Advisory Committee on Pesticides Annual Report 2001
ACP Annual Report 2001 - Pesticides Safety Directorate
ACP Annual Report 2001 - Pesticides Safety Directorate
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Department for Envir<strong>on</strong>ment, Food and Rural Affairs<br />
Health and Safety Executive<br />
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g><br />
<strong>on</strong> <strong>Pesticides</strong><br />
<strong>Annual</strong> <strong>Report</strong><br />
<strong>2001</strong>
Department for Envir<strong>on</strong>ment, Food and Rural Affairs<br />
Health and Safety Executive<br />
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g><br />
<strong>on</strong> <strong>Pesticides</strong><br />
<strong>Annual</strong> <strong>Report</strong><br />
<strong>2001</strong>
Department for Envir<strong>on</strong>ment, Food and Rural Affairs<br />
Nobel House<br />
17 Smith Square<br />
L<strong>on</strong>d<strong>on</strong> SW1P 3JR<br />
Teleph<strong>on</strong>e 020 7238 6000<br />
Website: www.defra.gov.uk<br />
© Crown copyright 2002<br />
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This publicati<strong>on</strong> (excluding the logo) may be reproduced free of charge in any format<br />
or medium provided that it is reproduced accurately and not used in a misleading<br />
c<strong>on</strong>text. The material must be acknowledged as Crown copyright with the title and<br />
source of the publicati<strong>on</strong> specified.<br />
Further copies of this publicati<strong>on</strong> are available from:<br />
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SW1A 2XX<br />
Tel: 08459 556000<br />
This document is also available <strong>on</strong> the <strong>Pesticides</strong> Safety Directorate website.<br />
www.pesticides.gov.uk/committee/acp<br />
Published by the Department for Envir<strong>on</strong>ment, Food and Rural Affairs. Printed in the<br />
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Foreword<br />
Foreword<br />
<strong>2001</strong> was another busy year for the ACP. In additi<strong>on</strong> to the assessment of 22<br />
new pesticides and a major <strong>on</strong>going review of anti-cholinesterase compounds,<br />
we addressed several important generic issues.<br />
Following discussi<strong>on</strong> at our first open meeting in September 2000 and a<br />
subsequent request for advice from Ministers, we initiated an investigati<strong>on</strong><br />
into the scope for comparative risk assessment in the regulati<strong>on</strong> of pesticides.<br />
It seems obvious that where either of two pesticides will c<strong>on</strong>trol a problem<br />
effectively, it is desirable to choose the <strong>on</strong>e that carries the bigger margins<br />
of safety. In practice, however, implementati<strong>on</strong> of such a policy is not<br />
straightforward. For example, <strong>on</strong>e product may be preferable in relati<strong>on</strong> to<br />
the health of users, while the other poses less threat to wildlife. Moreover, a<br />
product that is best for <strong>on</strong>e use may not be best for another. After a helpful<br />
c<strong>on</strong>sultati<strong>on</strong> exercise, we c<strong>on</strong>cluded that it might be possible to develop a<br />
system in which products were graded as first-, sec<strong>on</strong>d- or third-line for each<br />
of their uses. There could then be an <strong>on</strong>us <strong>on</strong> the user to justify applying any<br />
product that was not first-line for the pest problem he or she was trying to<br />
c<strong>on</strong>trol. Our next step is to explore exactly how grades might be assigned.<br />
If this can be achieved satisfactorily, we may wish to c<strong>on</strong>sult stakeholders<br />
again <strong>on</strong> more detailed proposals.<br />
iii<br />
Risk assessment for pesticides undergoes c<strong>on</strong>tinual refinement, and as part<br />
of that process we are now turning our attenti<strong>on</strong> to their indirect effects <strong>on</strong><br />
wildlife. At present, we assess the toxicity of individual pesticides to a wide<br />
range of wildlife species, but they may also cause harm through other<br />
mechanisms. For example, use of a herbicide or insecticide might deprive<br />
birds of a vital food source. It will not be easy to disentangle such effects<br />
from those attributable to other aspects of agricultural practice, but through<br />
our Envir<strong>on</strong>mental Panel we are looking to promote the research that<br />
is needed.<br />
Another significant development in <strong>2001</strong> was the effect of two court rulings<br />
<strong>on</strong> the openness of our proceedings. In each case, legal acti<strong>on</strong> by a company<br />
holding approval for a pesticide prevented publicati<strong>on</strong> of secti<strong>on</strong>s of our<br />
minutes, pending review of any regulatory acti<strong>on</strong> that might follow from our<br />
advice <strong>on</strong> their products. This runs counter to the recommendati<strong>on</strong>s of the<br />
Phillips report, and risks compromising public c<strong>on</strong>fidence in the regulatory<br />
process. We very much hope that it will not become a regular occurrence.
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
I would like to thank two members, Mike Roberts and Colin Soutar, who left<br />
the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> during <strong>2001</strong>, and as ever, I am grateful to the secretariat for<br />
their excellent support.<br />
Professor David Cogg<strong>on</strong>, Chairman of the ACP<br />
iv
C<strong>on</strong>tents<br />
C<strong>on</strong>tents<br />
Page<br />
Foreword<br />
iii<br />
Introducti<strong>on</strong> 1<br />
The Regulatory System 1<br />
The UK pesticide approvals process 1<br />
The European Community pesticide approvals process 2<br />
The work of the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> 3<br />
The roles of the <strong>Pesticides</strong> Safety Directorate and the Health and<br />
Safety Executive 4<br />
Openness 4<br />
Secti<strong>on</strong> A: C<strong>on</strong>tinuing/existing approvals 5<br />
Agricultural use 5<br />
Fluazifop-P-butyl 5<br />
Methyl bromide 5<br />
Secti<strong>on</strong> B: Applicati<strong>on</strong>s for provisi<strong>on</strong>al approvals<br />
for products c<strong>on</strong>taining new active substances 7<br />
New provisi<strong>on</strong>al approvals 7<br />
Beta-cyfluthrin 7<br />
Clomaz<strong>on</strong>e 8<br />
Cyazofamid 10<br />
Flufenacet 12<br />
Iodosulfur<strong>on</strong>-methyl-sodium 14<br />
Mepanipyrim 16<br />
Picolinafen 17<br />
Picoxystrobin 19<br />
Propoxycarbaz<strong>on</strong>e-sodium 20<br />
Pyraclostrobin 22<br />
Silthiofam 23<br />
Spinosad 24<br />
Sulfosulfur<strong>on</strong> 27<br />
Zoxamide 28<br />
Commodity substances 30<br />
v
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
Secti<strong>on</strong> C: Inclusi<strong>on</strong> of new active substances <strong>on</strong><br />
Annex I of Directive 91/414/EEC 31<br />
Acetamiprid 31<br />
Azafenidin 32<br />
Benzoic acid 32<br />
D-Carv<strong>on</strong>e 33<br />
Profoxydim 33<br />
Dimethenamid-p 34<br />
Foramsulfur<strong>on</strong> 35<br />
S-metolachlor 36<br />
Secti<strong>on</strong> D: Experimental approvals and permits 37<br />
vi<br />
Secti<strong>on</strong> E: UK review programme 38<br />
Routine reviews 38<br />
Agricultural use 38<br />
Azamethiphos 39<br />
B<strong>on</strong>e oil 40<br />
Chlorpyrifos-methyl – envir<strong>on</strong>mental risk assessment 40<br />
Chlorpyrifos – dog study 41<br />
Chlorpyrifos – ornamental bulb dipping 42<br />
Dichlorophen 43<br />
Dichlorvos 43<br />
Dimethoate 46<br />
Malathi<strong>on</strong> 47<br />
Oxamyl 48<br />
Phosphides 49<br />
Pirimicarb 49<br />
Pirimiphos-methyl 50<br />
Tolclofos-methyl 51<br />
N<strong>on</strong>-agricultural use 52<br />
3-iodo-2-propynyl-N-butyl carbamate (IPBC) 52<br />
Azamethiphos 53<br />
CCA 54<br />
Dichlorophen 55<br />
Dichlorvos 57<br />
Diur<strong>on</strong> 60<br />
Fenitrothi<strong>on</strong> 60<br />
Irgarol 62<br />
Lindane 62<br />
Pirimiphos-methyl 62
C<strong>on</strong>tents<br />
Secti<strong>on</strong> F: Other items c<strong>on</strong>sidered during the year 64<br />
Pesticide usage survey reports 64<br />
<strong>Report</strong> 162: Rodenticide use <strong>on</strong> farms in Great Britain growing arable<br />
crops 1998 64<br />
<strong>Report</strong> 164: Protected crops (edible and ornamental) in Great Britain 1999 65<br />
<strong>Report</strong> 165: Mushroom crops in Great Britain 1999 67<br />
<strong>Report</strong> 172: Orchards and fruit stores in Great Britain 2000 69<br />
<strong>Report</strong> 173: Hops in Great Britain 2000 71<br />
<strong>Report</strong> 179: Farm grain stores in Great Britain 1998/1999 72<br />
<strong>Report</strong> 180: Commercial grain stores in Great Britain 1998/1999 73<br />
Other Items 75<br />
Aquatic risk management opti<strong>on</strong>s 75<br />
Bioavailability of triazophos for treated apples 75<br />
Comparative risk assessment 76<br />
Degradati<strong>on</strong> of chlorothal<strong>on</strong>il residues prior to analysis – follow-up report 76<br />
How a broader approach to the producti<strong>on</strong> of biodiversity may affect<br />
ecological risk assessments of plant protecti<strong>on</strong> products 77<br />
Reappraisal of Local Envir<strong>on</strong>mental Risk Assessments for <strong>Pesticides</strong> (LERAPs)<br />
for horiz<strong>on</strong>tal boom sprayers 78<br />
Revised proposals for a scheme of Local Envir<strong>on</strong>ment at Risk Assessments<br />
for <strong>Pesticides</strong> (LERAPs) for broadcast air-assisted sprayers 78<br />
Mutual recogniti<strong>on</strong> of Member State product approvals in support of<br />
applicati<strong>on</strong>s for extensi<strong>on</strong>s of use (off-label use) of products approved<br />
under the Plant Protecti<strong>on</strong> Products Regulati<strong>on</strong>s 1995 (as amended). 79<br />
Operator exposure in applying amenity herbicides by All-Terrain Vehicle (ATV)<br />
and C<strong>on</strong>trolled Droplet Applicator (CDA) 79<br />
Papers to address re-entry time policy for certain wood preservatives 80<br />
Pesticide exposure and Parkins<strong>on</strong>’s disease – review of the literature 81<br />
Pesticide Incident <strong>Report</strong> 2000/<strong>2001</strong>: report <strong>on</strong> HSE’s Field Operati<strong>on</strong>s<br />
Directorate’s investigati<strong>on</strong>s 1 April 2000–31 March <strong>2001</strong> 81<br />
Proposed representati<strong>on</strong>s procedure 83<br />
Review of CMO advice to peel fruit 83<br />
The Precauti<strong>on</strong>ary Principle 83<br />
vii<br />
Secti<strong>on</strong> G: Fees 84<br />
Chairman’s fees 84<br />
Deputy Chairman’s fees and members fees 84<br />
Appendix I 85<br />
Terms of reference 85<br />
Appendix II 86<br />
Membership of the <str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> up to<br />
31 December <strong>2001</strong> 86
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
Appendix III 89<br />
Independent members’ annual declarati<strong>on</strong> of interests in the pesticides<br />
industry <strong>2001</strong> 89<br />
Appendix IV 90<br />
Inter-Departmental Secretariat 90<br />
Terms of Reference 90<br />
Membership (as at 31 December <strong>2001</strong>) 90<br />
Envir<strong>on</strong>mental Panel 92<br />
Terms of reference 92<br />
Membership (as at 31 December <strong>2001</strong>) 92<br />
<strong>Pesticides</strong> Residues <str<strong>on</strong>g>Committee</str<strong>on</strong>g> 94<br />
Medical and Toxicological Panel 94<br />
Terms of reference 94<br />
Membership (as at 31 December <strong>2001</strong>) 94<br />
Working Party <strong>on</strong> Pesticide Usage Surveys 96<br />
Membership (as at 31 December <strong>2001</strong>) 96<br />
viii<br />
Appendix V 97<br />
Published evaluati<strong>on</strong>s (as at 31 December <strong>2001</strong>) 97<br />
Appendix VI 104<br />
Terms and Abbreviati<strong>on</strong>s 104
Introducti<strong>on</strong><br />
Introducti<strong>on</strong><br />
The Regulatory<br />
System<br />
The principal aim of pesticide regulati<strong>on</strong> in the UK is to protect the health<br />
of human beings, creatures, plants and the envir<strong>on</strong>ment. Other important<br />
objectives are to ensure that pesticide approval procedures are independent<br />
of sectoral interest; to limit the use of individual pesticide products to the<br />
minimum necessary for the effective c<strong>on</strong>trol of pests; to review regularly all<br />
approvals and to act <strong>on</strong> significant new informati<strong>on</strong>; and to make informati<strong>on</strong><br />
supporting decisi<strong>on</strong>s <strong>on</strong> the use of pesticides publicly available.<br />
The UK pesticide approvals process<br />
Statutory powers to c<strong>on</strong>trol pesticides are provided by the Food and<br />
Envir<strong>on</strong>ment Protecti<strong>on</strong> Act 1985 (FEPA) and underpin the C<strong>on</strong>trol of<br />
<strong>Pesticides</strong> Regulati<strong>on</strong>s 1986 (as amended) (COPR). These define in detail<br />
the types of pesticides subject to c<strong>on</strong>trol; prescribe the approvals required<br />
before any pesticide may be sold, stored, supplied, advertised or used;<br />
and allow for general c<strong>on</strong>diti<strong>on</strong>s to be attached to sale, supply, storage,<br />
advertisement and use.<br />
1<br />
Applicati<strong>on</strong>s for approval under COPR may result in <strong>on</strong>e of three levels<br />
of approval – experimental, provisi<strong>on</strong>al (usually with requirements for<br />
submissi<strong>on</strong> of c<strong>on</strong>firmatory data), or full approval. When pesticides are first<br />
c<strong>on</strong>sidered for commercial use, or are reviewed, decisi<strong>on</strong>s are made by<br />
Ministers in all the departments resp<strong>on</strong>sible for regulating pesticides: the<br />
Department for Envir<strong>on</strong>ment, Food and Rural Affairs 1 ; the Department for<br />
Transport, Local Government and the Regi<strong>on</strong>s 2 ; the Department of Health;<br />
the Scottish Executive Envir<strong>on</strong>ment and Rural Affairs Department; and the<br />
Nati<strong>on</strong>al Assembly for Wales Agriculture Department. The Food Standards<br />
Agency has oversight of all matters to do with food safety, including the<br />
safety of pesticides.<br />
Approvals are subsequently issued by the Pesticide Safety Directorate (PSD)<br />
and the Health and Safety Executive (HSE). Once a pesticide has been<br />
approved it will be subject to routine review, and it may also be reviewed<br />
if at any time new evidence casts doubt <strong>on</strong> its safety. As a c<strong>on</strong>sequence<br />
of review, the approval may, if appropriate, be restricted or revoked.<br />
1 This resp<strong>on</strong>sibility was previously held in part by the Ministry of Agriculture, Fisheries<br />
and Food.<br />
2 This resp<strong>on</strong>sibility was previously held in part by the Department of Envir<strong>on</strong>ment, Transport<br />
and the Regi<strong>on</strong>s.
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
The European Community pesticide approvals process<br />
The current UK system of pesticide approvals provided under COPR is<br />
gradually being replaced by arrangements based <strong>on</strong> European Community<br />
(EC) requirements. These are based up<strong>on</strong> Council Directive 91/414/EEC,<br />
which establishes rules for placing plant protecti<strong>on</strong> products (broadly<br />
agricultural pesticides) <strong>on</strong> the market. This legislati<strong>on</strong> is implemented in<br />
Great Britain by the Plant Protecti<strong>on</strong> Products Regulati<strong>on</strong>s 1995 (PPPR)<br />
(as amended).<br />
2<br />
Since implementati<strong>on</strong> of the Directive <strong>on</strong> 25 July 1993, all products c<strong>on</strong>taining<br />
active substances, which are new to the Community, must be authorised<br />
under Directive 91/414/EEC (and hence in the UK they are subject to PPPR).<br />
The Directive is intended to harm<strong>on</strong>ise arrangements for authorisati<strong>on</strong> of plant<br />
protecti<strong>on</strong> products within the Community although authorisati<strong>on</strong> will remain<br />
the resp<strong>on</strong>sibility of individual Member States. Products c<strong>on</strong>taining active<br />
substances, which were already <strong>on</strong> the market at the date of implementati<strong>on</strong><br />
of the Directive, c<strong>on</strong>tinue to be subject to nati<strong>on</strong>al rules (COPR in the UK).<br />
However, these active substances are being scheduled for review under a<br />
collaborative EC Review Programme. If they are found to be acceptable at<br />
review, authorisati<strong>on</strong> will be granted under Directive 91/414/EEC (PPPR in the<br />
UK). A list of active substances authorised by the Community for use in plant<br />
protecti<strong>on</strong> products is being assembled in Annex I to the Directive. This will<br />
be augmented over a period of time as existing active substances are reviewed<br />
and new <strong>on</strong>es authorised.<br />
Under PPPR, provisi<strong>on</strong>al approvals for a new active substance may be issued<br />
for three years whilst the EC is evaluating the active substance for inclusi<strong>on</strong><br />
in Annex I of the Council Directive 91/414/EEC. Once an active substance<br />
is included in Annex I, plant protecti<strong>on</strong> products that c<strong>on</strong>tain it may be<br />
approved under a system of mutual recogniti<strong>on</strong>. This allows authorisati<strong>on</strong>s<br />
to be granted more easily in individual Member States, but it is still necessary<br />
to dem<strong>on</strong>strate that the specific uses proposed for each product will be<br />
acceptable, taking into account the way in which the active substance<br />
will be formulated, and nati<strong>on</strong>al climatic and agr<strong>on</strong>omic c<strong>on</strong>diti<strong>on</strong>s.<br />
In additi<strong>on</strong> to the legislati<strong>on</strong> already menti<strong>on</strong>ed, Council Directive 98/8/EC<br />
lays down a regime for biocidal products (including all other products<br />
regulated as pesticides in the UK and some that are not so regulated at<br />
present). The Biocidal Products Regulati<strong>on</strong>s <strong>2001</strong> implement this Directive<br />
in the UK.
Introducti<strong>on</strong><br />
The work of the <str<strong>on</strong>g>Committee</str<strong>on</strong>g><br />
The <str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> (ACP) advises Ministers <strong>on</strong> all major<br />
pesticide issues. It met <strong>on</strong> eight occasi<strong>on</strong>s during <strong>2001</strong> to c<strong>on</strong>sider applicati<strong>on</strong>s<br />
for approval, reviews of approved pesticides and other issues relevant to its<br />
terms of reference under the Food and Envir<strong>on</strong>ment Protecti<strong>on</strong> Act 1985<br />
(FEPA). Additi<strong>on</strong>ally, in July <strong>2001</strong> the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> held its sec<strong>on</strong>d open meeting.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g>’s terms of reference and its membership during <strong>2001</strong> are<br />
included at Appendices I and II, respectively. It is important that the<br />
<str<strong>on</strong>g>Committee</str<strong>on</strong>g> is independent of Government and of the agrochemicals industry,<br />
and arrangements are in place to this end. Throughout the year, members are<br />
required to declare any interests or potential c<strong>on</strong>flicts of interest they may<br />
have, and declared interests for <strong>2001</strong> are listed at Appendix III.<br />
In <strong>2001</strong> the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sisted of 14 members, 12 selected for their scientific<br />
and technical expertise and two lay members. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> is supported by<br />
about 20 advisers who complement the scientific expertise of the <str<strong>on</strong>g>Committee</str<strong>on</strong>g><br />
and provide expertise in policy and operati<strong>on</strong>al matters. In additi<strong>on</strong> to the<br />
advisers, a number of assessors attend <str<strong>on</strong>g>Committee</str<strong>on</strong>g> meetings. Assessors<br />
represent each department involved in the regulatory process and are<br />
resp<strong>on</strong>sible for ensuring that the <str<strong>on</strong>g>Committee</str<strong>on</strong>g>’s recommendati<strong>on</strong>s are properly<br />
c<strong>on</strong>sidered by those departments.<br />
3<br />
The <str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> is further supported by several subsidiary<br />
bodies which this year comprised the Inter-Departmental Secretariat, the<br />
Envir<strong>on</strong>mental Panel, the Medical and Toxicological Panel, and the Working<br />
Party <strong>on</strong> Pesticide Usage Surveys (WPPUS). The former Working Party <strong>on</strong><br />
<strong>Pesticides</strong> Residues (WPPR) was established as an independent committee,<br />
the <strong>Pesticides</strong> Residues <str<strong>on</strong>g>Committee</str<strong>on</strong>g> (PRC), in January <strong>2001</strong>. The terms of<br />
reference for these bodies are given at Appendix IV.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>siders documents prepared by the <strong>Pesticides</strong> Safety<br />
Directorate, the Health and Safety Executive and by its supporting groups.<br />
However, it is also able to c<strong>on</strong>sider representati<strong>on</strong>s from companies and<br />
organisati<strong>on</strong>s seeking or holding approvals for pesticides, and from<br />
other parties. Following discussi<strong>on</strong>, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g>’s c<strong>on</strong>clusi<strong>on</strong>s and<br />
recommendati<strong>on</strong>s are drawn together and put forward for c<strong>on</strong>siderati<strong>on</strong><br />
by Ministers in all Government departments c<strong>on</strong>cerned with pesticides.<br />
If Ministers agree then the recommendati<strong>on</strong>s made by the <str<strong>on</strong>g>Committee</str<strong>on</strong>g><br />
are taken forward.
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
Documents detailing the <str<strong>on</strong>g>Committee</str<strong>on</strong>g>’s evaluati<strong>on</strong> of individual active<br />
substances are published. A list of those available (as at 31 December <strong>2001</strong>)<br />
can be found at Appendix V. Documents can be obtained <strong>on</strong> written<br />
applicati<strong>on</strong> to the Finance and Corporate Services Unit, Mallard House,<br />
Kings Pool, 3 Peasholme Green, York, YO1 7PX.<br />
The roles of the <strong>Pesticides</strong> Safety Directorate and the Health and<br />
Safety Executive<br />
The <strong>Pesticides</strong> Safety Directorate (PSD), an executive agency of the<br />
Department for Envir<strong>on</strong>ment, Food and Rural Affairs, administers the<br />
regulati<strong>on</strong> of pesticides used in agriculture, horticulture, forestry, food<br />
storage and the home garden.<br />
For n<strong>on</strong>-agricultural pesticides (e.g. mas<strong>on</strong>ry biocides and marine anti-fouling<br />
products), this role is taken by the Biocides and <strong>Pesticides</strong> Assessment Unit<br />
(BPAU) of the Health and Safety Executive (HSE).<br />
4<br />
The principal functi<strong>on</strong>s of the PSD and the BPAU of HSE are to evaluate and<br />
process applicati<strong>on</strong>s for approval of pesticide products for use in Great Britain<br />
and to provide advice to Government <strong>on</strong> pesticides policy. The PSD and the<br />
BPAU also provide the secretariat for the ACP.<br />
In order to obtain approval for a new pesticide, or to secure the c<strong>on</strong>tinued<br />
approval of an existing pesticide, an extensive package of scientific data must<br />
be submitted addressing its identity; functi<strong>on</strong>; efficacy; the risks it could<br />
present to humans, n<strong>on</strong>-target creatures and plants and to the envir<strong>on</strong>ment;<br />
and the effectiveness of any measures to reduce risks. With regard to potential<br />
risks to humans, account must be taken of exposures that might occur in<br />
applicati<strong>on</strong> of the pesticide, through c<strong>on</strong>tact with treated plants or materials<br />
(e.g. workers picking treated crops), and through c<strong>on</strong>sumpti<strong>on</strong> of food<br />
derived from treated crops.<br />
Openness<br />
In order to assist in making informati<strong>on</strong> <strong>on</strong> the pesticide approvals process<br />
available, agendas of meetings are displayed <strong>on</strong> the ACP website in advance<br />
of meetings and draft minutes of meetings are displayed <strong>on</strong> the website three<br />
weeks after each meeting. Minutes are finalised at the following meeting and<br />
the website is subsequently updated.<br />
The website address is www.pesticides.gov.uk/committees/acp
Secti<strong>on</strong> A: C<strong>on</strong>tinuing/existing approvals<br />
Secti<strong>on</strong> A:<br />
C<strong>on</strong>tinuing/existing approvals<br />
Agricultural use<br />
During <strong>2001</strong> the ACP recommended c<strong>on</strong>tinuing existing approval for products<br />
based <strong>on</strong> the following active substances.<br />
●<br />
●<br />
Fluazifop-P-butyl<br />
Methyl bromide<br />
Fluazifop-P-butyl<br />
‘Fusilade 250 EW’ is an oil-in-water emulsi<strong>on</strong> c<strong>on</strong>taining 250 g/l fluazifop-P-butyl<br />
with approval for use as an agricultural, horticultural and forestry herbicide for<br />
grass weed c<strong>on</strong>trol.<br />
The ACP c<strong>on</strong>sidered an applicati<strong>on</strong> for the removal of a restricti<strong>on</strong> prohibiting<br />
the applicati<strong>on</strong> of ‘Fusilade 250 EW’ using hand-held equipment. In support of<br />
this applicati<strong>on</strong> the company had proposed to use dermal absorpti<strong>on</strong> data to<br />
refine the operator exposure assessment and had submitted data to support an<br />
acceptable operator exposure level (AOEL) of 0.05 mg/kg bodyweight (bw)/day,<br />
based <strong>on</strong> a no observed adverse effect level (NOAEL) of 5 mg/kg bw/day,<br />
derived from new rat developmental studies.<br />
5<br />
However, the ACP did not c<strong>on</strong>sider that the additi<strong>on</strong>al toxicological studies<br />
submitted supported the proposed AOEL and recommended that the<br />
applicati<strong>on</strong> for removal of the restricti<strong>on</strong> prohibiting applicati<strong>on</strong> via<br />
hand-held equipment be refused.<br />
In additi<strong>on</strong>, because the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered that the new data might indicate<br />
a higher risk than had previously been assessed, it c<strong>on</strong>sidered whether a review<br />
of fluazifop-P-butyl was required ahead of the scheduled review in the EU<br />
programme. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> compared the new data with their previous<br />
evaluati<strong>on</strong>s of fluazifop-P-butyl and c<strong>on</strong>cluded that the new data did not indicate<br />
need for urgent acti<strong>on</strong>. They recommended that fluazifop-p-butyl should not be<br />
formally reviewed in the UK ahead of the EU review but that the company should<br />
be asked to provide a positi<strong>on</strong> paper addressing the c<strong>on</strong>cerns of the <str<strong>on</strong>g>Committee</str<strong>on</strong>g>.<br />
Methyl bromide<br />
Methyl bromide is currently approved within the UK as a commodity substance, to<br />
be used as a fumigant in public hygiene and vertebrate c<strong>on</strong>trol under the C<strong>on</strong>trol
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
of <strong>Pesticides</strong> Regulati<strong>on</strong>s 1986 (COPR). A commodity substance is not sold or<br />
advertised as a pesticide product in this c<strong>on</strong>text and there are no approval holders.<br />
Methyl bromide manufacture is currently restricted under the M<strong>on</strong>treal Protocol,<br />
which envisages a phased withdrawal leading to a world-wide ban.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered a brief evaluati<strong>on</strong> of informati<strong>on</strong> submitted by<br />
interested parties to address data requirements set previously by the ACP<br />
for support of commodity substances.<br />
6<br />
In additi<strong>on</strong> to the data reported, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> noted that studies performed in<br />
France and the USA suggested that neurobehavioural effects could result from<br />
repeated occupati<strong>on</strong>al exposure to methyl bromide. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> also c<strong>on</strong>sidered<br />
that methyl bromide was likely to be genotoxic although it was not aware of any<br />
cytogenetic studies in exposed populati<strong>on</strong>s. However, it noted that methyl bromide<br />
was required to be used under strictly c<strong>on</strong>trolled situati<strong>on</strong>s in compliance with an<br />
Approved Code of Practice (ACOP) for fumigati<strong>on</strong>. Fumigati<strong>on</strong>s were carried out<br />
by a small number of dedicated c<strong>on</strong>tractors who had in place good standards of<br />
training and supervisi<strong>on</strong>. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered that the strict engineering<br />
c<strong>on</strong>trols and requirements for pers<strong>on</strong>al protective equipment that were currently in<br />
place in the UK would mitigate exposure and minimise the risks to workers. Given<br />
these c<strong>on</strong>trols, the small number of highly trained professi<strong>on</strong>al workers involved,<br />
the low level of incidents involving methyl bromide over the last 10 years and the<br />
rarity of claims for occupati<strong>on</strong>al injury by methyl bromide, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed<br />
that there was no pressing need for further data to refine the risk assessment if<br />
methyl bromide was to be phased out by 2005.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> noted that there was a provisi<strong>on</strong> to allow essential uses of<br />
methyl bromide to remain bey<strong>on</strong>d 2005, but that it was not yet clear what these<br />
might be. It c<strong>on</strong>sidered that when methyl bromide was phased out under the<br />
M<strong>on</strong>treal Protocol, it would lose its approval as a commodity substance and any<br />
c<strong>on</strong>tinued essential use as a pesticide after 2005 was likely to require specific<br />
approval. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> briefly discussed alternatives to methyl bromide such<br />
as hydrogen cyanide, but c<strong>on</strong>sidered that, depending <strong>on</strong> the circumstances and<br />
the area of use, these might not be particularly suitable replacements.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that the data requirements set previously by the<br />
ACP had been addressed adequately and that currently there should be no<br />
requirement for any further data. It noted the need to identify any essential<br />
uses that might remain bey<strong>on</strong>d 2005, the users who would require them,<br />
and the administrative arrangements by which uses would be classified as<br />
essential. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that, depending <strong>on</strong> the answers to these<br />
questi<strong>on</strong>s, more data might be required to support remaining uses.
Secti<strong>on</strong> B: Applicati<strong>on</strong>s for provisi<strong>on</strong>al approvals for products c<strong>on</strong>taining new active substances<br />
Secti<strong>on</strong> B:<br />
Applicati<strong>on</strong>s for provisi<strong>on</strong>al approvals<br />
for products c<strong>on</strong>taining new active<br />
substances<br />
New<br />
provisi<strong>on</strong>al<br />
approvals<br />
The ACP c<strong>on</strong>sidered provisi<strong>on</strong>al approval for products based <strong>on</strong> the following<br />
active substances:<br />
● BETA CYFLUTHRIN<br />
●<br />
CLOMAZONE<br />
●<br />
CYAZOFAMID<br />
●<br />
FLUFENACET<br />
●<br />
IODOSULFURON-METHYL-SODIUM<br />
●<br />
●<br />
MEPANIPYRIM<br />
PICOLINAFEN<br />
7<br />
●<br />
PICOXYSTROBIN<br />
●<br />
PROPOXYCARBAZONE-SODIUM<br />
●<br />
PYRACLOSTROBIN<br />
●<br />
SILTHIOFAM<br />
●<br />
SPINOSAD<br />
●<br />
SULFOSULFURON<br />
●<br />
ZOXAMIDE<br />
Beta-cyfluthrin<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered the sec<strong>on</strong>d evaluati<strong>on</strong> of ‘Chinook’, a seed<br />
treatment product c<strong>on</strong>taining beta-cyfluthrin and imidacloprid. In 2000<br />
members had c<strong>on</strong>cluded that insufficient data to address the envir<strong>on</strong>mental<br />
risk had been presented to recommend a commercial level of approval.<br />
New data were presented addressing the risks to birds and small mammals<br />
and the levels of beta-cyfluthrin likely to occur in surface waters as a result of<br />
drainflow. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered that these data indicated an acceptable
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
risk to wildlife and recommended approval for the use <strong>on</strong> winter oilseed<br />
rape as proposed. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> also recommended that the approval holder<br />
be required to implement a user educati<strong>on</strong> scheme to minimise further any<br />
envir<strong>on</strong>mental effects.<br />
Clomaz<strong>on</strong>e<br />
Clomaz<strong>on</strong>e is a new isoxazolidin<strong>on</strong>e herbicide that acts by inhibiti<strong>on</strong> of<br />
biosynthesis of photosynthetic pigments in plants. The ACP c<strong>on</strong>sidered<br />
applicati<strong>on</strong>s for approval of two products ‘Centium 50 WP’, a wettable powder<br />
(WP), and ‘Centium 360 CS’, a capsule suspensi<strong>on</strong> (CS), for residual c<strong>on</strong>trol<br />
of broad-leaved weeds in winter oilseed rape.<br />
Clomaz<strong>on</strong>e was rapidly and extensively absorbed, metabolised and excreted<br />
in the rat, mainly via urine. Very little unmetabolised parent compound<br />
was excreted and a large number of metabolites were identified,<br />
mostly hydroxylated derivatives of the parent compound, especially<br />
5-hydroxyclomaz<strong>on</strong>e.<br />
8<br />
The active substance is classifiable as ‘Harmful if swallowed and by inhalati<strong>on</strong>’<br />
based <strong>on</strong> acute oral and inhalati<strong>on</strong>al studies in rats.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that the main toxicological effect was liver enlargement<br />
and that the acceptable daily intake (ADI) should be based <strong>on</strong> the no<br />
observed adverse effect level (NOAEL) of 12.5 mg/kg bodyweight (bw)/day)<br />
from a <strong>on</strong>e-year dog study. With a 100-fold assessment factor, this gave an<br />
ADI of 0.13 mg/kg bw/day. It was also c<strong>on</strong>sidered appropriate that the shortterm<br />
systemic admissible operator exposure level (AOEL) should be derived<br />
in the same way. An acute reference dose (ARfD) of 0.3 mg/kg bw/day was<br />
agreed based <strong>on</strong> the NOAEL of 30 mg/kg bw/day for maternal toxicity in a<br />
rabbit teratogenicity study, with a 100-fold assessment factor. Members agreed<br />
that there were no apparent c<strong>on</strong>cerns in relati<strong>on</strong> to genotoxicity,<br />
carcinogenicity or reproductive toxicity.<br />
Residue trials indicated that clomaz<strong>on</strong>e residues were present below the limit<br />
of quantificati<strong>on</strong> (LOQ) in oilseed rape at harvest, and calculati<strong>on</strong>s indicated<br />
that the c<strong>on</strong>sumer exposure would be acceptable. The exposures of operators<br />
from use of ‘Centium 50 WP’ were c<strong>on</strong>sidered acceptable if protective gloves<br />
were worn when handling the product. For ‘Centium 360 CS’ coveralls and<br />
protective gloves should be required when handling the product. Exposures<br />
of bystanders and workers were regarded as acceptable. ‘Centium 360 CS’<br />
was classifiable as a skin sensitiser <strong>on</strong> the basis of a Buehler test, and the ACP
Secti<strong>on</strong> B: Applicati<strong>on</strong>s for provisi<strong>on</strong>al approvals for products c<strong>on</strong>taining new active substances<br />
agreed that the feasibility of removal of the sensitising co-formulant from the<br />
formulati<strong>on</strong> should be explored.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that clomaz<strong>on</strong>e was of low toxicity to birds and<br />
animals and that the risks to bees, arthropods, earthworms, soil macroand<br />
micro-organisms and biological methods for sewage treatment were<br />
acceptable. The most sensitive aquatic organisms were green algae, and based<br />
<strong>on</strong> toxicity to this group ‘Centium 50 WP’ was classified as ‘Harmful to fish<br />
or other aquatic life’ whilst ‘Centium 360 CS’ was less toxic, requiring the<br />
warning phrase ‘Do not c<strong>on</strong>taminate waters or ditches with chemical or used<br />
c<strong>on</strong>tainer’. However, the risk to aquatic life from spray drift and drainflow<br />
was regarded as acceptable.<br />
The ACP expressed serious c<strong>on</strong>cern about the potential risk to n<strong>on</strong>-target<br />
flora from spray drift and possible volatilisati<strong>on</strong> of the active substance. The<br />
<str<strong>on</strong>g>Committee</str<strong>on</strong>g> recommended that for spray drift management, a ‘coarse’ spray<br />
setting, in accordance with the British Crop Protecti<strong>on</strong> Council (BCPC)<br />
classificati<strong>on</strong>, should be specified for both products. The ACP agreed that<br />
there was less volatilisati<strong>on</strong> potential from the capsule formulati<strong>on</strong> ‘Centium<br />
360 CS’ and that provisi<strong>on</strong>al approval could be recommended. However, no<br />
appropriate risk management strategy had been proposed to reduce potential<br />
adverse effects <strong>on</strong> n<strong>on</strong>-target flora for ‘Centium 50 WP’ and provisi<strong>on</strong>al<br />
approval could not be recommended for this product. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g><br />
agreed that a m<strong>on</strong>itoring programme should be undertaken to assess adverse<br />
off-target effects <strong>on</strong> flora, including from l<strong>on</strong>g-term exposure. Members<br />
also agreed that, as greater volatilisati<strong>on</strong> was likely in warmer weather, the<br />
additi<strong>on</strong>al ecotoxicological data specified should be required to support any<br />
applicati<strong>on</strong> for spring use of clomaz<strong>on</strong>e.<br />
9<br />
The ACP noted that satisfactory weed c<strong>on</strong>trol had been dem<strong>on</strong>strated but<br />
stipulated that cultivati<strong>on</strong>s should be at least 15 cm deep to minimise effects<br />
in following crops in fields where reduced tillage was used. C<strong>on</strong>cerns were<br />
also expressed with respect to residues in adjacent crops when using ‘Centium<br />
50 WP’ due to vapour drift.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> advised that provisi<strong>on</strong>al approval be recommended for use of<br />
‘Centium 360 CS’, subject to label amendments, the c<strong>on</strong>firmatory data specified<br />
and a product stewardship programme, to be agreed with PSD. A commercial<br />
level of approval for ‘Centium 50 WP’ was not recommended in view of the<br />
potential adverse effects <strong>on</strong> n<strong>on</strong>-target flora.
