The Advisory Committee on Pesticides provides independent advice to Ministers on matters relating to the regulation and use of pesticides, including applications for approval of new products and reviews of existing approvals. It usually meets in closed session (because of intellectual property and commercial secrecy considerations) approximately eight times a year in York.
Those present:
Chairman: Prof D Coggon
Deputy Chairman: Prof A Boobis
Members: Mrs S Owen, Mrs E Brown, Prof R Smith, Dr N Bateman,
Mr C Stopes, Prof G Matthews, Dr A Carter, Dr P McElhatton, Mr J Orson
Prof G Edwards Jones, Prof M Roberts, Prof P Calow, Dr C Soutar
No apologies were received from Members.
Representatives from the following Departments and other organisations were present:
The Pesticides Safety Directorate (PSD), Ministry of Agriculture Fisheries and Food (MAFF), Department of Health (DH), Department of Environment, Transport & the Regions (DETR), English Nature (EN), Scottish Agricultural Science Agency (SASA), Health & Safety Executive (HSE), Institute of Arable Crop Research (IACR), and Food Standards Agency (FSA).
At its meeting on 7th September 2000 the Committee discussed the following issues:
1. Agenda Item 1: Detailed Record of Discussion and Minutes of the 277th Meeting [ACP 288 & 289 (278/00)]
1.1 Agreed as amended.
2. Agenda Item 2 : Matters Arising
2.1 Application for Annex I Inclusion and UK Provisional Approval of YRC 2894 in the Product "YRC 2894 SC480" Formulated as a Suspension Concentrate Containing 480 G/L (40.4% W/W) Thiacloprid
2.2 At the July ACP meeting, Members had considered thiacloprid (codename YRC 2894), a chloronicotinyl insecticide. The chemical was under evaluation for Annex I listing with the UK acting as the Rapporteur Member State. Bayer were also seeking provisional approval in the UK for the formulated product ‘YRC 2894 SC480’ to control aphids in apple crops. Following the July meeting, Ministers had been advised that provisional approval should not be granted for the product until worker exposure had been demonstrated to be satisfactory. In addition, the applicant was asked to comment on a number of toxicological issues, including the potential of the compound to cause neuropathy.
2.3 At this meeting the ACP considered the applicant's responses to the concerns identified. As a result the Committee were able to advise Ministers that ‘YRC 2894 SC480’ should now be granted a provisional approval for use on apples under the Plant Protection Products Regulations for three years pending a Commission decision on inclusion of YRC 2894 in Annex I of Council Directive 91/414/EEC. Members concluded that Annex I inclusion could also now be recommended.
2.4 Second Evaluation for UK Approval (PPPR) of Tepraloxydim in the Product 'Aramo'
2.5 At the July meeting ACP Members had considered an application for approval of the product 'Aramo' containing the new active substance tepraloxydim [ACP 254 (277/00)]. Following that meeting Ministers had been advised that provisional approval should be granted for a limited number of crops subject to certain restrictions because of a lack of data to support the additional uses requested.
2.6 Subsequently, the applicant had requested the opportunity to submit a written case to address a concern regarding the effect of cooking on the nature of residues in foodstuffs, and so enable the approval to be issued for a wider range of crops. Developments had also taken place in a number of other areas relevant to the risk assessment and these were also presented to the Committee with proposals for consequent minor changes in labelling.
2.7 Members considered that the applicant's case, and the other additional information presented, did not warrant a change to the recommendations made at the July meeting. The proposed label changes were agreed. Provisional approval for use of Aramo on sugar beet, fodder beet, oilseed rape, field beans, vining peas, linseed, flax and green cover on land temporarily removed from production would therefore be granted in line with the original recommendations, but with the minor changes to the label.
2.8 Chlorpyrifos (Agricultural Use)
2.9 Members were advised that the recommendations concerning the agricultural uses of chloropyrifos from the July meeting had been agreed by all Ministers except one. It was noted that action could not be taken to implement the recommendations until all Ministers had signed to indicate their agreement. Members expressed concern that in cases where revocation was recommended on safety grounds, a disagreement between Departments which resulted in one or more Ministers not signing recommendations, might prolong the use of products for which there was inadequate reassurance of safety. However, in this particular case, Members were advised that the recommended revocation had come into effect anyway. Thus, at the July meeting the Committee had recommended that the home garden product 'New Chlorophos' should be revoked for failure to provide adequate evidence that the exposures of users were acceptable. The approval holder had since decided not to provide other data that had previously been requested to support continued approval, and approval for the product was therefore subject to automatic revocation by PSD.
