Advisory Committee on Pesticides Annual Report 2001

Department for Environment, Food and Rural Affairs 

Health and Safety Executive 

<strong>Advisory</strong> <strong>Committee</strong> 

on Pesticides 

Annual Report 

2001



<strong>Advisory</strong> <strong>Committee</strong> 

on Pesticides 

Annual Report 

2001


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17 Smith Square 

London SW1P 3JR 

Telephone 020 7238 6000 

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This document is also available on the Pesticides Safety Directorate website. 

www.pesticides.gov.uk/committee/acp 

Published by the Department for Environment, Food and Rural Affairs. Printed in the 

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Foreword 

Foreword 

2001 was another busy year for the ACP. In addition to the assessment of 22 

new pesticides and a major ongoing review of anti-cholinesterase compounds, 

we addressed several important generic issues. 

Following discussion at our first open meeting in September 2000 and a 

subsequent request for advice from Ministers, we initiated an investigation 

into the scope for comparative risk assessment in the regulation of pesticides. 

It seems obvious that where either of two pesticides will control a problem 

effectively, it is desirable to choose the one that carries the bigger margins 

of safety. In practice, however, implementation of such a policy is not 

straightforward. For example, one product may be preferable in relation to 

the health of users, while the other poses less threat to wildlife. Moreover, a 

product that is best for one use may not be best for another. After a helpful 

consultation exercise, we concluded that it might be possible to develop a 

system in which products were graded as first-, second- or third-line for each 

of their uses. There could then be an onus on the user to justify applying any 

product that was not first-line for the pest problem he or she was trying to 

control. Our next step is to explore exactly how grades might be assigned. 

If this can be achieved satisfactorily, we may wish to consult stakeholders 

again on more detailed proposals. 

iii 

Risk assessment for pesticides undergoes continual refinement, and as part 

of that process we are now turning our attention to their indirect effects on 

wildlife. At present, we assess the toxicity of individual pesticides to a wide 

range of wildlife species, but they may also cause harm through other 

mechanisms. For example, use of a herbicide or insecticide might deprive 

birds of a vital food source. It will not be easy to disentangle such effects 

from those attributable to other aspects of agricultural practice, but through 

our Environmental Panel we are looking to promote the research that 

is needed. 

Another significant development in 2001 was the effect of two court rulings 

on the openness of our proceedings. In each case, legal action by a company 

holding approval for a pesticide prevented publication of sections of our 

minutes, pending review of any regulatory action that might follow from our 

advice on their products. This runs counter to the recommendations of the 

Phillips report, and risks compromising public confidence in the regulatory 

process. We very much hope that it will not become a regular occurrence.

<strong>Advisory</strong> <strong>Committee</strong> on Pesticides Annual Report 2001 

I would like to thank two members, Mike Roberts and Colin Soutar, who left 

the <strong>Committee</strong> during 2001, and as ever, I am grateful to the secretariat for 

their excellent support. 

Professor David Coggon, Chairman of the ACP 

iv

Contents 


Page 

Foreword 

iii 

Introduction 1 

The Regulatory System 1 

The UK pesticide approvals process 1 

The European Community pesticide approvals process 2 

The work of the <strong>Committee</strong> 3 

The roles of the Pesticides Safety Directorate and the Health and 

Safety Executive 4 

Openness 4 

Section A: Continuing/existing approvals 5 

Agricultural use 5 

Fluazifop-P-butyl 5 

Methyl bromide 5 

Section B: Applications for provisional approvals 

for products containing new active substances 7 

New provisional approvals 7 

Beta-cyfluthrin 7 

Clomazone 8 

Cyazofamid 10 

Flufenacet 12 

Iodosulfuron-methyl-sodium 14 

Mepanipyrim 16 

Picolinafen 17 

Picoxystrobin 19 

Propoxycarbazone-sodium 20 

Pyraclostrobin 22 

Silthiofam 23 

Spinosad 24 

Sulfosulfuron 27 

Zoxamide 28 

Commodity substances 30 

v


Section C: Inclusion of new active substances on 

Annex I of Directive 91/414/EEC 31 

Acetamiprid 31 

Azafenidin 32 

Benzoic acid 32 

D-Carvone 33 

Profoxydim 33 

Dimethenamid-p 34 

Foramsulfuron 35 

S-metolachlor 36 

Section D: Experimental approvals and permits 37 

vi 

Section E: UK review programme 38 

Routine reviews 38 

Agricultural use 38 

Azamethiphos 39 

Bone oil 40 

Chlorpyrifos-methyl – environmental risk assessment 40 

Chlorpyrifos – dog study 41 

Chlorpyrifos – ornamental bulb dipping 42 

Dichlorophen 43 

Dichlorvos 43 

Dimethoate 46 

Malathion 47 

Oxamyl 48 

Phosphides 49 

Pirimicarb 49 

Pirimiphos-methyl 50 

Tolclofos-methyl 51 

Non-agricultural use 52 

3-iodo-2-propynyl-N-butyl carbamate (IPBC) 52 

Azamethiphos 53 

CCA 54 

Dichlorophen 55 

Dichlorvos 57 

Diuron 60 

Fenitrothion 60 

Irgarol 62 

Lindane 62 

Pirimiphos-methyl 62


Section F: Other items considered during the year 64 

Pesticide usage survey reports 64 

Report 162: Rodenticide use on farms in Great Britain growing arable 

crops 1998 64 

Report 164: Protected crops (edible and ornamental) in Great Britain 1999 65 

Report 165: Mushroom crops in Great Britain 1999 67 

Report 172: Orchards and fruit stores in Great Britain 2000 69 

Report 173: Hops in Great Britain 2000 71 

Report 179: Farm grain stores in Great Britain 1998/1999 72 

Report 180: Commercial grain stores in Great Britain 1998/1999 73 

Other Items 75 

Aquatic risk management options 75 

Bioavailability of triazophos for treated apples 75 

Comparative risk assessment 76 

Degradation of chlorothalonil residues prior to analysis – follow-up report 76 

How a broader approach to the production of biodiversity may affect 

ecological risk assessments of plant protection products 77 

Reappraisal of Local Environmental Risk Assessments for Pesticides (LERAPs) 

for horizontal boom sprayers 78 

Revised proposals for a scheme of Local Environment at Risk Assessments 

for Pesticides (LERAPs) for broadcast air-assisted sprayers 78 

Mutual recognition of Member State product approvals in support of 

applications for extensions of use (off-label use) of products approved 

under the Plant Protection Products Regulations 1995 (as amended). 79 

Operator exposure in applying amenity herbicides by All-Terrain Vehicle (ATV) 

and Controlled Droplet Applicator (CDA) 79 

Papers to address re-entry time policy for certain wood preservatives 80 

Pesticide exposure and Parkinson’s disease – review of the literature 81 

Pesticide Incident Report 2000/2001: report on HSE’s Field Operations 

Directorate’s investigations 1 April 2000–31 March 2001 81 

Proposed representations procedure 83 

Review of CMO advice to peel fruit 83 

The Precautionary Principle 83 

vii 

Section G: Fees 84 

Chairman’s fees 84 

Deputy Chairman’s fees and members fees 84 

Appendix I 85 

Terms of reference 85 

Appendix II 86 

Membership of the <strong>Advisory</strong> <strong>Committee</strong> on Pesticides up to 

31 December 2001 86


Appendix III 89 

Independent members’ annual declaration of interests in the pesticides 

industry 2001 89 

Appendix IV 90 

Inter-Departmental Secretariat 90 

Terms of Reference 90 

Membership (as at 31 December 2001) 90 

Environmental Panel 92 



Pesticides Residues <strong>Committee</strong> 94 

Medical and Toxicological Panel 94 



Working Party on Pesticide Usage Surveys 96 


viii 

Appendix V 97 

Published evaluations (as at 31 December 2001) 97 

Appendix VI 104 

Terms and Abbreviations 104

Introduction 


The Regulatory 

System 

The principal aim of pesticide regulation in the UK is to protect the health 

of human beings, creatures, plants and the environment. Other important 

objectives are to ensure that pesticide approval procedures are independent 

of sectoral interest; to limit the use of individual pesticide products to the 

minimum necessary for the effective control of pests; to review regularly all 

approvals and to act on significant new information; and to make information 

supporting decisions on the use of pesticides publicly available. 

The UK pesticide approvals process 

Statutory powers to control pesticides are provided by the Food and 

Environment Protection Act 1985 (FEPA) and underpin the Control of 

Pesticides Regulations 1986 (as amended) (COPR). These define in detail 

the types of pesticides subject to control; prescribe the approvals required 

before any pesticide may be sold, stored, supplied, advertised or used; 

and allow for general conditions to be attached to sale, supply, storage, 

advertisement and use. 

1 

Applications for approval under COPR may result in one of three levels 

of approval – experimental, provisional (usually with requirements for 

submission of confirmatory data), or full approval. When pesticides are first 

considered for commercial use, or are reviewed, decisions are made by 

Ministers in all the departments responsible for regulating pesticides: the 

Department for Environment, Food and Rural Affairs 1 ; the Department for 

Transport, Local Government and the Regions 2 ; the Department of Health; 

the Scottish Executive Environment and Rural Affairs Department; and the 

National Assembly for Wales Agriculture Department. The Food Standards 

Agency has oversight of all matters to do with food safety, including the 

safety of pesticides. 

Approvals are subsequently issued by the Pesticide Safety Directorate (PSD) 

and the Health and Safety Executive (HSE). Once a pesticide has been 

approved it will be subject to routine review, and it may also be reviewed 

if at any time new evidence casts doubt on its safety. As a consequence 

of review, the approval may, if appropriate, be restricted or revoked. 

1 This responsibility was previously held in part by the Ministry of Agriculture, Fisheries 

and Food. 

2 This responsibility was previously held in part by the Department of Environment, Transport 

and the Regions.


The European Community pesticide approvals process 

The current UK system of pesticide approvals provided under COPR is 

gradually being replaced by arrangements based on European Community 

(EC) requirements. These are based upon Council Directive 91/414/EEC, 

which establishes rules for placing plant protection products (broadly 

agricultural pesticides) on the market. This legislation is implemented in 

Great Britain by the Plant Protection Products Regulations 1995 (PPPR) 

(as amended). 

2 

Since implementation of the Directive on 25 July 1993, all products containing 

active substances, which are new to the Community, must be authorised 

under Directive 91/414/EEC (and hence in the UK they are subject to PPPR). 

The Directive is intended to harmonise arrangements for authorisation of plant 

protection products within the Community although authorisation will remain 

the responsibility of individual Member States. Products containing active 

substances, which were already on the market at the date of implementation 

of the Directive, continue to be subject to national rules (COPR in the UK). 

However, these active substances are being scheduled for review under a 

collaborative EC Review Programme. If they are found to be acceptable at 

review, authorisation will be granted under Directive 91/414/EEC (PPPR in the 

UK). A list of active substances authorised by the Community for use in plant 

protection products is being assembled in Annex I to the Directive. This will 

be augmented over a period of time as existing active substances are reviewed 

and new ones authorised. 

Under PPPR, provisional approvals for a new active substance may be issued 

for three years whilst the EC is evaluating the active substance for inclusion 

in Annex I of the Council Directive 91/414/EEC. Once an active substance 

is included in Annex I, plant protection products that contain it may be 

approved under a system of mutual recognition. This allows authorisations 

to be granted more easily in individual Member States, but it is still necessary 

to demonstrate that the specific uses proposed for each product will be 

acceptable, taking into account the way in which the active substance 

will be formulated, and national climatic and agronomic conditions. 

In addition to the legislation already mentioned, Council Directive 98/8/EC 

lays down a regime for biocidal products (including all other products 

regulated as pesticides in the UK and some that are not so regulated at 

present). The Biocidal Products Regulations 2001 implement this Directive 

in the UK.


The work of the <strong>Committee</strong> 

The <strong>Advisory</strong> <strong>Committee</strong> on Pesticides (ACP) advises Ministers on all major 

pesticide issues. It met on eight occasions during 2001 to consider applications 

for approval, reviews of approved pesticides and other issues relevant to its 

terms of reference under the Food and Environment Protection Act 1985 

(FEPA). Additionally, in July 2001 the <strong>Committee</strong> held its second open meeting. 

The <strong>Committee</strong>’s terms of reference and its membership during 2001 are 

included at Appendices I and II, respectively. It is important that the 

<strong>Committee</strong> is independent of Government and of the agrochemicals industry, 

and arrangements are in place to this end. Throughout the year, members are 

required to declare any interests or potential conflicts of interest they may 

have, and declared interests for 2001 are listed at Appendix III. 

In 2001 the <strong>Committee</strong> consisted of 14 members, 12 selected for their scientific 

and technical expertise and two lay members. The <strong>Committee</strong> is supported by 

about 20 advisers who complement the scientific expertise of the <strong>Committee</strong> 

and provide expertise in policy and operational matters. In addition to the 

advisers, a number of assessors attend <strong>Committee</strong> meetings. Assessors 

represent each department involved in the regulatory process and are 

responsible for ensuring that the <strong>Committee</strong>’s recommendations are properly 

considered by those departments. 

3 

The <strong>Advisory</strong> <strong>Committee</strong> is further supported by several subsidiary 

bodies which this year comprised the Inter-Departmental Secretariat, the 

Environmental Panel, the Medical and Toxicological Panel, and the Working 

Party on Pesticide Usage Surveys (WPPUS). The former Working Party on 

Pesticides Residues (WPPR) was established as an independent committee, 

the Pesticides Residues <strong>Committee</strong> (PRC), in January 2001. The terms of 

reference for these bodies are given at Appendix IV. 

The <strong>Committee</strong> considers documents prepared by the Pesticides Safety 

Directorate, the Health and Safety Executive and by its supporting groups. 

However, it is also able to consider representations from companies and 

organisations seeking or holding approvals for pesticides, and from 

other parties. Following discussion, the <strong>Committee</strong>’s conclusions and 

recommendations are drawn together and put forward for consideration 

by Ministers in all Government departments concerned with pesticides. 

If Ministers agree then the recommendations made by the <strong>Committee</strong> 

are taken forward.


Documents detailing the <strong>Committee</strong>’s evaluation of individual active 

substances are published. A list of those available (as at 31 December 2001) 

can be found at Appendix V. Documents can be obtained on written 

application to the Finance and Corporate Services Unit, Mallard House, 

Kings Pool, 3 Peasholme Green, York, YO1 7PX. 

The roles of the Pesticides Safety Directorate and the Health and 

Safety Executive 

The Pesticides Safety Directorate (PSD), an executive agency of the 

Department for Environment, Food and Rural Affairs, administers the 

regulation of pesticides used in agriculture, horticulture, forestry, food 

storage and the home garden. 

For non-agricultural pesticides (e.g. masonry biocides and marine anti-fouling 

products), this role is taken by the Biocides and Pesticides Assessment Unit 

(BPAU) of the Health and Safety Executive (HSE). 

4 

The principal functions of the PSD and the BPAU of HSE are to evaluate and 

process applications for approval of pesticide products for use in Great Britain 

and to provide advice to Government on pesticides policy. The PSD and the 

BPAU also provide the secretariat for the ACP. 

In order to obtain approval for a new pesticide, or to secure the continued 

approval of an existing pesticide, an extensive package of scientific data must 

be submitted addressing its identity; function; efficacy; the risks it could 

present to humans, non-target creatures and plants and to the environment; 

and the effectiveness of any measures to reduce risks. With regard to potential 

risks to humans, account must be taken of exposures that might occur in 

application of the pesticide, through contact with treated plants or materials 

(e.g. workers picking treated crops), and through consumption of food 

derived from treated crops. 

Openness 

In order to assist in making information on the pesticide approvals process 

available, agendas of meetings are displayed on the ACP website in advance 

of meetings and draft minutes of meetings are displayed on the website three 

weeks after each meeting. Minutes are finalised at the following meeting and 

the website is subsequently updated. 

The website address is www.pesticides.gov.uk/committees/acp

Section A: Continuing/existing approvals 

Section A: 

Continuing/existing approvals 

Agricultural use 

During 2001 the ACP recommended continuing existing approval for products 

based on the following active substances. 

● 

● 

Fluazifop-P-butyl 

Methyl bromide 

Fluazifop-P-butyl 

‘Fusilade 250 EW’ is an oil-in-water emulsion containing 250 g/l fluazifop-P-butyl 

with approval for use as an agricultural, horticultural and forestry herbicide for 

grass weed control. 

The ACP considered an application for the removal of a restriction prohibiting 

the application of ‘Fusilade 250 EW’ using hand-held equipment. In support of 

this application the company had proposed to use dermal absorption data to 

refine the operator exposure assessment and had submitted data to support an 

acceptable operator exposure level (AOEL) of 0.05 mg/kg bodyweight (bw)/day, 

based on a no observed adverse effect level (NOAEL) of 5 mg/kg bw/day, 

derived from new rat developmental studies. 

5 

However, the ACP did not consider that the additional toxicological studies 

submitted supported the proposed AOEL and recommended that the 

application for removal of the restriction prohibiting application via 

hand-held equipment be refused. 

In addition, because the <strong>Committee</strong> considered that the new data might indicate 

a higher risk than had previously been assessed, it considered whether a review 

of fluazifop-P-butyl was required ahead of the scheduled review in the EU 

programme. The <strong>Committee</strong> compared the new data with their previous 

evaluations of fluazifop-P-butyl and concluded that the new data did not indicate 

need for urgent action. They recommended that fluazifop-p-butyl should not be 

formally reviewed in the UK ahead of the EU review but that the company should 

be asked to provide a position paper addressing the concerns of the <strong>Committee</strong>. 

Methyl bromide 

Methyl bromide is currently approved within the UK as a commodity substance, to 

be used as a fumigant in public hygiene and vertebrate control under the Control


of Pesticides Regulations 1986 (COPR). A commodity substance is not sold or 

advertised as a pesticide product in this context and there are no approval holders. 

Methyl bromide manufacture is currently restricted under the Montreal Protocol, 

which envisages a phased withdrawal leading to a world-wide ban. 

The <strong>Committee</strong> considered a brief evaluation of information submitted by 

interested parties to address data requirements set previously by the ACP 

for support of commodity substances. 

6 

In addition to the data reported, the <strong>Committee</strong> noted that studies performed in 

France and the USA suggested that neurobehavioural effects could result from 

repeated occupational exposure to methyl bromide. The <strong>Committee</strong> also considered 

that methyl bromide was likely to be genotoxic although it was not aware of any 

cytogenetic studies in exposed populations. However, it noted that methyl bromide 

was required to be used under strictly controlled situations in compliance with an 

Approved Code of Practice (ACOP) for fumigation. Fumigations were carried out 

by a small number of dedicated contractors who had in place good standards of 

training and supervision. The <strong>Committee</strong> considered that the strict engineering 

controls and requirements for personal protective equipment that were currently in 

place in the UK would mitigate exposure and minimise the risks to workers. Given 

these controls, the small number of highly trained professional workers involved, 

the low level of incidents involving methyl bromide over the last 10 years and the 

rarity of claims for occupational injury by methyl bromide, the <strong>Committee</strong> agreed 

that there was no pressing need for further data to refine the risk assessment if 

methyl bromide was to be phased out by 2005. 

The <strong>Committee</strong> noted that there was a provision to allow essential uses of 

methyl bromide to remain beyond 2005, but that it was not yet clear what these 

might be. It considered that when methyl bromide was phased out under the 

Montreal Protocol, it would lose its approval as a commodity substance and any 

continued essential use as a pesticide after 2005 was likely to require specific 

approval. The <strong>Committee</strong> briefly discussed alternatives to methyl bromide such 

as hydrogen cyanide, but considered that, depending on the circumstances and 

the area of use, these might not be particularly suitable replacements. 

The <strong>Committee</strong> agreed that the data requirements set previously by the 

ACP had been addressed adequately and that currently there should be no 

requirement for any further data. It noted the need to identify any essential 

uses that might remain beyond 2005, the users who would require them, 

and the administrative arrangements by which uses would be classified as 

essential. The <strong>Committee</strong> agreed that, depending on the answers to these 

questions, more data might be required to support remaining uses.

Section B: Applications for provisional approvals for products containing new active substances 

Section B: 

Applications for provisional approvals 

for products containing new active 

substances 

New 

provisional 

approvals 

The ACP considered provisional approval for products based on the following 

active substances: 

● BETA CYFLUTHRIN 

● 

CLOMAZONE 

● 

CYAZOFAMID 

● 

FLUFENACET 

● 

IODOSULFURON-METHYL-SODIUM 

● 

● 

MEPANIPYRIM 

PICOLINAFEN 

7 

● 

PICOXYSTROBIN 

● 

PROPOXYCARBAZONE-SODIUM 

● 

PYRACLOSTROBIN 

● 

SILTHIOFAM 

● 

SPINOSAD 

● 

SULFOSULFURON 

● 

ZOXAMIDE 

Beta-cyfluthrin 

The <strong>Committee</strong> considered the second evaluation of ‘Chinook’, a seed 

treatment product containing beta-cyfluthrin and imidacloprid. In 2000 

members had concluded that insufficient data to address the environmental 

risk had been presented to recommend a commercial level of approval. 

New data were presented addressing the risks to birds and small mammals 

and the levels of beta-cyfluthrin likely to occur in surface waters as a result of 

drainflow. The <strong>Committee</strong> considered that these data indicated an acceptable


risk to wildlife and recommended approval for the use on winter oilseed 

rape as proposed. The <strong>Committee</strong> also recommended that the approval holder 

be required to implement a user education scheme to minimise further any 

environmental effects. 

Clomazone 

Clomazone is a new isoxazolidinone herbicide that acts by inhibition of 

biosynthesis of photosynthetic pigments in plants. The ACP considered 

applications for approval of two products ‘Centium 50 WP’, a wettable powder 

(WP), and ‘Centium 360 CS’, a capsule suspension (CS), for residual control 

of broad-leaved weeds in winter oilseed rape. 

Clomazone was rapidly and extensively absorbed, metabolised and excreted 

in the rat, mainly via urine. Very little unmetabolised parent compound 

was excreted and a large number of metabolites were identified, 

mostly hydroxylated derivatives of the parent compound, especially 

5-hydroxyclomazone. 

8 

The active substance is classifiable as ‘Harmful if swallowed and by inhalation’ 

based on acute oral and inhalational studies in rats. 

The <strong>Committee</strong> agreed that the main toxicological effect was liver enlargement 

and that the acceptable daily intake (ADI) should be based on the no 

observed adverse effect level (NOAEL) of 12.5 mg/kg bodyweight (bw)/day) 

from a one-year dog study. With a 100-fold assessment factor, this gave an 

ADI of 0.13 mg/kg bw/day. It was also considered appropriate that the shortterm 

systemic admissible operator exposure level (AOEL) should be derived 

in the same way. An acute reference dose (ARfD) of 0.3 mg/kg bw/day was 

agreed based on the NOAEL of 30 mg/kg bw/day for maternal toxicity in a 

rabbit teratogenicity study, with a 100-fold assessment factor. Members agreed 

that there were no apparent concerns in relation to genotoxicity, 

carcinogenicity or reproductive toxicity. 

Residue trials indicated that clomazone residues were present below the limit 

of quantification (LOQ) in oilseed rape at harvest, and calculations indicated 

that the consumer exposure would be acceptable. The exposures of operators 

from use of ‘Centium 50 WP’ were considered acceptable if protective gloves 

were worn when handling the product. For ‘Centium 360 CS’ coveralls and 

protective gloves should be required when handling the product. Exposures 

of bystanders and workers were regarded as acceptable. ‘Centium 360 CS’ 

was classifiable as a skin sensitiser on the basis of a Buehler test, and the ACP


agreed that the feasibility of removal of the sensitising co-formulant from the 

formulation should be explored. 

The <strong>Committee</strong> agreed that clomazone was of low toxicity to birds and 

animals and that the risks to bees, arthropods, earthworms, soil macroand 

micro-organisms and biological methods for sewage treatment were 

acceptable. The most sensitive aquatic organisms were green algae, and based 

on toxicity to this group ‘Centium 50 WP’ was classified as ‘Harmful to fish 

or other aquatic life’ whilst ‘Centium 360 CS’ was less toxic, requiring the 

warning phrase ‘Do not contaminate waters or ditches with chemical or used 

container’. However, the risk to aquatic life from spray drift and drainflow 

was regarded as acceptable. 

The ACP expressed serious concern about the potential risk to non-target 

flora from spray drift and possible volatilisation of the active substance. The 

<strong>Committee</strong> recommended that for spray drift management, a ‘coarse’ spray 

setting, in accordance with the British Crop Protection Council (BCPC) 

classification, should be specified for both products. The ACP agreed that 

there was less volatilisation potential from the capsule formulation ‘Centium 

360 CS’ and that provisional approval could be recommended. However, no 

appropriate risk management strategy had been proposed to reduce potential 

adverse effects on non-target flora for ‘Centium 50 WP’ and provisional 

approval could not be recommended for this product. The <strong>Committee</strong> 

agreed that a monitoring programme should be undertaken to assess adverse 

off-target effects on flora, including from long-term exposure. Members 

also agreed that, as greater volatilisation was likely in warmer weather, the 

additional ecotoxicological data specified should be required to support any 

application for spring use of clomazone. 

9 

The ACP noted that satisfactory weed control had been demonstrated but 

stipulated that cultivations should be at least 15 cm deep to minimise effects 

in following crops in fields where reduced tillage was used. Concerns were 

also expressed with respect to residues in adjacent crops when using ‘Centium 

50 WP’ due to vapour drift. 

The <strong>Committee</strong> advised that provisional approval be recommended for use of 

‘Centium 360 CS’, subject to label amendments, the confirmatory data specified 

and a product stewardship programme, to be agreed with PSD. A commercial 

level of approval for ‘Centium 50 WP’ was not recommended in view of the 

potential adverse effects on non-target flora.


Cyazofamid 

Cyazofamid (codename IKF-916) is the proposed name for 4-chloro-2cyano-N, 

N-dimethyl-5-P-tolylimidazole-1-sulfonamide. It belongs to a new chemical 

class of fungicide based on the cyanoimidazole moiety. Cyazofamid inhibits 

respiration specifically at cytochrome bc1 complex in the mitochondria of 

Oomycetes fungi, acting on the Qi site (ubiquinone-reducing site) of the 

complex. The active substance is also being considered for inclusion in Annex 

I of Directive 91/414/EEC with France acting as Rapporteur Member State. 

