tg_efficacy_pt18pt19_superseded_en

12
Transitional Guidance on PT18 + PT19
September 2016
is claimed not all organisms have to be tested when appropriate bridging studies are
available.
In the case of field trials where true replication is almost certainly impossible to achieve,
a full description of any factors that might be expected to influence product performance
should be given. These may include the risk of re-invasion from adjacent areas, general
levels of sanitation, treatment history etc. and are intended to provide the authorities
with information to assist with the interpretation of the results obtained.
In the following sections (2 to 12) more specific dossier requirements are given per pest
species. In most cases a general description of a proposed method is provided. This is
only to give an idea of what kind of tests should be provided. More detailed descriptions
of tests can be found in the standard test methods (norms) listed in Appendix 3. This is a
list of all available methods (as far as we know now) without distinction on usefulness,
repeatability, order of acceptability or robustness. Some norms might have a different
approach than described in the section for that insect. If this approach is more suitable
for the product under investigation the norm should be used.
1.3.4 The importance of controls on efficacy studies
The importance of control experiments for efficacy studies must be stressed with regard
to the efficacy evaluation. Studies should be conducted alongside negative controls
wherever possible to provide a reference point for the treatment results. A useful
definition of this term is given: “A negative control situation may be one in which the
experimental design of the study is identical to that of the biocide challenge test except
that the biocidal agent is not applied in the control study. A biocidal agent may be
considered as the formulation or as the actual biocidal active gredient itself.”
The negative control trial should normally be of similar size (i.e. number of replications)
as the test itself, to make statistical comparison possible and to get a fair impression of
control mortality.
A relevant reference product (authorised, commercially available) can often be included
at label rates in a protocol for laboratory and/or field studies as positive control.
Unfortunately at this moment no standard reference products are available, however, an
authorised reference can be included.
It is recognised that generation of such control data can be relatively straightforward in
well-defined test situations such as laboratory and simulated-use tests. However, it is
also recognised that this can present a problem in field situations, where control sites
may not be environmentally equivalent to the treatment site.
In such instances, there may be an alternative means of generating reference data other
than collecting data from an untreated site. This method may involve pre-treatment
monitoring of the site in question. This monitoring must be quantitative, e.g.,
assessment of numbers of trapped insects. In these instances, a ‘baseline’ infestation
level would be established through such monitoring and then the effect of treatment on
this baseline can be assessed. Post-treatment monitoring is required for this method.
1.3.5 Specific data to support label claims
In assessing the efficacy of a biocidal product to control, repel or attract insects and
other arthropods competent authorities should in particular take the following
parameters into account
target organisms/spectrum of activity;
mode of action/effect;
use patterns/methods of application;