2.10 The Committee had also recommended in July that a protocol for an operator exposure study be required to support any continued off-label use as a dipping treatment. However, members were informed that these uses had now expired.
2.11 When considering the exposure of workers harvesting fruit, PSD had indicated at the July meeting that on the basis of US data for citrus crops, absorbed doses might be unacceptably high, and that a re-entry period longer than the UK pre-harvest interval might be necessary. The Committee had advised that if the predicted exposure exceeded 0.01 mg/kg, the pre-harvest interval would need to be altered, and had requested that the calculations be checked.
2.12 PSD confirmed that the calculations had now been checked and, on the basis of the available data, the predicted worker exposure had been calculated as 0.003 mg/kg. It was agreed that some further information should be sought regarding the potential differences between practice in the US and the UK.
Action : Technical Secretariat
2.13 PHOSPHIDES
2.14 At its May meeting the Committee had considered strategies to address the potential genotoxicity of phosphides. On the basis of the strategies proposed, it had been recommended that those approvals held by one consortium of companies should continue whilst the strategy which they had put forward was pursued. However, other companies had not, in the view of the ACP, provided adequate strategies and it had been recommended that their approvals be revoked.
2.15 Following notification of the ACP’s recommendations, the companies whose approvals were to be revoked had made representations against these decisions. They alluded to the possibility of additional data which had not yet been seen by the ACP and raised a number of other points.
2.16 It was noted that revised submissions had been received and were currently under consideration by PSD. A full report would be made to the ACP at its October meeting.
3. Agenda Item 3 : IDS Chairman’s Report [ACP 291 (278/00)]
3.1 The IDS Chairman updated Members on business conducted at the IDS meeting on 25 July 2000.
4. Agenda Item 4 : Review of Chlorpyrifos: Risks to Amateur Users and Residents of Treated Premises Following Use of Non-Agricultural Products [ACP 299 (278/00)]
4.1 At the previous meeting, HSE had provided a short preliminary paper to Members, outlining possible exposure scenarios and worst-case estimates of the risks to amateur users and residents from the use of non-agricultural chlorpyrifos-based products. The most recent paper presented further refined the risk assessment and Members were invited to consider and discuss the findings.
4.2 The paper identified a number of uncertainties and assumptions associated with the exposure predictions proposed. The ACP’s views were sought on whether these, and certain use scenarios were reasonable. The paper did not address the risks to professional users of chlorpyrifos-containing products, which were to be considered as part of the main review.
4.3 Members agreed that the data produced by the applicant, and HSE, on user and residential exposure to chlorpyrifos were sufficiently reliable that exposure predictions may be based on these data. In addition, reference scenarios put forward to represent user and residential exposure were acceptable. It was agreed that approval for amateur baits should continue provided that the bait stations are sufficiently child resistant to prevent accidental access and ingestion. Members requested that HSE should, within 6 months, liase with other interested parties to determine the feasibility of developing a national standard for child resistance.
4.4 Members also agreed that approval holders should consider the feasibility of reformulating with micro-encapsulated chlorpyrifos amateur baits and all water-based products, and make an initial response to HSE within 6 months in order that this can be taken into account in the full review of chlorpyrifos in 2001. It was agreed that professional use of gel baits containing micro-encapsulated chlorpyrifos in domestic situations should be allowed to continue. It was also agreed that amateur and professional use in domestic situations of chlorpyrifos containing aerosols, trigger sprays and other sprays should continue, given the conservative nature of the exposure reference scenario and pending identification of an appropriate NOAEL following submission of an additional study.
4.5 It was noted that HSE would present proposals for simplifying the current labelling of all chlorpyrifos-containing aerosols, trigger sprays and other sprays, to ensure that children and pets are kept away from treated areas until dry, as part of the complete review due to be completed in 2001.
