Does CEPA Adequately Protect Canadians and Communities from the Threats Posed by Emerging Biotechnologies and GMOs? Will Bill C-28 Address the Need for Changes?

Summary: In this article, David McRobert and Angela Dittrich examine whether Part 6 of the Canadian Environmental Protection Act (CEPA) adequately regulates the animate products of biotechnology.[1] Canadian environmental groups have advocated reforms to Part 6 since the early 2000s. Part 6 of CEPA has been neglected by government officials and ENGOs relative to other sections of CEPA, but biotechnology poses some of the most unpredictable, long-term risks to the environment, vulnerable populations and community health. The process for considering new genetically modified (GM) organisms needs to be more transparent, and the approvals timeline should be lengthened allowing for substantial public involvement, a full assessment of risks, and seeking the necessary consent of Indigenous peoples while upholding Indigenous rights.

Parts of this analysis were undertaken prior to the tabling of Bill C-28, Strengthening Environmental Protection for a Healthier Canada Act on April 13, 2021 (First Reading). Links to Bill C-28 and background materials are provided in the endnotes.[2] In concluding sections of this article the authors briefly examine the extent to which Bill C-28, as proposed, could address some of the challenges set out in the analysis below.

By David McRobert[3] and Angela Dittrich[4]

Introduction

Part 6 of CEPA regulates the animate products (i.e. from animals and animal byproducts) of biotechnology. Over the last two decades, there have been significant advances in both genetic engineering (e.g., CRISPR) and knowledge surrounding the environmental impacts of the new genetically modified (GM) organisms. Thus, significant amendments are needed to bring CEPA up to date with current scientific knowledge and best practices, followed by frequent reviews in the future. These were highlighted in a webinar sponsored by the Canadian Environmental Law Association in early 2021[5] as part of a four-part series held in the autumn and winter of 2020-2021.

There are several genetically modified foods and grains currently on the Canadian market, including corn, soy, canola, sugar beet, alfalfa, papaya, squash, and apples.[6] Unlike GM crops and plants, Health Canada and Environment and Climate Change Canada (ECCC) regulate animals and animal products using provisions in CEPA.[7] In 2013, Health Canada and ECCC approved the first GM animal product, AquaBounty’s AquAdvantage Atlantic salmon, and these GM salmon has been sold in Canadian markets since 2017.[8] The Ecology Action Centre, based in Halifax, challenged this approval in Federal Court, and though the applicants were unsuccessful, several limitations and issues with Parts 5 and 6 of CEPA were revealed during the litigation process, particularly the lack of public consultation and the waivers of information requirements.[9]

Prior to AquaBounty’s Atlantic salmon, a genetically modified pig (Enviropig) was slated to become the first GM food animal on the market, but the University of Guelph ended its Enviropig research in 2012.[10] A memorandum of understanding between Health Canada, the Department of Fisheries and Oceans (DFO), and Environment and Climate Change Canada (ECCC) outlines the implementation of the New Substances Notification Regulations (Organisms) under CEPA whereby DFO will conduct risk assessments of the use of biotechnology in fish aquaculture and provide advice to Health Canada and ECCC.[11] This MOU outlines a process that seems to be more transparent and collaborative than what would have been in place for Enviropig, but several concerns regarding GM salmon and future GM animals remain.

Deficiencies in Public Notice and Consultation related to approvals GM organisms

CEPA currently has no requirements for public notification, consultation, or a comment period on GM organisms, and there is no consultation process to obtain the free, prior, and informed consent of Indigenous peoples as proposed by the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP). One reason commonly cited for this lack of public participation is the 120-day turnaround time for these applications, which places a false sense of urgency on projects which benefit producers and can pose great environmental risks. The seriousness of these impacts should be reflected in CEPA through lengthened application periods and adequate public consultation. These application processes also heavily protect confidential business information, which could hinder the ability of individuals or organizations to provide informed comments and recommendations, or to detect problems in the real world following development, deployment or release (intentional or accidental) of the GMO.

