Experience with evaluating the efficacy of biopesticides in the Netherlands

The OECD Seminar on Different aspects of efficacy evaluation of biopesticides, held on 28-29 June 2021, covered the similarities and differences of the efficacy evaluation of the different categories of biopesticides, new application techniques, efficacy evaluation of biopesticides based on plant defence inducers (PDI), comparison of efficacy requirements for biostimulants vs. biopesticides, how to evaluate different Integrated Pest Management (IPM) modules, and registration pathways with limited or no evaluation of efficacy. The event facilitated exchanges between policy makers, academia, and industry.

1. Experience with
evaluating the efficacy
of biopesticides in the
Netherlands
Henk Brouwer

2. 2
There have been many recent developments for
efficacy evaluations of biopesticides. This
presentation will discuss:
Overview of the presentation
-Issues/problems faced
before recent developments -approach taken.
-results, and remaining
issues.

3. 3
Biopesticides and low risk status
Low risk products have a separate regulatory status in the
EU.
For efficacy evaluations in the EU/NL Low risk status of a
PPP has a major impact on efficacy evaluation.
Biopesticide and low risk status do not always overlap. E.g.
some chemicals are also eligible for low risk status.
For biopesticides that are not low risk, some specific
guidance also exists, but much of this presentation will
assume we are discussing a low risk biopesticide.

4. 4
-Due to variable and lower efficacy data is
harder to interpret/evaluate.
-This conflicts with the desire to have lower data
requirements.
-What level of efficacy is required?
-Biopesticides are a very diverse group of
products.
-lack of guidance documents.
-Quality of dossiers
Issues in 2015

5. 5
The following issues were not specific to
efficacy, but were general issues.
Broader issues
-The evaluation process was based on
conventional products.
-Guidance for biopesticides was difficult to find
for applicants.
-Expertise on biopesticides was there, but not
organized.

6. 6
Members of all
expertises
CTGB Green Team

7. 7
•Guidance for applicants on how to prepare a
dossier, has sections on:
-microorganisms
-botanicals
-semiochemicals
(link to manual)
•Encourage meetings
with applicants
Biopesticide evaluation manual

8. 8
-EPPO PP1 296 Principles of efficacy
evaluation for low-risk plant protection
products
-Workshop in April 2016 in Ede, the Netherlands.
-Conclusion was that an EPPO standard was needed.
-Adopted in September 2017
Record time for writing and implementation of
an EPPO standard.
Development of efficacy guidance

9. 9
-Minimum effective dose rate trials not
required if explained.
-lower efficacy and more variability can be
acceptable (explain in dossier). However a
significant effect compared to untreated is
required.
-lower data requirements
-On top of that Data requirements are
reduced by a lot by allowing broad and
flexible extrapolations
Highlights from Low risk guidance:

10. 10
Mode of action is keyin whatextrapolations
are possible.
Ifa product has multiple modes of action it
shouldbeexplainedwhichoneis themost
relevant.
Mode of action is important!
A good explanation of the
MOA is needed both for the
evaluation and for good
label advice to the farmer.

11. 11
-Other eppoguidance has recently been
developed in addition to PP1-296.
-PP1/319; General principles for efficacy
evaluation of plant protection products with a
mode of action as plant defenceinducers.
-Evaluation of mating disruption techniques
against lepidopteran pests in grapevine, pome
and stone fruits under
-semi field conditions (PP1/323)
-field conditions (PP1/314)
Ongoing development of guidance

12. 12
•PPP applications at Ctgbare currently ~5%
based on low-risk substances (including
potential low-risk). However:
•Ctgbcurrently handles about ~30% of new
active substance applications in the EU
•About 60% of these a.s. are non-chemical
(micro- organisms and plant extracts)
PPP biopesticide numbers are expected to
go up.
Current situation

13. 13
•Policy vision on plant protection in 2030:
–Plants and growing systems are resilient
–Agriculture and nature are connected
–Almost no emissions to the environment and
almost no residues on products.
•For PPP’s: If needed, low-risk products
preferable and emmission reduction
technologies important
•Biopesticides important candidate group of
low-risk products
Developments in NL

14. 14
Integration of IPM in efficacy dossiers.
-Efficacytrials are usuallyset up to test one
specificproduct without otherinfluences.
-IPM is complex
, andsituationdependent.
-new guidanceon plant defense inducers
alreadytakes spray
programs intoaccount
-low risk status.
Open issues:

15. 15
New techniques and products
-New applicationtechniques. Sensor driven
applicatons, variabledoserates.
-novelbiopesticidemodes of action, (RNAi,
bacteriophages, etc)
-Strip cropping

16. 16
Questions?