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
Cyazofamid<br />
Cyazofamid (codename IKF-916) is the proposed name for 4-chloro-2cyano-N,<br />
N-dimethyl-5-P-tolylimidazole-1-sulf<strong>on</strong>amide. It bel<strong>on</strong>gs to a new chemical<br />
class of fungicide based <strong>on</strong> the cyanoimidazole moiety. Cyazofamid inhibits<br />
respirati<strong>on</strong> specifically at cytochrome bc1 complex in the mitoch<strong>on</strong>dria of<br />
Oomycetes fungi, acting <strong>on</strong> the Qi site (ubiquin<strong>on</strong>e-reducing site) of the<br />
complex. The active substance is also being c<strong>on</strong>sidered for inclusi<strong>on</strong> in Annex<br />
I of Directive 91/414/EEC with France acting as Rapporteur Member State.<br />
The ACP c<strong>on</strong>sidered an applicati<strong>on</strong> for a plant protecti<strong>on</strong> product, ‘Ranman’,<br />
which is packaged in a dual compartment pack with ‘IKF-916 400SC’ in <strong>on</strong>e<br />
compartment and an approved organosilic<strong>on</strong>e adjuvant in the other. ‘IKF-916<br />
400SC’ is a suspensi<strong>on</strong> c<strong>on</strong>centrate (SC) formulati<strong>on</strong> c<strong>on</strong>taining 400 g/l<br />
cyazofamid. The proposed use of the product was as a c<strong>on</strong>tact/protective<br />
fungicide against potato blight (Phytophthora infestans).<br />
10<br />
Cyazofamid is rapidly absorbed when ingested by mammals, but the extent<br />
of absorpti<strong>on</strong> is limited and there was no evidence of retenti<strong>on</strong> in organs and<br />
tissues. Further studies showed the major pathway for the eliminati<strong>on</strong> of<br />
absorbed radiolabel was in urine with a significant amount, predominantly<br />
c<strong>on</strong>jugates, being eliminated in bile. Unabsorbed cyazofamid was eliminated<br />
in faeces.<br />
In metabolism studies, the metabolites identified indicated that, following<br />
oral administrati<strong>on</strong>, cyazofamid was hydrolysed, removing the N, N-<br />
dimethylsulf<strong>on</strong>amide group. The 4-chloro-5-p-tolylimidazole-2-carb<strong>on</strong>itrile<br />
(CCIM) generated by this hydrolysis was c<strong>on</strong>sidered to be the primary<br />
metabolite from which others were derived. CCIM was, however, not detected<br />
as a major metabolite in urine. Instead, the benzyl methyl group underwent<br />
oxidati<strong>on</strong> to form 4-(4-chloro-2-cyanoimidazol-5-yl)benzoic acid (CCBA) or<br />
c<strong>on</strong>jugati<strong>on</strong> with glutathi<strong>on</strong>e and oxidati<strong>on</strong> to form other metabolites.<br />
Cyazofamid was shown to be of low acute toxicity. The compound was not<br />
classified as a primary eye irritant or a skin irritant and did not produce<br />
delayed c<strong>on</strong>tact hypersensitivity in a skin sensitisati<strong>on</strong> test. The toxicological<br />
studies submitted indicated that the compound was not genotoxic, carcinogenic<br />
or teratogenic, and no adverse reproductive effects had been observed.<br />
The ACP agreed an ADI of 0.2 mg/kg bodyweight (bw)/day, based <strong>on</strong> a no<br />
observed adverse effect level (NOAEL) of 500 ppm from a rat two-year study.<br />
Effects at the next dose were an increase in kidney weight, increased urine<br />
volume and higher chloride levels in urine. Estimated c<strong>on</strong>sumer exposures
Secti<strong>on</strong> B: Applicati<strong>on</strong>s for provisi<strong>on</strong>al approvals for products c<strong>on</strong>taining new active substances<br />
were all less than 1 percent of the ADI. Hence, the l<strong>on</strong>g-term c<strong>on</strong>sumer<br />
exposure was c<strong>on</strong>sidered acceptable.<br />
No acute reference dose was proposed, as it appeared there was negligible<br />
acute dietary risk from cyazofamid. Investigati<strong>on</strong>s in rats indicated that CCIM<br />
might present a greater acute dietary risk. However, it was c<strong>on</strong>sidered that<br />
since CCIM was the primary metabolite in rat metabolism and CCIM residues<br />
in potatoes were low (less than 0.01 mg/kg), dietary exposure to CCIM would<br />
be acceptable. The applicant attributed apparent differences in the toxicity of<br />
cyazofamid and CCIM to differences in oral absorpti<strong>on</strong> of the two compounds.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed a short-term systemic acceptable operator exposure<br />
level (AOEL) of 0.03 mg/kg bw/day, based <strong>on</strong> the NOAEL of 500 ppm in a<br />
90-day rat study. This was determined <strong>on</strong> increased kidney weight, basophilic<br />
tubules and clinical chemistry changes, with a 10 per cent oral absorpti<strong>on</strong><br />
correcti<strong>on</strong> factor and a 100-fold assessment factor. The ACP c<strong>on</strong>sidered it<br />
unlikely that the exposure of users, workers or bystanders would exceed<br />
the AOEL. However, it was agreed that gloves should be worn when<br />
mixing/loading and during applicati<strong>on</strong> of the product. In additi<strong>on</strong>, as the<br />
product was classified as a severe eye irritant, the use of a faceshield when<br />
handling the c<strong>on</strong>centrate should be required.<br />
11<br />
The metabolite, CTCA (4-chloro-5-p-tolylimidazole-2-carboxylic acid) was likely<br />
to be very persistent in UK soils under both aerobic and anaerobic c<strong>on</strong>diti<strong>on</strong>s.<br />
However, it was agreed that the ecotoxicology evaluati<strong>on</strong> indicated an<br />
acceptable risk to n<strong>on</strong>-target species. Due to a combinati<strong>on</strong> of relatively high<br />
sorpti<strong>on</strong> and a summer applicati<strong>on</strong>, c<strong>on</strong>taminati<strong>on</strong> of shallow vulnerable<br />
groundwater by CTCA was c<strong>on</strong>sidered unlikely.<br />
The ACP agreed that use of ‘Ranman’ as proposed for post-emergence<br />
treatment in potato crops did not pose any unacceptable risks to birds, aquatic<br />
life, wild mammals, bees, other terrestrial arthropods, earthworms, soil macro<br />
and micro-organisms, or to n<strong>on</strong>-target flora.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>cluded that the submitted efficacy data showed that<br />
commercially acceptable c<strong>on</strong>trol of foliar potato blight could be obtained if<br />
‘Ranman’ was used as recommended. There were no adverse effects in terms<br />
of phytotoxicity or <strong>on</strong> yield or quality of yield. It was c<strong>on</strong>sidered that there<br />
would be no unacceptable risk to following or adjacent crops.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered there was a high risk of resistance development<br />
and agreed a strategy of a maximum of six applicati<strong>on</strong>s of ‘Ranman’ per
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
potato crop, to be delivered in tranches of three applicati<strong>on</strong>s in alternati<strong>on</strong><br />
with fungicides from a different cross-resistance group.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> recommended provisi<strong>on</strong>al approval for ‘Ranman’ for use <strong>on</strong><br />
potatoes under the Plant Protecti<strong>on</strong> Products Regulati<strong>on</strong>s, for three years<br />
pending the Commissi<strong>on</strong> decisi<strong>on</strong> <strong>on</strong> inclusi<strong>on</strong> of cyazofamid (IKF-916) in<br />
Annex I of Council Directive 91/414/EEC. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> also highlighted<br />
a number of issues to be discussed as part of the European c<strong>on</strong>siderati<strong>on</strong>.<br />
Flufenacet<br />
Flufenacet (code name FOE 5043) is the proposed name for a new<br />
oxyacetamide herbicide. The molecular mode of acti<strong>on</strong> of oxyacetamides is<br />
unclear but at the cellular level inhibiti<strong>on</strong> of cell divisi<strong>on</strong> in root and shoot<br />
meristematic regi<strong>on</strong>s of plants is observed.<br />
12<br />
The ACP c<strong>on</strong>sidered applicati<strong>on</strong>s for two products, namely ‘ACH 210’ and<br />
‘Artist’, c<strong>on</strong>taining flufenacet in mixture with pendimethalin and metribuzin,<br />
respectively. ‘ACH 210’ is an emulsifiable c<strong>on</strong>centrate (EC) c<strong>on</strong>taining 60 g<br />
flufenacet/l and 300 g pendimethalin/l for use <strong>on</strong> winter wheat and barley.<br />
‘Artist’ is a water dispersible granule (WG) c<strong>on</strong>taining 240 g flufenacet/kg and<br />
175 g metribuzin/kg for use <strong>on</strong> potatoes prior to emergence of both crop and<br />
weeds. The rates of use of pendimethalin and metribuzin are within precedent<br />
of extant UK approvals.<br />
Flufenacet was also new to the European Uni<strong>on</strong> (EU) with France acting as<br />
the Rapporteur Member State (RMS). A different product, ‘FOE 5043 WG 60’,<br />
a WG c<strong>on</strong>taining 600 g flufenacet/kg for pre-emergence weed c<strong>on</strong>trol in<br />
maize, cereals, soybean and sunflower was evaluated. A Draft Assessment<br />
<strong>Report</strong> (DAR) had been prepared and end points agreed at EU (ECCO) peer<br />
review meetings and flufenacet was being c<strong>on</strong>sidered by the EU Scientific<br />
<str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> Plants (SCP). Although a final decisi<strong>on</strong> <strong>on</strong> inclusi<strong>on</strong> of<br />
flufenacet in Annex I of Directive 91/414/EEC had not been made, the end<br />
point list agreed in the EU was used in the UK assessment and, al<strong>on</strong>g with<br />
the DAR, was appended to the UK evaluati<strong>on</strong> document.<br />
Acute toxicological studies required ‘ACH 210’ to be classified as ‘Harmful if<br />
swallowed’ and ‘Irritating to skin’ and for ‘Artist’ to be classified as ‘Harmful<br />
if swallowed’. The ACP c<strong>on</strong>cluded that there was little evidence to suggest<br />
a potentiati<strong>on</strong> of toxicological effects by the sec<strong>on</strong>d active substance in the<br />
formulati<strong>on</strong>s when compared with flufenacet al<strong>on</strong>e and that the effects seen in<br />
these studies <strong>on</strong> the formulated products could be attributable to high dosage.
Secti<strong>on</strong> B: Applicati<strong>on</strong>s for provisi<strong>on</strong>al approvals for products c<strong>on</strong>taining new active substances<br />
The acceptable daily intake (ADI), acceptable operator exposure level (AOEL)<br />
and acute reference dose (ARfD) agreed at ECCO were used in the UK risk<br />
assessments. The ACP noted that it was difficult to comment <strong>on</strong> the<br />
mammalian toxicological reference doses for flufenacet in the absence of<br />
informati<strong>on</strong> <strong>on</strong> derivati<strong>on</strong> of end points and key toxicological c<strong>on</strong>cerns<br />
and that further detail should be included in the evaluati<strong>on</strong> document.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> regarded the assumpti<strong>on</strong> of 10 percent dermal absorpti<strong>on</strong><br />
for flufenacet as acceptable. They agreed that a slight exceedance of the AOEL<br />
by predicted operator exposure from use of ‘ACH 210’ was acceptable, since<br />
the model used to predict exposure was very c<strong>on</strong>servative. A proposed use<br />
of smaller c<strong>on</strong>tainers would be expected to further reduce the risk.<br />
Members noted that for ‘Artist’ estimates of operator exposure were<br />
approximately two times greater than the AOEL. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered<br />
evidence that the POEM estimates were based <strong>on</strong> c<strong>on</strong>servative parameters.<br />
The applicant had submitted what they c<strong>on</strong>sidered to be ‘more realistic’<br />
exposure estimates, based <strong>on</strong> EUROPOEM, which were closer to the AOEL.<br />
The ACP c<strong>on</strong>cluded that although provisi<strong>on</strong>al approval was acceptable, a<br />
precauti<strong>on</strong>ary approach was required and the requirement for RPE should<br />
remain and further operator exposure data should be submitted to refine<br />
the risk assessment.<br />
13<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> had no c<strong>on</strong>cerns with respect to c<strong>on</strong>sumer exposure.<br />
The ACP noted that it was unclear whether the toxicological relevance of<br />
the soil metabolites M1 (flufenacet oxalate) and M2 (flufenacet sulf<strong>on</strong>ic acid)<br />
which could potentially c<strong>on</strong>taminate groundwater had been sufficiently<br />
addressed in the EU evaluati<strong>on</strong> and recommended that the SCP should<br />
c<strong>on</strong>sider this issue.<br />
The ACP agreed with the overall recommendati<strong>on</strong>s of the ecotoxicological<br />
assessment, noting that an acute risk to fish had been identified and a 5 m<br />
buffer z<strong>on</strong>e proposed for ‘ACH 210’. The risk to aquatic plants was c<strong>on</strong>sidered<br />
to be acceptable and the evidence suggested that the risk to algae was low.<br />
The ACP c<strong>on</strong>cluded that there was sufficient assurance <strong>on</strong> aquatic<br />
ecotoxicological grounds to allow provisi<strong>on</strong>al approval for ‘Artist’ and ‘ACH<br />
210’ but that the acceptability of the submitted microcosm study should be<br />
c<strong>on</strong>sidered by the SCP.<br />
The ACP expressed c<strong>on</strong>cern about the poor standard and lack of detail of<br />
the resistance management strategy submitted for ‘ACH 210’, particularly<br />
with respect to black-grass. An appropriate label warning was proposed.
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
The ACP agreed that, pending the Commissi<strong>on</strong> decisi<strong>on</strong> <strong>on</strong> inclusi<strong>on</strong> of<br />
flufenacet in Annex I of Council Directive 91/414/EEC, provisi<strong>on</strong>al approval<br />
could be recommended for ‘ACH 210’ and ‘Artist’ subject to label amendments<br />
and data requirements specified in the UK evaluati<strong>on</strong> document, which was<br />
also to be amended as requested by the <str<strong>on</strong>g>Committee</str<strong>on</strong>g>.<br />
Iodosulfur<strong>on</strong>-methyl-sodium<br />
Iodosulfur<strong>on</strong>-methyl-sodium (abbreviated to iodosulfur<strong>on</strong>) is a new<br />
sulf<strong>on</strong>ylurea herbicide intended for use to c<strong>on</strong>trol certain annual grass and<br />
broad-leaved weeds in cereals. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered an applicati<strong>on</strong> for<br />
approval of the product ‘Chekker’, a water dispersible granule c<strong>on</strong>taining<br />
iodosulfur<strong>on</strong>, amidosulfur<strong>on</strong> and mefenpyr-diethyl. Amidosulfur<strong>on</strong> is another<br />
sulf<strong>on</strong>ylurea herbicide that is present in a number of approved products.<br />
Mefenpyr-diethyl is a crop safener that is also present in some approved<br />
products. Iodosulfur<strong>on</strong> was also being c<strong>on</strong>sidered for inclusi<strong>on</strong> in Annex I<br />
of Directive 91/414/EEC with Germany acting as Rapporteur Member State.<br />
14<br />
Toxicological studies showed that both iodosulfur<strong>on</strong> and the formulated<br />
product are of low toxicity. The active substance did not require classificati<strong>on</strong><br />
<strong>on</strong> the grounds of human health effects. However, findings indicated that the<br />
product ‘Chekker’ should be labelled as an IRRITANT and carry the risk<br />
phrase ‘Irritating to eyes’.<br />
In both rats and dogs there was clear evidence of effects <strong>on</strong> the haematopoietic<br />
system, with the effects <strong>on</strong> dogs being far more pr<strong>on</strong>ounced. In the dog, at<br />
higher dose levels, effects included severe hyperplasia of haematopoietic tissues<br />
and extramedullary haematopoiesis al<strong>on</strong>g with marked depressi<strong>on</strong> of red cell<br />
parameters. The active substance iodosulfur<strong>on</strong> is to be used in combinati<strong>on</strong><br />
with the crop safener mefenpyr diethyl, which can also cause effects <strong>on</strong> blood<br />
parameters in rats, dogs and mice, indicative of a slight/mild anaemia, although<br />
not haematopoietic hyperplasia. These effects had been shown to be mostly<br />
reversible in the rat and dog. A study had been c<strong>on</strong>ducted with dogs to<br />
investigate the reversibility of the haematotoxic effects observed with<br />
iodosulfur<strong>on</strong>, and also to determine whether or not co-administrati<strong>on</strong> of the<br />
safener mefenpyr diethyl would alter the haematotoxicity profile. The study<br />
produced clear haematotoxicity in dogs dosed with iodosulfur<strong>on</strong> al<strong>on</strong>e, with<br />
the effects expressed primarily in decreased red blood cell counts, haemoglobin,<br />
and haematocrit. These changes were fully reversible after 6 weeks.<br />
Co-administrati<strong>on</strong> of iodosulfur<strong>on</strong> and mefenpyr diethyl caused no apparent<br />
increase in the severity of the toxicity observed although there was evidence
Secti<strong>on</strong> B: Applicati<strong>on</strong>s for provisi<strong>on</strong>al approvals for products c<strong>on</strong>taining new active substances<br />
of a modest interacti<strong>on</strong>. Again during the recovery period the effects of<br />
treatment were shown to be reversible.<br />
An acceptable daily intake (ADI) of 0.03 mg/kg bodyweight (bw)/day was<br />
agreed based <strong>on</strong> the no observed adverse effect level (NOAEL) for decreased<br />
bodyweight in a two-year combined carcinogenicity/chr<strong>on</strong>ic feeding study in<br />
rats and applying a standard assessment factor of 100. Iodosulfur<strong>on</strong> is not<br />
acutely toxic and therefore, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>cluded that it was not<br />
appropriate to set an acute reference dose (ARfD).<br />
An acceptable operator exposure level (AOEL) of 0.07 mg/kg bw/day was<br />
derived from the NOAEL in both 90-day and 12-m<strong>on</strong>th feeding studies in the<br />
dog (haemopoietic hyperplasia and increases in cholesterol levels in females<br />
were seen at higher doses) and applying a standard assessment factor of 100.<br />
As levels of radioactivity found in the urine in the dog ADME (absorpti<strong>on</strong>,<br />
distributi<strong>on</strong>, metabolism and excreti<strong>on</strong>) study indicated that, oral absorpti<strong>on</strong><br />
is almost complete (> 95 percent), a correcti<strong>on</strong> factor for incomplete oral<br />
absorpti<strong>on</strong> was not needed.<br />
Estimates of the exposure of operators, bystanders and workers to<br />
iodosulfur<strong>on</strong> resulting from the proposed use of ‘Chekker’ were c<strong>on</strong>siderably<br />
below the AOEL. However, mefenpyr-diethyl has photo-irritancy properties<br />
and therefore operators must wear coveralls and gloves when handling the<br />
c<strong>on</strong>centrated product.<br />
15<br />
Satisfactory data were submitted <strong>on</strong> the nature and magnitude of residues<br />
in cereals when iodosulfur<strong>on</strong> was used in accordance with the principles of<br />
good agricultural practice and also <strong>on</strong> residues in crops likely to be grown<br />
in successi<strong>on</strong>. These data were c<strong>on</strong>sidered to address the effects of the use<br />
of the crop safener mefenpyr-diethyl <strong>on</strong> crop residues. Estimates of dietary<br />
intakes by adults, children, toddlers and infants were substantially below<br />
the ADI.<br />
Iodosulfur<strong>on</strong> was shown to be of low toxicity to birds in acute, short-term<br />
dietary and reproducti<strong>on</strong> studies. The risk to birds was c<strong>on</strong>sidered to be<br />
acceptable. The risks to mammals, bees, n<strong>on</strong>-target terrestrial arthropods,<br />
earth-worms, soil microbial processes and to sewage treatment processes<br />
were all c<strong>on</strong>sidered acceptable. On the basis of the effects observed in<br />
algae, iodosulfur<strong>on</strong> was categorised as ‘Very toxic to aquatic organisms’. As<br />
iodosulfur<strong>on</strong> is not readily biodegradable, it was categorised as ‘May cause<br />
l<strong>on</strong>g-term adverse effects in the aquatic envir<strong>on</strong>ment’. The product, ‘Chekker’<br />
is highly toxic to the aquatic plant Lemna gibba (the most sensitive aquatic
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
organism tested) and should be classified as ‘EXTREMELY DANGEROUS TO<br />
FISH OR OTHER AQUATIC LIFE’. However, the risk to aquatic plants was<br />
c<strong>on</strong>sidered to be acceptable with a five metre buffer z<strong>on</strong>e.<br />
In soil, the main degradati<strong>on</strong> product of iodosulfur<strong>on</strong> is metsulfur<strong>on</strong>-methyl<br />
(also an approved sulf<strong>on</strong>ylurea herbicide). Iodosulfur<strong>on</strong>, metsulfur<strong>on</strong>-methyl<br />
and amidosulfur<strong>on</strong> could all reach surface water via drainflow. To address the<br />
potential risk to aquatic plants exposed to these substances as a c<strong>on</strong>sequence<br />
of drainflow, the applicant submitted data generated by the preferential flow<br />
model, MACRO 4.2. This was used to predict the movement of all three<br />
substances to field drains under a range of c<strong>on</strong>diti<strong>on</strong>s that could be<br />
encountered when ‘Chekker’ was applied to cereals. These data indicated<br />
that <strong>on</strong>ly in a very few excepti<strong>on</strong>al scenarios would the c<strong>on</strong>centrati<strong>on</strong>s of<br />
iodosulfur<strong>on</strong>, metsulfur<strong>on</strong>-methyl and amidosulfur<strong>on</strong> in surface water pose<br />
a risk to higher aquatic plants.<br />
16<br />
Iodosulfur<strong>on</strong> is a broad spectrum herbicide. Given its high level of activity,<br />
there is a potential risk from spray drift <strong>on</strong>to n<strong>on</strong>-target plants adjacent to<br />
treated areas. Therefore, in line with other sulf<strong>on</strong>ylurea based products, the<br />
warning phrase ‘Take extreme care to avoid drift <strong>on</strong>to crops and n<strong>on</strong>-target<br />
plants outside the target area’ must appear <strong>on</strong> the product label.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> recommended provisi<strong>on</strong>al approval for ‘Chekker’ for use <strong>on</strong><br />
cereals pending the Commissi<strong>on</strong> decisi<strong>on</strong> <strong>on</strong> inclusi<strong>on</strong> of iodosulfur<strong>on</strong> in<br />
Annex I of Council Directive 91/414/EEC.<br />
Mepanipyrim<br />
Mepanipyrim is a new anilinopyrimidine fungicide. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered<br />
an applicati<strong>on</strong> for approval of the product ‘Frupica’, a wettable powder, for<br />
use <strong>on</strong> strawberries to c<strong>on</strong>trol Botrytis cineria. The active substance is also<br />
being c<strong>on</strong>sidered for inclusi<strong>on</strong> in Annex I of Directive 91/414/EEC with Italy<br />
acting as Rapporteur Member State.<br />
Neither mepanipyrim nor the formulated product required classificati<strong>on</strong> for acute<br />
toxicity. An acceptable daily intake (ADI) of 0.025 mg/kg bodyweight (bw)/day<br />
was established, based <strong>on</strong> the no observed adverse effect level (NOAEL) of<br />
2.5 mg/kg bw/day for liver pathology, abnormal clinical chemistry and<br />
haematological changes seen in a rat carcinogenicity study and applying a<br />
standard assessment factor of 100. An acute reference dose (ARfD) of 0.3<br />
mg/kg bw was derived from the NOAEL of 30 mg/kg bw/day in rat and rabbit<br />
developmental toxicity studies (effects <strong>on</strong> maternal bodyweight) and applying<br />
a standard assessment factor of 100. A short-term acceptable operator
Secti<strong>on</strong> B: Applicati<strong>on</strong>s for provisi<strong>on</strong>al approvals for products c<strong>on</strong>taining new active substances<br />
exposure level (AOEL) of 0.07 mg/kg bw/day was determined using the<br />
NOAEL of 7 mg/kg bw/day from a 90-day rat study and applying a standard<br />
assessment factor of 100. A l<strong>on</strong>g-term AOEL of 0.025 mg/kg bw/day was<br />
derived using the NOAEL of 2.5 mg/kg bw/day from a chr<strong>on</strong>ic rat study and<br />
applying a standard assessment factor of 100. Correcti<strong>on</strong> for incomplete oral<br />
absorpti<strong>on</strong> was not necessary as mepanipyrim was shown to be almost totally<br />
absorbed at low dose levels.<br />
It was proposed that ‘Frupica’ be applied by tractor mounted or hand held<br />
sprayers. Provided operators wear an impermeable coverall when using hand<br />
held sprayers, operator exposure was estimated to be at about half of the AOEL.<br />
Sufficient data were submitted <strong>on</strong> the nature and magnitude of residues in<br />
strawberries when mepanipyrim was used in accordance with the principles<br />
of good agricultural practice. Estimates of l<strong>on</strong>g-term and acute c<strong>on</strong>sumer<br />
exposure were substantially below the ADI and ARfD, respectively.<br />
Use of ‘Frupica’ as a post-emergence treatment in strawberry crops was judged<br />
not to pose any unacceptable risks to birds, wild mammals, bees, other<br />
terrestrial arthropods, earthworms, soil macro- and micro-organisms, and to<br />
n<strong>on</strong>-target flora. The risk to aquatic life is also acceptable provided ‘Frupica’<br />
is applied using a five metre ‘no spray’ buffer z<strong>on</strong>e.<br />
17<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> recommended provisi<strong>on</strong>al approval for ‘Frupica’ for use <strong>on</strong><br />
strawberries pending the Commissi<strong>on</strong> decisi<strong>on</strong> <strong>on</strong> inclusi<strong>on</strong> of mepanipyrim<br />
in Annex I of Council Directive 91/414/EEC.<br />
Picolinafen<br />
Picolinafen is a new aryloxypicolinamide herbicide. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered<br />
an applicati<strong>on</strong> for approval of the product ‘AC 900001’, in which picolinafen<br />
was formulated as a water dispersible granule for use <strong>on</strong> winter wheat and<br />
winter barley.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered that there were no c<strong>on</strong>cerns regarding human<br />
exposure to acetaminophen (paracetamol) through the metabolic c<strong>on</strong>versi<strong>on</strong><br />
of picolinafen. In coming to this c<strong>on</strong>clusi<strong>on</strong>, they took account of the fact that<br />
<strong>on</strong>e of the enzymes involved in the formati<strong>on</strong> of acetaminophen might exhibit<br />
a genetic polymorphism.<br />
Members agreed that the acceptable daily intake (ADI) should be based<br />
<strong>on</strong> the no observed adverse effect level (NOAEL) of 1.3 mg picolinafen/kg<br />
bodyweight (bw)/day in a <strong>on</strong>e-year dog study. Adverse effects reported at<br />
higher doses were reduced bodyweight, bodyweight gain and food efficiency.
