
2002	QC	fish	McGill	26,188
2002	QC	general	McGill	34,000
2002	ON	general	Waterloo	31,000
2002	ON	animal	Ottawa	47,200
2002	ON	animal	Ottawa	168,500
2002	SK	pharmaceutical	Saskatchewan	89,000
2002	ON	plants	Guelph	18,900
2002	ON	algae	Toronto	60,600
2002	AB	plants	Calgary	190,000
2002	QC	pharmaceutical	McGill	43,500
2002	ON	fish	Guelph	177,860
2002	ON	plants	Wilfrid Laurier	21,000
2002	SK	plants	Saskatchewan	19,400
2002	SK	plants	Saskatchewan	55,000
2002	ON	general	Laurentian	26,250
2002	ON	animal	Guelph	90,338
2002	ON	general	Toronto	21,000
2002	ON	plants	Waterloo	40,000
2002	ON	plants	Guelph	40,000
2002	QC	plants	Concordia	32,000
2002	ON	plants	Guelph	25,000
2002	ON	plants	Guelph	87,500
2002	ON	animal	Ottawa	44,100
2002	MB	general	Manitoba	30,000
2002	ON	fish	Windsor	29,000
2002	QC	pharmaceutical	Montréal	28,000
2002	ON	general	Toronto	57,850
2002	QC	plants	Québec à Montréal	34,016
2002	ON	general	York	38,000
2002	QC	pharmaceutical	Montréal	708,875
2002	ON	animal	Guelph	20,500
2002	BC	wine	British Columbia	38,850
2002	BC	wine	British Columbia	16,435
2002	ON	plants	Ottawa	15,000
2002	BC	general	Simon Fraser	28,000
2002	BC	plants	Simon Fraser	190,915
2002	QC	tree	Laval	20,000
2002	QC	tree	Laval	9,600
2002	QC	tree	Laval	105,000
2002	ON	animal	Western Ontario	65,000
2002	ON	plants	Toronto	69,600
2002	AB	plants	Lethbridge	48,898
2002	AB	plants	Lethbridge	35,079
2002	ON	plants	Western Ontario	43,575
2002	ON	plants	Western Ontario	141,860
2002	SK	fish	Saskatchewan	38,325
2002	BC	general	British Columbia	59,400
2002	BC	plants	British Columbia	107,000
2002	QC	general	Sherbrooke	32,000
2002	QC	plants	Institut national de recherche scientifique	28,245
2002	QC	plants	Institut national de recherche scientifique	85,000
2002	QC	tree	Montréal	50,000
2002	ON	plants	Guelph	43,890
2002	NS	algae	Dalhousie	44,900
2002	QC	algae	Laval	136,200
2002	ON	animal	Guelph	30,000
2002	ON	animal	Guelph	28,650
2002	ON	animal	Guelph	45,560
2002	ON	plants	Western Ontario	18,000
2002	QC	tree	Laval	47,835
2002	BC	tree	British Columbia	146,775
2002	BC	general	British Columbia	42,280
2002	ON	fish	Ottawa	28,000
2002	BC	tree	Northern British Columbia	30,000
2002	QC	plants	McGill	36,600
2002	QC	plants	McGill	114,300
2002	QC	plants	Montréal	56,000
2002	ON	plants	Toronto	68,250
2002	QC	plants	Laval	32,000
2002	BC	tree	Victoria	30,000
2002	QC	animal	Montréal	133,525
2002	SK	general	Saskatchewan	25,000
2002	QC	plants	Laval	20,000
2002	ON	tree	Laurentian	17,850
2002	QC	general	Laval	58,905
2002	ON	tree	Lakehead	18,000
2002	QC	general	Sherbrooke	66,400
2002	ON	general	Guelph	55,600
2002	AB	animal	Lethbridge	30,000
2002	ON	plants	Guelph	44,646
2002	NS	tree	Dalhousie	32,600
2002	NS	tree	Dalhousie	135,750
2002	ON	tree	Carleton	46,900
2002	QC	animal	Montréal	19,000
2002	BC	tree	British Columbia	40,226
2002	ON	animal	McMaster	17,850
2002	BC	plants	British Columbia	32,600
2002	ON	plants	Toronto	34,000
2002	AB	general	Calgary	25,000
2002	QC	general	Laval	142,500
2002	QC	animal	Laval	79,800
2002	QC	animal	Laval	32,000
2002	BC	general	Simon Fraser	52,000
2002	ON	general	Ottawa	26,145
2002	NF	general	Memorial Univ. of Nfld	25,000
2002	ON	fish	Guelph	31,500
2002	ON	plants	Guelph	15,000
2002	ON	plants	Guelph	15,000
2002	ON	wine	Guelph	18,000
2002	QC	plants	Institut national de recherche scientifique	217,370
2002	ON	plants	Western Ontario	25,000
2002	SK	plants	Saskatchewan	17,325
2002	ON	plants	Guelph	44,000
2002	ON	general	Toronto	42,000
2002	QC	tree	Concordia	255,250
2002	ON	animal	Ottawa	27,000
2002	QC	plants	Laval	131,703
2002	QC	animal	Montréal	30,000
2002	SK	pharmaceutical	Saskatchewan	140,634
2002	ON	general	Carleton	30,000
2002	ON	plants	Guelph	37,205
2002	ON	plants	Guelph	65,430
2002	SK	general	Saskatchewan	40,000
2002	AB	tree	Alberta	15,750
2002	BC	plants	British Columbia	43,583

