Trends in Approval Times for Genetically Engineered Crops in the United States and the European Union

Abstract

Genetically engineered (GE) crops are subject to regulatory oversight to ensure their safety for humans and the environment. Their approval in the European Union (EU) starts with an application in a given Member State followed by a scientific risk assessment, and ends with a political decision‐making step (risk management). In the United States (US) approval begins with a scientific (field trial) step and ends with a ‘bureaucratic’ decision‐making step. We investigate trends for the time taken for these steps and the overall time taken for approving GE crops in the US and the EU. Our results show that from 1996–2015 the overall time trend for approval in the EU decreased and then flattened off, with an overall mean completion‐time of 1,763 days. In the US in 1998 there was a break in the trend of the overall approval time. Initially, from 1988 until 1997 the trend decreased with a mean approval time of 1,321 days; from 1998–2015, the trend almost stagnated with a mean approval time of 2,467 days.

Maximum vs minimum harmonization: what to expect from the institutional and legal battles in the EU on gene editing technologies

“…These are reasonable numbers. Smart et al estimated the time for approval of GMOs to be about 6.7 years on average while Fredericks and Wesseler estimated the approval length for microbial biological control agents to be about 4.7 years. The reported hurdles are substantially larger than one stressing the importance of regulatory policies on investment.…”

“…These are reasonable numbers. Smart et al 13 estimated the time for approval of GMOs to be about 6.7 years on average while Fredericks and Wesseler 14 estimated the approval length The hurdle rates are calculated applying Eqn (6). Other parameter values are fixed at = 0.04, q = 0.5, E( i ) = 10 if not otherwise.…”

A comparison of the EU and US regulatory frameworks for the active substance registration of microbial biological control agents

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Tomato tolerance to abiotic stress: a review of most often engineered target sequences

“…However, no matter how effective the genetic strategies would be, there is one drawback very difficult to overcome, its genetic character. Although transgenic crops are subject to much stricter safety tests and regulations before sale to the market in comparison to nontransgenic crops, they are being questioned in many parts of the world raising strong public concerns (Eisenstein 2013;Chow et al 2016;Smart et al 2016). In this field, alternative methods, such as conventional breeding, in vitro screening or Molecular Marker Assisted Breeding (MAS) can be used.…”