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
With a 100-fold assessment factor this gave an ADI of 0.013 mg/kg bw/day.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that an acute reference dose (ARfD) should be set,<br />
as it was possible that haemolysis could be caused after a single exposure.<br />
It c<strong>on</strong>sidered that the NOAEL of 11 mg/kg bw/day in a rat 28-day oral study<br />
was the most appropriate starting point for setting an ARfD. Adverse effects<br />
reported at higher doses were haemolysis as characterised by changes in<br />
haematology accompanied by splenic and Kupffer cell haemosiderin and<br />
haematopoiesis in b<strong>on</strong>e spleen and liver. Use of a 100-fold assessment factor<br />
gave an ARfD of 0.11 mg/kg bw/day. Calculated c<strong>on</strong>sumer exposures were<br />
acceptable.<br />
For derivati<strong>on</strong> of the acceptable operator exposure level (AOEL) it was<br />
c<strong>on</strong>sidered appropriate to use the NOAEL of 1.8 mg/kg bw/day from the<br />
90-day time point in a <strong>on</strong>e-year dog study. This was based <strong>on</strong> reducti<strong>on</strong>s in<br />
bodyweight, bodyweight gain and food efficiency in males at higher doses.<br />
Applying a 100-fold assessment factor and a correcti<strong>on</strong> factor of 60 percent to<br />
take account of incomplete oral absorpti<strong>on</strong> gave an AOEL of 0.01 mg/kg bw/day.<br />
18<br />
It was c<strong>on</strong>cluded that dermal absorpti<strong>on</strong> appeared to be greater than 10 percent<br />
as there seemed to be approximately equal levels of anaemia in rats dosed<br />
orally and dermally at around 100 mg/kg bw/day The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that<br />
without further data, a c<strong>on</strong>servative value of 25 percent dermal absorpti<strong>on</strong><br />
should be assumed. Operator, worker and bystander exposures were<br />
acceptable when calculated using this dermal absorpti<strong>on</strong> value.<br />
It was agreed that based <strong>on</strong> acute toxicity of the formulati<strong>on</strong> to algae, ‘AC<br />
900001’ required a classificati<strong>on</strong> of ‘Extremely dangerous to fish or aquatic<br />
life’. Initial risk assessment had indicated unacceptable risks to aquatic life.<br />
However, a microcosm study was presented which mimicked more realistic<br />
c<strong>on</strong>diti<strong>on</strong>s and indicated that effects <strong>on</strong> algae were transient with recovery<br />
occurring within six weeks. No direct or indirect effects <strong>on</strong> zooplankt<strong>on</strong> were<br />
observed. Based <strong>on</strong> this study, and the fact that <strong>on</strong>ly <strong>on</strong>e applicati<strong>on</strong> per crop<br />
was proposed and picolinafen did not persist in water, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g><br />
c<strong>on</strong>cluded that the risks to aquatic life were acceptable without a buffer z<strong>on</strong>e.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that the l<strong>on</strong>g-term risks of the active substance to<br />
earthworms were acceptable based <strong>on</strong> the low l<strong>on</strong>g-term persistence of<br />
picolinafen in soil. The main soil metabolite, picolinafen acid, was more<br />
persistent and its l<strong>on</strong>g-term risk to earthworms was c<strong>on</strong>sidered. An outdoor<br />
soil macro-organisms study indicated no adverse effect <strong>on</strong> the breakdown<br />
of leaf material over a six-m<strong>on</strong>th period in plots treated with 100 g<br />
picolinafen/ha. It was c<strong>on</strong>sidered reas<strong>on</strong>able to assume that the main
Secti<strong>on</strong> B: Applicati<strong>on</strong>s for provisi<strong>on</strong>al approvals for products c<strong>on</strong>taining new active substances<br />
soil metabolite would be present in this study. Members therefore agreed<br />
that the risks to earthworms posed by the metabolite were acceptable.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> recommended to Ministers that provisi<strong>on</strong>al approval should<br />
be granted for the product ‘AC 900001’ for a period of three years, pending<br />
the Commissi<strong>on</strong> decisi<strong>on</strong> <strong>on</strong> inclusi<strong>on</strong> of picolinafen in Annex I of Council<br />
Directive 91/414/EEC.<br />
Picoxystrobin<br />
Picoxystrobin is a new strobilurin fungicide. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered an<br />
applicati<strong>on</strong> for approval of <strong>on</strong>e product, ‘Acanto’, in which picoxystrobin<br />
was formulated as an emulsifiable c<strong>on</strong>centrate for use <strong>on</strong> wheat and barley.<br />
The active substance was also being c<strong>on</strong>sidered for inclusi<strong>on</strong> in Annex I<br />
of Directive 91/414/EEC with Ireland acting as Rapporteur Member State.<br />
Members agreed that the acceptable daily intake (ADI) should be based<br />
<strong>on</strong> the no observed adverse effect level (NOAEL) of 4.6 mg/kg bodyweight<br />
(bw)/day in a <strong>on</strong>e-year dog dietary study. With a 100-fold assessment factor,<br />
an ADI of 0.05 mg/kg bw/day was derived. The ACP agreed that the<br />
appropriate value for the acceptable operator exposure level (AOEL) was<br />
also 0.05 mg/kg bw/day. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> was c<strong>on</strong>tent that the estimates<br />
of exposure for operators, workers and bystanders were acceptable.<br />
19<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that in the absence of more relevant data, the acute<br />
reference dose (ARfD) should be the same as the ADI, 0.05 mg/kg bw/day.<br />
A residue definiti<strong>on</strong> of picoxystrobin was c<strong>on</strong>sidered appropriate, and<br />
estimates of c<strong>on</strong>sumer intake were regarded as acceptable.<br />
With respect to efficacy, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> noted that in general strobilurins did<br />
not have curative acti<strong>on</strong> and it agreed that some changes to the proposed<br />
label were required.<br />
The submitted envir<strong>on</strong>mental data were discussed and the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> was<br />
c<strong>on</strong>tent that the risk to aquatic organisms was acceptable. It was agreed that<br />
‘Acanto’ should be classified as ‘Dangerous to fish or other aquatic life’, <strong>on</strong> the<br />
basis of acute toxicity to Daphnia. The ACP discussed earthworm mortalities,<br />
which had been seen in a few field trials c<strong>on</strong>ducted in France in <strong>2001</strong>. It was<br />
noted that the toxicity exposure ratio (TER) in the risk assessment was very<br />
close to the trigger value and it c<strong>on</strong>sidered that the observed mortalities were<br />
therefore a c<strong>on</strong>cern. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> suggested that an interacti<strong>on</strong> with<br />
envir<strong>on</strong>mental stresses such as flooding could have caused the earthworm
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
deaths, but that further earthworm data should be required to clarify the risk<br />
assessment with a study protocol to be agreed with PSD.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> recommended provisi<strong>on</strong>al approval for use of ‘Acanto’ <strong>on</strong><br />
cereals pending the Commissi<strong>on</strong> decisi<strong>on</strong> <strong>on</strong> inclusi<strong>on</strong> of picoxystrobin in<br />
Annex I of Council Directive 91/414/EEC.<br />
Propoxycarbaz<strong>on</strong>e-sodium<br />
Propoxycarbaz<strong>on</strong>e-sodium (MKH 6561) is a sulf<strong>on</strong>ylaminocarb<strong>on</strong>yltriazolin<strong>on</strong>e<br />
herbicide, which acts by inhibiting the enzyme acetolactate synthase (ALS).<br />
The ACP c<strong>on</strong>sidered an applicati<strong>on</strong> for approval of propoxycarbaz<strong>on</strong>e-sodium<br />
in a plant protecti<strong>on</strong> product ‘Attribut’, for use to c<strong>on</strong>trol grass weeds in<br />
wheat. The formulati<strong>on</strong> was defined as a water soluble granule (SG), based <strong>on</strong><br />
the compound’s solubility in water. At the time of <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>siderati<strong>on</strong>,<br />
propoxycarbaz<strong>on</strong>e-sodium was new to the EC, with Germany acting as the<br />
Rapporteur Member State (RMS) for its inclusi<strong>on</strong> in Annex I of Council<br />
Directive 91/414/EEC.<br />
20<br />
Propoxycarbaz<strong>on</strong>e-sodium was of low acute toxicity. It was not classifiable<br />
as a skin or eye irritant, nor as a skin sensitiser. The compound was not<br />
shown to be <strong>on</strong>cogenic in mice or rats, or to have any neurotoxic potential.<br />
The ACP was satisfied that there was sufficient evidence to c<strong>on</strong>clude that the<br />
compound was not genotoxic and did not present a significant<br />
immunotoxicological hazard.<br />
The residue definiti<strong>on</strong> in crops was agreed to be the major plant metabolite<br />
M01 (2-hydroxy propoxy MKH 6561) <strong>on</strong>ly, based <strong>on</strong> supporting crop<br />
metabolism data and the results of residue trials. Members agreed that<br />
the acceptable daily intake (ADI) should be based <strong>on</strong> the NOAEL of<br />
43 mg/kg bodyweight (bw)/day from a 24-m<strong>on</strong>th combined chr<strong>on</strong>ic<br />
toxicity/carcinogenicity study in rats. With a 100-fold assessment factor, this<br />
gave an ADI of 0.4 mg/kg bw/day. An ARfD of 1 mg/kg bw was also agreed<br />
based <strong>on</strong> the NOAEL of 100 mg/kg in a rabbit developmental toxicity study,<br />
with a 100-fold assessment factor. Both of these reference values were<br />
c<strong>on</strong>sidered applicable for the metabolite M01.<br />
The ACP agreed that the short-term systemic acceptable operator exposure<br />
level (AOEL) should be based <strong>on</strong> the NOAEL of 100 mg/kg bw/day in a<br />
rabbit developmental toxicity study, (taking into account oral absorpti<strong>on</strong> of<br />
24 percent). With a 100-fold assessment factor, this gave an AOEL of 2 mg/kg bw.<br />
A l<strong>on</strong>g-term systemic AOEL was not c<strong>on</strong>sidered appropriate because of the<br />
short durati<strong>on</strong> of use of the product.
Secti<strong>on</strong> B: Applicati<strong>on</strong>s for provisi<strong>on</strong>al approvals for products c<strong>on</strong>taining new active substances<br />
Calculati<strong>on</strong>s indicated that the exposures of c<strong>on</strong>sumers, operators, workers<br />
and bystanders would be acceptable.<br />
Members agreed that the risk assessment for the fate and behaviour of the<br />
compound in the envir<strong>on</strong>ment indicated that adverse effects were unlikely.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> was satisfied that a computer modelling of leaching losses<br />
used appropriate scenarios, and showed that leaching of propoxycarbaz<strong>on</strong>esodium<br />
to groundwater was not expected to result in c<strong>on</strong>centrati<strong>on</strong>s as high<br />
as the EU 0.1 µg/l drinking water limit, following applicati<strong>on</strong> as proposed in<br />
the UK.<br />
The metabolites M05 (sulf<strong>on</strong>amide ester), M07 (saccharin) and M10 (N-methyl<br />
propoxy triazolin<strong>on</strong>e) were established as ‘not relevant’, in terms of biological<br />
activity, and mammalian toxicological and ecotoxicological significance.<br />
Metabolite M08 (4-hydroxy saccharin) was less mobile and c<strong>on</strong>sidered not to<br />
pose a risk of c<strong>on</strong>taminati<strong>on</strong> of groundwater. Predicted c<strong>on</strong>centrati<strong>on</strong>s of<br />
metabolite M09 (N-methyl propoxy triazolin<strong>on</strong>e amide) in ground water were<br />
less than 0.1 µg/l. The minor soil metabolites M04 (MKH 6561 carboxylic acid)<br />
and M06 (sulf<strong>on</strong>amide acid) were also not c<strong>on</strong>sidered relevant.<br />
Members c<strong>on</strong>sidered that the approach taken to calculate potential movement<br />
of the compound to drainage and to address the potential risk to higher<br />
aquatic plants from exposure via drains and surface streams, following the<br />
proposed use, was acceptable.<br />
21<br />
The risks to birds, terrestrial vertebrates, bees, earthworms, arthropods and soil<br />
micro-organisms from the proposed use of propoxycarbaz<strong>on</strong>e-sodium and<br />
metabolites formed in the envir<strong>on</strong>ment were c<strong>on</strong>sidered acceptable. The risk<br />
to n<strong>on</strong>-target plants was agreed to be acceptable with a label warning to<br />
minimise spray drift, in line with other ALS inhibitor herbicides. The risk to<br />
aquatic life was judged acceptable with appropriate risk mitigati<strong>on</strong> measures,<br />
(five metre buffer z<strong>on</strong>e to protect aquatic higher plants).<br />
The ACP agreed the wording of an amendment to the product label, to<br />
emphasise that when used to c<strong>on</strong>trol comm<strong>on</strong> couch, if black-grass was also<br />
a problem in the same field, then other herbicides with different modes<br />
of acti<strong>on</strong> which c<strong>on</strong>trol black-grass should also be applied in sequence,<br />
particularly where resistance was a problem.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> recommended provisi<strong>on</strong>al approval for ‘Attribut’ for use<br />
<strong>on</strong> winter wheat pending the Commissi<strong>on</strong> decisi<strong>on</strong> <strong>on</strong> inclusi<strong>on</strong> of<br />
propoxycarbaz<strong>on</strong>e-sodium in Annex I of Council Directive 91/414/EEC.
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
Members supported several c<strong>on</strong>firmatory data requirements proposed for<br />
inclusi<strong>on</strong> of propoxycarbaz<strong>on</strong>e-sodium in Annex I.<br />
Pyraclostrobin<br />
Pyraclostrobin (BAS 500F) is a new strobilurin fungicide. The ACP c<strong>on</strong>sidered<br />
an applicati<strong>on</strong> for use of ‘BAS 500 01F’ (trade name ‘Comet’), an emulsifiable<br />
c<strong>on</strong>centrate formulati<strong>on</strong> for c<strong>on</strong>trol of a range of fungal diseases in wheat,<br />
barley, oats, rye and triticale. The active substance is also being c<strong>on</strong>sidered<br />
for inclusi<strong>on</strong> in Annex I of Directive 91/414/EEC with Germany acting<br />
as Rapporteur Member State.<br />
‘BAS 500 01F’ was classified <strong>on</strong> the basis of toxicological properties as<br />
‘Harmful if swallowed and by inhalati<strong>on</strong>’ and ‘Irritating to skin’. An ADI of<br />
0.03 mg/kg bw/day was derived from the NOAEL of 3.4 mg/kg bw/day in<br />
a two-year rat chr<strong>on</strong>ic toxicity and carcinogenicity study. The NOAEL was<br />
based <strong>on</strong> reduced food efficiency and bodyweight gain, and liver cell<br />
necrosis in males.<br />
22<br />
An ARfD of 0.05 mg/kg bw/day was established based <strong>on</strong> a NOAEL of<br />
5 mg/kg bw/day from a rabbit developmental study, with reduced food<br />
c<strong>on</strong>sumpti<strong>on</strong> after gavage dosing at higher levels (this was the <strong>on</strong>ly acute<br />
systemic effect that could be identified as relevant for setting the ARfD).<br />
The residue profile was c<strong>on</strong>sidered to have been adequately addressed.<br />
Estimates of c<strong>on</strong>sumer intakes (from both chr<strong>on</strong>ic exposure and acute<br />
exposure over a single day) were well below the ADI and ARfD. An MRL<br />
of 0.2 mg/kg, based <strong>on</strong> the residue definiti<strong>on</strong> of parent pyraclostrobin,<br />
was c<strong>on</strong>sidered appropriate for wheat, barley and oats.<br />
A short-term systemic AOEL of 0.03 mg/kg bw/day was derived from a<br />
NOAEL in a 90-day dog study of 5.8 mg/kg bw/day based <strong>on</strong> hypertrophy<br />
of the duodenum in both sexes and bodyweight loss in females. The AOEL<br />
allowed for a 100-fold assessment factor. Estimated exposure to pyraclostrobin,<br />
arising from the use of ‘BAS 500 01F’, assuming gloves were worn when<br />
handling the c<strong>on</strong>centrate, was within the AOEL and thus c<strong>on</strong>sidered<br />
acceptable to operators, bystanders and other workers.<br />
The presence of minor phytotoxic effects combined with evidence of<br />
damage to some plants, including maize, in glasshouse screens meant that<br />
extrapolati<strong>on</strong> to rye or triticale could not be accepted without some<br />
c<strong>on</strong>firmatory data <strong>on</strong> the safety of ‘BAS 500 01F’ to these crops. Therefore<br />
it was recommended claims for use <strong>on</strong> these crops should be deleted from<br />
the label.
Secti<strong>on</strong> B: Applicati<strong>on</strong>s for provisi<strong>on</strong>al approvals for products c<strong>on</strong>taining new active substances<br />
Pyraclostrobin was classified as moderately persistent in soil (based <strong>on</strong> a<br />
field DT 50 of 55 days) whilst the <strong>on</strong>ly relevant metabolite 500M01 detected<br />
in the field was classified as persistent in soil (based <strong>on</strong> a laboratory DT 50<br />
of 166 days). Overall, the mobility and leaching studies dem<strong>on</strong>strated that<br />
pyraclostrobin and its metabolites were str<strong>on</strong>gly adsorbed to soil, largely<br />
n<strong>on</strong>-mobile and were not expected to represent a significant leaching risk.<br />
The risk to relevant wildlife groups from the proposed use of pyraclostrobin<br />
and ‘BAS 500 01F’ was assessed to be low. However, the product required<br />
labelling as ‘DANGEROUS TO FISH OR OTHER AQUATIC LIFE’, and a five<br />
metre buffer z<strong>on</strong>e was needed to manage the acute risk to fish.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> recommended provisi<strong>on</strong>al approval for ‘BAS 500 01F’ pending<br />
an EU decisi<strong>on</strong> <strong>on</strong> the inclusi<strong>on</strong> of pyraclostrobin in Annex I of Council<br />
Directive 91/414/EEC.<br />
Silthiofam<br />
Silthiofam (code name MON 65500) is a new benzamide fungicidal cereal seed<br />
treatment for c<strong>on</strong>trol of ‘take-all’ fungus (Gaeumannomyces graminis var.<br />
tritici). The active substance inhibits energy producti<strong>on</strong> within fungal cells.<br />
23<br />
Silthiofam was new to the EU and an applicati<strong>on</strong> for inclusi<strong>on</strong> in Annex I of<br />
EU Directive 91/414/EEC was being c<strong>on</strong>sidered by the Rapporteur Member<br />
State (RMS), Ireland. The ACP c<strong>on</strong>sidered a UK applicati<strong>on</strong> for approval for<br />
use of the product ‘Latitude’, a flowable c<strong>on</strong>centrate cereal seed treatment<br />
c<strong>on</strong>taining 125 g/l of silthiofam.<br />
Both the active substance and the product were not classifiable <strong>on</strong> the basis<br />
of acute mammalian toxicological studies. The ACP was c<strong>on</strong>tent with the<br />
proposed ADI of 0.05 mg/kg bw/day based <strong>on</strong> the no observed adverse effect<br />
level (NOAEL) of 5 mg/kg bw/day for liver pathology in a rat two-year study<br />
with a 100-fold assessment factor. An AOEL of 0.1 mg/kg bw/day was derived<br />
for silthiofam, based <strong>on</strong> the NOAEL of 10 mg/kg bw/day for liver weight gain<br />
and abnormal clinical chemistry in a 90-day dog study with a 100-fold<br />
assessment factor. An ARfD of 0.2 mg/kg bw/day was agreed, derived from a<br />
rabbit developmental study NOAEL for maternal toxicity (20 mg/kg bw/day)<br />
with a 100-fold assessment factor.<br />
No significant mutagenicity, carcinogenicity or reproductive toxicology<br />
c<strong>on</strong>cerns were identified. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that the mutagenic potential<br />
of two impurities (IMP 1 and IMP 4) present in the technical material had<br />
been adequately tested and was not a c<strong>on</strong>cern.
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
The ACP agreed that the estimated exposures of operators, bystanders,<br />
workers and c<strong>on</strong>sumers were acceptable. Two minor metabolites present<br />
in wheat but not found in the rat were c<strong>on</strong>sidered by the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> not<br />
to be a cause for c<strong>on</strong>cern.<br />
It was agreed that the potential for soil accumulati<strong>on</strong> was slight and the<br />
ACP c<strong>on</strong>cluded that the weight of evidence indicated an acceptable risk<br />
to n<strong>on</strong>-target organisms without the need for further data.<br />
The ACP also c<strong>on</strong>sidered potential groundwater c<strong>on</strong>taminati<strong>on</strong> and the<br />
likelihood of exceedance of the EU drinking water limit. It was noted that<br />
interpretati<strong>on</strong> of probabilistic modelling data, particularly involving preferential<br />
flow, was difficult and needed further elucidati<strong>on</strong>. However, the compound<br />
was applied at low rates and its sorpti<strong>on</strong> and persistence properties were not<br />
c<strong>on</strong>sistent with significant leaching. Overall the ACP agreed that the potential<br />
for c<strong>on</strong>taminati<strong>on</strong> of groundwater was likely to be low and was acceptable<br />
for approval.<br />
24<br />
The ACP initially required further assessment of the potential of silthiofam<br />
to accumulate in sediment and of the chr<strong>on</strong>ic risk presented to sedimentdwelling<br />
organisms. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> subsequently c<strong>on</strong>sidered a revised risk<br />
assessment based <strong>on</strong> potential cumulative depositi<strong>on</strong> scenarios in sediment<br />
and data from a chr<strong>on</strong>ic Daphnia study. It was c<strong>on</strong>cluded that the risk was<br />
acceptable for approval of silthiofam but that generic issues pertaining to<br />
exposure of sediment-dwelling organisms should be addressed.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> recommended provisi<strong>on</strong>al approval for ‘Latitude’ for use<br />
as a cereal seed treatment pending the Commissi<strong>on</strong> decisi<strong>on</strong> <strong>on</strong> inclusi<strong>on</strong><br />
of silthiofam in Annex 1 of Council Directive 91/414/EEC.<br />
Spinosad<br />
Spinosad is new macrolide insecticide with a novel mode of acti<strong>on</strong> <strong>on</strong> the<br />
insect nervous system. The active substance was also being c<strong>on</strong>sidered for<br />
inclusi<strong>on</strong> in Annex I of Directive 91/414/EEC with Netherlands acting as<br />
Rapporteur Member State.<br />
The ACP c<strong>on</strong>sidered authorisati<strong>on</strong> of ‘C<strong>on</strong>serve’ (formerly ‘NAF-313’), a<br />
suspensi<strong>on</strong> c<strong>on</strong>centrate formulati<strong>on</strong> c<strong>on</strong>taining 120 g/l of the active substance<br />
spinosad. The proposed use of the product was for the c<strong>on</strong>trol of western<br />
flower thrips (Frankliniella occidentalis) in protected ornamental plant<br />
producti<strong>on</strong>.
Secti<strong>on</strong> B: Applicati<strong>on</strong>s for provisi<strong>on</strong>al approvals for products c<strong>on</strong>taining new active substances<br />
Spinosad c<strong>on</strong>sists of a mixture of two active, structurally similar molecules,<br />
spinosyn A and spinosyn D. It is produced by a submerged fermentati<strong>on</strong><br />
process using a strain of Saccharopolyspora spinosa. Approval of a broad ratio<br />
of the two spinosyns had been requested. However, the ACP stipulated that<br />
the technical specificati<strong>on</strong> for the product should be based <strong>on</strong> the submitted<br />
batch analysis, hence reflecting the test material used in the assessments.<br />
When comparing the findings for spinosyn A and spinosyn D, there were no<br />
major differences in the bioavailability, routes or rates of excreti<strong>on</strong>, or<br />
metabolism. The <strong>on</strong>ly notable differences were that excreti<strong>on</strong> in urine and bile<br />
(and therefore absorpti<strong>on</strong>) of spinosyn A was slightly higher than for spinosyn<br />
D. Also the amount of unchanged spinosyn D in faeces was higher than<br />
spinosyn A.<br />
The toxicity of spinosad, spinosyn A, and spinosyn D was generally similar,<br />
but spinosyn D was slightly less toxic than spinosyn A. Vacuolati<strong>on</strong> was the<br />
primary effect associated with exposure. It was observed <strong>on</strong> histopathological<br />
examinati<strong>on</strong> of a wide range of tissues in all test species, and was apparently<br />
reversible.<br />
In accordance with European classificati<strong>on</strong> criteria, spinosad was not<br />
classifiable <strong>on</strong> the basis of acute toxicity, skin or eye irritati<strong>on</strong>, or skin<br />
sensitisati<strong>on</strong>. It showed low short-term and chr<strong>on</strong>ic toxicity, and there was<br />
also no indicati<strong>on</strong> of a genotoxic, carcinogenic or neurotoxic hazard.<br />
25<br />
In a teratogenicity study in rats, there was an apparent increase in the<br />
incidence of microphthalmia at doses below maternal toxicity. However,<br />
based <strong>on</strong> historical c<strong>on</strong>trol data this finding was c<strong>on</strong>sidered to be incidental<br />
to treatment and not of c<strong>on</strong>cern.<br />
The ACP agreed an ADI of 0.02 mg/kg bw/day, derived from a 24-m<strong>on</strong>th oral<br />
toxicity study in rats and based <strong>on</strong> effects (vacuolati<strong>on</strong> and inflammati<strong>on</strong>)<br />
seen in the thyroid glands. An assessment factor for inter- and intraspecies<br />
differences of 100 was applied to the NOAEL of 2.4 mg/kg bw/day. The<br />
<str<strong>on</strong>g>Committee</str<strong>on</strong>g> also agreed that it was not appropriate to set an ARfD for<br />
spinosad. The applicati<strong>on</strong> under c<strong>on</strong>siderati<strong>on</strong> was <strong>on</strong>ly for use <strong>on</strong><br />
protected ornamentals, and no exposure to c<strong>on</strong>sumers was expected.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>cluded that an oral study should be used to set the<br />
AOEL. The AOEL for short-term exposure was based <strong>on</strong> effects (vacuolati<strong>on</strong><br />
in several tissues and other microscopic changes) seen in an oral 90-day<br />
study in the dog. An assessment factor of 100 and a factor of 0.5 (to correct
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
for incomplete oral absorpti<strong>on</strong>) were applied to the NOAEL of 4.89 mg/kg<br />
bw/day. This resulted in a systemic short-term AOEL of 0.02 mg/kg bw/day.<br />
The informati<strong>on</strong> submitted <strong>on</strong> operator exposure was c<strong>on</strong>sidered sufficient to<br />
support approval of ‘C<strong>on</strong>serve’ for use <strong>on</strong> ornamental crops. No further data<br />
were required. However, use of protective gloves and coveralls when handling<br />
the product and during applicati<strong>on</strong> when applying by hand-held equipment or<br />
handling c<strong>on</strong>taminated surfaces was recommended. Modelling of operator<br />
exposure with this level of pers<strong>on</strong>al protective equipment (PPE) predicted<br />
exposures at or below the AOEL.<br />
The evaluati<strong>on</strong> indicated that recommended uses of ‘C<strong>on</strong>serve’ might result in<br />
exposure of bystanders, but this was acceptable, as the extent of exposure<br />
was likely to be significantly less than the AOEL. With respect to worker<br />
exposure, the estimated systemic exposure from the use of ‘C<strong>on</strong>serve’ under<br />
cover (glass or plastic) was less than the AOEL. Therefore, worker exposure<br />
was also judged acceptable, with no requirement for PPE or a re-entry interval.<br />
26<br />
Given the proposed use, it was c<strong>on</strong>sidered that envir<strong>on</strong>mental c<strong>on</strong>taminati<strong>on</strong><br />
(i.e. to soil, surface water and groundwater) by the active substance and its<br />
metabolites from direct use was likely to be limited. The incorporati<strong>on</strong> of<br />
spinosad-c<strong>on</strong>taminated compost (as waste from ornamental plant producti<strong>on</strong>)<br />
into field soils was c<strong>on</strong>sidered to pose a low risk with respect to terrestrial<br />
organisms, rotati<strong>on</strong>al field crops and c<strong>on</strong>taminati<strong>on</strong> of surface and ground water.<br />
The proposed use <strong>on</strong> protected ornamentals would result in limited exposure<br />
of wildlife. Spinosad is highly toxic to bees and certain n<strong>on</strong>-target arthropod<br />
species. Neither of these groups of organisms would be directly exposed at<br />
the time of applicati<strong>on</strong>. However, bees and other n<strong>on</strong>-target arthropods might<br />
be attracted to certain types of treated ornamentals subsequently moved to<br />
outside locati<strong>on</strong>s. Therefore, the risk to bees from residues of spinosad was<br />
assessed. It was c<strong>on</strong>sidered, <strong>on</strong> the basis of field studies, to be acceptable.<br />
Studies <strong>on</strong> the residual toxicity of spinosad to a range arthropod species used<br />
in Integrated Pest Management (IPM) systems indicated that toxicity of the<br />
compound declines with age. These studies provided reassurance that<br />
significant impacts <strong>on</strong> natural populati<strong>on</strong>s of n<strong>on</strong>-target arthropods would<br />
be unlikely.<br />
Spinosad is of moderate toxicity to certain groups of aquatic life (i.e. Daphnia<br />
magna and Chir<strong>on</strong>omus riparius). Therefore, the product was classified as<br />
‘Harmful to fish and other aquatic life’. Potential c<strong>on</strong>taminati<strong>on</strong> of surface<br />
water via spray drift and drainage was c<strong>on</strong>sidered to be minimal from the
Secti<strong>on</strong> B: Applicati<strong>on</strong>s for provisi<strong>on</strong>al approvals for products c<strong>on</strong>taining new active substances<br />
proposed use. Therefore, no formal risk assessment for aquatic organisms<br />
was c<strong>on</strong>ducted. Spinosad is of low toxicity to other forms of wildlife<br />
(i.e. mammals, birds, earthworms and soil microbial processes). Given the<br />
low toxicity and limited exposure, the risk to these groups was c<strong>on</strong>sidered<br />
sufficiently low not to warrant detailed assessment.<br />
The efficacy data submitted were c<strong>on</strong>sidered sufficient to support the use<br />
of ‘C<strong>on</strong>serve’ to c<strong>on</strong>trol western flower thrips in protected ornamentals.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> recommended that ‘C<strong>on</strong>serve’ should be granted a provisi<strong>on</strong>al<br />
approval for use <strong>on</strong> protected ornamentals under the Plant Protecti<strong>on</strong> Product<br />
Regulati<strong>on</strong>s, for three years pending the Commissi<strong>on</strong> decisi<strong>on</strong> <strong>on</strong> inclusi<strong>on</strong> of<br />
spinosad in Annex I of Council Directive 91/414/EEC. The ACP highlighted a<br />
number of issues to be discussed as part of the European c<strong>on</strong>siderati<strong>on</strong>.<br />
Sulfosulfur<strong>on</strong><br />
Sulfosulfur<strong>on</strong> is a new sulf<strong>on</strong>ylurea herbicide. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered an<br />
applicati<strong>on</strong> for approval of the product ‘M<strong>on</strong>itor’, a water dispersible granule,<br />
for use <strong>on</strong> winter wheat to c<strong>on</strong>trol certain grass and broad-leaved weeds.<br />
The active substance was also being c<strong>on</strong>sidered for inclusi<strong>on</strong> in Annex I of<br />
Directive 91/414/EEC with Ireland acting as Rapporteur Member State.<br />
27<br />
Sulfosulfur<strong>on</strong> and the formulated product are of low acute toxicity and are not<br />
classifiable <strong>on</strong> the grounds of human health effects. For both the acceptable<br />
daily intake (ADI) and systemic acceptable operator exposure level (AOEL),<br />
the toxic end point was the formati<strong>on</strong> of calculi and associated lesi<strong>on</strong>s in the<br />
urinary bladder. An ADI of 0.24 mg/kg bw/day was agreed, based <strong>on</strong> a no<br />
observable adverse effect level (NOAEL) of 24 mg/kg bw/day observed in<br />
a two-year combined carcinogenicity/chr<strong>on</strong>ic feeding study in the rat and<br />
applying a 100-fold assessment factor. A systemic AOEL of 1.0 mg/kg bw/day<br />
was set, based <strong>on</strong> the NOAEL of 100 mg/kg bw/day observed in a 90-day dog<br />
study and a 100-fold assessment factor. A correcti<strong>on</strong> for oral absorpti<strong>on</strong> was<br />
not c<strong>on</strong>sidered necessary for sulfosulfur<strong>on</strong> because absorpti<strong>on</strong>, distributi<strong>on</strong>,<br />
metabolism and excreti<strong>on</strong> (ADME) studies indicated a high extent of oral<br />
absorpti<strong>on</strong>. A dermal AOEL of 10 mg/kg bw/day was set based <strong>on</strong> the limit<br />
dose of 1000 mg/kg bw/day used in a 28-day dermal study in the rat (the<br />
study showed no effects related to treatment) and applying a 100-fold<br />
assessment factor. This was in line with the systemic AOEL (1.0 mg/kg<br />
bw/day) when the default dermal absorpti<strong>on</strong> value of ten percent was<br />
applied. A c<strong>on</strong>servative estimate of operator exposure was two percent<br />
of the systemic AOEL.
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
Acceptable data were available <strong>on</strong> the nature and magnitude of residues that<br />
would result in wheat when sulfosulfur<strong>on</strong> was used in accordance with the<br />
principles of Good Agricultural Practice. Estimates of c<strong>on</strong>sumer dietary intakes<br />
were significantly lower than the ADI.<br />
The risks to birds, terrestrial vertebrates, bees, earthworms and soil microorganisms<br />
from the proposed use of sulfosulfur<strong>on</strong> and from metabolites<br />
formed in the envir<strong>on</strong>ment were c<strong>on</strong>sidered acceptable. The potential risk<br />
to aquatic higher plants is high. On the basis of its toxicity to Lemna gibba,<br />
‘M<strong>on</strong>itor’ is classified as extremely dangerous to aquatic organisms. A five<br />
metre no spray z<strong>on</strong>e was c<strong>on</strong>sidered sufficient to manage the risk to aquatic<br />
higher plants from spray drift.<br />
28<br />
Sulfosulfur<strong>on</strong> might reach surface waters via drainflow. To address the<br />
potential risk to aquatic higher plants posed by parent compound as a<br />
c<strong>on</strong>sequence of drainflow, the applicant submitted modelling data for a<br />
number of scenarios covering five soil types and three climate types and<br />
using weather data for 30 years. These data indicated that <strong>on</strong>ly in a very few<br />
excepti<strong>on</strong>al scenarios would the c<strong>on</strong>centrati<strong>on</strong> of sulfosulfur<strong>on</strong> in surface<br />
water pose a risk to higher aquatic plants.<br />
The data <strong>on</strong> n<strong>on</strong>-target plants provided indicated that there is a potential risk to<br />
plants close to the treated area. It was therefore recommended that the product<br />
label should carry a str<strong>on</strong>g warning to avoid drift <strong>on</strong>to n<strong>on</strong>-target plants.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> recommended provisi<strong>on</strong>al approval for ‘M<strong>on</strong>itor’ for use <strong>on</strong><br />
winter wheat pending the Commissi<strong>on</strong> decisi<strong>on</strong> <strong>on</strong> inclusi<strong>on</strong> of sulfosulfur<strong>on</strong><br />
in Annex I of Council Directive 91/414/EEC.<br />
Zoxamide<br />
Zoxamide (Development code RH-7281) is the ISO proposed name for a new<br />
fungicide intended to c<strong>on</strong>trol late blight <strong>on</strong> potato and downy mildew <strong>on</strong><br />
grape. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered an applicati<strong>on</strong> for approval of RH-7281<br />
mancozeb, a water dispersible granule c<strong>on</strong>taining both zoxamide and<br />
mancozeb, a fungicidally active substance used in a number of products that<br />
are already approved for use in the UK. It was noted that the use of the two<br />
active substances in combinati<strong>on</strong> provided improved disease c<strong>on</strong>trol over that<br />
achieved with mancozeb al<strong>on</strong>e and allowed for a reducti<strong>on</strong> in the rate of use<br />
for mancozeb. Zoxamide is also being c<strong>on</strong>sidered for inclusi<strong>on</strong> in Annex I of<br />
Directive 91/414/EEC with the UK acting as Rapporteur Member State.
