Regulatory threats to pesticides

Crop protection chemicals have always had to comply with legislation to protect people and wildlife.

But over recent years that legislation has become tougher, forcing products from the market and preventing new materials from arriving. And the pressure continues.

Farmers could permanently lose neonicotinoid insecticides, metaldehyde slug pellets, triazole fungicides, chlorpyriphos insecticides and a raft of other products too, and face significant limitations on the use of pesticides that continue to be approved.

“We are essentially moving towards a European regulatory system more driven by ideology than science, and that is more than a little concerning,” says John Peck, BASF’s technical lead for the UK and Northern Europe.

The regulatory system once looked at the intrinsic hazard a pesticide posed and the factors in place to minimise that hazard. It was a risk-based system. But it is increasingly looking at hazard alone, ignoring the factors put in place to minimise that hazard. “It is a flawed concept,” Mr Peck warns.

This new wave of legislative pressure could leave farmers with a very depleted chemistry set (see Table 1). In some cases entire crops could become uneconomic to produce; in others the use of certain pesticides may only be permitted in certain parts of the country, at certain times of the year, or on certain parts of the farm.

“The next few years could present a real challenge for the agricultural sector in terms of crop protection,” says Don Pendergrast, NFU plant health adviser.

“With EU regulation on pesticides becoming increasingly hazard-based, we appear to be moving away from an appreciation of real field risk and management of those risks. The result is ever-tightening restrictions, based often on theoretical risk and a requirement for absolute certainty, that ignores the balance that needs to be struck between protection of the environment and food security.

This represents a real danger to UK agriculture, because the regulatory change could outstrip the development of alternatives, forcing significant challenges across the UK crop production sector.”

High stakes

The stakes are certainly high. On the one hand, ever more precise science is identifying more potential impacts on people and the environment, which increasingly cautious policymakers are reacting to. On the other hand, there could be profound impacts on crop productivity.

The latest twist in the European Commission’s long-running Endocrine Disruptor Review highlights the challenge. Endocrine disruptors, including azole fungicides, may interfere with natural human hormones, because of their strong potential to bind with estrogen or androgen receptors.

A new proposal from the EC’s Directorate General for the Environment could lead to a ban on all azole fungicides, because it draws no distinction between high and low levels of endocrine disruption, nor does it require any evidence of such activity having a harmful effect in an intact organism.

A forecast from Italian research institute Nomisma suggests the loss of triazole fungicides would cut EU wheat yields by 12%, as they are left more vulnerable to septoria. The crop area would need to rise by 14% to maintain the EU’s self-sufficiency in wheat. It could cost the EU €4.6bn (£3.9bn) a year by 2020.

Closer to home, ADAS suggests that in addition to cereal yield losses, the demise of key triazoles could mean inferior disease control and plant growth regulator benefits in oilseed rape, cutting yields by almost 10%, costing the UK economy an estimated £75m/year. A further study by Teagasc in Ireland suggests wheat would be uneconomic to produce there if triazole chemistry were not available.

The EC’s much publicised two-year suspension of the use of key neonicotinoid insecticides, ostensibly to protect bees, is further evidence of the shift to a precautionary, hazard-based approach. DEFRA is contesting the restriction, and has commissioned new work to better understand the situation.

The Humboldt Forum for Food and Agriculture suggests a complete ban on the use of neonicotinoid insecticides would mean that an additional 3m hectares of land would need to be farmed to maintain EU crop productivity, costing as much as €17bn (£13.8bn) over five years.

Nick van Westenholz, head of the UK’s Crop Protection Association, is particularly concerned by the politicisation of the issue. “It very clearly became very political and we need to avoid those sorts of knee-jerk reactions. We need a clear and consistent regulatory system where we all know the rules.”

But there is huge pressure for the rules themselves to further reflect the precautionary, hazard-based approach. The European Food Safety Authority has issued guidance suggesting all pesticides, not just insecticides, should be assessed for bee safety, with a headline lab-based assessment so stringent that 90% of current pesticides would fail for honey bees and 100% for bumble and solitary bees.

“The complexity of the second tier environmental studies that would then be required is such that there is no agreed methodology and there simply would not be the capacity to undertake the work in Europe,” says Mr Peck. “The bottom line is that it would be pretty much impossible to register any new insecticides, or re-register existing ones, and much more difficult and expensive to register other products such as herbicides and fungicides.”

