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Minutes of ACP 279 held on 12 October 2000

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, Mr C Stopes,

Dr D N Bateman, Prof G Matthews, Dr A Carter, Dr P McElhatton,

Prof G Edwards Jones, Prof M Roberts, Prof P Calow, Mr J Orson

Apologies were received from the following Members :

Dr C Soutar.

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), Environment Agency (EA) Health & Safety Executive (HSE), The Food and Environment Research Agency(FERA) Institute of Arable Crop Research (IACR), and Food Standards Agency (FSA).

At its meeting on 12th October 2000 the Committee discussed the following issues:

1. Agenda Item 1:

a) 278th Meeting: Detailed Record of Discussion [ACP 308 (279/00)]

1.1 Agreed as amended.

b) 278th Meeting: Minutes [ACP 309 (279/00)].

1.2 Agreed as amended.

c) ‘Open’ Meeting Minutes [ACP 334 (279/00)]

1.3 Agreed as amended.

1.4 Agenda Item 1.1 : Secretary’s Report [ACP 310 (279/00)]

1.5 The Secretary to the Committee reported on recommendations from the ‘open’ meeting held on 6th September 2000, the 278th meeting held on 7th September 2000 and outstanding recommendations from previous meetings.

Agenda Item 2 : Matters Arising

2.1 (a) Phosphides – Representation Against ACP Recommendations [ACP 326 (279/00)]

2.2 At its May meeting the ACP considered proposals for strategies to address the potential genotoxicity of metal phosphides and phosphine. The approach proposed by a consortium of companies as a way of addressing the data requirement set previously (to provide a study of potential cytogenetic effects in exposed operators, of a nature to confirm the findings of Garry et al (1989, 1992) or provide reassurance that the results are not repeatable under conditions of UK exposure) had been accepted. It was agreed that those approvals held by the consortium should continue whilst their strategy was pursued. At that meeting, the Committee also recommended that approvals be revoked for those products supported by two other companies for failure to submit an adequate strategy and those supported by another for failure to respond to the data call in.

2.3 Representations were received from those companies for which product revocation had been recommended. These representations suggested that further data were available that had not been considered by the ACP. On this basis the companies involved were asked to provide further details. The document presented to Members at this meeting contained an assessment of the information.

2.4 The Committee considered the cases put forward by each of the three companies in turn and reached the following conclusions. Ministers should be advised that the approvals supported by Casa Bernardo Limited should be revoked for failure to supply an acceptable strategy to meet the data requirement set. However, approvals for products containing zinc phosphide, supported by Killgerm Chemicals Limited and Bell Laboratories Inc., should be allowed to continue whilst data are generated to demonstrate the levels of operator exposure that result from the approved use of zinc phosphide in all relevant exposure scenarios.

2.5 (b) Review of Chlorpyrifos [ACP 338 (279/00, ACP 325 (279/00), ACP 341 (279/00)]

2.6 The ACP originally considered the human health review of chlorpyrifos at its meeting in July . Three separate issues had subsequently arisen which required the further consideration of the Committee.

2.7 Firstly, at the July meeting a data requirement was recommended for an additional study to provide reassurance that a figure proposed for the Acceptable Daily Intake (ADI) (a) was appropriate. Although this was not yet a formal data requirement as Ministers had not yet agreed to the recommendations, the company concerned wished to clarify certain points relating to this requirement. A case submitted presented a number of issues regarding the existing database for chlorpyrifos and its potential to meet the concerns of the ACP without the need to conduct a further study.

2.8 The Committee considered the case submitted and concluded that the Secretariat should meet with the applicant to clarify the ACP’s concerns. Members agreed that the data requirement should remain applicable.

2.9 Secondly, with respect to the use of chlorpyrifos as a dip for forestry transplants, at the July meeting the Committee had noted that the company concerned had not provided any information on exposure of operators from this use. An assessment of this use had not therefore been conducted, but an assessment had been made for exposure from the off label use (b) as a bulb dip, and on the basis of this the Committee recommended that unless a protocol for an operator exposure study was provided within 8 weeks approval should be revoked. At the September meeting Members were informed that the off label use on bulbs had subsequently expired and therefore no study would be conducted.

