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Expert Witness From Landmark Monsanto Trial Offers 5 Fixes to Shortcomings in Current GE Food Regulations

Charles Benbrook on the mistakes made in the approval of the first genetically engineered crops—and what we can learn from them

Editor's note: Charles Benbrook served as an expert witness in support of Lee Johnson, a groundskeeper suffering from terminal non-Hodgkin lymphoma following heavy use of, and exposures to Monsanto's Roundup herbicide.

Johnson sued Monsanto and was awarded $289 million in damages last week, after the jury delivered a stunning, unanimous verdict against Monsanto. 

Hardly a day goes by without a new scientific paper or news coverage addressing problems down on the farm.

Just this month, for example, two studies highlighted the growing problem of weeds resistant to the herbicide glyphosate—the main ingredient in Monsanto's Roundup—and how this continues to push herbicide use, expenditures, and collateral damage upward. The more herbicide farmers spray, the faster herbicide efficacy slips.

The studies found:

- The effectiveness of Bt-cotton, which initially had positive impacts on yields, is now declining worldwide because of the spread of resistant insects. Bees exposed to glyphosate in a recently treated field have reduced brood survival and altered gut microbiomes.

-Both wild and managed pollinators are in decline as a result of exposure to toxics, loss of healthy habitat, and poor nutrition.

Unfortunately, there is no Plan B for committed, large-scale genetically engineered (GE) crop farmers, many of whom find themselves locked onto a costly herbicide-use treadmill.

For corn, soybean, and cotton farmers in the U.S., many of today's problems are rooted in bad decisions made in the early 1990s as first-generation, GE crops were reviewed and approved by government agencies, and then marketed by the industry.

In a new paper I focus on how the industry, regulators, and the scientific community dealt with the significant increase in selection pressure on insect populations and weed communities. 

Past mistakes in the testing and regulation of first-generation GE-crops are widely recognized

While there is general agreement of why the GE-crop train jumped the tracks, there has been little serious discussion of solutions and today, constructive engagement by regulators or Congress is nearly unimaginable. 

In the hope of triggering reforms, here are five fixes to shortcomings in current law and ag biotech regulation.

Problem #1: Excessive confidence in current federal regulation

Each new GE crop technology goes through a voluntary review of food safety risks triggered by a letter from technology developers to the U.S. Food and Drug Administration (FDA). Through these "voluntary consultations," the companies provide basic information to the FDA on the genes moved into the new GE crop.

The primary focus of the FDA's voluntary consultation is whether the composition and nutrients in the GE crop is "substantially equivalent" to that of the not-engineered crop. The FDA reviews the data, raises any questions it has, and, in most cases, accepts the conclusions of the technology developer.

The FDA does not conduct an independent safety determination, nor does it do any testing of a newly proposed GE crop, but rather accepts the company's assertion of its safety. It is a shallow and flawed process, that has been "under review" for two decades, but persists because of the lack of consensus on a better way forward.

The U.S. Department of Agriculture's (USDA) focus in the regulatory review process is driven by an old federal statute, the Plant Pest Act. The USDA must determine whether the technology might trigger a new, or worsen an existing "plant pest" (i.e., a weed, insect, or fungal pathogen that attacks or competes with plants). If there is no evidence of such "plant pest" risk, the USDA deregulates the new GE-crop trait, and companies are then free to move the new trait into various crop cultivars.

In the case of GE crops that entail expression of compounds that act as pesticides, the EPA also has to approve the new crops under national pesticide law. For GE crops engineered to tolerate applications of herbicides after the crop has emerged and is actively growing, the EPA typically has to approve: (a) new and/or higher tolerance levels covering residues in food, and (b) herbicide product labels that contain different directions for use.

Each agency's role and authority is seriously limited because Congress has been unable to pass new legislation to give the agencies the tools and mandates needed to conduct thorough reviews of the risks, benefits, costs, and uncertainties associated with novel GE-crop technologies. As a result, pre-approval risk assessments are typically a mile wide but just inches deep. Some of the most worrisome risks are largely ignored. 

Problem #2: Ignoring “inert” ingredients

Every pesticide sold to farmers contains one or more "active ingredients" that kill or control pests, and several "inert ingredients" that help assure the pesticide accomplishes its desired impact.

Inert ingredients help keep the active ingredient in suspension, and assure the pesticide sticks to plant or weed tissues long enough to be absorbed or come into contact with an insect pest. Some promote compatibility when mixed with other pesticides or liquid fertilizers, prior to spraying on a field.

