How do we know that pest control products work as they say they do? In the first of a two-part series looking at product testing, we reveal the process manufacturers are required to follow in order to have a product registered.
What data do manufacturers require in order for them to make a performance claim? With discussions about which products are the best and the conversations in some online forums about products that don’t work or fail to meet expectations, it’s worth a look at what testing manufacturers undertake during the development of their products to make sure they do indeed work as claimed.
The key point to note is one of law – that a manufacturer can only make performance claims regarding a registered product that are consistent with the approved label. As part of the (very costly) registration process the registrant has to submit a comprehensive set of efficacy data to support their proposed claims. The regulatory authority – the APVMA (the Australian Pesticides and Veterinary Medicines Authority) – then reviews the data to make sure it supports the proposed claim. If it does, it becomes an approved claim; if it doesn’t they will go back to the registrant to ask for clarification or more data.
The APVMA provides comprehensive guidelines for product efficacy testing. The basic requirement is that efficacy data is provided for all the insects claimed on the label. In some cases the use of laboratory test data is deemed satisfactory, in other cases field trials are also required. The data may be carried out by the applicant themselves, although the APVMA does have a preference for at least some of the data to be generated through independent testing from a suitably qualified testing company or institution. The APVMA will accept data generated overseas, especially for laboratory trials, but for field trials they will often require Australian supporting data.
Going into the methodology of the trials, manufacturers are required to specify the application method and rate, and normally provide data over a range of application rates. The trials should also include an ‘industry standard’ – a registered product that is generally recognised as an established product in the market. The testing of products in different locations can also be required. For products such as termiticides it is necessary to carry out the trials in different locations (climates/soil conditions) and surface sprays need to be challenged on a variety of surfaces.
The design of these trials is important, so that clear conclusions can be drawn. Within each trial a suitable number of replicates needs to be carried out and often trials themselves need to be replicated. Statistical analysis also needs to be applied to the data to demonstrate that the product to be registered delivers a level of control significantly better than the control/no treatment regime and at a level similar to or better than the industry standard.
However, although two different products may make the same claim, it may be that they don’t deliver the same level of performance. There are three potential reasons for this.
Firstly, there is no standard testing procedure. The registrant simply has to carry out trials using a methodology that is scientifically valid. An example where variation typically occurs is in the generation of residual data for surface sprays. Different types of surfaces both porous and non-porous are treated with product and stored for various lengths of time to determine the duration of protection. However, the conditions under which the treated surfaces are stored and the duration of time the insects are confined to the treated surface will likely vary between protocols. Whether an insect is confined to a surface for five minutes, one hour or 24 hours, will obviously have a big impact on the performance achieved.
Secondly, when manufacturers submit a registration they are appointed a reviewer within the APVMA. Even though the reviewers follow guidelines, how these guidelines are applied does vary between reviewers. Furthermore, over time the APVMA changes regulations such that claims that were allowed on previously registered products can no longer be made on new registrations, even if the performance of the new product matches or exceeds the previously registered product.
Thirdly, the APVMA allows ‘image registrations’. This is where a manufacturer submits a registration for a product that has a very similar formulation and the same claims as a product already on the market. As part of the registration package the registrant does not have to submit a complete efficacy data package – they have to demonstrate bioequivalence through a reduced data package. The formulations must have exactly the same actives and must be close to identical in other aspects for the registrant to avoid submitting the full data package. The more differences in the formulation, the more data required.
It is also important to consider the wording used in the claim; elimination, control and suppression all have different meanings and indicate decreasing levels of control. Similarly a product that delivers control for ‘up to six months’ is different to one that delivers control for ‘at least six months’. The APVMA typically uses 90% mortality as a cut off for making a claim of control.
In short, suppliers carry out a robust regime of efficacy testing before the product can be registered, such that if applied correctly, it will deliver the performance claimed on the label. Suppliers are normally pretty open in sharing the data in literature and at conferences and roadshows. So if you really want to understand the performance of the products you are using, don’t fall asleep during those conference PowerPoint presentations! Make sure you understand the data being presented and the testing methodology used.
In the second part of this series on product testing in the next issue, we will consider how pest managers can do their own product comparisons in the field.