The ACP considered an application for a plant protection product, ‘Ranman’, 

which is packaged in a dual compartment pack with ‘IKF-916 400SC’ in one 

compartment and an approved organosilicone adjuvant in the other. ‘IKF-916 

400SC’ is a suspension concentrate (SC) formulation containing 400 g/l 

cyazofamid. The proposed use of the product was as a contact/protective 

fungicide against potato blight (Phytophthora infestans). 

10 

Cyazofamid is rapidly absorbed when ingested by mammals, but the extent 

of absorption is limited and there was no evidence of retention in organs and 

tissues. Further studies showed the major pathway for the elimination of 

absorbed radiolabel was in urine with a significant amount, predominantly 

conjugates, being eliminated in bile. Unabsorbed cyazofamid was eliminated 

in faeces. 

In metabolism studies, the metabolites identified indicated that, following 

oral administration, cyazofamid was hydrolysed, removing the N, N- 

dimethylsulfonamide group. The 4-chloro-5-p-tolylimidazole-2-carbonitrile 

(CCIM) generated by this hydrolysis was considered to be the primary 

metabolite from which others were derived. CCIM was, however, not detected 

as a major metabolite in urine. Instead, the benzyl methyl group underwent 

oxidation to form 4-(4-chloro-2-cyanoimidazol-5-yl)benzoic acid (CCBA) or 

conjugation with glutathione and oxidation to form other metabolites. 

Cyazofamid was shown to be of low acute toxicity. The compound was not 

classified as a primary eye irritant or a skin irritant and did not produce 

delayed contact hypersensitivity in a skin sensitisation test. The toxicological 

studies submitted indicated that the compound was not genotoxic, carcinogenic 

or teratogenic, and no adverse reproductive effects had been observed. 

The ACP agreed an ADI of 0.2 mg/kg bodyweight (bw)/day, based on a no 

observed adverse effect level (NOAEL) of 500 ppm from a rat two-year study. 

Effects at the next dose were an increase in kidney weight, increased urine 

volume and higher chloride levels in urine. Estimated consumer exposures


were all less than 1 percent of the ADI. Hence, the long-term consumer 

exposure was considered acceptable. 

No acute reference dose was proposed, as it appeared there was negligible 

acute dietary risk from cyazofamid. Investigations in rats indicated that CCIM 

might present a greater acute dietary risk. However, it was considered that 

since CCIM was the primary metabolite in rat metabolism and CCIM residues 

in potatoes were low (less than 0.01 mg/kg), dietary exposure to CCIM would 

be acceptable. The applicant attributed apparent differences in the toxicity of 

cyazofamid and CCIM to differences in oral absorption of the two compounds. 

The <strong>Committee</strong> agreed a short-term systemic acceptable operator exposure 

level (AOEL) of 0.03 mg/kg bw/day, based on the NOAEL of 500 ppm in a 

90-day rat study. This was determined on increased kidney weight, basophilic 

tubules and clinical chemistry changes, with a 10 per cent oral absorption 

correction factor and a 100-fold assessment factor. The ACP considered it 

unlikely that the exposure of users, workers or bystanders would exceed 

the AOEL. However, it was agreed that gloves should be worn when 

mixing/loading and during application of the product. In addition, as the 

product was classified as a severe eye irritant, the use of a faceshield when 

handling the concentrate should be required. 

11 

The metabolite, CTCA (4-chloro-5-p-tolylimidazole-2-carboxylic acid) was likely 

to be very persistent in UK soils under both aerobic and anaerobic conditions. 

However, it was agreed that the ecotoxicology evaluation indicated an 

acceptable risk to non-target species. Due to a combination of relatively high 

sorption and a summer application, contamination of shallow vulnerable 

groundwater by CTCA was considered unlikely. 

The ACP agreed that use of ‘Ranman’ as proposed for post-emergence 

treatment in potato crops did not pose any unacceptable risks to birds, aquatic 

life, wild mammals, bees, other terrestrial arthropods, earthworms, soil macro 

and micro-organisms, or to non-target flora. 

The <strong>Committee</strong> concluded that the submitted efficacy data showed that 

commercially acceptable control of foliar potato blight could be obtained if 

‘Ranman’ was used as recommended. There were no adverse effects in terms 

of phytotoxicity or on yield or quality of yield. It was considered that there 

would be no unacceptable risk to following or adjacent crops. 

The <strong>Committee</strong> considered there was a high risk of resistance development 

and agreed a strategy of a maximum of six applications of ‘Ranman’ per


potato crop, to be delivered in tranches of three applications in alternation 

with fungicides from a different cross-resistance group. 

The <strong>Committee</strong> recommended provisional approval for ‘Ranman’ for use on 

potatoes under the Plant Protection Products Regulations, for three years 

pending the Commission decision on inclusion of cyazofamid (IKF-916) in 

Annex I of Council Directive 91/414/EEC. The <strong>Committee</strong> also highlighted 

a number of issues to be discussed as part of the European consideration. 

Flufenacet 

Flufenacet (code name FOE 5043) is the proposed name for a new 

oxyacetamide herbicide. The molecular mode of action of oxyacetamides is 

unclear but at the cellular level inhibition of cell division in root and shoot 

meristematic regions of plants is observed. 

12 

The ACP considered applications for two products, namely ‘ACH 210’ and 

‘Artist’, containing flufenacet in mixture with pendimethalin and metribuzin, 

respectively. ‘ACH 210’ is an emulsifiable concentrate (EC) containing 60 g 

flufenacet/l and 300 g pendimethalin/l for use on winter wheat and barley. 

‘Artist’ is a water dispersible granule (WG) containing 240 g flufenacet/kg and 

175 g metribuzin/kg for use on potatoes prior to emergence of both crop and 

weeds. The rates of use of pendimethalin and metribuzin are within precedent 

of extant UK approvals. 

Flufenacet was also new to the European Union (EU) with France acting as 

the Rapporteur Member State (RMS). A different product, ‘FOE 5043 WG 60’, 

a WG containing 600 g flufenacet/kg for pre-emergence weed control in 

maize, cereals, soybean and sunflower was evaluated. A Draft Assessment 

Report (DAR) had been prepared and end points agreed at EU (ECCO) peer 

review meetings and flufenacet was being considered by the EU Scientific 

<strong>Committee</strong> on Plants (SCP). Although a final decision on inclusion of 

flufenacet in Annex I of Directive 91/414/EEC had not been made, the end 

point list agreed in the EU was used in the UK assessment and, along with 

the DAR, was appended to the UK evaluation document. 

Acute toxicological studies required ‘ACH 210’ to be classified as ‘Harmful if 

swallowed’ and ‘Irritating to skin’ and for ‘Artist’ to be classified as ‘Harmful 

if swallowed’. The ACP concluded that there was little evidence to suggest 

a potentiation of toxicological effects by the second active substance in the 

formulations when compared with flufenacet alone and that the effects seen in 

these studies on the formulated products could be attributable to high dosage.


The acceptable daily intake (ADI), acceptable operator exposure level (AOEL) 

and acute reference dose (ARfD) agreed at ECCO were used in the UK risk 

assessments. The ACP noted that it was difficult to comment on the 

mammalian toxicological reference doses for flufenacet in the absence of 

information on derivation of end points and key toxicological concerns 

and that further detail should be included in the evaluation document. 

The <strong>Committee</strong> regarded the assumption of 10 percent dermal absorption 

for flufenacet as acceptable. They agreed that a slight exceedance of the AOEL 

by predicted operator exposure from use of ‘ACH 210’ was acceptable, since 

the model used to predict exposure was very conservative. A proposed use 

of smaller containers would be expected to further reduce the risk. 

Members noted that for ‘Artist’ estimates of operator exposure were 

approximately two times greater than the AOEL. The <strong>Committee</strong> considered 

evidence that the POEM estimates were based on conservative parameters. 

The applicant had submitted what they considered to be ‘more realistic’ 

exposure estimates, based on EUROPOEM, which were closer to the AOEL. 

The ACP concluded that although provisional approval was acceptable, a 

precautionary approach was required and the requirement for RPE should 

remain and further operator exposure data should be submitted to refine 

the risk assessment. 

13 

The <strong>Committee</strong> had no concerns with respect to consumer exposure. 

The ACP noted that it was unclear whether the toxicological relevance of 

the soil metabolites M1 (flufenacet oxalate) and M2 (flufenacet sulfonic acid) 

which could potentially contaminate groundwater had been sufficiently 

addressed in the EU evaluation and recommended that the SCP should 

consider this issue. 

The ACP agreed with the overall recommendations of the ecotoxicological 

assessment, noting that an acute risk to fish had been identified and a 5 m 

buffer zone proposed for ‘ACH 210’. The risk to aquatic plants was considered 

to be acceptable and the evidence suggested that the risk to algae was low. 

The ACP concluded that there was sufficient assurance on aquatic 

ecotoxicological grounds to allow provisional approval for ‘Artist’ and ‘ACH 

210’ but that the acceptability of the submitted microcosm study should be 

considered by the SCP. 

The ACP expressed concern about the poor standard and lack of detail of 

the resistance management strategy submitted for ‘ACH 210’, particularly 

with respect to black-grass. An appropriate label warning was proposed.


The ACP agreed that, pending the Commission decision on inclusion of 

flufenacet in Annex I of Council Directive 91/414/EEC, provisional approval 

could be recommended for ‘ACH 210’ and ‘Artist’ subject to label amendments 

and data requirements specified in the UK evaluation document, which was 

also to be amended as requested by the <strong>Committee</strong>. 

Iodosulfuron-methyl-sodium 

Iodosulfuron-methyl-sodium (abbreviated to iodosulfuron) is a new 

sulfonylurea herbicide intended for use to control certain annual grass and 

broad-leaved weeds in cereals. The <strong>Committee</strong> considered an application for 

approval of the product ‘Chekker’, a water dispersible granule containing 

iodosulfuron, amidosulfuron and mefenpyr-diethyl. Amidosulfuron is another 

sulfonylurea herbicide that is present in a number of approved products. 

Mefenpyr-diethyl is a crop safener that is also present in some approved 

products. Iodosulfuron was also being considered for inclusion in Annex I 

of Directive 91/414/EEC with Germany acting as Rapporteur Member State. 

14 

Toxicological studies showed that both iodosulfuron and the formulated 

product are of low toxicity. The active substance did not require classification 

on the grounds of human health effects. However, findings indicated that the 

product ‘Chekker’ should be labelled as an IRRITANT and carry the risk 

phrase ‘Irritating to eyes’. 

In both rats and dogs there was clear evidence of effects on the haematopoietic 

system, with the effects on dogs being far more pronounced. In the dog, at 

higher dose levels, effects included severe hyperplasia of haematopoietic tissues 

and extramedullary haematopoiesis along with marked depression of red cell 

parameters. The active substance iodosulfuron is to be used in combination 

with the crop safener mefenpyr diethyl, which can also cause effects on blood 

parameters in rats, dogs and mice, indicative of a slight/mild anaemia, although 

not haematopoietic hyperplasia. These effects had been shown to be mostly 

reversible in the rat and dog. A study had been conducted with dogs to 

investigate the reversibility of the haematotoxic effects observed with 

iodosulfuron, and also to determine whether or not co-administration of the 

safener mefenpyr diethyl would alter the haematotoxicity profile. The study 

produced clear haematotoxicity in dogs dosed with iodosulfuron alone, with 

the effects expressed primarily in decreased red blood cell counts, haemoglobin, 

and haematocrit. These changes were fully reversible after 6 weeks. 

Co-administration of iodosulfuron and mefenpyr diethyl caused no apparent 

increase in the severity of the toxicity observed although there was evidence


of a modest interaction. Again during the recovery period the effects of 

treatment were shown to be reversible. 

An acceptable daily intake (ADI) of 0.03 mg/kg bodyweight (bw)/day was 

agreed based on the no observed adverse effect level (NOAEL) for decreased 

bodyweight in a two-year combined carcinogenicity/chronic feeding study in 

rats and applying a standard assessment factor of 100. Iodosulfuron is not 

acutely toxic and therefore, the <strong>Committee</strong> concluded that it was not 

appropriate to set an acute reference dose (ARfD). 

An acceptable operator exposure level (AOEL) of 0.07 mg/kg bw/day was 

derived from the NOAEL in both 90-day and 12-month feeding studies in the 

dog (haemopoietic hyperplasia and increases in cholesterol levels in females 

were seen at higher doses) and applying a standard assessment factor of 100. 

As levels of radioactivity found in the urine in the dog ADME (absorption, 

distribution, metabolism and excretion) study indicated that, oral absorption 

is almost complete (> 95 percent), a correction factor for incomplete oral 

absorption was not needed. 

Estimates of the exposure of operators, bystanders and workers to 

iodosulfuron resulting from the proposed use of ‘Chekker’ were considerably 

below the AOEL. However, mefenpyr-diethyl has photo-irritancy properties 

and therefore operators must wear coveralls and gloves when handling the 

concentrated product. 

15 

Satisfactory data were submitted on the nature and magnitude of residues 

in cereals when iodosulfuron was used in accordance with the principles of 

good agricultural practice and also on residues in crops likely to be grown 

in succession. These data were considered to address the effects of the use 

of the crop safener mefenpyr-diethyl on crop residues. Estimates of dietary 

intakes by adults, children, toddlers and infants were substantially below 

the ADI. 

Iodosulfuron was shown to be of low toxicity to birds in acute, short-term 

dietary and reproduction studies. The risk to birds was considered to be 

acceptable. The risks to mammals, bees, non-target terrestrial arthropods, 

earth-worms, soil microbial processes and to sewage treatment processes 

were all considered acceptable. On the basis of the effects observed in 

algae, iodosulfuron was categorised as ‘Very toxic to aquatic organisms’. As 

iodosulfuron is not readily biodegradable, it was categorised as ‘May cause 

long-term adverse effects in the aquatic environment’. The product, ‘Chekker’ 

is highly toxic to the aquatic plant Lemna gibba (the most sensitive aquatic


organism tested) and should be classified as ‘EXTREMELY DANGEROUS TO 

FISH OR OTHER AQUATIC LIFE’. However, the risk to aquatic plants was 

considered to be acceptable with a five metre buffer zone. 

In soil, the main degradation product of iodosulfuron is metsulfuron-methyl 

(also an approved sulfonylurea herbicide). Iodosulfuron, metsulfuron-methyl 

and amidosulfuron could all reach surface water via drainflow. To address the 

potential risk to aquatic plants exposed to these substances as a consequence 

of drainflow, the applicant submitted data generated by the preferential flow 

model, MACRO 4.2. This was used to predict the movement of all three 

substances to field drains under a range of conditions that could be 

encountered when ‘Chekker’ was applied to cereals. These data indicated 

that only in a very few exceptional scenarios would the concentrations of 

iodosulfuron, metsulfuron-methyl and amidosulfuron in surface water pose 

a risk to higher aquatic plants. 

16 

Iodosulfuron is a broad spectrum herbicide. Given its high level of activity, 

there is a potential risk from spray drift onto non-target plants adjacent to 

treated areas. Therefore, in line with other sulfonylurea based products, the 

warning phrase ‘Take extreme care to avoid drift onto crops and non-target 

plants outside the target area’ must appear on the product label. 

The <strong>Committee</strong> recommended provisional approval for ‘Chekker’ for use on 

cereals pending the Commission decision on inclusion of iodosulfuron in 

Annex I of Council Directive 91/414/EEC. 

Mepanipyrim 

Mepanipyrim is a new anilinopyrimidine fungicide. The <strong>Committee</strong> considered 

an application for approval of the product ‘Frupica’, a wettable powder, for 

use on strawberries to control Botrytis cineria. The active substance is also 

being considered for inclusion in Annex I of Directive 91/414/EEC with Italy 

acting as Rapporteur Member State. 

Neither mepanipyrim nor the formulated product required classification for acute 

toxicity. An acceptable daily intake (ADI) of 0.025 mg/kg bodyweight (bw)/day 

was established, based on the no observed adverse effect level (NOAEL) of 

2.5 mg/kg bw/day for liver pathology, abnormal clinical chemistry and 

haematological changes seen in a rat carcinogenicity study and applying a 

standard assessment factor of 100. An acute reference dose (ARfD) of 0.3 

mg/kg bw was derived from the NOAEL of 30 mg/kg bw/day in rat and rabbit 

developmental toxicity studies (effects on maternal bodyweight) and applying 

a standard assessment factor of 100. A short-term acceptable operator


exposure level (AOEL) of 0.07 mg/kg bw/day was determined using the 

NOAEL of 7 mg/kg bw/day from a 90-day rat study and applying a standard 

assessment factor of 100. A long-term AOEL of 0.025 mg/kg bw/day was 

derived using the NOAEL of 2.5 mg/kg bw/day from a chronic rat study and 

applying a standard assessment factor of 100. Correction for incomplete oral 

absorption was not necessary as mepanipyrim was shown to be almost totally 

absorbed at low dose levels. 

It was proposed that ‘Frupica’ be applied by tractor mounted or hand held 

sprayers. Provided operators wear an impermeable coverall when using hand 

held sprayers, operator exposure was estimated to be at about half of the AOEL. 

Sufficient data were submitted on the nature and magnitude of residues in 

strawberries when mepanipyrim was used in accordance with the principles 

of good agricultural practice. Estimates of long-term and acute consumer 

exposure were substantially below the ADI and ARfD, respectively. 

Use of ‘Frupica’ as a post-emergence treatment in strawberry crops was judged 

not to pose any unacceptable risks to birds, wild mammals, bees, other 

terrestrial arthropods, earthworms, soil macro- and micro-organisms, and to 

non-target flora. The risk to aquatic life is also acceptable provided ‘Frupica’ 

is applied using a five metre ‘no spray’ buffer zone. 

17 

The <strong>Committee</strong> recommended provisional approval for ‘Frupica’ for use on 

strawberries pending the Commission decision on inclusion of mepanipyrim 

in Annex I of Council Directive 91/414/EEC. 

Picolinafen 

Picolinafen is a new aryloxypicolinamide herbicide. The <strong>Committee</strong> considered 

an application for approval of the product ‘AC 900001’, in which picolinafen 

was formulated as a water dispersible granule for use on winter wheat and 

winter barley. 

The <strong>Committee</strong> considered that there were no concerns regarding human 

exposure to acetaminophen (paracetamol) through the metabolic conversion 

of picolinafen. In coming to this conclusion, they took account of the fact that 

one of the enzymes involved in the formation of acetaminophen might exhibit 

a genetic polymorphism. 

Members agreed that the acceptable daily intake (ADI) should be based 

on the no observed adverse effect level (NOAEL) of 1.3 mg picolinafen/kg 

bodyweight (bw)/day in a one-year dog study. Adverse effects reported at 

higher doses were reduced bodyweight, bodyweight gain and food efficiency.


With a 100-fold assessment factor this gave an ADI of 0.013 mg/kg bw/day. 

The <strong>Committee</strong> agreed that an acute reference dose (ARfD) should be set, 

as it was possible that haemolysis could be caused after a single exposure. 

It considered that the NOAEL of 11 mg/kg bw/day in a rat 28-day oral study 

was the most appropriate starting point for setting an ARfD. Adverse effects 

reported at higher doses were haemolysis as characterised by changes in 

haematology accompanied by splenic and Kupffer cell haemosiderin and 

haematopoiesis in bone spleen and liver. Use of a 100-fold assessment factor 

gave an ARfD of 0.11 mg/kg bw/day. Calculated consumer exposures were 

acceptable. 

For derivation of the acceptable operator exposure level (AOEL) it was 

considered appropriate to use the NOAEL of 1.8 mg/kg bw/day from the 

90-day time point in a one-year dog study. This was based on reductions in 

bodyweight, bodyweight gain and food efficiency in males at higher doses. 

Applying a 100-fold assessment factor and a correction factor of 60 percent to 

take account of incomplete oral absorption gave an AOEL of 0.01 mg/kg bw/day. 

18 

It was concluded that dermal absorption appeared to be greater than 10 percent 

as there seemed to be approximately equal levels of anaemia in rats dosed 

orally and dermally at around 100 mg/kg bw/day The <strong>Committee</strong> agreed that 

without further data, a conservative value of 25 percent dermal absorption 

should be assumed. Operator, worker and bystander exposures were 

acceptable when calculated using this dermal absorption value. 

It was agreed that based on acute toxicity of the formulation to algae, ‘AC 

900001’ required a classification of ‘Extremely dangerous to fish or aquatic 

life’. Initial risk assessment had indicated unacceptable risks to aquatic life. 

However, a microcosm study was presented which mimicked more realistic 

conditions and indicated that effects on algae were transient with recovery 

occurring within six weeks. No direct or indirect effects on zooplankton were 

observed. Based on this study, and the fact that only one application per crop 

was proposed and picolinafen did not persist in water, the <strong>Committee</strong> 

concluded that the risks to aquatic life were acceptable without a buffer zone. 

The <strong>Committee</strong> agreed that the long-term risks of the active substance to 

earthworms were acceptable based on the low long-term persistence of 

picolinafen in soil. The main soil metabolite, picolinafen acid, was more 

persistent and its long-term risk to earthworms was considered. An outdoor 

soil macro-organisms study indicated no adverse effect on the breakdown 

of leaf material over a six-month period in plots treated with 100 g 

picolinafen/ha. It was considered reasonable to assume that the main


soil metabolite would be present in this study. Members therefore agreed 

that the risks to earthworms posed by the metabolite were acceptable. 

The <strong>Committee</strong> recommended to Ministers that provisional approval should 

be granted for the product ‘AC 900001’ for a period of three years, pending 

the Commission decision on inclusion of picolinafen in Annex I of Council 

Directive 91/414/EEC. 

Picoxystrobin 

Picoxystrobin is a new strobilurin fungicide. The <strong>Committee</strong> considered an 

application for approval of one product, ‘Acanto’, in which picoxystrobin 

was formulated as an emulsifiable concentrate for use on wheat and barley. 

The active substance was also being considered for inclusion in Annex I 

of Directive 91/414/EEC with Ireland acting as Rapporteur Member State. 

Members agreed that the acceptable daily intake (ADI) should be based 

on the no observed adverse effect level (NOAEL) of 4.6 mg/kg bodyweight 

(bw)/day in a one-year dog dietary study. With a 100-fold assessment factor, 

an ADI of 0.05 mg/kg bw/day was derived. The ACP agreed that the 

appropriate value for the acceptable operator exposure level (AOEL) was 

also 0.05 mg/kg bw/day. The <strong>Committee</strong> was content that the estimates 

of exposure for operators, workers and bystanders were acceptable. 

19 

The <strong>Committee</strong> agreed that in the absence of more relevant data, the acute 

reference dose (ARfD) should be the same as the ADI, 0.05 mg/kg bw/day. 

A residue definition of picoxystrobin was considered appropriate, and 

estimates of consumer intake were regarded as acceptable. 

With respect to efficacy, the <strong>Committee</strong> noted that in general strobilurins did 

not have curative action and it agreed that some changes to the proposed 

label were required. 

The submitted environmental data were discussed and the <strong>Committee</strong> was 

content that the risk to aquatic organisms was acceptable. It was agreed that 

‘Acanto’ should be classified as ‘Dangerous to fish or other aquatic life’, on the 

basis of acute toxicity to Daphnia. The ACP discussed earthworm mortalities, 

which had been seen in a few field trials conducted in France in 2001. It was 

noted that the toxicity exposure ratio (TER) in the risk assessment was very 

close to the trigger value and it considered that the observed mortalities were 

therefore a concern. The <strong>Committee</strong> suggested that an interaction with 

environmental stresses such as flooding could have caused the earthworm


deaths, but that further earthworm data should be required to clarify the risk 

assessment with a study protocol to be agreed with PSD. 

The <strong>Committee</strong> recommended provisional approval for use of ‘Acanto’ on 

cereals pending the Commission decision on inclusion of picoxystrobin in 

Annex I of Council Directive 91/414/EEC. 

Propoxycarbazone-sodium 

Propoxycarbazone-sodium (MKH 6561) is a sulfonylaminocarbonyltriazolinone 

herbicide, which acts by inhibiting the enzyme acetolactate synthase (ALS). 

The ACP considered an application for approval of propoxycarbazone-sodium 

in a plant protection product ‘Attribut’, for use to control grass weeds in 

wheat. The formulation was defined as a water soluble granule (SG), based on 

the compound’s solubility in water. At the time of <strong>Committee</strong> consideration, 

propoxycarbazone-sodium was new to the EC, with Germany acting as the 

Rapporteur Member State (RMS) for its inclusion in Annex I of Council 


20 

Propoxycarbazone-sodium was of low acute toxicity. It was not classifiable 

as a skin or eye irritant, nor as a skin sensitiser. The compound was not 

shown to be oncogenic in mice or rats, or to have any neurotoxic potential. 

The ACP was satisfied that there was sufficient evidence to conclude that the 

compound was not genotoxic and did not present a significant 

immunotoxicological hazard. 

The residue definition in crops was agreed to be the major plant metabolite 

M01 (2-hydroxy propoxy MKH 6561) only, based on supporting crop 

metabolism data and the results of residue trials. Members agreed that 

the acceptable daily intake (ADI) should be based on the NOAEL of 

43 mg/kg bodyweight (bw)/day from a 24-month combined chronic 

toxicity/carcinogenicity study in rats. With a 100-fold assessment factor, this 

gave an ADI of 0.4 mg/kg bw/day. An ARfD of 1 mg/kg bw was also agreed 

based on the NOAEL of 100 mg/kg in a rabbit developmental toxicity study, 

with a 100-fold assessment factor. Both of these reference values were 

considered applicable for the metabolite M01. 

The ACP agreed that the short-term systemic acceptable operator exposure 

level (AOEL) should be based on the NOAEL of 100 mg/kg bw/day in a 

rabbit developmental toxicity study, (taking into account oral absorption of 

24 percent). With a 100-fold assessment factor, this gave an AOEL of 2 mg/kg bw. 

A long-term systemic AOEL was not considered appropriate because of the 

short duration of use of the product.


Calculations indicated that the exposures of consumers, operators, workers 

and bystanders would be acceptable. 

Members agreed that the risk assessment for the fate and behaviour of the 

compound in the environment indicated that adverse effects were unlikely. 

The <strong>Committee</strong> was satisfied that a computer modelling of leaching losses 

used appropriate scenarios, and showed that leaching of propoxycarbazonesodium 

to groundwater was not expected to result in concentrations as high 

as the EU 0.1 µg/l drinking water limit, following application as proposed in 

the UK. 

