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

Self Cite

New plant‐breeding technologies (NPBTs), including gene editing, are widely used and drive the development of new crops. However, these new technologies are disputed, creating uncertainty in how their application for agricultural and food uses will be regulated. While in North America regulatory systems respond with a differentiated approach to NPBTs, the Court of Justice of the European Union (EU) has in effect made most if not all NPBT subject to the same regulatory regime as genetically modified organisms (GMOs). This paper discusses from a law and economics point of view different options that are available for the EU's multi‐level legal order. Using an ex‐ante regulation versus ex‐post liability framework allows the economic implications of different options to be addressed. The results show that under current conditions, some options are more expensive than others. The least costly option encompasses regulating new crops derived from NPBTs similar to those used in ‘conventional’ breeding. The current regulatory situation in the EU, namely making the use of NPBTs subject to the same conditions as GMOs, is the most costly option. © 2019 The Authors. Pest Management Science published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry.

Section: Economic Model Assessing Investments In Npbtsmentioning

confidence: 99%

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

Purnhagen

Wesseler

2019

Self Cite

“…EU biopesticide regulations are more cumbersome than those in the USA; the EU would like to accelerate more biological tools to the market. In 2014 the EU passed the Sustainable Use Directive, and due to the subsequent restriction and elimination of so many chemical active ingredients, biopesticides are assessed on a case‐by‐case basis that costs several millions of dollars more than a US registration and takes several more years for approval . Note that all countries except the USA require efficacy data for registration.…”

Section: Definitions and Regulationsmentioning

confidence: 99%

“…In 2014 the EU passed the Sustainable Use Directive, and due to the subsequent restriction and elimination of so wileyonlinelibrary.com/journal/ps many chemical active ingredients, biopesticides are assessed on a case-by-case basis that costs several millions of dollars more than a US registration and takes several more years for approval. 1 Note that all countries except the USA require efficacy data for registration. California's Department of Pesticide Regulation does its own review, which could take up to 18 months after EPA approval.…”

Section: Plant-incorporated Protectantsmentioning

confidence: 99%

Pesticidal natural products – status and future potential

Marrone

2019

230

160

There is a long history of using natural products as the basis for creating new pesticides but there is still a relatively low percentage of naturally derived pesticides relative to the number of pharmaceuticals derived from natural sources. Biopesticides as defined and regulated by the US Environmental Protection Agency (EPA) have been around for 70 years, starting with Bacillus thuringiensis, but they are experiencing rapid growth as the products have got better and more science‐based, and there are more restrictions on synthetic chemical pesticides. As such, biopesticides are still a small percentage (approximately US$3–4 billion) of the US$61.3 billion pesticide market. The growth of biopesticides is projected to outpace that of chemical pesticides, with compounded annual growth rates of between 10% and 20%. When integrated into crop production and pest management programs, biopesticides offer the potential for higher crop yields and quality than chemical‐only programs. Added benefits include reduction or elimination of chemical residues, therefore easing export, enabling delay in the development of resistance by pests and pathogens to chemicals and shorter field re‐entry, biodegradability and production using agricultural raw materials versus fossil fuels, and low risk to non‐target organisms, including pollinators. Challenges to the adoption of biopesticides include lack of awareness and education in how to deploy their unique modes of action in integrated programs, testing products alone versus in integrated programs, and lingering perceptions of cost and efficacy. © 2019 Society of Chemical Industry

“…The approval takes time and can be very costly. Time and costs vary by jurisdiction and for the case of the European Union are also highly politicized including transgenic crops, biological control methods or pest management of invasive species . As mentioned above the approval procedures delay access to the technology, resulting in foregone benefits …”

Section: The Approval Of Pest Management Strategiesmentioning

confidence: 99%

“…Many economists as well as other stakeholders are concerned about the recent regulatory policy developments . They have increased the research, approval, and application costs without often providing additional benefits justifying the additional costs.…”

Section: Introductionmentioning

confidence: 99%

Perspective: regulation of pest and disease control strategies and why (many) economists are concerned

Wesseler

2018

Pests and diseases are a continuous challenge in agriculture production. A wide range of control strategies have been and will continue to be developed. New control strategies are in almost all countries around the world assessed prior to approval for use in farmers' fields. This is rightly so to avoid and even reduce negative effects for human health and the environment. Over the past decades the approval processes have become increasingly politicized resulting in an increase in the direct approval costs and the length in approval time without increasing the safety of the final product. This reduces the development of control strategies and often has negative human health and environmental effects. Possibilities exist for improvements. They include reducing approval costs and approval time by streamlining the approval process and substituting approval requirements by strengthening ex-post liability. © 2018 Society of Chemical Industry.