Biopesticides Pilot Scheme launched

With the recently completed EU pesticides review having led to the withdrawal of over two thirds of the 1,000 or so existing active substances under evaluation, and with newer legislation set to cut a second swathe through what is left, interest in biopesticides across the sports and amenity sector is at an all time high. However, before they become mainstream products in turf care, biopesticide producers need to negotiate an imperfect regulatory system and see a viable route to market.

Natural born killers

The majority of biopesticides are based on naturally occurring microorganisms such as bacteria, fungi and viruses which are pathogenic to the target pest or disease. These are isolated from the soil or from insect cadavers before being mass produced and formulated for application to crops. One of the oldest, Bacillus thuringiensis, was originally identified as a pest of silkworm caterpillars in Japan at the start of the 20th century and, by the late 1930s, was being used commercially in France to control caterpillars in crops.

The range of biopesticides has increased considerably over the last fifty years, and now includes products for controlling foliar and soil-borne diseases, insects, mites, nematodes and even weeds.

As the relationships with their host organisms evolved over millions of years, microbial biopesticides generally exhibit a high degree of specificity with very few non-target affects, often making them more benign alternatives to broader spectrum chemicals. Most are unable to persist in the environment for very long without a suitable host so, once their work is done, they either return to an equilibrium or disappear altogether.

Another large group of biopesticides is based on plant extracts, such as garlic or citrus, which exhibit a variety of pesticidal effects as a consequence of their often complex chemical compositions. These may include suppressing feeding or oviposition, interfering with the synthesis of essential compounds, stripping away protective coatings, or direct toxicity.

Despite the many benefits of biopesticides over synthetic agrochemicals, they do have some significant drawbacks. They are often more variable in their affects than their chemical counterparts, a fact that accounts for their almost exclusive use in protected horticulture where environmental conditions best suit the requirements of the organisms. They are also generally slower to act.

Furthermore, whilst the greater degree of host specificity among biopesticides is advantageous from an environmental perspective, it can be a distinct disadvantage from the economic standpoint, where the registration costs for a product with efficacy against just one or two targets are disproportionate to the value of the market. Thus, despite there being hundreds of promising candidates in laboratories and commercial research departments throughout the world, very few products actually make it into circulation.

Green pesticides, red tape

The commercialisation of biopesticides in Europe has long been hampered by a regulatory framework that was designed for the evaluation of chemical substances, and which does not adequately account for the specifics of biological agents. Successfully negotiating the regulatory system with novel products often relies on the flexibility and pragmatism of the authority conducting the evaluation, which across 27 Member States is variable at best. Consequently the EU regulatory system has acted as a significant barrier to market entry for many years, and stifled research and development within the industry.

It has also led to a proliferation in the number of products that attempt to avoid the approvals process altogether by judicious use of marketing claims. Under European pesticide law, anything that claims to be a pesticide is a pesticide, and needs to be authorised as such. By removing pesticidal claims from their labels and marketing literature, some companies hoped to keep below the regulatory radar, presenting their products to the market as biostimulants, plant tonics or plant strengtheners. This did little to dispel the notion in some quarters that biopesticides were mere 'muck and magic', and caused considerable confusion among growers who struggled to separate them from some legitimate products that genuinely didn't need to be approved.

It also became apparent that the authorities had lost almost complete regulatory oversight of this section of the industry, and that a system which drove the wholesale withdrawal of chemical pesticides, whilst simultaneously making it impossible for the alternatives to get to market, was a disaster waiting to happen. What was needed was a completely new approach.

The Pilot Scheme

With relations between the industry and its regulators at their lowest point, many companies were engaged in intractable battles with individual Member State authorities, often on obscure points of microbiology. Not only was this an ineffective way of getting the decision makers to be more accommodating, but it also made it very difficult for them to get an overview of the wider issues.

The industry thus organised itself into the International Biocontrol Manufacturers' Association, a trade group that represents the majority of biopesticide producers throughout the world, and which presents a single, coherent voice to the authorities.

The UK branch of the IBMA immediately set about engaging afresh with what was then the Pesticides Safety Directorate, inviting them to association meetings and fostering constructive dialogue. In return, the PSD invited IBMA members to address their annual conferences, and to present the issues that they felt needed to be resolved.

By their very nature, regulators are intrinsically risk-averse, and the kind of regulatory innovation that was needed to jump-start the industry does not come easily.

Nevertheless, within a short period, a Pilot Scheme was launched whereby qualifying products would benefit from a reduced fee structure and, in which, greater flexibility would be permitted in how the data requirements were satisfied. There would also be free pre-submission meetings, in which the approach would be agreed by both sides before any investment had been made into data generation.

This, in itself, represented a quantum leap forward, as the cost of conducting regulatory studies can rapidly spiral out of control, especially when regulators are operating out of their comfort zone: the tendency in such situations is to stall the process by asking for more data, and there were some well known horror stories in the industry of applicants whose money ran out long before the evaluation of their dossier had been completed.

Tentatively, the industry responded to the new scheme, and the first products for many years were submitted.

The Biopesticides Scheme and beyond

The Pilot Scheme proved sufficiently successful to be formally adopted as the permanent Biopesticides Scheme and, although it took time for companies to gain confidence in the new system and put together their dossiers, a number of products have since come forward and sought authorisation.

The situation is still not perfect, not least because the recent merger of the PSD with the HSE led to a reduction in staff at the newly formed Chemicals Regulation Directorate, and a corresponding increase in workload.

Elsewhere in Europe the picture is mixed. Some countries have endeavoured to assist biopesticides to market for some time, whilst others are still lagging behind. The biopesticide industry also needs to become better at promoting the benefits of its products, particularly within the contexts of residue reduction, environmental safety and sustainable use.

Although the major market for biopesticides continues to be protected horticulture, the Holy Grail has always been to find products that work well in field situations. There are some such products, and Biosphere Amenity is working with producers to identify them, to assess their usefulness to the turf industry, and to resolve the regulatory issues necessary to bring them to market.

We will be reporting on our progress in future issues of Pitchcare but, in the meantime, anyone interested in learning more about what is in the pipeline can contact Mark Whittaker directly on 07515 850 772 or by email at mark@biosphereamenity.com.

About the author: Dr Mark Whittaker is the Managing Director of Biosphere Amenity Ltd, a new company that specialises in sourcing the highest quality biological products for the amenity sector. He is a founding member of the International Biocontrol Manufacturers' Association and was instrumental in setting up the UK Biopesticides Scheme. He also acts as a regulatory consultant to the biopesticide industry worldwide.