The metabolites M05 (sulfonamide ester), M07 (saccharin) and M10 (N-methyl 

propoxy triazolinone) were established as ‘not relevant’, in terms of biological 

activity, and mammalian toxicological and ecotoxicological significance. 

Metabolite M08 (4-hydroxy saccharin) was less mobile and considered not to 

pose a risk of contamination of groundwater. Predicted concentrations of 

metabolite M09 (N-methyl propoxy triazolinone amide) in ground water were 

less than 0.1 µg/l. The minor soil metabolites M04 (MKH 6561 carboxylic acid) 

and M06 (sulfonamide acid) were also not considered relevant. 

Members considered that the approach taken to calculate potential movement 

of the compound to drainage and to address the potential risk to higher 

aquatic plants from exposure via drains and surface streams, following the 

proposed use, was acceptable. 

21 

The risks to birds, terrestrial vertebrates, bees, earthworms, arthropods and soil 

micro-organisms from the proposed use of propoxycarbazone-sodium and 

metabolites formed in the environment were considered acceptable. The risk 

to non-target plants was agreed to be acceptable with a label warning to 

minimise spray drift, in line with other ALS inhibitor herbicides. The risk to 

aquatic life was judged acceptable with appropriate risk mitigation measures, 

(five metre buffer zone to protect aquatic higher plants). 

The ACP agreed the wording of an amendment to the product label, to 

emphasise that when used to control common couch, if black-grass was also 

a problem in the same field, then other herbicides with different modes 

of action which control black-grass should also be applied in sequence, 

particularly where resistance was a problem. 

The <strong>Committee</strong> recommended provisional approval for ‘Attribut’ for use 

on winter wheat pending the Commission decision on inclusion of 

propoxycarbazone-sodium in Annex I of Council Directive 91/414/EEC.


Members supported several confirmatory data requirements proposed for 

inclusion of propoxycarbazone-sodium in Annex I. 

Pyraclostrobin 

Pyraclostrobin (BAS 500F) is a new strobilurin fungicide. The ACP considered 

an application for use of ‘BAS 500 01F’ (trade name ‘Comet’), an emulsifiable 

concentrate formulation for control of a range of fungal diseases in wheat, 

barley, oats, rye and triticale. The active substance is also being considered 

for inclusion in Annex I of Directive 91/414/EEC with Germany acting 

as Rapporteur Member State. 

‘BAS 500 01F’ was classified on the basis of toxicological properties as 

‘Harmful if swallowed and by inhalation’ and ‘Irritating to skin’. An ADI of 

0.03 mg/kg bw/day was derived from the NOAEL of 3.4 mg/kg bw/day in 

a two-year rat chronic toxicity and carcinogenicity study. The NOAEL was 

based on reduced food efficiency and bodyweight gain, and liver cell 

necrosis in males. 

22 

An ARfD of 0.05 mg/kg bw/day was established based on a NOAEL of 

5 mg/kg bw/day from a rabbit developmental study, with reduced food 

consumption after gavage dosing at higher levels (this was the only acute 

systemic effect that could be identified as relevant for setting the ARfD). 

The residue profile was considered to have been adequately addressed. 

Estimates of consumer intakes (from both chronic exposure and acute 

exposure over a single day) were well below the ADI and ARfD. An MRL 

of 0.2 mg/kg, based on the residue definition of parent pyraclostrobin, 

was considered appropriate for wheat, barley and oats. 

A short-term systemic AOEL of 0.03 mg/kg bw/day was derived from a 

NOAEL in a 90-day dog study of 5.8 mg/kg bw/day based on hypertrophy 

of the duodenum in both sexes and bodyweight loss in females. The AOEL 

allowed for a 100-fold assessment factor. Estimated exposure to pyraclostrobin, 

arising from the use of ‘BAS 500 01F’, assuming gloves were worn when 

handling the concentrate, was within the AOEL and thus considered 

acceptable to operators, bystanders and other workers. 

The presence of minor phytotoxic effects combined with evidence of 

damage to some plants, including maize, in glasshouse screens meant that 

extrapolation to rye or triticale could not be accepted without some 

confirmatory data on the safety of ‘BAS 500 01F’ to these crops. Therefore 

it was recommended claims for use on these crops should be deleted from 

the label.


Pyraclostrobin was classified as moderately persistent in soil (based on a 

field DT 50 of 55 days) whilst the only relevant metabolite 500M01 detected 

in the field was classified as persistent in soil (based on a laboratory DT 50 

of 166 days). Overall, the mobility and leaching studies demonstrated that 

pyraclostrobin and its metabolites were strongly adsorbed to soil, largely 

non-mobile and were not expected to represent a significant leaching risk. 

The risk to relevant wildlife groups from the proposed use of pyraclostrobin 

and ‘BAS 500 01F’ was assessed to be low. However, the product required 

labelling as ‘DANGEROUS TO FISH OR OTHER AQUATIC LIFE’, and a five 

metre buffer zone was needed to manage the acute risk to fish. 

The <strong>Committee</strong> recommended provisional approval for ‘BAS 500 01F’ pending 

an EU decision on the inclusion of pyraclostrobin in Annex I of Council 


Silthiofam 

Silthiofam (code name MON 65500) is a new benzamide fungicidal cereal seed 

treatment for control of ‘take-all’ fungus (Gaeumannomyces graminis var. 

tritici). The active substance inhibits energy production within fungal cells. 

23 

Silthiofam was new to the EU and an application for inclusion in Annex I of 

EU Directive 91/414/EEC was being considered by the Rapporteur Member 

State (RMS), Ireland. The ACP considered a UK application for approval for 

use of the product ‘Latitude’, a flowable concentrate cereal seed treatment 

containing 125 g/l of silthiofam. 

Both the active substance and the product were not classifiable on the basis 

of acute mammalian toxicological studies. The ACP was content with the 

proposed ADI of 0.05 mg/kg bw/day based on the no observed adverse effect 

level (NOAEL) of 5 mg/kg bw/day for liver pathology in a rat two-year study 

with a 100-fold assessment factor. An AOEL of 0.1 mg/kg bw/day was derived 

for silthiofam, based on the NOAEL of 10 mg/kg bw/day for liver weight gain 

and abnormal clinical chemistry in a 90-day dog study with a 100-fold 

assessment factor. An ARfD of 0.2 mg/kg bw/day was agreed, derived from a 

rabbit developmental study NOAEL for maternal toxicity (20 mg/kg bw/day) 

with a 100-fold assessment factor. 

No significant mutagenicity, carcinogenicity or reproductive toxicology 

concerns were identified. The <strong>Committee</strong> agreed that the mutagenic potential 

of two impurities (IMP 1 and IMP 4) present in the technical material had 

been adequately tested and was not a concern.


The ACP agreed that the estimated exposures of operators, bystanders, 

workers and consumers were acceptable. Two minor metabolites present 

in wheat but not found in the rat were considered by the <strong>Committee</strong> not 

to be a cause for concern. 

It was agreed that the potential for soil accumulation was slight and the 

ACP concluded that the weight of evidence indicated an acceptable risk 

to non-target organisms without the need for further data. 

The ACP also considered potential groundwater contamination and the 

likelihood of exceedance of the EU drinking water limit. It was noted that 

interpretation of probabilistic modelling data, particularly involving preferential 

flow, was difficult and needed further elucidation. However, the compound 

was applied at low rates and its sorption and persistence properties were not 

consistent with significant leaching. Overall the ACP agreed that the potential 

for contamination of groundwater was likely to be low and was acceptable 

for approval. 

24 

The ACP initially required further assessment of the potential of silthiofam 

to accumulate in sediment and of the chronic risk presented to sedimentdwelling 

organisms. The <strong>Committee</strong> subsequently considered a revised risk 

assessment based on potential cumulative deposition scenarios in sediment 

and data from a chronic Daphnia study. It was concluded that the risk was 

acceptable for approval of silthiofam but that generic issues pertaining to 

exposure of sediment-dwelling organisms should be addressed. 

The <strong>Committee</strong> recommended provisional approval for ‘Latitude’ for use 

as a cereal seed treatment pending the Commission decision on inclusion 

of silthiofam in Annex 1 of Council Directive 91/414/EEC. 

Spinosad 

Spinosad is new macrolide insecticide with a novel mode of action on the 

insect nervous system. The active substance was also being considered for 

inclusion in Annex I of Directive 91/414/EEC with Netherlands acting as 

Rapporteur Member State. 

The ACP considered authorisation of ‘Conserve’ (formerly ‘NAF-313’), a 

suspension concentrate formulation containing 120 g/l of the active substance 

spinosad. The proposed use of the product was for the control of western 

flower thrips (Frankliniella occidentalis) in protected ornamental plant 

production.


Spinosad consists of a mixture of two active, structurally similar molecules, 

spinosyn A and spinosyn D. It is produced by a submerged fermentation 

process using a strain of Saccharopolyspora spinosa. Approval of a broad ratio 

of the two spinosyns had been requested. However, the ACP stipulated that 

the technical specification for the product should be based on the submitted 

batch analysis, hence reflecting the test material used in the assessments. 

When comparing the findings for spinosyn A and spinosyn D, there were no 

major differences in the bioavailability, routes or rates of excretion, or 

metabolism. The only notable differences were that excretion in urine and bile 

(and therefore absorption) of spinosyn A was slightly higher than for spinosyn 

D. Also the amount of unchanged spinosyn D in faeces was higher than 

spinosyn A. 

The toxicity of spinosad, spinosyn A, and spinosyn D was generally similar, 

but spinosyn D was slightly less toxic than spinosyn A. Vacuolation was the 

primary effect associated with exposure. It was observed on histopathological 

examination of a wide range of tissues in all test species, and was apparently 

reversible. 

In accordance with European classification criteria, spinosad was not 

classifiable on the basis of acute toxicity, skin or eye irritation, or skin 

sensitisation. It showed low short-term and chronic toxicity, and there was 

also no indication of a genotoxic, carcinogenic or neurotoxic hazard. 

25 

In a teratogenicity study in rats, there was an apparent increase in the 

incidence of microphthalmia at doses below maternal toxicity. However, 

based on historical control data this finding was considered to be incidental 

to treatment and not of concern. 

The ACP agreed an ADI of 0.02 mg/kg bw/day, derived from a 24-month oral 

toxicity study in rats and based on effects (vacuolation and inflammation) 

seen in the thyroid glands. An assessment factor for inter- and intraspecies 

differences of 100 was applied to the NOAEL of 2.4 mg/kg bw/day. The 

<strong>Committee</strong> also agreed that it was not appropriate to set an ARfD for 

spinosad. The application under consideration was only for use on 

protected ornamentals, and no exposure to consumers was expected. 

The <strong>Committee</strong> concluded that an oral study should be used to set the 

AOEL. The AOEL for short-term exposure was based on effects (vacuolation 

in several tissues and other microscopic changes) seen in an oral 90-day 

study in the dog. An assessment factor of 100 and a factor of 0.5 (to correct


for incomplete oral absorption) were applied to the NOAEL of 4.89 mg/kg 

bw/day. This resulted in a systemic short-term AOEL of 0.02 mg/kg bw/day. 

The information submitted on operator exposure was considered sufficient to 

support approval of ‘Conserve’ for use on ornamental crops. No further data 

were required. However, use of protective gloves and coveralls when handling 

the product and during application when applying by hand-held equipment or 

handling contaminated surfaces was recommended. Modelling of operator 

exposure with this level of personal protective equipment (PPE) predicted 

exposures at or below the AOEL. 

The evaluation indicated that recommended uses of ‘Conserve’ might result in 

exposure of bystanders, but this was acceptable, as the extent of exposure 

was likely to be significantly less than the AOEL. With respect to worker 

exposure, the estimated systemic exposure from the use of ‘Conserve’ under 

cover (glass or plastic) was less than the AOEL. Therefore, worker exposure 

was also judged acceptable, with no requirement for PPE or a re-entry interval. 

26 

Given the proposed use, it was considered that environmental contamination 

(i.e. to soil, surface water and groundwater) by the active substance and its 

metabolites from direct use was likely to be limited. The incorporation of 

spinosad-contaminated compost (as waste from ornamental plant production) 

into field soils was considered to pose a low risk with respect to terrestrial 

organisms, rotational field crops and contamination of surface and ground water. 

The proposed use on protected ornamentals would result in limited exposure 

of wildlife. Spinosad is highly toxic to bees and certain non-target arthropod 

species. Neither of these groups of organisms would be directly exposed at 

the time of application. However, bees and other non-target arthropods might 

be attracted to certain types of treated ornamentals subsequently moved to 

outside locations. Therefore, the risk to bees from residues of spinosad was 

assessed. It was considered, on the basis of field studies, to be acceptable. 

Studies on the residual toxicity of spinosad to a range arthropod species used 

in Integrated Pest Management (IPM) systems indicated that toxicity of the 

compound declines with age. These studies provided reassurance that 

significant impacts on natural populations of non-target arthropods would 

be unlikely. 

Spinosad is of moderate toxicity to certain groups of aquatic life (i.e. Daphnia 

magna and Chironomus riparius). Therefore, the product was classified as 

‘Harmful to fish and other aquatic life’. Potential contamination of surface 

water via spray drift and drainage was considered to be minimal from the


proposed use. Therefore, no formal risk assessment for aquatic organisms 

was conducted. Spinosad is of low toxicity to other forms of wildlife 

(i.e. mammals, birds, earthworms and soil microbial processes). Given the 

low toxicity and limited exposure, the risk to these groups was considered 

sufficiently low not to warrant detailed assessment. 

The efficacy data submitted were considered sufficient to support the use 

of ‘Conserve’ to control western flower thrips in protected ornamentals. 

The <strong>Committee</strong> recommended that ‘Conserve’ should be granted a provisional 

approval for use on protected ornamentals under the Plant Protection Product 

Regulations, for three years pending the Commission decision on inclusion of 

spinosad in Annex I of Council Directive 91/414/EEC. The ACP highlighted a 

number of issues to be discussed as part of the European consideration. 

Sulfosulfuron 

Sulfosulfuron is a new sulfonylurea herbicide. The <strong>Committee</strong> considered an 

application for approval of the product ‘Monitor’, a water dispersible granule, 

for use on winter wheat to control certain grass and broad-leaved weeds. 

The active substance was also being considered for inclusion in Annex I of 

Directive 91/414/EEC with Ireland acting as Rapporteur Member State. 

27 

Sulfosulfuron and the formulated product are of low acute toxicity and are not 

classifiable on the grounds of human health effects. For both the acceptable 

daily intake (ADI) and systemic acceptable operator exposure level (AOEL), 

the toxic end point was the formation of calculi and associated lesions in the 

urinary bladder. An ADI of 0.24 mg/kg bw/day was agreed, based on a no 

observable adverse effect level (NOAEL) of 24 mg/kg bw/day observed in 

a two-year combined carcinogenicity/chronic feeding study in the rat and 

applying a 100-fold assessment factor. A systemic AOEL of 1.0 mg/kg bw/day 

was set, based on the NOAEL of 100 mg/kg bw/day observed in a 90-day dog 

study and a 100-fold assessment factor. A correction for oral absorption was 

not considered necessary for sulfosulfuron because absorption, distribution, 

metabolism and excretion (ADME) studies indicated a high extent of oral 

absorption. A dermal AOEL of 10 mg/kg bw/day was set based on the limit 

dose of 1000 mg/kg bw/day used in a 28-day dermal study in the rat (the 

study showed no effects related to treatment) and applying a 100-fold 

assessment factor. This was in line with the systemic AOEL (1.0 mg/kg 

bw/day) when the default dermal absorption value of ten percent was 

applied. A conservative estimate of operator exposure was two percent 

of the systemic AOEL.


Acceptable data were available on the nature and magnitude of residues that 

would result in wheat when sulfosulfuron was used in accordance with the 

principles of Good Agricultural Practice. Estimates of consumer dietary intakes 

were significantly lower than the ADI. 

The risks to birds, terrestrial vertebrates, bees, earthworms and soil microorganisms 

from the proposed use of sulfosulfuron and from metabolites 

formed in the environment were considered acceptable. The potential risk 

to aquatic higher plants is high. On the basis of its toxicity to Lemna gibba, 

‘Monitor’ is classified as extremely dangerous to aquatic organisms. A five 

metre no spray zone was considered sufficient to manage the risk to aquatic 

higher plants from spray drift. 

28 

Sulfosulfuron might reach surface waters via drainflow. To address the 

potential risk to aquatic higher plants posed by parent compound as a 

consequence of drainflow, the applicant submitted modelling data for a 

number of scenarios covering five soil types and three climate types and 

using weather data for 30 years. These data indicated that only in a very few 

exceptional scenarios would the concentration of sulfosulfuron in surface 

water pose a risk to higher aquatic plants. 

The data on non-target plants provided indicated that there is a potential risk to 

plants close to the treated area. It was therefore recommended that the product 

label should carry a strong warning to avoid drift onto non-target plants. 

The <strong>Committee</strong> recommended provisional approval for ‘Monitor’ for use on 

winter wheat pending the Commission decision on inclusion of sulfosulfuron 

in Annex I of Council Directive 91/414/EEC. 

Zoxamide 

Zoxamide (Development code RH-7281) is the ISO proposed name for a new 

fungicide intended to control late blight on potato and downy mildew on 

grape. The <strong>Committee</strong> considered an application for approval of RH-7281 

mancozeb, a water dispersible granule containing both zoxamide and 

mancozeb, a fungicidally active substance used in a number of products that 

are already approved for use in the UK. It was noted that the use of the two 

active substances in combination provided improved disease control over that 

achieved with mancozeb alone and allowed for a reduction in the rate of use 

for mancozeb. Zoxamide is also being considered for inclusion in Annex I of 

Directive 91/414/EEC with the UK acting as Rapporteur Member State.


The ACP considered that zoxamide and the formulated products were of low 

toxicity but could cause sensitisation by skin contact. Therefore, both the 

active substance and the formulated products were classified as “Irritant”. 

Metabolism in the rat was moderately rapid and distribution to organs and 

tissues was extensive. However, elimination was also rapid and almost 

complete. In toxicology studies, the dog was found to be the most sensitive 

species tested. An ADI of 2.6 mg/kg bw/day, a short term AOEL of 1.7 mg/kg 

bw/day and long-term AOEL of 1.5 mg/kg bw/day were agreed. The ADI and 

long-term AOEL were derived from the NOAEL from a one-year dog study 

where liver effects were seen at higher doses. The short-term AOEL was 

derived from the NOAEL from a 90-day dog study where reduced bodyweight 

gain and changes in red blood cell parameters were seen at higher doses. In 

all cases, a standard assessment factor of 100 was used to derive the reference 

values. As zoxamide was of low acute toxicity no ARfD was set. 

The exposures of operators, bystanders and workers to zoxamide were low 

and considered to be at acceptable levels. An extensive data package was 

presented on the nature and magnitude of residues in potatoes, grapes and 

rotational crops that were likely to result from the use of zoxamide in 

accordance with the principles of Good Agricultural Practice. Estimates of 

dietary exposure for humans and domestic animals were low. 

29 

Given the effects seen in tests with the alga Scenedesmus subspicatus, and 

evidence that the active substance was not readily biodegradable, zoxamide 

was categorised as ‘Very toxic to aquatic organisms’ and ‘May cause long-term 

adverse effects in the aquatic environment’. On this basis, zoxamide was 

classified as ‘Dangerous for the environment’. The formulated products were 

classified as ‘Dangerous to fish and other aquatic life’. 

The risks to birds, terrestrial vertebrates, bees, earthworms and soil microorganisms 

from the proposed use of zoxamide and from metabolites formed 

in the environment were considered acceptable. The risk to aquatic life was 

acceptable with appropriate risk mitigation measures. Uses on potatoes and 

grapes were recommended in the UK with five metre and twenty metre buffer 

zones respectively for the protection of aquatic life. The need for risk 

mitigation measures, to be considered at Member State level, was highlighted 

for non-target arthropods. In the UK, it was proposed that this be addressed 

by an advisory label phrase for the product. 

The <strong>Committee</strong> recommended provisional approval for ‘RH-7281/mancozeb 

75% WG’ for use on potatoes and grapes pending the Commission decision on 

inclusion of zoxamide in Annex I of Council Directive 91/414/EEC. It was also


agreed that the draft assessment report could be forwarded to the European 

Commission for consideration of inclusion on Annex I of Council Directive 

91/414/EEC. 

Commodity 

substances 

Commodity substances are compounds, which have a variety of alternative 

and often widespread non-pesticidal uses but also have potential use as a 

pesticide. For a commodity substance to be used as a pesticide it requires 

approval under COPR. Approval is given only for use of the substance, 

which is not formulated; (approval is not given for sale, storage, supply or 

advertisement). There is no approval holder and no pesticide product label 

but the approval and associated conditions of use are published in the 

‘Pesticides Guide’ on www.pesticides.gov.uk/blue_book/contents.htm 

No new applications for commodity substances approval were 

considered during 2001. 

30

Section C: Inclusion of new active substances in Annex I of Directive 91/414/EEC 

Section C: 

Inclusion of new active substances 

in Annex I of Directive 91/414/EEC 

The <strong>Committee</strong> considered the following active substances for inclusion on 

Annex I of Directive 91/414/EEC: 

● 

ACETAMIPRID 

● 

AZAFENIDIN 

● 

BENZOIC ACID 

● 

D-CARVONE 

● 

PROFOXYDIM 

● 

DIMETHENAMID-P 

● 

● 

FORAMSULFURON 

S-METOLACHLOR 

31 

Acetamiprid 

Acetamiprid is a new chloronicotinyl insecticide. It is foliar applied and 

acts, by ingestion and contact, as an antagonist to the neurotransmitter 

acetylcholine at the neuro-binding site leading to insect paralysis. It is 

a new pesticide to the EU. 

The EU application had been evaluated by Greece, the Rapporteur Member 

State (RMS), and a Draft Assessment Report (DAR) prepared. The DAR 

assessed the product ‘Gazelle’, a water soluble powder (SP) containing 

202g/kg acetamiprid used to control aphids, leaf miner and whitefly in citrus, 

pome and stone fruits; fruiting vegetables (tomato, aubergine & pepper); 

cotton and tobacco. Although no applications for UK uses had been notified, 

both northern and southern EU uses were considered in the DAR and future 

UK use was possible. The DAR had been distributed to all Member States for 

consideration in the EU peer review process. 

The ACP was invited to consider the DAR and provide written comments. The 

summary was considered to be lacking transparency and consequently it was 

difficult to follow the derivation of end points. Derivation of the ARfD from a


sub chronic neurotoxicity study was considered more appropriate than the 

method proposed. The absence of dermal studies was also noted. 

Azafenidin 

Azafenidin is a selective triazolone herbicide new to the EU. It affects sensitive 

weeds through inhibition of protoporphyrinogen oxidase involved in the 

protoporphyrin biosynthesis pathway. 

The EU application had been evaluated by Spain, the Rapporteur Member 


considered the use of a water dispersible granule formulation containing 

800g/kg azafenidin, to be used in grape vineyards, citrus and olive orchards 

to control broad-leaved weeds. No applications for use in the UK had 

been made. 

32 

The DAR had been distributed to all Member States for consideration in the 

EU peer review process. The RMS proposed a postponement of a decision 

on inclusion of azafenidin in Annex I of Directive 91/414/EEC until evaluation 

of certain further data. 

ACP members provided written comments on the assessment that generally 

agreed with the report but questioned some aspects of the toxicology 

assessment. 

Benzoic acid 

Benzoic acid is a contact disinfectant. Its proposed uses in horticulture 

(floriculture) were regarded as within the remit of EU Directive 91/414/EEC 

for consideration as a new pesticide active substance. 

The EU application had been evaluated by Germany, the Rapporteur Member 


assessed a soluble liquid (SL) formulation containing 90 g/l benzoic acid 

used for the control of fungi, bacteria, viruses and viroids by disinfection 

of surfaces, culture vessels and equipment by watering, dipping and soaking 

in glasshouses and similar protected cultivation areas. There had been no 

applications for UK use. The DAR had been distributed to all Member States 

for consideration in the EU peer review process. 

The ACP considered the DAR and draft comments prepared by PSD. The 

<strong>Committee</strong> noted that benzoic acid was an approved food additive and agreed 

with the proposed ADI and AOEL and, as no effects were seen in acute 

studies, that an ARfD was not needed. Members noted that the in vitro


teratogenicity screening test had not been validated. The ACP was content 

with the environmental risk assessment, particularly as the use was largely 

in glasshouses, and agreed with the comments on appropriate disposal of 

benzoic acid. 

D-Carvone 

Carvone is a naturally occurring terpenoid compound and is the main 

ingredient of caraway oil, which is prepared by fractional distillation of 

caraway seed oil. Carvone is a racemic mixture of D and L stereoisomers. 

Carvone is used as a plant growth regulator, possibly acting by reversible 

enzyme inhibition in the plant terpenoid (mevalonic acid) biosynthetic 

pathway. The partially resolved isomer, D-carvone (>4:1 D:L enantiomers), 

was regarded as a new active substance within the remit of EU Directive 

91/414/EEC. 

The EU application had been evaluated by Netherlands, the Rapporteur 

Member State (RMS), and a Draft Assessment Report (DAR) prepared. The 

DAR assessed the product ‘Talent’ a liquid containing 950 g/l carvone applied 

by fogging equipment in enclosed potato stores to suppress potato sprouting. 

There had been no UK applications for use of carvone, although a future 

application was possible. The DAR had been distributed to all Member States 

for consideration in the EU peer review process. 

33 


<strong>Committee</strong> noted that carvone was a natural product and a zero exposure 

level was not achievable. It was accepted that information based on 

experience of use could be extrapolated to human exposure scenarios. 

The ACP noted that estimated consumer exposures exceeded the proposed 

ADI, but that the estimates were likely to err on the high side. The <strong>Committee</strong> 

also observed that there were no teratogenic effects. However, overall the 

<strong>Committee</strong> agreed that the logic of the safety assessment was not well 

presented and derivation of the end points was largely unsubstantiated, 

and supported the conclusions and shortcomings that PSD had identified. 

Profoxydim 

Profoxydim (also previously known as clefoxydim) is a new cyclohexanone 

herbicide. It is racemic mixture of four (E/Z-R/S) stereoisomers, each 

purportedly having equal biological activity. The mode of action is inhibition 

of the acetyl coenzyme A carboxylase (ACCase) activity in the lipid 

biosynthetic pathway of sensitive plant species. It is a new pesticide to the EU.