5. Agenda Item 5: Review of Booster Biocides in Antifouling Products: [ACP 214 (277/00), 214/1 (277/00), 214/2 (277/00), 214/3 (277/00), 214/4 (277/00), 214/5 (278/00)]
5.1 Consideration of this paper had originally been timetabled for the July meeting but had not been completed due to lack of time. Following the reviews of triorganotins and copper compounds in antifouling products, high priority was given to reviews of ‘booster biocides’ (the organic active ingredients used in association with copper and/or triorganotins) . The ACP had previously agreed that a hazard evaluation should be undertaken by 2000, so that all of the reviews could be considered together and a concerted approach to the environmental risk assessment undertaken.
5.2 This particular agenda item included a number of individual papers which dealt with specific issues i.e. overview /skin sensitisation & amateur use/ operator exposure & antifouling applications / derivation of AOELs for booster biocides used in antifouling products.
5.3 Members concluded that in the light of the proposed global ban on the use of triorganotins (TOTs) by the International Maritime Organisation, the further review of TOT compounds, originally intended to follow consideration of the Booster Biocide reviews, should be deferred until further details on the extent of the ban had been received. It was noted that this might depend on the outcome of an international conference in 2001.
5.4 Members agreed that efficacy data on products containing both a booster biocide and a TOT should be requested within the proposed deadline of 3 years, but that approval holders should be allowed 12 months to confirm compliance with the data requirements so that they could take into account the outcome of the international conference in 2001. It was also agreed that approval holders should not be required to provide acute toxicity data for all formulations, but they should be asked to make a case for the overall safety of their products as formulated, taking into account the mechanism of action, metabolism and target organs of each potentially toxic co-formulant and likely changes in absorption as a result of the formulation type.
5.5 Members considered that amateur application of antifouling products by roller, brush or spreader, could continue where there are no, or only very rare, reports of skin sensitisation or severe irritation in humans and use of the active ingredient had been fairly widespread. However, it was noted that amateurs should wear suitable gloves in these circumstances. Where information from humans indicated that skin sensitisation or severe irritation is of concern then all amateur uses should be revoked.
5.6 It was agreed that the presence of rosin as a co-formulant should not be a reason for withdrawing amateur use of a product, since rosin occurs in many household products. Spray application could continue, pending clarification of the properties of the particular rosin used in antifouling products and potential risks by inhalation. The recommendation to wear gloves would be extended to these products.
5.7 The Committee considered that the approaches to describe operator exposure and derive indicative values for use in risk assessment were acceptable and that pending clarification of the approach to risk assessment that will be required under the Biocides Directive, the current HSE approach should continue.
5.8 Members indicated that as a general principle, the risks to amateurs should be estimated using data from sub acute toxicity studies rather than LD50 values, and in the absence of appropriate sub acute studies, the same NOAEL as identified for professional use should be used.
5.9 It was confirmed that for compounds with toxic effects primarily at the site of contact, it was still necessary to ensure that the systemic risk is acceptable. Further consideration of the use of indicative values in exposure estimates should be organised, either at a workshop or at a meeting of the Medical and Toxicological Panel. In general, it was agreed that approval should continue where the TER for systemic toxicity based on a "central tendency" estimate of operator exposure was acceptable. However, where the worst case TER (assuming unusually high operator exposure) identified potential concerns, further data should be required.
5.10 Members agreed that since the application methods indicated the potential for inhalation exposure, the risk assessments should take account of acute inhalation toxicity, generally by comparison with an LC50.
5.11 Finally HSE agreed to undertake an analysis of the available respiratory data on a range of chemicals to determine the acceptability of the current approach for assessing inhalation risk (LC50 and safety factor of 1000).
6. Agenda Item 6 : The Environmental Risk Assessment of Booster Biocides Currently Approved for Use in UK Antifouling Products. [ACP 215/1 (277/00)]
6.1 This document, the first risk assessment presented to the ACP using the validated model REMA, had been presented twice to an Ad-hoc Environmental Panel in 1999, followed by the IDS in March 2000. The paper had originally been timetabled for the ACP meeting in July 2000, but there had been insufficient time to address the issues and points raised in the paper and hence it was presented again.
