Women in Sustainable Agriculture and Food Biotechnology by Laura S. Privalle

Author:Laura S. Privalle
Language: eng
Format: epub
Publisher: Springer International Publishing, Cham

Global Issues

We had assumed that once we had approvals from Europe , Japan would follow suit. Little did we know that Europe would end up being a bigger road block than Japan. With regard to our application, it was submitted using France as the rapporteur country, in accordance with Directive 90/220/EEC. The rapporteur country was selected based on a couple of factors relating to the relative support of the product. France would have been a potential production country for this product and was advanced scientifically in the biotechnology area. Now, they are one of the strongest anti-GMO advocates. Nevertheless, back in the nineties our application was made via France. Patricia Ahl-Goy was our person on the ground in Europe to support and defend our dossier. Europe wasn’t too keen on the idea of using the Bt protein purified from B. thuringiensis and not from the plant in our safety studies, so we prepared an enriched fraction from maize leaves (enriched 40× but still <0.1% of the protein) for another acute oral mouse study. This proved acceptable to Europe but the EPA rejected this study. The timing in Europe was not ideal, although approval was received in late 1996 it was so controversial that a “moratorium” on biotech plants was imposed in Europe to allow them to prepare a major revision of their processes and policy. (This nicely delayed approval of our competitor’s product which was great for us.) However, the new policies also included a very conservative and controversial labeling policy. Europe had experienced several food security issues the biggest ones were mad cow disease (1996), dioxin contamination in animal feed (1999) and a carbon dioxide issue in Coke products (1999) during this time that led to an overhaul of their system, new regulations and the formation of the European Food Safety Agency (EFSA) in 2002. EFSA has issued more than 10 guidance documents in the ensuing ten years and these together with the so-called Implementing Regulation that went into effect in December of 2013 have greatly raised the hurdles and constricted the pathway towards approvals of biotech products in Europe (Devos et al. 2014). Only a couple of European countries actually grow any biotech products and only a couple of products are actually approved for cultivation there (James 2014). Trade disputes and changes in practices have resulted. However, since Europe is dependent upon the import of soybean to support its livestock industry, import approvals have been granted.

As we were awaiting approval from Europe , we were responding to questions from Japan as well. It was amazing the level of detail required from a country where the product wasn’t going to be marketed or planted. The review was based on the possibility that when maize grain arrived in Japan some might fall off of a truck and germinate on Japanese soil. This all seemed pretty far-fetched, nevertheless, all studies were submitted and a thorough evaluation was made. In the end, we received approval in 1996 prior to that from Europe!

Canada was also a key country on our radar.

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