The EU application had been evaluated by Spain, the Rapporteur Member 


assessed the product ‘Aura’ an emulsifiable concentrate (EC) containing 200 

g/l profoxydim. It is a contact herbicide to be used in combination with an 

adjuvant for the control of Echinochloa crus-galli, an annual grass weed, in 

rice crops. No other uses had been notified and there were no applications 

for approval for use of profoxydim-containing products in the UK. The DAR 

had been distributed to all Member States for consideration in the EU peer 

review process. 

34 

The ACP was invited to consider the DAR and provide written comments. It 

was noted that the toxicological implications of there being four enantiomers 

had not been considered and the method of analysis did not distinguish 

individual enantiomers. Anaemia had been identified as an adverse effect but 

had not been fully characterised and discussed. The carcinogenicity identified 

in the liver and urinary tract was regarded as non-genotoxic but a nongenotoxic 

mechanism had not been proposed. The reasoning for setting an 

ARfD (based on the ADI) was considered unclear, and the appropriateness of 

basing the AOEL on a 12-month dog study, was also questioned. It was noted 

that incomplete uptake by the gut (66 percent) may not have been taken into 

account in deriving the proposed AOEL. 

Dimethenamid-p 

Dimethenamid, a racemic mixture of P and M enantiomers, belongs to the 

chloroacetamide class of herbicides. The molecular mode of action of 

chloroacetamides has not been fully elucidated but growth of germinating and 

developing seedlings is severely inhibited apparently due to effects on cell 

division in meristematic tissue, possibly mediated via interaction with protein 

thiol (SH) groups. The resolved isomer, dimethenamid-P (approximate 96:4 

P:M enantiomer ratio) is considered to be a new active ingredient within the 

remit of EU Directive 91/414/EEC. 



assessed an emulsifiable concentrate (EC) formulation containing 720 g/l active 

substance, which is used to control broad-leaved and grass weeds in maize 

and sugar beet. Uses were proposed both in northern and southern European 

Member States, but no applications for use in the UK had been made.


The DAR had been distributed to all Member States for consideration in the 

EU peer review process. A number of key deficiencies and minor issues were 

identified that had to be addressed prior to inclusion of dimethenamid-P in 

Annex 1 of Directive 91/414 EEC. 

The ACP considered the DAR and draft comments prepared by PSD. The key 

concern related to the data available to support the contention that activity 

resided solely in the P-isomer and the possibility that adjustment to the 

proposed ADI and AOEL could be required. The ACP agreed that the one year 

dog study was appropriate to set the ARfD. A further in vivo UDS study was 

considered unnecessary, particularly as the submitted in vitro study was 

negative and the dosing in the available in vivo study was acceptable. The 

ACP noted that metabolites M23 and M27 were mobile and persistent and 

might contaminate ground water. Thus evidence could be needed that these 

metabolites were not toxicologically relevant. The <strong>Committee</strong> commented that 

acceptable uses could only be achieved using large buffer zones that would 

currently not be acceptable in the UK. It was also noted that there was no 

aquatic plant risk assessment for exposure via drainflow, which would be 

relevant in consideration of any UK use. 

35 

Foramsulfuron 

Foramsulfuron is a new sulfonylurea herbicide. The biochemical target site is 

the enzyme acetolactate synthase (ALS) in the aliphatic amino acid pathway in 

sensitive plants. It is a new pesticide to the EU. 



assessed the product ‘Equip’, a non-aqueous oil-based suspension concentrate 

(SC), containing 22.5 g/l foramsulfuron and 22.5 g/l of a safener. The safener, 

isoxadifen-ethyl, acts by increasing foramsulfuron degradation in meristematic 

regions of the crop. The product is intended to control post-germination grass 

and dicotyledonous weed species in maize (not seed or sweet maize). No UK 

applications had been notified. The DAR had been distributed to all Member 

States for consideration in the EU peer review process. 

The ACP was invited to consider the DAR and provide written comments. The 

DAR was considered to be well produced and the toxicological end points 

acceptable, provided the interpretations of toxicological studies were 

appropriate. It was also agreed that setting an ARfD was unnecessary.


S-metolachlor 

Metolachlor belongs to the chloroacetamide class of herbicides, which inhibit 

germination and seedling growth via effects on cell division. It is a racemic 

mixture of four R and S stereoisomers. The partially resolved S-metolachlor 

isomeric form (>80–100 percent S form/0–20 percent R form) is considered 

to be a new active ingredient in the EU within the remit of EU Directive 

91/414/EEC. 

The EU application had been evaluated by Belgium, the Rapporteur Member 


assessed the product ‘Dual Gold 960 EC’ an emulsifiable concentrate (EC) 

containing 960 g/l S-metolachlor used to control annual weeds in maize, 

sweetcorn, sorghum, beet crops, sunflower, soybean and potato in northern 

and southern EU Member States. There had been no applications for use of 

S-metolachlor in the UK, although future applications were possible. The DAR 

had been distributed to all Member States for consideration in the EU peer 

review process. 

36 


<strong>Committee</strong> noted that the aquatic risk was only acceptable with stipulation 

of a large (10–20 m) buffer zone, which would not currently be an option for 

UK use. Overall the <strong>Committee</strong> endorsed the critique provided by PSD.

37 

Section D: Experimental approvals and permits 

Section D: 

Experimental approvals and permits 

The <strong>Committee</strong> recommended experimental approval for products based on 

the following active substances: 

● 

CLOMAZONE 

● 

GLUFOSINATE-AMMONIUM 

● 

GLYPHOSATE 

● 

IODOSULFURON-METHYL-SODIUM


Section E: 

UK Review Programme 

38 

Routine reviews 

Agricultural 

use 

The UK routine review programme was established by the ACP in 1989. 

In 1994, steps were taken to integrate this work with the EC review 

programme. Under the EC programme all UK-approved active substances 

were to be reassessed over a 10-year period. The UK programme was 

therefore stepped down. 

In 1998 it was decided that, because the progress of the EU programme 

was disappointingly slow, a new round of UK reviews should be initiated. 

A review of 40 anticholinesterase compounds was therefore commenced in 

addition to the continued partial reviews of compounds initiated in response 

to the submission of adverse data. 

● AZAMETHIPHOS 

● BONE OIL 

● CHLORPYRIFOS-METHYL 

● 

Chlorpyrifos – (dog study) 

● 

● 

CHLORPYRIFOS – ORNAMENTAL BULB DIPPING 

DICHLOROPHEN 

● 

DICHLORVOS 

● 

DIMETHOATE 

● 

MALATHION 

● 

OXAMYL 

● 

PHOSPHIDES 

● 

PIRIMICARB 

● 

PIRIMIPHOS-METHYL 

● 

TOLCLOFOS-METHYL

Section E: UK Review Programme 

Azamethiphos 

Azamethiphos is an organophosphorus insecticide, formulated as a wettable 

powder, approved for use in animal and poultry houses. This review was part 

of the routine UK review programme of anticholinesterase compounds. 

The <strong>Committee</strong> agreed that a repeat exposure acceptable operator exposure 

(AOEL) value should be set at 0.002 mg/kg bodyweight (bw)/day based on 

the no observed adverse effect level (NOAEL) of 0.2 mg/kg bw/day for 

cholinesterase inhibition in a 13-week neurotoxicity study in rats. This end 

point was also used as the basis for setting an acceptable daily intake (ADI) 

of 0.002 mg/kg bw/day. In addition, the <strong>Committee</strong> agreed that it was 

relevant to set a single exposure AOEL value of 0.01 mg/kg bw based on 

full cholinesterase inhibition recovery seen after 14 days in the single dose 

neurotoxicity study in rats. This single exposure AOEL value would only be 

used where the use pattern could be restricted to not more than once every 

14 days. This end point was also used as the basis for setting an acute 

reference dose (ARfD) of 0.01 mg/kg bw. For these reference values, a 

100-fold assessment factor was used. 

With regard to operator exposure, the <strong>Committee</strong> noted that estimates 

indicated that operator exposure levels would be below the AOEL and that a 

minimum 14-day interval should be specified where azamethiphos is applied 

by brush or a combination of brush and spray applications. 

39 

The <strong>Committee</strong> agreed that risks to consumers were acceptable because no 

residues should occur in products of animal origin and consequently there 

would be no significant residues of azamethiphos in the diet of humans. 

The <strong>Committee</strong> concluded that approvals could continue subject to the 

imposition of additional operator protection and worker protection 

requirements and subject to the provision of further data. 

At a subsequent meeting, the <strong>Committee</strong> considered the evaluation of three 

new genotoxicity studies. The <strong>Committee</strong> agreed that although the findings 

suggested a possible genotoxic hazard at high doses, further investigation of 

this hazard would only be justified if the available toxicology studies did not 

provide adequate reassurance about possible carcinogenicity or developmental 

toxicity. It was agreed that the <strong>Committee</strong> should reconsider the relevant 

toxicology data before agreeing final recommendations. This matter was to 

be considered by the ACP at the January 2002 meeting.


Bone oil 

Bone oil has been used as a repellent against various animals since the 1890s. 

Following the introduction of the Control of Pesticides Regulations (COPR) 

in 1986, approval was granted for the outdoor use of a product containing 

bone oil as a repellent in the home garden. 

The ACP noted that it had set requirements in November 1999 for a 

description of a more standardised manufacturing process to ensure that the 

constituents of bone oil fell within a defined range together with the resultant 

technical specification details. 

Data had since been submitted but the <strong>Committee</strong> considered that a 

satisfactory risk assessment could not be conducted because a large 

proportion of the bone oil remained uncharacterised. The bone oil was of 

a potentially variable nature and was manufactured in a way that did not 

exclude the possibility of harmful compounds being present. 

40 

The <strong>Committee</strong> concluded that despite a serious attempt, the approval holder 

had been unable to meet the requirements satisfactorily and therefore the 

<strong>Committee</strong> considered that approval for ‘Renardine 72–2’ (MAFF 06769) 

should be revoked. 

However, in response to representations from the approval holder, the 

<strong>Committee</strong> reconsidered bone oil at a subsequent meeting at which the 

approval holder made a presentation. The ACP remained doubtful that it 

would be possible to generate further data to address their concerns within 

a reasonable timeframe. However, they agreed not to provide advice to 

Ministers until they had received further guidance from an independent 

chemist. They would consider bone oil again when this advice was received. 

Chlorpyrifos-methyl – environmental risk assessment 

Chlorpyrifos-methyl is an insecticide for the fabric treatment of cereal grain 

stores/handling machinery and for use in food storage in the treatment of 

cereal grain. 

The ACP considered that the sole approved use of chlorpyrifos-methyl in the 

UK, for post-harvest protection of cereal grain, would not lead to any direct 

contamination of soil or water, either during or after application. It was 

considered that direct pollution of air in the open environment might occur 

during venting or fumigation procedures at storage facilities. However, such 

pollution would be limited in geographical extent and duration and would 

occur only in the locality of the storage facility. Concentrations in the air


would rapidly dissipate and dissipation could be expected to be enhanced by 

the moderate volatility of chlorpyrifos-methyl. Any material that did volatilise 

was unlikely to be persistent in the atmosphere. 

Some information had been provided to show the environmental fate and 

behaviour of chlorpyrifos-methyl in soil, water and air should accidental 

exposure occur. As a precaution and in line with other products, the ACP 

considered that the standard warning ‘Exclude wildlife from buildings during 

treatment’ should appear on the product label. 

The ACP recommended that current approvals for chlorpyrifos-methyl should 

be allowed to continue. 

Chlorpyrifos – dog study 

At its meeting in July 2000 the ACP had considered a proposed acceptable 

daily intake (ADI) and acceptable operator exposure level (AOEL) of 0.01 

mg/kg bodyweight (bw) [which was in line with that set by the Joint 

FAO/WHO Meeting on Pesticide Residues (JMPR)]. 

Although no new scientific data had become available to raise concerns 

about chlorpyrifos, the <strong>Committee</strong> had been concerned that the evidence 

underpinning the proposed ADI was not as strong as it would like to see, in 

particular regarding the possibility of effects on the peripheral nervous system. 

The <strong>Committee</strong> had therefore requested a four-week study in dogs to provide 

the reassurance sought. Ministers’ agreement to the ACP recommendations 

had not been reached. However, the company had undertaken a six-week 

study in dogs of the type required. 

41 

The new study showed that within the peripheral tissues there was no 

consistent inhibition of acetyl cholinesterase (AChE) activity in any tissue. 

Where inhibition was recorded, it was not dose-related (with the exception 

of the atrium in males), and in no tissue was inhibition recorded consistently 

in both sexes. There were no statistically significant effects in any peripheral 

tissue. It was concluded that the differences recorded in peripheral tissues 

resulted from a natural variation in AChE activity rather than treatment-related 

effects. Also the <strong>Committee</strong> did not consider that the inhibition in the atrium 

in males was a treatment-related effect. No inhibition was recorded in females, 

and it was considered to be biologically implausible that there would be a 

sex difference in the effects of chlorpyrifos which only affected atrial tissue 

and no other tissue.


Overall the ACP concluded that this study showed no marked difference in 

sensitivity to AChE inhibition between brain AChE and AChE in peripheral 

tissues. Red blood cell (RBC) AChE was significantly more sensitive. Therefore 

reference values based on no observed adverse effect levels (NOAELs) for 

inhibition of brain AChE would be expected to cover AChE in the peripheral 

nervous system, and reference values based on inhibition of red blood cell 

AChE in dogs would be conservative. The <strong>Committee</strong> thus decided that 

reference values for chlorpyrifos should be based on NOAELs for inhibition of 

brain AChE in dogs, since the results of the dog study examining peripheral 

tissues suggest that such reference values would also protect the peripheral 

nervous system. It was concluded that the ADI and AOEL for chlorpyrifos 

should be maintained at 0.01 mg/kg bw/day. 

On the basis of this reference value the <strong>Committee</strong> recommended that 

approvals for chlorpyrifos could continue as previously recommended. 

The <strong>Committee</strong> also asked that some further investigation of drench 

treatment with chlorpyrifos be carried out. 

42 

Chlorpyrifos – ornamental bulb dipping 

When the ACP had considered chlorpyrifos in July 2000, it had recommended, 

among other things, that off-label approval for use as a bulb dip should be 

revoked unless a suitable protocol for an operator exposure study was 

provided within eight weeks. However, subsequent to the ACP consideration, 

the off-label approval for this use expired and no further action was taken. 

The ACP heard that this approval had been allowed to lapse through oversight 

on the part of the off-label applicants and was an important use which grower 

groups were prepared to continue to support. The ACP noted that exposure 

had been estimated using the Health and Safety Executive’s (HSE’s) waterbased 

timber pre-treatment model based on 95 th percentile values and that 

estimated exposure was 130 percent of the AOEL. The <strong>Committee</strong> felt that 

when based on the usual 75 th percentile values, estimated exposures were 

likely to fall within the AOEL. 

The ACP recommended that the off-label approval for the use of chlorpyrifos 

for bulb dipping should be reinstated and that the secretariat should consider, 

with the off-label applicants, further refinement of the risk assessment 

including handling of treated bulbs and disposal of dipping solution. 

Note: The recommendation to reinstate the off-label approval was not a 

unanimous conclusion of the <strong>Committee</strong>.


Dichlorophen 

See non-agricultural uses, page 52. 

Dichlorvos 

Dichlorvos is a contact, ingestion and inhalation insecticide, approved for use 

in agricultural situations. This active substance was considered as part of the 

UK review of anticholinesterase compounds. Three products were covered 

in the review of agricultural uses – ‘Nuvan 500 EC’, used to control flies and 

mites in animal units, particularly poultry houses; and ‘Luxan Dichlorvos 600’ 

and ‘Luxan Dichlorvos Aerosol 15’, used in glasshouses to control insect pests 

of cucumbers and other protected edible and non-edible crops. The review 

considered human health issues only. Non-agricultural uses were also 

considered in parallel by the <strong>Committee</strong> (see page 53). 

Two approval holders, who provided data relating to the active substance and 

products, supported the review. The ACP also took into consideration 

additional comments on the importance of the use of dichlorvos in 

glasshouses, supplied by representatives of the horticultural industry. 

Based on all the information then available, the <strong>Committee</strong> agreed in April 

2001 that Ministers should be advised: 

43 

● 

● 

To revoke approvals for use of ‘Nuvan 500 EC’ in animal husbandry, where 

animals were present at the time of treatment. Use of the product where 

animals were not present during application could continue, subject to the 

provision of further data. 

To suspend, with immediate effect for approval holders and their agents, 

the use of ‘Luxan Dichlorvos 600’ and ‘Luxan Dichlorvos Aerosol 15’ on 

cucumbers and other edible crops because there was insufficient 

reassurance that long-term dietary exposures would be acceptable. 

Members did not identify any immediate consumer concerns, and advised 

that use of existing stocks of the products on edible crops could continue 

for a further two years. They recommended that reinstatement of uses on 

edible crops should depend on the approval holders satisfactorily 

addressing concerns about the long-term exposures of consumers by 

submission of further data. Approvals for the use of ‘Luxan Dichlorvos 600’ 

and ‘Luxan Dichlorvos Aerosol 15’ on ornamentals could continue, subject 

to the provision of data.


● 

● 

● 

That approvals for all continuing uses (both animal husbandry and 

glasshouse crop use) should be amended to impose a requirement for 

the use of automated application equipment, to ensure that operators are 

excluded from structures during application. 

That approvals should be subject to provision of further data (physicalchemical 

properties, methods of analysis, mammalian toxicology, operator 

exposure and consumer exposure). 

That approval holders must notify their intent to support these approvals 

within short deadlines. 

The ACP also noted that dichlorvos was under discussion by the <strong>Committee</strong> 

on Mutagenicity of Chemicals in Food, Consumer Products and the 

Environment (COM), and recognised that the above recommendations would 

perhaps require modification in accordance with the COM’s findings. 

44 

At the May ACP meeting, members were informed that the COM findings were 

not finalised, and thus it maintained its recommendations from the previous 

meeting, with the minor change that ‘clean-up’ use on empty glasshouses 

could remain, subject to the use of automated application machinery and the 

provision of further data. 

At the same time as the ACP review of dichlorvos, the COM reviewed all the 

available mutagenicity data. The COM produced a preliminary statement, 

concluding that dichlorvos was an in-vivo mutagen (i.e. capable of causing 

mutations in living animals) at the site of contact. Approval holders were 

invited to provide comments on this conclusion. 

At the July ACP meeting, the <strong>Committee</strong> considered the possible implications 

of the draft COM statement, and agreed to advise Ministers as follows: 

If COM’s final conclusions were that dichlorvos was an in-vivo mutagen, 

and COM could not exclude the possibility that the occurrence of tumours 

in animal tests of carcinogenicity resulted from a genotoxic mechanism, 

there should be immediate revocation of all uses (both agricultural and 

non-agricultural). 

This was to include recall of stocks from the supply chain for products 

used in both the amateur and professional areas. This advice was given 

as a precautionary measure, since the possibility of human genotoxic 

carcinogenicity could not be excluded. The <strong>Committee</strong> agreed that any risk 

of human carcinogenicity was likely to be very small, and would be mainly 

associated with certain uses in the home and with exposures to some


operators in the agricultural sector. The consumption of produce already 

treated with dichlorvos (sourced from within or outside the UK) would not 

raise the same level of concern since the levels of dietary exposure (based 

on food residues monitoring data) were considered minimal. 

Alternatively, if COM concluded that dichlorvos was an in-vivo mutagen, but 

that the tumours observed in animal tests did not result from a genotoxic 

mechanism, or if it could not confirm that dichlorvos was an in-vivo mutagen, 

or it took the view that dichlorvos was not an in-vivo mutagen, the ACP’s 

previous recommendations would be maintained. 

Following consideration of all the available mutagenicity data, and comments 

from the data owners, the COM concluded that dichlorvos should be regarded 

as an in-vivo mutagen at site of contact, and that it could not exclude the 

possibility of it acting as a genotoxic carcinogen. It finalised a statement on 

30 July 2001. The ACP considered the COM advice, and whilst they recognised 

that any risks from exposure would be low, they agreed that the possibility 

of genotoxic carcinogenicity could not be excluded. The <strong>Committee</strong> therefore 

recommended to Ministers that, as a precautionary measure, it would be 

prudent to revoke, with immediate effect, all agricultural and non-agricultural 

uses of dichlorvos. 

45 

Before such regulatory action could be carried out, AMVAC Chemical UK Ltd 

(an approval holder) obtained an injunction, which prevented regulatory 

action. Government agencies were also prohibited from making any 

announcement to the public about the regulatory action that was proposed. 

The approval holder also gained permission for a judicial review, which was 

heard in November 2001. 

The grounds for the challenge were that AMVAC had not been properly 

informed of the proposed regulatory action or the basis for it, and had not 

been given sufficient time to make representations. AMVAC also claimed that 

Ministers had not given proper regard to the precautionary principle and to 

the European Convention on Human Rights. 

The judgement of the Court was issued on 3 December 2001. Mr Justice Crane 

rejected most of the company’s submissions, including those concerning the 

precautionary principle and the Convention on Human Rights. However, he 

ruled that the company had been given insufficient time to respond to the 

conclusions of the Government’s expert advisers prior to regulatory action 

being taken. He accepted that the matter was urgent but considered that the 

claimant had now had full opportunity to present any further material.


During the period of the injunction, the <strong>Committee</strong> were unable to publish the 

minutes of their meetings. The <strong>Committee</strong> had concerns that this compromised 

the openness of the advice given to Ministers, and could thereby have 

an adverse effect on public confidence in the regulatory process. They were 

also concerned that speculation about the missing minutes might create 

unwarranted public anxiety. Notwithstanding these concerns, the <strong>Committee</strong> 

agreed that while rapid implementation of regulatory action was desirable 

once decisions had been made, it was also important that the regulatory 

process be fair and open to scrutiny. In this case, the <strong>Committee</strong>’s advice had 

been precautionary (i.e. based on insufficient reassurance that exposures to 

the compound were acceptable rather than direct evidence that people were 

being harmed), and the delay caused by the legal action would be acceptable 

provided that it was not unduly prolonged. 

Following the Court judgement, approval holders for both agricultural and 

non-agricultural products were asked to provide any further information 

relating to the potential genotoxic carcinogenicity of dichlorvos. This 

information would be considered by the ACP at the earliest opportunity in 2002. 

46 

Dimethoate 

Dimethoate was reviewed as part of the UK review of anticholinesterase 

compounds. Dimethoate is a broad-spectrum contact and systemic 

organophosphorus insecticide, formulated as an emulsifiable concentrate. 

Products containing dimethoate are approved for use in agriculture, 

horticulture and the home garden on a range of crops. 

The ACP noted that dimethoate had previously been reviewed as part of 

the UK routine review programme and that the reference doses [acceptable 

daily intake (ADI), acceptable operator exposure level (AOEL) and acute 

reference dose (ARfD)] used in the current review had been established 

in 1993 and 1998. 

The ACP considered estimates of consumer exposure for dimethoate and its 

metabolite omethoate against the current ADI for dimethoate of 0.0008 mg/kg 

bw/day. It was concerned that the estimated long-term consumer exposure 

exceeded the ADI and agreed that the approvals for adding new stocks of 

dimethoate products to the supply chain be suspended while a strategy for 

reducing consumer exposure was submitted. The ACP considered that the 

stocks already in the supply chain could continue to be used.


The <strong>Committee</strong> agreed that the active substance did not warrant classification 

as a sensitiser. It also noted that the dimethoate ADI established in 1993 was 

different from the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) ADI 

and therefore asked that the basis for the ADI be re-examined. 

The ACP subsequently reconsidered the ADI for dimethoate. The current ADI 

of 0.0008 mg/kg bw/day had been established in 1993, based on applying a 

100-fold uncertainty factor to the no observed adverse effect level (NOAEL) of 

1 ppm (approximately 0.08 mg/kg bw/day) from a rat multigeneration study. 

The ACP agreed that the ADI for dimethoate should now be derived by 

applying a 100-fold assessment factor to the NOAEL of 0.2 mg/kg bw/day in a 

human volunteer study. Therefore, an ADI of 0.002 mg/kg bw for dimethoate 

was agreed. This new ADI would be used when the strategy for reducing 

consumer exposure was considered by ACP. 

Malathion 

Malathion is an organophosphorus insecticide, formulated as an emulsifiable 

concentrate, approved for use on agricultural/horticultural crops and in pigeon 

lofts. This review formed part of the routine UK review programme of 

anticholinesterase compounds. 

47 

The ACP agreed a repeat exposure systemic acceptable operator exposure 

level (AOEL) of 0.2 mg/kg bodyweight (bw)/day based on the lowest no 

observed adverse effect level (NOAEL) in an 18-month mouse oncogenicity 

study. The NOAEL of 100ppm (equivalent to approximately 17 mg/kg bw/day) 

was based on statistically significant red blood cell (RBC) cholinesterase 

depression in females at the 9- and 18-month interval, at a dose of 800ppm. 

This end point was also used as the basis for setting an acceptable daily 

intake (ADI) of 0.2 mg/kg bw/day. For these reference values, a 100-fold 

assessment factor was used. In addition, the <strong>Committee</strong> agreed that it was 

relevant to set a single exposure systemic AOEL of 1.5 mg/kg bw based on an 

absence of observed effects at the top dose tested of 15 mg/kg bw/day in a 

human volunteer study. This-end point was also used as the basis for setting 

an acute reference dose (ARfD). For these reference values, a 10-fold 

assessment factor was used. 

The ACP noted that ongoing mutagenicity studies would require completion 

before a conclusion could be reached on the genotoxicity of malathion. 

With regard to operator exposure, the <strong>Committee</strong> noted that estimated 

operator exposure levels were below the repeat exposure systemic AOEL with 

use of personal protective equipment, and were therefore acceptable.


The <strong>Committee</strong> agreed that approval for use on edible crops should be 

revoked due to lack of appropriate residues data. However, this did not 

apply to the off-label watercress use, which was supported by residues data. 

Intake estimates indicated that consumer exposures would be within an 

acceptable range. 

The <strong>Committee</strong> wished to consider further refinements to the toxicology 

reference values and associated amendments to the operator exposure and 

consumer exposure risk assessments at its January 2002 meeting. 