6.2 Members agreed that the approach to risk assessment using the REMA model was satisfactory for the use of antifouling products on leisure craft in the marine environment. It was considered that the use of products containing Irgarol 1051 and diuron on vessels less than 25 m in length should be revoked according to standard procedures and timescales due to adverse environmental data. Approval holders would be asked to comment on the consequent impact. As far as their environmental effects were concerned, the use of the other booster biocides in antifouling products could continue subject to the fulfillment of the data requirements identified for the individual compounds.
6.3 It was concluded that there was a need for further consideration of levels of the booster biocides in enclosed water bodies, in freshwater and as a consequence of shipping. HSE agreed to liase with DETR, Environment Agency (EA) and English Nature and investigate the potential for further monitoring via the National Marine Monitoring Programme or other organisations. HSE would also liase with the Pesticides Residue Committee to determine whether it may be appropriate to undertake monitoring of residues in shellfish for specific booster biocides, particularly Irgarol 1051 and diuron, as significant levels of these had been detected in waters. It was also agreed that the Environmental Panel of the ACP should consider further issues relating to booster biocides including the potential for endocrine disruption and the exposure of marine and freshwater mammals.
7. Agenda Item 7 : Review Of Booster Biocides Approved for Use in UK Antifouling Products: IRGAROL 1051 [ACP 216 , ACP 216/1, ACP 216/2 (277/00)].
7.1 Irgarol 1051 is a triazine herbicide possessing biocidal activity against algal and diatom fouling species. It is currently approved for use in antifouling products on yachts and deep sea vessels of any size and also on structures below the waterline. This paper presented an evaluation of all of the data and additional information submitted in response to data requirements which were identified during the 1997 review of Irgarol 1051.
7.2 Members agreed that approval for professional and amateur use of antifouling products containing Irgarol 1051, on vessels less than 25 m, should be revoked in accordance with standard procedures and timescales due to adverse environmental monitoring data. It was anticipated that this would lead to revocation of all amateur uses of Irgarol 1051.
7.3 Although revocation was being recommended on environmental grounds, it was noted that the skin sensitisation potential of Irgarol 1051 was of sufficient concern to recommend that amateur application by spray or aerosol of antifouling products containing Irgarol 1051 should be revoked. However, application by brush and roller by amateurs would have been acceptable, with a recommendation for gloves to be worn as a precautionary measure.
7.4 Members considered that the use of antifouling products containing Irgarol 1051 by professionals on vessels greater than 25 m, at a maximum concentration of 10% w/w, for application by brush, roller and spray, could continue subject to a number of conditions and data requirements. The full nature and extent of data required will be outlined to individual approval holders, as appropriate, by HSE.
8. Agenda Item 8 : Review of Booster Biocides Approved for Use in UK Antifouling Products: Diuron [ACP 217, ACP 217/1, ACP 217/2 (277/00)].
8.1 Diuron is a urea based herbicide which is used in agriculture as well as in antifouling products. For the purpose of this review only its uses as an antifoulant were considered. It is currently approved for use on vessels of any size and also on structures below the waterline. This paper presented an evaluation of all of the data and additional information submitted in response to data requirements which were identified during the review.
8.2 Members agreed that approvals for all antifouling products containing diuron should be revoked in accordance with standard procedures and timescales, in view of the adverse environmental monitoring data collected in 1998, the predicted data supplied by the validated REMA model assuming maximum usage on pleasure craft; and additionally on human health grounds because comparison of the level of exposure of professional and amateur users with the NOAEL for haematological effects did not show that the safety margin was sufficiently large to recommend continued approval.
9. Agenda Item 9 : Review of Booster Biocides Approved for Use in UK Antifouling Products: RH 287 [ACP 218, ACP 218/1, ACP 218/2, ACP 218/3 (277/00)]
9.1 RH-287 has been used in antifouling products since before 1987. This paper presented an evaluation of all of the data and additional information submitted in response to data requirements which were identified during the review.
9.2 Members concluded that approval for continued professional use of antifouling products containing up to 10 % w/w RH-287 by brush, roller and spray may continue, subject to a number of conditions and data requirements.