For decades, a dangerous myth has persisted -- "inert ingredients" in formulated, ready-for-sale pesticides are not harmful to human health and the environment. For this reason, the impact of inert ingredients are not taken into account when the industry and government conducts a risk assessment of an active ingredient. Federal law classifies inert ingredients as "Confidential Business Information" (CBI), and blocks disclosure to poison control centers and physicians routinely treating pesticide poisoning victims.

The heightened toxicity of Roundup and other glyphosate-based herbicides, in contrast to pure glyphosate, played a dual role in Lee Johnson's trial in San Francisco, CA. 

EPA's near-sole focus on the toxicity of pure glyphosate undermined the relevance of the agency's reassuring risk assessment, since no one ever sprays, or is exposed to pure glyphosate. 

Monsanto's systematic effort over decades to suppress chronic animal studies on formulated Roundup, despite knowing from its own studies that the inert ingredients in its many Roundup brands increased risks substantially, no doubt influenced the jury, especially as it pondered the award of punitive damages. 

Old myths die hard, despite the now well-known fact that inert ingredients in the world's leading, formulated herbicide, Roundup, and the world's leading family of insecticides (called neonicotinyls) dramatically increase toxicity to organisms up and down the tree of life, including people. 

The policy fixes for problem #2 are obvious and simple—Congress needs to amend the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to: (a) require all active and inert ingredients to be disclosed on pesticide product labels, and (b) direct the EPA to require chronic feeding studies in mice and rats on at least some major formulations when there is evidence from short-term testing of heightened toxicity following exposures to formulated pesticides, as opposed to pure active ingredients.

Problem # 3: Lack of real-world monitoring 

Despite shortcomings in risk assessments, regulators generally are aware of the major areas of concern and uncertainty. In the first few years post-approval of a new GE technology, research and mandatory monitoring should be conducted to gain deeper understanding of human exposures and risks, unforeseen environmental impacts, or whether efficacy is slipping or uneven, raising the risk of resistance.

By targeting such monitoring in areas where new GE technology, and/or associated pesticides, have been most rapidly adopted, post-approval monitoring can serve as an early-warning system. Data gathered can alert the industry, farmers, and regulators of the need for more in-depth study and possible changes in the way a pesticide or GE-crop technology is used.

Problem #4: Focusing on one pesticide at a time

Regulators focus on the impact of one pesticide at a time, in isolation. Yet, adverse impacts arise as a result of all the pesticides, toxics, and technology deployed by farmers in a given area.

Tactical changes within prevention-based pest management systems are the surest way to achieve real progress toward safer pest management. Tweaking labels can reduce risks at the margins, but do nothing to stabilize failing pest management systems.

Both farmers and regulators need help, and new tools to recognize when a pest management system is failing because of the spread of resistant organisms, emergence of secondary pests, or unacceptable collateral damage on the environment, human health, or international trade flows. 

In such cases, systemic pesticide regulatory interventions need to be considered that help farmers move away from heavy reliance on pesticides, and toward multi-tactic, prevention-based management systems. 

Problem # 5: Lack of tools for struggling farmers 

Pest management specialists generally agree on the factors eroding the efficacy of a pest management system, or nudging risks and costs incrementally higher year to year. But they lack the tools and support needed to convince farmers to adopt system changes to alter underlying crop and pest-population dynamics.

Finding ways to reduce reliance on pesticides has proven elusive over the last half-century, despite general consensus that such system changes are necessary, especially in the case of pest management systems in active decline (e.g., soybean and cotton weed management; whiteflies and thrips in some vegetable and citrus crops). 

Tackling this 5th problem will be difficult and take time. Fortunately, progress in addressing the other four problems will reduce risks in the interim, while also encouraging farmers to invest more management attention in preventing spikes in pest populations. 

Ironically, reducing reliance on pesticides is the surest way to assure effective ones will be accessible when really needed.

Charles Benbrook is a Visiting Scholar in the Bloomberg School of Public Health, Johns Hopkins University, and a Visiting Professor at the University of Newcastle in the U.K. 

Benbrook has served as an expert witness in several major pesticide and food-labeling related cases in which government regulatory policy has played a central role. He worked as a testifying expert in the Lee Johnson case, and is involved in other, similar litigation. 

Visit his website or contact him at charlesbenbrook@gmail.com.

Posted with permission from Environmental Health News.

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