Oxamyl 

Oxamyl was reviewed as part of the UK review of anticholinesterase 

compounds. Oxamyl is a carbamate compound formulated as a granule for 

use as a systemic insecticide and nematicide. Use on potato and sugar beet 

was supported in the review and there were also a number of off-label 

approvals on vegetable crops. 

48 

In 2000, the following reference doses had been set: an acceptable daily 

intake (ADI) and an admissible operator exposure level (AOEL) of 0.0004 

mg/kg bodyweight (bw)/day and an acute reference dose (ARfD) of 0.06 

mg/kg bw/day. 

At that time the estimated operator exposure exceeded the AOEL and 

inadequate data had been submitted to assess consumer exposure. The ACP 

had therefore recommended that all approvals for products containing oxamyl 

should be revoked on the basis that the data submitted provided inadequate 

reassurance that operator and consumer exposures would be acceptable. 

Following this, the approval holder drew attention to new data now available, 

which might support continued use. The ACP considered a new operator 

exposure study and residue trials data for potatoes and sugar beet and in the 

light of these, agreed that operator and consumer exposure was acceptable. It 

considered that approvals could continue subject to the provision of further 

data (including further data on plant metabolism) and amendments to the 

product label. 

The <strong>Committee</strong> also recommended that approvals for use on crops that were 

not supported by acceptable residue trials data should be revoked.


Phosphides 

The ACP was updated regarding the review of phosphides and progress with 

a requirement set previously for a strategy to address potential genotoxicity 

in exposed operators. 

The <strong>Committee</strong> noted the conclusions from a new assessment by the 

<strong>Committee</strong> on Mutagenicity of Chemicals in Food, Consumer Products and the 

Environment (CoM). The CoM now considered that, in the light of new data 

available, a study of genotoxicity in UK pesticide applicators, as previously 

proposed, was no longer necessary. The ACP agreed with this conclusion 

but considered that a study of operator exposure was still required. 

Pirimicarb 

Pirimicarb is a carbamate insecticide formulated in a range of products, 

approved for use on various agricultural and horticultural crops and in one 

product for amateur use. In April 2001, the ACP considered a human health 

review of this active substance as part of a comprehensive review of 

anticholinesterase compounds. 

The <strong>Committee</strong> had previously considered reviews of pirimicarb in 1994 

and 1997, at which time it restricted uses and specified data requirements for 

continuing approval. The human health anticholinesterase review incorporated 

new data that had been submitted in response to the requirements identified 

at the earlier reviews. 

49 

Based on the toxicological evidence provided, the following critical end points 

were agreed: an ADI and AOEL of 0.035 mg/kg bw/day; ARfD of 0.1 mg/kg 

bw/day. 

The <strong>Committee</strong> considered that the estimates of exposures to operators, 

workers and bystanders (based on calculations using standard predictive 

models) were acceptable, subject to a requirement for additional personal 

protective clothing to be worn during knapsack spraying. 

Although not all the residues data provided reflected UK Good Agricultural 

Practice (GAP), the <strong>Committee</strong> considered the consumer risk assessment was 

adequate to allow continued approval on most crops, pending the generation 

of further residues data. Since there were no residues data to support use on 

celery, kohlrabi, grassland and plums, the <strong>Committee</strong> advised that these uses 

should be revoked.


The <strong>Committee</strong> agreed to advise Ministers that approvals for use on the 

remaining crops should be allowed to continue, subject to: a requirement for 

additional personal protective equipment for use during knapsack spraying; 

the provision of further data on physical/chemical properties, methods of 

analysis, mammalian toxicology, operator exposure and consumer exposure; 

and the provision of protocols for all ongoing and planned residue trials 

within three months. 

Pirimiphos-methyl 

Pirimiphos-methyl is an organophosphorus insecticide formulated in a range 

of products approved for use as a structural spray treatment, an admixture to 

stored cereal grains, and as a smoke generator for glasshouse and grain store 

use. There is one smoke generator product approved for amateur use. In 

January 2001, the ACP considered the human health review of this active 

substance as part of a comprehensive review of anticholinesterase compounds. 

50 

The <strong>Committee</strong> had previously considered a review of pirimiphos methyl in 

1997, at which time it was concluded that approvals could continue subject to 

additional operator and environmental protection requirements, and further 

data requirements. The human health anticholinesterase review incorporated 

the new data required following the previous review. 

The <strong>Committee</strong> agreed that an ADI value should be set at 0.03 mg/kg bw/day 

based on the NOAEL for inhibition of erythrocyte cholinesterase activity in two 

repeat-dose human volunteer studies, and applying an assessment factor of 10. 

This end point was also used as the basis for setting a systemic AOEL of 0.03 

mg/kg bw/day. In addition, the <strong>Committee</strong> agreed an ARfD of 0.15 mg/kg 

bw/day based on the NOAEL for minimal reductions in erythrocyte and brain 

acetylcholinesterase activity in an acute neurotoxicity study in rats, with an 

assessment factor of 100. 

The <strong>Committee</strong> considered that the estimates of exposure to operators, 

workers and bystanders were acceptable, subject to additional operator 

protection requirements, and the provision of confirmatory data. 

On the basis of the residue data provided, the <strong>Committee</strong> considered that 

estimates of consumer exposure were acceptable, although confirmatory data 

were required. 

The <strong>Committee</strong> agreed to advise Ministers that approvals should be allowed 

to continue subject to a restriction on the maximum concentration of one 

impurity in the technical specification, the imposition of additional operator


protection requirements and the provision of further data. It also identified 

a need for continuing monitoring of residues in food, particularly bran. 

This need would be referred to the Pesticides Residues <strong>Committee</strong>. 

Tolclofos-methyl 

Tolclofos-methyl is an organophosphorus fungicide formulated in a range of 

products approved for use on potato and various horticultural crops. There are 

no products approved for amateur use. In January 2001, the ACP considered 

a human health review of this active substance as part of a comprehensive 

review of anticholinesterase compounds. 

The <strong>Committee</strong> agreed that an ADI value should be set at 0.07 mg/kg bw/day 

based on the NOAEL of 6.5 mg/kg bw/day for reduced brain cholinesterase 

activity and increased absolute and relative kidney weights in a two-year 

mouse carcinogenicity study, and applying a 100-fold assessment factor. 

The <strong>Committee</strong> agreed that there were no acute or developmental effects on 

which it was appropriate to set an ARfD. 

In view of the usage patterns of tolclofos methyl, the <strong>Committee</strong> agreed that 

both short-term and long-term systemic AOELs were appropriate to the 

operator risk assessment. A short-term systemic AOEL of 0.13 mg/kg bw/day 

was agreed for the operator risk assessment relating to seasonal uses (i.e. < 90 

days’ operator exposure per year), based on the NOAEL for increased liver 

weights, reduced bodyweight gain and increased alkaline phosphatase activity 

in a six-month dog study. A long-term systemic AOEL of 0.042 mg/kg bw/day 

was agreed for the operator risk assessment relating to more frequent usage 

(i.e. > 90 days’ operator exposure per year), based on the same end point as 

the ADI. For both of these reference values, a correction factor of 60 percent 

was applied to take account of incomplete oral absorption, and a 100-fold 

assessment factor was used. 

51 

The <strong>Committee</strong> considered that the estimates of exposure to operators, 

workers and bystanders were acceptable, subject to additional operator 

protection requirements, and the provision of confirmatory data. 

On the basis of the residue data provided, the <strong>Committee</strong> considered that 

estimates of consumer exposure were acceptable, although confirmatory data 

were required. 

The <strong>Committee</strong> agreed to advise Ministers that approvals should be allowed 

to continue subject to the imposition of additional operator protection


Nonagricultural 

use 

requirements, and the provision of further data on physical/chemical 

properties, methods of analysis, consumer exposure and operator exposure. 

● 3-IODO-2-PROPYNYL-N-BUTYL CARBAMATE (IPBC) 

● AZAMETHIPHOS 

● 

CCA 

● 

DICHLOROPHEN 

● 

DICHLORVOS 

● 

DIURON 

● 

FENITROTHION 

● 

IRGAROL 

● 

LINDANE 

● 

PIRIMIPHOS-METHYL 

52 

3-iodo-2-propynyl-N-butyl carbamate (IPBC) 

3-iodo-2-propynyl-N-butyl carbamate (IPBC) is a broad-spectrum carbamate 

fungicide used in wood preservatives and surface biocides. It is one of the 

chemicals in the current UK review of organophosphorus and carbamate 

compounds. The ACP recommended, in June 1999, that all pesticide products 

containing a cholinesterase-inhibiting compound should be labelled to reflect 

this fact. Letters were sent to all approval holders to notify them of this 

requirement. 

The main manufacturer and data holder for IPBC did not feel that this label 

was justified for products containing IPBC. It presented a reasoned case to 

remove this labelling of its products on the grounds that any effects seen were 

very weak. The <strong>Committee</strong> considered summaries of the studies submitted as 

part of the reasoned case. 

The <strong>Committee</strong> was content that adequate data were available to indicate 

the cholinesterase-inhibiting properties of IPBC and that no further data were 

required at this stage. On the basis of these data the <strong>Committee</strong> concluded 

that IPBC should continue to be part of the UK review of anticholinesterase 

compounds used in non-agricultural pesticides. The <strong>Committee</strong> recommended 

that the products should have the following revised precautionary labelling 

phrase:


3-iodo-2-propynyl-N-butyl carbamate is a carbamate compound that has 

weak anticholinesterase activity. DO NOT USE if under medical advice not 

to work with anticholinesterase compounds. 

Having been informed that the ACP had rejected its case for removal of the 

original label, and recommended that an alternative phrase must be used, the 

company asked the ACP whether it could continue to use the original rather 

than the alternative phrase. The company stated that, since the new phrase 

was unique to IPBC, introducing it would risk confusion and uncertainty 

among its customers. It was also reluctant to have its clients reprint labels 

when further changes might be necessary on completion of the review. 

The <strong>Committee</strong> agreed to this request. 

Azamethiphos 

Azamethiphos is an organophosphorus compound approved for use both as 

an agricultural and non-agricultural insecticide. It is one of the chemicals in 

the current UK review of organophosphorous and carbamate compounds. 

At the time of the review there were two approved non-agricultural pesticide 

products containing azamethiphos. These were impregnated bait stickers for 

application to hard surfaces by non-professional users. 

53 

A human health review of the agricultural uses of azamethiphos had 

previously been considered by the ACP earlier in the year. The supplier 

was common to both agricultural and non-agricultural uses and therefore 

its physical chemistry and mammalian toxicology data had already been 

considered (see page 41). The <strong>Committee</strong> examined additional published 

toxicology data and considered the human health and efficacy issues 

associated with the non-agricultural uses of azamethiphos. 

Results obtained from a storage stability study for one of the products showed 

a significant loss of azamethiphos over a two-week period. The <strong>Committee</strong> 

agreed that approval holders should be required to provide an appropriate 

storage stability study. The <strong>Committee</strong> was also concerned that people might 

wish to remove the bait stickers within the lifespan of the product, and 

perhaps come into contact with the remaining azamethiphos. Therefore 

it recommended that approval holders be required to provide information 

on the change in azamethiphos content with time during product use. 

The <strong>Committee</strong> also noted that azamethiphos was classified as a skin sensitiser 

and that one of the products also attracted this classification. However, there 

had been no reports of skin sensitisation arising from use of these products,


in the literature. Therefore, the <strong>Committee</strong> agreed that it had no concerns in 

this respect and that no further data should be required at this stage. 

The estimated exposures from initial handling of the product and continued 

residential use gave no cause for concern. The <strong>Committee</strong> considered that the 

assessment for continued residential exposure should assume use in at least 

two rooms. This did not identify any cause for concern. 

The acute exposure estimated to occur following accidental ingestion of the 

entire product by infants or children did give cause for concern. However, 

data from the National Poisons Information Service (NPIS) on incidents 

involving these products provided some reassurance that the likelihood of 

this occurring was low. 

54 

Overall, the <strong>Committee</strong> concluded that approval for the two products 

should continue subject to the companies redesigning products to include a 

mechanism to prevent skin contact when attaching them to windows, more 

secure adhesion to windows, both products containing a bittering agent, and 

information on changes in azamethiphos content during the lifetime of the 

product. These recommendations would ensure that the risk of acute exposure 

by contact or ingestion was acceptably low. Continued approval was also 

subject to further data requirements. 

CCA 

Copper chrome arsenic (CCA) wood preservatives contain arsenic pentoxide, 

hexavalent chromium (chromium trioxide or sodium dichromate) and copper 

(II) oxide or copper (II) sulphate. They are supplied as pastes or water-based 

concentrates which are diluted to between one percent and ten percent w/w 

total salts and used in the industrial vacuum-pressure impregnation of timber. 

The <strong>Committee</strong> had considered a review of the use of CCA in industrial wood 

preservation in September 1999. It had agreed that approval for CCA products 

could be allowed to continue, subject to a number of conditions and 

requirements, including the provision of specific environmental data. 

The <strong>Committee</strong> now considered the approval holders’ responses to the 

environmental data requirements, which had previously been considered by 

its Environmental Panel. The <strong>Committee</strong> agreed that the exposure scenario 

proposed by approval holders was an acceptable alternative to HSE’s previous 

exposure scenario. However, it noted that this scenario assumed good 

practice, of which the British Wood Preserving and Damp Proofing Association 

(BWPDA) voluntary code of practice was considered to be an appropriate 

benchmark. The <strong>Committee</strong>’s Environmental Panel had identified several


outstanding issues concerning data to support the assumptions in the 

alternative exposure model and practices at UK treatment plants. The 

<strong>Committee</strong> noted that the main concern was contamination of the ground, 

from excess treatment solution running off newly treated timber and rain 

washing solution from newly treated timber. The <strong>Committee</strong> recognised that, 

although treatment sites were originally built to high standards, some were not 

maintained and there was cracking of bunds and concrete floors. In addition, 

a survey conducted on HSE’s behalf had reported that freshly treated and 

dripping timber was frequently stored outside the contained area. 

The <strong>Committee</strong> considered approval holders’ proposals to address these 

concerns. It agreed that the newly proposed exposure scenario for industrial 

wood preservation products was acceptable for CCA, subject to the submission 

of specific data to address the inhibition of respiration in sewage sludge 

micro-organisms, data on the bioavailability of metals in the water column and 

the issue of sediment toxicity, data to support a reasonable worst-case usage 

level for CCA at UK installations and UK data to support a reduction of the 

presumed emission from treatment plants from one percent to 0.2 percent. 

The <strong>Committee</strong> also agreed that the labels of CCA industrial wood 

preservation products should include the additional phrase: 

55 

TREATED WOOD MUST BE HELD FOR LEAST 48 HOURS AFTER 

TREATMENT AND UNTIL SURFACES ARE DRY WITHIN A BUNDED AREA 

ON A SITE WHICH IS MAINTAINED TO PREVENT LOSS OF TREATMENT 

PRODUCT TO THE ENVIRONMENT. 

The <strong>Committee</strong> welcomed the proposals for an industry-led awareness 

campaign across the whole industrial wood preservation industry to reduce 

emissions to the environment. 

Dichlorophen 

Dichlorophen and sodium dichlorophen are used in approved 

herbicide/fungicide products registered with PSD and HSE. In 1998, the ACP 

had agreed that approval holders for amateur surface biocides containing 

sodium dichlorophen should consider the feasibility of reformulation to 

negate the requirement for products containing 40 g/l or more to be labelled 

‘Risk of serious damage to eyes’. It also had identified a number of data 

requirements with respect to the physical chemistry, mammalian toxicology 

and environmental hazard of dichlorophen/sodium dichlorophen. Two years 

were allowed for the provision of these data.


The <strong>Committee</strong> now considered reports submitted by the manufacturer 

and one approval holder to address the feasibility of reformulation and/or 

repackaging of non-agricultural products containing dichlorophen/sodium 

dichlorophen. It also considered the progress made with the other data 

requirements it had identified. 

56 

The <strong>Committee</strong> noted that the company that supplied sodium dichlorophen 

for use in biocides had provided some data but had not complied fully with 

the data requirements. One approval holder had expressed concern at the 

apparent lack of response and indicated that it would be willing to support 

dichlorophen by generating the missing data itself, if the <strong>Committee</strong> agreed 

to allow it the time to do so. Subsequently the supplier had made a similar 

appeal for extra time to generate data. The <strong>Committee</strong> agreed that the 

supplier’s submission was deficient in a number of aspects and although the 

company had cited both animal welfare and economic considerations, its 

response was unacceptable. The <strong>Committee</strong> considered that this company 

should not be allowed an extension to the deadline for addressing the data 

requirements and that approval for products reliant on support from it should 

be revoked. 

The <strong>Committee</strong> noted that the majority of enquiries and incidents relating 

to dichlorophen that had been reported to centres of the National Poisons 

Information Service around the country involved access by young children to 

veterinary worming tablets. Only two incidents in recent years had involved 

eye contact with a dichlorophen-containing product and at least one of the 

adults concerned had suffered no long-term effects. For the other no details 

were available. As no major toxicological concerns had yet been identified, 

the <strong>Committee</strong> agreed to allow the specific approval holder extra time to 

generate the missing data. However, the approval holder would need to 

provide an early commitment to fulfil the requirements and adhere to a 

strict timetable. 

The <strong>Committee</strong> then considered the reports on the feasibility of reformulation 

of the single product marketed by this approval holder. It appeared that a 

more dilute concentrate of product was not a viable option due to the large 

volumes that would then be needed for a single treatment. The <strong>Committee</strong> 

had previously agreed that, where eye protection was considered necessary, 

amateur use of a product would not be permitted. However, the apparent lack 

of incidents related to use of this product reassured the <strong>Committee</strong> that eye 

protection was not necessary. The company had reported on progress with 

reformulation and had explored three options, each of which posed some


legitimate difficulty. The <strong>Committee</strong> agreed that currently there were no 

grounds for revocation of the existing product. It agreed that approval for the 

product should be allowed to continue subject to a commitment within two 

months to produce the necessary data identified in accordance with agreed 

deadlines. In addition, the <strong>Committee</strong> agreed that the company should be 

required to produce a further report on the potential for reformulation of 

its product. 

Some time after the <strong>Committee</strong>’s consideration of this subject, the approval 

holder reported that it was currently unable to comply with the requirements. 

Therefore the <strong>Committee</strong> agreed that this remaining product should also 

be revoked. 

It was also noted that the position with respect to PSD approvals needed to 

be considered and it was concluded that a short period should be provided 

for approval holders for products registered with PSD to provide commitments 

to produce the relevant data. 

On the basis of the evidence provided by the main data holder on behalf of 

the PSD approval holders of their support for dichlorophen, both in the UK 

and under the EU programme, the <strong>Committee</strong> recommended that approvals 

be allowed to continue pending submission of the specified data. 

57 

Dichlorvos 

Dichlorvos is an organophosphorus compound currently approved for use as 

an insecticide against crawling and flying insects in non-agricultural pesticides. 

It is one of the chemicals included in the review of organophosphorus and 

carbamate compounds. Twelve approval holders submitted data on the active 

substance and approved products to the review. At its meetings in April and 

May 2001, the ACP considered the available physicochemical, toxicological 

and efficacy data on dichlorvos and recommended in May 2001 that Ministers 

be advised that: 

a) approval for all aerosols containing dichlorvos be revoked based on the 

unacceptable toxicity-exposure ratios (TERs) derived for primary and 

secondary exposures from professional and amateur use; 

b) approval for residential uses of slow release controllable and noncontrollable 

cassettes containing dichlorvos be revoked based on the 

unacceptable TERs derived for secondary exposures from professional 

and amateur use;


c) approval for the professional use of slow-release strips and controllable and 

non-controllable cassettes containing dichlorvos in museums be retained 

subject to the fulfilment of physicochemical, operator exposure and efficacy 

data requirements; 

d) approval for the use of slow-release strips in pheromone traps in areas 

where food may be stored, prepared or consumed be suspended pending 

the provision of information on food residues; and 

e) approval for the use of slow release strips in pheromone traps in areas 

where food is not present be retained subject to the fulfilment of 

physicochemical and efficacy data requirements. 

A review of the agricultural uses of dichlorvos was also considered by the 

ACP at the same time (see page 42). 

58 

The ACP also noted that dichlorvos was under discussion by the <strong>Committee</strong> 

on Mutagenicity of Chemicals in Food, Consumer Products and the 

Environment (CoM), and recognised that their recommendations would 

perhaps require modification in accordance with the COM’s findings. 

At the July 2001 ACP meeting, the <strong>Committee</strong> considered the implications of 

the COM’s possible conclusions, and agreed to advise Ministers as follows: 

a) If the COM’s final conclusions were that dichlorvos was an in-vivo 

mutagen, and it could not exclude the possibility that the occurrence 

of tumours in animal tests of carcinogenicity resulted from a genotoxic 

mechanism, there should be immediate revocation of all uses (both 

agricultural and non-agricultural). 

b) Alternatively, if the COM concluded that dichlorvos was an in-vivo 

mutagen, but that the tumours observed in animal tests did not result from 

a genotoxic mechanism, or if it could not confirm that dichlorvos was an 

in-vivo mutagen, or if it took the view that dichlorvos was not an in-vivo 

mutagen, then the ACP’s previous recommendations would be maintained. 

The COM concluded, following a second meeting in July 2001, that dichlorvos 

should be regarded as an in-vivo mutagen (i.e. capable of inducing mutations 

in living animals) at site of contact and that it could not exclude the possibility 

of it acting as a genotoxic carcinogen. The COM statement on dichlorvos was 

finalised in late July 2001. 

Consequently the ACP recommended to Ministers that, as a precautionary 

measure, it would be prudent to revoke, with immediate effect, all agricultural


and non-agricultural uses of dichlorvos. This advice was given as a 

precautionary measure, since the possibility of genotoxic carcinogenicity could 

not be excluded. The ACP considered that any risk of human carcinogenicity 

was likely to be very small, and would be mainly associated with certain uses 

in the home and with exposures to some operators in the agricultural sector. 

Before such regulatory action could be carried out, AMVAC Chemical UK Ltd 

(an approval holder and manufacturer of dichlorvos) obtained an injunction, 

which prevented regulatory action. Government agencies were also prohibited 

from making any announcement to the public about the regulatory action that 

was proposed. AMVAC also gained permission for a judicial review hearing, 

which was heard in November 2001. 

The grounds for the challenge were that AMVAC had not been properly 

informed of the proposed regulatory action or the basis for it, and had not 

been given sufficient time to make representations. AMVAC also claimed that 

Ministers had not given proper regard to the precautionary principle and to 

the European Convention on Human Rights. 

The judgement of the Court was issued in December 2001. Mr Justice Crane 

rejected most of the company’s submissions, including those concerning the 

precautionary principle and the Convention on Human Rights. However, he 

ruled that the company had been given insufficient time to respond to the 

conclusions of the Government’s expert advisers prior to regulatory action 

being taken. He accepted that the matter was urgent but considered that the 

claimant had now had full opportunity to present any further material. 

59 

During the period of the injunction, the ACP was unable to publish the 

minutes of its meetings. The ACP had concerns that this compromised the 

openness of the advice given to Ministers, and could thereby have an adverse 

effect on public confidence in the regulatory process. It was also concerned 

that speculation about the missing minutes might create unwarranted public 

anxiety. Notwithstanding these concerns, the ACP agreed that while rapid 

implementation of regulatory action was desirable once decisions had been 

made, it was also important that the regulatory process be fair and open to 

scrutiny. In this case, the ACP’s advice to Ministers had been precautionary 

(i.e. based on insufficient reassurance that exposures to the compound were 

acceptable rather than direct evidence that people were being harmed), and 

the delay caused by the legal action would be acceptable provided that it was 

not unduly prolonged.


Following the Court judgement, approval holders for both agricultural and 

non-agricultural products were asked to provide any further data relating to 

the potential genotoxic carcinogenicity of dichlorvos. These data would be 

considered by the ACP early in 2002. 

Diuron 

The ACP considered submissions received from four companies concerned 

with antifouling products containing diuron. The <strong>Committee</strong> had considered 

the use of this compound in antifouling products in September 2000. Members 

had considered that the safety margins for professional and amateur users of 

products were not as high as they would wish and that use of these products 

posed an unacceptable risk to the aquatic environment. Therefore the ACP 

had recommended that all uses of diuron in antifouling products should be 

revoked. The companies responding now expressed concern that action taken 

only in the UK would be a barrier to trade and put them at a competitive 

disadvantage and asked for an extended phase-out period for products, to 

enable alternatives to be developed. 

60 

The <strong>Committee</strong> considered that companies had been provided with adequate 

information regarding the possibility of revocation. Few had submitted 

comments to the <strong>Committee</strong> and it concluded that the submissions made were 

not sufficient to justify cancellation of, or changes to the timescales for, the 

revocations agreed previously. 

Fenitrothion 

Fenitrothion is an organophosphorus compound currently approved for nonagricultural 

use as an insecticide against crawling and flying insects. It is one 

of the chemicals included in the current review of organophosphorus and 

carbamate compounds. Currently, non-agricultural pesticide products 

containing fenitrothion are approved for both professional and amateur use, 

with amateur use restricted to aerosol space and surface sprays. Professional 

use encompasses emulsifiable and microencapsulated concentrates, wettable 

and dusting powders approved for use as public hygiene insecticides and 

animal husbandry insecticides. The <strong>Committee</strong> considered a review of the 

physical chemistry, mammalian toxicity and efficacy of fenitrothion. 

The main health effect of concern for fenitrothion was its anticholinesterase 

activity. However, the review also identified a number of other health effects 

that the <strong>Committee</strong> needed to consider. The evidence presented demonstrated 

that acute poisoning with fenitrothion caused Intermediate Syndrome (IMS).


The <strong>Committee</strong> agreed that, as IMS was a condition resulting from serious 

acute poisoning, it was likely that those developing the syndrome would 

already be hospitalised, and as IMS rarely occurred in the UK, it was not 

necessary for approval holders to include guidance on the treatment of IMS 

on the product label. 

The <strong>Committee</strong> considered the potential for fenitrothion to cause skin 

sensitisation. It was noted that fenitrothion had been widely used for many 

years and that it was highly likely that any potential for fenitrothion to cause 

skin sensitisation would be reflected in the clinical literature. Therefore, in 

light of the lack of reported cases of skin sensitisation, the <strong>Committee</strong> agreed 

there were no grounds for concern on this issue. 

