Make labeling mandatory for foods derived from GE organisms which then allows for post-market surveillance
Introduction to solutions
They key challenge is to revamp GE technology development and approval systems to make applications consistent with some of the guiding principles discussed here - agroecology, social determinants of health and food justice. Underlying these conceptual frameworks is the precautionary principle which is largely absent from the current regulatory system (see Intro to this entire section on input approvals). The precautionary principle first emerged in Germany in the 1970s. “At the center of the precautionary principle is the concept of taking anticipatory action in the absence of complete proof of harm, particularly when there is scientific uncertainty about causal links" (Tickner, 1997).
Change the research questions
The molecular sciences at the heart of genetic engineering are part of a specific paradigmatic approach to science known as positivism / reductionism (see Goal 3, Public research). As discussed under Goal 5, Protecting Genetic Resources, Plants and Seeds, Efficiency, Agrocological training, there is an urgent need to change the training of breeders, whether for conventional or GE applications. The different scientific approaches generate different kinds of research questions. Many GE applications have been described as 'a solution looking for a problem'. Because the wrong questions have been asked, the wrong answers have been found. For example, regarding weed management, an agroecologists ask questions such as:
- How do conditions in this landscape favour the weed? Since an organism has preferences for living conditions, what are they for this plant and how does that relate to this landscape?
- Related to this, weeds are indicators of soil conditions. What is the weed telling us about the soil? How might soil conditions be altered to disfavour the weed?
- Are tillage and crop rotation part of a design problem that contributes to weed prevalence?
- How can a weed be prevented by altering conditions within the socio-economic circumstance of the farm?
In contrast, a molecular biologist, especially one working for a biotechnology company, might ask:
- What gene sequences contribute to this weed's competitiveness?
- What changes to its genetic structure might make it more susceptible to chemical control (of chemicals we sell in the case of a chemical firm)?
- How can we make the crop resistant to the most effective chemical controls and widen the window of its application?
- Can we develop an rDNA process or use gene editing to make these genetic manipulations commercially viable?
As characterized by agrecology, the problems of sustainability can not be solved with strictly molecular questions. However, a molecular scientist with agroecological training could ask some different questions:
- how can better understanding of weed gene - environment interactions help with weed management? Might different soil management regimes, in combination with gene editing, suppress weed populations?
- can tweaking of the genes of a crop enhance it's capacity to resist weed pressures?
- Can such interventions be done with minimal negative secondary effects, both ecological and socio-economic? This is critical because many technology introductions in the food system have negative effects on vulnerable populations.
These different questions then change the R&D cycle and should produce different kinds of applications. Although shifting training will help, regulators also need to impose these types of questions in guidance to manufacturers and importers regarding the types of applications that will receive priority attention. This is this first stage in what at the Substitution stage becomes a process of soliciting solutions to pressing problems.
Make labeling mandatory for foods derived from GE organisms which then allows for post-market surveillance (adapted from CIELAP, 2002)
Over 60 countries have some form of mandatory labeling, but not Canada or the US (CBAN, 2015). The US, however, will have a partial system in place in 2022. Mandatory labeling has been suppressed, with government assistance, because manufacturers do not want to face the market, knowing that sales will be negatively affected by concerned consumers. Surveys of consumers consistently show that a very large majority of Canadians want mandatory labels (see studies reviewed in CBAN, 2015). In this industry view, consumers are only sovereign when it suits sales which flies in the face of market theory and contributes to food illiteracy. GE developers excuse this capitalist contradiction by arguing that: a) GE products are the same as conventional; and b) consumers are misinformed about the risks and rewards of GE technology. As discussed under the regulatory assumptions section, how can they be the same and novel at the same time? But of course this "misinformation" is partly generated by GE industry messaging, messaging they can readily finance while other interpretations offered by critics can not so readily be disseminated for lack of comparable resources. Mandatory labeling is part of correcting such information failures (see also Goal 1, Consumer Information Systems).
Mandatory labeling should be guided by the following concepts:
- A process-based system, that requires labels when GE traits are detected and when the food or ingredients are derived through the processes of genetic engineering.
- Required for crops and foods derived from rDNA (transgenic) technology and gene editing, but not as broad as the Novel Food or Plant with Novel Traits definition
- A full audit trail and segregation, spot checks by CFIA.
- Positive claims are mandatory with provisions for voluntary negative claims, some of which already exist, eg. organic (see Goal 5 Sustainable Food) and the Non-GMO project. These claims are supported by standards, inspections and audit trails.
- No deliberate inclusion of GE traits is the threshold for voluntary negative claims; however since accidental/adventitious contamination occurs, inadvertent contamination between 0.1-1 % would have to be acceptable as verified through the audit trail and testing. Given that definitions, testing, audit procedures and threshold levels are very variable internationally, further study to determine precisely which level is required, with harmonization. A related challenge is whether thresholds should be different for contamination by approved vs. unapproved GE traits. Canada is supposed to be working with the US and Mexico on an agreed upon standard. However, it must be set at a level that demands better performance from developers and regulators, and not serve as an excuse for poor containment. Developers, not surprisingly, are pushing for high thresholds. Presumably as label and non-GE infrastructure improves, the acceptable threshold could decline, but given the millions of acres currently devoted to GE crops, a zero threshold is unlikely to be achievable.
- For mandatory positive claims, any deliberate inclusion of a GE material or material derived from a GE process would trigger the mandatory label provision, as would accidental/adventitious contamination above the determined threshold.
- The cost of positive labeling and segregation would be borne by the developer, farmer or manufacturer.
