An introduction to Act 36

The implications of registration

Agricultural remedies and fertilisers must be registered in SA to be used here, regardless of their status elsewhere. Act 36 makes provision for the appointment of a registrar to handle registrations.
One aim of registration is to ensure that products contain and do what the label says. Users should be able to trust that the active ingredients and their concentrations listed on the label reflect the product's composition.

The acceptable ranges and permissible deviations for product ingredients are stipulated in regulations, and products may not contain undeclared active ingredients.

Applicants for registration of agricultural remedies and Group 3 fertilisers must provide supporting evidence for efficacy claims. Products must undergo at least three successful field trials for each use on each crop and, in some cases, even on specific cultivars. Trials must be conducted at different sites representing the bioclimatic zones where the crops are grown, and for which registration is sought.

Besides demonstrating efficacy, applicants must submit reports on their product's pharmacology, toxicology, and environmental impact. The registrar requires trial data showing negligible and manageable adverse effects on the treated crop and non-target organisms. Residue studies are necessary if products could leave residues on edible crop parts.

The number of local trials and level of detail will vary depending on the novelty of the active ingredient and formulation. First-time registration of a new product is more onerous than minor changes to an existing registration.

Registration doesn't guarantee that a product will be effective on the farm – real life has too many variables – but it does equip growers with realistic expectations of application outcomes, if they adhere to the label.

Who is responsible for what?

The registration holder is responsible for supplying the product specified in the registration. Very few active ingredients of agricultural remedies are synthesised in SA. In some cases, actives are imported, and the product is formulated in SA, in accordance with its local registration. In others, the finished product is imported pre-packaged or in bulk.

Registration holders can formulate products themselves or outsource the formulation, but in either case, they remain responsible for defective products. Samples of each product batch must be collected and retained for at least two years from the date of manufacture – the regulated definition of manufacture includes formulation and packaging.

The implication is that questions about defective products can be readily resolved through testing the retained product samples.

Act 36 specifies that only registered pest control operators may use or supervise the use of agricultural remedies. Criteria for registration are specified in the regulations. Trained spray operators employed by farms for standard on-farm agricultural-remedy use do not need to be registered.

According to the regulations, pest control operators are responsible for using agricultural remedies safely and correctly. Operators must adhere to the label: recommending or using agricultural remedies in any other way is illegal.

One aspect of product use that deserves special mention is residues. Maximum residue limits – MRLs – are the maximum permitted concentration of an active ingredient on a food item. The withholding period is the minimum time between the last product application and harvest – this interval is calculated to meet the MRL.

MRLs for local sales are regulated under the Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972 and fall under the Department of Health. The country of import determines MRLs for export. Hortgro regularly publishes updated guidelines for MRLs for export. Fruit buyers such as retailers increasingly set their own – more stringent – MRLs.

Failure to meet the MRLs required by markets can lead to the rejection of consignments and may have broader implications for the marketability of South African fruit.

Practical pointers for growers

Growers can reduce their risk by paying attention to a few basics – the most important is following the label to the letter. Deviations are illegal and increase the risk of losses due to phytotoxicity, ineffective applications, reduced fruit yields or quality, and unforeseen residues.

Growers should obtain crop-protection advice through a written crop-protection strategy or spray programme. They then issue written application instructions to their on-farm spray operators and keep records of completed applications. The ultimate responsibility for crop-protection decisions and label adherence lies with the grower. Having a documented process reduces the risk of misunderstandings or grey areas in the event of a problem.

Keep in mind that advertisements for agricultural remedies may not go beyond the information on the label. Anything else is considered false and misleading in terms of Act 36. For the purposes of the Act, advertisements include any written, visual, and verbal communication intended to promote the sale or encourage the use of a product.

Even when agricultural remedies are applied according to the label, results might not always be as expected. Inadequate or inconsistent spray deposition is a common problem. Smartphone apps are available to help growers identify poor deposition so they can take corrective action.

Growers should also be cautious when preparing tank mixtures. The more products in the tank, the greater the risk of interactions that reduce the efficacy or induce unforeseen plant responses.

Besides the legal and practical implications of Act 36, growers must consider the health and safety aspects of using agricultural remedies and fertilisers. Although regulator and consumer concerns largely drive the demands for lower and zero residues, the health risks due to other routes of exposure also influence regulators.

Bans on carcinogenic, mutagenic, and reproductive toxins are driven by the potential impact on human health, including that of agricultural workers. If regulators are not confident that workers adhere to health and safety measures such as wearing protective clothing, they will continue to manage the risk by removing the products altogether.

Deciduous-fruit growers depend on agricultural remedies and fertilisers. Like all legislation and regulation, Act 36 can sometimes seem like an obstacle, but working with, rather than against it, is in our collective interest. These regulations help protect growers against counterfeit products and snake oils while safeguarding our markets and the health of all South Africans.

Further Reading