Secti<strong>on</strong> B: Applicati<strong>on</strong>s for provisi<strong>on</strong>al approvals for products c<strong>on</strong>taining new active substances<br />
The ACP c<strong>on</strong>sidered that zoxamide and the formulated products were of low<br />
toxicity but could cause sensitisati<strong>on</strong> by skin c<strong>on</strong>tact. Therefore, both the<br />
active substance and the formulated products were classified as “Irritant”.<br />
Metabolism in the rat was moderately rapid and distributi<strong>on</strong> to organs and<br />
tissues was extensive. However, eliminati<strong>on</strong> was also rapid and almost<br />
complete. In toxicology studies, the dog was found to be the most sensitive<br />
species tested. An ADI of 2.6 mg/kg bw/day, a short term AOEL of 1.7 mg/kg<br />
bw/day and l<strong>on</strong>g-term AOEL of 1.5 mg/kg bw/day were agreed. The ADI and<br />
l<strong>on</strong>g-term AOEL were derived from the NOAEL from a <strong>on</strong>e-year dog study<br />
where liver effects were seen at higher doses. The short-term AOEL was<br />
derived from the NOAEL from a 90-day dog study where reduced bodyweight<br />
gain and changes in red blood cell parameters were seen at higher doses. In<br />
all cases, a standard assessment factor of 100 was used to derive the reference<br />
values. As zoxamide was of low acute toxicity no ARfD was set.<br />
The exposures of operators, bystanders and workers to zoxamide were low<br />
and c<strong>on</strong>sidered to be at acceptable levels. An extensive data package was<br />
presented <strong>on</strong> the nature and magnitude of residues in potatoes, grapes and<br />
rotati<strong>on</strong>al crops that were likely to result from the use of zoxamide in<br />
accordance with the principles of Good Agricultural Practice. Estimates of<br />
dietary exposure for humans and domestic animals were low.<br />
29<br />
Given the effects seen in tests with the alga Scenedesmus subspicatus, and<br />
evidence that the active substance was not readily biodegradable, zoxamide<br />
was categorised as ‘Very toxic to aquatic organisms’ and ‘May cause l<strong>on</strong>g-term<br />
adverse effects in the aquatic envir<strong>on</strong>ment’. On this basis, zoxamide was<br />
classified as ‘Dangerous for the envir<strong>on</strong>ment’. The formulated products were<br />
classified as ‘Dangerous to fish and other aquatic life’.<br />
The risks to birds, terrestrial vertebrates, bees, earthworms and soil microorganisms<br />
from the proposed use of zoxamide and from metabolites formed<br />
in the envir<strong>on</strong>ment were c<strong>on</strong>sidered acceptable. The risk to aquatic life was<br />
acceptable with appropriate risk mitigati<strong>on</strong> measures. Uses <strong>on</strong> potatoes and<br />
grapes were recommended in the UK with five metre and twenty metre buffer<br />
z<strong>on</strong>es respectively for the protecti<strong>on</strong> of aquatic life. The need for risk<br />
mitigati<strong>on</strong> measures, to be c<strong>on</strong>sidered at Member State level, was highlighted<br />
for n<strong>on</strong>-target arthropods. In the UK, it was proposed that this be addressed<br />
by an advisory label phrase for the product.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> recommended provisi<strong>on</strong>al approval for ‘RH-7281/mancozeb<br />
75% WG’ for use <strong>on</strong> potatoes and grapes pending the Commissi<strong>on</strong> decisi<strong>on</strong> <strong>on</strong><br />
inclusi<strong>on</strong> of zoxamide in Annex I of Council Directive 91/414/EEC. It was also
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
agreed that the draft assessment report could be forwarded to the European<br />
Commissi<strong>on</strong> for c<strong>on</strong>siderati<strong>on</strong> of inclusi<strong>on</strong> <strong>on</strong> Annex I of Council Directive<br />
91/414/EEC.<br />
Commodity<br />
substances<br />
Commodity substances are compounds, which have a variety of alternative<br />
and often widespread n<strong>on</strong>-pesticidal uses but also have potential use as a<br />
pesticide. For a commodity substance to be used as a pesticide it requires<br />
approval under COPR. Approval is given <strong>on</strong>ly for use of the substance,<br />
which is not formulated; (approval is not given for sale, storage, supply or<br />
advertisement). There is no approval holder and no pesticide product label<br />
but the approval and associated c<strong>on</strong>diti<strong>on</strong>s of use are published in the<br />
‘<strong>Pesticides</strong> Guide’ <strong>on</strong> www.pesticides.gov.uk/blue_book/c<strong>on</strong>tents.htm<br />
No new applicati<strong>on</strong>s for commodity substances approval were<br />
c<strong>on</strong>sidered during <strong>2001</strong>.<br />
30
Secti<strong>on</strong> C: Inclusi<strong>on</strong> of new active substances in Annex I of Directive 91/414/EEC<br />
Secti<strong>on</strong> C:<br />
Inclusi<strong>on</strong> of new active substances<br />
in Annex I of Directive 91/414/EEC<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered the following active substances for inclusi<strong>on</strong> <strong>on</strong><br />
Annex I of Directive 91/414/EEC:<br />
●<br />
ACETAMIPRID<br />
●<br />
AZAFENIDIN<br />
●<br />
BENZOIC ACID<br />
●<br />
D-CARVONE<br />
●<br />
PROFOXYDIM<br />
●<br />
DIMETHENAMID-P<br />
●<br />
●<br />
FORAMSULFURON<br />
S-METOLACHLOR<br />
31<br />
Acetamiprid<br />
Acetamiprid is a new chlor<strong>on</strong>icotinyl insecticide. It is foliar applied and<br />
acts, by ingesti<strong>on</strong> and c<strong>on</strong>tact, as an antag<strong>on</strong>ist to the neurotransmitter<br />
acetylcholine at the neuro-binding site leading to insect paralysis. It is<br />
a new pesticide to the EU.<br />
The EU applicati<strong>on</strong> had been evaluated by Greece, the Rapporteur Member<br />
State (RMS), and a Draft Assessment <strong>Report</strong> (DAR) prepared. The DAR<br />
assessed the product ‘Gazelle’, a water soluble powder (SP) c<strong>on</strong>taining<br />
202g/kg acetamiprid used to c<strong>on</strong>trol aphids, leaf miner and whitefly in citrus,<br />
pome and st<strong>on</strong>e fruits; fruiting vegetables (tomato, aubergine & pepper);<br />
cott<strong>on</strong> and tobacco. Although no applicati<strong>on</strong>s for UK uses had been notified,<br />
both northern and southern EU uses were c<strong>on</strong>sidered in the DAR and future<br />
UK use was possible. The DAR had been distributed to all Member States for<br />
c<strong>on</strong>siderati<strong>on</strong> in the EU peer review process.<br />
The ACP was invited to c<strong>on</strong>sider the DAR and provide written comments. The<br />
summary was c<strong>on</strong>sidered to be lacking transparency and c<strong>on</strong>sequently it was<br />
difficult to follow the derivati<strong>on</strong> of end points. Derivati<strong>on</strong> of the ARfD from a
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
sub chr<strong>on</strong>ic neurotoxicity study was c<strong>on</strong>sidered more appropriate than the<br />
method proposed. The absence of dermal studies was also noted.<br />
Azafenidin<br />
Azafenidin is a selective triazol<strong>on</strong>e herbicide new to the EU. It affects sensitive<br />
weeds through inhibiti<strong>on</strong> of protoporphyrinogen oxidase involved in the<br />
protoporphyrin biosynthesis pathway.<br />
The EU applicati<strong>on</strong> had been evaluated by Spain, the Rapporteur Member<br />
State (RMS), and a Draft Assessment <strong>Report</strong> (DAR) prepared. The DAR<br />
c<strong>on</strong>sidered the use of a water dispersible granule formulati<strong>on</strong> c<strong>on</strong>taining<br />
800g/kg azafenidin, to be used in grape vineyards, citrus and olive orchards<br />
to c<strong>on</strong>trol broad-leaved weeds. No applicati<strong>on</strong>s for use in the UK had<br />
been made.<br />
32<br />
The DAR had been distributed to all Member States for c<strong>on</strong>siderati<strong>on</strong> in the<br />
EU peer review process. The RMS proposed a postp<strong>on</strong>ement of a decisi<strong>on</strong><br />
<strong>on</strong> inclusi<strong>on</strong> of azafenidin in Annex I of Directive 91/414/EEC until evaluati<strong>on</strong><br />
of certain further data.<br />
ACP members provided written comments <strong>on</strong> the assessment that generally<br />
agreed with the report but questi<strong>on</strong>ed some aspects of the toxicology<br />
assessment.<br />
Benzoic acid<br />
Benzoic acid is a c<strong>on</strong>tact disinfectant. Its proposed uses in horticulture<br />
(floriculture) were regarded as within the remit of EU Directive 91/414/EEC<br />
for c<strong>on</strong>siderati<strong>on</strong> as a new pesticide active substance.<br />
The EU applicati<strong>on</strong> had been evaluated by Germany, the Rapporteur Member<br />
State (RMS), and a Draft Assessment <strong>Report</strong> (DAR) prepared. The DAR<br />
assessed a soluble liquid (SL) formulati<strong>on</strong> c<strong>on</strong>taining 90 g/l benzoic acid<br />
used for the c<strong>on</strong>trol of fungi, bacteria, viruses and viroids by disinfecti<strong>on</strong><br />
of surfaces, culture vessels and equipment by watering, dipping and soaking<br />
in glasshouses and similar protected cultivati<strong>on</strong> areas. There had been no<br />
applicati<strong>on</strong>s for UK use. The DAR had been distributed to all Member States<br />
for c<strong>on</strong>siderati<strong>on</strong> in the EU peer review process.<br />
The ACP c<strong>on</strong>sidered the DAR and draft comments prepared by PSD. The<br />
<str<strong>on</strong>g>Committee</str<strong>on</strong>g> noted that benzoic acid was an approved food additive and agreed<br />
with the proposed ADI and AOEL and, as no effects were seen in acute<br />
studies, that an ARfD was not needed. Members noted that the in vitro
Secti<strong>on</strong> C: Inclusi<strong>on</strong> of new active substances in Annex I of Directive 91/414/EEC<br />
teratogenicity screening test had not been validated. The ACP was c<strong>on</strong>tent<br />
with the envir<strong>on</strong>mental risk assessment, particularly as the use was largely<br />
in glasshouses, and agreed with the comments <strong>on</strong> appropriate disposal of<br />
benzoic acid.<br />
D-Carv<strong>on</strong>e<br />
Carv<strong>on</strong>e is a naturally occurring terpenoid compound and is the main<br />
ingredient of caraway oil, which is prepared by fracti<strong>on</strong>al distillati<strong>on</strong> of<br />
caraway seed oil. Carv<strong>on</strong>e is a racemic mixture of D and L stereoisomers.<br />
Carv<strong>on</strong>e is used as a plant growth regulator, possibly acting by reversible<br />
enzyme inhibiti<strong>on</strong> in the plant terpenoid (meval<strong>on</strong>ic acid) biosynthetic<br />
pathway. The partially resolved isomer, D-carv<strong>on</strong>e (>4:1 D:L enantiomers),<br />
was regarded as a new active substance within the remit of EU Directive<br />
91/414/EEC.<br />
The EU applicati<strong>on</strong> had been evaluated by Netherlands, the Rapporteur<br />
Member State (RMS), and a Draft Assessment <strong>Report</strong> (DAR) prepared. The<br />
DAR assessed the product ‘Talent’ a liquid c<strong>on</strong>taining 950 g/l carv<strong>on</strong>e applied<br />
by fogging equipment in enclosed potato stores to suppress potato sprouting.<br />
There had been no UK applicati<strong>on</strong>s for use of carv<strong>on</strong>e, although a future<br />
applicati<strong>on</strong> was possible. The DAR had been distributed to all Member States<br />
for c<strong>on</strong>siderati<strong>on</strong> in the EU peer review process.<br />
33<br />
The ACP c<strong>on</strong>sidered the DAR and draft comments prepared by PSD. The<br />
<str<strong>on</strong>g>Committee</str<strong>on</strong>g> noted that carv<strong>on</strong>e was a natural product and a zero exposure<br />
level was not achievable. It was accepted that informati<strong>on</strong> based <strong>on</strong><br />
experience of use could be extrapolated to human exposure scenarios.<br />
The ACP noted that estimated c<strong>on</strong>sumer exposures exceeded the proposed<br />
ADI, but that the estimates were likely to err <strong>on</strong> the high side. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g><br />
also observed that there were no teratogenic effects. However, overall the<br />
<str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that the logic of the safety assessment was not well<br />
presented and derivati<strong>on</strong> of the end points was largely unsubstantiated,<br />
and supported the c<strong>on</strong>clusi<strong>on</strong>s and shortcomings that PSD had identified.<br />
Profoxydim<br />
Profoxydim (also previously known as clefoxydim) is a new cyclohexan<strong>on</strong>e<br />
herbicide. It is racemic mixture of four (E/Z-R/S) stereoisomers, each<br />
purportedly having equal biological activity. The mode of acti<strong>on</strong> is inhibiti<strong>on</strong><br />
of the acetyl coenzyme A carboxylase (ACCase) activity in the lipid<br />
biosynthetic pathway of sensitive plant species. It is a new pesticide to the EU.
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
The EU applicati<strong>on</strong> had been evaluated by Spain, the Rapporteur Member<br />
State (RMS), and a Draft Assessment <strong>Report</strong> (DAR) prepared. The DAR<br />
assessed the product ‘Aura’ an emulsifiable c<strong>on</strong>centrate (EC) c<strong>on</strong>taining 200<br />
g/l profoxydim. It is a c<strong>on</strong>tact herbicide to be used in combinati<strong>on</strong> with an<br />
adjuvant for the c<strong>on</strong>trol of Echinochloa crus-galli, an annual grass weed, in<br />
rice crops. No other uses had been notified and there were no applicati<strong>on</strong>s<br />
for approval for use of profoxydim-c<strong>on</strong>taining products in the UK. The DAR<br />
had been distributed to all Member States for c<strong>on</strong>siderati<strong>on</strong> in the EU peer<br />
review process.<br />
34<br />
The ACP was invited to c<strong>on</strong>sider the DAR and provide written comments. It<br />
was noted that the toxicological implicati<strong>on</strong>s of there being four enantiomers<br />
had not been c<strong>on</strong>sidered and the method of analysis did not distinguish<br />
individual enantiomers. Anaemia had been identified as an adverse effect but<br />
had not been fully characterised and discussed. The carcinogenicity identified<br />
in the liver and urinary tract was regarded as n<strong>on</strong>-genotoxic but a n<strong>on</strong>genotoxic<br />
mechanism had not been proposed. The reas<strong>on</strong>ing for setting an<br />
ARfD (based <strong>on</strong> the ADI) was c<strong>on</strong>sidered unclear, and the appropriateness of<br />
basing the AOEL <strong>on</strong> a 12-m<strong>on</strong>th dog study, was also questi<strong>on</strong>ed. It was noted<br />
that incomplete uptake by the gut (66 percent) may not have been taken into<br />
account in deriving the proposed AOEL.<br />
Dimethenamid-p<br />
Dimethenamid, a racemic mixture of P and M enantiomers, bel<strong>on</strong>gs to the<br />
chloroacetamide class of herbicides. The molecular mode of acti<strong>on</strong> of<br />
chloroacetamides has not been fully elucidated but growth of germinating and<br />
developing seedlings is severely inhibited apparently due to effects <strong>on</strong> cell<br />
divisi<strong>on</strong> in meristematic tissue, possibly mediated via interacti<strong>on</strong> with protein<br />
thiol (SH) groups. The resolved isomer, dimethenamid-P (approximate 96:4<br />
P:M enantiomer ratio) is c<strong>on</strong>sidered to be a new active ingredient within the<br />
remit of EU Directive 91/414/EEC.<br />
The EU applicati<strong>on</strong> had been evaluated by Germany, the Rapporteur Member<br />
State (RMS), and a Draft Assessment <strong>Report</strong> (DAR) prepared. The DAR<br />
assessed an emulsifiable c<strong>on</strong>centrate (EC) formulati<strong>on</strong> c<strong>on</strong>taining 720 g/l active<br />
substance, which is used to c<strong>on</strong>trol broad-leaved and grass weeds in maize<br />
and sugar beet. Uses were proposed both in northern and southern European<br />
Member States, but no applicati<strong>on</strong>s for use in the UK had been made.
Secti<strong>on</strong> C: Inclusi<strong>on</strong> of new active substances in Annex I of Directive 91/414/EEC<br />
The DAR had been distributed to all Member States for c<strong>on</strong>siderati<strong>on</strong> in the<br />
EU peer review process. A number of key deficiencies and minor issues were<br />
identified that had to be addressed prior to inclusi<strong>on</strong> of dimethenamid-P in<br />
Annex 1 of Directive 91/414 EEC.<br />
The ACP c<strong>on</strong>sidered the DAR and draft comments prepared by PSD. The key<br />
c<strong>on</strong>cern related to the data available to support the c<strong>on</strong>tenti<strong>on</strong> that activity<br />
resided solely in the P-isomer and the possibility that adjustment to the<br />
proposed ADI and AOEL could be required. The ACP agreed that the <strong>on</strong>e year<br />
dog study was appropriate to set the ARfD. A further in vivo UDS study was<br />
c<strong>on</strong>sidered unnecessary, particularly as the submitted in vitro study was<br />
negative and the dosing in the available in vivo study was acceptable. The<br />
ACP noted that metabolites M23 and M27 were mobile and persistent and<br />
might c<strong>on</strong>taminate ground water. Thus evidence could be needed that these<br />
metabolites were not toxicologically relevant. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> commented that<br />
acceptable uses could <strong>on</strong>ly be achieved using large buffer z<strong>on</strong>es that would<br />
currently not be acceptable in the UK. It was also noted that there was no<br />
aquatic plant risk assessment for exposure via drainflow, which would be<br />
relevant in c<strong>on</strong>siderati<strong>on</strong> of any UK use.<br />
35<br />
Foramsulfur<strong>on</strong><br />
Foramsulfur<strong>on</strong> is a new sulf<strong>on</strong>ylurea herbicide. The biochemical target site is<br />
the enzyme acetolactate synthase (ALS) in the aliphatic amino acid pathway in<br />
sensitive plants. It is a new pesticide to the EU.<br />
The EU applicati<strong>on</strong> had been evaluated by Germany, the Rapporteur Member<br />
State (RMS), and a Draft Assessment <strong>Report</strong> (DAR) prepared. The DAR<br />
assessed the product ‘Equip’, a n<strong>on</strong>-aqueous oil-based suspensi<strong>on</strong> c<strong>on</strong>centrate<br />
(SC), c<strong>on</strong>taining 22.5 g/l foramsulfur<strong>on</strong> and 22.5 g/l of a safener. The safener,<br />
isoxadifen-ethyl, acts by increasing foramsulfur<strong>on</strong> degradati<strong>on</strong> in meristematic<br />
regi<strong>on</strong>s of the crop. The product is intended to c<strong>on</strong>trol post-germinati<strong>on</strong> grass<br />
and dicotyled<strong>on</strong>ous weed species in maize (not seed or sweet maize). No UK<br />
applicati<strong>on</strong>s had been notified. The DAR had been distributed to all Member<br />
States for c<strong>on</strong>siderati<strong>on</strong> in the EU peer review process.<br />
The ACP was invited to c<strong>on</strong>sider the DAR and provide written comments. The<br />
DAR was c<strong>on</strong>sidered to be well produced and the toxicological end points<br />
acceptable, provided the interpretati<strong>on</strong>s of toxicological studies were<br />
appropriate. It was also agreed that setting an ARfD was unnecessary.
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
S-metolachlor<br />
Metolachlor bel<strong>on</strong>gs to the chloroacetamide class of herbicides, which inhibit<br />
germinati<strong>on</strong> and seedling growth via effects <strong>on</strong> cell divisi<strong>on</strong>. It is a racemic<br />
mixture of four R and S stereoisomers. The partially resolved S-metolachlor<br />
isomeric form (>80–100 percent S form/0–20 percent R form) is c<strong>on</strong>sidered<br />
to be a new active ingredient in the EU within the remit of EU Directive<br />
91/414/EEC.<br />
The EU applicati<strong>on</strong> had been evaluated by Belgium, the Rapporteur Member<br />
State (RMS), and a Draft Assessment <strong>Report</strong> (DAR) prepared. The DAR<br />
assessed the product ‘Dual Gold 960 EC’ an emulsifiable c<strong>on</strong>centrate (EC)<br />
c<strong>on</strong>taining 960 g/l S-metolachlor used to c<strong>on</strong>trol annual weeds in maize,<br />
sweetcorn, sorghum, beet crops, sunflower, soybean and potato in northern<br />
and southern EU Member States. There had been no applicati<strong>on</strong>s for use of<br />
S-metolachlor in the UK, although future applicati<strong>on</strong>s were possible. The DAR<br />
had been distributed to all Member States for c<strong>on</strong>siderati<strong>on</strong> in the EU peer<br />
review process.<br />
36<br />
The ACP c<strong>on</strong>sidered the DAR and draft comments prepared by PSD. The<br />
<str<strong>on</strong>g>Committee</str<strong>on</strong>g> noted that the aquatic risk was <strong>on</strong>ly acceptable with stipulati<strong>on</strong><br />
of a large (10–20 m) buffer z<strong>on</strong>e, which would not currently be an opti<strong>on</strong> for<br />
UK use. Overall the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> endorsed the critique provided by PSD.
37<br />
Secti<strong>on</strong> D: Experimental approvals and permits<br />
Secti<strong>on</strong> D:<br />
Experimental approvals and permits<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> recommended experimental approval for products based <strong>on</strong><br />
the following active substances:<br />
●<br />
CLOMAZONE<br />
●<br />
GLUFOSINATE-AMMONIUM<br />
●<br />
GLYPHOSATE<br />
●<br />
IODOSULFURON-METHYL-SODIUM
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
Secti<strong>on</strong> E:<br />
UK Review Programme<br />
38<br />
Routine reviews<br />
Agricultural<br />
use<br />
The UK routine review programme was established by the ACP in 1989.<br />
In 1994, steps were taken to integrate this work with the EC review<br />
programme. Under the EC programme all UK-approved active substances<br />
were to be reassessed over a 10-year period. The UK programme was<br />
therefore stepped down.<br />
In 1998 it was decided that, because the progress of the EU programme<br />
was disappointingly slow, a new round of UK reviews should be initiated.<br />
A review of 40 anticholinesterase compounds was therefore commenced in<br />
additi<strong>on</strong> to the c<strong>on</strong>tinued partial reviews of compounds initiated in resp<strong>on</strong>se<br />
to the submissi<strong>on</strong> of adverse data.<br />
● AZAMETHIPHOS<br />
● BONE OIL<br />
● CHLORPYRIFOS-METHYL<br />
●<br />
Chlorpyrifos – (dog study)<br />
●<br />
●<br />
CHLORPYRIFOS – ORNAMENTAL BULB DIPPING<br />
DICHLOROPHEN<br />
●<br />
DICHLORVOS<br />
●<br />
DIMETHOATE<br />
●<br />
MALATHION<br />
●<br />
OXAMYL<br />
●<br />
PHOSPHIDES<br />
●<br />
PIRIMICARB<br />
●<br />
PIRIMIPHOS-METHYL<br />
●<br />
TOLCLOFOS-METHYL
Secti<strong>on</strong> E: UK Review Programme<br />
Azamethiphos<br />
Azamethiphos is an organophosphorus insecticide, formulated as a wettable<br />
powder, approved for use in animal and poultry houses. This review was part<br />
of the routine UK review programme of anticholinesterase compounds.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that a repeat exposure acceptable operator exposure<br />
(AOEL) value should be set at 0.002 mg/kg bodyweight (bw)/day based <strong>on</strong><br />
the no observed adverse effect level (NOAEL) of 0.2 mg/kg bw/day for<br />
cholinesterase inhibiti<strong>on</strong> in a 13-week neurotoxicity study in rats. This end<br />
point was also used as the basis for setting an acceptable daily intake (ADI)<br />
of 0.002 mg/kg bw/day. In additi<strong>on</strong>, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that it was<br />
relevant to set a single exposure AOEL value of 0.01 mg/kg bw based <strong>on</strong><br />
full cholinesterase inhibiti<strong>on</strong> recovery seen after 14 days in the single dose<br />
neurotoxicity study in rats. This single exposure AOEL value would <strong>on</strong>ly be<br />
used where the use pattern could be restricted to not more than <strong>on</strong>ce every<br />
14 days. This end point was also used as the basis for setting an acute<br />
reference dose (ARfD) of 0.01 mg/kg bw. For these reference values, a<br />
100-fold assessment factor was used.<br />
With regard to operator exposure, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> noted that estimates<br />
indicated that operator exposure levels would be below the AOEL and that a<br />
minimum 14-day interval should be specified where azamethiphos is applied<br />
by brush or a combinati<strong>on</strong> of brush and spray applicati<strong>on</strong>s.<br />
39<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that risks to c<strong>on</strong>sumers were acceptable because no<br />
residues should occur in products of animal origin and c<strong>on</strong>sequently there<br />
would be no significant residues of azamethiphos in the diet of humans.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>cluded that approvals could c<strong>on</strong>tinue subject to the<br />
impositi<strong>on</strong> of additi<strong>on</strong>al operator protecti<strong>on</strong> and worker protecti<strong>on</strong><br />
requirements and subject to the provisi<strong>on</strong> of further data.<br />
At a subsequent meeting, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered the evaluati<strong>on</strong> of three<br />
new genotoxicity studies. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that although the findings<br />
suggested a possible genotoxic hazard at high doses, further investigati<strong>on</strong> of<br />
this hazard would <strong>on</strong>ly be justified if the available toxicology studies did not<br />
provide adequate reassurance about possible carcinogenicity or developmental<br />
toxicity. It was agreed that the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> should rec<strong>on</strong>sider the relevant<br />
toxicology data before agreeing final recommendati<strong>on</strong>s. This matter was to<br />
be c<strong>on</strong>sidered by the ACP at the January 2002 meeting.
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
B<strong>on</strong>e oil<br />
B<strong>on</strong>e oil has been used as a repellent against various animals since the 1890s.<br />
Following the introducti<strong>on</strong> of the C<strong>on</strong>trol of <strong>Pesticides</strong> Regulati<strong>on</strong>s (COPR)<br />
in 1986, approval was granted for the outdoor use of a product c<strong>on</strong>taining<br />
b<strong>on</strong>e oil as a repellent in the home garden.<br />
The ACP noted that it had set requirements in November 1999 for a<br />
descripti<strong>on</strong> of a more standardised manufacturing process to ensure that the<br />
c<strong>on</strong>stituents of b<strong>on</strong>e oil fell within a defined range together with the resultant<br />
technical specificati<strong>on</strong> details.<br />
Data had since been submitted but the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered that a<br />
satisfactory risk assessment could not be c<strong>on</strong>ducted because a large<br />
proporti<strong>on</strong> of the b<strong>on</strong>e oil remained uncharacterised. The b<strong>on</strong>e oil was of<br />
a potentially variable nature and was manufactured in a way that did not<br />
exclude the possibility of harmful compounds being present.<br />
40<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>cluded that despite a serious attempt, the approval holder<br />
had been unable to meet the requirements satisfactorily and therefore the<br />
<str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered that approval for ‘Renardine 72–2’ (MAFF 06769)<br />
should be revoked.<br />
However, in resp<strong>on</strong>se to representati<strong>on</strong>s from the approval holder, the<br />
<str<strong>on</strong>g>Committee</str<strong>on</strong>g> rec<strong>on</strong>sidered b<strong>on</strong>e oil at a subsequent meeting at which the<br />
approval holder made a presentati<strong>on</strong>. The ACP remained doubtful that it<br />
would be possible to generate further data to address their c<strong>on</strong>cerns within<br />
a reas<strong>on</strong>able timeframe. However, they agreed not to provide advice to<br />
Ministers until they had received further guidance from an independent<br />
chemist. They would c<strong>on</strong>sider b<strong>on</strong>e oil again when this advice was received.<br />
Chlorpyrifos-methyl – envir<strong>on</strong>mental risk assessment<br />
Chlorpyrifos-methyl is an insecticide for the fabric treatment of cereal grain<br />
stores/handling machinery and for use in food storage in the treatment of<br />
cereal grain.<br />
The ACP c<strong>on</strong>sidered that the sole approved use of chlorpyrifos-methyl in the<br />
UK, for post-harvest protecti<strong>on</strong> of cereal grain, would not lead to any direct<br />
c<strong>on</strong>taminati<strong>on</strong> of soil or water, either during or after applicati<strong>on</strong>. It was<br />
c<strong>on</strong>sidered that direct polluti<strong>on</strong> of air in the open envir<strong>on</strong>ment might occur<br />
during venting or fumigati<strong>on</strong> procedures at storage facilities. However, such<br />
polluti<strong>on</strong> would be limited in geographical extent and durati<strong>on</strong> and would<br />
occur <strong>on</strong>ly in the locality of the storage facility. C<strong>on</strong>centrati<strong>on</strong>s in the air
Secti<strong>on</strong> E: UK Review Programme<br />
would rapidly dissipate and dissipati<strong>on</strong> could be expected to be enhanced by<br />
the moderate volatility of chlorpyrifos-methyl. Any material that did volatilise<br />
was unlikely to be persistent in the atmosphere.<br />
Some informati<strong>on</strong> had been provided to show the envir<strong>on</strong>mental fate and<br />
behaviour of chlorpyrifos-methyl in soil, water and air should accidental<br />
exposure occur. As a precauti<strong>on</strong> and in line with other products, the ACP<br />
c<strong>on</strong>sidered that the standard warning ‘Exclude wildlife from buildings during<br />
treatment’ should appear <strong>on</strong> the product label.<br />
The ACP recommended that current approvals for chlorpyrifos-methyl should<br />
be allowed to c<strong>on</strong>tinue.<br />
Chlorpyrifos – dog study<br />
At its meeting in July 2000 the ACP had c<strong>on</strong>sidered a proposed acceptable<br />
daily intake (ADI) and acceptable operator exposure level (AOEL) of 0.01<br />
mg/kg bodyweight (bw) [which was in line with that set by the Joint<br />
FAO/WHO Meeting <strong>on</strong> Pesticide Residues (JMPR)].<br />
Although no new scientific data had become available to raise c<strong>on</strong>cerns<br />
about chlorpyrifos, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> had been c<strong>on</strong>cerned that the evidence<br />
underpinning the proposed ADI was not as str<strong>on</strong>g as it would like to see, in<br />
particular regarding the possibility of effects <strong>on</strong> the peripheral nervous system.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> had therefore requested a four-week study in dogs to provide<br />
the reassurance sought. Ministers’ agreement to the ACP recommendati<strong>on</strong>s<br />
had not been reached. However, the company had undertaken a six-week<br />
study in dogs of the type required.<br />
41<br />
The new study showed that within the peripheral tissues there was no<br />
c<strong>on</strong>sistent inhibiti<strong>on</strong> of acetyl cholinesterase (AChE) activity in any tissue.<br />
Where inhibiti<strong>on</strong> was recorded, it was not dose-related (with the excepti<strong>on</strong><br />
of the atrium in males), and in no tissue was inhibiti<strong>on</strong> recorded c<strong>on</strong>sistently<br />
in both sexes. There were no statistically significant effects in any peripheral<br />
tissue. It was c<strong>on</strong>cluded that the differences recorded in peripheral tissues<br />
resulted from a natural variati<strong>on</strong> in AChE activity rather than treatment-related<br />
effects. Also the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> did not c<strong>on</strong>sider that the inhibiti<strong>on</strong> in the atrium<br />
in males was a treatment-related effect. No inhibiti<strong>on</strong> was recorded in females,<br />
and it was c<strong>on</strong>sidered to be biologically implausible that there would be a<br />
sex difference in the effects of chlorpyrifos which <strong>on</strong>ly affected atrial tissue<br />
and no other tissue.
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
Overall the ACP c<strong>on</strong>cluded that this study showed no marked difference in<br />
sensitivity to AChE inhibiti<strong>on</strong> between brain AChE and AChE in peripheral<br />
tissues. Red blood cell (RBC) AChE was significantly more sensitive. Therefore<br />
reference values based <strong>on</strong> no observed adverse effect levels (NOAELs) for<br />
inhibiti<strong>on</strong> of brain AChE would be expected to cover AChE in the peripheral<br />
nervous system, and reference values based <strong>on</strong> inhibiti<strong>on</strong> of red blood cell<br />
AChE in dogs would be c<strong>on</strong>servative. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> thus decided that<br />
reference values for chlorpyrifos should be based <strong>on</strong> NOAELs for inhibiti<strong>on</strong> of<br />
brain AChE in dogs, since the results of the dog study examining peripheral<br />
tissues suggest that such reference values would also protect the peripheral<br />
nervous system. It was c<strong>on</strong>cluded that the ADI and AOEL for chlorpyrifos<br />
should be maintained at 0.01 mg/kg bw/day.<br />
On the basis of this reference value the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> recommended that<br />
approvals for chlorpyrifos could c<strong>on</strong>tinue as previously recommended.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> also asked that some further investigati<strong>on</strong> of drench<br />
treatment with chlorpyrifos be carried out.<br />
42<br />
Chlorpyrifos – ornamental bulb dipping<br />
When the ACP had c<strong>on</strong>sidered chlorpyrifos in July 2000, it had recommended,<br />
am<strong>on</strong>g other things, that off-label approval for use as a bulb dip should be<br />
revoked unless a suitable protocol for an operator exposure study was<br />
provided within eight weeks. However, subsequent to the ACP c<strong>on</strong>siderati<strong>on</strong>,<br />
the off-label approval for this use expired and no further acti<strong>on</strong> was taken.<br />
The ACP heard that this approval had been allowed to lapse through oversight<br />
<strong>on</strong> the part of the off-label applicants and was an important use which grower<br />
groups were prepared to c<strong>on</strong>tinue to support. The ACP noted that exposure<br />
had been estimated using the Health and Safety Executive’s (HSE’s) waterbased<br />
timber pre-treatment model based <strong>on</strong> 95 th percentile values and that<br />
estimated exposure was 130 percent of the AOEL. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> felt that<br />
when based <strong>on</strong> the usual 75 th percentile values, estimated exposures were<br />
likely to fall within the AOEL.<br />
The ACP recommended that the off-label approval for the use of chlorpyrifos<br />
for bulb dipping should be reinstated and that the secretariat should c<strong>on</strong>sider,<br />
with the off-label applicants, further refinement of the risk assessment<br />
including handling of treated bulbs and disposal of dipping soluti<strong>on</strong>.<br />
Note: The recommendati<strong>on</strong> to reinstate the off-label approval was not a<br />
unanimous c<strong>on</strong>clusi<strong>on</strong> of the <str<strong>on</strong>g>Committee</str<strong>on</strong>g>.