10. Agenda Item 10 : Review of Booster Biocides Approved for Use in UK Antifouling Products: TCMTB [ACP 219, ACP 219/1, ACP 219/2 (277/00)]
10.1 TCMTB is used as a fungicide in wood preservation and is used in association with copper or other active ingredients in antifouling products. The antifouling use only was considered by the Committee on this occasion.
10.2 Members considered that provisional approval could continue for the professional use of TCMTB antifouling products at a maximum formulation concentration of 6.2 % w/w for application by spray, brush, roller and spreader. A number of conditions and data requirements were agreed. The full nature and extent of data required will be outlined to individual approval holders, as appropriate, by HSE.
11. Agenda Item 11 : Review of Booster Biocides Approved for Use in UK Antifouling Products: Chorothalonil [ACP 220, ACP 220/1, ACP 220/2 (277/00)]
11.1 This paper presented an evaluation of all data submitted to support the use of chlorothalonil as an antifouling product for professional and amateur use on vessels of any size, plus structures below the waterline. Chlorothalonil is also used in agriculture, but for the purpose of this review only uses as an antifoulant were considered.
11.2 Members agreed that all amateur uses of antifouling products containing chlorothalonil should be revoked as data indicated that the risk of skin sensitisation from these uses is unacceptable. However, it was agreed that approvals for the professional use of antifouling products containing chlorothalonil at a maximum concentration of 5 % w/w, for application by brush, roller and spray could continue, subject to a number of data requirements and conditions.
12. Agenda Item 12 : Review of Booster Biocides Approved for Use in UK Antifouling Products: Dichlofluanid [ACP 221, ACP 221/1, ACP 221/2 (277/00)]
12.1 Dichlofluanid is a fungicide which has been used in antifouling products since before 1987. It also has agricultural uses but for the purposes of this review only the antifouling use was considered.
12.2 Members agreed that the skin sensitisation potential of dichlofluanid was of sufficient concern that amateur application of antifouling products containing dichlofluanid by spray or aerosol should be revoked. However, continued approval of antifouling products for amateur use containing up to 10 % w/w dichlofluanid, for application by brush and roller is acceptable, if gloves are worn as a precautionary measure.
12.3 It was agreed that provisional approval may be allowed to continue for the professional use of antifouling products containing dichlofluanid at a maximum concentration of 10 % w/w, for application by brush, roller, spreader and spray, subject to certain conditions and data requirements. The full nature and extent of data required will be outlined to individual approval holders, as appropriate, by HSE.
13. Agenda Item 13 : Review of Booster Biocides Approved for Use in UK Antifouling Products: Full Review of Zineb [ACP 222, ACP 222/1, ACP 222/2 (277/00)]
13.1 Zineb is a fungicide which is used in antifouling products. It also has agricultural uses but for the purposes of this consideration only the antifouling use was considered.
13.2 Members considered that the skin sensitisation potential of zineb was of sufficient concern that amateur use of antifouling products containing zineb to be applied as a spray should be revoked. However, continued approval of antifouling products containing up to 20 % w/w zineb for application by brush and roller by amateurs was acceptable, with a recommendation for gloves to be worn as a precautionary measure.
13.3 It was also agreed that provisional approval could be allowed to continue for the professional use of antifouling products containing zineb at a maximum concentration of 20 % w/w, for application by brush, roller and spray, subject to certain conditions and data requirements.
14. Agenda Item 14 : Review of Booster Biocides Approved for Use in UK Antifouling Products: Zinc Pyrithione [ACP 223, ACP 223/1, ACP 223/2 (277/00)]
14.1 Zinc pyrithone has been used in antifouling products since before 1987.
14.2 Members agreed that provisional approval for the professional use by brush, roller spray and aerosol and amateur use by brush and roller, of antifouling products containing zinc pyrithione at a maximum concentration of 4 % w/w (3.6 % for amateur spraying could continue, subject to a number of conditions and data requirements.
15. Agenda Items 15 and 16: Date of Next Meeting; Any other business:
15.1 The meeting closed at 2:35 pm. The next meeting will be on 12 October in York
