Crop Enhancement provides a pathway to improving how we grow food and will have a lasting impact on today’s food production chain. But what are the regulatory hurdles that must be overcome in order to get to market?
by Kevin Chen
Today, I sat down with Jerry Hjelle, Ph.D, D.A.B.T., an expert in food safety and global regulatory affairs who is excited about the prospects for Crop Enhancement’s technology in different applications. Jerry is a member of the Crop Enhancement Industry Advisors Board and actively advises the company on global regulatory strategy.
Jerry is president of Hjelle Advisors LLC, a regulatory science, regulatory affairs, and research and development consulting network offering services and strategies for startups and early-phase companies. Previously, he worked at Monsanto from 1986 to 2015 in various director or vice president positions in Monsanto’s nutrition/consumer products and agricultural products businesses, including as vice-president of Regulatory and vice-president of Science Policy. In these roles, Jerry was involved with many breakthrough products including aspartame, neotame, glyposhate, and several agricultural and veterinary drug biotechnology products. Jerry’s complete bio can be found here.
What in particular interests you about Crop Enhancement?
Sustainable agriculture is a key interest of mine, and Crop Enhancement is dedicated to the pursuit of finding safer and sustainable approaches to pest management. Crop Enhancement’s technology is elegant, demonstrably safe, and addresses an unmet need to control economic insect pests and pathogens. As an advisor, I like to get involved with a company early on to shape the product strategy and ensure compliance with regulations in various countries. Making the right decisions early in the product development phase is very important — the business decisions a company takes today can ensure avoidance of wrong turns. That said, de-risking product development is critical at every stage, not just pre-launch.
What are the major trends shaping the regulatory landscape worldwide?
There’s mounting pressure on developers, regulators, downstream food companies and farmers themselves to grow and market safer products. Unfortunately, the complexity of how agriculture works and how we determine whether a product is safe for a particular use leads to confusion, and some groups use this confusion to sow distrust in science globally. In the case of pesticides, there are emerging alternatives to older, more toxic chemicals — and Crop Enhancement’s approach is both novel and safe.
At the same time, consumers today have high expectations of corporate responsibility, and they are interested in having farmers of all sizes —not just the very big operations— implement sustainable operations. These factors are influencing the behavior of both companies and regulators, and those companies that focus on scientific breakthroughs to enable a lower ecological footprint will be valuable.
Another trend we’re seeing is the emergence of trade wars. Should these escalate significantly, they may prolong time to market in affected countries. Although product launches occur one country at a time, the regulatory strategies to enable commercial success in one country can be determined by the approvals needed in importing countries.
Increasingly, food safety and local/international agricultural economies are intertwined. Ag is a large part of the economy for many countries—especially in the less developed countries—and so ag exports are increasingly important to governments and their regulatory bodies. For example, growers in one country may use pesticides that are legal domestically. However, in the country to which that food is to be exported, that same pesticide may be banned or may be acceptable at such low levels that disruptions in trade are a possible outcome.
What’s driving the need for safe and ecologically friendly crop protection strategies?
Regulatory pressure is a key driver here, and it’s especially noticeable in two areas:
- Longer-term, there is a need for systematic removal of older pesticides that represent human applicator toxicity concerns, residue issues, or products that are more prone to be formulated or applied incorrectly (leading to human or animal poisoning or environmental damage). Over the years, companies have developed new chemistries to address these concerns and lower the so-called “pounds on the ground” application rates in order to lessen target effects.
- Removal of specific pesticides from some markets after new data indicate adverse effects. For example, unexpected effects of chemicals on beneficial insects like honey bees has led to the EU’s decision to ban neonicotinoid-based pesticides.
What do you see as the implications for other pesticides and longer-term trends?
A key aspect of understanding the safety of pesticides, or any product for that matter, is a clear description of the dose required to produce toxicity and a well-defined intended use to allow an estimate of exposures. If the pesticide has low toxicity compared with the estimated exposure, then the product has a high safety margin. Some of the older, more toxic pesticides yield safety margins that are now too low when calibrated against the modern standards of leading regulatory agencies in the US, EU, Japan, and other countries.
Because of toxicology- and development-related costs, and regulatory review timeframes for a truly new active ingredient, only a handful of global companies have the capacity, from a resources perspective, to be successful. But regulatory agencies globally have developed guidelines that recognize that some products are inherently safer, based on mechanism of action and other attributes. Therefore, it is essential to build in the environmental and human health friendliness aspects into the entire R&D effort.
The base technology that Crop Enhancement is developing accomplishes just that. It leverages an understanding of insect pest feeding behavior and critical application periods, and uses non-toxic ingredients that will be an important addition to the grower toolbox.
From a regulatory standpoint, what is the appeal of using a product such as CropCoat?
I think there’s a growing understanding that insect pest management doesn’t always have to involve neurotoxins or other mechanisms, but rather can leverage understanding of insect behavior using a more systems-based approach for crop protection. Also, the testing and securing approvals for new active ingredients or formulations is getting more complicated each year.
Crop Enhancement’s products are formulated from components that are well understood, are of low toxicity, and are arguably much safer for the environment. Many regulatory agencies have specific testing and approval pathways for products or formulations that meet these characteristics. Although each country is somewhat different, most have easier paths to approval and market, and this is a key benefit of Crop Enhancement’s approach.