Secti<strong>on</strong> E: UK Review Programme<br />
Dichlorophen<br />
See n<strong>on</strong>-agricultural uses, page 52.<br />
Dichlorvos<br />
Dichlorvos is a c<strong>on</strong>tact, ingesti<strong>on</strong> and inhalati<strong>on</strong> insecticide, approved for use<br />
in agricultural situati<strong>on</strong>s. This active substance was c<strong>on</strong>sidered as part of the<br />
UK review of anticholinesterase compounds. Three products were covered<br />
in the review of agricultural uses – ‘Nuvan 500 EC’, used to c<strong>on</strong>trol flies and<br />
mites in animal units, particularly poultry houses; and ‘Luxan Dichlorvos 600’<br />
and ‘Luxan Dichlorvos Aerosol 15’, used in glasshouses to c<strong>on</strong>trol insect pests<br />
of cucumbers and other protected edible and n<strong>on</strong>-edible crops. The review<br />
c<strong>on</strong>sidered human health issues <strong>on</strong>ly. N<strong>on</strong>-agricultural uses were also<br />
c<strong>on</strong>sidered in parallel by the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> (see page 53).<br />
Two approval holders, who provided data relating to the active substance and<br />
products, supported the review. The ACP also took into c<strong>on</strong>siderati<strong>on</strong><br />
additi<strong>on</strong>al comments <strong>on</strong> the importance of the use of dichlorvos in<br />
glasshouses, supplied by representatives of the horticultural industry.<br />
Based <strong>on</strong> all the informati<strong>on</strong> then available, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed in April<br />
<strong>2001</strong> that Ministers should be advised:<br />
43<br />
●<br />
●<br />
To revoke approvals for use of ‘Nuvan 500 EC’ in animal husbandry, where<br />
animals were present at the time of treatment. Use of the product where<br />
animals were not present during applicati<strong>on</strong> could c<strong>on</strong>tinue, subject to the<br />
provisi<strong>on</strong> of further data.<br />
To suspend, with immediate effect for approval holders and their agents,<br />
the use of ‘Luxan Dichlorvos 600’ and ‘Luxan Dichlorvos Aerosol 15’ <strong>on</strong><br />
cucumbers and other edible crops because there was insufficient<br />
reassurance that l<strong>on</strong>g-term dietary exposures would be acceptable.<br />
Members did not identify any immediate c<strong>on</strong>sumer c<strong>on</strong>cerns, and advised<br />
that use of existing stocks of the products <strong>on</strong> edible crops could c<strong>on</strong>tinue<br />
for a further two years. They recommended that reinstatement of uses <strong>on</strong><br />
edible crops should depend <strong>on</strong> the approval holders satisfactorily<br />
addressing c<strong>on</strong>cerns about the l<strong>on</strong>g-term exposures of c<strong>on</strong>sumers by<br />
submissi<strong>on</strong> of further data. Approvals for the use of ‘Luxan Dichlorvos 600’<br />
and ‘Luxan Dichlorvos Aerosol 15’ <strong>on</strong> ornamentals could c<strong>on</strong>tinue, subject<br />
to the provisi<strong>on</strong> of data.
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
●<br />
●<br />
●<br />
That approvals for all c<strong>on</strong>tinuing uses (both animal husbandry and<br />
glasshouse crop use) should be amended to impose a requirement for<br />
the use of automated applicati<strong>on</strong> equipment, to ensure that operators are<br />
excluded from structures during applicati<strong>on</strong>.<br />
That approvals should be subject to provisi<strong>on</strong> of further data (physicalchemical<br />
properties, methods of analysis, mammalian toxicology, operator<br />
exposure and c<strong>on</strong>sumer exposure).<br />
That approval holders must notify their intent to support these approvals<br />
within short deadlines.<br />
The ACP also noted that dichlorvos was under discussi<strong>on</strong> by the <str<strong>on</strong>g>Committee</str<strong>on</strong>g><br />
<strong>on</strong> Mutagenicity of Chemicals in Food, C<strong>on</strong>sumer Products and the<br />
Envir<strong>on</strong>ment (COM), and recognised that the above recommendati<strong>on</strong>s would<br />
perhaps require modificati<strong>on</strong> in accordance with the COM’s findings.<br />
44<br />
At the May ACP meeting, members were informed that the COM findings were<br />
not finalised, and thus it maintained its recommendati<strong>on</strong>s from the previous<br />
meeting, with the minor change that ‘clean-up’ use <strong>on</strong> empty glasshouses<br />
could remain, subject to the use of automated applicati<strong>on</strong> machinery and the<br />
provisi<strong>on</strong> of further data.<br />
At the same time as the ACP review of dichlorvos, the COM reviewed all the<br />
available mutagenicity data. The COM produced a preliminary statement,<br />
c<strong>on</strong>cluding that dichlorvos was an in-vivo mutagen (i.e. capable of causing<br />
mutati<strong>on</strong>s in living animals) at the site of c<strong>on</strong>tact. Approval holders were<br />
invited to provide comments <strong>on</strong> this c<strong>on</strong>clusi<strong>on</strong>.<br />
At the July ACP meeting, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered the possible implicati<strong>on</strong>s<br />
of the draft COM statement, and agreed to advise Ministers as follows:<br />
If COM’s final c<strong>on</strong>clusi<strong>on</strong>s were that dichlorvos was an in-vivo mutagen,<br />
and COM could not exclude the possibility that the occurrence of tumours<br />
in animal tests of carcinogenicity resulted from a genotoxic mechanism,<br />
there should be immediate revocati<strong>on</strong> of all uses (both agricultural and<br />
n<strong>on</strong>-agricultural).<br />
This was to include recall of stocks from the supply chain for products<br />
used in both the amateur and professi<strong>on</strong>al areas. This advice was given<br />
as a precauti<strong>on</strong>ary measure, since the possibility of human genotoxic<br />
carcinogenicity could not be excluded. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that any risk<br />
of human carcinogenicity was likely to be very small, and would be mainly<br />
associated with certain uses in the home and with exposures to some
Secti<strong>on</strong> E: UK Review Programme<br />
operators in the agricultural sector. The c<strong>on</strong>sumpti<strong>on</strong> of produce already<br />
treated with dichlorvos (sourced from within or outside the UK) would not<br />
raise the same level of c<strong>on</strong>cern since the levels of dietary exposure (based<br />
<strong>on</strong> food residues m<strong>on</strong>itoring data) were c<strong>on</strong>sidered minimal.<br />
Alternatively, if COM c<strong>on</strong>cluded that dichlorvos was an in-vivo mutagen, but<br />
that the tumours observed in animal tests did not result from a genotoxic<br />
mechanism, or if it could not c<strong>on</strong>firm that dichlorvos was an in-vivo mutagen,<br />
or it took the view that dichlorvos was not an in-vivo mutagen, the ACP’s<br />
previous recommendati<strong>on</strong>s would be maintained.<br />
Following c<strong>on</strong>siderati<strong>on</strong> of all the available mutagenicity data, and comments<br />
from the data owners, the COM c<strong>on</strong>cluded that dichlorvos should be regarded<br />
as an in-vivo mutagen at site of c<strong>on</strong>tact, and that it could not exclude the<br />
possibility of it acting as a genotoxic carcinogen. It finalised a statement <strong>on</strong><br />
30 July <strong>2001</strong>. The ACP c<strong>on</strong>sidered the COM advice, and whilst they recognised<br />
that any risks from exposure would be low, they agreed that the possibility<br />
of genotoxic carcinogenicity could not be excluded. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> therefore<br />
recommended to Ministers that, as a precauti<strong>on</strong>ary measure, it would be<br />
prudent to revoke, with immediate effect, all agricultural and n<strong>on</strong>-agricultural<br />
uses of dichlorvos.<br />
45<br />
Before such regulatory acti<strong>on</strong> could be carried out, AMVAC Chemical UK Ltd<br />
(an approval holder) obtained an injuncti<strong>on</strong>, which prevented regulatory<br />
acti<strong>on</strong>. Government agencies were also prohibited from making any<br />
announcement to the public about the regulatory acti<strong>on</strong> that was proposed.<br />
The approval holder also gained permissi<strong>on</strong> for a judicial review, which was<br />
heard in November <strong>2001</strong>.<br />
The grounds for the challenge were that AMVAC had not been properly<br />
informed of the proposed regulatory acti<strong>on</strong> or the basis for it, and had not<br />
been given sufficient time to make representati<strong>on</strong>s. AMVAC also claimed that<br />
Ministers had not given proper regard to the precauti<strong>on</strong>ary principle and to<br />
the European C<strong>on</strong>venti<strong>on</strong> <strong>on</strong> Human Rights.<br />
The judgement of the Court was issued <strong>on</strong> 3 December <strong>2001</strong>. Mr Justice Crane<br />
rejected most of the company’s submissi<strong>on</strong>s, including those c<strong>on</strong>cerning the<br />
precauti<strong>on</strong>ary principle and the C<strong>on</strong>venti<strong>on</strong> <strong>on</strong> Human Rights. However, he<br />
ruled that the company had been given insufficient time to resp<strong>on</strong>d to the<br />
c<strong>on</strong>clusi<strong>on</strong>s of the Government’s expert advisers prior to regulatory acti<strong>on</strong><br />
being taken. He accepted that the matter was urgent but c<strong>on</strong>sidered that the<br />
claimant had now had full opportunity to present any further material.
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
During the period of the injuncti<strong>on</strong>, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> were unable to publish the<br />
minutes of their meetings. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> had c<strong>on</strong>cerns that this compromised<br />
the openness of the advice given to Ministers, and could thereby have<br />
an adverse effect <strong>on</strong> public c<strong>on</strong>fidence in the regulatory process. They were<br />
also c<strong>on</strong>cerned that speculati<strong>on</strong> about the missing minutes might create<br />
unwarranted public anxiety. Notwithstanding these c<strong>on</strong>cerns, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g><br />
agreed that while rapid implementati<strong>on</strong> of regulatory acti<strong>on</strong> was desirable<br />
<strong>on</strong>ce decisi<strong>on</strong>s had been made, it was also important that the regulatory<br />
process be fair and open to scrutiny. In this case, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g>’s advice had<br />
been precauti<strong>on</strong>ary (i.e. based <strong>on</strong> insufficient reassurance that exposures to<br />
the compound were acceptable rather than direct evidence that people were<br />
being harmed), and the delay caused by the legal acti<strong>on</strong> would be acceptable<br />
provided that it was not unduly prol<strong>on</strong>ged.<br />
Following the Court judgement, approval holders for both agricultural and<br />
n<strong>on</strong>-agricultural products were asked to provide any further informati<strong>on</strong><br />
relating to the potential genotoxic carcinogenicity of dichlorvos. This<br />
informati<strong>on</strong> would be c<strong>on</strong>sidered by the ACP at the earliest opportunity in 2002.<br />
46<br />
Dimethoate<br />
Dimethoate was reviewed as part of the UK review of anticholinesterase<br />
compounds. Dimethoate is a broad-spectrum c<strong>on</strong>tact and systemic<br />
organophosphorus insecticide, formulated as an emulsifiable c<strong>on</strong>centrate.<br />
Products c<strong>on</strong>taining dimethoate are approved for use in agriculture,<br />
horticulture and the home garden <strong>on</strong> a range of crops.<br />
The ACP noted that dimethoate had previously been reviewed as part of<br />
the UK routine review programme and that the reference doses [acceptable<br />
daily intake (ADI), acceptable operator exposure level (AOEL) and acute<br />
reference dose (ARfD)] used in the current review had been established<br />
in 1993 and 1998.<br />
The ACP c<strong>on</strong>sidered estimates of c<strong>on</strong>sumer exposure for dimethoate and its<br />
metabolite omethoate against the current ADI for dimethoate of 0.0008 mg/kg<br />
bw/day. It was c<strong>on</strong>cerned that the estimated l<strong>on</strong>g-term c<strong>on</strong>sumer exposure<br />
exceeded the ADI and agreed that the approvals for adding new stocks of<br />
dimethoate products to the supply chain be suspended while a strategy for<br />
reducing c<strong>on</strong>sumer exposure was submitted. The ACP c<strong>on</strong>sidered that the<br />
stocks already in the supply chain could c<strong>on</strong>tinue to be used.
Secti<strong>on</strong> E: UK Review Programme<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that the active substance did not warrant classificati<strong>on</strong><br />
as a sensitiser. It also noted that the dimethoate ADI established in 1993 was<br />
different from the Joint FAO/WHO Meeting <strong>on</strong> Pesticide Residues (JMPR) ADI<br />
and therefore asked that the basis for the ADI be re-examined.<br />
The ACP subsequently rec<strong>on</strong>sidered the ADI for dimethoate. The current ADI<br />
of 0.0008 mg/kg bw/day had been established in 1993, based <strong>on</strong> applying a<br />
100-fold uncertainty factor to the no observed adverse effect level (NOAEL) of<br />
1 ppm (approximately 0.08 mg/kg bw/day) from a rat multigenerati<strong>on</strong> study.<br />
The ACP agreed that the ADI for dimethoate should now be derived by<br />
applying a 100-fold assessment factor to the NOAEL of 0.2 mg/kg bw/day in a<br />
human volunteer study. Therefore, an ADI of 0.002 mg/kg bw for dimethoate<br />
was agreed. This new ADI would be used when the strategy for reducing<br />
c<strong>on</strong>sumer exposure was c<strong>on</strong>sidered by ACP.<br />
Malathi<strong>on</strong><br />
Malathi<strong>on</strong> is an organophosphorus insecticide, formulated as an emulsifiable<br />
c<strong>on</strong>centrate, approved for use <strong>on</strong> agricultural/horticultural crops and in pige<strong>on</strong><br />
lofts. This review formed part of the routine UK review programme of<br />
anticholinesterase compounds.<br />
47<br />
The ACP agreed a repeat exposure systemic acceptable operator exposure<br />
level (AOEL) of 0.2 mg/kg bodyweight (bw)/day based <strong>on</strong> the lowest no<br />
observed adverse effect level (NOAEL) in an 18-m<strong>on</strong>th mouse <strong>on</strong>cogenicity<br />
study. The NOAEL of 100ppm (equivalent to approximately 17 mg/kg bw/day)<br />
was based <strong>on</strong> statistically significant red blood cell (RBC) cholinesterase<br />
depressi<strong>on</strong> in females at the 9- and 18-m<strong>on</strong>th interval, at a dose of 800ppm.<br />
This end point was also used as the basis for setting an acceptable daily<br />
intake (ADI) of 0.2 mg/kg bw/day. For these reference values, a 100-fold<br />
assessment factor was used. In additi<strong>on</strong>, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that it was<br />
relevant to set a single exposure systemic AOEL of 1.5 mg/kg bw based <strong>on</strong> an<br />
absence of observed effects at the top dose tested of 15 mg/kg bw/day in a<br />
human volunteer study. This-end point was also used as the basis for setting<br />
an acute reference dose (ARfD). For these reference values, a 10-fold<br />
assessment factor was used.<br />
The ACP noted that <strong>on</strong>going mutagenicity studies would require completi<strong>on</strong><br />
before a c<strong>on</strong>clusi<strong>on</strong> could be reached <strong>on</strong> the genotoxicity of malathi<strong>on</strong>.<br />
With regard to operator exposure, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> noted that estimated<br />
operator exposure levels were below the repeat exposure systemic AOEL with<br />
use of pers<strong>on</strong>al protective equipment, and were therefore acceptable.
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that approval for use <strong>on</strong> edible crops should be<br />
revoked due to lack of appropriate residues data. However, this did not<br />
apply to the off-label watercress use, which was supported by residues data.<br />
Intake estimates indicated that c<strong>on</strong>sumer exposures would be within an<br />
acceptable range.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> wished to c<strong>on</strong>sider further refinements to the toxicology<br />
reference values and associated amendments to the operator exposure and<br />
c<strong>on</strong>sumer exposure risk assessments at its January 2002 meeting.<br />
Oxamyl<br />
Oxamyl was reviewed as part of the UK review of anticholinesterase<br />
compounds. Oxamyl is a carbamate compound formulated as a granule for<br />
use as a systemic insecticide and nematicide. Use <strong>on</strong> potato and sugar beet<br />
was supported in the review and there were also a number of off-label<br />
approvals <strong>on</strong> vegetable crops.<br />
48<br />
In 2000, the following reference doses had been set: an acceptable daily<br />
intake (ADI) and an admissible operator exposure level (AOEL) of 0.0004<br />
mg/kg bodyweight (bw)/day and an acute reference dose (ARfD) of 0.06<br />
mg/kg bw/day.<br />
At that time the estimated operator exposure exceeded the AOEL and<br />
inadequate data had been submitted to assess c<strong>on</strong>sumer exposure. The ACP<br />
had therefore recommended that all approvals for products c<strong>on</strong>taining oxamyl<br />
should be revoked <strong>on</strong> the basis that the data submitted provided inadequate<br />
reassurance that operator and c<strong>on</strong>sumer exposures would be acceptable.<br />
Following this, the approval holder drew attenti<strong>on</strong> to new data now available,<br />
which might support c<strong>on</strong>tinued use. The ACP c<strong>on</strong>sidered a new operator<br />
exposure study and residue trials data for potatoes and sugar beet and in the<br />
light of these, agreed that operator and c<strong>on</strong>sumer exposure was acceptable. It<br />
c<strong>on</strong>sidered that approvals could c<strong>on</strong>tinue subject to the provisi<strong>on</strong> of further<br />
data (including further data <strong>on</strong> plant metabolism) and amendments to the<br />
product label.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> also recommended that approvals for use <strong>on</strong> crops that were<br />
not supported by acceptable residue trials data should be revoked.
Secti<strong>on</strong> E: UK Review Programme<br />
Phosphides<br />
The ACP was updated regarding the review of phosphides and progress with<br />
a requirement set previously for a strategy to address potential genotoxicity<br />
in exposed operators.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> noted the c<strong>on</strong>clusi<strong>on</strong>s from a new assessment by the<br />
<str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> Mutagenicity of Chemicals in Food, C<strong>on</strong>sumer Products and the<br />
Envir<strong>on</strong>ment (CoM). The CoM now c<strong>on</strong>sidered that, in the light of new data<br />
available, a study of genotoxicity in UK pesticide applicators, as previously<br />
proposed, was no l<strong>on</strong>ger necessary. The ACP agreed with this c<strong>on</strong>clusi<strong>on</strong><br />
but c<strong>on</strong>sidered that a study of operator exposure was still required.<br />
Pirimicarb<br />
Pirimicarb is a carbamate insecticide formulated in a range of products,<br />
approved for use <strong>on</strong> various agricultural and horticultural crops and in <strong>on</strong>e<br />
product for amateur use. In April <strong>2001</strong>, the ACP c<strong>on</strong>sidered a human health<br />
review of this active substance as part of a comprehensive review of<br />
anticholinesterase compounds.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> had previously c<strong>on</strong>sidered reviews of pirimicarb in 1994<br />
and 1997, at which time it restricted uses and specified data requirements for<br />
c<strong>on</strong>tinuing approval. The human health anticholinesterase review incorporated<br />
new data that had been submitted in resp<strong>on</strong>se to the requirements identified<br />
at the earlier reviews.<br />
49<br />
Based <strong>on</strong> the toxicological evidence provided, the following critical end points<br />
were agreed: an ADI and AOEL of 0.035 mg/kg bw/day; ARfD of 0.1 mg/kg<br />
bw/day.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered that the estimates of exposures to operators,<br />
workers and bystanders (based <strong>on</strong> calculati<strong>on</strong>s using standard predictive<br />
models) were acceptable, subject to a requirement for additi<strong>on</strong>al pers<strong>on</strong>al<br />
protective clothing to be worn during knapsack spraying.<br />
Although not all the residues data provided reflected UK Good Agricultural<br />
Practice (GAP), the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered the c<strong>on</strong>sumer risk assessment was<br />
adequate to allow c<strong>on</strong>tinued approval <strong>on</strong> most crops, pending the generati<strong>on</strong><br />
of further residues data. Since there were no residues data to support use <strong>on</strong><br />
celery, kohlrabi, grassland and plums, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> advised that these uses<br />
should be revoked.
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed to advise Ministers that approvals for use <strong>on</strong> the<br />
remaining crops should be allowed to c<strong>on</strong>tinue, subject to: a requirement for<br />
additi<strong>on</strong>al pers<strong>on</strong>al protective equipment for use during knapsack spraying;<br />
the provisi<strong>on</strong> of further data <strong>on</strong> physical/chemical properties, methods of<br />
analysis, mammalian toxicology, operator exposure and c<strong>on</strong>sumer exposure;<br />
and the provisi<strong>on</strong> of protocols for all <strong>on</strong>going and planned residue trials<br />
within three m<strong>on</strong>ths.<br />
Pirimiphos-methyl<br />
Pirimiphos-methyl is an organophosphorus insecticide formulated in a range<br />
of products approved for use as a structural spray treatment, an admixture to<br />
stored cereal grains, and as a smoke generator for glasshouse and grain store<br />
use. There is <strong>on</strong>e smoke generator product approved for amateur use. In<br />
January <strong>2001</strong>, the ACP c<strong>on</strong>sidered the human health review of this active<br />
substance as part of a comprehensive review of anticholinesterase compounds.<br />
50<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> had previously c<strong>on</strong>sidered a review of pirimiphos methyl in<br />
1997, at which time it was c<strong>on</strong>cluded that approvals could c<strong>on</strong>tinue subject to<br />
additi<strong>on</strong>al operator and envir<strong>on</strong>mental protecti<strong>on</strong> requirements, and further<br />
data requirements. The human health anticholinesterase review incorporated<br />
the new data required following the previous review.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that an ADI value should be set at 0.03 mg/kg bw/day<br />
based <strong>on</strong> the NOAEL for inhibiti<strong>on</strong> of erythrocyte cholinesterase activity in two<br />
repeat-dose human volunteer studies, and applying an assessment factor of 10.<br />
This end point was also used as the basis for setting a systemic AOEL of 0.03<br />
mg/kg bw/day. In additi<strong>on</strong>, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed an ARfD of 0.15 mg/kg<br />
bw/day based <strong>on</strong> the NOAEL for minimal reducti<strong>on</strong>s in erythrocyte and brain<br />
acetylcholinesterase activity in an acute neurotoxicity study in rats, with an<br />
assessment factor of 100.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered that the estimates of exposure to operators,<br />
workers and bystanders were acceptable, subject to additi<strong>on</strong>al operator<br />
protecti<strong>on</strong> requirements, and the provisi<strong>on</strong> of c<strong>on</strong>firmatory data.<br />
On the basis of the residue data provided, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered that<br />
estimates of c<strong>on</strong>sumer exposure were acceptable, although c<strong>on</strong>firmatory data<br />
were required.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed to advise Ministers that approvals should be allowed<br />
to c<strong>on</strong>tinue subject to a restricti<strong>on</strong> <strong>on</strong> the maximum c<strong>on</strong>centrati<strong>on</strong> of <strong>on</strong>e<br />
impurity in the technical specificati<strong>on</strong>, the impositi<strong>on</strong> of additi<strong>on</strong>al operator
Secti<strong>on</strong> E: UK Review Programme<br />
protecti<strong>on</strong> requirements and the provisi<strong>on</strong> of further data. It also identified<br />
a need for c<strong>on</strong>tinuing m<strong>on</strong>itoring of residues in food, particularly bran.<br />
This need would be referred to the <strong>Pesticides</strong> Residues <str<strong>on</strong>g>Committee</str<strong>on</strong>g>.<br />
Tolclofos-methyl<br />
Tolclofos-methyl is an organophosphorus fungicide formulated in a range of<br />
products approved for use <strong>on</strong> potato and various horticultural crops. There are<br />
no products approved for amateur use. In January <strong>2001</strong>, the ACP c<strong>on</strong>sidered<br />
a human health review of this active substance as part of a comprehensive<br />
review of anticholinesterase compounds.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that an ADI value should be set at 0.07 mg/kg bw/day<br />
based <strong>on</strong> the NOAEL of 6.5 mg/kg bw/day for reduced brain cholinesterase<br />
activity and increased absolute and relative kidney weights in a two-year<br />
mouse carcinogenicity study, and applying a 100-fold assessment factor.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that there were no acute or developmental effects <strong>on</strong><br />
which it was appropriate to set an ARfD.<br />
In view of the usage patterns of tolclofos methyl, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that<br />
both short-term and l<strong>on</strong>g-term systemic AOELs were appropriate to the<br />
operator risk assessment. A short-term systemic AOEL of 0.13 mg/kg bw/day<br />
was agreed for the operator risk assessment relating to seas<strong>on</strong>al uses (i.e. < 90<br />
days’ operator exposure per year), based <strong>on</strong> the NOAEL for increased liver<br />
weights, reduced bodyweight gain and increased alkaline phosphatase activity<br />
in a six-m<strong>on</strong>th dog study. A l<strong>on</strong>g-term systemic AOEL of 0.042 mg/kg bw/day<br />
was agreed for the operator risk assessment relating to more frequent usage<br />
(i.e. > 90 days’ operator exposure per year), based <strong>on</strong> the same end point as<br />
the ADI. For both of these reference values, a correcti<strong>on</strong> factor of 60 percent<br />
was applied to take account of incomplete oral absorpti<strong>on</strong>, and a 100-fold<br />
assessment factor was used.<br />
51<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered that the estimates of exposure to operators,<br />
workers and bystanders were acceptable, subject to additi<strong>on</strong>al operator<br />
protecti<strong>on</strong> requirements, and the provisi<strong>on</strong> of c<strong>on</strong>firmatory data.<br />
On the basis of the residue data provided, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered that<br />
estimates of c<strong>on</strong>sumer exposure were acceptable, although c<strong>on</strong>firmatory data<br />
were required.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed to advise Ministers that approvals should be allowed<br />
to c<strong>on</strong>tinue subject to the impositi<strong>on</strong> of additi<strong>on</strong>al operator protecti<strong>on</strong>
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
N<strong>on</strong>agricultural<br />
use<br />
requirements, and the provisi<strong>on</strong> of further data <strong>on</strong> physical/chemical<br />
properties, methods of analysis, c<strong>on</strong>sumer exposure and operator exposure.<br />
● 3-IODO-2-PROPYNYL-N-BUTYL CARBAMATE (IPBC)<br />
● AZAMETHIPHOS<br />
●<br />
CCA<br />
●<br />
DICHLOROPHEN<br />
●<br />
DICHLORVOS<br />
●<br />
DIURON<br />
●<br />
FENITROTHION<br />
●<br />
IRGAROL<br />
●<br />
LINDANE<br />
●<br />
PIRIMIPHOS-METHYL<br />
52<br />
3-iodo-2-propynyl-N-butyl carbamate (IPBC)<br />
3-iodo-2-propynyl-N-butyl carbamate (IPBC) is a broad-spectrum carbamate<br />
fungicide used in wood preservatives and surface biocides. It is <strong>on</strong>e of the<br />
chemicals in the current UK review of organophosphorus and carbamate<br />
compounds. The ACP recommended, in June 1999, that all pesticide products<br />
c<strong>on</strong>taining a cholinesterase-inhibiting compound should be labelled to reflect<br />
this fact. Letters were sent to all approval holders to notify them of this<br />
requirement.<br />
The main manufacturer and data holder for IPBC did not feel that this label<br />
was justified for products c<strong>on</strong>taining IPBC. It presented a reas<strong>on</strong>ed case to<br />
remove this labelling of its products <strong>on</strong> the grounds that any effects seen were<br />
very weak. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered summaries of the studies submitted as<br />
part of the reas<strong>on</strong>ed case.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> was c<strong>on</strong>tent that adequate data were available to indicate<br />
the cholinesterase-inhibiting properties of IPBC and that no further data were<br />
required at this stage. On the basis of these data the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>cluded<br />
that IPBC should c<strong>on</strong>tinue to be part of the UK review of anticholinesterase<br />
compounds used in n<strong>on</strong>-agricultural pesticides. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> recommended<br />
that the products should have the following revised precauti<strong>on</strong>ary labelling<br />
phrase:
Secti<strong>on</strong> E: UK Review Programme<br />
3-iodo-2-propynyl-N-butyl carbamate is a carbamate compound that has<br />
weak anticholinesterase activity. DO NOT USE if under medical advice not<br />
to work with anticholinesterase compounds.<br />
Having been informed that the ACP had rejected its case for removal of the<br />
original label, and recommended that an alternative phrase must be used, the<br />
company asked the ACP whether it could c<strong>on</strong>tinue to use the original rather<br />
than the alternative phrase. The company stated that, since the new phrase<br />
was unique to IPBC, introducing it would risk c<strong>on</strong>fusi<strong>on</strong> and uncertainty<br />
am<strong>on</strong>g its customers. It was also reluctant to have its clients reprint labels<br />
when further changes might be necessary <strong>on</strong> completi<strong>on</strong> of the review.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed to this request.<br />
Azamethiphos<br />
Azamethiphos is an organophosphorus compound approved for use both as<br />
an agricultural and n<strong>on</strong>-agricultural insecticide. It is <strong>on</strong>e of the chemicals in<br />
the current UK review of organophosphorous and carbamate compounds.<br />
At the time of the review there were two approved n<strong>on</strong>-agricultural pesticide<br />
products c<strong>on</strong>taining azamethiphos. These were impregnated bait stickers for<br />
applicati<strong>on</strong> to hard surfaces by n<strong>on</strong>-professi<strong>on</strong>al users.<br />
53<br />
A human health review of the agricultural uses of azamethiphos had<br />
previously been c<strong>on</strong>sidered by the ACP earlier in the year. The supplier<br />
was comm<strong>on</strong> to both agricultural and n<strong>on</strong>-agricultural uses and therefore<br />
its physical chemistry and mammalian toxicology data had already been<br />
c<strong>on</strong>sidered (see page 41). The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> examined additi<strong>on</strong>al published<br />
toxicology data and c<strong>on</strong>sidered the human health and efficacy issues<br />
associated with the n<strong>on</strong>-agricultural uses of azamethiphos.<br />
Results obtained from a storage stability study for <strong>on</strong>e of the products showed<br />
a significant loss of azamethiphos over a two-week period. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g><br />
agreed that approval holders should be required to provide an appropriate<br />
storage stability study. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> was also c<strong>on</strong>cerned that people might<br />
wish to remove the bait stickers within the lifespan of the product, and<br />
perhaps come into c<strong>on</strong>tact with the remaining azamethiphos. Therefore<br />
it recommended that approval holders be required to provide informati<strong>on</strong><br />
<strong>on</strong> the change in azamethiphos c<strong>on</strong>tent with time during product use.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> also noted that azamethiphos was classified as a skin sensitiser<br />
and that <strong>on</strong>e of the products also attracted this classificati<strong>on</strong>. However, there<br />
had been no reports of skin sensitisati<strong>on</strong> arising from use of these products,
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
in the literature. Therefore, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that it had no c<strong>on</strong>cerns in<br />
this respect and that no further data should be required at this stage.<br />
The estimated exposures from initial handling of the product and c<strong>on</strong>tinued<br />
residential use gave no cause for c<strong>on</strong>cern. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered that the<br />
assessment for c<strong>on</strong>tinued residential exposure should assume use in at least<br />
two rooms. This did not identify any cause for c<strong>on</strong>cern.<br />
The acute exposure estimated to occur following accidental ingesti<strong>on</strong> of the<br />
entire product by infants or children did give cause for c<strong>on</strong>cern. However,<br />
data from the Nati<strong>on</strong>al Pois<strong>on</strong>s Informati<strong>on</strong> Service (NPIS) <strong>on</strong> incidents<br />
involving these products provided some reassurance that the likelihood of<br />
this occurring was low.<br />
54<br />
Overall, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>cluded that approval for the two products<br />
should c<strong>on</strong>tinue subject to the companies redesigning products to include a<br />
mechanism to prevent skin c<strong>on</strong>tact when attaching them to windows, more<br />
secure adhesi<strong>on</strong> to windows, both products c<strong>on</strong>taining a bittering agent, and<br />
informati<strong>on</strong> <strong>on</strong> changes in azamethiphos c<strong>on</strong>tent during the lifetime of the<br />
product. These recommendati<strong>on</strong>s would ensure that the risk of acute exposure<br />
by c<strong>on</strong>tact or ingesti<strong>on</strong> was acceptably low. C<strong>on</strong>tinued approval was also<br />
subject to further data requirements.<br />
CCA<br />
Copper chrome arsenic (CCA) wood preservatives c<strong>on</strong>tain arsenic pentoxide,<br />
hexavalent chromium (chromium trioxide or sodium dichromate) and copper<br />
(II) oxide or copper (II) sulphate. They are supplied as pastes or water-based<br />
c<strong>on</strong>centrates which are diluted to between <strong>on</strong>e percent and ten percent w/w<br />
total salts and used in the industrial vacuum-pressure impregnati<strong>on</strong> of timber.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> had c<strong>on</strong>sidered a review of the use of CCA in industrial wood<br />
preservati<strong>on</strong> in September 1999. It had agreed that approval for CCA products<br />
could be allowed to c<strong>on</strong>tinue, subject to a number of c<strong>on</strong>diti<strong>on</strong>s and<br />
requirements, including the provisi<strong>on</strong> of specific envir<strong>on</strong>mental data.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> now c<strong>on</strong>sidered the approval holders’ resp<strong>on</strong>ses to the<br />
envir<strong>on</strong>mental data requirements, which had previously been c<strong>on</strong>sidered by<br />
its Envir<strong>on</strong>mental Panel. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that the exposure scenario<br />
proposed by approval holders was an acceptable alternative to HSE’s previous<br />
exposure scenario. However, it noted that this scenario assumed good<br />
practice, of which the British Wood Preserving and Damp Proofing Associati<strong>on</strong><br />
(BWPDA) voluntary code of practice was c<strong>on</strong>sidered to be an appropriate<br />
benchmark. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g>’s Envir<strong>on</strong>mental Panel had identified several
Secti<strong>on</strong> E: UK Review Programme<br />
outstanding issues c<strong>on</strong>cerning data to support the assumpti<strong>on</strong>s in the<br />
alternative exposure model and practices at UK treatment plants. The<br />
<str<strong>on</strong>g>Committee</str<strong>on</strong>g> noted that the main c<strong>on</strong>cern was c<strong>on</strong>taminati<strong>on</strong> of the ground,<br />
from excess treatment soluti<strong>on</strong> running off newly treated timber and rain<br />
washing soluti<strong>on</strong> from newly treated timber. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> recognised that,<br />
although treatment sites were originally built to high standards, some were not<br />
maintained and there was cracking of bunds and c<strong>on</strong>crete floors. In additi<strong>on</strong>,<br />
a survey c<strong>on</strong>ducted <strong>on</strong> HSE’s behalf had reported that freshly treated and<br />
dripping timber was frequently stored outside the c<strong>on</strong>tained area.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered approval holders’ proposals to address these<br />
c<strong>on</strong>cerns. It agreed that the newly proposed exposure scenario for industrial<br />
wood preservati<strong>on</strong> products was acceptable for CCA, subject to the submissi<strong>on</strong><br />
of specific data to address the inhibiti<strong>on</strong> of respirati<strong>on</strong> in sewage sludge<br />
micro-organisms, data <strong>on</strong> the bioavailability of metals in the water column and<br />
the issue of sediment toxicity, data to support a reas<strong>on</strong>able worst-case usage<br />
level for CCA at UK installati<strong>on</strong>s and UK data to support a reducti<strong>on</strong> of the<br />
presumed emissi<strong>on</strong> from treatment plants from <strong>on</strong>e percent to 0.2 percent.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> also agreed that the labels of CCA industrial wood<br />
preservati<strong>on</strong> products should include the additi<strong>on</strong>al phrase:<br />
55<br />
TREATED WOOD MUST BE HELD FOR LEAST 48 HOURS AFTER<br />
TREATMENT AND UNTIL SURFACES ARE DRY WITHIN A BUNDED AREA<br />
ON A SITE WHICH IS MAINTAINED TO PREVENT LOSS OF TREATMENT<br />
PRODUCT TO THE ENVIRONMENT.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> welcomed the proposals for an industry-led awareness<br />
campaign across the whole industrial wood preservati<strong>on</strong> industry to reduce<br />
emissi<strong>on</strong>s to the envir<strong>on</strong>ment.<br />
Dichlorophen<br />
Dichlorophen and sodium dichlorophen are used in approved<br />
herbicide/fungicide products registered with PSD and HSE. In 1998, the ACP<br />
had agreed that approval holders for amateur surface biocides c<strong>on</strong>taining<br />
sodium dichlorophen should c<strong>on</strong>sider the feasibility of reformulati<strong>on</strong> to<br />
negate the requirement for products c<strong>on</strong>taining 40 g/l or more to be labelled<br />
‘Risk of serious damage to eyes’. It also had identified a number of data<br />
requirements with respect to the physical chemistry, mammalian toxicology<br />
and envir<strong>on</strong>mental hazard of dichlorophen/sodium dichlorophen. Two years<br />
were allowed for the provisi<strong>on</strong> of these data.