The <strong>Committee</strong> agreed that the evidence presented indicated that fenitrothion 

was not genotoxic and that ocular toxicity gave no cause for concern. 

Observations in developmental studies included the occurrence of enlarged 

sub-arachnoid space in rat pups and decreases in pup survival postpartum at 

high doses. The <strong>Committee</strong> examined the data and agreed that the occurrence 

of enlarged sub-arachnoid space was not treatment related. The <strong>Committee</strong> 

also agreed that the decrease in pup survival postpartum seen at high doses 

could be related to the palatability of the mother’s milk and concluded that 

as these effects were seen only at high doses, there were no concerns for 

human health. 

61 

The <strong>Committee</strong> considered the predicted exposure of users of products 

containing free fenitrothion for public hygiene and animal husbandry uses and 

concluded that, with the exception of aerosol space sprays used professionally 

in industrial premises, approvals should be revoked. This was because of 

inadequate reassurance that exposures of users or consumers would be 

acceptable. The <strong>Committee</strong> also considered that further data presented by 

the data holder were not sufficient to support the continued approval of 

wettable powders and dust formulations. 

The <strong>Committee</strong> agreed that the data submitted indicated that 

microencapsulated fenitrothion was far less toxic than free fenitrothion. 

It recommended that approval for products containing microencapsulated 

fenitrothion should be allowed to continue for use in industrial areas only, 

and subject to a number of data requirements. In addition to these data 

requirements, for approval to be allowed to continue for professional use 

aerosol space sprays containing free fenitrothion in industrial areas, further 

data were requested. Any future request to extend approval for


microencapsulated products to include use in domestic premises or animal 

husbandry uses would need to be supported by appropriate additional data. 

Irgarol 

The ACP considered a submission from the data holder for Irgarol 1051, an 

active substance used in antifouling products. The <strong>Committee</strong> had considered 

the use of this compound in antifouling products in September 2000. The ACP 

had concluded that there was an unacceptable risk posed to the aquatic 

environment and recommended revocation of the amateur use of products 

containing this compound and restriction of professional use to vessels above 

25 m in length. The data holder had focused on deficiencies in experimental 

design of the key study used to estimate the risk posed to the environment 

and had offered to carry out further testing. 

The <strong>Committee</strong> noted that it had previously debated the limitations of the 

study and considered that further data would not alter the overall conclusions. 

Therefore the <strong>Committee</strong> agreed that the revocations and restrictions on the 

antifouling uses of this active substance remained appropriate. 

62 

Lindane 

The <strong>Committee</strong> considered a submission made by the approval holder for an 

aerosol insecticide product containing lindane. This product had been revoked 

following the environmental review of lindane in March 2000, on the grounds 

that the approval holder had failed to supply adequate data or reasoned cases 

to address all the core environmental data requirements. The approval holder 

asked for an extended phase-out period because of a problem with 

communication with HSE regarding the expiry date of the product and 

because the company was not aware of any adverse incidents during 20 years 

of product use. The <strong>Committee</strong> indicated that although there had been a slight 

problem with communication, the company had been allowed sufficient time 

to comply with the data requirements. Therefore the <strong>Committee</strong> concluded 

that the arguments put forward were insufficient to justify products not being 

revoked according to the intended timescales. 

Pirimiphos-methyl 

Pirimiphos-methyl is an organophosphorus compound approved for use as 

an insecticide in agricultural and non-agricultural pesticides. It is one of the 

chemicals included in the current review of organophosphorus and carbamate 

compounds. There are currently two approved non-agricultural pesticide


products containing pirimiphos-methyl, both of which are approved for use 

by professionals only. They are an emulsifiable concentrate insecticide/wood 

preservative and a dusting powder insecticide for professional use against 

flying and crawling insects. 

A human health review of pirimiphos-methyl had been undertaken by PSD 

and considered by the <strong>Committee</strong> earlier in the year (see page 50). The 

<strong>Committee</strong> then considered a review of the human health and efficacy issues 

associated with the non-agricultural use of pirimiphos-methyl. The <strong>Committee</strong> 

noted that it had already agreed a NOAEL of 0.25 mg/kg/bw/day for repeated 

exposure. In addition, it had agreed values for the dermal absorption of 

pirimiphos-methyl of one percent from an emulsifiable concentrate and a 

100 g/l dilution, five percent for a 1 g/l dilution and one percent for the 

dermal absorption of pirimiphos-methyl from a dustable powder. 

The <strong>Committee</strong> agreed that the predicted exposure of those using products 

was generally acceptable but gave cause for concern when exposures at the 

95 th percentile level were considered. It considered that the use of personal 

protective equipment (PPE) would mitigate exposure of workers and asked for 

further consideration of the way in which data had been used to predict highlevel 

exposures. The <strong>Committee</strong> noted that the operator exposure assessments 

for agricultural products used the 75 th percentile and, for comparative 

purposes, asked HSE to present exposure predictions on the same basis. 

63 

The <strong>Committee</strong> considered that, once surface residues were dry, further 

dislodging of active substance from treated surfaces was highly unlikely. Also, 

there would be a provision for the exclusion of people and animals during 

application of the pesticide. The predicted long-term exposure to pirimiphosmethyl 

after treatments had been carried out gave some cause for concern, 

although the exposure predictions were not well-established and were based 

on a series of assumptions in the absence of actual data. The <strong>Committee</strong> 

agreed that its concerns should be communicated to the approval holder, who 

should be asked to comment on the current exposure predictions and provide 

assurance that exposures of children and adults would be acceptable. 

The <strong>Committee</strong> agreed that further clarification was required from the 

approval holder regarding the possible photodegradation of pirimiphosmethyl. 

It also asked HSE to consider further various issues relating to the 

efficacy of the products and to liase with PSD regarding the consumer risk 

assessment for stored food.


Section F: 

Other items considered during the year 

The <strong>Committee</strong> considered the following additional items during 2001: 

Pesticide usage 

survey reports 

Report 162 – Rodenticide use on farms in Great Britain growing 

arable crops 1998 

This report presented results of the fourth fully co-ordinated survey of 

rodenticide usage throughout Great Britain on farms growing arable crops, 

previous surveys having been conducted in 1992, 1994 and 1996. 

64 

A survey of rodenticide usage on 997 holdings growing arable crops in Great 

Britain in 1998 provided data which had been extrapolated to give an estimate 

of national usage on such holdings. The most extensively used rodenticides, 

in terms of number of occurrences, were difenacoum, bromadiolone, 

chlorophacinone, coumatetralyl, brodifacoum and cholecalciferol/difenacoum. 

These six active substances accounted for 95 percent of all occurrences 

excluding holdings where the product was unknown, and the report 

concentrates on the comparison of usage between these six principal 

rodenticides. All other rodenticides had only limited occurrence and 

information concerning their usage requires cautious interpretation as the 

data may have been subject to statistical error. 

Eastern region accounted for 37 percent, by weight, of the total amount of the 

principal active substances used in Great Britain, with Scotland and Northern 

region accounting for a further 15 percent and 20 percent respectively. The 

majority of the principal rodenticides were applied in autumn and winter 

(33 percent each). Rodenticides applied around buildings accounted for 

63 percent of the total weight of bait applied. By weight, 39 percent of the 

principal active substances were purchased as ready-to-use baits and farmers 

applied 82 percent of the total weight of the principal active substances used. 

The number of farms using rodenticides has risen since 1996, with 

86 percent of all farms using one or more rodenticides during the year. 

The corresponding figures had been 78 percent in 1996, 79 percent in 

1994 and 74 percent in 1992. 

The percentage of rodenticides applied around buildings had increased from 

37 percent in 1996 to 59 percent of the total weight of bait applied in 1998 

with a corresponding reduction in the use of rodenticides inside buildings

Section F: Other items considered during the year 

from 56 percent to 32 percent. This may have been due to the increased 

uptake of crop assurance schemes, whose aim is to prevent the contamination 

of stored products, from rodent damage/fouling and from accidental spillage 

of rodenticide bait inside buildings. 

The proportion of rodenticides purchased as concentrates in 1998 remained 

close to a quarter of the total principal active substances used, as in 1996. 

There had been a decrease in the use of ready-to-use formulations from 

47 percent in 1996 to 39 percent in 1998 and also a subsequent increase 

in both contact dusts (20 percent in 1996 to 22 percent in 1998) and sachets 

(11 percent to 13 percent). 

There had been a further rise in the amount of bait applied by farmers as 

opposed to contractors. In 1994 farmers applied 55 percent of the principal 

six active substances. In 1996 this had risen to 75 percent, and in 1998 farmers 

applied 82 percent. This may have resulted from the increasing cost of 

employing a contractor as well as an increase in the number of the ’user 

friendly’ formulations available on the market such as sachets, contact dusts 

and wax blocks. 

Report 164: Protected crops (edible and ornamental) in 

Great Britain 1999 

This report presented information on all aspects of pesticide usage on 

protected crops, both edible and ornamental, grown in Great Britain in 1999. 

More than 188 distinct crop types were encountered in the survey and data on 

pesticide usage were collected during visits by pesticide usage surveyors to 

377 holdings throughout Great Britain. The total area surveyed represented 

30 percent of the area of all protected crops grown in Great Britain in 1999, 

while the area visited in each region was proportional to the area of protected 

crops grown in that region. The data on the area of pesticide treatments and 

the amounts of active substances applied had been extrapolated to give 

estimates of national pesticide usage on protected crops. Information was 

also presented concerning the extent of usage of biological control agents. 

65 

Edible crops accounted for 38 percent of the total area of protected crops 

grown in 1999. 

Usage of all biological control agents accounted for 51 percent of the total 

treated area for pest, disease and weed control on edible crops, although no 

such usage was recorded on lettuce, celery or edible plants in propagation. 

Fungicides accounted for 27 percent of the total treated area, insecticides 

14 percent, acaricides three percent and sulphur two percent.


Encarsia formosa and Phytoseiulus persimilis were the most extensively 

used biological control agents on edible crops. The most extensively used 

fungicides were propamocarb hydrochloride, iprodione, fosetyl-aluminium, 

metalaxyl/thiram and tolclofos-methyl. The organophosphates were the most 

extensively used group of insecticides and were used on 36 percent of the 

total insecticide-treated area. The pyrethroids were used on 34 percent of the 

insecticide-treated area and the carbamates 19 percent. The most extensively 

used individual insecticides were cypermethrin, pirimicarb and heptenophos. 

Fenbutatin oxide was used on 42 percent of the acaricide-treated area and 

abamectin on 32 percent. 

66 

Although the area of edible protected crops had declined by 38 percent since 

1991 the area treated with registered pesticides had decreased by 52 percent. 

In contrast, since 1991, the area treated with non-registered biological control 

agents decreased, by 42 percent, in line with changes in the area grown. 

Usage of registered biological control agents had declined by 77 percent since 

1991. The areas treated with all registered pesticides had declined by 

26 percent, between 1995 and 1999, and in particular fungicide usage had 

decreased by 33 percent, insecticides by five percent, molluscicides by 

71 percent and herbicides by 42 percent. Only the areas treated with sulphur 

had increased since 1995. The weight of registered active substances applied 

to edible protected crops had decreased by 60 percent since 1991 and by 

15 percent since the last survey. Soil sterilants accounted for less than one 

percent of the treated area but for 50 percent of the total weight of active 

substances applied. 

The total area of protected ornamental crops grown in 1999 was 84 percent 

greater than in 1995 and 34 percent greater than in 1991. With the exception 

of other “flowers and foliage”, where the area grown had increased by 

21 percent since 1995, the areas of all other flowers for cutting had declined 

markedly, reflecting the increased pressure from imports. The area of pinks 

had declined by 55 percent, carnations by 40 percent, chrysanthemums 

by 21 percent and alstroemeria by four percent. 

Growth regulators accounted for 35 percent of the total area of protected 

ornamental crops treated for pest, disease and weed control, fungicides 

29 percent, insecticides 26 percent, acaricides five percent, herbicides two 

percent, molluscicides one percent and registered biological control agents 

one percent. When all biological control agents were included, the level of 

biological control increased to 15 percent of the combined total. Soil sterilants


accounted for less than one percent of the area of ornamental crops treated 

but for 55 percent of the weight applied. 

Usage of daminozide accounted for over half of the area of ornamentals 

treated with growth regulators. Two fungicides accounted for 41 percent of 

the total fungicide-treated area of protected ornamental crops: chlorothalonil 

21 percent, and iprodione 20 percent. The organophosphates were again the 

most extensively used group of insecticides and accounted for 28 percent of 

the insecticide-treated area, the pyrethroids 25 percent and the carbamates 

16 percent. The most extensively used individual insecticides were pirimicarb 

14 percent, cypermethrin 14 percent, deltamethrin 11 percent, heptenophos 

11 percent, dichlorvos ten percent and nicotine nine percent. Two species 

accounted for 53 percent of the biological control agent treated area: Encarsia 

formosa 28 percent and Aphidius colemani 25 percent. Two acaricides 

accounted for 85 percent of the acaricide-treated area of ornamental crops, 

abamectin 56 percent and bifenthrin 28 percent. 

While the area of protected ornamental crops had increased by 84 percent 

since 1995, the area treated with registered pesticides increased by 61 percent 

over the same period. There had been increases in the use of both fungicides, 

64 percent, and insecticides, two percent, between 1995 and 1999. However, 

the use of growth regulators, mainly for bedding plants and pot plants, had 

increased to ten times the area recorded in 1995. The use of registered and 

other biological control agents had decreased by 45 percent. In line with the 

increases in the areas treated, the weight of registered pesticides applied had 

increased by 68 percent since 1995. 

67 

Report 165: Mushroom crops in Great Britain 1999 

This report presented information concerning all aspects of pesticide usage 

on mushrooms grown in Great Britain in a 12-month period during the 1999 

growing season. Data were collected during visits to 61 holdings growing 

mushrooms throughout Great Britain, representing 52 percent of total 

mushroom production. The holdings surveyed in each region were 

proportional to the production of mushrooms grown in that region and the 

data on the area of pesticide treatments and the amount of active substances 

applied had been extrapolated to give estimates of national usage. 

Since 1995 there had been a 39 percent reduction in the production area of 

mushrooms. This has been accompanied by a corresponding decrease in the 

area treated of 40 percent but a reduction in the weight of pesticides applied, 

mainly disinfectants, of 90 percent.


Fungicides accounted for 37 percent of the total pesticide-treated area 

of mushrooms grown in Great Britain in 1999, disinfectants 36 percent, 

insecticides 25 percent, biological control agents two percent and tar oils less 

than one percent. In contrast, disinfectants accounted for 80 percent of the 

total weight of pesticide active substances applied, fungicides for 16 percent, 

insecticides four percent, and tar oil less than one percent. 

By area treated, the most extensively used fungicides were prochloraz, 

accounting for 88 percent of the total fungicide-treated area, used mainly 

during production, and carbendazim, comprising 11 percent, used during 

both production and casing. By weight applied, prochloraz accounted for 

71 percent of the total fungicides applied, with carbendazim comprising 

a further 27 percent. 

68 

The most extensively used insecticide formulations were permethrin 

(48 percent), pyrethrins/resmethrin (18 percent), diflubenzuron (17 percent), 

and methoprene (11 percent). The use of gamma-HCH was confined to 

periods between flushes or when the mushroom house was empty. By weight 

applied, diflubenzuron, used mainly during pre-production, accounted for 

65 percent of the total. 

In terms of area treated, sodium hypochlorite (81 percent) and formaldehyde 

(18 percent) were the two main registered disinfectants recorded. 

Unlike previous surveys conducted in 1991 and 1995, no acaricides or soil 

sterilants were recorded in 1999. 

Overall, the area treated with insecticides had more than halved, (59 percent), 

since 1995, while the use of fungicides had declined by 29 percent over the 

same period. The change in insecticide use was principally the result of a 

reduced use of pyrethrins/resmethrin, diflubenzuron, diazinon, gamma-HCH 

and dichlorvos. Use of the fungicides azaconazole and thiabendazole, both 

accounting for large areas in 1995, was not recorded in the current survey. 

By weight applied, insecticide usage had decreased by 91 percent, mainly 

resulting from a reduced use of diazinon, which has lost its approval status 

since 1995, diflubenzuron, pyrethrins/resmethrin, dichlorvos and permethrin. 

The weight of methoprene applied had increased by 19 percent. Fungicide 

usage decreased 74 percent by weight applied, due to the use of azaconazole 

not being recorded in this survey. Use of carbendazim, prochloraz and 

dichlorophen had also fallen.


Changes in the weight of registered disinfectants used were largely the result 

of an 86 percent reduction in the use of sodium hypochlorite and a 75 percent 

reduction in the use of formaldehyde. 

The use of the biological control agent Steinernema feltiae had fallen by 

10 percent since the previous survey, being recorded on a total of 28 hectares 

of growing area. 

Report 172: Orchards and fruit stores in Great Britain 2000 

This report presented information concerning all aspects of pesticide usage 

on orchard crops in Great Britain during the 2000 fruiting season. Information 

was obtained from visits to 256 holdings, which represented 33 percent of the 

total area of commercial orchards grown. Data were collected on the area of 

pesticide treatments and the amount of active substances applied and these 

had been extrapolated to give estimates of national pesticide usage. 

There had been a continual decrease in the area of orchard crops grown over 

the last nine years, with the present area being 21 percent less than that 

grown in 1992 and eight percent less than the last survey in 1996. With the 

exception of cider apples and perry pears, all crops surveyed showed 

reductions in the area grown since 1996, with a 29 percent drop in cherries, 

26 percent in other culinary apples, 23 percent in Cox’s apples and plums, 

21 percent in pears, five percent in Bramley apples, two percent in other 

top fruit (including nuts) and one percent in other dessert apples. Only cider 

apples and perry pears showed an increase, the area grown being 23 percent 

more than in 1996, and 42 percent greater than in 1992. 

69 

Both the total spray area and the weight of pesticides applied had decreased 

considerably since 1992. This trend was reflected in every major pesticide 

group except for sulphur and growth regulators, with an overall reduction in 

area treated of 16 percent since 1992. This trend had continued between 1996 

and the current survey where overall pesticide usage had fallen by five 

percent, with only fungicides, sulphur and growth regulators increasing in use. 

The weight of active substances applied, had declined by 19 percent between 

1996 and 2000 and by 21 percent since 1992. 

With long-season perennial crops it is essential to protect growth throughout 

the growing season in order to ensure the production of high-quality fruit. 

This results in the majority of crops receiving some degree of treatment. For 

example in 2000, Cox’s dessert apple crops received on average, including 

repeat applications, a total of 18 pesticide sprays, 35 products and 38 active 

substances. In contrast, over 60 percent of other top fruit (incl. nuts); almost


one-third, 32 percent, of cider apples and perry pears; 22 percent of plums; 

and seven percent of cherries received no pesticides. 

Fungicides and pruning paints accounted for 60 percent of the total pesticidetreated 

area of orchard crops grown in Great Britain in 2000, insecticides 

12 percent, herbicides 11 percent, growth regulators ten percent, sulphur two 

percent, urea two percent, acaricides one percent and acaricide/insecticides, 

biological control agents, tar oil/acids, all less than one percent each. In 

contrast, fungicides and pruning paints accounted for 50 percent of the total 

weight of pesticide active substances applied, herbicides 12 percent, sulphur 

12 percent, insecticides ten percent, tar oil/acids ten percent, urea five percent 

and growth regulators one percent. 

70 

The principal fungicide formulations were captan (20 percent), myclobutanil 

(14 percent), dithianon (13 percent), penconazole (nine percent), pyrifenox 

(six percent) and bupirimate (six percent). By weight applied, however, while 

captan was still the most extensively used formulation, it accounted 

for 47 percent of all fungicide use, while dithianon comprised 15 percent, 

captan/penconazole ten percent, dodine eight percent and mancozeb 

seven percent. 

The organophosphates were the most extensively used insecticides, 

accounting for 60 percent of the insecticide-treated area, followed by the 

carbamates, 16 percent, ‘other insecticides’, mainly the juvenile hormone 

analogue fenoxycarb, 15 percent, pyrethroids, six percent and the 

benzoylureas, two percent. Five formulations accounted for approximately 

90 percent of the total insecticide-treated area of all orchard crops: 

chlorpyrifos 54 percent; fenoxycarb 15 percent; pirimicarb 12 percent; 

cypermethrin five percent and carbaryl four percent, which was also used 

specifically as a fruit thinning agent on apples (see growth regulators). 

Chlorpyrifos accounted for 69 percent of the total weight of insecticides 

applied and carbaryl, used on four percent of the total insecticide area, 

accounted for a further 11 percent. 

The most extensively used herbicide formulations were glyphosate, accounting 

for 28 percent of the area treated, simazine, 14 percent, glufosinateammonium, 

nine percent, 2,4-D/dichlorprop/MCPA/mecoprop, eight percent 

and amitrole, seven percent. In terms of weight applied, glyphosate accounted 

for 30 percent of the total, simazine 14 percent, 2,4-D/dichlorprop/MCPA/ 

mecoprop, ten percent, amitrole, eight percent, and dicamba/MCPA/mecoprop, 

eight percent.


The most frequently used growth regulators by area treated were paclobutrazol, 

62 percent, gibberellins, 34 percent, and carbaryl, three percent, with 

paclobutrazol and carbaryl accounting for 50 percent and 44 percent 

respectively by weight applied. 

The most extensively used acaricides were amitraz, which accounted for 

42 percent of the acaricide-treated area, fenpyroximate, used on 34 percent, 

and clofentezine, comprising a further 20 percent. By weight applied, amitraz 

accounted for 83 percent of the total. Tebufenpyrad was the only 

acaricide/insecticide recorded. 

Biological control agents represented less than one percent of all pesticide 

usage, with Bacillus thuringiensis being the only agent recorded. Anthracene 

oil was the only defoliant recorded. 

Report 173: Hops in Great Britain 2000 

This report presented information concerning all aspects of pesticide usage on 

hops in England and Wales during the 2000 cropping season. Information was 

collected from visits to 41 holdings, which represented 32 percent of the total 

area of hops grown. Data collected on the area of pesticide treatments and the 

amount of active substances applied had been extrapolated to give estimates 

of national pesticide usage. 

71 

There had been a continual decrease in the area of hops grown in recent 

years, with the area grown in 2000 being 35 percent less than in 1992 and 

32 percent less than at the time of the previous survey in 1996. Since 1996, 

there had been a 26 percent decrease in the total pesticide-treated area, and 

a 54 percent decrease in the weight of active substances applied. 

Pest and disease control in hops is frequently achieved using routine spray 

programmes, particularly in the case of protectant fungicide sprays to control 

downy and powdery mildew. On average, crops received 14 separate spray 

applications, 25 products (including repeat applications of the same product) and 

30 active substances (including repeat applications of the same active substance). 

Fungicides accounted for 59 percent of the total pesticide-treated area of hops 

grown in England and Wales in 2000, herbicides 19 percent, acaricides eight 

percent, sulphur six percent, insecticides four percent, defoliants three percent 

and molluscicides and tar oils less than one percent. In terms of the weight of 

active substances applied, herbicides accounted for 34 percent of the total, 

fungicides 23 percent, defoliants 23 percent, sulphur 12 percent, tar oils seven 

percent, acaricides, insecticides and all other groups less than one percent.


The most extensively used fungicide formulations were copper oxychloride/ 

metalaxyl, pyrazophos, copper oxychloride, fenpropimorph, zineb and 

myclobutanil, which together accounted for 83 percent of the total area of 

fungicides used. In terms of weight applied, copper oxychloride was the most 

important fungicide formulation, accounting for 31 percent of the total. 

Sulphur accounted for six percent of the total area treated and 12 percent 

of the weight applied, reflecting its high rate of application. 

The most extensively used herbicide formulations were diquat/paraquat, used 

mainly for defoliation, sodium monochloroacetate, again for defoliation, and 

simazine and glyphosate, used mainly for general weed control, all of which 

accounted for 90 percent of the area treated with herbicides. 

The most extensively used acaricide was tebufenpyrad, which accounted for 

60 percent of the area treated with acaricides and was used mainly to control 

red spider mites. 

72 

The most extensively used insecticide was imidacloprid, which accounted for 

81 percent of the insecticide-treated area, applied primarily to the ‘hills’ in the 

hop garden or yard. Insecticide usage had decreased by 23 percent from that 

in 1996 and by 80 percent from that in 1992. The decrease in insecticide usage 

overall reflected dramatic declines for all major insecticide groups including 

carbamates, organochlorines, organophosphates and pyrethroids. The 

introduction of imidacloprid has radically changed insecticide usage on hops, 

with a single application on many crops being made early in the year to give 

all-season control of the damson-hop aphid Phorodon humuli (Schrank). 

The area treated with defoliants and tar oils combined accounted for three 

percent of the total area treated and 30 percent of the weight applied in 2000. 

The use of tar oil as a defoliant had decreased by 79 percent since 1996 in 

terms of area treated and by 84 percent of weight applied, reflecting the 

continued move towards anthracene oil as a defoliant. 

Report 179: Farm grain stores in Great Britain 1998/1999 

This report presented data from 1,858 replies from a preliminary questionnaire 

sent to 2,997 arable holdings in Great Britain and the results from visits to 

444 holdings both using pesticides and storing grain from the 1998 harvest in 

Great Britain. Data had been extrapolated to give national estimates of usage 

in Great Britain. 

A total of almost 18 million tonnes of grain was stored of which 74 percent 

was in flat stores, and the remainder being stored in bins or silos.


The questionnaire showed that 72 percent of all holdings contacted stored 

grain and 51 percent used pesticides either as fabric treatments or admixture 

treatments. Those holdings in the South Western and Midlands and Western 

regions were more likely to be applying fabric treatments, while the 

application of both fabric and admixture treatments was more prevalent 

in the South Eastern region. 

Almost 16 tonnes of pesticides were applied in farm grain stores in Great 

Britain with Eastern region accounting for 29 percent of the total weight 

applied, South Eastern 25 percent, Midlands and Western 19 percent and 

South Western 14 percent. 

By weight 54 percent of pesticides were applied as fabric treatments, with 

pirimiphos-methyl accounting for 88 percent of all fabric treatments. The 

remaining 46 percent of pesticides were applied to the grain either at or 

during storage. Of all grain treated, 57 percent by weight was treated with 

an admixture, the rest receiving surface treatments. Pirimiphos-methyl 

accounted for 78 percent of the weight of pesticide applied, either as 

admixture treatments or incorporated into the surface of the grain in store. 