Another serious deficiency that undermines the protections within CEPA is the lack of transparency and rushed timelines in the waiver process. Under CEPA subsections 81(8) and 106(8), companies can request waivers of information requirements if Environment and Climate Change Canada determines that certain requirements have been met.[12] AquaBounty was granted a waiver for “data from a test conducted to determine its pathogenicity, toxicity, or invasiveness” as the government stated, “the person requesting the waiver is able to contain the living organism so as to satisfactorily protect the environment and human health.”[13] This waiver was not published in the Canada Gazette in a timely or intelligible manner, making this information inaccessible to the public.

Lucy Sharrat of the Canadian Biotechnology Action Network (CBAN) argues that information on new GM applications should be shared with the public in a timely, complete, transparent, and accessible manner. Moreover, she contends the requirements for approving a waiver should be more stringent and that proponents and the federal government should provide all the information needed for a complete assessment of the potential impacts of proposed waivers by the public and stakeholders. We support this argument, noting it will serve to reinforce a precautionary approach in the face of increasingly challenging regulatory trends faced by Health Canada and ECCC such as extreme weather events (e.g. warming of coastal waters that may facilitate parasite growth on farmed fish and marine products) linked to ongoing global climate change.

Similar issues seen in the waiver process are also found in the publication of significant new activity notices (SNAc). SNAcs are required if a substance or organism previously approved under CEPA is to be used in a different way than was specified under the initial approval, but this process does not have requirements for public consultation. Similar to the waivers process, SNAcs should automatically trigger a new round of public notification and consultation periods in a timely manner. Clear rules also need to be present within CEPA regarding the circumstances under which approval of a new substance or organism is transferrable (e.g., if the AquAdvantage salmon approval could be transferred to another company without a SNAc).

A 2019 CBAN report notes that in Canada, GM crops such as canola, flax, and wheat have contaminated the natural environment. There have also been two separate contamination incidents of GM pigs in Canada entering the food system.[14] AquaBounty was able to obtain a waiver from ECCC and Health Canada for various data requirements due to their proposed containment plan, but this does not eliminate the potential for human error and escape from containment as seen with other approved GM crops and animals. It is likely that new GM animals will be proposed for assessment in the future due to new and improved genome editing techniques. These techniques are said to lower risk, but as explained in a 2020 CBAN report, even new genetic engineering techniques can be imprecise, resulting in unintended and unpredictable on- or off-target impacts.[15] These techniques have also made “gene drives” possible, which aim to alter an entire population’s genetic composition, or eradicate a species altogether. The US Department of Agriculture is considering an application to plant GM American chestnut trees in the wild, which could spread to Canadian forests. The spread of this species will be virtually impossible to track, and the impacts on forest ecosystems will not be known until decades following this approval.[16]

Indigenous Community concerns about GM Salmon

GM organisms also pose several concerns in relation to Indigenous rights. These GM applications are an anthropogenic push to intervene in processes that occur over the long term in natural world, and to create abrupt, immediate genetic changes without understanding the potential impacts or obtaining consent. Many Indigenous nations have had relationships with salmon and other species for thousands of years. Indigenous peoples also have inherent Treaty rights to hunt and fish protected under section 35 of the Constitution Act, 1867. Charlie Greg Sark, an Indigenous webinar presenter from the University of Prince Edward Island suggested that AquaBounty is applying settler colonial legal principles by claiming they “own” the salmon and other animals and plants they’ve genetically modified. The risk of contamination or escape of GM animals poses several critical questions. What happens if a GM fish that escaped into the wild is caught by an Indigenous fisherman? Does this genetic pollution infringe upon Indigenous rights? Can a settler company (e.g. AquaBounty) alter the genetic identity of animals without the consideration of Indigenous and animal rights? Should companies have the ability to patent and own the genetic makeup of a living organism? As explained by Charlie Greg Sark, these are not just legal questions, but raise important ethical and legal questions regarding the honour of the Crown and the ethics of private businesses.

Food security is also an indirect but vital concern, especially for indigenous communities and low-income populations. Commercial salmon is typically consumed by Canadians living in food-secure and higher socioeconomic status areas. Rather than using GM faster-growing fish to address caloric inequities in society, farmed salmon are fed large quantities of smaller, wild, edible fish and the salmon is subsequently often shipped to urban and suburban centres for consumption, which Sark and other food experts argue already are over-nourished. The concepts of need, environmental justice, and Indigenous rights should be guiding principles when making approval decisions for new substances or biotechnology. It is clear that Part 6 of CEPA must be modernized to address scientific advances. The current exposure- and risk-based notion of harm is often incomplete due to granted waivers and a lack of scientific or public perspectives, and the 120-day timeline benefits corporate interests over the protection of human health and the environment. CEPA amendments must address these concerns to ensure this approvals process is transparent, just, and takes all steps needed to minimize risks to environmental and human health.