[Post meeting note : the company concerned wish it to be noted that they had considered that there was no need to develop any further operator safety data as the forestry dip was no longer used commercially.]

2.10 As a result it had become apparent that the use of chlorpyrifos as a dip for forestry transplants had not been considered with the bulb dipping use. The Committee were therefore asked whether, on the basis of the limited information which was available, and a case submitted by the company regarding operator exposure, approval for this use of chlorpyrifos should continue.

2.11 Members concluded that Ministers should be advised that approval for the use of chlorpyrifos to dip forestry transplants should be revoked because of the extent to which estimates of operator exposure exceeded the Acceptable Operator Exposure Level (AOEL)(c).

2.12 Thirdly, following action taken in the USA to limit the use of chlorpyrifos on apples (restricting its use to the period before flowering only), Ministers had again requested the Committee’s advice on this use. Members therefore considered a paper outlining the basis for the USA action and the equivalent assessment that the ACP had previously considered for use in the UK. It was noted that the action taken in the USA was intended to ameliorate short-term risk against a reference dose substantially lower than that set by the ACP. The conclusion of PSD’s initial assessment of consumer risk was that exposures were acceptable.

2.13 Members agreed that Ministers should be advised that action to limit the use of chlorpyrifos on apples in the UK was not required, pending consideration of the further data sought by the ACP at their July 2000 meeting. Members noted that there were a number of key differences between the assessment undertaken in the UK and that conducted by the US authorities, including the use of available human data in ACP’s assessments. This resulted in different reference doses. Members considered that the UK assessment offered a sufficient margin of safety to the consumer and therefore no restriction on use was required at this stage.

2.14 (c) Review of Lindane [ACP 342 (279/00)]

2.15 In July this year the EC Standing Committee on Plant Health (SCPH) voted not to include lindane on Annex I to Directive 91/414/EEC. All Member States would therefore be required to withdraw marketing authorisations for the plant protection uses of lindane within six months and use up stocks within eighteen months. However, it was noted that the decision would not take effect until it had been adopted by the European Commission, and that it was currently subject to further consultation within the Commission. It was therefore unclear when adoption would take place.

2.16 Ministers therefore wished to seek the ACP’s views on whether it would be appropriate to move ahead and revoke the remaining plant protection uses of lindane currently approved in the UK in anticipation of the Community decision.

2.17 It was agreed that whilst the ACP supported the action proposed following the European review which resulted from concerns over gaps in the environmental risk assessment, there was no urgency on scientific grounds for the UK to proceed with action at a national level ahead of a Community decision. Members agreed that it was a matter for Ministers to decide the timetable they wish to pursue with regard to its withdrawal.

3. Agenda Item 3 : Inter-Departmental Secretariat (IDS) Chairman’s Report

3.1 The IDS Chairman updated Members on business conducted at the IDS meeting on 19 September 2000.

4. Agenda Item 4 : First Evaluation for UK Provisional Approval (COPR) of Nicosulfuron, in the Product ‘Samson’ [ACP 324 (279/00)]

4.1 Nicosulfuron is a new sulphonyl urea herbicide. The application under consideration by Members was for provisional approval for the product ‘Samson’, a suspension concentrate formulation containing 40 g/l nicosulfuron. This product was proposed for use on fodder maize to control a number of weed species. Products containing nicosulfuron already hold approval for use in several EU countries.

4.2 Members requested that the Secretariat clarify certain details regarding the scenario used in modelling the risk from drainflow. It was agreed that this would be discussed outside of the meeting and, if found to be acceptable, Ministers should be advised to grant provisional approval for ‘Samson’ for use on forage maize (under the Control of Pesticides Regulations 1986). This would be subject to provision of further modelling data on groundwater contamination by one year from the date of issue of the approval, and certain other data would be required within three years of issue of the approval.

[Post-meeting note: The details regarding the modelling used for drainflow were subsequently clarified and found acceptable].