Contractors applied 14 percent, by weight applied, of fabric treatments but 

only seven percent of the admixture treatments. Contractors made all 

applications of aluminium phosphide recorded in this survey. 

73 

Since the survey conducted in 1994/95 there had been a two percent increase 

in the tonnage of grain stored, with the weight of active substances applied 

having increased by less than one percent. There has been a decrease in the 

number of active substances applied to grain. Organophosphates continued to 

account for the majority of pesticides used in grain stores and in the current 

survey they accounted for 97 percent of the total weight of pesticides applied. 

Report 180: Commercial grain stores in Great Britain 1998/1999 

This report presented data from 210 replies from a preliminary questionnaire 

sent to 283 potential commercial grain stores and the results from visits to 

143 premises storing grain from the 1998 harvest in Great Britain and using 

pesticides. Data had been extrapolated to give national estimates of usage 

in Great Britain. 

A total of 8.3 million tonnes of grain was stored of which 52 percent was 

in upright stores. The questionnaire showed that 94 percent of all premises 

contacted stored grain and 88 percent used pesticides either as fabric 

treatments or grain treatments. Stores in Scotland and South Eastern region


were more likely to apply fabric treatments, while the application of both 

fabric and grain treatments was more prevalent in the South Western region. 

A single commercial store in Wales was encountered in the sample which 

applied both fabric and grain treatments. 

Approximately 4.7 tonnes of pesticides were applied in commercial grain 

stores in Great Britain with Scotland, accounting for 38 percent of the weight, 

Eastern region 24 percent, Northern region 23 percent, Midlands and Western 

region 11 percent, South Western region three percent, South Eastern region 

one percent and Wales less than one percent. 

By weight, 80 percent of pesticides was applied to the grain either at or 

during storage. Pirimiphos-methyl accounted for 61 percent of the weight 

of pesticide applied, either as admixture treatments or incorporated into the 

surface or the grain in store. Of all grain treated, 92 percent by weight was 

treated with an admixture, the rest receiving surface treatments. 

74 

The remaining 20 percent of pesticides were applied as fabric treatments, 

with pirimiphos-methyl accounting for 53 percent of all fabric treatments and 

methyl bromide a further 37 percent. 

Contractors applied 50 percent, by weight applied, of fabric treatments but 

only eight percent of the admixture treatments. The use of methyl bromide, 

which can be applied only by contractors, accounted for the bulk of 

contractor applications made to the fabric. 

In terms of the number of stores treated, rodenticides were used on 

96 percent of commercial grain stores in Great Britain in 1998. Difenacoum 

was the most commonly occurring rodenticide, being used at 35 percent of 

all commercial grain stores, followed by bromadiolone at 25 percent. 

Excluding holdings where the product used was unknown, these two active 

substances accounted for 68 percent of all recorded occurrences. 

Totals of just under one kilogram of active substance and approximately ten 

tonnes of bait were recorded in the current survey, reflecting the extremely 

low percentage of active substance contained within rodenticide baits. 

Since the survey conducted in 1994/95, the tonnage of grain stored had more 

than doubled, with some of the increase being due to the storage of 

intervention grain, which was minimal in the previous survey period. 

The weight of active substances applied had increased by 40 percent, which 

is significantly less than the increase in the grain stored since 1994/95. There 

had been a continued decrease in the number of active substances applied


to grain. Organophosphates continued to account for the majority of pesticides 

used in grain stores and in the current survey they accounted for 85 percent 

of the total weight of pesticides applied. 

Other Items 

Aquatic risk management options 

In the UK, buffer zones are required for some products to prevent an 

unacceptable risk of damage to aquatic life. A buffer zone is a strip of land 

adjacent to surface water left untreated with that product. The size of the 

buffer zone may be reduced under some circumstances following an 

appropriate Local Environmental Risk Assessment conducted under the 

relevant LERAP scheme. However, at present the maximum size of buffer zone 

that could be required for a product approved for use on arable crops is five 

metres. There are different risk management options used in other European 

Member States resulting in some differences in the range of products available 

to growers across Europe. The ACP considered a number of the approaches 

adopted by other Member States, some of which allow for buffer zones in 

arable crops of greater than five metres. It also considered the results of a 

limited survey giving evidence on compliance with the existing risk 

management strategy in the UK. Overall, members concluded that while 

larger buffer zones in arable crops would be capable of providing risk 

mitigation, they would require better evidence of compliance with the 

current arrangements before considering any increase in the maximum 

size of buffer zones in the arable sector. 

75 

Bioavailability of triazophos for treated apples 

In 1998, PSD/MAFF initiated a research project to investigate the bioavailability 

of the organophosphorus compound triazophos. The primary aim was to 

compare the results in animals administered triazophos in corn oil with those 

receiving a similar dose from pureed apples treated in line with agricultural 

practice. The corn oil exposure was typical of that used in toxicity studies 

used to derive acute reference doses, with the apple exposure representing 

human exposures. If there were differences between the results for the 

vehicles there might be a need to introduce an appropriate correction into risk 

assessments. 

The peak levels and ‘area under the curve’ (AUC) values for total plasma 

radioactivity were broadly similar, whether the triazophos was present as an 

incurred residue in orally dosed apple puree, or present in orally dosed corn 

oil. The <strong>Committee</strong> noted that the results of the research showed similar 

absorption patterns and plasma profiles for both preparations. The <strong>Committee</strong>


agreed that the current default assumption that corn oil administration was an 

acceptable model for dietary exposure was supported. It was suggested that, 

if applicants wished to make a case for reduced bioavailability in respect of 

specific crops and pesticides, the onus should be on them to submit data to 

support such a case. 

The <strong>Committee</strong> recommended that the research be submitted for publication 

in a peer-reviewed scientific journal. 

76 

Comparative risk assessment 

The ACP was asked by Ministers to consider the value of comparative 

assessment and substitution in the regulation of pesticides. At the July meeting 

it was agreed that PSD should issue a consultation letter seeking views from 

approval holders, users, consumers and environmental interests. Following 

this, the ACP began to develop possible schemes for comparative assessment, 

taking account of the responses to the consultation. During 2002, the 

<strong>Committee</strong> will continue to consider these options, together with related issues 

of relevance to the re-negotiation of the Pesticide Authorisation Directive 

(91/414/EEC). 

Degradation of chlorothalonil residues prior to analysis – 

follow-up report 

During Pesticide Residues <strong>Committee</strong> (PRC) routine monitoring in 1994, it was 

noted that fortified residues of chlorothalonil were being ‘lost’. A study was 

initiated to examine the extent and possible mode of the degradation in five 

crops: lettuce, onion, celery, broccoli and lemon. 

The study was considered at the November 1994 ACP meeting. The results 

showed that significant losses were occurring as a result of comminution and 

freezer storage and/or storage of extracts at room temperature prior to 

analysis. These losses were greatest in lettuce, celery and onions and less in 

broccoli and lemons. If lettuce was ‘killed’ by microwaving prior to storage 

and analysis, losses were greatly reduced, indicating that the problem was 

likely to be enzymatic degradation. The ACP had recommended that a further 

study be conducted on the fate of chlorothalonil residues during processing 

and analysis of lettuce and onions. 

The follow-up study was considered at the June 1997 ACP meeting. The 

results showed that losses of chlorothalonil and also dichlofluanid could be 

minimised by cryogenic milling of lettuce samples and extracting the subsamples 

partially frozen. In the case of onions, the use of cryogenic milling


did not prevent the loss of chlorothalonil. Losses, however, were not observed 

in extracts fortified with chlorothalonil, after prior removal of sulphurcontaining 

compounds by the use of an alumina column impregnated with 

silver nitrate. It was therefore tentatively proposed that silver nitrate should 

be added to frozen onion subsamples before extraction. The ACP had 

recommended that a further study be conducted into the use of silver nitrate 

and the use of acetone containing 10N sulphuric acid as used by industry. 

Several other techniques were also examined, one of which was the addition 

of orthophosphoric acid pre-milling. 

The additional study on onions was considered at the January 2001 ACP 

meeting. The results showed that losses of chlorothalonil during the analysis 

of onions could be minimised by the addition of 2.2M orthophosphoric acid 

to the samples before milling. 

The <strong>Committee</strong> recommended that: 

● 

● 

● 

the findings of these studies be passed on to the EU rapporteur 

(Netherlands) for consideration when evaluating the methods of analysis 

used to analyse crop samples for chlorothalonil and commercial/domestic 

processing data; 

the use of orthophosphoric acid in the preparation of subsamples of crops 

should be routinely adopted, when analysing onions (and other allium 

crops) for chlorothalonil; and 

industry should be informed of the findings and recommendations from 

the study. 

77 

How a broader approach to the protection of biodiversity may affect 

ecological risk assessments of plant protection products 

This report highlighted that the <strong>Advisory</strong> <strong>Committee</strong> on Releases to the 

Environment (ACRE) considers the risks to biodiversity from genetically 

modified organisms, which has implications for the ACP. On the basis of this 

report the ACP agreed to review its approach to wider biodiversity issues as a 

matter of some urgency. It considered that the aim should be to take account 

of risks to biodiversity in the regulation of pesticides and that the approach 

taken should be based on sound science. It was also agreed that the policy 

and management issues raised by the report should be discussed with the 

ACRE subgroup. Once a clear way forward was identified it would also be 

necessary for discussions to take place with relevant stakeholders.


Reappraisal of Local Environmental Risk Assessments for Pesticides 

(LERAPs) for horizontal boom sprayers 

LERAPs provide a framework for those using agricultural pesticides to take 

action to protect watercourses appropriate to their own local circumstances 

and practices. The scheme was developed for use in the arable crop sector 

and was introduced in 1999. Following a survey commissioned by PSD in the 

summer of 2000, the scheme was amended in response to feedback and the 

survey results. 

In 2001 the scheme guidance was revised and simplified after consulting with 

industry and other interested parties. In addition, the <strong>Committee</strong> advised that 

further steps be taken to increase awareness of and compliance with the 

scheme among farmers and growers to ensure the scheme delivered its aim 

of environmental protection of watercourses. 

78 

Revised proposals for a scheme of Local Environmental Risk Assessments 

for Pesticides (LERAPs) for broadcast air-assisted sprayers 

LERAPs provide a framework for those using agricultural pesticides to 

take appropriate action to protect watercourses in the light of their own 

circumstances and practices. A proposed parallel scheme had been developed 

for the orchard, hop and soft fruit sector. 

In July 2000 the <strong>Committee</strong> considered revised proposals for this scheme. 

Original proposals put to the <strong>Committee</strong> in 1999 had been revised in the light 

of views received from a public consultation. A second public consultation 

followed in October 2000 and the inclusion of living windbreaks into the 

scheme was confirmed by the ACP in the summer of 2001. Following further 

refinements regarding buffer zones for orchards and hops, a final scheme was 

agreed in time for implementation for the 2002 growing season. 

Mutual recognition of Member State product approvals in support of 

applications for extensions of use (off-label use) of products approved 

under the Plant Protection Products Regulations 1995 (as amended). 

Directive 91/414/EEC introduced a requirement for Member States to mutually 

recognise plant protection product approvals after an active substance has 

been included on Annex I. The paper considered by the ACP proposed that 

under specified conditions, approvals for minor uses in the UK could be given 

on the basis of mutually recognising other Member State approvals, where 

a product has been provisionally approved, in advance of Annex I listing. 

Additionally, for outdoor crops, the provisional approval would have to


have been granted in a northern Member State, to ensure that the supporting 

field data were generated under similar climatic conditions to those prevailing 

in the United Kingdom. The conditions proposed broadly replicated the 

specified conditions of the existing scheme to recognise approvals for minor 

uses of products approved under the Control of Pesticides Regulations. 

The ACP agreed to advise Ministers to accept the proposed mutual recognition 

scheme for extension of use for plant protection products and to agree to its 

publication. 

Operator exposure in applying amenity herbicides by All-Terrain 

Vehicle (ATV) and Controlled Droplet Applicator (CDA) 

There are no published exposure data for amenity application of herbicides 

using spray booms front-mounted on ATVs or a separate lance and CDA. 

To inform risk assessments, HSE had commissioned research to enable the 

assessment of exposure during use of these methods of herbicide application. 

The <strong>Committee</strong> considered a report on the outcome of the research. This 

presented the results for the two types of application, by ATV with frontmounted 

spray bars, and CDA sprayer. The <strong>Committee</strong> noted the findings 

of the research and agreed that the following indicative values should inform 

exposure predictions and risk assessments for these types of application: 

79 

ATV: 

The potential dermal exposure to spray fluid (21 data points) ranged between 

11 and 113 mg fluid per minute, median 32.7 mg/min, based on patch 

samplers. These data also indicated a median penetration of work wear 

at 11 percent. Exposure of hands as collected on cotton gloves (21 data 

points) ranged between 9.18 and 227 mg spray fluid per minute, median 

49.9 mg/min. Exposure by inhalation to spray fluid was found in 85 percent 

of samples, range 6.51 to 36.5 mg/m 3 , median of non-zero values 15.5 mg/m 3 . 

CDA: 

The potential dermal exposure to spray fluid (12 data points) ranged between 

0.05 and 13.8 mg fluid per minute, median 2.21 mg/min, based on patch 

samplers. There were no meaningful data for clothing penetration from this 

study. Exposure of hands as collected on cotton gloves inside protective 

gloves (12 data points) ranged between 0.003 and 0.98 mg spray fluid per 

minute, median 0.06 mg/min, and on socks (12 data points) ranged between 

0.001 and 0.76 mg spray fluid per minute, median 0.02 mg/min. Exposure by


inhalation was low, occurring in just 33 percent of samples, range 0.02 to 0.61 

mg/m 3 , median of non-zero values, 0.12 mg/m 3 . 

Papers to address re-entry time policy for certain wood preservatives 

When a liquid wood preservative product is used indoors by a professional 

operator, there is a specified exclusion period in which unprotected persons 

and animals should be kept away from the treated area. The time at which 

this exclusion finishes is known as the ‘re-entry time’. Previously, there were 

two label phrases regarding re-entry time. These stipulated either a 48-hour 

or an eight-hour re-entry time, depending upon the product. 

80 

A 48-hour re-entry time was required unless data demonstrated that the 

exposure of people re-entering treated areas after eight hours was acceptable. 

The <strong>Committee</strong> considered a review of the existing re-entry time policy, and 

the criteria used to identify appropriate re-entry times and reconsidered 

whether shorter exclusion periods might be acceptable for certain liquid wood 

preservatives. It compared the airborne concentrations over time of the active 

substances, with appropriate NOAELs, and of any solvents in the product 

formulation, with the occupational exposure standards (OES) or equivalent. 

The <strong>Committee</strong> agreed that the exposure of people to both the solvents and 

the active substances was consistently and acceptably low for a range of 

representative products. 

The <strong>Committee</strong> recognised that, historically, many products had contained 

volatile active substances and high concentrations of solvents, and evaporation 

of surface residues had been significant. However, the products used in these 

areas had, over a number of years, been reformulated as water-based products 

containing involatile active substances and low concentrations of solvents. 

As a consequence of this, the <strong>Committee</strong> agreed that there was no clear 

relationship between aerial concentrations of the solvent or active substance 

and surface wetness of treated timber. Therefore, it agreed that exclusion from 

the application area should be considered solely on the basis of the possibility 

of exposure to air concentrations, with a physical barrier to prevent access to 

the treated timber until it was dry. 

The <strong>Committee</strong> considered that it should be possible to allow certain liquid 

wood preservative products a one-hour re-entry time. However, for this, 

the applicant would need to demonstrate convincingly that the aerial 

concentrations of the active substance and solvent, for its individual products, 

were appropriately low within one hour of application at low levels of


ventilation and that the exposure of people re-entering treated premises 

would be acceptable. 

The <strong>Committee</strong> agreed that such products would need the following label: 

EXCLUDE ALL UNPROTECTED PERSONS AND ANIMALS DURING 

TREATMENT AND FOR AT LEAST 1 HOUR AFTER TREATMENT IS 

COMPLETED. 

ENSURE THERE IS A PHYSICAL BARRIER TO PREVENT CONTACT BY 

UNPROTECTED PERSONS AND ANIMALS UNTIL TREATED SURFACES 

ARE VISIBLY DRY. 

ENSURE ADEQUATE VENTILATION BEFORE REOCCUPATION. 

The <strong>Committee</strong> also agreed that HSE should assess the individual applications 

and annually review the reports of the Pesticides Incidents Appraisal Panel for 

any incidents relating to this reduction in re-entry time. 

Pesticide exposure and Parkinson’s disease – review of the literature 

The <strong>Committee</strong> considered a review of the literature covering epidemiological 

investigations of pesticides in relation to Parkinson’s disease, and also an 

evaluation of mechanistic studies that have explored the potential of specific 

pesticides to induce Parkinson’s disease in experimental animals. 

81 

The <strong>Committee</strong> agreed that a more detailed specialist assessment of the 

epidemiology relating to Parkinson’s disease and pesticides should be 

carried out. 

Pesticide Incident Report 2000/2001: report on HSE’s Field Operations 

Directorate’s investigations 1 April 2000–31 March 2001 

The <strong>Committee</strong> noted the content of the report into pesticide complaints 

investigated by the Field Operations Directorate of HSE between 1 April 2000 

and 31 March 2001. 

The Pesticide Incident Report for 2000/2001 was published on 13 November 

2001. The report provided an analysis of incidents and complaints involving 

pesticides investigated by HSE’s Field Operations Directorate and the 

enforcement action taken. Summaries of complaints alleging ill health were 

included, with details of the outcome of assessments by the Pesticides 

Incidents Appraisal Panel (PIAP). In addition, a series of case studies was 

included to encourage the prior notification of pesticide use and the accurate


measurement of wind speed. One case illustrated the continuing issue of 

‘parallel imports’ where non-approved products had been imported into the UK. 

During 2000–2001, 170 incidents had been investigated and this represented 

a 33 percent fall compared with the previous year. There was, however, no 

discernible long-term trend. Seventy-one allegations of ill health had been 

made and these ranged from reports of general ill health to specific symptoms 

presented to GPs. There had been a 14 percent reduction in allegations of ill 

health compared with the previous year and this was the lowest number of 

reports for ten years. Decisions in a number of cases were pending and many 

of these resulted from the previous year’s investigation of incidents on the Isle 

of Wight. The <strong>Committee</strong> noted that the Chair of PIAP wrote to individual 

complainants to explain the panel’s decision in relation to their cases. 

82 

The frequency of incidents not associated with alleged ill health had also 

fallen in the last year. There had been no significant change in the incidence 

of complaints classified according to sector of use, work activity or method 

of application. As in previous years, most complaints were associated with 

agricultural use and the majority of these with the use of conventional crop 

boom sprayers. The <strong>Committee</strong> noted an increasing number of complaints 

related to the use of knapsacks, particularly from users concerned about 

leakage during use. 

Over the last year, there had been 12 prosecutions in connection with 

pesticides, most of these cases being heard in magistrates’ courts. Average 

fines were in the order of £1000. Ninety-eight enforcement notices had been 

issued, representing a reduction of approximately one-third compared with 

the previous year. The effect of the foot and mouth disease outbreak was 

considered to be marginal since it had affected only the last five weeks of 

the reporting year. 

As in previous years, the <strong>Committee</strong> commented on the usefulness of the 

report and asked that HSE endeavour to include information on the type 

of boom sprayers involved in incidents, since a variety were available. 

Proposed representations procedure 

At present there is no mechanism in the pesticide approval system allowing 

companies to make formal representation with respect to recommendations 

to Ministers made by the regulatory authorities directly or via the ACP. In 

September 2001, the <strong>Committee</strong> was invited to consider the content of a 

proposed consultation paper outlining proposals for a non-statutory 

mechanism for representations. This would apply to new active substances


and reviews of existing active substances assessed by the <strong>Committee</strong> and to 

applications for product approvals that have been assessed by PSD or HSE. 

The <strong>Committee</strong> agreed that PSD should carry out a public consultation, and 

that members would provide their comments as part of that consultation. 

Review of CMO advice to peel fruit 

At the request of the Food Standards Agency the ACP commenced a review 

of advice issued in 1997 by the Chief Medical Officer (CMO). This review was 

still ongoing at the end of 2001 and a fuller description will be included in a 

future annual report once the ACP has reached a conclusion. 

The Precautionary Principle 

Members of the <strong>Committee</strong> considered that the precautionary principle would 

be an item ideally suited to discussion at the open meeting in 2001. They 

concluded that they would request papers from a broad range of organisations 

to inform the discussion. PSD prepared a document on pesticides regulation 

and the precautionary principle, setting out the background to the principle 

and its position in international law. The Crop Protection Association, Friends 

of the Earth and Pesticides Action Network agreed to present papers outlining 

their views. These papers, together with one from the chairman of the ACP 

were discussed at the open meeting and have been made available on the 

ACP website, together with a record of the discussion. 

83


Section G: 

Fees 

Members of the ACP are not salaried staff but they do receive a fee for their 

attendance at ACP meetings. Members are not paid if they do not attend 

meetings. 

Chairman’s fees 

Until April 01 

Attendance fee £148 

Preparation fee £37 

After April 01 



84 

Deputy Chairman’s fees and members’ fees 

Until April 01 



After April 01 



Members also receive reimbursement of reasonable actual travel and 

subsistence when attending meetings.

Appendix I 

Appendix I: 

Terms of reference 

Under Section 16(7) of the Food and Environment Protection Act 1985, 

Ministers have established the <strong>Advisory</strong> <strong>Committee</strong> on Pesticides* to give them 

advice, either when requested to do so or otherwise, on any matters relating 

to the control of pests in furthering the general purposes of Part III of the Act. 

The general purposes of Part III of the Food and Environment Protection Act 

are that the provisions of that part of the Act shall have effect: 

(i) 

With a view to the continuous development of means 

(ii) 

(a) to protect the health of human beings, creatures and plants; 

(b) to safeguard the environment; and 

(c) to secure safe, efficient and humane methods of controlling 

pests; and 

with a view to making information about pesticides available to 

the public. 

85 

Under Section 16(9) Ministers are required to consult the <strong>Advisory</strong> <strong>Committee</strong>: 

(i) 

(ii) 

as to regulations which they contemplate making; 

as to approvals of pesticides which they contemplate giving, 

revoking or suspending; and 

(iii) as to conditions to which they contemplate making approvals 

subject. 

* Under the Control of Pesticides (<strong>Advisory</strong> <strong>Committee</strong>) Order (Northern Ireland) 1987, the 

<strong>Committee</strong> was established as the <strong>Committee</strong> on Pesticides for Northern Ireland


Appendix II: 

Membership of the <strong>Advisory</strong> <strong>Committee</strong> 

on Pesticides up to 31 December 2001 

Chairman 

Professor David Coggon MA, PhD, DM, FRCP, FFOM, FMedSci, Professor of 

Occupational and Environmental Medicine at the Medical Research Council 

Environmental Epidemiology Unit, University of Southampton. 

Deputy Chairman 

Professor Alan Boobis BSc, PhD, FIBiol, Professor of Biochemical 

Pharmacology at the Royal Postgraduate Medical School, University of London. 

86 

Members 

Dr Nicholas Bateman BSc MD FRCP FRCP (E), Reader in Clinical 

Pharmacology, Consultant Physician & Director, Scottish Poisons Information 

Bureau, Royal Infirmary Edinburgh. 

Mrs Elaine Brown BSc (lay member) formerly teacher of biology at 

St Margaret’s School, Midhurst, Sussex. 

Professor Peter Calow OBE BSc, PhD, DSc, FIBiol, FLS, FRSA, Professor of 

Zoology at the University of Sheffield. 

Dr I Grieve BSc, PhD, Soil Physics Senior Lecturer & Head of Department – 

University of Stirling. 

Professor Gareth Edward Jones BSc, PhD, Professor of Agricultural Economics 

– University of Wales. 

Professor Graham Matthews BSc, ARCS, PhD DSc, FIBiol, Professor of Pest 

Management – Imperial College of Science & Technology, Berkshire. 

Dr Patricia R McElhatton MSc, PhD, Cbiol, MIBiol, National Teratology 

Information Service, Newcastle Upon Tyne. 

Mr Jim Orson BSc Director, Morley Research Centre.

Appendix II 

Mrs Sylvia Owen BSc (lay member) formerly Principal of Polam Hall Day and 

Boarding Independent School. Consumer interests include Vice Chair of the 

Science and Technology <strong>Committee</strong> of the National Council of Women (NCW). 

Professor Michael Roberts BSc, Phd, FIBiol, Director, Centre for Ecology and 

Hydrology – Natural Environment Research Council (Resigned on appointment 

to CSL) 

Professor Robert H Smith BA(Hons), MSc, PhD, Professor of Agricultural 

Biology, University of Leicester. 

Dr Colin Soutar MD, FRCPE, FFOM, Chief Executive of the Institute of 

Occupational Medicine, Edinburgh. (Retired 31 Dec 2001) 

Mr Christopher Stopes BSc, MSC, Organic Farming – Eco-Stopes Consultancy, 

Newbury. 

Departmental assessors 

Departmental assessors are officials who receive and endorse the 

advice/recommendations supplied by the ACP members to Ministers on behalf 

of their department. 

87 

Dr S Smith 

Dr C J Griffiths 

Mr H Jones 

Mr P Lees 

Dr S Popple 

Dr J Norman 

Dr David Atkins 

Health and Safety Executive (HSE) 

Scottish Agriculture Science Agency (SO) 

National Assembly for Wales Agriculture 

Department.(Replaced Ms L Griffiths) 

Department of Health (DH) 

Pesticides Safety Directorate (DEFRA) 

(Replaced Mr John Bainton) (DEFRA) 

Food Standards Agency (FSA) 

Food Standards Agency (FSA)


Departmental advisers 

Departmental advisers are officials with specialist expertise who are able to 

advise the ACP. 

