Overview
Crops that are improved through biotechnology help farmers increase the production of much-needed grains, oilseeds and fiber while better coping with the effects of climate change and using natural resources more efficiently. In order to help secure food supplies and pricing, trade in all agriculture goods must flow safely and efficiently from markets where crops are produced to places where they’re needed.
However, the introduction of each new biotechnology crop product raises the potential for disruptions to agriculture trade. To understand why, it’s important to understand the dynamics of regulatory review and approval for biotechnology crops, within and across countries.
Approval Processes
New crops improved through biotechnology must undergo rigorous approval processes by competent national authorities before entering the marketplace.
The regulatory systems in many countries follow principles and guidelines for food safety assessment that have been developed by the Codex Alimentarius Commission. The safety of biotech food products is systematically assessed relative to their conventional counterparts, identifying and analysing any hazard (such as allergenicity or toxicity), nutritional or other potential difference in safety between the two.
When the crop is approved (in some countries, approval is referred to as “authorization”), it may be grown by farmers in that country and go into commodity grain shipments meant for domestic processing and food manufacturing systems.
Importing countries sometimes review and complete their approval decisions for new biotech products in step with review and approval timelines in exporting countries. Ideally this is achieved within 12 months from the date of submission. Synchronized approvals in exporting and importing countries thus avoid trade disruptions.
Because grain from the new crop is not allowed into shipments destined for countries where it has not yet been approved, the timing of approvals across agricultural trading partners is critically important for avoiding trade disruptions.
Asynchronous and Asymmetric Approvals
Asynchronous approvals occur when there is a gap of time between the approval of a biotech trait in the country of origin (or exporting country) and an importing country.
An asymmetric approval (also known as an isolated foreign approval) occurs when a cultivating country has approved a biotech crop, but its developer does not seek approval in key importing countries
Also, some importing countries will not accept applications for regulatory review until full approval (authorization) has been granted by one or more countries. This gap in time, which can range from several months to multiple years, automatically and unavoidably creates the condition of asynchronous approval.
An asymmetric approval (also known as an isolated foreign approval) occurs when a cultivating country has approved a biotech crop, but its developer does not seek approval in key importing countries. This is more common in Asia where biotech crops are developed for domestic consumption rather than export, so they are less likely to be submitted for approval in the EU or United States.
Impacts
Asynchronous approvals and asymmetric approvals can have the same disruptive impact on trade if a new biotech product is found in a country where it is not approved, and the risk increases as the time gap lengthens. The disruption occurs when low level presence (LLP) of the unapproved trait is detected in grain or seed shipments, or in an ingredient or finished food product. Such a situation can result in costly fines, lost revenue on the total grain shipment, expensive testing and clean-up, unsold or destroyed grain or seed, product recalls in importing countries, and the loss of export market share as the importing country sources grain from another country.
Because of this risk, sometimes the lack of approval in an importing country leads to a delay of the commercial launch in the country of origin itself. Even though the country may have approved the biotech seed, seed developers may choose not to make it commercially available until it is approved in key importing countries. For farmers, this means a lack of access to the latest technologies, and a delay in access for new agronomic, environmental and economic benefits.
Therefore, asynchronous and asymmetric approvals increase the commercial risk and uncertainty for the technology provider and the entire agricultural value chain.