5. Agenda Item 5: Review of Lindane in Non-Agricultural Pesticides: Revised Human Health Risk Assessments for Smoke Generator Products [ACP 323 (279/00)]

5.1 In 1999 the ACP had considered a review of the non-agricultural uses of lindane and this resulted in the initiation of an environmental review. A data requirement was also set to address the operator and consumer risks associated with the products concerned. In March 2000, the ACP considered the environmental and physicochemical data submitted by approval holders in response to the data call-in. Following the 1999 review no support had been provided for industrial timber treatment products and these products had been subsequently revoked. Data submitted in support of the remaining aerosol and for three smoke generator products were considered and Members recommended that the aerosol should be revoked as the approval holder had failed to address the data requirements adequately. Members also recommended that amateur uses of smoke generators be revoked due to concerns that amateurs would not be able to comply with the assessment of risks to wildlife. Provisional approval was allowed to continue for professional uses of smoke generators subject to the fulfillment of further efficacy and environmental data requirements. (Ministerial agreement is still awaited for these recommendations).

5.2 The document under consideration at this meeting addressed the operator and consumer risks arising from the professional use of smoke generators.

5.3 The ACP considered that the data available gave inadequate reassurance of safety for people occupying treated buildings. Members agreed that Ministers should be advised that all non-agricultural uses of smoke generator and pellet products containing lindane should be revoked in accordance with usual timescales.

5.4 Members indicated that if the approval holder wished to provide data to support the continued use in unoccupied premises, they would need to provide further data to demonstrate safety to persons occupying treated buildings and the environment.

5.5 It was agreed that if these data were submitted, and deemed acceptable, the conditions of approval identified for protection of professional users would be appropriate.

6. Agenda Item 6 : Third Evaluation for UK Provisional Approval (COPR) of Famoxadone, in the Product ‘DPX-MC444EC’ [ACP 320 (279/00)]

6.1 The application under consideration by Members was for a formulated plant protection product called ‘DPX-MC444 EC’. It was an emulsifiable concentrate formulation containing 100 g/l famoxadone and 106.7 g/l flusilazole which was to be applied to winter wheat and winter and spring barley for the control of a range of diseases. Famoxadone, an oxazolidinedione contact fungicide, affects susceptible fungal pathogens through inhibition of mitochondrial respiration. Famoxadone has been evaluated under 91/1414/EC by France, the rapporteur Member State, for inclusion in Annex I. Members noted that the monograph was still under discussion within Europe and that no decision had yet been taken. Products containing flusilazole currently held provisional approval in the UK and this active substance was also being considered for inclusion in Annex I via the EU Review programme.

6.2 This application had previously been considered by the ACP in November 1999, when it was agreed that before a commercial approval could be granted, it must be demonstrated that the acute risk to fish was acceptable. In addition, the Secretariat were requested to consider further the possible risk to aphid parasitoids and make a number of amendments to the text in the toxicology section of the evaluation. The document presented to the Committee satisfactorily addressed these points.

6.3 Members agreed that Ministers should be advised that ‘DPX-MC444 EC’ should be granted provisional approval for use on cereals until 25 July 2003, pending the Commission decision on inclusion of famoxadone in Annex I of Council Directive 91/414/EEC.

7. Agenda Item 7 : Human Health Review of Tri-Allate [ACP 312 (279/00)]

7.1 Members heard that tri-allate, a thiocarbamate compound, was first cleared for commercial use in 1964 under the Pesticides Safety Precautions Scheme. Three products containing tri-allate were currently approved for use as selective herbicides (all are granule formulations). These products held approval for both ground and aerial application. No products were approved for amateur use. In 1998, following the receipt of adverse data a special review was initiated to investigate the risk to operators posed by use of this compound. At that time five products containing tri-allate were approved (covering granule and emulsifiable concentrate formulations).

