By Steven Levine, Ph.D., Senior Science Fellow and Environmental Assessment Strategy Lead, Global Regulatory Sciences
Every season, for every field, farmers have to make more than 40 key decisions – all of which can make or break a harvest. Many of these decisions relate to crop protection, because at every stage of the growing season, seeds and plants are at risk from weeds, insects and diseases.
Crop protection tools, such as herbicides, insecticides and fungicides, known collectively as pesticides, play an essential role in a farmer’s ability to have a good harvest. At Monsanto, these tools represent an important part of our current product offerings to farmers and are a significant focus of our research and development efforts.
While bringing the most innovative and effective tools to farmers is our focus, we don’t sell anything unless we are fully confident in the safe use of a product. We base our confidence on comprehensive and rigorous safety assessments and conclusions made by regulatory authorities around the world.
Indeed, before Monsanto and other companies can make these tools available to farmers, all pesticides must undergo evaluations by regulatory authorities. In the U.S., the Environmental Protection Agency (EPA) regulates pesticides to ensure they can be used safely, and, like other authorities around the world, their process for reviewing and registering products is exhaustive and based on the best available science.
A key part of the regulatory process for pesticides is the risk assessment. These assessments are conducted on both new and existing pesticides to ensure products pose no unreasonable risk to human health or the environment. To conduct these assessments, the EPA requires companies to fund, perform and submit a wide-range of studies for review by EPA scientists. On average, for a pesticide, we are required to submit more than 100 different studies broadly across the areas of human and environmental toxicology, environmental fate, crop residues, applicator exposure and product chemistry. Completing the required studies for a pesticide and preparing the documentation to support a registration takes several years, and, according to a 2010 study, can cost more than $80 million. In the U.S., federal law requires registrants to assume these considerable costs rather than placing the burden on taxpayers.
When Monsanto and other registrants conduct studies for pesticide regulatory submissions, those studies are carried out according to internationally recognized quality standards called Good Laboratory Practices (GLP), which provide a framework for how laboratory studies are planned, performed, monitored, recorded, audited and archived. These strict compliance guidelines ensure the quality and integrity of the data that are submitted for regulatory review. In the U.S., the EPA strictly enforces the GLP program, conducting regular inspections to monitor compliance and prosecuting any violators.
Among other things, the GLP program ensures studies submitted for EPA review contain all of the raw data that were used to generate the final report. Even if findings are unfavorable to a company’s interest, data cannot be omitted. For registered pesticides, companies are also required by law to report all finding of adverse effects and incidents on an ongoing basis. At Monsanto, employees are notified annually about our obligation to report any potential adverse effects of our products. As consumers ourselves, my colleagues and I fully support these measures to ensure the safety of our products to people and the environment.
As part of the ongoing process to assess the safety of a pesticide, most regulatory authorities, including the EPA, actively seek out and consider relevant information from the peer-reviewed scientific literature and evaluations by other government authorities to supplement information submitted by companies. In fact, the EPA has standard processes in place to ensure supplemental studies are considered and represent sound science.
After a comprehensive and rigorous review of the submitted data and other scientifically relevant information is completed, the detailed risk assessments are made available online and the public is invited to comment. The actual submission by the company is often accessible along with the regulatory authority’s risk assessment or through open records laws unless the data is deemed company confidential. This process helps enable a transparent public process and promote scientific integrity, which is central to EPA decision making.
What’s more, after a pesticide has gone through this exhaustive assessment process and receives regulatory approval, authorities continue to consider new information to assess the safety of registered products. Like other authorities, the EPA conducts new reviews, called registration reviews, at least every 15 years to ensure the data supporting the safe use of a registered pesticide is sufficient based on evolving science and regulations. Beyond these scheduled registration reviews, regulators continually evaluate new information as it emerges and request new studies from registrants under some circumstances to further validate product safety.
In my role at Monsanto, I have dedicated my career to evaluating the environmental safety of pesticides and meeting the regulatory requirements outlined in this article for our crop protection portfolio. While the process presents many scientific and logistical challenges, I am energized every time I talk to a farmer and hear how the products I worked on contribute to a better harvest.