Quality control in the production of agrochemicals

By: Elriza Theron
Afrikaans version published in SA Graan
April 2020

Crop protection plays a pivotal role in agricultural production, whether chemical or biological, and farmers spend a significant amount of effort and investment in ensuring safe and healthy crops. Naturally a farmer would expect the same dedication toward quality assurance from the manufacturers of the very agrochemicals used to protect these crops. Luckily there are a magnitude of controls in place to ensure the best possible products are available to the farmer.

Let’s firstly take a look at how active ingredients are developed. These molecules, or group of molecules, aren’t accidentally discovered, they are designed precisely for a specific purpose, in other words, to manage a specific pest or weed. A wide range of science is used to ensure that these actives are effective, easy to use and cost-effective for the farmer, in addition of course, to being safe to operators, consumers and the environment. Scientists use genomics, physiology, biochemistry and biokinetics to ensure that the molecule does exactly what it needs to do. Over the years, scientists have managed to dramatically decrease the amount of pesticides needed for a particular problem, from more than 10kg/h in the 1960s, to less than 10g/h in certain instances.

In order to improve an active ingredient’s efficacy and safety, certain compounds are added which make up the formulation of the product.  The formulation can be seen as the delivery system and reduces the toxicity and volatility of the crop protection product. There are various considerations when choosing the ingredients, such as biodegradability, whether the raw material was made from renewable sources, as well as the ease with which the product can be applied.

It goes without saying that this is a very lengthy and expensive process. Typically, the crop protection industry spends $50 every minute for a period of 11 years, which is the average time it takes to bring a new pesticide to market, to develop these products for farmers. This is mostly due to the rise in volume and complexity of data required by regulatory bodies to ensure products are safe and effective. The regulatory process, however, does not stop there and continues once authorisation has been granted.

CropLife International and its member companies, along with product integrity experts have developed a document on the Contamination Prevention in the Manufacture of Crop Protection Products to which all CropLife International members must adhere. The document, which defines the industry standard, outlines guidelines and best practices in all manufacturing steps in order to mediate the risk of contamination of crop protection products during the manufacturing process. It covers risk assessment elements, cleaning level determination, manufacturing practices, production unit cleaning, analysis of residual and impurities.

The authorisation process for crop protection products is one of the most stringent in the world and more than 150 safety studies are conducted on each potential product before its approval for commercial use.

In South Africa, all imported products must be analysed after import to ascertain the quality. Products that are manufactured locally are also subjected to these quality control tests. A product must be registered in terms of the Act on Fertilisers, Farm Feeds, Agrochemicals and Stock Remedies, 1947 (Act Nr. 36 of 1947). The requirements are set in Article 7 (1) of the Act and are further supported by the fact that the Registrar of the Act may set any other conditions before approving an application for registration.

All this speaks to the original reason for the formulation of Act Nr. 36 of 1947, namely, to ensure that the pesticides being manufactured and distributed, have the necessary efficacy to manage pests, plant diseases and weeds in order to benefit the farmer.

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