How does Bill C-28[17] propose to address the concerns described in this article?

On April 13, 2021 the federal government tabled Bill C-28, Strengthening Environmental Protection for a Healthier Canada Act for First Reading. Bill C-28, if enacted, will establish new provisions to regulate new substances and Significant New Activities (SNAc) and has the potential to address many of the concerns raised above. Among the issues addressed are the following:

Varying Significant New Activity (SNAc) Information: Under proposed new sections[18] the Minister will be able to vary elements of a SNAc or order beyond the significant new activity itself, such as the data or information that needs to be submitted for evaluation prior to undertaking the activity, as well as the timelines for submitting that information.

Downstream Communication of Significant New Activities (SNAc): Under various clauses of Bill C-28,[19] the transferor of a new substance must notify transferees of any obligation to comply with the significant new activity provisions in respect of the new substance. This obligation will be extended so that it also applies vis-à-vis any obligation to comply with the significant new activity provisions in respect of existing substances. Moreover, the Minister will be able to tailor the scope of that obligation by specifying, in the SNAc notice or order itself, the class of persons who are not required to be so notified. As noted in the federal government’s summary of Bill C-28,[20] the proposed amendments are intended to empower the Minister to specify that persons downstream of product formulators, such as retailers of finished products, do not need to be notified of the obligation to comply with the SNAc.

Changes to the regulation of environmental and health impacts of drugs

According to federal government’s summary of Bill C-28,[21] amendments to the Food and Drugs Act (FDA) will enable the creation of an environmental risk assessment and risk management regime for drugs under the Food and Drug Regulations (currently limited to health risk).[22] This reform is intended to enable the Government of Canada to move towards creating an environmental notification, risk assessment and risk management framework for drugs under the FDA that the Minister of Health could recommend to the Governor in Council for addition to CEPA’s Schedules 2 and 4 (e.g. a regime that provides CEPA-equivalent pre-market notification and assessment for certain new substances). If the environmental notification, risk assessment and risk management framework for drugs under the FDA is found to meet the requirements necessary to be added to Schedules 2 and 4, this regime would be treated in the same manner as the Pest Control Products Act, the Fertilizers Act and the other scheduled federal statutes and regulations—that is, new substances that are manufactured or imported for use in drugs would no longer be subject to notice and comment or assessed under CEPA, as this would happen entirely under the FDA. The federal government argues that this regime would strengthen the environmental risk assessment and risk management of drugs, and remove the duplicate notification process between the FDA and CEPA (for safety, efficacy and quality and environmental assessments), creating a more streamlined regulatory approach for industry with respect to the assessment and approval of drugs in Canada.

Conclusion

Canadian environmental groups, Indigenous communities and public health experts have advocated reforms to Part 6 of CEPA since the early 2000s. As argued in this paper biotechnology and GMOs pose some of the most unpredictable, long-term risks to the health of Canadians and resilience of communities, particularly Indigenous communities. We support arguments that the process for considering and approving new GM organisms in Canada needs to be more transparent, and the approvals timeline should be lengthened allowing for substantial public involvement, a full assessment of risks, and seeking the necessary consent of Indigenous peoples while upholding Indigenous rights.

Bill C-28, if enacted, will establish new provisions to regulate new substances and Significant New Activities (SNAc) and has the potential to address many of the concerns raised above. Under various clauses the Minister will be able to vary elements of a significant activity notice or order beyond the significant new activity itself, such as the data or information that needs to be submitted for evaluation prior to undertaking the activity, as well as the timelines for submitting that information. In sum, the proposed amendments are positive developments and should promote greater accountability and transparency in decision-making on approvals for new biotechnologies and drugs under CEPA and the FDA.

Endnotes

Any article or other information or content expressed or made available in this Section is that of the respective author(s) and not of the OBA.