AGRI Committee Report

GOVERNMENT RESPONSE TO THE REPORT OF THE STANDING COMMITTEE ON AGRICULTURE AND AGRI-FOOD ENTITLED: GENETICALLY MODIFIED ANIMALS FOR HUMAN CONSUMPTION

The Government of Canada is pleased to respond to the Report of the Standing Committee on Agriculture and Agri-Food (the Committee) entitled: Genetically Modified Animals for Human Consumption (the Report).

The Government commends the members of the Committee, and the witnesses who appeared before it, for their insight and commitment toward beginning to understand the challenges and opportunities that the approval of genetically-modified (GM) animals for human consumption presents for Canada. The Government supports the positive approach and the constructive thoughts and ideas put forth by the Committee. The Government of Canada agrees with the Committee’s commitment to ensure an effective, predictable and transparent science-based regulatory system when considering the approval of GM animals for human consumption.

GM animals for human consumption is a new and emerging issue which, according to witnesses appearing before the Committee,  potentially involves ethical and environmental concerns. The Government recognizes that this issue requires a particular focus. The Government will continue to work with Canadians to assess the progress of this, and future emerging technologies, to ensure the regulatory system keeps pace with the evolving technological landscape and international approaches.

As the issue of GM animals for human consumption is new and emerging, the Government endeavours to meet the recommendations of the Committee by providing greater transparency in the regulatory system, support for research, and information to consumers. The Government will continue to engage Canadians on these new and emerging issues.

The Government of Canada remains committed to having a rigorous, science-based regulatory system in place to assess GM animals, prior to authorizing their use in Canada. Health Canada assesses the safety of GM products for use as food whereas the Canadian Food Inspection Agency (CFIA) assesses the safety of these products for use as livestock feed. While the CFIA conducts environmental safety assessments of GM plants, the environmental safety of GM animals are assessed by Environment and Climate Change Canada (ECCC) and Health Canada. For aquatic animals, Fisheries and Oceans Canada collaborates in the regulatory decision-making process by providing risk assessment science advice to ECCC and Health Canada, who, in turn, are responsible for making the final decision. 

ECCC and Health Canada regulate certain organisms under the Canadian Environmental Protection Act (CEPA) under its New Substances Notification Regulations (NSNR). The information from notifications under the NSNR, in addition to other available information, is used by ECCC and Health Canada to assess living organisms to ensure that human health, the environment and biological diversity are protected. 

The Government of Canada is working with experts and stakeholders to adequately address the full range of issues and challenges, and to maximize the potential opportunities, that GM animals approved for human consumption present for Canada, as well as determining what steps should be taken to best inform the public about novel products of biotechnology planned for introduction to the market. As new technologies and applications emerge, the Government will continue to explore how potential ethical concerns may be considered in the process for market entry of GM animals for human consumption. The Government will continue to ensure that all potential health, safety and environmental considerations are addressed related to GM animals. Details are provided below regarding the Government’s response to the specific recommendations of the Committee in this regard.

RECOMMENDATION 1

The Committee recommends that the government provide greater transparency in the regulatory system that evaluates genetically modified animals intended for human consumption.

The Government supports this recommendation. The Government agrees with the Committee on the need for transparency within the regulatory system that evaluates GM animals intended for human consumption and is continually exploring changes that can be made to maximize transparency and openness of the regulatory system, while, at the same time, respecting the protection of confidential information supplied by a third party, as per the provisions of the Access to Information Act.

The Government is committed to providing Canadians with useful and timely information on the process to assess the safety of GM animals for human consumption. The Government is also committed to providing information to the public on the outcomes of the rigorous assessments it conducts regarding data submitted by petitioners for applications of GM animals for consumption. To this end, relevant departments and agencies (i.e., Health Canada, the CFIA, ECCC, and Fisheries and Oceans Canada) publish plain language risk assessment summaries, scientific advice and resulting decisions (decision documents) on their respective websites. These documents summarize the thorough scientific assessments that underpin decisions to authorize GM animal products in Canada, as well as other GM products. For example, since 1994, the Government has published decision documents for more than 100 novel organisms (including GM organisms), approved for use as food, feed and/or for environmental release.