7.2 Following the consideration of data resulting from the special review the Committee concluded that approvals for the emulsifiable concentrate products should be revoked (July 1999). Approvals for the granule products were permitted to continue subject to further operator protection requirements. It was also recommended that further data requirements should be established to enable a full review to be conducted of the risk to operators and consumers posed by the use of tri-allate. The paper under consideration here presented an evaluation of the mammalian toxicology, residues and operator exposure data provided in response to the data call-in issued following the special review.

7.3 Members agreed that Ministers should be advised that approvals for tri-allate products should continue subject to the provision of further data in relation to residues, physical/chemical properties and the nerve conduction study previously requested.

8. Agenda Item 8 : Consideration of ‘Beret Gold’ and ‘Celest’ Containing Fludioxonil for Continuing UK Approval [ACP 319 (279/00)]

8.1 PSD advised Members that ‘Beret Gold’ and ‘Celest’ were existing fungicidal seed treatments approved for use on winter and spring wheat, winter and spring barley and winter and spring oats. The products were similar flowable concentrate formulations both containing 25 g/l fludioxonil. The paper considered at this meeting contained details of a case submitted by the applicant to address a data requirement regarding the risk posed to workers from use of the product, which had been set following consideration of an earlier application. The applicant had requested a revision to the ADI for fludioxonil.

8.2 Members agreed that approval for ‘Beret Gold’ and ‘Celest’ could be allowed to continue. It was also agreed that, in view of the additional data submitted, Ministers should be advised that the ADI for fludioxonil should be revised from 0.01 to 0.03 mg/kg bw/day and the AOEL for fludioxonil be revised from 0.01 to 0.06 mg/kg bw/day.

9. Agenda Item 9 : Potential Dermal Exposure – Proposals for a Model [ACP 333 (279/00)]

9.1 HSE have conducted numerous studies to determine potential dermal exposure to pesticides (i.e. what deposits on work clothing and could lead to skin exposure) in different usage scenarios. The data from those studies, classified by the tasks in using pesticides, form the basis for "empirical exposure models" which allow estimates to be made of exposure to operators and workers when undertaking various tasks. Some of these models, specific to their field of use, had previously been presented to, and accepted by the ACP, for use in human risk assessment. The paper considered by Members at this meeting described a concept of ‘indicative distribution’ underpinned by these exposure models and suggested a way of applying the resulting matrix more widely.

9.2 Members were advised that HSE was undertaking further work to develop an expert system based on the original exposure data. The concept was also under discussion in Europe and should be regarded as an interim position.

9.3 It was noted that this paper had been tabled previously for information only, but this time it was for discussion.

9.4 Members agreed that Ministers should be advised that where there are no other data available, and for screening level human risk assessments only, the "indicative distributions" model matrix could be used to predict potential dermal exposure before requiring an operator exposure study. Members also agree that HSE should consider commissioning further experimental work to support the concept of indicative distributions.

10. Agenda Item 10 : Use of Data from Human Volunteer Studies in the Pesticide Approval Process [ACP 318 (279/00)]

10.1 At its 19th meeting, in March 2000, the Medical and Toxicology Panel of the ACP was invited to consider issues surrounding the regulatory use of data derived from human volunteer studies on pesticides. Members considered the main conclusions arising from the Panel. One Member wished it to be noted that he could not agree in principle to the generation of human experimental data on pesticides, but others did not take this view.

10.2 Members offered advice to PSD on when it might be appropriate to consider available human data but agreed that there was a need to investigate the approach taken by other similar Committees across Government before they could consider some of the issues contained within the paper. It was therefore suggested that a consultation exercise might be conducted and the Secretariat should investigate which would be the appropriate department to initiate this.

11. Agenda Item 11 : Evaluation of Data Required by the Committee on the Environmental Fate and Behaviour of Fenbuconazole [ACP 336 (279/00)]

11.1 Fenbuconazole, a triazole fungicide, was first approved in the UK in 1995 for use on cereals in the product 'Indar 5EC' and use on apples and pears in the product 'Indar 5EW'. Due to concerns primarily associated with the persistence of fenbuconazole in the environment, approvals were restricted to 5 years and limitations on the crop areas to be treated were imposed. Data requirements were set to allow refinement of the environmental risk assessment. The Committee requested to see the further data when they were submitted. This paper evaluated the data provided.

