Product registration chaos costs millions

The Department of Agriculture’s registration of new agricultural and stock remedies is fraught with delays and apparent disorganisation. And it’s costing farmers and input suppliers millions, reports Robyn Joubert.

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The Department of Agriculture’s registration of new agricultural and stock remedies is fraught with delays and apparent disorganisation. And it’s costing farmers and input suppliers millions, reports Robyn Joubert.

Delays in the registering of agricultural and stock remedies by the Department of Agriculture are causing huge financial losses to farmers and input suppliers alike. Offers of assistance by the Association of Veterinary and Crop Associations of South Africa (AVCASA) have been ignored.
Dr Mike Morris, managing director of Plant Health Products in the KwaZulu-Natal Midlands, said they’ve been frustrated by product registration delays of over a year. “We don’t know when the registrations will come through and inquiries as to their status have been fruitless. This leaves you hanging and you can’t plan marketing strategies. You can’t get any returns on products which have taken five years and large capital investments to develop. For a small company, this can close your doors.”
He speculated that agriculture department employees were probably overworked and understaffed but doing their best under the circumstances.
Tony Lourens, who is in the process of registering a company for importing veterinary medicines such as anthelmintics and antiparacides, said for the past eight months he’d been met with “ineptitude and an archaic system which is surely going to cost farmers dearly, not only in livestock losses, but financially as well”.
“The products I’m trying to register are already on sale in African countries, Europe and South America. Trials have been conducted and data is available, but for some inexplicable reason, the department expects all products to go through a trial test at a facility in this country as well, irrespective of the overseas status,” Lourens fumed.
He spent four months being shunted from one department to another. “Eventually, I was told I had to have the product tested in South Africa, that it would take over a year and tests would cost anything from R70 000 to R150 000. We have innovative and new products whereas the current range here is building up resistance already.
In the meantime, we have to use what’s available and to hell with resistance which could see livestock die.”
AVCASA consultant Dr Gerhard Verdoorn said on 7 March they’d submitted a proposal of recommendations to improve performance to Jonathan Mudzunga, the Registrar of Act No. 36 of 1947, the Fertilisers, Farm Feeds, Agricultural Remedies and Stock Remedies Act. However, they’d heard nothing from him.
“We offered to work with them to sort out their problems, but they don’t seem to understand the contribution we can make. They also don’t seem to have the competence to regulate this industry on their own,” Verdoorn said.
“Our problem is that we received instruction from the registrar that we must start phasing out group 1A and B products for crops, but we don’t have any new chemicals to use in their place.”
The time frames for registering new molecules and formulations is a major concern – delays can be as long as four or five years. This has been attributed to a lack of toxicologists at the departments of agriculture and health, and is exacerbated when applications are lost by the registrar’s office.

Delays, disorganisation, disappearing data
There are also delays in minor authorisations, for example in submitting new names, or changing a label or formulation.
“When we submit a protocol for approval to the Department of Agriculture, which must be done before we can deploy a product, it can take up to six months,” Verdoorn said. He added that the department told them that they’d only recently began working on submission from April 2007. “Submissions are lying around on desks somewhere. Their whole database is basically gone. They can’t produce a pesticide guide anymore because they don’t have a database.
“Manual record-keeping is also lacking and is demonstrated by the disappearance of some registration applications. Their communication with stakeholders is also not good. There’s basically a total collapse and no light at the end of the tunnel,” he said.
Other issues were inconsistent implementation of guidelines by technical advisers, ineffective administration in the registrar’s office, insufficient technical and administrative staff and a lack of appropriate experience amongst some staff members.
Furthermore, the inspectorate couldn’t cope with issues like law enforcement of pesticide misuse and pesticide-related criminal activities, while the inspection of products and food products was no longer a regular activity.
Among AVCASA’s recommendations to the registrar were that an appropriate number of well-trained and experienced staff be appointed, including technical advisers and toxicologists, and that an external expert panel be appointed to assist technical advisers.
A new electronic record-keeping and tracking system had to be installed by which all registered products could be electronically recorded and all registrations electronically tracked. In addition, they called for consistency in terms of the technical advisers’ implementation of the guidelines.
They also requested an urgent review of the pesticide policies and legislation, the Act No. 36 of 1947 and the drafting of new pesticide legislation. – Robyn Joubert

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