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> now c<strong>on</strong>sidered reports submitted by the manufacturer<br />
and <strong>on</strong>e approval holder to address the feasibility of reformulati<strong>on</strong> and/or<br />
repackaging of n<strong>on</strong>-agricultural products c<strong>on</strong>taining dichlorophen/sodium<br />
dichlorophen. It also c<strong>on</strong>sidered the progress made with the other data<br />
requirements it had identified.<br />
56<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> noted that the company that supplied sodium dichlorophen<br />
for use in biocides had provided some data but had not complied fully with<br />
the data requirements. One approval holder had expressed c<strong>on</strong>cern at the<br />
apparent lack of resp<strong>on</strong>se and indicated that it would be willing to support<br />
dichlorophen by generating the missing data itself, if the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed<br />
to allow it the time to do so. Subsequently the supplier had made a similar<br />
appeal for extra time to generate data. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that the<br />
supplier’s submissi<strong>on</strong> was deficient in a number of aspects and although the<br />
company had cited both animal welfare and ec<strong>on</strong>omic c<strong>on</strong>siderati<strong>on</strong>s, its<br />
resp<strong>on</strong>se was unacceptable. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered that this company<br />
should not be allowed an extensi<strong>on</strong> to the deadline for addressing the data<br />
requirements and that approval for products reliant <strong>on</strong> support from it should<br />
be revoked.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> noted that the majority of enquiries and incidents relating<br />
to dichlorophen that had been reported to centres of the Nati<strong>on</strong>al Pois<strong>on</strong>s<br />
Informati<strong>on</strong> Service around the country involved access by young children to<br />
veterinary worming tablets. Only two incidents in recent years had involved<br />
eye c<strong>on</strong>tact with a dichlorophen-c<strong>on</strong>taining product and at least <strong>on</strong>e of the<br />
adults c<strong>on</strong>cerned had suffered no l<strong>on</strong>g-term effects. For the other no details<br />
were available. As no major toxicological c<strong>on</strong>cerns had yet been identified,<br />
the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed to allow the specific approval holder extra time to<br />
generate the missing data. However, the approval holder would need to<br />
provide an early commitment to fulfil the requirements and adhere to a<br />
strict timetable.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> then c<strong>on</strong>sidered the reports <strong>on</strong> the feasibility of reformulati<strong>on</strong><br />
of the single product marketed by this approval holder. It appeared that a<br />
more dilute c<strong>on</strong>centrate of product was not a viable opti<strong>on</strong> due to the large<br />
volumes that would then be needed for a single treatment. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g><br />
had previously agreed that, where eye protecti<strong>on</strong> was c<strong>on</strong>sidered necessary,<br />
amateur use of a product would not be permitted. However, the apparent lack<br />
of incidents related to use of this product reassured the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> that eye<br />
protecti<strong>on</strong> was not necessary. The company had reported <strong>on</strong> progress with<br />
reformulati<strong>on</strong> and had explored three opti<strong>on</strong>s, each of which posed some
Secti<strong>on</strong> E: UK Review Programme<br />
legitimate difficulty. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that currently there were no<br />
grounds for revocati<strong>on</strong> of the existing product. It agreed that approval for the<br />
product should be allowed to c<strong>on</strong>tinue subject to a commitment within two<br />
m<strong>on</strong>ths to produce the necessary data identified in accordance with agreed<br />
deadlines. In additi<strong>on</strong>, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that the company should be<br />
required to produce a further report <strong>on</strong> the potential for reformulati<strong>on</strong> of<br />
its product.<br />
Some time after the <str<strong>on</strong>g>Committee</str<strong>on</strong>g>’s c<strong>on</strong>siderati<strong>on</strong> of this subject, the approval<br />
holder reported that it was currently unable to comply with the requirements.<br />
Therefore the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that this remaining product should also<br />
be revoked.<br />
It was also noted that the positi<strong>on</strong> with respect to PSD approvals needed to<br />
be c<strong>on</strong>sidered and it was c<strong>on</strong>cluded that a short period should be provided<br />
for approval holders for products registered with PSD to provide commitments<br />
to produce the relevant data.<br />
On the basis of the evidence provided by the main data holder <strong>on</strong> behalf of<br />
the PSD approval holders of their support for dichlorophen, both in the UK<br />
and under the EU programme, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> recommended that approvals<br />
be allowed to c<strong>on</strong>tinue pending submissi<strong>on</strong> of the specified data.<br />
57<br />
Dichlorvos<br />
Dichlorvos is an organophosphorus compound currently approved for use as<br />
an insecticide against crawling and flying insects in n<strong>on</strong>-agricultural pesticides.<br />
It is <strong>on</strong>e of the chemicals included in the review of organophosphorus and<br />
carbamate compounds. Twelve approval holders submitted data <strong>on</strong> the active<br />
substance and approved products to the review. At its meetings in April and<br />
May <strong>2001</strong>, the ACP c<strong>on</strong>sidered the available physicochemical, toxicological<br />
and efficacy data <strong>on</strong> dichlorvos and recommended in May <strong>2001</strong> that Ministers<br />
be advised that:<br />
a) approval for all aerosols c<strong>on</strong>taining dichlorvos be revoked based <strong>on</strong> the<br />
unacceptable toxicity-exposure ratios (TERs) derived for primary and<br />
sec<strong>on</strong>dary exposures from professi<strong>on</strong>al and amateur use;<br />
b) approval for residential uses of slow release c<strong>on</strong>trollable and n<strong>on</strong>c<strong>on</strong>trollable<br />
cassettes c<strong>on</strong>taining dichlorvos be revoked based <strong>on</strong> the<br />
unacceptable TERs derived for sec<strong>on</strong>dary exposures from professi<strong>on</strong>al<br />
and amateur use;
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
c) approval for the professi<strong>on</strong>al use of slow-release strips and c<strong>on</strong>trollable and<br />
n<strong>on</strong>-c<strong>on</strong>trollable cassettes c<strong>on</strong>taining dichlorvos in museums be retained<br />
subject to the fulfilment of physicochemical, operator exposure and efficacy<br />
data requirements;<br />
d) approval for the use of slow-release strips in pherom<strong>on</strong>e traps in areas<br />
where food may be stored, prepared or c<strong>on</strong>sumed be suspended pending<br />
the provisi<strong>on</strong> of informati<strong>on</strong> <strong>on</strong> food residues; and<br />
e) approval for the use of slow release strips in pherom<strong>on</strong>e traps in areas<br />
where food is not present be retained subject to the fulfilment of<br />
physicochemical and efficacy data requirements.<br />
A review of the agricultural uses of dichlorvos was also c<strong>on</strong>sidered by the<br />
ACP at the same time (see page 42).<br />
58<br />
The ACP also noted that dichlorvos was under discussi<strong>on</strong> by the <str<strong>on</strong>g>Committee</str<strong>on</strong>g><br />
<strong>on</strong> Mutagenicity of Chemicals in Food, C<strong>on</strong>sumer Products and the<br />
Envir<strong>on</strong>ment (CoM), and recognised that their recommendati<strong>on</strong>s would<br />
perhaps require modificati<strong>on</strong> in accordance with the COM’s findings.<br />
At the July <strong>2001</strong> ACP meeting, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered the implicati<strong>on</strong>s of<br />
the COM’s possible c<strong>on</strong>clusi<strong>on</strong>s, and agreed to advise Ministers as follows:<br />
a) If the COM’s final c<strong>on</strong>clusi<strong>on</strong>s were that dichlorvos was an in-vivo<br />
mutagen, and it could not exclude the possibility that the occurrence<br />
of tumours in animal tests of carcinogenicity resulted from a genotoxic<br />
mechanism, there should be immediate revocati<strong>on</strong> of all uses (both<br />
agricultural and n<strong>on</strong>-agricultural).<br />
b) Alternatively, if the COM c<strong>on</strong>cluded that dichlorvos was an in-vivo<br />
mutagen, but that the tumours observed in animal tests did not result from<br />
a genotoxic mechanism, or if it could not c<strong>on</strong>firm that dichlorvos was an<br />
in-vivo mutagen, or if it took the view that dichlorvos was not an in-vivo<br />
mutagen, then the ACP’s previous recommendati<strong>on</strong>s would be maintained.<br />
The COM c<strong>on</strong>cluded, following a sec<strong>on</strong>d meeting in July <strong>2001</strong>, that dichlorvos<br />
should be regarded as an in-vivo mutagen (i.e. capable of inducing mutati<strong>on</strong>s<br />
in living animals) at site of c<strong>on</strong>tact and that it could not exclude the possibility<br />
of it acting as a genotoxic carcinogen. The COM statement <strong>on</strong> dichlorvos was<br />
finalised in late July <strong>2001</strong>.<br />
C<strong>on</strong>sequently the ACP recommended to Ministers that, as a precauti<strong>on</strong>ary<br />
measure, it would be prudent to revoke, with immediate effect, all agricultural
Secti<strong>on</strong> E: UK Review Programme<br />
and n<strong>on</strong>-agricultural uses of dichlorvos. This advice was given as a<br />
precauti<strong>on</strong>ary measure, since the possibility of genotoxic carcinogenicity could<br />
not be excluded. The ACP c<strong>on</strong>sidered that any risk of human carcinogenicity<br />
was likely to be very small, and would be mainly associated with certain uses<br />
in the home and with exposures to some operators in the agricultural sector.<br />
Before such regulatory acti<strong>on</strong> could be carried out, AMVAC Chemical UK Ltd<br />
(an approval holder and manufacturer of dichlorvos) obtained an injuncti<strong>on</strong>,<br />
which prevented regulatory acti<strong>on</strong>. Government agencies were also prohibited<br />
from making any announcement to the public about the regulatory acti<strong>on</strong> that<br />
was proposed. AMVAC also gained permissi<strong>on</strong> for a judicial review hearing,<br />
which was heard in November <strong>2001</strong>.<br />
The grounds for the challenge were that AMVAC had not been properly<br />
informed of the proposed regulatory acti<strong>on</strong> or the basis for it, and had not<br />
been given sufficient time to make representati<strong>on</strong>s. AMVAC also claimed that<br />
Ministers had not given proper regard to the precauti<strong>on</strong>ary principle and to<br />
the European C<strong>on</strong>venti<strong>on</strong> <strong>on</strong> Human Rights.<br />
The judgement of the Court was issued in December <strong>2001</strong>. Mr Justice Crane<br />
rejected most of the company’s submissi<strong>on</strong>s, including those c<strong>on</strong>cerning the<br />
precauti<strong>on</strong>ary principle and the C<strong>on</strong>venti<strong>on</strong> <strong>on</strong> Human Rights. However, he<br />
ruled that the company had been given insufficient time to resp<strong>on</strong>d to the<br />
c<strong>on</strong>clusi<strong>on</strong>s of the Government’s expert advisers prior to regulatory acti<strong>on</strong><br />
being taken. He accepted that the matter was urgent but c<strong>on</strong>sidered that the<br />
claimant had now had full opportunity to present any further material.<br />
59<br />
During the period of the injuncti<strong>on</strong>, the ACP was unable to publish the<br />
minutes of its meetings. The ACP had c<strong>on</strong>cerns that this compromised the<br />
openness of the advice given to Ministers, and could thereby have an adverse<br />
effect <strong>on</strong> public c<strong>on</strong>fidence in the regulatory process. It was also c<strong>on</strong>cerned<br />
that speculati<strong>on</strong> about the missing minutes might create unwarranted public<br />
anxiety. Notwithstanding these c<strong>on</strong>cerns, the ACP agreed that while rapid<br />
implementati<strong>on</strong> of regulatory acti<strong>on</strong> was desirable <strong>on</strong>ce decisi<strong>on</strong>s had been<br />
made, it was also important that the regulatory process be fair and open to<br />
scrutiny. In this case, the ACP’s advice to Ministers had been precauti<strong>on</strong>ary<br />
(i.e. based <strong>on</strong> insufficient reassurance that exposures to the compound were<br />
acceptable rather than direct evidence that people were being harmed), and<br />
the delay caused by the legal acti<strong>on</strong> would be acceptable provided that it was<br />
not unduly prol<strong>on</strong>ged.
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
Following the Court judgement, approval holders for both agricultural and<br />
n<strong>on</strong>-agricultural products were asked to provide any further data relating to<br />
the potential genotoxic carcinogenicity of dichlorvos. These data would be<br />
c<strong>on</strong>sidered by the ACP early in 2002.<br />
Diur<strong>on</strong><br />
The ACP c<strong>on</strong>sidered submissi<strong>on</strong>s received from four companies c<strong>on</strong>cerned<br />
with antifouling products c<strong>on</strong>taining diur<strong>on</strong>. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> had c<strong>on</strong>sidered<br />
the use of this compound in antifouling products in September 2000. Members<br />
had c<strong>on</strong>sidered that the safety margins for professi<strong>on</strong>al and amateur users of<br />
products were not as high as they would wish and that use of these products<br />
posed an unacceptable risk to the aquatic envir<strong>on</strong>ment. Therefore the ACP<br />
had recommended that all uses of diur<strong>on</strong> in antifouling products should be<br />
revoked. The companies resp<strong>on</strong>ding now expressed c<strong>on</strong>cern that acti<strong>on</strong> taken<br />
<strong>on</strong>ly in the UK would be a barrier to trade and put them at a competitive<br />
disadvantage and asked for an extended phase-out period for products, to<br />
enable alternatives to be developed.<br />
60<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered that companies had been provided with adequate<br />
informati<strong>on</strong> regarding the possibility of revocati<strong>on</strong>. Few had submitted<br />
comments to the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> and it c<strong>on</strong>cluded that the submissi<strong>on</strong>s made were<br />
not sufficient to justify cancellati<strong>on</strong> of, or changes to the timescales for, the<br />
revocati<strong>on</strong>s agreed previously.<br />
Fenitrothi<strong>on</strong><br />
Fenitrothi<strong>on</strong> is an organophosphorus compound currently approved for n<strong>on</strong>agricultural<br />
use as an insecticide against crawling and flying insects. It is <strong>on</strong>e<br />
of the chemicals included in the current review of organophosphorus and<br />
carbamate compounds. Currently, n<strong>on</strong>-agricultural pesticide products<br />
c<strong>on</strong>taining fenitrothi<strong>on</strong> are approved for both professi<strong>on</strong>al and amateur use,<br />
with amateur use restricted to aerosol space and surface sprays. Professi<strong>on</strong>al<br />
use encompasses emulsifiable and microencapsulated c<strong>on</strong>centrates, wettable<br />
and dusting powders approved for use as public hygiene insecticides and<br />
animal husbandry insecticides. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered a review of the<br />
physical chemistry, mammalian toxicity and efficacy of fenitrothi<strong>on</strong>.<br />
The main health effect of c<strong>on</strong>cern for fenitrothi<strong>on</strong> was its anticholinesterase<br />
activity. However, the review also identified a number of other health effects<br />
that the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> needed to c<strong>on</strong>sider. The evidence presented dem<strong>on</strong>strated<br />
that acute pois<strong>on</strong>ing with fenitrothi<strong>on</strong> caused Intermediate Syndrome (IMS).
Secti<strong>on</strong> E: UK Review Programme<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that, as IMS was a c<strong>on</strong>diti<strong>on</strong> resulting from serious<br />
acute pois<strong>on</strong>ing, it was likely that those developing the syndrome would<br />
already be hospitalised, and as IMS rarely occurred in the UK, it was not<br />
necessary for approval holders to include guidance <strong>on</strong> the treatment of IMS<br />
<strong>on</strong> the product label.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered the potential for fenitrothi<strong>on</strong> to cause skin<br />
sensitisati<strong>on</strong>. It was noted that fenitrothi<strong>on</strong> had been widely used for many<br />
years and that it was highly likely that any potential for fenitrothi<strong>on</strong> to cause<br />
skin sensitisati<strong>on</strong> would be reflected in the clinical literature. Therefore, in<br />
light of the lack of reported cases of skin sensitisati<strong>on</strong>, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed<br />
there were no grounds for c<strong>on</strong>cern <strong>on</strong> this issue.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that the evidence presented indicated that fenitrothi<strong>on</strong><br />
was not genotoxic and that ocular toxicity gave no cause for c<strong>on</strong>cern.<br />
Observati<strong>on</strong>s in developmental studies included the occurrence of enlarged<br />
sub-arachnoid space in rat pups and decreases in pup survival postpartum at<br />
high doses. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> examined the data and agreed that the occurrence<br />
of enlarged sub-arachnoid space was not treatment related. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g><br />
also agreed that the decrease in pup survival postpartum seen at high doses<br />
could be related to the palatability of the mother’s milk and c<strong>on</strong>cluded that<br />
as these effects were seen <strong>on</strong>ly at high doses, there were no c<strong>on</strong>cerns for<br />
human health.<br />
61<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered the predicted exposure of users of products<br />
c<strong>on</strong>taining free fenitrothi<strong>on</strong> for public hygiene and animal husbandry uses and<br />
c<strong>on</strong>cluded that, with the excepti<strong>on</strong> of aerosol space sprays used professi<strong>on</strong>ally<br />
in industrial premises, approvals should be revoked. This was because of<br />
inadequate reassurance that exposures of users or c<strong>on</strong>sumers would be<br />
acceptable. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> also c<strong>on</strong>sidered that further data presented by<br />
the data holder were not sufficient to support the c<strong>on</strong>tinued approval of<br />
wettable powders and dust formulati<strong>on</strong>s.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that the data submitted indicated that<br />
microencapsulated fenitrothi<strong>on</strong> was far less toxic than free fenitrothi<strong>on</strong>.<br />
It recommended that approval for products c<strong>on</strong>taining microencapsulated<br />
fenitrothi<strong>on</strong> should be allowed to c<strong>on</strong>tinue for use in industrial areas <strong>on</strong>ly,<br />
and subject to a number of data requirements. In additi<strong>on</strong> to these data<br />
requirements, for approval to be allowed to c<strong>on</strong>tinue for professi<strong>on</strong>al use<br />
aerosol space sprays c<strong>on</strong>taining free fenitrothi<strong>on</strong> in industrial areas, further<br />
data were requested. Any future request to extend approval for
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
microencapsulated products to include use in domestic premises or animal<br />
husbandry uses would need to be supported by appropriate additi<strong>on</strong>al data.<br />
Irgarol<br />
The ACP c<strong>on</strong>sidered a submissi<strong>on</strong> from the data holder for Irgarol 1051, an<br />
active substance used in antifouling products. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> had c<strong>on</strong>sidered<br />
the use of this compound in antifouling products in September 2000. The ACP<br />
had c<strong>on</strong>cluded that there was an unacceptable risk posed to the aquatic<br />
envir<strong>on</strong>ment and recommended revocati<strong>on</strong> of the amateur use of products<br />
c<strong>on</strong>taining this compound and restricti<strong>on</strong> of professi<strong>on</strong>al use to vessels above<br />
25 m in length. The data holder had focused <strong>on</strong> deficiencies in experimental<br />
design of the key study used to estimate the risk posed to the envir<strong>on</strong>ment<br />
and had offered to carry out further testing.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> noted that it had previously debated the limitati<strong>on</strong>s of the<br />
study and c<strong>on</strong>sidered that further data would not alter the overall c<strong>on</strong>clusi<strong>on</strong>s.<br />
Therefore the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that the revocati<strong>on</strong>s and restricti<strong>on</strong>s <strong>on</strong> the<br />
antifouling uses of this active substance remained appropriate.<br />
62<br />
Lindane<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered a submissi<strong>on</strong> made by the approval holder for an<br />
aerosol insecticide product c<strong>on</strong>taining lindane. This product had been revoked<br />
following the envir<strong>on</strong>mental review of lindane in March 2000, <strong>on</strong> the grounds<br />
that the approval holder had failed to supply adequate data or reas<strong>on</strong>ed cases<br />
to address all the core envir<strong>on</strong>mental data requirements. The approval holder<br />
asked for an extended phase-out period because of a problem with<br />
communicati<strong>on</strong> with HSE regarding the expiry date of the product and<br />
because the company was not aware of any adverse incidents during 20 years<br />
of product use. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> indicated that although there had been a slight<br />
problem with communicati<strong>on</strong>, the company had been allowed sufficient time<br />
to comply with the data requirements. Therefore the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>cluded<br />
that the arguments put forward were insufficient to justify products not being<br />
revoked according to the intended timescales.<br />
Pirimiphos-methyl<br />
Pirimiphos-methyl is an organophosphorus compound approved for use as<br />
an insecticide in agricultural and n<strong>on</strong>-agricultural pesticides. It is <strong>on</strong>e of the<br />
chemicals included in the current review of organophosphorus and carbamate<br />
compounds. There are currently two approved n<strong>on</strong>-agricultural pesticide
Secti<strong>on</strong> E: UK Review Programme<br />
products c<strong>on</strong>taining pirimiphos-methyl, both of which are approved for use<br />
by professi<strong>on</strong>als <strong>on</strong>ly. They are an emulsifiable c<strong>on</strong>centrate insecticide/wood<br />
preservative and a dusting powder insecticide for professi<strong>on</strong>al use against<br />
flying and crawling insects.<br />
A human health review of pirimiphos-methyl had been undertaken by PSD<br />
and c<strong>on</strong>sidered by the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> earlier in the year (see page 50). The<br />
<str<strong>on</strong>g>Committee</str<strong>on</strong>g> then c<strong>on</strong>sidered a review of the human health and efficacy issues<br />
associated with the n<strong>on</strong>-agricultural use of pirimiphos-methyl. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g><br />
noted that it had already agreed a NOAEL of 0.25 mg/kg/bw/day for repeated<br />
exposure. In additi<strong>on</strong>, it had agreed values for the dermal absorpti<strong>on</strong> of<br />
pirimiphos-methyl of <strong>on</strong>e percent from an emulsifiable c<strong>on</strong>centrate and a<br />
100 g/l diluti<strong>on</strong>, five percent for a 1 g/l diluti<strong>on</strong> and <strong>on</strong>e percent for the<br />
dermal absorpti<strong>on</strong> of pirimiphos-methyl from a dustable powder.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that the predicted exposure of those using products<br />
was generally acceptable but gave cause for c<strong>on</strong>cern when exposures at the<br />
95 th percentile level were c<strong>on</strong>sidered. It c<strong>on</strong>sidered that the use of pers<strong>on</strong>al<br />
protective equipment (PPE) would mitigate exposure of workers and asked for<br />
further c<strong>on</strong>siderati<strong>on</strong> of the way in which data had been used to predict highlevel<br />
exposures. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> noted that the operator exposure assessments<br />
for agricultural products used the 75 th percentile and, for comparative<br />
purposes, asked HSE to present exposure predicti<strong>on</strong>s <strong>on</strong> the same basis.<br />
63<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered that, <strong>on</strong>ce surface residues were dry, further<br />
dislodging of active substance from treated surfaces was highly unlikely. Also,<br />
there would be a provisi<strong>on</strong> for the exclusi<strong>on</strong> of people and animals during<br />
applicati<strong>on</strong> of the pesticide. The predicted l<strong>on</strong>g-term exposure to pirimiphosmethyl<br />
after treatments had been carried out gave some cause for c<strong>on</strong>cern,<br />
although the exposure predicti<strong>on</strong>s were not well-established and were based<br />
<strong>on</strong> a series of assumpti<strong>on</strong>s in the absence of actual data. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g><br />
agreed that its c<strong>on</strong>cerns should be communicated to the approval holder, who<br />
should be asked to comment <strong>on</strong> the current exposure predicti<strong>on</strong>s and provide<br />
assurance that exposures of children and adults would be acceptable.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that further clarificati<strong>on</strong> was required from the<br />
approval holder regarding the possible photodegradati<strong>on</strong> of pirimiphosmethyl.<br />
It also asked HSE to c<strong>on</strong>sider further various issues relating to the<br />
efficacy of the products and to liase with PSD regarding the c<strong>on</strong>sumer risk<br />
assessment for stored food.
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
Secti<strong>on</strong> F:<br />
Other items c<strong>on</strong>sidered during the year<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered the following additi<strong>on</strong>al items during <strong>2001</strong>:<br />
Pesticide usage<br />
survey reports<br />
<strong>Report</strong> 162 – Rodenticide use <strong>on</strong> farms in Great Britain growing<br />
arable crops 1998<br />
This report presented results of the fourth fully co-ordinated survey of<br />
rodenticide usage throughout Great Britain <strong>on</strong> farms growing arable crops,<br />
previous surveys having been c<strong>on</strong>ducted in 1992, 1994 and 1996.<br />
64<br />
A survey of rodenticide usage <strong>on</strong> 997 holdings growing arable crops in Great<br />
Britain in 1998 provided data which had been extrapolated to give an estimate<br />
of nati<strong>on</strong>al usage <strong>on</strong> such holdings. The most extensively used rodenticides,<br />
in terms of number of occurrences, were difenacoum, bromadiol<strong>on</strong>e,<br />
chlorophacin<strong>on</strong>e, coumatetralyl, brodifacoum and cholecalciferol/difenacoum.<br />
These six active substances accounted for 95 percent of all occurrences<br />
excluding holdings where the product was unknown, and the report<br />
c<strong>on</strong>centrates <strong>on</strong> the comparis<strong>on</strong> of usage between these six principal<br />
rodenticides. All other rodenticides had <strong>on</strong>ly limited occurrence and<br />
informati<strong>on</strong> c<strong>on</strong>cerning their usage requires cautious interpretati<strong>on</strong> as the<br />
data may have been subject to statistical error.<br />
Eastern regi<strong>on</strong> accounted for 37 percent, by weight, of the total amount of the<br />
principal active substances used in Great Britain, with Scotland and Northern<br />
regi<strong>on</strong> accounting for a further 15 percent and 20 percent respectively. The<br />
majority of the principal rodenticides were applied in autumn and winter<br />
(33 percent each). Rodenticides applied around buildings accounted for<br />
63 percent of the total weight of bait applied. By weight, 39 percent of the<br />
principal active substances were purchased as ready-to-use baits and farmers<br />
applied 82 percent of the total weight of the principal active substances used.<br />
The number of farms using rodenticides has risen since 1996, with<br />
86 percent of all farms using <strong>on</strong>e or more rodenticides during the year.<br />
The corresp<strong>on</strong>ding figures had been 78 percent in 1996, 79 percent in<br />
1994 and 74 percent in 1992.<br />
The percentage of rodenticides applied around buildings had increased from<br />
37 percent in 1996 to 59 percent of the total weight of bait applied in 1998<br />
with a corresp<strong>on</strong>ding reducti<strong>on</strong> in the use of rodenticides inside buildings
Secti<strong>on</strong> F: Other items c<strong>on</strong>sidered during the year<br />
from 56 percent to 32 percent. This may have been due to the increased<br />
uptake of crop assurance schemes, whose aim is to prevent the c<strong>on</strong>taminati<strong>on</strong><br />
of stored products, from rodent damage/fouling and from accidental spillage<br />
of rodenticide bait inside buildings.<br />
The proporti<strong>on</strong> of rodenticides purchased as c<strong>on</strong>centrates in 1998 remained<br />
close to a quarter of the total principal active substances used, as in 1996.<br />
There had been a decrease in the use of ready-to-use formulati<strong>on</strong>s from<br />
47 percent in 1996 to 39 percent in 1998 and also a subsequent increase<br />
in both c<strong>on</strong>tact dusts (20 percent in 1996 to 22 percent in 1998) and sachets<br />
(11 percent to 13 percent).<br />
There had been a further rise in the amount of bait applied by farmers as<br />
opposed to c<strong>on</strong>tractors. In 1994 farmers applied 55 percent of the principal<br />
six active substances. In 1996 this had risen to 75 percent, and in 1998 farmers<br />
applied 82 percent. This may have resulted from the increasing cost of<br />
employing a c<strong>on</strong>tractor as well as an increase in the number of the ’user<br />
friendly’ formulati<strong>on</strong>s available <strong>on</strong> the market such as sachets, c<strong>on</strong>tact dusts<br />
and wax blocks.<br />
<strong>Report</strong> 164: Protected crops (edible and ornamental) in<br />
Great Britain 1999<br />
This report presented informati<strong>on</strong> <strong>on</strong> all aspects of pesticide usage <strong>on</strong><br />
protected crops, both edible and ornamental, grown in Great Britain in 1999.<br />
More than 188 distinct crop types were encountered in the survey and data <strong>on</strong><br />
pesticide usage were collected during visits by pesticide usage surveyors to<br />
377 holdings throughout Great Britain. The total area surveyed represented<br />
30 percent of the area of all protected crops grown in Great Britain in 1999,<br />
while the area visited in each regi<strong>on</strong> was proporti<strong>on</strong>al to the area of protected<br />
crops grown in that regi<strong>on</strong>. The data <strong>on</strong> the area of pesticide treatments and<br />
the amounts of active substances applied had been extrapolated to give<br />
estimates of nati<strong>on</strong>al pesticide usage <strong>on</strong> protected crops. Informati<strong>on</strong> was<br />
also presented c<strong>on</strong>cerning the extent of usage of biological c<strong>on</strong>trol agents.<br />
65<br />
Edible crops accounted for 38 percent of the total area of protected crops<br />
grown in 1999.<br />
Usage of all biological c<strong>on</strong>trol agents accounted for 51 percent of the total<br />
treated area for pest, disease and weed c<strong>on</strong>trol <strong>on</strong> edible crops, although no<br />
such usage was recorded <strong>on</strong> lettuce, celery or edible plants in propagati<strong>on</strong>.<br />
Fungicides accounted for 27 percent of the total treated area, insecticides<br />
14 percent, acaricides three percent and sulphur two percent.