11.2 Having considered these data Members agreed that Ministers should be advised that provisional approval for use of 'Indar 5EW' and 'Indar 5EC', on cereals and orchards respectively, could continue without the need for any restriction on areas to be treated. However, it was noted that for full approval the final report of a soil accumulation study must be submitted.

12. Agenda Item 12 : Application for Off-Label Use of ‘Dynamec’ as a Horticultural Insecticide on Cherry Tomatoes [ACP 321 (279/00)]

12.1 Abamectin, as approved in the product ‘Dynamec’, is currently approved for use as an acaricide/insecticide on various ornamental and edible crops, including standard tomatoes. Approval for use on cherry tomatoes was not granted when it was initially sought due to concerns over the potential for higher residues to occur then in standard tomatoes, which had implications for the consumer risk assessment.

12.2 Members were asked to consider an assessment for an emergency application for the off label use of ‘Dynamec’ on cherry tomatoes which was supported by specific residue data.

12.3 Members concluded that Ministers should be advised that the application for the off label use of ‘Dynamec’ on cherry tomatoes should be refused due to inadequate data being submitted to show that the exposure of consumers from residues of abamectin would be acceptable. Members asked the Secretariat to provide some additional information to enable them to confirm the continuing acceptability of the approved uses.

13 Agenda Item 13 : Date of Next Meeting

13.1 The next meeting of the Advisory Committee will be held on Thursday, 23 November 2000.

14 Agenda Item 14 : Any Other Business

14.1 The Chairman advised Members of the feedback received following the first open meeting of the Committee. It was noted that a positive message had been received and a suggestion had been made that attendees at future meetings might be invited to submit questions in writing in advance of the meeting. Members also suggested that the meeting might be scheduled to coincide with the publication of the ACP Annual Report and that the meeting might start later in the day to allow attendees more time to travel from other parts of the country.

14.2 Members were advised that, following an earlier request by the ACP, the Committee on Toxicity (a DH advisory committee) would be setting up a working group to investigate ways of assessing the risk posed to consumers from cumulative and aggregate exposure to pesticide residues.

14.3 Members were informed that the ACP had been commended by Maurice Frankel, leader of the Freedom of Information Campaign. He had cited the presentation of the ACP minutes on the PSD website as a shining example of Open Government.

Professor Coggon

November 2000

Notes/Glossary of Terms:

(a) Acceptable Daily Intake (ADI)

This is the amount of a chemical which can be consumed every day for a lifetime in the practical certainty, on the basis of all known facts, that no harm will result. It is expressed in milligrams of the chemical per kilogramme body weight of the consumer. The starting point for the derivation of the ADI is usually the lowest ‘no adverse effect level’ (NOAEL) that has been observed in animal studies for toxicity. This is then divided by an uncertainty factor (most often 100) to allow for the possibility that animals may be less sensitive than humans and also to account for possible variation in sensitivity between individuals. The studies from which NOAELs and hence ADIs are derived take into account any impurities in the pesticide active substance as manufactured, and also any toxic breakdown products of the pesticide.

(b) Off label approval

Uses of a product on crops for which, for a variety of reasons, no recommendation appears on the approved pesticide label, but for which a grower or representative organisations have submitted data on safety. A full safety assessment for users, consumers and the environment is required. However, the effectiveness of the use is not assessed and is at the grower’s own risk. Many off label approvals extend the use of products, which have recommendations on the label for major crops to minor crops which are grown on a comparatively small scale in the UK.

(c) Acceptable Operator Exposure Level (AOEL)

This is intended to define a level of daily exposure that would not cause adverse effects in operators who work with a pesticide regularly over a period of days, weeks or months. Depending on the pattern of usage it may be appropriate to define a short-term AOEL (i.e. for exposures over several weeks or on a seasonal basis), long-term AOEL: (i.e. for repeated exposures over the course of a year) or both. AOELs are normally derived form a short-term toxicity study or multi-generation study in a manner analogous to the ADI.

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