Q. How do crop protection products receive regulatory approval?
A: Securing regulatory approval for crop protection products is an extensive process, requiring an average of 11 years between discovery and commercialization, significant cost investment, and the submission of detailed safety and efficacy data to authorities.
Because crop protection products interact with our environment and support our global food chain, their development and sale is highly regulated, with individual markets and countries maintaining their own rigorous approval standards. Each new product typically requires that the company seeking approval carry out more than 150 safety studies, as well as generate ongoing data after approval as part of periodic reviews and safety monitoring by regulatory authorities.
Q. Why is regulatory data transparency important?
A: One of Corteva’s most important responsibilities is ensuring the safety of our products – for humans, animals and the environment. We understand that in order to enable customer success and improve consumer confidence, it is essential to enhance transparency into the development and regulatory process for crop protection products.
Consistent with this, we support industry and regulatory efforts to make information about safety measures, efficacy and benefits of crop protection products more readily accessible to all stakeholders.
Q. What information is Corteva sharing with the public and why?
A: We understand that being more open about not just what we do, but how we do it is of interest to consumers and is important to the success of our farmer customers and our own success. This includes the development and regulatory process for our crop protection products. To that end, we created this website to provide stakeholders with information about the product development, scientific assessment and regulatory processes for crop protection products and how they contribute to meeting the needs of our customers and supporting the global food supply. We look forward to adding further resources in the future.
With respect to the safety data provided to regulators,Corteva supports the efforts of industry and regulators to promote greater transparency by making available scientific assessments, safety studies and other related information submitted to European regulators. Consistent with EU Regulation 2019/1381, submissions made by Corteva in 2021 and beyond will be listed on this website, and the related documentation will be accessible via the European Food Safety Authority (EFSA) website.
Q. What is EU Regulation 2019/1381?
A: In June 2019, the European Union (EU) formally adopted a new regulation amending the existing EU General Food Law (GFL). This new regulation is aimed at increasing the transparency of EU risk assessment in the food chain, as well as strengthening the reliability, objectivity and independence of the studies used by the European Food Safety Authority (EFSA).
As part of this amendment, EFSA will, among other things, disclose scientific data, studies and other information supporting applications for the approval of crop protection products. This information will be made public on a dedicated section of the EFSA website for all applications involving EFSA review and made after 27 March 2021.
Q. How are safety studies conducted and what information do they provide?
A: Safety studies assess the active substances in crop protection products according to the rigorous requirements set out by regulatory bodies worldwide. Each substance must meet the standards defined in more than 150 safety studies before it can be brought to market.
Through these assessments, a company must test all routes of exposure over different lengths of time and at different concentrations to examine the impact to users of the product and consumers, as well as to the environment. In short, safety studies tell us how crop protection products interact with the environment and the body. From the safety studies, we learn:
How the active substance behaves in plants and the environment (soil, water, air), what does it degrade into and at what pace, how long does it reside in the environment, whether it may accumulate in any form of wildlife.
Whether the substance shows toxicity to humans and wildlife, what are the symptoms, what is the exposure above which they appear and below which they don’t.
What are the conditions under which the substance is effective without harming humans, animals, plants or the environment, i.e. how can it be used effectively and safely.
Q. What use do external regulators make of safety studies?
A: Regulators use data from safety studies to determine if a product is safe for use. This means assessing the dose levels that produce toxic effects and comparing them to the exposure that will result from the product’s normal use. If the exposure is well below (at least 100x lower) doses that cause no adverse effects in the studies, the product is considered to be safe for use.
Q. Can products exhibit certain toxic effects and still meet the standards of safety studies and be approved for use?
A: Almost any substance can become toxic in certain quantities, including the most basic chemicals such as water and oxygen. Toxicity is what occurs when an organism cannot effectively process the substance, creating a toxic effect.
Crop protection products are designed to be toxic to the weeds, pests and diseases they are used to combat; and safety studies are specifically designed to identify their toxicity on the environment and the body. Chemicals are tested at sufficiently high levels to show toxicity in representative species, so virtually every safety study will show toxic levels for a chemical, even if that level will never be reached in how the product is ultimately used.
Through these studies, regulators can understand the safety profile of the chemical and estimate what the exposure level will be based on the product use. As noted in the question above, if the exposure is well below (at least 100x lower) doses that cause no adverse effects in the studies, the product is considered to be safe for use.
Q. How trustworthy is the information in these studies, given that they are conducted by companies themselves?
A: Studies are conducted following Good Laboratory Practice guidelines, which are internationally agreed upon standards that are part of the 1981 European Council Decision on the Mutual Acceptance of Data in Assessment of Chemicals. In addition to closely monitoring compliance with these standards internally, Corteva, like all other companies, is subject to external monitoring, inspections, and audits by regulatory bodies. This includes observation of testing in Corteva’s facilities and document inspections. GLP guidelines ensure that studies are traceable at any stage, from initiation to archiving.
Q. What information is already publicly available?
A: All relevant health and environmental safety information is already public. It is included on product labels and in brochures, disclosed on websites, published in scientific literature and disclosed in summaries by regulatory authorities.
In the EU, the European Commission publishes regulatory risk assessment and study summaries for all active ingredients and some crop protection substances, alongside authorization decisions. The European Food Safety Authority also publishes a peer-reviewed journal that includes examinations of active substance registration reports.