Genetic engineering

Introduction

Why do current approaches to GE not contribute to sustainability?

Jurisdiction and regulatory authority

What is the regulatory approach and what are it's fundamental assumptions ?

What is approved and in the pipeline?

Intro to Solutions

Efficiency

Substitution

Redesign

Financing the Transition

Introduction

Genetic engineering has been a controversial technology since first evolving in  the 1980s and has generated significant opposition, some of which has successfully blocked specific applications (see Case Studies in Food Policy Advocacy). The position taken here is that the current approaches to GE impede the transition to a sustainable, health - promoting and equitable food system, but  could contribute if the science and regulation of GE were significantly altered.  The fundamental problem is that GE is not developed or regulated within the frameworks of agroecology, social determinants of health and food justice. The current applications are essentially the quintessential extension of the reductionist / positivist tradition of European science (see Goal 3, Public Research).  Because of this, the current dominant approaches to GE have no way to advance transition. The transition stages set out here show how they could contribute, but it means fundamental changes to the kind of research questions scientists ask, the products they develop and  how the regulatory system is structured.  The strategies proposed here shift the focus of GE opponents, away from case by case advocacy to institutions, processes and structures.

Why do current approaches to GE not contribute to sustainability?

There are 5 fundamental ways that GE crop, animal and food applications do not contribute to sustainability, health and justice:

  1. We don't primarily have a yield problem in the food system, and hunger is not a result of inadequate yields. Essentially, GE products are not designed and produced to address global hunger. The GE industry builds on the myth that our primary global food problem is yield rather than distribution, poverty and inequality (see Get Started, Myths).  Hunger due to low yields is certainly not a problem in the industrial world, and in the global south most food - producing smallholder farmers cannot afford GE technology even if its yield claims were legitimate.  Much of the  GE adoption in the global south has been Bt-cotton, a non-food crop.  Because GE varieties are developed in a high input environment, typically for farmers in the developed world using varieties adapted to industrial world conditions and GE traits that focus on their perceived problems, their research performance is rarely achieved amongst most peasant farmers in the regions of greatest hunger.  Success typically depends upon very good soil, fertility and moisture conditions, rural credit, good transport infrastructure, and useable information, conditions that are hard to meet in many regions of the Global South.  This yield gap problem has been recognized for years (cf. Ruttan, 1982), but science and extension actors and  organizations and firms are often unwilling to acknowledge it. There is significant evidence that agroecologically-oriented smallholder farming is a more viable strategy in the face of these limiting conditions (cf. Pretty et al. 2006; Hine and Pretty, 2008; De Schutter, 2010).
  2. Chemical use declines are modest compared to more ecological approaches. The GE industry claims significant reductions in pesticide use, and there are some relative to very conventional production, but compared to Integrated Pest Management, organic and other agroecological approaches, the reductions are relatively minor and often result in more concentrated spraying of a more limited set of pesticides.  Since most field crops applications are for herbicide tolerance, there has been dramatic increases in use of those herbicides for which crops are tolerant.  This, in turn, is increasing weed resistance pressures, and then subsequently resulting in increased spraying of herbicides to control those resistant weeds (cf. Benbrook 2012; Benbrook 2016; CBAN, 2015).
  3. Secondary negative impacts on other organisms.  A wide range of impacts on non-target organisms have been identified, particularly soil biota, beneficial insects and close plant relatives of the GE variety.  See discussion and citations in the section on Regulatory assumptions, data is supplied by the applicant.
  4. Do not necessarily improve farm finances.  GE varieties appear to increase convenience, but not necessarily farm finances, especially when compared to low input approaches. A key feature of GE varieties was supposed to be increased yields, which would justify increased seed prices.  While seed prices have increased, yield increases specific to GE trait introduction are not easy to discern. Realized net farm income associated with GE technology has also not improved, in part again because of higher input costs (CBAN, 2015).
  5. The pressing issues of sustainability are not addressed by most GE applications, for producers, processors or consumers.  A central problem of farm sustainability is longer crop rotation for soil health, pest management and more diversified farm income. Many growers have not been practicing appropriate crop rotation and have turned to GE crops in the hopes of continuing what are fundamentally unsustainable cropping practices.  GE varieties allow farmers in the short term to maintain too short rotations for pest control which contributes to soil quality, poor biodiversity and moisture retention problems, and potentially more significant long-term pest management challenges. Really challenging pest management problems, such as fungal pests in apples and potatoes, have yet to be addressed, in part because they are genetically more complex, in part because the firm profitability profile for these crops is not substantial compared to corn, soybeans, canola and cotton. There do not appear to be applications in the pipeline to facilitate intercropping and better crop rotation design.  Similarly, most GE applications do not address substantive issues of food quality.  Many applications presented as consumer facing are really about reducing costs for processors and creating convenience, not about health-promoting and sustainable diets. There are also concerns, although the evidence is not definitive, that GE foods can contribute to a number of problems in plant and animal products, including: metabolic disruptions leading to inner organ dysfunctions and inflammations in farm animals;¡Increased production of anti-nutrients; problems associated with viral gene promoters (e.g., the cauliflower mosaic virus) and with antibiotic markers (commonly for kanamycin and ampicillin);  creation of unknown allergens; and health problems associated with inputs used in GE applications (for a review, see CBAN, 2015).