In 2004, the CFIA implemented a Notice of Submission process to give the public an opportunity to provide input on scientific matters relevant to the safety assessment of each submission, as well as to increase the transparency of, and confidence in, the regulatory process, and to achieve greater openness regarding product information.

When a petitioner requests a safety assessment from Health Canada and the CFIA for a GM plant’s use as a novel food, novel feed and/or unconfined environmental release, the petitioner may voluntarily provide information to the public through the Notice of Submission process. This public notice includes a brief description of the product and summarizes the type of data that has been submitted for assessment. Notices of Submission are posted on the CFIA website for 60 days to allow public comment. Scientific questions or information provided during the comment period are forwarded to CFIA and Health Canada evaluators for consideration in the assessment.

Non-scientific input is evaluated and appropriate ways of addressing it explored. Subject to obtaining consent from the submitter, the CFIA forwards comments to developers whose products are being assessed and may post them on the CFIA and Health Canada websites. Personal information is not shared with developers or posted on the CFIA or Health Canada websites. These measures are part of Government’s efforts to foster greater openness and accountability in the decision-making process while respecting legal obligations to protect privacy, as well as the petitioner’s confidential business information. While these measures are not specific to GM animals, there may be openness (particularly in light of the first GM animal approved for human consumption in 2016) to looking at how existing transparency measures, such as the Notice of Submission process employed for the assessment of GM plants, could be applied and potentially expanded in the case of GM animal products. 

Complementary to the assessments relating to food and feed safety, the New Substances program of ECCC and Health Canada conducts assessments of new living organisms, including GM organisms, under the authority of CEPA. These assessments are conducted prior to their manufacture or import into Canada, to determine whether there is a potential for adverse effects of the organism on the environment and/or human health. The human health aspect of these assessments is related to human health effects from environmental exposures (i.e., “indirect” exposure) to the GM organism, as opposed to the assessments of products or effects of consumption as conducted by the CFIA and Health Canada.

The New Substances program has published, to date, risk assessment decision documents for 26 new organisms including the first GM animal approved for sale and consumption in Canada (salmon). These decisions summarize selected risk assessment conclusions that were made prior to the manufacture or import of the new living organism in Canada, while appropriately protecting confidential business information.

The Government will continue to explore ways to enhance transparency with respect to the approval of GM animals for consumption in Canada. The Government will also provide Canadians with more information about the regulatory framework and approved products.

RECOMMENDATION 2

The Committee recommends that the government provide support for independent research into the health, environmental and other effects of new genetic modification technologies (including those to produce genetically modified animals).

The Government supports this recommendation as it continues to provide support for independent research on GM technologies, which can include research into their health, environmental and other effects.

Independent research in Canada, defined as a scientific program or project designed and led by qualified individuals who are autonomous regarding their research activities and are free from conflict of interest, is carried out predominately by academia and government scientists. The Government of Canada currently supports independent research related to GM technologies through the contributions of federal granting councils, such as the Natural Sciences and Engineering Research Council of Canada, and the Social Sciences and Humanities Research Council, and the activities of research scientists employed by the federal science-based departments and agencies. This can include independent research contracts and partnerships with academia, as well as collaboration with the international research community.

The Government may seek information through independent research contracts to address gaps in knowledge, or additional research needs, in support of risk assessments for the approval of GM products, such as GM animals for consumption. CFIA scientists contract research, or convene expert groups with members of the scientific community, to gain further advice and insights about specific products when necessary. The CFIA compiles an annual research “needs” list that identifies specific topics/areas where research is required to help inform evidence-based risk management and science-based decision making in support of its mandate. The CFIA welcomes the participation of scientists from the CFIA, other government departments and Canadian universities in undertaking research to meet these needs.