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
Encarsia formosa and Phytoseiulus persimilis were the most extensively<br />
used biological c<strong>on</strong>trol agents <strong>on</strong> edible crops. The most extensively used<br />
fungicides were propamocarb hydrochloride, iprodi<strong>on</strong>e, fosetyl-aluminium,<br />
metalaxyl/thiram and tolclofos-methyl. The organophosphates were the most<br />
extensively used group of insecticides and were used <strong>on</strong> 36 percent of the<br />
total insecticide-treated area. The pyrethroids were used <strong>on</strong> 34 percent of the<br />
insecticide-treated area and the carbamates 19 percent. The most extensively<br />
used individual insecticides were cypermethrin, pirimicarb and heptenophos.<br />
Fenbutatin oxide was used <strong>on</strong> 42 percent of the acaricide-treated area and<br />
abamectin <strong>on</strong> 32 percent.<br />
66<br />
Although the area of edible protected crops had declined by 38 percent since<br />
1991 the area treated with registered pesticides had decreased by 52 percent.<br />
In c<strong>on</strong>trast, since 1991, the area treated with n<strong>on</strong>-registered biological c<strong>on</strong>trol<br />
agents decreased, by 42 percent, in line with changes in the area grown.<br />
Usage of registered biological c<strong>on</strong>trol agents had declined by 77 percent since<br />
1991. The areas treated with all registered pesticides had declined by<br />
26 percent, between 1995 and 1999, and in particular fungicide usage had<br />
decreased by 33 percent, insecticides by five percent, molluscicides by<br />
71 percent and herbicides by 42 percent. Only the areas treated with sulphur<br />
had increased since 1995. The weight of registered active substances applied<br />
to edible protected crops had decreased by 60 percent since 1991 and by<br />
15 percent since the last survey. Soil sterilants accounted for less than <strong>on</strong>e<br />
percent of the treated area but for 50 percent of the total weight of active<br />
substances applied.<br />
The total area of protected ornamental crops grown in 1999 was 84 percent<br />
greater than in 1995 and 34 percent greater than in 1991. With the excepti<strong>on</strong><br />
of other “flowers and foliage”, where the area grown had increased by<br />
21 percent since 1995, the areas of all other flowers for cutting had declined<br />
markedly, reflecting the increased pressure from imports. The area of pinks<br />
had declined by 55 percent, carnati<strong>on</strong>s by 40 percent, chrysanthemums<br />
by 21 percent and alstroemeria by four percent.<br />
Growth regulators accounted for 35 percent of the total area of protected<br />
ornamental crops treated for pest, disease and weed c<strong>on</strong>trol, fungicides<br />
29 percent, insecticides 26 percent, acaricides five percent, herbicides two<br />
percent, molluscicides <strong>on</strong>e percent and registered biological c<strong>on</strong>trol agents<br />
<strong>on</strong>e percent. When all biological c<strong>on</strong>trol agents were included, the level of<br />
biological c<strong>on</strong>trol increased to 15 percent of the combined total. Soil sterilants
Secti<strong>on</strong> F: Other items c<strong>on</strong>sidered during the year<br />
accounted for less than <strong>on</strong>e percent of the area of ornamental crops treated<br />
but for 55 percent of the weight applied.<br />
Usage of daminozide accounted for over half of the area of ornamentals<br />
treated with growth regulators. Two fungicides accounted for 41 percent of<br />
the total fungicide-treated area of protected ornamental crops: chlorothal<strong>on</strong>il<br />
21 percent, and iprodi<strong>on</strong>e 20 percent. The organophosphates were again the<br />
most extensively used group of insecticides and accounted for 28 percent of<br />
the insecticide-treated area, the pyrethroids 25 percent and the carbamates<br />
16 percent. The most extensively used individual insecticides were pirimicarb<br />
14 percent, cypermethrin 14 percent, deltamethrin 11 percent, heptenophos<br />
11 percent, dichlorvos ten percent and nicotine nine percent. Two species<br />
accounted for 53 percent of the biological c<strong>on</strong>trol agent treated area: Encarsia<br />
formosa 28 percent and Aphidius colemani 25 percent. Two acaricides<br />
accounted for 85 percent of the acaricide-treated area of ornamental crops,<br />
abamectin 56 percent and bifenthrin 28 percent.<br />
While the area of protected ornamental crops had increased by 84 percent<br />
since 1995, the area treated with registered pesticides increased by 61 percent<br />
over the same period. There had been increases in the use of both fungicides,<br />
64 percent, and insecticides, two percent, between 1995 and 1999. However,<br />
the use of growth regulators, mainly for bedding plants and pot plants, had<br />
increased to ten times the area recorded in 1995. The use of registered and<br />
other biological c<strong>on</strong>trol agents had decreased by 45 percent. In line with the<br />
increases in the areas treated, the weight of registered pesticides applied had<br />
increased by 68 percent since 1995.<br />
67<br />
<strong>Report</strong> 165: Mushroom crops in Great Britain 1999<br />
This report presented informati<strong>on</strong> c<strong>on</strong>cerning all aspects of pesticide usage<br />
<strong>on</strong> mushrooms grown in Great Britain in a 12-m<strong>on</strong>th period during the 1999<br />
growing seas<strong>on</strong>. Data were collected during visits to 61 holdings growing<br />
mushrooms throughout Great Britain, representing 52 percent of total<br />
mushroom producti<strong>on</strong>. The holdings surveyed in each regi<strong>on</strong> were<br />
proporti<strong>on</strong>al to the producti<strong>on</strong> of mushrooms grown in that regi<strong>on</strong> and the<br />
data <strong>on</strong> the area of pesticide treatments and the amount of active substances<br />
applied had been extrapolated to give estimates of nati<strong>on</strong>al usage.<br />
Since 1995 there had been a 39 percent reducti<strong>on</strong> in the producti<strong>on</strong> area of<br />
mushrooms. This has been accompanied by a corresp<strong>on</strong>ding decrease in the<br />
area treated of 40 percent but a reducti<strong>on</strong> in the weight of pesticides applied,<br />
mainly disinfectants, of 90 percent.
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
Fungicides accounted for 37 percent of the total pesticide-treated area<br />
of mushrooms grown in Great Britain in 1999, disinfectants 36 percent,<br />
insecticides 25 percent, biological c<strong>on</strong>trol agents two percent and tar oils less<br />
than <strong>on</strong>e percent. In c<strong>on</strong>trast, disinfectants accounted for 80 percent of the<br />
total weight of pesticide active substances applied, fungicides for 16 percent,<br />
insecticides four percent, and tar oil less than <strong>on</strong>e percent.<br />
By area treated, the most extensively used fungicides were prochloraz,<br />
accounting for 88 percent of the total fungicide-treated area, used mainly<br />
during producti<strong>on</strong>, and carbendazim, comprising 11 percent, used during<br />
both producti<strong>on</strong> and casing. By weight applied, prochloraz accounted for<br />
71 percent of the total fungicides applied, with carbendazim comprising<br />
a further 27 percent.<br />
68<br />
The most extensively used insecticide formulati<strong>on</strong>s were permethrin<br />
(48 percent), pyrethrins/resmethrin (18 percent), diflubenzur<strong>on</strong> (17 percent),<br />
and methoprene (11 percent). The use of gamma-HCH was c<strong>on</strong>fined to<br />
periods between flushes or when the mushroom house was empty. By weight<br />
applied, diflubenzur<strong>on</strong>, used mainly during pre-producti<strong>on</strong>, accounted for<br />
65 percent of the total.<br />
In terms of area treated, sodium hypochlorite (81 percent) and formaldehyde<br />
(18 percent) were the two main registered disinfectants recorded.<br />
Unlike previous surveys c<strong>on</strong>ducted in 1991 and 1995, no acaricides or soil<br />
sterilants were recorded in 1999.<br />
Overall, the area treated with insecticides had more than halved, (59 percent),<br />
since 1995, while the use of fungicides had declined by 29 percent over the<br />
same period. The change in insecticide use was principally the result of a<br />
reduced use of pyrethrins/resmethrin, diflubenzur<strong>on</strong>, diazin<strong>on</strong>, gamma-HCH<br />
and dichlorvos. Use of the fungicides azac<strong>on</strong>azole and thiabendazole, both<br />
accounting for large areas in 1995, was not recorded in the current survey.<br />
By weight applied, insecticide usage had decreased by 91 percent, mainly<br />
resulting from a reduced use of diazin<strong>on</strong>, which has lost its approval status<br />
since 1995, diflubenzur<strong>on</strong>, pyrethrins/resmethrin, dichlorvos and permethrin.<br />
The weight of methoprene applied had increased by 19 percent. Fungicide<br />
usage decreased 74 percent by weight applied, due to the use of azac<strong>on</strong>azole<br />
not being recorded in this survey. Use of carbendazim, prochloraz and<br />
dichlorophen had also fallen.
Secti<strong>on</strong> F: Other items c<strong>on</strong>sidered during the year<br />
Changes in the weight of registered disinfectants used were largely the result<br />
of an 86 percent reducti<strong>on</strong> in the use of sodium hypochlorite and a 75 percent<br />
reducti<strong>on</strong> in the use of formaldehyde.<br />
The use of the biological c<strong>on</strong>trol agent Steinernema feltiae had fallen by<br />
10 percent since the previous survey, being recorded <strong>on</strong> a total of 28 hectares<br />
of growing area.<br />
<strong>Report</strong> 172: Orchards and fruit stores in Great Britain 2000<br />
This report presented informati<strong>on</strong> c<strong>on</strong>cerning all aspects of pesticide usage<br />
<strong>on</strong> orchard crops in Great Britain during the 2000 fruiting seas<strong>on</strong>. Informati<strong>on</strong><br />
was obtained from visits to 256 holdings, which represented 33 percent of the<br />
total area of commercial orchards grown. Data were collected <strong>on</strong> the area of<br />
pesticide treatments and the amount of active substances applied and these<br />
had been extrapolated to give estimates of nati<strong>on</strong>al pesticide usage.<br />
There had been a c<strong>on</strong>tinual decrease in the area of orchard crops grown over<br />
the last nine years, with the present area being 21 percent less than that<br />
grown in 1992 and eight percent less than the last survey in 1996. With the<br />
excepti<strong>on</strong> of cider apples and perry pears, all crops surveyed showed<br />
reducti<strong>on</strong>s in the area grown since 1996, with a 29 percent drop in cherries,<br />
26 percent in other culinary apples, 23 percent in Cox’s apples and plums,<br />
21 percent in pears, five percent in Bramley apples, two percent in other<br />
top fruit (including nuts) and <strong>on</strong>e percent in other dessert apples. Only cider<br />
apples and perry pears showed an increase, the area grown being 23 percent<br />
more than in 1996, and 42 percent greater than in 1992.<br />
69<br />
Both the total spray area and the weight of pesticides applied had decreased<br />
c<strong>on</strong>siderably since 1992. This trend was reflected in every major pesticide<br />
group except for sulphur and growth regulators, with an overall reducti<strong>on</strong> in<br />
area treated of 16 percent since 1992. This trend had c<strong>on</strong>tinued between 1996<br />
and the current survey where overall pesticide usage had fallen by five<br />
percent, with <strong>on</strong>ly fungicides, sulphur and growth regulators increasing in use.<br />
The weight of active substances applied, had declined by 19 percent between<br />
1996 and 2000 and by 21 percent since 1992.<br />
With l<strong>on</strong>g-seas<strong>on</strong> perennial crops it is essential to protect growth throughout<br />
the growing seas<strong>on</strong> in order to ensure the producti<strong>on</strong> of high-quality fruit.<br />
This results in the majority of crops receiving some degree of treatment. For<br />
example in 2000, Cox’s dessert apple crops received <strong>on</strong> average, including<br />
repeat applicati<strong>on</strong>s, a total of 18 pesticide sprays, 35 products and 38 active<br />
substances. In c<strong>on</strong>trast, over 60 percent of other top fruit (incl. nuts); almost
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
<strong>on</strong>e-third, 32 percent, of cider apples and perry pears; 22 percent of plums;<br />
and seven percent of cherries received no pesticides.<br />
Fungicides and pruning paints accounted for 60 percent of the total pesticidetreated<br />
area of orchard crops grown in Great Britain in 2000, insecticides<br />
12 percent, herbicides 11 percent, growth regulators ten percent, sulphur two<br />
percent, urea two percent, acaricides <strong>on</strong>e percent and acaricide/insecticides,<br />
biological c<strong>on</strong>trol agents, tar oil/acids, all less than <strong>on</strong>e percent each. In<br />
c<strong>on</strong>trast, fungicides and pruning paints accounted for 50 percent of the total<br />
weight of pesticide active substances applied, herbicides 12 percent, sulphur<br />
12 percent, insecticides ten percent, tar oil/acids ten percent, urea five percent<br />
and growth regulators <strong>on</strong>e percent.<br />
70<br />
The principal fungicide formulati<strong>on</strong>s were captan (20 percent), myclobutanil<br />
(14 percent), dithian<strong>on</strong> (13 percent), penc<strong>on</strong>azole (nine percent), pyrifenox<br />
(six percent) and bupirimate (six percent). By weight applied, however, while<br />
captan was still the most extensively used formulati<strong>on</strong>, it accounted<br />
for 47 percent of all fungicide use, while dithian<strong>on</strong> comprised 15 percent,<br />
captan/penc<strong>on</strong>azole ten percent, dodine eight percent and mancozeb<br />
seven percent.<br />
The organophosphates were the most extensively used insecticides,<br />
accounting for 60 percent of the insecticide-treated area, followed by the<br />
carbamates, 16 percent, ‘other insecticides’, mainly the juvenile horm<strong>on</strong>e<br />
analogue fenoxycarb, 15 percent, pyrethroids, six percent and the<br />
benzoylureas, two percent. Five formulati<strong>on</strong>s accounted for approximately<br />
90 percent of the total insecticide-treated area of all orchard crops:<br />
chlorpyrifos 54 percent; fenoxycarb 15 percent; pirimicarb 12 percent;<br />
cypermethrin five percent and carbaryl four percent, which was also used<br />
specifically as a fruit thinning agent <strong>on</strong> apples (see growth regulators).<br />
Chlorpyrifos accounted for 69 percent of the total weight of insecticides<br />
applied and carbaryl, used <strong>on</strong> four percent of the total insecticide area,<br />
accounted for a further 11 percent.<br />
The most extensively used herbicide formulati<strong>on</strong>s were glyphosate, accounting<br />
for 28 percent of the area treated, simazine, 14 percent, glufosinateamm<strong>on</strong>ium,<br />
nine percent, 2,4-D/dichlorprop/MCPA/mecoprop, eight percent<br />
and amitrole, seven percent. In terms of weight applied, glyphosate accounted<br />
for 30 percent of the total, simazine 14 percent, 2,4-D/dichlorprop/MCPA/<br />
mecoprop, ten percent, amitrole, eight percent, and dicamba/MCPA/mecoprop,<br />
eight percent.
Secti<strong>on</strong> F: Other items c<strong>on</strong>sidered during the year<br />
The most frequently used growth regulators by area treated were paclobutrazol,<br />
62 percent, gibberellins, 34 percent, and carbaryl, three percent, with<br />
paclobutrazol and carbaryl accounting for 50 percent and 44 percent<br />
respectively by weight applied.<br />
The most extensively used acaricides were amitraz, which accounted for<br />
42 percent of the acaricide-treated area, fenpyroximate, used <strong>on</strong> 34 percent,<br />
and clofentezine, comprising a further 20 percent. By weight applied, amitraz<br />
accounted for 83 percent of the total. Tebufenpyrad was the <strong>on</strong>ly<br />
acaricide/insecticide recorded.<br />
Biological c<strong>on</strong>trol agents represented less than <strong>on</strong>e percent of all pesticide<br />
usage, with Bacillus thuringiensis being the <strong>on</strong>ly agent recorded. Anthracene<br />
oil was the <strong>on</strong>ly defoliant recorded.<br />
<strong>Report</strong> 173: Hops in Great Britain 2000<br />
This report presented informati<strong>on</strong> c<strong>on</strong>cerning all aspects of pesticide usage <strong>on</strong><br />
hops in England and Wales during the 2000 cropping seas<strong>on</strong>. Informati<strong>on</strong> was<br />
collected from visits to 41 holdings, which represented 32 percent of the total<br />
area of hops grown. Data collected <strong>on</strong> the area of pesticide treatments and the<br />
amount of active substances applied had been extrapolated to give estimates<br />
of nati<strong>on</strong>al pesticide usage.<br />
71<br />
There had been a c<strong>on</strong>tinual decrease in the area of hops grown in recent<br />
years, with the area grown in 2000 being 35 percent less than in 1992 and<br />
32 percent less than at the time of the previous survey in 1996. Since 1996,<br />
there had been a 26 percent decrease in the total pesticide-treated area, and<br />
a 54 percent decrease in the weight of active substances applied.<br />
Pest and disease c<strong>on</strong>trol in hops is frequently achieved using routine spray<br />
programmes, particularly in the case of protectant fungicide sprays to c<strong>on</strong>trol<br />
downy and powdery mildew. On average, crops received 14 separate spray<br />
applicati<strong>on</strong>s, 25 products (including repeat applicati<strong>on</strong>s of the same product) and<br />
30 active substances (including repeat applicati<strong>on</strong>s of the same active substance).<br />
Fungicides accounted for 59 percent of the total pesticide-treated area of hops<br />
grown in England and Wales in 2000, herbicides 19 percent, acaricides eight<br />
percent, sulphur six percent, insecticides four percent, defoliants three percent<br />
and molluscicides and tar oils less than <strong>on</strong>e percent. In terms of the weight of<br />
active substances applied, herbicides accounted for 34 percent of the total,<br />
fungicides 23 percent, defoliants 23 percent, sulphur 12 percent, tar oils seven<br />
percent, acaricides, insecticides and all other groups less than <strong>on</strong>e percent.
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
The most extensively used fungicide formulati<strong>on</strong>s were copper oxychloride/<br />
metalaxyl, pyrazophos, copper oxychloride, fenpropimorph, zineb and<br />
myclobutanil, which together accounted for 83 percent of the total area of<br />
fungicides used. In terms of weight applied, copper oxychloride was the most<br />
important fungicide formulati<strong>on</strong>, accounting for 31 percent of the total.<br />
Sulphur accounted for six percent of the total area treated and 12 percent<br />
of the weight applied, reflecting its high rate of applicati<strong>on</strong>.<br />
The most extensively used herbicide formulati<strong>on</strong>s were diquat/paraquat, used<br />
mainly for defoliati<strong>on</strong>, sodium m<strong>on</strong>ochloroacetate, again for defoliati<strong>on</strong>, and<br />
simazine and glyphosate, used mainly for general weed c<strong>on</strong>trol, all of which<br />
accounted for 90 percent of the area treated with herbicides.<br />
The most extensively used acaricide was tebufenpyrad, which accounted for<br />
60 percent of the area treated with acaricides and was used mainly to c<strong>on</strong>trol<br />
red spider mites.<br />
72<br />
The most extensively used insecticide was imidacloprid, which accounted for<br />
81 percent of the insecticide-treated area, applied primarily to the ‘hills’ in the<br />
hop garden or yard. Insecticide usage had decreased by 23 percent from that<br />
in 1996 and by 80 percent from that in 1992. The decrease in insecticide usage<br />
overall reflected dramatic declines for all major insecticide groups including<br />
carbamates, organochlorines, organophosphates and pyrethroids. The<br />
introducti<strong>on</strong> of imidacloprid has radically changed insecticide usage <strong>on</strong> hops,<br />
with a single applicati<strong>on</strong> <strong>on</strong> many crops being made early in the year to give<br />
all-seas<strong>on</strong> c<strong>on</strong>trol of the dams<strong>on</strong>-hop aphid Phorod<strong>on</strong> humuli (Schrank).<br />
The area treated with defoliants and tar oils combined accounted for three<br />
percent of the total area treated and 30 percent of the weight applied in 2000.<br />
The use of tar oil as a defoliant had decreased by 79 percent since 1996 in<br />
terms of area treated and by 84 percent of weight applied, reflecting the<br />
c<strong>on</strong>tinued move towards anthracene oil as a defoliant.<br />
<strong>Report</strong> 179: Farm grain stores in Great Britain 1998/1999<br />
This report presented data from 1,858 replies from a preliminary questi<strong>on</strong>naire<br />
sent to 2,997 arable holdings in Great Britain and the results from visits to<br />
444 holdings both using pesticides and storing grain from the 1998 harvest in<br />
Great Britain. Data had been extrapolated to give nati<strong>on</strong>al estimates of usage<br />
in Great Britain.<br />
A total of almost 18 milli<strong>on</strong> t<strong>on</strong>nes of grain was stored of which 74 percent<br />
was in flat stores, and the remainder being stored in bins or silos.
Secti<strong>on</strong> F: Other items c<strong>on</strong>sidered during the year<br />
The questi<strong>on</strong>naire showed that 72 percent of all holdings c<strong>on</strong>tacted stored<br />
grain and 51 percent used pesticides either as fabric treatments or admixture<br />
treatments. Those holdings in the South Western and Midlands and Western<br />
regi<strong>on</strong>s were more likely to be applying fabric treatments, while the<br />
applicati<strong>on</strong> of both fabric and admixture treatments was more prevalent<br />
in the South Eastern regi<strong>on</strong>.<br />
Almost 16 t<strong>on</strong>nes of pesticides were applied in farm grain stores in Great<br />
Britain with Eastern regi<strong>on</strong> accounting for 29 percent of the total weight<br />
applied, South Eastern 25 percent, Midlands and Western 19 percent and<br />
South Western 14 percent.<br />
By weight 54 percent of pesticides were applied as fabric treatments, with<br />
pirimiphos-methyl accounting for 88 percent of all fabric treatments. The<br />
remaining 46 percent of pesticides were applied to the grain either at or<br />
during storage. Of all grain treated, 57 percent by weight was treated with<br />
an admixture, the rest receiving surface treatments. Pirimiphos-methyl<br />
accounted for 78 percent of the weight of pesticide applied, either as<br />
admixture treatments or incorporated into the surface of the grain in store.<br />
C<strong>on</strong>tractors applied 14 percent, by weight applied, of fabric treatments but<br />
<strong>on</strong>ly seven percent of the admixture treatments. C<strong>on</strong>tractors made all<br />
applicati<strong>on</strong>s of aluminium phosphide recorded in this survey.<br />
73<br />
Since the survey c<strong>on</strong>ducted in 1994/95 there had been a two percent increase<br />
in the t<strong>on</strong>nage of grain stored, with the weight of active substances applied<br />
having increased by less than <strong>on</strong>e percent. There has been a decrease in the<br />
number of active substances applied to grain. Organophosphates c<strong>on</strong>tinued to<br />
account for the majority of pesticides used in grain stores and in the current<br />
survey they accounted for 97 percent of the total weight of pesticides applied.<br />
<strong>Report</strong> 180: Commercial grain stores in Great Britain 1998/1999<br />
This report presented data from 210 replies from a preliminary questi<strong>on</strong>naire<br />
sent to 283 potential commercial grain stores and the results from visits to<br />
143 premises storing grain from the 1998 harvest in Great Britain and using<br />
pesticides. Data had been extrapolated to give nati<strong>on</strong>al estimates of usage<br />
in Great Britain.<br />
A total of 8.3 milli<strong>on</strong> t<strong>on</strong>nes of grain was stored of which 52 percent was<br />
in upright stores. The questi<strong>on</strong>naire showed that 94 percent of all premises<br />
c<strong>on</strong>tacted stored grain and 88 percent used pesticides either as fabric<br />
treatments or grain treatments. Stores in Scotland and South Eastern regi<strong>on</strong>
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
were more likely to apply fabric treatments, while the applicati<strong>on</strong> of both<br />
fabric and grain treatments was more prevalent in the South Western regi<strong>on</strong>.<br />
A single commercial store in Wales was encountered in the sample which<br />
applied both fabric and grain treatments.<br />
Approximately 4.7 t<strong>on</strong>nes of pesticides were applied in commercial grain<br />
stores in Great Britain with Scotland, accounting for 38 percent of the weight,<br />
Eastern regi<strong>on</strong> 24 percent, Northern regi<strong>on</strong> 23 percent, Midlands and Western<br />
regi<strong>on</strong> 11 percent, South Western regi<strong>on</strong> three percent, South Eastern regi<strong>on</strong><br />
<strong>on</strong>e percent and Wales less than <strong>on</strong>e percent.<br />
By weight, 80 percent of pesticides was applied to the grain either at or<br />
during storage. Pirimiphos-methyl accounted for 61 percent of the weight<br />
of pesticide applied, either as admixture treatments or incorporated into the<br />
surface or the grain in store. Of all grain treated, 92 percent by weight was<br />
treated with an admixture, the rest receiving surface treatments.<br />
74<br />
The remaining 20 percent of pesticides were applied as fabric treatments,<br />
with pirimiphos-methyl accounting for 53 percent of all fabric treatments and<br />
methyl bromide a further 37 percent.<br />
C<strong>on</strong>tractors applied 50 percent, by weight applied, of fabric treatments but<br />
<strong>on</strong>ly eight percent of the admixture treatments. The use of methyl bromide,<br />
which can be applied <strong>on</strong>ly by c<strong>on</strong>tractors, accounted for the bulk of<br />
c<strong>on</strong>tractor applicati<strong>on</strong>s made to the fabric.<br />
In terms of the number of stores treated, rodenticides were used <strong>on</strong><br />
96 percent of commercial grain stores in Great Britain in 1998. Difenacoum<br />
was the most comm<strong>on</strong>ly occurring rodenticide, being used at 35 percent of<br />
all commercial grain stores, followed by bromadiol<strong>on</strong>e at 25 percent.<br />
Excluding holdings where the product used was unknown, these two active<br />
substances accounted for 68 percent of all recorded occurrences.<br />
Totals of just under <strong>on</strong>e kilogram of active substance and approximately ten<br />
t<strong>on</strong>nes of bait were recorded in the current survey, reflecting the extremely<br />
low percentage of active substance c<strong>on</strong>tained within rodenticide baits.<br />
Since the survey c<strong>on</strong>ducted in 1994/95, the t<strong>on</strong>nage of grain stored had more<br />
than doubled, with some of the increase being due to the storage of<br />
interventi<strong>on</strong> grain, which was minimal in the previous survey period.<br />
The weight of active substances applied had increased by 40 percent, which<br />
is significantly less than the increase in the grain stored since 1994/95. There<br />
had been a c<strong>on</strong>tinued decrease in the number of active substances applied
Secti<strong>on</strong> F: Other items c<strong>on</strong>sidered during the year<br />
to grain. Organophosphates c<strong>on</strong>tinued to account for the majority of pesticides<br />
used in grain stores and in the current survey they accounted for 85 percent<br />
of the total weight of pesticides applied.<br />
Other Items<br />
Aquatic risk management opti<strong>on</strong>s<br />
In the UK, buffer z<strong>on</strong>es are required for some products to prevent an<br />
unacceptable risk of damage to aquatic life. A buffer z<strong>on</strong>e is a strip of land<br />
adjacent to surface water left untreated with that product. The size of the<br />
buffer z<strong>on</strong>e may be reduced under some circumstances following an<br />
appropriate Local Envir<strong>on</strong>mental Risk Assessment c<strong>on</strong>ducted under the<br />
relevant LERAP scheme. However, at present the maximum size of buffer z<strong>on</strong>e<br />
that could be required for a product approved for use <strong>on</strong> arable crops is five<br />
metres. There are different risk management opti<strong>on</strong>s used in other European<br />
Member States resulting in some differences in the range of products available<br />
to growers across Europe. The ACP c<strong>on</strong>sidered a number of the approaches<br />
adopted by other Member States, some of which allow for buffer z<strong>on</strong>es in<br />
arable crops of greater than five metres. It also c<strong>on</strong>sidered the results of a<br />
limited survey giving evidence <strong>on</strong> compliance with the existing risk<br />
management strategy in the UK. Overall, members c<strong>on</strong>cluded that while<br />
larger buffer z<strong>on</strong>es in arable crops would be capable of providing risk<br />
mitigati<strong>on</strong>, they would require better evidence of compliance with the<br />
current arrangements before c<strong>on</strong>sidering any increase in the maximum<br />
size of buffer z<strong>on</strong>es in the arable sector.<br />
75<br />
Bioavailability of triazophos for treated apples<br />
In 1998, PSD/MAFF initiated a research project to investigate the bioavailability<br />
of the organophosphorus compound triazophos. The primary aim was to<br />
compare the results in animals administered triazophos in corn oil with those<br />
receiving a similar dose from pureed apples treated in line with agricultural<br />
practice. The corn oil exposure was typical of that used in toxicity studies<br />
used to derive acute reference doses, with the apple exposure representing<br />
human exposures. If there were differences between the results for the<br />
vehicles there might be a need to introduce an appropriate correcti<strong>on</strong> into risk<br />
assessments.<br />
The peak levels and ‘area under the curve’ (AUC) values for total plasma<br />
radioactivity were broadly similar, whether the triazophos was present as an<br />
incurred residue in orally dosed apple puree, or present in orally dosed corn<br />
oil. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> noted that the results of the research showed similar<br />
absorpti<strong>on</strong> patterns and plasma profiles for both preparati<strong>on</strong>s. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g>
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
agreed that the current default assumpti<strong>on</strong> that corn oil administrati<strong>on</strong> was an<br />
acceptable model for dietary exposure was supported. It was suggested that,<br />
if applicants wished to make a case for reduced bioavailability in respect of<br />
specific crops and pesticides, the <strong>on</strong>us should be <strong>on</strong> them to submit data to<br />
support such a case.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> recommended that the research be submitted for publicati<strong>on</strong><br />
in a peer-reviewed scientific journal.<br />
76<br />
Comparative risk assessment<br />
The ACP was asked by Ministers to c<strong>on</strong>sider the value of comparative<br />
assessment and substituti<strong>on</strong> in the regulati<strong>on</strong> of pesticides. At the July meeting<br />
it was agreed that PSD should issue a c<strong>on</strong>sultati<strong>on</strong> letter seeking views from<br />
approval holders, users, c<strong>on</strong>sumers and envir<strong>on</strong>mental interests. Following<br />
this, the ACP began to develop possible schemes for comparative assessment,<br />
taking account of the resp<strong>on</strong>ses to the c<strong>on</strong>sultati<strong>on</strong>. During 2002, the<br />
<str<strong>on</strong>g>Committee</str<strong>on</strong>g> will c<strong>on</strong>tinue to c<strong>on</strong>sider these opti<strong>on</strong>s, together with related issues<br />
of relevance to the re-negotiati<strong>on</strong> of the Pesticide Authorisati<strong>on</strong> Directive<br />
(91/414/EEC).<br />
Degradati<strong>on</strong> of chlorothal<strong>on</strong>il residues prior to analysis –<br />
follow-up report<br />
During Pesticide Residues <str<strong>on</strong>g>Committee</str<strong>on</strong>g> (PRC) routine m<strong>on</strong>itoring in 1994, it was<br />
noted that fortified residues of chlorothal<strong>on</strong>il were being ‘lost’. A study was<br />
initiated to examine the extent and possible mode of the degradati<strong>on</strong> in five<br />
crops: lettuce, <strong>on</strong>i<strong>on</strong>, celery, broccoli and lem<strong>on</strong>.<br />
The study was c<strong>on</strong>sidered at the November 1994 ACP meeting. The results<br />
showed that significant losses were occurring as a result of comminuti<strong>on</strong> and<br />
freezer storage and/or storage of extracts at room temperature prior to<br />
analysis. These losses were greatest in lettuce, celery and <strong>on</strong>i<strong>on</strong>s and less in<br />
broccoli and lem<strong>on</strong>s. If lettuce was ‘killed’ by microwaving prior to storage<br />
and analysis, losses were greatly reduced, indicating that the problem was<br />
likely to be enzymatic degradati<strong>on</strong>. The ACP had recommended that a further<br />
study be c<strong>on</strong>ducted <strong>on</strong> the fate of chlorothal<strong>on</strong>il residues during processing<br />
and analysis of lettuce and <strong>on</strong>i<strong>on</strong>s.<br />
The follow-up study was c<strong>on</strong>sidered at the June 1997 ACP meeting. The<br />
results showed that losses of chlorothal<strong>on</strong>il and also dichlofluanid could be<br />
minimised by cryogenic milling of lettuce samples and extracting the subsamples<br />
partially frozen. In the case of <strong>on</strong>i<strong>on</strong>s, the use of cryogenic milling
Secti<strong>on</strong> F: Other items c<strong>on</strong>sidered during the year<br />
did not prevent the loss of chlorothal<strong>on</strong>il. Losses, however, were not observed<br />
in extracts fortified with chlorothal<strong>on</strong>il, after prior removal of sulphurc<strong>on</strong>taining<br />
compounds by the use of an alumina column impregnated with<br />
silver nitrate. It was therefore tentatively proposed that silver nitrate should<br />
be added to frozen <strong>on</strong>i<strong>on</strong> subsamples before extracti<strong>on</strong>. The ACP had<br />
recommended that a further study be c<strong>on</strong>ducted into the use of silver nitrate<br />
and the use of acet<strong>on</strong>e c<strong>on</strong>taining 10N sulphuric acid as used by industry.<br />
Several other techniques were also examined, <strong>on</strong>e of which was the additi<strong>on</strong><br />
of orthophosphoric acid pre-milling.<br />
The additi<strong>on</strong>al study <strong>on</strong> <strong>on</strong>i<strong>on</strong>s was c<strong>on</strong>sidered at the January <strong>2001</strong> ACP<br />
meeting. The results showed that losses of chlorothal<strong>on</strong>il during the analysis<br />
of <strong>on</strong>i<strong>on</strong>s could be minimised by the additi<strong>on</strong> of 2.2M orthophosphoric acid<br />
to the samples before milling.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> recommended that:<br />
●<br />
●<br />
●<br />
the findings of these studies be passed <strong>on</strong> to the EU rapporteur<br />
(Netherlands) for c<strong>on</strong>siderati<strong>on</strong> when evaluating the methods of analysis<br />
used to analyse crop samples for chlorothal<strong>on</strong>il and commercial/domestic<br />
processing data;<br />
the use of orthophosphoric acid in the preparati<strong>on</strong> of subsamples of crops<br />
should be routinely adopted, when analysing <strong>on</strong>i<strong>on</strong>s (and other allium<br />
crops) for chlorothal<strong>on</strong>il; and<br />
industry should be informed of the findings and recommendati<strong>on</strong>s from<br />
the study.<br />
77<br />
How a broader approach to the protecti<strong>on</strong> of biodiversity may affect<br />
ecological risk assessments of plant protecti<strong>on</strong> products<br />
This report highlighted that the <str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> Releases to the<br />
Envir<strong>on</strong>ment (ACRE) c<strong>on</strong>siders the risks to biodiversity from genetically<br />
modified organisms, which has implicati<strong>on</strong>s for the ACP. On the basis of this<br />
report the ACP agreed to review its approach to wider biodiversity issues as a<br />
matter of some urgency. It c<strong>on</strong>sidered that the aim should be to take account<br />
of risks to biodiversity in the regulati<strong>on</strong> of pesticides and that the approach<br />
taken should be based <strong>on</strong> sound science. It was also agreed that the policy<br />
and management issues raised by the report should be discussed with the<br />
ACRE subgroup. Once a clear way forward was identified it would also be<br />
necessary for discussi<strong>on</strong>s to take place with relevant stakeholders.
