Insight •  2023-11-10

A look at the Corteva Agriscience crop protection product regulatory process

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corteva regulatory team

What does it take to deliver performance, quality and stewardship to your crops? Here’s a brief look at the process Corteva Agriscience follows to develop sustainable and innovative crop protection solutions for Canadians.

On average, it can take between 10 to 15 years and hundreds of millions of dollars to take a registered crop protection product from discovery to commercialization. The path to deliver products like herbicides or seed treatments follows strict regulations and processes to ensure they offer a sustainable solution to help farmers, growers and end-users of crop protection products.

The process starts with identifying a solution to a problem, like managing a new type of pest or one that has become resistant. Corteva Agriscience is focused on generating sustainable innovations that benefit both farmers and society as a whole. Optimal product effectiveness, lowest application rates and maximum benefits must be weighed against factors like risks, economics, alternative solutions, and existing products. Once the need for a new tool or on-farm solution has been identified, our experts work to identify molecules, screen them and develop the necessary chemistry.

Product development is a lengthy process, identifying a single candidate chemical out of thousands, conducting comparison studies, finding the right formulation for optimal delivery of the chemical solution and as well as building other concepts in the innovation pipeline. Building the product registration dossier includes studies for the active ingredient as well as product testing for chemical and physical properties, efficacy, toxicity among many others to assess potential human health and environmental impact. A new crop protection product can undergo more than 300 individual research studies across the globe. One of our newest global innovations, Reklemel™ active involved 10 years of testing in various areas and soil types. Through this research, Corteva scientists developed a sustainable solution allowing flexibility through excellent crop safety, planting, and application timing. Assessing any potential product risks along with benefits through responsible research and development is a process that takes years and considers various climates, geographies, soil types and growing conditions.

Once a solution has been fully developed and characterized, the registration process begins. Here in Canada, Health Canada’s Pest Management Regulatory Agency (PMRA) is responsible for pesticide regulation in Canada. The process to register a new active ingredient and its end-use products in Canada can take two to three years, and Corteva Agriscience has dedicated teams of regulatory and stewardship (RAS) professionals in Canada and around the globe to ensure the product is managed throughout its lifecycle, from submissions and renewals to discontinuation.

Canada is well known for having some of the most stringent regulatory systems in the world for any controlled or regulated substances, consequently the PMRA follows a diligent screening and evaluation process. The first step is to determine if the product offers value and benefit to Canadians. All studies, data and information are assessed and evaluated by the PMRA’s many scientists and professionals using the registration dossiers prepared by Corteva Agriscience.  The PMRA reviews and evaluates all of the research and studies and can request additional information to thoroughly assess the potential impact of the product on both human health and the environment through product risk assessments. Once a proposed registration decision has been determined, the PMRA publishes a detailed summary of how the decision was made as a public consultation open for anyone to comment or challenge their decision. Open publication has been an important part of the process for many years for transparency and is an opportunity, offering stakeholders, interested parties and anyone among the general public an opportunity to weigh in on a decision made for Canada. A thorough peer review of all research, studies, and data evaluation as well as all comments received during the public consultation is also part of the PMRA’s thorough review process. Only once a final product registration decision is made can the crop protection product be sold and marketed in Canada.

The product registration process isn’t just for new products coming to market. The PMRA is also responsible for conducting any necessary reviews of products and active ingredients throughout a registered product’s lifecycle. For example, if an existing chemistry is being considered for a new use, combination with another chemistry, or requires a re-evaluation or special review to allow continued use in Canada, the PMRA is involved.

As new crop protection application technology continues to emerge, like the use of drones, thorough testing and product use registrations are also required by the PMRA. Corteva Agriscience works diligently to meet or exceed all requirements of a country or region-specific regulating authority to ensure farmers, growers and all end-users around the world have access to the best innovative and sustainable solutions and technology required to sustainably produce crops in today’s globally competitive environment. We’re proud to provide our customers with the finest in reliable agricultural solutions through scientific excellence and our amazing people in R&D, regulatory affairs, stewardship and throughout Corteva Agriscience, all while operating under the highest standards for ethical, responsible and sustainable practices.