Biocontrols Could Quadruple By 2025; Will Regulators Play Along?

Biocontrol as a business is growing indeed — U.S. $1.7 billion in value in 2014 and projected to quadruple to U.S. $7 billion by 2025, as reported by Syngenta’s Rob Neil and Dr. Gerardo Ramos at the recent ninth Annual Biocontrol Industry Meeting (ABIM) in Basel, Switzerland. Key positive drivers include product performance, favorable public perception, resistance management programs and a steadily growing call in the food processor/retailer and consumer sectors for reduced or even no pesticide residues.

BioControls 2015

Advertisement

But growth will have its challenges, especially in emerging markets.

Top Articles
TFI: Phosphate and Potash Are Critical Minerals, Senate Bill to Solidify

On the commercial side, creating demand and educating growers about the benefits of biocontrols alongside conventional (often lower-cost generic) agrochemicals will be difficult, particularly in production areas such as China and India where growers are smaller and more fragmented. On the technical side is a need for developing local formulation know-how and dealing with an “evolving” regulatory environment.

A Better Regulatory Reception Ahead?

Can manufacturers hope to be greeted with a more ideal regulatory system that is less bureaucratic and time-consuming, less politicized and expensive than has often been the case with crop protection products and genetically-modified organisms (GMOs) — something more along the lines of the Canadian model?

Prof. Joyce Tait of the Innogen Institute, University of Edinburgh, is guardedly optimistic. She believes the odds of reaching a Canada-like regulatory environment for crop protection/production products in Europe have increased from less than 50% a few years ago to more than 50% now, especially with signs that the European Commission could become more open to “enabling innovation, minimizing risks to people and the environment, and balancing the interests and values of all relevant stakeholders.” And with European Union (EU) regulators typically viewing their system as the “gold standard” for regulatory vigor, this could have global implications.

Tait’s involvement in deciphering the social impacts of regulation in crop protection dates to the 1970s, and while biocontrols “don’t have as much negative perception” as GM crops or traditional chemicals, she believes today’s manufacturers have inherited some of the regulatory legacy of GM crops. Working in an unprecedented regulatory environment, developers of GM crops in the 1990s asked that their products be regulated like chemicals “because the companies felt comfortable with this path,” Tait said. The result was a missed opportunity to create a regulatory system that accommodates what she called “disruptive innovation” in the life sciences, including crop protection.

Instead what we have is “regulation that needs to be enabling of innovation,” allowing smaller, innovative life sciences companies to grow up to become big companies like their tech counterparts Google and Apple. Too often such smaller R&D firms — facing the complexity and cost of registering their products — must sell out to multinationals, and “what you end up with is an innovation system that is dominated by multinationals.”

Exacerbating the GM issue were a few industry missteps in managing public perception, such as the acquisition of seed companies by traits developers “as their route to markets” — unpopular in Europe and “one of the reasons the European public opposes GM crops” today. Had this not occurred, GM products with nutritional qualities such as Syngenta’s GM tomato puree “might have had a better reception in Europe,” Tait said.

She sees a line from GM crops to the biologicals of today. “There is [still] no clear regulatory path,” she said. “In effect the regulatory bodies have said, ‘We’ll regulate biologicals as if they’re chemicals.’”

How To Engage Stakeholders

There is understandable frustration with the EU’s regulatory system, which Tait said “could be described as a mess.” She said “it’s a European tendency to regulate across the board in a way that’s not really thinking things through. It’s important [for industry] to extend the thinking.” But biocontrols manufacturers may be able to avoid many of the regulatory pitfalls and consumer pushbacks that befell GM crops through “constructive stakeholder engagement,” parallel to the pursuit of regulatory approvals.

Biologicals in Emerging Markets Map.

Attitudes on Biologicals in Emerging Markets.. Click to enlarge

Tait highly recommends “The Debunking Handbook,” by John Cook and Stephan Le­wandowsky, which was developed to counter climate change deniers but which can be used effectively for any lobbying cause, including crop protection. She said “effective debunking” requires three major elements: (1) The refutation must focus on core facts rather than the myth, to avoid misinformation becoming more familiar; (2) Any mention of a myth should be preceded by explicit warnings to notify the reader that the upcoming information is false, and (3) The refutation should include an alternative explanation that accounts for important qualities in the original misinformation.

Tait offered other tips for engaging stakeholders effectively, among them:

  • Accommodate the full range of relevant opinions — the general public, scientists, industry and users of the technology.
  • Consider not just science, but also innovation and regulatory processes.
  • Consider also the benefits of the technology and weigh it against costs and risks.
  • Develop standards for engagement — including criteria for the quality of evidence on which decisions will be based.
  • Be equitably skeptical of the motivations of all stakeholders you engage, and do not allow one single perspective to dominate other opinions. Tait noted the “hearts and minds” duality of technology-related conflicts — that usually there are 20% that are “ideology-based” hearts, 20% who are “interest-based” (minds), and an uncommitted 60% squeezed in the middle.
  • Carefully consider timing. If approval for a new technology is pursued too early, it may be undermined by the level of uncertainty around the nature of future developments. If too late, stakeholder opinions and political positions may become so entrenched that accommodation will be difficult to achieve.
  • Manage expectations. It’s unlikely that all stakeholder views can be accommodated.

But more than anything, Tait suggested, don’t overreact. Engagement with stakeholders for biologicals and other crop protection products does not need to be lessened, it just needs to be more targeted and constructive than it has been in the past.

0
Advertisement