Fisheries and Oceans Canada’s Centre for Aquatic Biotechnology Regulatory Research (CABRR) conducts research on GM technologies in partnership with academic and other government groups, and research results are published in peer-reviewed literature. This research supports risk assessment and regulation of fish with novel traits, including GM / engineered fish. Research at CABRR currently focuses on the potential effects of growth-enhanced transgenic salmon on the environment; however, future research at CABRR includes research on new genetic modification techniques, such as gene editing.

The Government remains committed to supporting independent research of this nature as part of its ongoing commitment to good governance and stewardship for the protection of Canadians and the environment, which includes international ecosystems. 

A GM product is only permitted to be manufactured, imported or sold in Canada when all the evaluating scientists reach a consensus that there are no safety concerns. Canadian federal regulatory departments and agencies have a statutory responsibility to carry out risk-based safety assessments.

Government of Canada scientists base their safety assessments of GM products mainly on data generated by product developers through research trials; however, all available evidence is taken into consideration prior to making a final decision about the acceptability of a specific GM product. Accordingly, information provided by the developer is supplemented with published data from the scientific literature that is relevant to the product in question.

Government regulatory scientists undertake a thorough review of the data, protocols and methodology provided by the proponent before approving a product for use in Canada. To this end, there are product-specific regulations and guidelines that provide guidance to product developers on what data must be submitted. Additional information or testing will be requested from the petitioner in the event that any of the data provided is scientifically unsound, incomplete or inadequate.

RECOMMENDATION 3

The Committee recommends that the government support the mandatory labelling system only for issues of food health and safety.

The Government supports the recommendation to require mandatory labelling of GM foods when health and safety concerns have been established.

This is consistent with the Government of Canada’s current policy to require labelling of any foods, including GM foods, under the authority of the Food and Drugs Act, where Health Canada has determined that there is a health and safety concern that can be mitigated through labelling (e.g., contains food allergens), or where there has been a significant nutritional or compositional change as a result of genetic modification.

Health Canada and the CFIA share the federal responsibility for food labelling policies under the Food and Drugs Act. In accordance with its mandate, Health Canada is responsible for food labelling policies with respect to health and safety (e.g., food allergens, food colours, sulphites, gluten). The CFIA administers all non-safety related food labelling under its consumer protection mandate, including regulating labels to ensure they are truthful and not misleading. Additionally, the CFIA is responsible for enforcement of all labelling requirements.

Voluntary labelling of foods containing or not containing products of genetic engineering (one form of genetic modification) is permitted under current federal policy, provided the label is truthful and not misleading. This approach is consistent with labelling for method of production claims on foods in Canada (e.g., “raised without antibiotics”, “natural”), which are voluntary and market-driven; this approach is supported by international standards.

To provide specific guidance on voluntary labelling to Canadian manufacturers, and to address consumer demand for the labelling of GM foods in Canada, the federal government developed the Voluntary Labelling and Advertising of Foods that are and are not Products of Genetic Engineering standard by working with the Canadian General Standards Board and in consultation with food associations, consumer groups, food companies, producers, environmental groups, and others. The voluntary labelling standard was adopted by the Standards Council of Canada in April 2004 and its technical content was re-affirmed in April 2016 (http://www.tpsgc-pwgsc.gc.ca/ongc-cgsb/programme-program/normes-standards/internet/032-0315/index-eng.html).

Voluntary labelling is currently the primary means of communication between industry and consumers for non-health and safety related information. Industry has the responsibility to respond to consumers’ information needs, and have the means to do so without further government intervention through voluntary labelling claims. Companies can label GM foods using the national voluntary labelling standard designed to ensure label information is clear and not misleading.

The Government’s approach to labelling GM foods is consistent with international trade obligations, and is supported by the Codex Alimentarius, the international food standards body. At its July 2011 meeting, the Codex Alimentarius Commission adopted a compilation of existing Codex texts that provide guidance for the labelling of foods, including those derived from modern biotechnology. Canada’s approach is consistent with this guidance.

