Garden pesticide banned in UK

The Ministry of Agriculture, Fisheries and Food (MAFF) announced on 27 June that approvals in the UK for Roseclear, a garden pesticide, would immediately be revoked. According to MAFF the chemical, containing the insecticide pirimicarb, and fungicides triforine and bupirimate, poses a hazard of accidental eye damage which is unacceptable in an amateur garden pesticide. It remains unclear what in Roseclear causes the health concern, as not all the MAFF data is in the public domain.

The decision to ban the use of Roseclear was made following a routine review which included examining data on animal experiments. MAFF took action as a precautionary measure to protect consumers. Roseclear (manufactured by Zeneca Agrochemicals and marketed by Miracle Garden Care) can no longer be sold, advertised or used. However it may be stored until the end of the year, pending disposal. It has been used by gardeners since 1982 to control fungal diseases (such as black spot on roses) and to kill aphids on various flowers, fruit trees and bushes. It was sold as a concentrated liquid to be diluted for use. The manufacturers say that the advantage of Roseclear had been its lack of adverse effects on a number of beneficial insects including bees and ladybirds (which attack aphid pests).
Miracle Garden Care bought the Roseclear brand from Zeneca in 1994 as part of a £37 million acquisition of the group's garden chemical brands. Roseclear's value accounted for about 3% of the deal. Zeneca earns about £500,000 a year manufacturing the product. It is also responsible for its safety tests(1).

Animal tests show severe eye and skin irritancy
Toxicity data on the Roseclear concentrate was submitted to the Pesticides Safety Directorate (PSD) of MAFF in April 1995 and included studies on skin and eye irritancy. The studies, using the concentrated product (the form in which it is sold), on eye irritancy caused most concern. The corneas of test animals were severely damaged, resulting in the permanent clouding of vision, indicating that Roseclear is an extremely severe eye irritant, and should be classified as 'Risk of Serious Damage to Eyes'. In the skin irritation study, the concentrated product was applied directly to skin for four hours. The severe effects which followed indicate that the product is an extreme skin irritant.

Health surveillance from amateur use
Zeneca submitted detailed information on 70 enquiries, received over a 10 year period from 1986 (during which 40 million applications occurred). Of these, four were due to eye exposure, and 25 were related to skin exposure. None of the enquiries involved serious or permanent damage.
The data on Roseclear indicated to MAFF that the product might not meet certain safety requirements for home garden products. Although products for home garden use tend to be less concentrated than professional products, amateur users do not have the same access to training, supervision and protective clothing, often afforded to occupational users in the UK. MAFF says products cannot be approved for home garden use if:

they cannot be used safely without wearing protective equipment such as goggles;
they are classified as 'Risk of Serious Damage to Eyes';
they are classifiable as skin irritants or eye irritants (unless it can be shown that exposure is negligible
they are moderate to severe skin sensitisers(2).

The main line of defence from Zeneca and Miracle Grow Care has been that the eye hazard is related to the undiluted concentrate. Pack labels have always warned of this and there are no other risks once the product is diluted for use (300 parts of water to one part Roseclear)(3).

Pesticides in Roseclear
Pirimicarb: This insecticide belongs to the carbamate group of chemicals. It acts as a nerve poison by disrupting cholinesterase production. Its WHO rating is 'moderately hazardous'(4). MAFF reviewed pirimicarb in a unconnected exercise and published an evaluation document in June 1995. Issues of concern then were:

need for further food residue data and maximum residue limit data;
personal protective equipment requirements were revised to protect operator exposure, and further dermal penetration data to refine the operator exposure assessment was required;
the need for labelling : 'dangerous to fish or other aquatic life' and further data on effects on aquatic invertebrates in the field(5).

Triforine: This fungicide is harmful in contact with skin, and irritating to eyes(6), although its WHO rating is 'unlikely to present an acute hazard in normal use'(7).

Bupirimate: This systemic fungicide is an irritant to skin and eyes(8), and has the same WHO rating as Triforine.

Pesticides Trust [now PAN UK] comment
While MAFF acted swiftly in this case, in order to protect the consumer, this left little time for those marketing and retailing the product to set up help-lines and disposal arrangements to deal with concerned consumers. The retailers were particularly taken by surprise and DIY ('do-it-yourself') outlets started clearing their shelves of Roseclear only after being contacted by the press.

Is the problem related to a particular active ingredient in Roseclear?
Is the formulation too concentrated?
Is there a synergism/potentiation between the mixture of active ingredients?
Is the formulant or adjuvant causing irritation?

Neither MAFF nor Zeneca would clarify these points. Zeneca clearly thought the product was safe, but their risk assessment has been publicly over-ruled by MAFF.
The application of the precautionary principle is welcomed by the Pesticides Trust. We look forward to more similar restrictions in the future. (DB)

References
1. Financial Times, 28 June 1996.
2. MAFF press release and background paper, 27 June 1996
3. Zeneca press release, 28 June 1996.
4. WHO recommended classification of pesticides by hazard, Geneva, 1996.
5. Evaluation on pirimicarb: June 1995, MAFF.
6. The UK Pesticide Guide, BCPC/CABI, 1996.
7. Op. cit 4.
8. Op. cit. 6.
9. Op. cit. 1.

[This article first appeared in Pesticides News No. 33, September 1996, page 3]