This drive for a more hazard-based, precautionary approach is being enshrined in Brussels legislation. Here we hit some cumbersome names, but the gist is that various regulations and directives have been harmonised across the EU, following the EU Thematic Strategy for Pesticides, leaving two key pieces of legislation bearing down on pesticide availability:

  • EC Regulation 1107/2009 covers the registration of new active substances, renewal of existing approved active substances and regulation of plant protection products to ensure their safety and effectiveness.
  • EC Directive 2009/128 regulates the sustainable use of pesticides in Europe, covering the laws relating to the use of pesticides, adopted in the UK as the Plant Protection Products (Sustainable Use) Regulations 2012, which the UK’s regulatory body for pesticides, the Chemicals Regulation Directorate, implemented last July, and which is intrinsic to DEFRA’s 2013 UK National Action Plan for pesticides.

EC 1107/2009 effectively takes over from EC Directive 91/414, which oversaw the evaluation, authorisation and approval of pesticide active substances, giving them a place on the coveted Annex 1 list of approved substances if successful.

With new scientific understanding, that process led to the loss of many previously popular pesticides, either because they did not meet the tighter standards, or the cost of generating data to meet those standards was not justified by their potential sales.

The fly in the ointment is that the process continues. Annex 1 listings were only ever meant to last for 10 years, so a second round of reviews is now under way, creating a potential “death row” scenario, as pesticide review dates come up between now and 2020.

The good news is that the first seven active substances from Annex 1, including azoxystrobin, imazalil and fluroxypyr, were successfully renewed (under EC Regulation 737/2007) and added to the List of approved active substances, effectively creating a first tier of pesticides with a clean bill of health (until further requirements are imposed).

At present 31 more active substances are being reviewed under EC Regulation 1141/2010. Known as AIR 2, approvals in this group should be renewed, or revoked, by late 2015. It includes bentazone, diquat, glyphosate, metsulfuron, picolinafen and sulfosulfuron. A third stage of renewal for other active substances is expected to follow.

Even when a pesticide has passed the EU’s stringent approvals process, there are requirements for safe use. EC Regulation 396/2005 covers maximum residue levels in or on food and feed, and there is also the UK Food and Environment Protection Act 1985. The residue issue is putting pressure on potato sprout suppressant chlorpropham (CIPC), for example, where further stewardship is needed to prevent the 10mg/kg limit being exceeded, to satisfy the scrutiny of the UK’s Advisory Committee on Pesticides.

Other regulatory pressures include the EU’s Water Framework Directive (WFD), which came into force more than 10 years ago, to protect surface and drinking water quality. It led to the demise of the popular cereal herbicide isoproturon (IPU) in the UK and huge pressure on metaldehyde, the active ingredient in many slug pellets, which is now the biggest pesticide issue preventing the Environment Agency from meeting its WFD commitments.

The Voluntary Initiative, which encourages farmers, contractors and operators to handle pesticides more responsibly, has helped reduce pesticide impacts. Specific initiatives such as Say no to Drift to protect key insecticide chlorpyriphos and Get Pelletwise from the Metaldehyde Stewardship Group, aim to further protect specific active ingredients.

But with metaldehyde residue levels rising during last year’s wet winter, back above levels seen before the MSG started in 2008, targeted restrictions on the use of metaldehyde could be applied to 80 Drinking Water Protected Areas and associated upstream Safeguard Zones.

So will the research pipelines of the major manufacturers save the day? Probably not. Scientists are struggling to develop products able to comply with tough legislative requirements and to command enough sales potential to offset development costs now put at more than €200m (£170m) over 10 years for each new active substance launched. Unless a new pesticide has a place in the world’s key crops – maize, soya, rice and cotton – it can struggle to make it to market.

Regulatory pressure, combined with the growth of pesticide-resistant weeds, insects and diseases, means the farmer’s chemistry set is clearly destined to dwindle.

Key at-risk pesticides

Active ingredient Use Threat 
 Neonicotinoids Insecticide Ban
 Metaldehyde Slug pellets WFD
 Chlorpyriphos Cereal foliar insecticide  WFD
 Propyzamide Herbicide WFD
 Carbetamide Herbicide WFD
 Triazoles Foliar fungicide WFD
 Chlorpropham Sprout suppressant MRL
 Glyphosate Herbicide 1107
 Pendimethalin Herbicide 1107
 Sulfusulfuron Herbicide 1107

Key: WFD – Water Framework Directive, EDR – Endocrine Disruptor Review, 1107 – EC re-approval regulations; MRL – Maximum Residue Limits


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