88 

Dr R H Bromilow Institute of Arable Crops Research 

Dr J Garrod DEFRA 

Dr K Wilson Pesticides Safety Directorate (DEFRA) 

(Replaced Mr G K Bruce) 

Mr R Davis Pesticides Safety Directorate (DEFRA) 

Dr A Burn English Nature 

Dr S Dobson Natural Environmental Research Council 

Dr T C Marrs Food Standards Agency (FSA) 

Mr J Battershill Department of Health 

Prof J Marks Department for Agriculture & Rural Development – Belfast 

(Replaced Mr L McKibben and Mr B Murphy) 

Prof M Roberts Central Science Laboratory (DEFRA) 

(Replaced Prof P Stanley) 

Dr M Thomas Central Science Laboratory (DEFRA) 

Dr A Croxford Environment Agency 

Ms A Brazier Health and Safety Executive 

(Replaced Dr R Turner) 

Dr S Smith Health and Safety Executive 

Mr I Anderson Scottish Executive Environment and Rural Affairs Department 

Dr A Riley Scottish Office Department of Health 

Ms J McNeill Department of Trade and Industry 

Dr M Wakelin Medical Research Council

Appendix III 

Appendix III: 

Independent members’ annual 

declaration of interests in the 

pesticides industry 2001 

Name of Nature of Name of Current/former 

member interest companies interest 

Chairman 

Professor D Coggon None – – 

Deputy Chairman 

Professor A Boobis None – – 

Members 

Dr N Bateman Funding to Department via Astra Zeneca Current 

commercial contract for 

24-hour telephone support 

for clinical trials. 

Mrs E Brown None – – 

Professor P Calow None – – 

Dr I Grieve None – – 

Professor G E Jones None – – 

Prof G Matthews Consultant to companies Aventis Current 

manufacturing equipment 

but not agrochemical 

companies. 

Dr P R McElhatton None – – 

Mr Orson Morley Research Centre Syngenta, Monsanto, Current and former 

undertakes trials for HGCA and DEFRA interests 

agrochemical companies. 

These companies contract 

work to the centre and also 

act as sponsors. As Director, 

Mr Orson does not 

participate in day-to-day 

management of trials 

contracted by companies 

but does sign contracts and 

read reports. Also involved 

in LINK project. 

Mrs S Owen None – – 

Professor R Smith Research support for PhD English Nature and Current 

student and Chairman of Rodenticide 

RRAG. 

Resistance Action 

Group 

Dr C Soutar None – – 

Professor M Roberts None 

Mr C Stopes Consultancy Co-op Group Current 

89


Appendix IV: 

Inter-Departmental Secretariat 

Terms of 

reference 

The Inter-Departmental Secretariat (IDS) considers data submitted as part of 

the EC review programme and applications for Annex 1 listing under EC 

Directive 91/414. In these cases, the IDS proposes a course of action to the 

ACP which contributes the definitive scientific input to the UK negotiating 

position. The IDS also considers applications and reviews under COPR before 

they are referred to the ACP. 

Membership 

(as at 

31 December 

2001) 

Chairman 

Mr R Davis 

Deputy Chair 

Ms A Brazier 



90 

Members 

Mr N Bradshaw 

Mr H Jones 

Mr D Green 

Mrs I O’Neill 

Mr G Walker 

Dr S Smith 


ADAS Consulting Limited (representing National 

Assembly of Wales Agriculture Department) 

ADAS National Assembly of Wales 

ADAS Consulting Limited 




Scottish Agricultural Science Agency 

(representing Scottish Executive Environment and Rural 

Affairs Department) 

Dr J Garrod DEFRA. Replaced Dr Abel December 2001. 

Dr P Mercer 

Department of Agriculture and Rural Development 

Northern Ireland 

Dr A Saleem Department of Health (Replaced Dr Phillips August 2001) 

Dr D Dillon 

Mr P Lees 

Mr J Battershill 

Department of Health 


Department of Health

Appendix IV 

Dr J Norman 

Dr D Atkins 

Mr B Groves 

Dr J Ince 

Dr E Heller 

Dr Sue Popple 

Dr M Thomas 

Dr E Pemberton 

Food Standards Agency 






(Replaced Dr Martin March 2001) 

CSL (non-attending consultant) 

Environment Agency (consultant) 

(Replaced Mrs J Whiteman December 2001) 

Dr A Burn English Nature (consultant) Joined December 2001. 

Technical Secretariat 

Dr L Harrison 

Mrs J Wilder 


(Replaces Dr O’Hara from August 2001 until early 2002) 


91 

<strong>Advisory</strong> <strong>Committee</strong> Secretariat 

Mrs J Wilder Pesticides Safety Directorate (DEFRA)


Environmental 

Panel 

The Environmental Panel is responsible for providing advice to the <strong>Advisory</strong> 

<strong>Committee</strong> on Pesticides on issues related to the environmental fate and 

behaviour and ecotoxicological effects of pesticides. As the remit, structure 

and membership of the Panel was last reviewed in 1996, it was thought 

timely, with the appointment of a new chairman, Professor Peter Calow, to 

review the Environmental Panel. As a result of the review it was agreed that 

the remit should remain unchanged, but that there should be a closer working 

relationship between the Environmental Panel and the ACP. Therefore, the 

environmental members of the ACP have been invited to join the 

Environmental Panel. The structure was left unchanged. However, new 

appointments were made to ensure that the Panel had sufficient expertise in 

all environmental areas. It was considered desirable to have representation 

from both industry and environmental pressure groups. It was agreed that 

these would be invited to participate in meetings as appropriate. 

92 

Terms of 

reference 

To advise the IDS and the ACP on the environmental fate and behaviour of 

pesticides, effects on non-target organisms (other than man) from the use of 

pesticides and also on related problems put to it by the ACP or departments. 

To draw the attention of the IDS and ACP, or the regulatory departments as 

appropriate, to any matter concerning environmental impact of pesticides 

which, in the opinion of the Panel requires further investigation. 

Membership 

(as at 

31 December 


Chairman 

Prof Peter Calow 

Member’s name 

Mrs Elaine Brown 

Organisation 

University of Sheffield 


Lay member 

Prof Gareth Edwards-Jones University of Wales, Bangor 

Mr Christopher Stopes 

Dr Ian Grieve 

Prof Robert Smith 

Dr Alastair Burn 

Dr Andy Croxford 

Prof Tony Hardy 

Dr Peter Matthiessen 

Eco-Stopes Consultancy 

University of Stirling 

University of Leicester 

English Nature 

Environment Agency 

Central Science Laboratory 

Centre for Ecology and Hydrology, Cumbria

Appendix IV 

Dr Nick Sotherton 

Dr Tom Sherratt 

Dr Richard Shore 

Prof Allan Walker 

Dr Mark Crane 

Game Conservancy Trust 

University of Durham 

Centre for Ecology and Hydrology, Huntingdon 

Horticultural Research Institute 

Crane Consultants 

Observers 

Mr Mark Clook 

Mr John Garrod 

Mr David Williams 

Dr Ken Hunter 

Dr Andrew Craven 

Mr John Chadwick 

Mr Graeme Walker 


Pesticides Safety Directorate 

DEFRA 






Technical Secretary 

Dr Jo O’Leary Quinn 



93 

Main issues considered during the year 

● Use of European FOCUS groundwater scenarios. 

● 

● 

● 

● 

● 

● 

● 

● 

● 

Exposure of birds to treated seed. 

Issues relating to Local Environmental Risk Assessments for Pesticides 

(LERAPs). 

Partial review of second-generation anticoagulant rodenticides. 

Issues relating to the protection of biodiversity. 

HSE review of copper chrome arsenic. 

The use and disposal of growing media. 

Discussions on probabilistic risk assessment. 

Aquatic higher-tier laboratory testing. 

Implications of the Countryside and Rights of Way Act 2000 for pesticide 

regulation.


Pesticides 

Residues 

<strong>Committee</strong> 

The WPPR was replaced at the end of 2000 by the new Pesticides Residues 

<strong>Committee</strong>. This new committee advises the Chief Executive of PSD and the 

Food Standards Agency (FSA) on the formulation of the residues surveillance 

programmes and the results arising from them. It is independent from the 

ACP and is responsible for preparing its own annual report which is presented 

to Ministers. 

The website address is www.pesticides.gov.uk/committees/prc 

Medical and 

Toxicological 

Panel 

Terms of 

reference 

To advise the IDS and ACP on medical problems put to it and to draw the 

attention of the IDS and ACP to any matter concerning the impact of 

pesticides on human health, including exposure of operators which, in the 

opinion of the Panel, needs further investigation. 

94 

To advise the IDS on the development and application of toxicological test 

methods. 

Membership 

(as at 

31 December 


Chairman 

Professor A Boobis 

Members 

Dr S Barlow 

Dr N Bateman 

Mr J Battershill 

University of London 

Independent consultant 

Scottish Poisons Information Bureau 


Professor G Cohen University of Leicester (to May 2001) 

Professor D N M Coggon 

University of Southampton (ACP Chairman) 

Mr A Garrod Health and Safety Executive (left June 2001) 

Dr T C Marrs 

Dr P McElhatton 

Professor J Parry 


National Teratology Information Service 

University of Wales, Swansea 

Dr A Phillips Health and Safety Executive (to May 2001) 

Dr A Proudfoot Scottish Poisons Information Bureau (to May 2001) 

Dr D E Ray 

Medical Research Council

Appendix IV 

Dr K S Richards Independent lay member (to December 2001) 

Dr A Saleem Health and Safety Executive (started June 2001) 

Dr D Swanston 

Independent consultant 

Professor GT Williams University of Wales, Cardiff (To November 2001) 

Representative organisations 

Mr R Billington 

Crop Protection Association 

Dr C R Coggins 

Dr A Hay 

Dr R Hartley 

Ms J Hewitt 

Mr J A James 

Dr M Wilks 

Secretariat 

Dr I Dewhurst 

Dr K Murphy 

British Wood Preservation and Damp-Proofing 

Association (to May 2001) 

Trades Union Congress 

National Association of Agricultural Contractors 

(to May 2001) 

National Association of Agricultural Contractors 

(from Nov 2001) 

British Pest Control Association 




95 

The Panel met three times during 2001. 


● Significance of liver enlargement. 

● 

● 

● 

● 

● 

● 

● 

● 

● 

● 

Use of reproductive end points in acute risk assessment. 

Strategy for mutagenicity testing. 

Pesticide-related ill-health monitoring. 

Secondary exposure and Parkinson’s disease. 

Consumer exposures to non-agricultural pesticides. 

Analysis and evaluation of repeat-dose toxicity studies. 

IGHCR guidance on uncertainty factors. 

Epidemiology studies on pesticides – literature review. 

Use of amortisation in operator exposure assessments. 

Determination of dermal absorption values.


Working Party 

on Pesticide 

Usage Surveys 

Membership 

(as at 

31 December 


Chairman 

Ms H Kyle Pesticides Safety Directorate (DEFRA) 1 

Members 

Mr M Hadler British Pest Control Association 

96 

Dr P Gladders 


Dr A D M Hart 

Mr S Jess 

Mr M J Lole 

Dr P K Marsden 

Ms G Smith 

Mr N Simpson 

Dr M R Thomas 

Mrs T Clark 

ADAS 


Central Science Laboratory (DEFRA) 

Department of Agriculture and Rural Development 

Northern Ireland 

ADAS 

Department for Transport, Local Government and the 

Regions (DTLR) 


ADAS 

Central Science Laboratory (DEFRA) 


Technical Secretary 

Mr Martin Roberts 



● 

Comments and inputs to the draft versions of a number of pesticide usage 

survey reports. 

1 from August, previous chairman Ms P Chapman

Appendix V 

Appendix V: 

Published evaluations 

(as at 31 December 2001) 

1. Flocoumafen £3.00 

2. Quizalofop-ethyl £3.50 

3. Cyfluthrin £4.00 

4. Ethoprophos £5.50 

5. Benfuracarb £4.00 

6. RH 3866 £4.00 

7. DPX M6316 £3.50 

8. Azaconazole £3.00 

9. Oxine copper £3.50 

10. Fluazifop-P-butyl £5.50 

11. Flusilazole £10.50 

97 

12. Bifenthrin £3.50 

13. IPBC £4.50 

14. Daminozide £5.00 

15. Tributyltin naphthenate (1) £3.00 

16. Ethylene bisdithiocarbamates (1) £10.00 

17. Fenoxaprop-P-ethyl £8.00 

18. Fenoxaprop-ethyl £10.50 

19. HOE 070542 Triazole Coformulant £7.50 

20. PP321 (Lambda cyhalothrin) £5.00 

21. Cyhalothrin £4.00 

22. Alachlor (1) £8.50 

23. Fenpropathrin £9.50 

24. Tributyltin oxide (1) £7.00 

25. Fentin hydroxide £4.00 

26. Fenbutatin oxide £3.00 

27. Fentin acetate £3.00


28. Iprodione £4.00 

29. 2-Aminobutane £4.00 

30. Dimethoate (1) £3.50 

31. Cycloxydim £12.50 

32. Dinocap £9.00 

33. Glufosinate-ammonium £21.50 

34. Vinclozolin £12.00 

35. Diazinon (1) £25.00 

36. Ethylene bisdithiocarbamates (2) £25.00 

37. Chlorsulfuron £4.50 

38. Metsulfuron-methyl £7.50 

39. Thifensulfuron-methyl £5.00 

40. Teflubenzuron £1.50 

41. Alachlor (2) £7.00 

98 

42. Tefluthrin £13.00 

43. Diazinon (2) £3.00 

44. Hydroprene (1) £5.50 

45. SAN 619F (Cyproconazole) £25.00 

46. Diclofop-methyl (1) £25.00 

47. Gamma-HCH (Lindane 1) £4.00 

48. Triasulfuron £25.00 

49. Thiodicarb £25.00 

50. Fluoroglycofen-ethyl £25.00 

51. Atrazine (1) £9.50 

52. Simazine (1) £9.50 

53. Guazatine £9.50 

54. Thiabendazole £10.00 

55. Esfenvalerate £25.00 

56. Thiophanate-methyl £11.00 

57. Benomyl £14.00 

58. Carbendazim £18.00 

59. Grain Protectants – Review of use in the UK £5.00

Appendix V 

60. Abamectin £13.50 

61. Tribenuron-methyl £15.00 

62. Propamocarb hydrochloride £21.00 

63. Methyl bromide £12.00 

64. Gamma-HCH (Lindane 2) £18.50 

65. Tebuconazole (1) £25.00 

66. Imazaquin £17.00 

67. Fenpropidin £17.00 

68. 2,4-D £25.00 

69. Tolclofos-methyl £16.00 

70. Tralkoxydim £25.00 

71. Atrazine (2) £20.00 

72. Simazine (2) £18.50 

73. Imidacloprid £23.00 

74. Tributyltin oxide (2) £4.50 

75. Desmedipham £17.50 

99 

76. Oxydemeton-methyl £11.00 

77. Demeton-S-methyl £4.00 

78. Fenpiclonil £18.50 

79. Dimefuron £11.50 

80. Propiconazole £8.00 

81. Buprofezin £19.00 

82. 2-Phenylphenol £8.00 

83. Omethoate £13.50 

84. Triazophos £24.00 

85. S-Methoprene £5.50 

86. Dimethoate (2) £21.50 

87. Chlorpropham £5.50 

88. Tebuconazole (2) £7.00 

89. Cyromazine (1) £11.00 

90. Kathon 886 £9.00 

91. Amidosulfuron £21.00


92. Bitertanol £11.50 

93. Anilazine £19.50 

94. Propaquizfop £23.00 

95. Mecoprop £17.00 

96. Mecoprop-P £17.00 

97. Triazoxide £15.00 

98. Phorate £14.00 

99. Dimethomorph £12.50 

100. Fluazinam £17.00 

101. Bti (1) £3.50 

102. Hydramethylnon £6.50 

103. Commodity substances £6.00 

104. Lambda-cyhalothrin £3.00 

105. Bti (2) £4.00 

100 

106. Difenoconazole £14.00 

107. Chlorfenvinphos £25.00 

108. Epoxiconazole £25.00 

109. Aldicarb £9.50 

110. Tributyltin naphthenate (2) £4.50 

111. Triorganotin compounds £16.50 

112. Chlorothalonil £22.50 

113. Vinclozolin £12.50 

114. Pentachlorophenol £17.50 

115. 3-Iodo-2-propynyl-N-butylcarbamate £8.50 

116. Cyromazine (2) £6.00 

117. Diclofop-methyl (2) £4.50 

118. Fomesafen £15.00 

119. Metsulfuron-methyl and Thifensulfuron-methyl – Review of 

Environmental Persistence £5.50 

120. Dichlorvos £17.50 

121. Clodinafop-propargyl and Cloquintocet-mexyl £25.00 

122. Tebufenpyrad £25.00

Appendix V 

123. Ioxynil – Review of the Agricultural and Horticultural Uses £11.00 

124. Bromoxynil – Review of the Agricultural and Horticultural Uses £10.00 

125. Carbetamide £5.50 

126. Fludioxonil £20.00 

127. Tecnazene £20.00 

128. Fenbuconazole £25.00 

129. Amorphous silicon dioxide £5.50 

130. Fenpyroximate £22.00 

131. Prallethrin £6.50 

132. Linuron £18.00 

133. Monolinuron £9.00 

134. Pirimicarb £24.00 

135. Malathion £19.50 

136. Tolylfluanid £19.50 

137. Diflufenican £9.50 

138. Pyrimethanil £18.00 

101 

139. Triflusulfuron-methyl £25.00 

140. Isoproturon £23.00 

141. Trinexapac-ethyl £18.00 

142. Paclobutrazol £11.00 

143. Flufenoxuron £11.00 

144. Sodium cyanide £11.00 

145. Hydroprene (2) £7.00 

146. Rimsulfuron £25.00 

147. Pyriproxyfen £11.50 

148. Metosulam £22.00 

149. Imazethapyr £10.00 

150. Fenazaquin £25.00 

151. Lindane (3) £25.00 

152. Difenoconazole – ecotoxicity £3.50 

153. Metaldehyde £19.50 

154. Propyzamide £ 3.50


155. Carbaryl – MAFF approved uses £11.50 

156. Carbaryl – review of its use in public hygiene and 

amateur insecticides £ 5.50 

157. Dicofol £13.50 

158. Flutriafol £11.50 

159. Benzyl benzoate £ 6.00 

160. Bromuconazole £25.00 

161. Fenoxycarb £25.00 

162. Tau-fluvalinate £25.00 

163. Kresoxim-methyl £25.00 

164. Lindane – reproductive toxicity effects in dogs £6.50 

165. Transfluthrin £10.00 

166. S-methoprene (2) £8.00 

167. Pirimiphos-methyl £22.00 

102 

168. Strychnine hydrochloride £6.00 

169. Cyprodinil £25.00 

170. MBC fungicides – benomyl and carbendazim £6.00 

171. Assessment of humaneness of vertebrate control agents £6.00 

172. Triazamate £25.00 

173. Phlebiopsis gigantea £8.50 

174. Sulphuric acid £4.00 

175. Review of dinocap £13.00 

176. Kathon 886 (2) £6.00 

177. Quinmerac £25.00 

178. Tolclofos-methyl in the product ’Rizolex’ £8.50 

179. Review of methiocarb £25.00 

180. Flufenoxuron (2) – use as a wood preservative £14.50 

181. MBC fungicide – thiophanate methyl £4.50 

182. Triorganotin compounds (2) £8.50 

183. Copper compounds £18.00 

184. Fluquinconazole £25.00 

185. Tetraconazole £52.00

Appendix VI 

186. AEF107892 £24.50 

187. Fipronil: use as a public hygiene insecticide £16.00 

188. Transfluthrin (2): use with cyfluthrin in a public hygiene 

insecticide £7.50 

189. Epoxiconazole (2) £5.50 

190. Review of tridemorph £8.00 

191. The review of lindane £13.50 

192. UK review of sodium cyanide £6.50 

193. Metconazole £25.00 

194. Diclofop-methyl £5.00 

195. Cyfluthrin: use in wood preservation £8.00 

196. Flurtamone £23.00 

197. Lindane 5 (gamma HCH) (non-agricultural uses) £6.00 

198. Nicosulfuron £25.00 

199. Triticonazole £25.00 

200. Copper chrome arsenic (review of its uses as an industrial 

wood preservative) £25.00 

103 

201. Diuron (dichlorophenyl dimethylurea): use as a booster 

biocide in antifouling products £19.00 

Prices include postage and packing and are correct at time of publication. 

Copies of the published evaluation documents are available by application 

in writing to the Finance and Corporate Services Unit, Pesticides Safety 

Directorate, Room 313, Mallard House, Kings Pool, 3 Peasholme Green, 

York YO1 7PX.


Appendix VI: 

Terms and abbreviations 

104 

ACP 

Adenoma 

ADI 

Aneugenic 

Aneuploidy 

AOEL 

BCF 

bw 

d 

CAP 

Carcinogens 

<strong>Advisory</strong> <strong>Committee</strong> on Pesticides 

a benign tumour with a gland-like structure or developed from 

the glandular epithelium 

acceptable daily intake, defined as ’an estimate of the amount 

of a substance, expressed on a bodyweight basis, that can be 

ingested daily over a lifetime without appreciable health risk’ 

inducing aneuploidy (q.v.) 

the circumstances in which the total number of chromosomes 

within a cell is not an exact multiple of the normal haploid 

(see polyploidy) number. Chromosomes may be lost or gained 

during cell division 

acceptable operator exposure level 

bioconcentration factor 

bodyweight 

day 

Common Agricultural Policy 

the causal agents which induce tumours. They include external 

factors (chemicals, physical agents, viruses) and internal factors 

such as hormones. Chemical carcinogens are structurally diverse 

and include naturally occurring substances as well as synthetic 

compounds. An important distinction can be drawn between 

genotoxic (q.v.) carcinogens, which have been shown to react 

directly with and mutate DNA, and non-genotoxic carcinogens, 

which act through other mechanisms. The activity of genotoxic 

carcinogens can often be predicted from their chemical 

structure. Most chemical carcinogens exert their effects after 

prolonged exposure, show a dose-response relationship and 

tend to act on a limited range of susceptible target tissues. 

Carcinogens are sometimes species- or sex-specific. Several 

different chemical and other carcinogens may interact and

Appendix VI 

constitutional factors (genetic susceptibility, hormonal status) 

may also contribute to effects 

Carcinoma 

Clastogen 

malignant tumour arising from epithelial cells lining, for 

example, the alimentary, respiratory and urogenital tracts and 

from epidermis, also from solid viscera such as the liver, 

pancreas, kidneys and some endocrine glands 

an agent that produces chromosome breaks and other structural 

aberrations such as translocations (q.v.). Clastogens may be 

viruses or physical agents as well as chemicals. Clastogenic 

events play an important part in the development of some 

tumours 

COPR Control of Pesticides Regulations 1986 

DETR 

DNA 

DT 50 

EC 

ECCO 

EMDI 

FAO 

Department of the Environment, Transport and the Regions 

deoxyribonucleic acid. The carrier of genetic information for 

most organisms 

time taken to degrade by 50 percent 

European Community 

EC Co-ordination (EU expert peer review groups) 

estimated maximum daily intake 

Food and Agriculture Organisation 

105 

FEPA Food and Environment Protection Act 1985 

GAP 

GATT 

GIFAP 

GLP 

ha 

Half life 

good agricultural practice 

General Agreement on Tariffs and Trade 

Groupement International des Associations Nationales de 

Fabricants de Produits Agrochimiques (the European trade 

association for the agrochemical industry) 

Good Laboratory Practice 

hectare 

time interval required for half of a quantity of material to be 

eliminated naturally


Heinz bodies roughly spherical inclusion bodies in red blood cells resulting 

from precipitation of haemoglobin 

106 

HSE 

IDS 

IPM 

In vitro 

In vivo 

JMPR 

Koc 

LOAEL 

LC 50 

LD 50 

MAC 

MAFF 


Inter-Departmental Secretariat, a sub-committee of the ACP 

integrated pest management 

term used to describe effects in biological material outside 

the living animal 

term used to describe effects in living animals 

Joint FAO/WHO meeting on pesticide residues 

organic carbon adsorption coefficient 

lowest observable adverse effect level. The lowest administered 

dose at which an effect has been observed 

the theoretical lethal concentration for 50 percent of a group 

of animals 

the theoretical lethal dose for 50 percent of a group of animals 

maximum allowable concentration 

Ministry of Agriculture, Fisheries and Food (UK) 

µg microgram 

MRL 

n 

NAEL 

NEL 

NOAEL 

NOAEC 

NOEC 

NOEL 

OECD 

OPIDN 

Maximum Residue Limit 

normal (defining isomeric configuration) 

no adverse effect level 

no effect level 

no observed adverse effect level 

no observed adverse effect concentration 

no observed effect concentration 

no observed effect level 

Organisation for Economic Co-operation and Development 

organophosphate-induced delayed neuropathy

Appendix VI 

OPIDPN 

PA 

PEC 

PHI 

POEM 

Pow 

PPE 

ppm 

PRS 

PSD 

RPE 

RSPB 

safener 

SCPH 

TER 

Teratogen 

TMDI 

Tropospheric 

UDS 

w/w 

WHO 

organophosphate-induced delayed polyneuropathy 

provisional approval 

predicted environmental concentration 

pre-harvest interval 

predictive operator exposure model 

partition coefficient (n-octanol/water) 

personal protective equipment 

parts per million 

Pesticide Registration Section in the Health and Safety 

Directorate (UK) 

Pesticides Safety Directorate (UK) 

respiratory protective equipment 

Royal Society for the Protection of Birds 

a substance which reduces or eliminates the phytotoxic effects 

of a plant protection product on certain plant species 

Standing <strong>Committee</strong> on Plant Health 

toxicity exposure ratio 

a substance which causes congenital abnormalities (deformities) 

in the baby or offspring in the womb 

theoretical maximum daily intake 

pertaining to the lower part of the atmosphere extending from 

the surface up to a height varying from about 9 km at the poles 

to 17 km at the equator, in which the temperature decreases 

fairly regularly with height 

unscheduled DNA synthesis. DNA synthesis that occurs at some 

stage in the cell cycle other than in the S period (the normal or 

’scheduled’ DNA synthesis period) in response to DNA damage. 

It is usually associated with DNA repair 

weight per weight 

World Health Organisation 

107


WIIS 

WPPR 

wt 

Wildlife Incident Investigation Scheme (UK) 

Working Party on Pesticide Residues (UK) (superseded by the 

Pesticide Residues <strong>Committee</strong>) 

weight 

108

DEFRA Publications, Admail 6000, London SW1A 2XX. Tel: 08459 556000 

© Crown copyright 2002. PB 6871 

July 2002 

http://www.defra.gov.uk

Advisory Committee on Pesticides Annual Report 2001

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