So, given these negative effects, the question becomes why focus on the current GE applications? Are there not different approaches to addressing food system problems that don't create all these negative side effects?

Jurisdiction and regulatory authority

Genetically engineered organisms are primarily regulated under federal authority that flows from the constitutional provisions on patenting and other forms of intellectual property protection. As with many other legislative areas, the anti-fraud aspects of the criminal law power are also pertinent.

A decision was taken in the 1980s, in order to facilitate genetic engineering approvals (legally letters of no objection) as an economic development strategy, to regulate GE organisms through existing federal legislation rather than create a new legislative architecture specific to genetic engineering that would require public debate in the House of Commons (cf. Moran et al, 2009; Abergel, 2012).  Consequently, over the years, changes have been made, usually through Orders - in- Council, to existing legislation including the Patent Act, Seeds Act, Health of Animals Act, the Feeds Act, the Fertilizers Act, the Canadian Environmental Protection Act, the Pest Control Products Act, the Food and Drugs Act  and their associated regulations.  As a result,  the desirability of genetically engineered organisms and how to regulate them has never been a full parliamentary discussion since such changes are essential orchestrated by civil servants in the relevant line departments and the Privy Council Office.  There have been House of Commons Committee hearings and reports (e.g., the Environment and Sustainable Development Committee in the 1990s) and discussion of GE labeling in foods usually resulting from private member's bills (all of which have failed at different stages to proceed, see CBAN, 2015 for some history), but none of these represent a public discussion of the merits of GE and how approval should be structured.

The main federal departments involved in the system are Agriculture and Agrifood Canada, Health Canada, Environment and Climate Change Canada, and the CFIA.

Central to all this are provisions in the Patent Act. Plant breeders cannot patent a whole plant or plants bred through traditional breeding but can patent types of processes and gene sequences (Bauta, 2014). These plants are usually referred to as genetically engineered (GE), genetically modified (GM) crops, or “plants with novel traits”. “Plants with novel traits”, according to CFIA, is a plant that contains a trait which is both new to the Canadian environment and has the potential to affect the specific use and safety of the plant with respect to the environment and human health. Patents are reviewed and distributed by Health Canada and CFIA, a process separate from the Seeds Act variety registration and pedigreed seed certification (see Goal 5, Protecting Genetic Resources, Plants and Seeds). Once a patent is granted patent-holders can control their patents through technology use agreements (TUAs), which farmers are required to sign before they are able to purchase patented GE/GM seed.

Similarly, although the Patent Act is vague on this point, the Supreme Court has concluded that animals (and fish) are not patentable, but specific traits are.

Animals and fish are regulated under the authority of CEPA.  The Department of Oceans Canada (DOC) did not successfully develop regulations for fish using the Fisheries Act, and CEPA is the fallback legislation if other legislation has not been modified.  DOC collaborates with ECCC on fish assessments and Health Canada is  involved for a novel food assessment under the Food and Drugs Act.  For farm animals, AAFC, CFIA and Health Canada would collaborate with ECCC, since no specific regulatory processes have been developed for farm animals under the Health of Animals Act. Note that the progeny of cloned animals and products would also be regulated under novel food regulations, however, cloning is not a genetic engineering process (instead, somatic cell nuclear transfer).

The Health of Animals Act and regulations are used, however, to regulate GE veterinary biologicals.  The Feeds Act is the legislative authority for GE animal feed, with the CFIA the lead authority.

Insects and Micro-organisms are regulated primarily under CEPA. However, the products of GE microbes to be used in animal feed would be regulated under Draft Guidelines  for the Safety Assessment of Novel Feeds: Microbial Products administered by CFIA.

The provinces do not have a direct role in GE regulation except that they have some authority over varietal approvals and sales (see Goal 5, Protecting Genetic Resources).  The municipalities have no specific function, despite some creating GE-free zones.  These are symbolic and cannot be legally enforced as municipalities do not have such authority in the Canadian system, nor do we have monitoring and surveillance systems in place to permit their enforcement even if municipalities had such authority.

As with other food labels, the FDA is the legal authority guiding labeling of GE foods.  Canada only has a voluntary standard, developed with a third party, the Canadian General Standards Board.

Financing the transition

It is not obvious that the transition to a new regulatory regime will cost more.  The proposals here change the frameworks that guide the system, but the operational realities may be comparable. The R&D costs are on the industry, and the new liability proposals would also be industry / user financed.  Most of the current types of applications would have not chance of getting through the system so would not be put forward. There is even the possibility it will cost less because there would be fewer, more targeted, applications, so less time spent by regulators on review. Such a system would also progressively reduce the secondary and tertiary  problems associated with current GE applications because the new regulatory approach would be designed to identify them prior to approval.