Serious Shortcomings in U.S. Agricultural Biotechnology and Pesticide Regulation


Dear Friends and Colleagues

Serious Shortcomings in U.S. Agricultural Biotechnology and Pesticide Regulation

The sharply upward trajectory in herbicide drift and damage arising in the wake of growing use of dicamba and 2,4-D in conjunction with Roundup on herbicide-resistant genetically engineered (GE) crops is triggering new concerns and tensions in the United States. A peer-reviewed paper describes how and why "regulators lost track and control of pesticide risks". It focuses on the "collapse of Bt-transgenic technology" under pressure from resistant pests, as well as the ongoing catastrophe of weed resistance to the glyphosate herbicides sprayed on GE herbicide-tolerant crops.

These problems are rooted in poorly conceived policies that are incapable of response in real time to keep small, emerging problems from becoming big, long-lasting ones. The paper identifies five shortcomings in U.S. agricultural biotechnology and pesticide regulation, along with suggested solutions:

1.  Excessive confidence in the precision of pre-approval risk assessment methods

There is often a sizable mismatch between the risks of concern to regulators prior to a product’s first approved uses, and the risks that arise from the way a pesticide or GE trait is used once on the market. The limits of pre-market testing and risk assessment need to be acknowledged, and greater weight placed on post-approval monitoring that produces the hard data needed to refine risk assessments, detect resistant populations, and track levels in soil, water, and people.

2.  The current focus in risk assessments on pesticide active ingredients (e.g., glyphosate or imidacloprid), instead of formulated pesticide products (Roundup or Admire)

Many of the so-called inert ingredients in formulated pesticides, including Roundup, are themselves toxic and/or enhance the ability of the active ingredient to persist in biological systems and penetrate cell walls. Regulators should simply ban, or very heavily restrict, surfactants and adjuvants that are known to pose possibly substantial risks. Secondly, regulators should agree on a process to establish a global “Generally Recognized as Safe” (GRAS) directory of inert ingredients eligible for use in formulated, end-use pesticide products.

3.  Lack of post-approval monitoring of real-world performance and impacts

Post-approval monitoring should be thorough and rigorous, and mandatory for every new pesticide and GE trait. The timing and scope of such data collection should be a function of adoption thresholds, rather than in accord with an arbitrary number of years. The next two production seasons should be utilized to collect real-world data. Then, drawing on the new information generated, regulators should revisit and update their risk assessments, and determine whether any previously unforeseen risks warrant attention, and proceed accordingly.

4.  Failure to manage the collective impact of pest management tactics, pesticides, and Bt toxins on food safety, human health, and the environment

Farmers have become progressively more dependent on insecticide and toxin-based interventions, and incrementally more divorced from prevention-based, integrated systems that rely mostly on management of ecological interactions and biological control mechanisms. Authorities should approximate the5-year, rolling average number of herbicide, insecticide, or fungicide “kill units” required to bring a crop to harvest on a given type of farm in a given year, as well as over time. For crops and in places where the average “kill unit” trajectory begins to slope upward, this indicates that a change in pest management tactics and strategy is needed now or soon.

5.  Lack of tools to stabilize and/or reverse rising risk trajectories, even when the steps needed to do so are well known

In the U.S., the EPA and USDA only focus on one pesticide or GE trait at a time and make their judgements based on whether a new technology appears acceptably safe, in isolation, on a given field. They do not consider the scope and scale of adoption. There are a variety of ways through which agencies could begin to reduce system-generated risks, as opposed to single pesticide or trait-induced risks, for example, imposing similar pre-harvest intervals on all herbicides registered for uses known to lead to higher residues.

The paper concludes that over the next half-century, farmer and consumer demand for more assuredly safe food and prevention-based pest management systems will eventually slow down the pesticide/toxin treadmill, but the costs to society in the interim may remain sizable.


With best wishes,

Third World Network
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by Charles M. Benbrook
Food, Health, and the Environment
12 July 2018


Purpose of Review

The approval of genetically engineered (GE) crops in the late 1990s triggered dramatic changes in corn, soybean, and cotton pest management systems, as well as complex, novel regulatory challenges. Lessons learned are reviewed and solutions described.

Recent Findings

Government-imposed resistance management provisions can work and adapt to changing circumstances, but within the private sector, pressures to gain and hold market share have thus far trumped the widely recognized need for resistance management. Risks arising from the use of formulated pesticides often exceed by a wide margin those in regulatory risk assessments based on data derived from studies on nearly 100% pure active ingredients.


Innovative policy changes are needed in four problem areas: excessive faith in the accuracy of pre-market risk assessments and regulatory thresholds; post-approval monitoring of actual impacts; risk arising from formulated pesticides, rather than just pure active ingredient; challenges inherent in assessing and mitigating the combined impacts of all GE traits and associated pesticides on agroecosystems, as opposed to each trait or pesticide alone; and, tools to deal with failing pest management systems.

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