Guide Regulation of Agricultural Biotechnology: The United States and Canada

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Both regulate gene-edited product case-by-case and exempt them from regulation when there is no insertion of transgenes. There is optimism that other South American countries will adopt similar regulations. The Colombian government recently announced that it would not regulate gene-edited cacao developed by researchers at the University of California, Berkley with money from Mars Inc. At that time, experience with recombinant DNA technology for crops was limited. The US and Canada embraced the new technology, but Europe rejected it. The authorities took an overcautious approach that resulted in one of the most severe sets of GMO regulations in the world.

Strict safety assessments, cumbersome bureaucracy and activism against GM organisms have almost chocked research and release of GM crops in Europe. Almost no significant quantities of GM crops are cultivated on the continent. Scientists, breeders and seed producers are afraid that gene-edited crops will be placed under the same onerous GM regulations, which would make the technology too expensive and too slow for competitive agricultural biotech.

The EU Commission has been ducking and diving to avoid taking action on the issue. Arguably, molecular gene-editing techniques create similar products as conventional mutagenesis, but with greater precision. Therefore, Bobek does not see any grounds to update legislation, which could mean that gene-edited crops would not fall under laws restricting the use of GMOs the EU. Both North and South American countries paved the way for development of gene-edited crops by removing regulatory uncertainty.

Time will tell whether the European Commission also grasps the opportunity to re-consider its over-cautious approach to biotech crops. Regulating gene-edited crops as GMOs will do nothing to support sustainable agriculture.

Agriculture – USMCA Chapter 3

It would simply make it too expensive for European academics, small companies and humanitarian projects to develop such products. Especially in Europe, we need to learn from the GMO debate. Public concerns are important and the European Commission is well advised to listen to them. However, it is equally important not to let loud voices block the development of rational, evidence-based and non-discriminatory regulatory framework that provides legal certainty.

To find out more, take a look at the agenda. Suggested citation: Gilmour, B. AgBioForum , 18 1 , Its gross domestic product GDP growth rate in was almost the same as at 7. This is still one of the fastest growing nations within emerging markets. Figure 1. There are about 4. For other approved GM plants such as tomatoes, sweet peppers, and petunias, almost all are not currently planted because their biosafety certificates either have expired or have not been renewed due to a lack of commercial market US Department of Agriculture [USDA], Foreign Agriculture Service [FAS], In terms of importation, China has, in recent years, approved five biotech crops with 32 events 13 for corn, 7 for canola, 6 for cotton, 5 for soybeans, and 1 for sugar beets for processing or feed use USDA FAS, It also reviews its institutions for the decision-making process.

Biotech Regulations and Policies General Regulations As China has a centralized governance system, unlike western governments, it is important to understand Chinese regulations within its institutional framework. EU officials counter that their cautious approach to regulating biotechnology is necessary to cultivate trust among European consumers. At the same time, they also assert that they have shown good faith in moving to restart the approval process. The WTO dispute panel found that the EU had maintained a moratorium on approvals of genetically engineered crops between June and the beginning of panel deliberations in August The panel upheld the complainants' charge that the EU also violated the SPS agreement by not ensuring that approvals for 24 of 27 genetically modified GM products in the approval pipeline were carried out without "undue delay.

The dispute panel's ruling dismissed several other U.

AgBioForum 18(1): China's Agri-Biotech Policy, Regulation, and Governance

The panel made no recommendations as to how the EU should bring its practices in line with WTO rules, nor did the ruling require the EU to change its regulatory framework for approving GE products. The EU announced on December 19, , that it would not appeal the panel's ruling in the case. The United States and EU agreed that a reasonable period of time would be until November 21, , a deadline subsequently extended by mutual agreement until January 11, Time would likely be required to reach intra-EU agreement to lift the prohibitions on already approved GE products or to launch court challenges to require member countries to lift their prohibitions on GE products.

Since then, the EU has approved GE corn varieties Monsanto's NK for both human and animal consumption, Pioneer's corn for feed use, and 17 strains of GE corn seed all derived from the MON strain approved in for commercial use.

Account Options

While the United States and the EU are continuing technical discussions on market access issues for biotech products, both Canada and Argentina have settled their disputes with the EU. Similarly, Argentina and the EU announced their final settlement of the biotech dispute on March 18, All three parties have notified these settlements to the DSB as mutually agreed solutions. Both settlements provide for bilateral, biannual meetings between competent services of the European Commission and the co-complainants' authorities regarding the application of biotechnology to agriculture and related trade issues of mutual interest, including.

The United States has embraced the concept of substantial equivalence with regard to GE products: if a GE product is substantially the same as its conventional counterpart, it should be regulated no differently than the conventional product.

Canada’s Regulation of Agricultural Biotechnology by Phil Macdonald

The EU, on the other hand, takes a "precautionary approach," which means that if scientific evidence is insufficient or inconclusive regarding a practice's or product's potential dangers to human or environmental health, it should be more vigorously regulated or even prohibited if there are reasonable grounds for concern, thus providing a safeguard against future unforeseen problems.

Under this approach, the products of biotechnology are deemed to be inherently different from their conventional counterparts and to require a separate regulatory regime. The basic federal guidance for regulating biotechnology products is the Coordinated Framework for Regulation of Biotechnology. Once approved, food products do not have to be labeled as to whether or not they contain any genetically modified organisms, except to the extent that a GE food is substantially different e.


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Because they are deemed substantially equivalent, GE products are regulated under existing federal statutory authorities. The EU has established separate structures specifically for approving GE products and for labeling products derived from them.

The amended directive provides for a "one-door-one-key" approach, whereby the European Food Safety Authority EFSA conducts all scientific risk assessments and communicates risks to the public. EU regulations empower the European Commission to approve applications by default if the Council of Ministers fails to act on them within three months.

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Trump simplifies reviews of genetically modified farm products

The labeling and traceability regulations, adopted in July , require that most foods, ingredients, and for the first time animal feeds from GE products be labeled, even if they no longer contain detectable traces. Under the regulations, a tolerance level for non-GE foods, feeds, and processed products of 0. All products with more than 0. Products like meat, milk, and eggs from animals fed or treated with GE materials will not have to be labeled, however.

Traceability provisions now require all firms that produce, store, move, or process GE products to track and keep records on them from farm to consumer.


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Compliance with the EU labeling rule requires segregation of GE crops and foods derived from them from the time they are planted all the way through the processing and marketing chain. This entails prevention of pollen drift from GE to non-GE fields; and difficult and costly handling procedures such as using separate equipment, storage, and shipping containers, or at least painstakingly cleaning them.

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All of these problems discriminate against U. In practice, many U. The European Commission is currently discussing new technical guidelines for the allowable level of genetically engineered organisms in food and feed shipments for GE products that have been approved in exporting countries but not the EU. Differing U.


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  • Still, "U. Europeans may be much more wary of changes in how their food is produced due to a series of recent food safety crises during the s. Bovine spongiform encephalopathy BSE, or "mad cow disease" emerged in the United Kingdom and spread to other parts of Europe. By scientific evidence indicated there was a link between some cases of a similar human disease and consumption of BSE-contaminated beef. In , high levels of dioxin were found in meat products and eggs originating in Belgium.