Members of the 20162017 Arizona Crop Protection Association board of directors include front row from left  Mike Charles President Andy Hancock Willie Negroni Clark Webb and Cory Weddle Back row from left  Chris Denning Ken Narramore Treasurer Hank Mager and Andy Hampton Not pictured are Ty Currie and Vice President Jeff Boydston

Members of the 2016-2017 Arizona Crop Protection Association board of directors include: front row from left - Mike Charles, President Andy Hancock, Willie Negroni, Clark Webb, and Cory Weddle. Back row from left - Chris Denning, Ken Narramore, Treasurer Hank Mager, and Andy Hampton. Not pictured are Ty Currie and Vice President Jeff Boydston.

‘Discovery to launch’ – the slow road to bring pesticides to market

The average cost to bring a new farm chemical active ingredient to market from 2010-2014 was a budget-busting $286 million – about $134 million more than in 1995. Most research on new AI's focuses on the product’s impact on the environment and human health. That’s the way it should be, says Jesse Richardson of Dow AgroSciences.

Farmers often wonder why pesticides are expensive and why it takes so long to bring crop protection products to market.

The answer largely lies in the high costs associated with the discovery of a new pesticide active ingredient and the lengthy process to bring it to market. Also, chemical companies spend huge amounts of time and money to produce mountains of data to meet federal and state government requirements to achieve pesticide registration.

According to new data, the average cost to bring a new active ingredient to market from 2010-2014 was a budget-busting $286 million – about $134 million more than in 1995, according to the agricultural data firm Phillips McDougall.

 

 

The company says the average time from product discovery to market launch averaged about 11.3 years during the same time frame, four years longer compared to 1995.

“Product development and registration requirements are complex, interrelated, cross functional, and extremely expensive,” says Jesse Richardson, research scientist with Dow AgroSciences (Dow).

Richardson explained the lengthy and expensive process with pest control advisors and other agricultural industry members at the 2016 Desert Ag Conference held in Chandler, Ariz. in April, sponsored by the Arizona Crop Protection Association.

The Dow scientist provides technical services and product development support in agronomic and horticultural crops in California, Arizona, and New Mexico. He recently marked his 30th year with the company.

He has served as an adjunct professor at California State University, Fresno since 2009, guest lecturing in upper division pest management courses.

“When I look at a jug of farm chemical, I think of the tremendous amount of work that went to bring the product to market, and the incredible investments of money and time,” Richardson told the crowd.

Richardson prefaced his conference remarks, saying his comments were about the farm chemical industry overall, and not about every farm chemical company or Dow specifically.

Three stages of pesticide development

Richardson says many chemical companies follow three phases or stages to bring a pesticide active ingredient to market – discovery, pre-development, and development. The initial product discovery is kept hush-hush.

“When a new AI is discovered, chemical companies play this very close to the vest,” he says. “We keep it very quiet.”

During the tight-lipped period, the product’s potential uses are identified. The company determines initial use rates, product uses (insecticide, herbicide, fungicide, etc.), and its competitive performance against other products already in the marketplace.

The optimum formulation is determined, whether it’s an emulsifiable concentrate, wettable powder, a suspension concentrate, an oil dispersion, or other formulation. Companies also conduct critical preliminary toxicology and environmental evaluations.

On the legal side, companies assess if the product could meet registration requirements at the federal and state levels. A patent assessment determines whether another company has already patented the same chemistry.

Sales, volume, and profit estimates are established to determine if the product can financially make money for the company. If not, the company leadership will likely axe the product.

Launch of the green chemistry era

Richardson shared one Dow AgroSciences-specific story on a new product discovery. A Dow discovery scientist was on vacation in the Caribbean where he found an abandoned rum still. The scientist took a sample of the soil back home.

It is important to note that the site where the sample was found was part of company discovery efforts, and the scientist, even though on vacation, followed the correct protocols to bring the sample back.

In the Dow lab, he discovered the soil sample contained a new bacterium which during fermentation yielded a potent insecticide which had the performance attributes of a synthetic product, yet with the “eco-tox” package of a biological product.

This led to Dow’s introduction of the active ingredient spinosad in Dow’s Success SC and Entrust SC insecticides. Richardson says this AI started the “green chemistry” revolution.

Pre-development stage

The second step is pre-development, a very costly stage at that.

Richardson says, “If you are going to kill a product, you want to kill it before you get to this stage since the company spends serious money here to further the product for the market.”

Pre-development work focuses on product mixture candidates, commercial formulations, and identifying the best fit for product use globally. For example, would the product be a better fit for use in the Americas, Europe, or elsewhere?

In many cases, university researchers are asked to examine the product and provide the company with valuable feedback.

Development stage

The third and last stage – the development phase - includes finalizing the product studies for submission to the Environmental Protection Agency (EPA) for registration consideration.

Production, manufacturing, and packaging facilities must be completed since the product is near launch. A detailed business plan is put into place.

Bathtub pesticides?

As a sidebar note, Richardson said, “People outside of industry may think we only come up with a new product, mix it up in the bathtub, register it, and send it off for people to test it. It’s actually a very complex, highly regulated, and involved process from start to finish.”

When all three stages are completed, the chemical company submits its data electronically to the EPA for review, and to other countries if applicable. The paper document version can almost cover the wall of a room.

Federal law requirements

Submitted pesticide data to EPA must meet the criteria in four U.S. laws, including the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) which requires that any pesticide sold in the U.S. must first be registered by the EPA and states; and the Federal Food, Drug, and Cosmetic Act which governs pesticide tolerance, including the maximum residue levels (MRLs) of pesticide.

The third federal requirement falls under the requirements of the Food Quality Protection Act (FQPA) of 1996. This law amended FIFRA and FFDCA to increase product safety requirements for infants and children. The fourth law, the Pesticide Registration Improvement Act or PRIA, requires chemical companies to pay EPA to evaluate their products.

EPA enforces FIFRA, FFDCA, and FQPA.

“For those of us in research and development, the day a product receives EPA registration is a day of celebration since we spent so much of our lives, heart, and soul in the effort.”

Safety first!

Throughout a company’s product development process, he says the constant goal is product safety.

“The majority of the research is focused on the product’s impact on the environment and human health. That’s the way it should be,” says Richardson.

EPA motivates chem companies

While many in the agricultural industry are critical of the EPA’s perceived overreach, Richardson praised the agency for taking an action which has helped chemical companies. When EPA launched its reduced risk pesticide program, companies with such products in the pipeline received faster reviews by the agency, saving the companies money and time.

Richardson called the EPA move a “motivation.”

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These pesticides must have reduced risks to non-target organisms and the environment while performing similarly to other pest control strategies currently on the market.

“This move was a major motivation for chemical companies,” he says. “Since EPA’s reduced risk program took effect, many pesticides developed today are reduced risk products.”

In summary, the pesticide process is lengthy and expensive. Farmers continue to see fewer new pesticide products come to market for those reasons, and since the “easy chemistry” has been found, says Richardson.

“It’s harder and harder to find new active ingredients. This is despite the fact that chemical companies are screening more molecules than ever before.”

Only one in 160,000 active ingredients discovered today will pass the rigorous testing requirements to become a registered pest management product.

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