Preserving Lifecycles: Renewing Established Pesticides

The regulation that governs the marketing, sale, and use of pesticides is just a fact of life, but the standards imposed are constantly evolving as our scientific insight and knowledge increases. This series of informational blogs is designed to examine how existing active substances (ASs) are managed through the current regulatory renewal systems in the EU and USA.

We have been using chemicals to protect plants from pests and diseases since 2,500 BC, when, as records show, ancient Sumerians used sulfur to control mites/insects. However, it was really towards the end of the 19th century that the industrial usage of inorganic products and those derived naturally, such as pyrethrum, became common and widespread.

With the rise in the use of such products came increasing concerns about their effect on health and the environment. In the USA, specific regulation of such chemicals first appeared in the early 1900s, but it was not until 1970 that the Environmental Protection Agency (EPA) was created, with the remit of protecting the environment, and the health of humans and other animals. In Europe, the European Council (EC) issued its first directive on pesticide residues in 1976, with extensive regulatory activity beginning in the early 1990s.

Today, the regulation that governs the marketing, sale, and use of plant protection products (PPPs) is a standard part of international agrochemical business. However, the standards imposed by regulation are constantly evolving as our scientific insight and knowledge increases, so ASs and PPPs previously approved as safe may need to be reviewed against new standards.

Today, the regulation that governs the marketing, sale, and use of plant protection products (PPPs) is a standard part of international agrochemical business. However, the standards imposed by regulation are constantly evolving as our scientific insight and knowledge increases, so ASs and PPPs previously approved as safe may need to be reviewed against new standards.

Current Agrochemicals Market Backdrop

The global market for PPPs is expected to register a compound annual growth rate of 5.79% between 2017 and 2022. The growth in the market will mainly be driven by increasing food demand from a growing global population and the need to increase crop yields.2

On a broader political front, the EU is reviewing its current legislation through the REFIT program, while in the USA, President Trump’s reforms to the EPA may also impact the regulatory environment.

Challenges and opportunities also exist in the plant protection market. Important patent expiries are expected in the coming years, and merger and acquisition activity among agrochemical companies is changing the competitive landscape. For example, the merger of Dow Chemical and DuPont has required divestment of certain parts of each company’s business, with the USA requiring DuPont to shed its herbicide/insecticide business (acquired by FMC), and Brazil’s CADE (Administrative Council for Economic Defense) requiring Dow to divest part of its corn hybrid seed business, which it has sold to China’s Citic Agri Fund.3

Against this backdrop, the history, knowledge, and insight about established active substances could get ‘lost’, and such changes may pose risks for reauthorization of PPPs.

AS Review and Re-approval Regulation

In major global markets, regulatory approval usually constitutes two parts: first, approval of the so-called AS or technical-grade active ingredient (TGAI) and, second, approval of the actual end-use or formulated PPPs containing one or more approved ASs. Approvals are usually time-limited; therefore, both the ASs and the PPPs must be reapproved and reauthorized once approval lapses. The most sophisticated and developed programs for review and re-approval of ASs and PPPs are in the major US and European markets. This series of blogs focus on the review programs in use by those regions while recognizing that other important markets, such those in Japan, Australia and New Zealand, Canada and Brazil, have well-developed crop protection legislation to ensure safety to humans and the environment when PPPs are authorized for use in their territories.

The next blog in the “Preserving lifecycles: renewing existing plant protection active substances” series explores US regulation of ASs and PPPs.

About the Author

Gary started his career at Covance in 1985 and is currently the Business Lead Consultant for Crop Protection. As the business lead, Gary provides regulatory advice to Covance’s customers to ensure their programs of work and applications for active substance approval or product registration meet the highest possible scientific and regulatory standards set by global authorities.

1. Useful References1. Aspinal A. Pesticide usage in the United States: Trends During the 20th Century. Center for Integrated Pest Management. CIPM Technical Bulletin 2003; 105.

2. Mordor Intelligence. Crop protection chemicals (Pesticides) Market – Global Industry Growth, Trends, and Forecasts (2017 – 2022). Published February 2017. www.mordorintelligence.com/industry-reports/global-crop-protection-chemicals-pesticides-market-industry

3. Reuters. BRIEF-Dow to divest a portion of its corn hybrid seed business in Brazil to CITIC Agri Fund for $1.1 bln. 11 July 2017 http://uk.reuters.com/article/brief-dow-to-divest-portion-of-its-corn-idUKASA09WQR

For more information about Covance’s regulatory services for crop protection, click here.