Because not all possibilities can be anticipated (especially slowly evolving health conditions such as cancer, metabolic disruption, and reproductive disorders), the lack of requirements for feeding trails in many pre-market assessments, and the very limited number of existing long term feeding studies (those that do exist were conducted by independent scientists, see CBAN, 2015), with any controversial product or process, a post-market surveillance program is warranted. These work as complements to pre-market risk assessment and have for some products been required in Europe as part of the approval process. Post market surveillance programs .....
"provide the means to evaluate the actual intake of a food by consumers and may increase the probability of detecting adverse effects in small, well characterised segments of the population deemed most at risk in the pre-market assessment, when they are exposed to the food during long periods of time under conditions of every day life. It may thus provide helpful reassurance that the potential for an adverse effect, judged a priori during the pre-market assessment to be of low probability, is indeed unlikely for the significant majority of consumers (Hepburn et al., 2008:13).
By analyzing cases and reviewing the literature, Hepburn et al (2008) set out some of the likely operational requirements to make post-market surveillance useful and effective. They propose ways a number of existing market and non-market tracking tools, including barcodes and RFID technology, could be helpful sources of data. Audit trails and labels, increasingly used in the Canadian food system for a variety of purposes, are central to this process. Food intake data, another historical weakness in Canada, is also slowly improving to help address health and food insecurity assessments. Adverse effects reporting systems also exist to some degree across a range of conditions so multiple lessons can be drawn from these existing processes. Health Canada spent a number of years in the early 2000s considering such a program and failed to put one in place (CBAN, 2015).
Use precaution to refine assessment of harm in testing protocols, procedures and reviews
The problems with the regulatory system described earlier reveal that precaution is not central to the current system. As recommended by An Expert Panel Report on the Future of Food Biotechnology (2001), familiarity and substantial equivalence should be abandoned as decision thresholds. These regulatory concepts have no place in robust assessment system. Instead, precaution should become central. Barrett and Raffensperger (2002) (cited in CIELAP, 2002) proposed that risk assessment:
a. the following levels of potential impacts
b. the extent of harm, as the precautionary principle says that if the potential for harm is serious, preventive action must be taken when:
- The harm is not reversible – an irrevocable loss of ecosystem function or biodiversity. Reversible harm, however, doesn’t assure insignificance.
- The harm is widespread, extending beyond agricultural landscapes
- The harm is cumulative
- The harm is involuntary – those exposed have little opportunity to mitigate or avoid being exposed.
- The harm is unfairly distributed – certain organisms or people are more likely to suffer than others, and the benefits of the product’s use are concentrated within a small group.
- The harm is portentous – mitigating it will require additional commercialization of related products causing harm.
- The harm is restrictive – use of the product causing harm forecloses other options that are less likely to generate harm.
- The harm is avoidable using other approaches that are readily available.
Analyze uncertainty in the scientific data – use statistical methods to clarify what is uncertain and how much error and bias there is in the data.
Use the weight of evidence approach – do not rely on the science being absolutely definitive, instead look at how different lines of investigation lead to related conclusions.
Shift the burden of proof of the safety of GE products from the public sector to the companies that want to commercialize them.
Take precautionary action when many of the elements outlined here reveal there are significant reasons to be concerned.
The Edmonds Institute (1998) produced a two-volume biosafety assessment manual that set out review and evaluation procedures to be followed to integrate the precautionary principle into the safety evaluation of GE foods. Developed by an interdisciplinary group of scientists, it needs some updating to reflect new learning, new technologies, and new modeling of landscape level impacts since first published, but represents a completely different approach to human and environmental safety assessment. Because GE is regulated under existing provisions, it will take some time for regulators and developers to implement these changes across an extensive array of regulatory areas, including into the Substitution stage, although most of the changes are at the level of regulations and regulatory directives, not legislation. The final changes can be implemented as part of constructing an integrated sustainable GE legislative framework at Redesign.
Establish systems of harm compensation because sustainable producers are being penalized
Contamination has been an ongoing problem (see Price and Cotter, 2014; CBAN, 2015), with economic consequences for non-GE producers and distributors. Plant ecologists are not surprised, these outcomes were entirely predictable given how plant genes move across landscapes, compounded by the problems of regulatory risk assessments. Equally significant, many handling and supply chain systems are not capable of avoiding errors that will produce co-mingling (for a case study on the difficulties of introducing GE wheat, see MacRae et al., 2002). Without compensation for arm, co-existence of GE and non-GE crops, animals and foods (which regulators and industry say is a priority) is not actually possible, because GE traits will spread and compromise other forms of production, and reduce consumer choice.
"In the European Union, mandatory labels for GE products shift some of the cost of coexistence to GE produce processors and sellers. In fact, some EU countries require GE producers to use buffers and other prevention strategies, as well as to make them liable for economic damages to non-GE producers. Europe is also exploring the use of insurance markets to help compensate for economic losses experienced by organic and other non-GE producers."
Sligh and Benbrook proposed in 2011 a draft plan to be implemented by the US to help protect organic farmers (see Appendix, OTA, 2011). The plan included a compensation fund and advisory committee. The fund would be administered by the USDA and financed through approval charges to developers and licencees and through users, including charges per bag of GE seed sold. The fund would provide compensation, following recognized contamination events, for:
- Incident-triggered and on-going testing and related costs;
- On-going buffer zone control, production acreage losses and on-going maintenance to secure or maintain access to markets;
- Pollinator losses and related damages;
- Loss of organic or other third-party certification and costs associated with additional record-keeping, testing or surveillance to regain or retain certification;
- Costs of market rejections or price penalties;
- Segregation and commingling prevention plans, and supply-chain integrity costs;
- Seed contamination and decontamination costs, including seed replacement, crop and production losses;
- Costs to remove and destroy contaminated plants.
Canada must establish a regime of this kind.