Annex II:
Terms and conditions for the 14 trials of novel canola intended for plant molecular farming (1998-1999).

1.	The applicant must ensure that seed is transported in clearly identified, secure containers and is kept separate from other canola seed.
2.	To prevent dissemination of any transgenic seed, seeding and harvesting equipment must be thoroughly cleaned on site before removal to another location, and residue removed from equipment cleaning must be destroyed by heating or burning.
3.	Plants in the trial taking place in Saskatchewan must be securely covered with bee nets to prevent movement of pollinating insects into or out of the trial site.
4.	The trial taking place in British Columbia must be surrounded by a fence sufficient to prevent animals from entering the site.
5.	The trial in British Columbia must be isolated from commercial crops of Brassica species by a minimum of 10 km.
6.	The trials in Quebec must be reproductively isolated from Brassica species by a minimum 200-m isolation distance. Brassica species include: Brassica rapa (oilseed rape, Polish canola, turnip, bird rape), Brassica juncea (brown mustard, Indian mustard), Brassica carinata (Ethiopian mustard), Brassica nigra (black mustard), Sinapis alba (white mustard), Brassica oleracea (cabbage, cauliflower, Brussels sprouts, broccoli, Chinese cabbage, kale, kohlrabi). Should the guard rows fail to flower concurrently with the modified plants or be interrupted by gaps, a 200-m isolation distance from Brassica species will be required. In the case of protein products material, plants must be grown in cages that are erected before the plants flower.
7.	The following related weed species must be removed before seed set when found on the sites and, in the case of guard row failure, within 50 m of the site (including ditches, shelter belts, and neighbouring land): Diplotaxis muralis (sand rocket, stinking wall rocket), Raphanus raphanistrum (wild radish), Erucastrum gallicum (dog mustard). These related weeds must also be removed from the sites before flowering when found during the three years following harvest.
8.	In the case of accidental release, recoverable seeds must be collected and destroyed; the site must be marked and monitored; and the Canadian Food Inspection Agency (CFIA) must be promptly notified. Plants from unrecoverable seed must be controlled by spraying with a broad- spectrum herbicide.
9.	Plants must be harvested before full maturity to minimize silique shattering and seed dispersal. Plant matter remaining at the end of the trials must be soil incorporated.
10.	The trial boundaries will be marked for clear identification of the sites during the trials and the post-harvest land use restriction.
11.	Harvested seed must be securely transported and stored. It may be retained for future field testing provided that authorization is obtained from the CFIA.
12.	No plant material from these trials may enter the human or animal food chains unless approved by Health Canada or the Feed Section, CFIA.
13.	During the 1998 growing season the test plots must be monitored weekly to ensure compliance with these terms and conditions. The sites must be monitored monthly during the growing seasons of 2000, 2001, and 2002 to ensure that any volunteer plants and related species are removed before they flower.
14.	The test plots must not be seeded to Brassica species for three years after harvest of the trial.
15.	Measures will be taken to ensure that no dormant seed remains in the soil after the three-year post-harvest land use restriction period.
16.	A detailed seed and plant log must be kept. CFIA inspectors will have access to all trial records. A report summarizing the completed trial, including any amendments to the original protocol, will be made available to the Plant Health and Production Division, CFIA, upon request.

Biotechnology and "Pharming Crops"

Petition

Minister's Response: Canada Customs and Revenue Agency [1996-2003]

Minister's Response: Canadian International Development Agency

Minister's Response: Health Canada

Joint Response: Agriculture and Agri-Food Canada, Environment Canada, Finance Canada—Department of, Foreign Affairs and International Trade—Department of [1996-2003], Industry Canada

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