Asynchronous Approvals/Low Level Presence

  • 100% purity is impossible in the production of food, feed and seed. Agricultural commodities inevitably become inter-mixed to a small extent.
  • This mixing results in adventitious presence of impurities without affecting quality or salability of the crop.
  • Lack of policies to address low level presence can lead to disruption of international trade.
  • Acceptable adventitious presence levels must be science-based, feasible and non-discriminatory.
  • CropLife International would like to see the new Codex Alimentarius Ad Hoc Taskforce on Foods Derived from Biotechnology develop international guidelines for low level presence of GM material in food commodities.

Given the vast infrastructure dedicated to moving grain from farms to consumers around the world, the potential for the incidental commingling of products from different crops within grain, feed, and food production is well recognized and taken into account by governments. This mixing of small amounts of other varieties is normally called adventitious presence: it is incidental but unavoidable. Some commingling is virtually guaranteed, even in the most stringent of identity preservation system. This applies equally to GM products that are authorized for use in a country of production (and potentially in other countries as well), but not yet approved in an importing country.  International guidelines and/or practices that assist importing countries to assess the relative risks associated with the consumption of such technically unavoidable low levels of GM products will serve to assist trade, reduce administrative burdens, and reduce production costs.

What is Low Level Presence?

Low level presence (LLP) of impurities in agricultural commodities is the incidental presence of a material in a product at levels that could reasonably be expected to be present when using generally accepted agricultural and manufacturing practices.  This includes foreign matter (such as rat faeces) or grain from other traded crops, and it is normally managed by agreeing quality standards and monitoring.  When used in relation to genetically modified (GM) material, the term refers to the incidental presence of GM material in food, feed or grain at levels that are consistent with generally accepted agricultural and manufacturing practices.

What is the Issue?

A growing number of countries have established risk assessment procedures for approving the import of GM crops and derivatives. However, many of these countries have not, as yet, adapted these processes to address the potential low level presence in their imports of GM material already authorized and being produced in other countries, but not yet approved (and therefore not intended to be present) in the importing country. This gap has the potential to cause significant trade disruptions, as well as placing significant burdens on the importing country’s authorities when such presence is detected.  The situation will only become more prevalent as more and more new GM plants are developed and enter into commerce at different rates in different countries.

AP is Manageable

However, the situation is manageable. Minimization of LLP is always preferred over other solutions.  CropLife International companies believe that the primary approach to managing low level presence in the supply chain must remain:

  • the implementation of rigorous good agricultural practices (GAP) for the cultivation of GM plants.
  • the implementation of good manufacturing practices (GMP) throughout the agri-food chain for products that are authorized in the country of production but not [yet] in an importing country.

In addition, it is the policy and accepted best practice of the developers of GM plant varieties to seek authorizations in countries that import significant amounts of the crop in which a GM product has been introduced. The fact that authorizations are granted over different timescales is due to differences in the operation of different countries’ regulatory systems.

International Guidance and/or Practices to Address LLP is Essential

Despite this, presence of unauthorized events will inevitably occur from time to time, and when this happens importing countries will want to ensure this is dealt with without compromising the safety or food security of their citizens. To do this, governments must be able to make enforcement decisions that recognize the realities of low level adventitious presence of GM material. We suggest that this can best be achieved by:

  • recognizing the situations where a product has already been authorized in the country of origin, and accepting the risk assessment information that already exists, or
  • building on existing, globally-recognized, science-based principles and guidelines for food/feed safety assessment that have been developed in order to harmonize procedures internationally.

It is important for the Codex Alimentarius’ Ad Hoc Intergovernmental Taskforce on Foods Derived from Biotechnology to include LLP on its work program. This body has already developed internationally applicable principles for the risk analysis of foods derived from modern biotechnology and guidelines for the conduct of food safety assessment of foods derived from recombined-DNA plants. We believe that further work should now be undertaken to develop an international system to assess objectively the risks associated with the consumption of technically unavoidable low levels of plant material derived from GM crops not yet approved in all countries.

AP and Threshold Costs

Once the safety of low levels of a particular non-approved GM material has been accepted, some countries may then choose to establish, for various reasons, allowable levels or thresholds for the low level presence of the product. However, it is important to recognize that these thresholds would NOT be based on safety issues, but on achievable limits given current production and marketing norms.

Industry can implement different strategies and adopt various operational changes to reduce, but not eliminate, the likelihood of LLP. However, it must be born in mind that each intervention yields different probabilities of success and incurs additional costs as development, production, distribution and inventory expenditures rise, and as total supplies of marketable seeds are reduced. In fact, a survey of seed companies worldwide indicates that a company’s average per unit costs would increase by 7% at a 1% AP threshold.  At a stricter 0.3% threshold, a company’s average per unit costs would go up by 28%.