All approved GM foods in Canada have been reviewed by relevant departments and agencies under a rigorous and internationally respected scientific regulatory process, and deemed to pose no greater risk to consumers, animals and the environment than conventional foods. Labelling of GM foods could perpetuate the perception of risk regarding the safety of this technology and foods derived from it.

RECOMMENDATION 4

The Committee recommends that the government work with industry to establish tools to provide traceability for genetically modified animals.

The Government acknowledges this recommendation as it recognizes the importance of collaboration with industry to support and maintain transparency, innovation and competitiveness in the production and marketing of livestock, poultry, fish and seafood and their derived products. Traceability mechanisms create an ability to follow product through the supply chain, including at different stages of life, increase the response capacity of industry (and in some cases government) to address health and safety issues that may arise, and enable greater product differentiation for market purposes, as well as biologically secure transportation and handling (if required).

The Government of Canada currently has several existing tools, either in place or pending, for animal traceability to enable industry to meet domestic and export market requirements and assure Canada’s high quality food supply.

The Government of Canada provides traceability for animals through the following tools:

1.    Animal registration: Traceability of animals for breeding purposes, which includes processes for registration, certification and transfer, is enabled under the

Animal Pedigree Act (the Act) administered by Agriculture and Agri-Food Canada. The Canadian Livestock Records Corporation, along with 57 active breed associations representing breeds of 11 different species, currently operate under the Act. Registration allows for detailed traceability of all genetic transmissions, whether via use of live animals, embryos or semen. Detailed ownership, genetic makeup of animals and traceability of movements of genetic material including imports and exports, are managed through Canada’s animal pedigree database registries (www.agr.gc.ca/APA).

2.    Livestock identification and traceability: Identification and movement reporting requirements for cattle, bison, sheep, pigs and farmed wild boars apply under the Health of Animals Regulations. The ability to rapidly trace an animal throughout its life cycle is essential to isolating animal health emergencies and can help limit the economic, trade, environmental and social impacts of such emergencies. Implementation of identification and traceability systems are being enabled by several organisations, including the Canadian Cattle Identification Agency and Agri-Traçabilité Québec. The CFIA provides information on livestock identification and traceability in Canada on its website (http://www.inspection.gc.ca/animals/terrestrial/animals/traceability/eng/1300461751002/1300461804752).

3.    Safe Food for Canadians Regulations (pending): The proposed Safe Food for Canadians Regulations would consolidate numerous federal food inspection regulations in Canada into one overarching system. This would enable the CFIA to apply more consistent regulatory requirements and inspection approaches across all regulated food commodities. Traceability mechanisms will be in place, to trace a food one step forward and one step back so that unsafe food can be removed quickly from the market. As the consolidated federal regulatory framework is implemented, it will ensure that operators of food processing facilities are required to keep a record of their sources.

The regulatory provisions supporting these tools do not currently contain separate requirements for GM animals. However, the Safe Food for Canadians Act, in particular, has authorities that may enable the further development of tools to meet the product differentiation requirements desired by certain markets.

In addition to the above traceability mechanisms, the livestock and food industries have been able to leverage the legislated measures currently in place to develop additional traceability solutions. These traceability solutions, developed by the private sector, and in some cases global organisations, could be used to accommodate GM animals.

With respect to the fish and seafood sector, traceability is also an existing and growing requirement to access certain global markets. The objectives of such traceability requirements include ensuring conservation of fish stocks, sustainability of harvests, prevention of illegal, unreported, and unregulated fishing, and addressing seafood fraud. The Government of Canada actively engages with jurisdictions where special market requirements may exist, to ensure that measures are no more burdensome or trade restrictive on Canada’s industry than necessary to achieve their objectives.

The Government will consider future traceability needs relating to GM animals, in collaboration with Canadian stakeholders, to address market requirements. The Government of Canada is committed to working in partnership with the scientific community and Canadian industry to ensure Canada is at the forefront of leading science-based standards for addressing any existing and future needs for traceability requirements.

The Government will continue to ensure that all potential health, safety and environmental considerations are addressed related to GM animals, including any traceability considerations.