By Henk van der Westhuizen – CropLife SA ExCo Member (Philagro)
On June 5th, 1948, the Department of Agriculture became the custodian of the “Fertilizers, Farm Feeds, Seeds and Remedies Act” that was published in Government Gazette number 3977. The Act was applicable from July 1st, 1948. The purpose of the Act was to regulate the importation and sale of fertilizers, farm feeds and remedies, and to regulate the registration process of the aforementioned, as well as that of “sterilising plants” (the sterilising plants had nothing to do with physical buildings, but to register the botanical plants used in the sterilisation of animal bones and other animal products). This Act replaced the Act no. 21 of 1917.
Since the Act came into being, there have been numerous amendments to the Act, and I thought I would just mention a few interesting ones.
In 1970 a new definition of the word “advertisements” was incorporated, and rules regarding advertisements were specified. At the time the cost of obtaining a registration was “not to exceed R20”. The cost of a Wimpy cheeseburger and chips on the 1972 menu was R0.55, and today a Wimpy cheeseburger and chips is around R72, thus 130-fold increase. The actual cost of applying for a registration today is significantly higher than the 130-fold and now stands at R10 836, thus if the same were to apply to a Wimpy cheeseburger and chips, we would be paying R300 for a meal at Wimpy today…
Southwest Africa (now Namibia for the youngsters) was added as a territory in 1972.
In 1977 a definition was set out for advisors and analysts who could be appointed to assist the Registrar in his duties.
Products approved for registration should be “effective for use as specified in the registration application, not contrary to public interest and manufactured in establishments suitable for their manufacture” according to an amendment in 1980.
Various regulations were published, and changes made in support of the Act, and to keep the Act relevant. Nowadays I see many product labels that no longer adhere to the requirements as set out by the Act or the regulations, but that is a topic for another day.
Although the Department of Agriculture (now Department of Agriculture and Rural development) is responsible for the evaluation of all toxicological data submitted when an application is made for a product containing a new active ingredient, this responsibility was delegated many years ago, by mutual agreement, to the Department of Health. The Department of Health is thus responsible for making recommendations about the suitability of a product and active ingredient in the South African environment, and proposals of safe PHIs for a typical South African population food basket. Unfortunately for the past 15 years or so, the Department of Health did not employ personnel with the skillset to evaluate the full tox dossiers, and companies outsource this responsibility at tremendous costs.
Over the last couple of years, the backlog in processing of applications for new products, and amendments of existing registrations, has reached proportions where it will take years to eliminate the backlog, and companies and producers are becoming increasingly more frustrated. But is this as a result of the actual Act no. 36 of 1947?
I believe only partially, and the Act is basically still a sound piece of legislation, with one or two possible major exceptions.
- The cost of development of new products and uses for existing products is rising rapidly and is set to increase tremendously with the possible implementation of GLP residue trials, and the introduction of GEP for field contractors. Somewhere, the need for IP (intellectual property) protection needs to be implemented to encourage continued expensive development work by all companies involved.
- Over the past years, the emphasis in the use of agricultural and stock remedies has moved to the toxicological impact of these products on the environment, soil health, human health etc. The second major amendment to Act no. 36 should be that efficacy data should be scrapped as a requirement for registration, and more focus should be on the other issues mentioned here. Too much time is wasted by the employees of Act no. 36 to review efficacy data (which after all remains the responsibility of the registration holder).
If these two amendments are included in Act no. 36, I think it will remain relevant…but should the Department of Agriculture and Rural development still be the custodian, or should it be Department of Environmental affairs?
Maybe it is time South Africa follows the example of the UK and other developed countries, and leave this most important task to a body of independent experts, funded by the industry and organised agriculture?
(This is my personal opinion, and does not reflect the views of my employer, nor any member of CropLife South Africa)