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
Reappraisal of Local Envir<strong>on</strong>mental Risk Assessments for <strong>Pesticides</strong><br />
(LERAPs) for horiz<strong>on</strong>tal boom sprayers<br />
LERAPs provide a framework for those using agricultural pesticides to take<br />
acti<strong>on</strong> to protect watercourses appropriate to their own local circumstances<br />
and practices. The scheme was developed for use in the arable crop sector<br />
and was introduced in 1999. Following a survey commissi<strong>on</strong>ed by PSD in the<br />
summer of 2000, the scheme was amended in resp<strong>on</strong>se to feedback and the<br />
survey results.<br />
In <strong>2001</strong> the scheme guidance was revised and simplified after c<strong>on</strong>sulting with<br />
industry and other interested parties. In additi<strong>on</strong>, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> advised that<br />
further steps be taken to increase awareness of and compliance with the<br />
scheme am<strong>on</strong>g farmers and growers to ensure the scheme delivered its aim<br />
of envir<strong>on</strong>mental protecti<strong>on</strong> of watercourses.<br />
78<br />
Revised proposals for a scheme of Local Envir<strong>on</strong>mental Risk Assessments<br />
for <strong>Pesticides</strong> (LERAPs) for broadcast air-assisted sprayers<br />
LERAPs provide a framework for those using agricultural pesticides to<br />
take appropriate acti<strong>on</strong> to protect watercourses in the light of their own<br />
circumstances and practices. A proposed parallel scheme had been developed<br />
for the orchard, hop and soft fruit sector.<br />
In July 2000 the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered revised proposals for this scheme.<br />
Original proposals put to the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> in 1999 had been revised in the light<br />
of views received from a public c<strong>on</strong>sultati<strong>on</strong>. A sec<strong>on</strong>d public c<strong>on</strong>sultati<strong>on</strong><br />
followed in October 2000 and the inclusi<strong>on</strong> of living windbreaks into the<br />
scheme was c<strong>on</strong>firmed by the ACP in the summer of <strong>2001</strong>. Following further<br />
refinements regarding buffer z<strong>on</strong>es for orchards and hops, a final scheme was<br />
agreed in time for implementati<strong>on</strong> for the 2002 growing seas<strong>on</strong>.<br />
Mutual recogniti<strong>on</strong> of Member State product approvals in support of<br />
applicati<strong>on</strong>s for extensi<strong>on</strong>s of use (off-label use) of products approved<br />
under the Plant Protecti<strong>on</strong> Products Regulati<strong>on</strong>s 1995 (as amended).<br />
Directive 91/414/EEC introduced a requirement for Member States to mutually<br />
recognise plant protecti<strong>on</strong> product approvals after an active substance has<br />
been included <strong>on</strong> Annex I. The paper c<strong>on</strong>sidered by the ACP proposed that<br />
under specified c<strong>on</strong>diti<strong>on</strong>s, approvals for minor uses in the UK could be given<br />
<strong>on</strong> the basis of mutually recognising other Member State approvals, where<br />
a product has been provisi<strong>on</strong>ally approved, in advance of Annex I listing.<br />
Additi<strong>on</strong>ally, for outdoor crops, the provisi<strong>on</strong>al approval would have to
Secti<strong>on</strong> F: Other items c<strong>on</strong>sidered during the year<br />
have been granted in a northern Member State, to ensure that the supporting<br />
field data were generated under similar climatic c<strong>on</strong>diti<strong>on</strong>s to those prevailing<br />
in the United Kingdom. The c<strong>on</strong>diti<strong>on</strong>s proposed broadly replicated the<br />
specified c<strong>on</strong>diti<strong>on</strong>s of the existing scheme to recognise approvals for minor<br />
uses of products approved under the C<strong>on</strong>trol of <strong>Pesticides</strong> Regulati<strong>on</strong>s.<br />
The ACP agreed to advise Ministers to accept the proposed mutual recogniti<strong>on</strong><br />
scheme for extensi<strong>on</strong> of use for plant protecti<strong>on</strong> products and to agree to its<br />
publicati<strong>on</strong>.<br />
Operator exposure in applying amenity herbicides by All-Terrain<br />
Vehicle (ATV) and C<strong>on</strong>trolled Droplet Applicator (CDA)<br />
There are no published exposure data for amenity applicati<strong>on</strong> of herbicides<br />
using spray booms fr<strong>on</strong>t-mounted <strong>on</strong> ATVs or a separate lance and CDA.<br />
To inform risk assessments, HSE had commissi<strong>on</strong>ed research to enable the<br />
assessment of exposure during use of these methods of herbicide applicati<strong>on</strong>.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered a report <strong>on</strong> the outcome of the research. This<br />
presented the results for the two types of applicati<strong>on</strong>, by ATV with fr<strong>on</strong>tmounted<br />
spray bars, and CDA sprayer. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> noted the findings<br />
of the research and agreed that the following indicative values should inform<br />
exposure predicti<strong>on</strong>s and risk assessments for these types of applicati<strong>on</strong>:<br />
79<br />
ATV:<br />
The potential dermal exposure to spray fluid (21 data points) ranged between<br />
11 and 113 mg fluid per minute, median 32.7 mg/min, based <strong>on</strong> patch<br />
samplers. These data also indicated a median penetrati<strong>on</strong> of work wear<br />
at 11 percent. Exposure of hands as collected <strong>on</strong> cott<strong>on</strong> gloves (21 data<br />
points) ranged between 9.18 and 227 mg spray fluid per minute, median<br />
49.9 mg/min. Exposure by inhalati<strong>on</strong> to spray fluid was found in 85 percent<br />
of samples, range 6.51 to 36.5 mg/m 3 , median of n<strong>on</strong>-zero values 15.5 mg/m 3 .<br />
CDA:<br />
The potential dermal exposure to spray fluid (12 data points) ranged between<br />
0.05 and 13.8 mg fluid per minute, median 2.21 mg/min, based <strong>on</strong> patch<br />
samplers. There were no meaningful data for clothing penetrati<strong>on</strong> from this<br />
study. Exposure of hands as collected <strong>on</strong> cott<strong>on</strong> gloves inside protective<br />
gloves (12 data points) ranged between 0.003 and 0.98 mg spray fluid per<br />
minute, median 0.06 mg/min, and <strong>on</strong> socks (12 data points) ranged between<br />
0.001 and 0.76 mg spray fluid per minute, median 0.02 mg/min. Exposure by
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
inhalati<strong>on</strong> was low, occurring in just 33 percent of samples, range 0.02 to 0.61<br />
mg/m 3 , median of n<strong>on</strong>-zero values, 0.12 mg/m 3 .<br />
Papers to address re-entry time policy for certain wood preservatives<br />
When a liquid wood preservative product is used indoors by a professi<strong>on</strong>al<br />
operator, there is a specified exclusi<strong>on</strong> period in which unprotected pers<strong>on</strong>s<br />
and animals should be kept away from the treated area. The time at which<br />
this exclusi<strong>on</strong> finishes is known as the ‘re-entry time’. Previously, there were<br />
two label phrases regarding re-entry time. These stipulated either a 48-hour<br />
or an eight-hour re-entry time, depending up<strong>on</strong> the product.<br />
80<br />
A 48-hour re-entry time was required unless data dem<strong>on</strong>strated that the<br />
exposure of people re-entering treated areas after eight hours was acceptable.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered a review of the existing re-entry time policy, and<br />
the criteria used to identify appropriate re-entry times and rec<strong>on</strong>sidered<br />
whether shorter exclusi<strong>on</strong> periods might be acceptable for certain liquid wood<br />
preservatives. It compared the airborne c<strong>on</strong>centrati<strong>on</strong>s over time of the active<br />
substances, with appropriate NOAELs, and of any solvents in the product<br />
formulati<strong>on</strong>, with the occupati<strong>on</strong>al exposure standards (OES) or equivalent.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that the exposure of people to both the solvents and<br />
the active substances was c<strong>on</strong>sistently and acceptably low for a range of<br />
representative products.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> recognised that, historically, many products had c<strong>on</strong>tained<br />
volatile active substances and high c<strong>on</strong>centrati<strong>on</strong>s of solvents, and evaporati<strong>on</strong><br />
of surface residues had been significant. However, the products used in these<br />
areas had, over a number of years, been reformulated as water-based products<br />
c<strong>on</strong>taining involatile active substances and low c<strong>on</strong>centrati<strong>on</strong>s of solvents.<br />
As a c<strong>on</strong>sequence of this, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that there was no clear<br />
relati<strong>on</strong>ship between aerial c<strong>on</strong>centrati<strong>on</strong>s of the solvent or active substance<br />
and surface wetness of treated timber. Therefore, it agreed that exclusi<strong>on</strong> from<br />
the applicati<strong>on</strong> area should be c<strong>on</strong>sidered solely <strong>on</strong> the basis of the possibility<br />
of exposure to air c<strong>on</strong>centrati<strong>on</strong>s, with a physical barrier to prevent access to<br />
the treated timber until it was dry.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered that it should be possible to allow certain liquid<br />
wood preservative products a <strong>on</strong>e-hour re-entry time. However, for this,<br />
the applicant would need to dem<strong>on</strong>strate c<strong>on</strong>vincingly that the aerial<br />
c<strong>on</strong>centrati<strong>on</strong>s of the active substance and solvent, for its individual products,<br />
were appropriately low within <strong>on</strong>e hour of applicati<strong>on</strong> at low levels of
Secti<strong>on</strong> F: Other items c<strong>on</strong>sidered during the year<br />
ventilati<strong>on</strong> and that the exposure of people re-entering treated premises<br />
would be acceptable.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that such products would need the following label:<br />
EXCLUDE ALL UNPROTECTED PERSONS AND ANIMALS DURING<br />
TREATMENT AND FOR AT LEAST 1 HOUR AFTER TREATMENT IS<br />
COMPLETED.<br />
ENSURE THERE IS A PHYSICAL BARRIER TO PREVENT CONTACT BY<br />
UNPROTECTED PERSONS AND ANIMALS UNTIL TREATED SURFACES<br />
ARE VISIBLY DRY.<br />
ENSURE ADEQUATE VENTILATION BEFORE REOCCUPATION.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> also agreed that HSE should assess the individual applicati<strong>on</strong>s<br />
and annually review the reports of the <strong>Pesticides</strong> Incidents Appraisal Panel for<br />
any incidents relating to this reducti<strong>on</strong> in re-entry time.<br />
Pesticide exposure and Parkins<strong>on</strong>’s disease – review of the literature<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered a review of the literature covering epidemiological<br />
investigati<strong>on</strong>s of pesticides in relati<strong>on</strong> to Parkins<strong>on</strong>’s disease, and also an<br />
evaluati<strong>on</strong> of mechanistic studies that have explored the potential of specific<br />
pesticides to induce Parkins<strong>on</strong>’s disease in experimental animals.<br />
81<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that a more detailed specialist assessment of the<br />
epidemiology relating to Parkins<strong>on</strong>’s disease and pesticides should be<br />
carried out.<br />
Pesticide Incident <strong>Report</strong> 2000/<strong>2001</strong>: report <strong>on</strong> HSE’s Field Operati<strong>on</strong>s<br />
Directorate’s investigati<strong>on</strong>s 1 April 2000–31 March <strong>2001</strong><br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> noted the c<strong>on</strong>tent of the report into pesticide complaints<br />
investigated by the Field Operati<strong>on</strong>s Directorate of HSE between 1 April 2000<br />
and 31 March <strong>2001</strong>.<br />
The Pesticide Incident <strong>Report</strong> for 2000/<strong>2001</strong> was published <strong>on</strong> 13 November<br />
<strong>2001</strong>. The report provided an analysis of incidents and complaints involving<br />
pesticides investigated by HSE’s Field Operati<strong>on</strong>s Directorate and the<br />
enforcement acti<strong>on</strong> taken. Summaries of complaints alleging ill health were<br />
included, with details of the outcome of assessments by the <strong>Pesticides</strong><br />
Incidents Appraisal Panel (PIAP). In additi<strong>on</strong>, a series of case studies was<br />
included to encourage the prior notificati<strong>on</strong> of pesticide use and the accurate
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
measurement of wind speed. One case illustrated the c<strong>on</strong>tinuing issue of<br />
‘parallel imports’ where n<strong>on</strong>-approved products had been imported into the UK.<br />
During 2000–<strong>2001</strong>, 170 incidents had been investigated and this represented<br />
a 33 percent fall compared with the previous year. There was, however, no<br />
discernible l<strong>on</strong>g-term trend. Seventy-<strong>on</strong>e allegati<strong>on</strong>s of ill health had been<br />
made and these ranged from reports of general ill health to specific symptoms<br />
presented to GPs. There had been a 14 percent reducti<strong>on</strong> in allegati<strong>on</strong>s of ill<br />
health compared with the previous year and this was the lowest number of<br />
reports for ten years. Decisi<strong>on</strong>s in a number of cases were pending and many<br />
of these resulted from the previous year’s investigati<strong>on</strong> of incidents <strong>on</strong> the Isle<br />
of Wight. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> noted that the Chair of PIAP wrote to individual<br />
complainants to explain the panel’s decisi<strong>on</strong> in relati<strong>on</strong> to their cases.<br />
82<br />
The frequency of incidents not associated with alleged ill health had also<br />
fallen in the last year. There had been no significant change in the incidence<br />
of complaints classified according to sector of use, work activity or method<br />
of applicati<strong>on</strong>. As in previous years, most complaints were associated with<br />
agricultural use and the majority of these with the use of c<strong>on</strong>venti<strong>on</strong>al crop<br />
boom sprayers. The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> noted an increasing number of complaints<br />
related to the use of knapsacks, particularly from users c<strong>on</strong>cerned about<br />
leakage during use.<br />
Over the last year, there had been 12 prosecuti<strong>on</strong>s in c<strong>on</strong>necti<strong>on</strong> with<br />
pesticides, most of these cases being heard in magistrates’ courts. Average<br />
fines were in the order of £1000. Ninety-eight enforcement notices had been<br />
issued, representing a reducti<strong>on</strong> of approximately <strong>on</strong>e-third compared with<br />
the previous year. The effect of the foot and mouth disease outbreak was<br />
c<strong>on</strong>sidered to be marginal since it had affected <strong>on</strong>ly the last five weeks of<br />
the reporting year.<br />
As in previous years, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> commented <strong>on</strong> the usefulness of the<br />
report and asked that HSE endeavour to include informati<strong>on</strong> <strong>on</strong> the type<br />
of boom sprayers involved in incidents, since a variety were available.<br />
Proposed representati<strong>on</strong>s procedure<br />
At present there is no mechanism in the pesticide approval system allowing<br />
companies to make formal representati<strong>on</strong> with respect to recommendati<strong>on</strong>s<br />
to Ministers made by the regulatory authorities directly or via the ACP. In<br />
September <strong>2001</strong>, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> was invited to c<strong>on</strong>sider the c<strong>on</strong>tent of a<br />
proposed c<strong>on</strong>sultati<strong>on</strong> paper outlining proposals for a n<strong>on</strong>-statutory<br />
mechanism for representati<strong>on</strong>s. This would apply to new active substances
Secti<strong>on</strong> F: Other items c<strong>on</strong>sidered during the year<br />
and reviews of existing active substances assessed by the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> and to<br />
applicati<strong>on</strong>s for product approvals that have been assessed by PSD or HSE.<br />
The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that PSD should carry out a public c<strong>on</strong>sultati<strong>on</strong>, and<br />
that members would provide their comments as part of that c<strong>on</strong>sultati<strong>on</strong>.<br />
Review of CMO advice to peel fruit<br />
At the request of the Food Standards Agency the ACP commenced a review<br />
of advice issued in 1997 by the Chief Medical Officer (CMO). This review was<br />
still <strong>on</strong>going at the end of <strong>2001</strong> and a fuller descripti<strong>on</strong> will be included in a<br />
future annual report <strong>on</strong>ce the ACP has reached a c<strong>on</strong>clusi<strong>on</strong>.<br />
The Precauti<strong>on</strong>ary Principle<br />
Members of the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered that the precauti<strong>on</strong>ary principle would<br />
be an item ideally suited to discussi<strong>on</strong> at the open meeting in <strong>2001</strong>. They<br />
c<strong>on</strong>cluded that they would request papers from a broad range of organisati<strong>on</strong>s<br />
to inform the discussi<strong>on</strong>. PSD prepared a document <strong>on</strong> pesticides regulati<strong>on</strong><br />
and the precauti<strong>on</strong>ary principle, setting out the background to the principle<br />
and its positi<strong>on</strong> in internati<strong>on</strong>al law. The Crop Protecti<strong>on</strong> Associati<strong>on</strong>, Friends<br />
of the Earth and <strong>Pesticides</strong> Acti<strong>on</strong> Network agreed to present papers outlining<br />
their views. These papers, together with <strong>on</strong>e from the chairman of the ACP<br />
were discussed at the open meeting and have been made available <strong>on</strong> the<br />
ACP website, together with a record of the discussi<strong>on</strong>.<br />
83
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
Secti<strong>on</strong> G:<br />
Fees<br />
Members of the ACP are not salaried staff but they do receive a fee for their<br />
attendance at ACP meetings. Members are not paid if they do not attend<br />
meetings.<br />
Chairman’s fees<br />
Until April 01<br />
Attendance fee £148<br />
Preparati<strong>on</strong> fee £37<br />
After April 01<br />
Attendance fee £151<br />
Preparati<strong>on</strong> fee £38<br />
84<br />
Deputy Chairman’s fees and members’ fees<br />
Until April 01<br />
Attendance fee £116<br />
Preparati<strong>on</strong> fee £29<br />
After April 01<br />
Attendance fee £119<br />
Preparati<strong>on</strong> fee £30<br />
Members also receive reimbursement of reas<strong>on</strong>able actual travel and<br />
subsistence when attending meetings.
Appendix I<br />
Appendix I:<br />
Terms of reference<br />
Under Secti<strong>on</strong> 16(7) of the Food and Envir<strong>on</strong>ment Protecti<strong>on</strong> Act 1985,<br />
Ministers have established the <str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong>* to give them<br />
advice, either when requested to do so or otherwise, <strong>on</strong> any matters relating<br />
to the c<strong>on</strong>trol of pests in furthering the general purposes of Part III of the Act.<br />
The general purposes of Part III of the Food and Envir<strong>on</strong>ment Protecti<strong>on</strong> Act<br />
are that the provisi<strong>on</strong>s of that part of the Act shall have effect:<br />
(i)<br />
With a view to the c<strong>on</strong>tinuous development of means<br />
(ii)<br />
(a) to protect the health of human beings, creatures and plants;<br />
(b) to safeguard the envir<strong>on</strong>ment; and<br />
(c) to secure safe, efficient and humane methods of c<strong>on</strong>trolling<br />
pests; and<br />
with a view to making informati<strong>on</strong> about pesticides available to<br />
the public.<br />
85<br />
Under Secti<strong>on</strong> 16(9) Ministers are required to c<strong>on</strong>sult the <str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g>:<br />
(i)<br />
(ii)<br />
as to regulati<strong>on</strong>s which they c<strong>on</strong>template making;<br />
as to approvals of pesticides which they c<strong>on</strong>template giving,<br />
revoking or suspending; and<br />
(iii) as to c<strong>on</strong>diti<strong>on</strong>s to which they c<strong>on</strong>template making approvals<br />
subject.<br />
* Under the C<strong>on</strong>trol of <strong>Pesticides</strong> (<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g>) Order (Northern Ireland) 1987, the<br />
<str<strong>on</strong>g>Committee</str<strong>on</strong>g> was established as the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> for Northern Ireland
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
Appendix II:<br />
Membership of the <str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g><br />
<strong>on</strong> <strong>Pesticides</strong> up to 31 December <strong>2001</strong><br />
Chairman<br />
Professor David Cogg<strong>on</strong> MA, PhD, DM, FRCP, FFOM, FMedSci, Professor of<br />
Occupati<strong>on</strong>al and Envir<strong>on</strong>mental Medicine at the Medical Research Council<br />
Envir<strong>on</strong>mental Epidemiology Unit, University of Southampt<strong>on</strong>.<br />
Deputy Chairman<br />
Professor Alan Boobis BSc, PhD, FIBiol, Professor of Biochemical<br />
Pharmacology at the Royal Postgraduate Medical School, University of L<strong>on</strong>d<strong>on</strong>.<br />
86<br />
Members<br />
Dr Nicholas Bateman BSc MD FRCP FRCP (E), Reader in Clinical<br />
Pharmacology, C<strong>on</strong>sultant Physician & Director, Scottish Pois<strong>on</strong>s Informati<strong>on</strong><br />
Bureau, Royal Infirmary Edinburgh.<br />
Mrs Elaine Brown BSc (lay member) formerly teacher of biology at<br />
St Margaret’s School, Midhurst, Sussex.<br />
Professor Peter Calow OBE BSc, PhD, DSc, FIBiol, FLS, FRSA, Professor of<br />
Zoology at the University of Sheffield.<br />
Dr I Grieve BSc, PhD, Soil Physics Senior Lecturer & Head of Department –<br />
University of Stirling.<br />
Professor Gareth Edward J<strong>on</strong>es BSc, PhD, Professor of Agricultural Ec<strong>on</strong>omics<br />
– University of Wales.<br />
Professor Graham Matthews BSc, ARCS, PhD DSc, FIBiol, Professor of Pest<br />
Management – Imperial College of Science & Technology, Berkshire.<br />
Dr Patricia R McElhatt<strong>on</strong> MSc, PhD, Cbiol, MIBiol, Nati<strong>on</strong>al Teratology<br />
Informati<strong>on</strong> Service, Newcastle Up<strong>on</strong> Tyne.<br />
Mr Jim Ors<strong>on</strong> BSc Director, Morley Research Centre.
Appendix II<br />
Mrs Sylvia Owen BSc (lay member) formerly Principal of Polam Hall Day and<br />
Boarding Independent School. C<strong>on</strong>sumer interests include Vice Chair of the<br />
Science and Technology <str<strong>on</strong>g>Committee</str<strong>on</strong>g> of the Nati<strong>on</strong>al Council of Women (NCW).<br />
Professor Michael Roberts BSc, Phd, FIBiol, Director, Centre for Ecology and<br />
Hydrology – Natural Envir<strong>on</strong>ment Research Council (Resigned <strong>on</strong> appointment<br />
to CSL)<br />
Professor Robert H Smith BA(H<strong>on</strong>s), MSc, PhD, Professor of Agricultural<br />
Biology, University of Leicester.<br />
Dr Colin Soutar MD, FRCPE, FFOM, Chief Executive of the Institute of<br />
Occupati<strong>on</strong>al Medicine, Edinburgh. (Retired 31 Dec <strong>2001</strong>)<br />
Mr Christopher Stopes BSc, MSC, Organic Farming – Eco-Stopes C<strong>on</strong>sultancy,<br />
Newbury.<br />
Departmental assessors<br />
Departmental assessors are officials who receive and endorse the<br />
advice/recommendati<strong>on</strong>s supplied by the ACP members to Ministers <strong>on</strong> behalf<br />
of their department.<br />
87<br />
Dr S Smith<br />
Dr C J Griffiths<br />
Mr H J<strong>on</strong>es<br />
Mr P Lees<br />
Dr S Popple<br />
Dr J Norman<br />
Dr David Atkins<br />
Health and Safety Executive (HSE)<br />
Scottish Agriculture Science Agency (SO)<br />
Nati<strong>on</strong>al Assembly for Wales Agriculture<br />
Department.(Replaced Ms L Griffiths)<br />
Department of Health (DH)<br />
<strong>Pesticides</strong> Safety Directorate (DEFRA)<br />
(Replaced Mr John Baint<strong>on</strong>) (DEFRA)<br />
Food Standards Agency (FSA)<br />
Food Standards Agency (FSA)
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
Departmental advisers<br />
Departmental advisers are officials with specialist expertise who are able to<br />
advise the ACP.<br />
88<br />
Dr R H Bromilow Institute of Arable Crops Research<br />
Dr J Garrod DEFRA<br />
Dr K Wils<strong>on</strong> <strong>Pesticides</strong> Safety Directorate (DEFRA)<br />
(Replaced Mr G K Bruce)<br />
Mr R Davis <strong>Pesticides</strong> Safety Directorate (DEFRA)<br />
Dr A Burn English Nature<br />
Dr S Dobs<strong>on</strong> Natural Envir<strong>on</strong>mental Research Council<br />
Dr T C Marrs Food Standards Agency (FSA)<br />
Mr J Battershill Department of Health<br />
Prof J Marks Department for Agriculture & Rural Development – Belfast<br />
(Replaced Mr L McKibben and Mr B Murphy)<br />
Prof M Roberts Central Science Laboratory (DEFRA)<br />
(Replaced Prof P Stanley)<br />
Dr M Thomas Central Science Laboratory (DEFRA)<br />
Dr A Croxford Envir<strong>on</strong>ment Agency<br />
Ms A Brazier Health and Safety Executive<br />
(Replaced Dr R Turner)<br />
Dr S Smith Health and Safety Executive<br />
Mr I Anders<strong>on</strong> Scottish Executive Envir<strong>on</strong>ment and Rural Affairs Department<br />
Dr A Riley Scottish Office Department of Health<br />
Ms J McNeill Department of Trade and Industry<br />
Dr M Wakelin Medical Research Council
Appendix III<br />
Appendix III:<br />
Independent members’ annual<br />
declarati<strong>on</strong> of interests in the<br />
pesticides industry <strong>2001</strong><br />
Name of Nature of Name of Current/former<br />
member interest companies interest<br />
Chairman<br />
Professor D Cogg<strong>on</strong> N<strong>on</strong>e – –<br />
Deputy Chairman<br />
Professor A Boobis N<strong>on</strong>e – –<br />
Members<br />
Dr N Bateman Funding to Department via Astra Zeneca Current<br />
commercial c<strong>on</strong>tract for<br />
24-hour teleph<strong>on</strong>e support<br />
for clinical trials.<br />
Mrs E Brown N<strong>on</strong>e – –<br />
Professor P Calow N<strong>on</strong>e – –<br />
Dr I Grieve N<strong>on</strong>e – –<br />
Professor G E J<strong>on</strong>es N<strong>on</strong>e – –<br />
Prof G Matthews C<strong>on</strong>sultant to companies Aventis Current<br />
manufacturing equipment<br />
but not agrochemical<br />
companies.<br />
Dr P R McElhatt<strong>on</strong> N<strong>on</strong>e – –<br />
Mr Ors<strong>on</strong> Morley Research Centre Syngenta, M<strong>on</strong>santo, Current and former<br />
undertakes trials for HGCA and DEFRA interests<br />
agrochemical companies.<br />
These companies c<strong>on</strong>tract<br />
work to the centre and also<br />
act as sp<strong>on</strong>sors. As Director,<br />
Mr Ors<strong>on</strong> does not<br />
participate in day-to-day<br />
management of trials<br />
c<strong>on</strong>tracted by companies<br />
but does sign c<strong>on</strong>tracts and<br />
read reports. Also involved<br />
in LINK project.<br />
Mrs S Owen N<strong>on</strong>e – –<br />
Professor R Smith Research support for PhD English Nature and Current<br />
student and Chairman of Rodenticide<br />
RRAG.<br />
Resistance Acti<strong>on</strong><br />
Group<br />
Dr C Soutar N<strong>on</strong>e – –<br />
Professor M Roberts N<strong>on</strong>e<br />
Mr C Stopes C<strong>on</strong>sultancy Co-op Group Current<br />
89
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
Appendix IV:<br />
Inter-Departmental Secretariat<br />
Terms of<br />
reference<br />
The Inter-Departmental Secretariat (IDS) c<strong>on</strong>siders data submitted as part of<br />
the EC review programme and applicati<strong>on</strong>s for Annex 1 listing under EC<br />
Directive 91/414. In these cases, the IDS proposes a course of acti<strong>on</strong> to the<br />
ACP which c<strong>on</strong>tributes the definitive scientific input to the UK negotiating<br />
positi<strong>on</strong>. The IDS also c<strong>on</strong>siders applicati<strong>on</strong>s and reviews under COPR before<br />
they are referred to the ACP.<br />
Membership<br />
(as at<br />
31 December<br />
<strong>2001</strong>)<br />
Chairman<br />
Mr R Davis<br />
Deputy Chair<br />
Ms A Brazier<br />
<strong>Pesticides</strong> Safety Directorate (DEFRA)<br />
Health and Safety Executive<br />
90<br />
Members<br />
Mr N Bradshaw<br />
Mr H J<strong>on</strong>es<br />
Mr D Green<br />
Mrs I O’Neill<br />
Mr G Walker<br />
Dr S Smith<br />
Dr C J Griffiths<br />
ADAS C<strong>on</strong>sulting Limited (representing Nati<strong>on</strong>al<br />
Assembly of Wales Agriculture Department)<br />
ADAS Nati<strong>on</strong>al Assembly of Wales<br />
ADAS C<strong>on</strong>sulting Limited<br />
Health and Safety Executive<br />
Health and Safety Executive<br />
Health and Safety Executive<br />
Scottish Agricultural Science Agency<br />
(representing Scottish Executive Envir<strong>on</strong>ment and Rural<br />
Affairs Department)<br />
Dr J Garrod DEFRA. Replaced Dr Abel December <strong>2001</strong>.<br />
Dr P Mercer<br />
Department of Agriculture and Rural Development<br />
Northern Ireland<br />
Dr A Saleem Department of Health (Replaced Dr Phillips August <strong>2001</strong>)<br />
Dr D Dill<strong>on</strong><br />
Mr P Lees<br />
Mr J Battershill<br />
Department of Health<br />
Department of Health<br />
Department of Health
Appendix IV<br />
Dr J Norman<br />
Dr D Atkins<br />
Mr B Groves<br />
Dr J Ince<br />
Dr E Heller<br />
Dr Sue Popple<br />
Dr M Thomas<br />
Dr E Pembert<strong>on</strong><br />
Food Standards Agency<br />
Food Standards Agency<br />
Food Standards Agency<br />
Food Standards Agency<br />
Food Standards Agency<br />
<strong>Pesticides</strong> Safety Directorate (DEFRA)<br />
(Replaced Dr Martin March <strong>2001</strong>)<br />
CSL (n<strong>on</strong>-attending c<strong>on</strong>sultant)<br />
Envir<strong>on</strong>ment Agency (c<strong>on</strong>sultant)<br />
(Replaced Mrs J Whiteman December <strong>2001</strong>)<br />
Dr A Burn English Nature (c<strong>on</strong>sultant) Joined December <strong>2001</strong>.<br />
Technical Secretariat<br />
Dr L Harris<strong>on</strong><br />
Mrs J Wilder<br />
Health and Safety Executive<br />
(Replaces Dr O’Hara from August <strong>2001</strong> until early 2002)<br />
<strong>Pesticides</strong> Safety Directorate (DEFRA)<br />
91<br />
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> Secretariat<br />
Mrs J Wilder <strong>Pesticides</strong> Safety Directorate (DEFRA)
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
Envir<strong>on</strong>mental<br />
Panel<br />
The Envir<strong>on</strong>mental Panel is resp<strong>on</strong>sible for providing advice to the <str<strong>on</strong>g>Advisory</str<strong>on</strong>g><br />
<str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>on</strong> issues related to the envir<strong>on</strong>mental fate and<br />
behaviour and ecotoxicological effects of pesticides. As the remit, structure<br />
and membership of the Panel was last reviewed in 1996, it was thought<br />
timely, with the appointment of a new chairman, Professor Peter Calow, to<br />
review the Envir<strong>on</strong>mental Panel. As a result of the review it was agreed that<br />
the remit should remain unchanged, but that there should be a closer working<br />
relati<strong>on</strong>ship between the Envir<strong>on</strong>mental Panel and the ACP. Therefore, the<br />
envir<strong>on</strong>mental members of the ACP have been invited to join the<br />
Envir<strong>on</strong>mental Panel. The structure was left unchanged. However, new<br />
appointments were made to ensure that the Panel had sufficient expertise in<br />
all envir<strong>on</strong>mental areas. It was c<strong>on</strong>sidered desirable to have representati<strong>on</strong><br />
from both industry and envir<strong>on</strong>mental pressure groups. It was agreed that<br />
these would be invited to participate in meetings as appropriate.<br />
92<br />
Terms of<br />
reference<br />
To advise the IDS and the ACP <strong>on</strong> the envir<strong>on</strong>mental fate and behaviour of<br />
pesticides, effects <strong>on</strong> n<strong>on</strong>-target organisms (other than man) from the use of<br />
pesticides and also <strong>on</strong> related problems put to it by the ACP or departments.<br />
To draw the attenti<strong>on</strong> of the IDS and ACP, or the regulatory departments as<br />
appropriate, to any matter c<strong>on</strong>cerning envir<strong>on</strong>mental impact of pesticides<br />
which, in the opini<strong>on</strong> of the Panel requires further investigati<strong>on</strong>.<br />
Membership<br />
(as at<br />
31 December<br />
<strong>2001</strong>)<br />
Chairman<br />
Prof Peter Calow<br />
Member’s name<br />
Mrs Elaine Brown<br />
Organisati<strong>on</strong><br />
University of Sheffield<br />
Organisati<strong>on</strong><br />
Lay member<br />
Prof Gareth Edwards-J<strong>on</strong>es University of Wales, Bangor<br />
Mr Christopher Stopes<br />
Dr Ian Grieve<br />
Prof Robert Smith<br />
Dr Alastair Burn<br />
Dr Andy Croxford<br />
Prof T<strong>on</strong>y Hardy<br />
Dr Peter Matthiessen<br />
Eco-Stopes C<strong>on</strong>sultancy<br />
University of Stirling<br />
University of Leicester<br />
English Nature<br />
Envir<strong>on</strong>ment Agency<br />
Central Science Laboratory<br />
Centre for Ecology and Hydrology, Cumbria
Appendix IV<br />
Dr Nick Sothert<strong>on</strong><br />
Dr Tom Sherratt<br />
Dr Richard Shore<br />
Prof Allan Walker<br />
Dr Mark Crane<br />
Game C<strong>on</strong>servancy Trust<br />
University of Durham<br />
Centre for Ecology and Hydrology, Huntingd<strong>on</strong><br />
Horticultural Research Institute<br />
Crane C<strong>on</strong>sultants<br />
Observers<br />
Mr Mark Clook<br />
Mr John Garrod<br />
Mr David Williams<br />
Dr Ken Hunter<br />
Dr Andrew Craven<br />
Mr John Chadwick<br />
Mr Graeme Walker<br />
Organisati<strong>on</strong><br />
<strong>Pesticides</strong> Safety Directorate<br />
DEFRA<br />
<strong>Pesticides</strong> Safety Directorate<br />
Scottish Agricultural Science Agency<br />
<strong>Pesticides</strong> Safety Directorate<br />
Health and Safety Executive<br />
Health and Safety Executive<br />
Technical Secretary<br />
Dr Jo O’Leary Quinn<br />
Organisati<strong>on</strong><br />
<strong>Pesticides</strong> Safety Directorate<br />
93<br />
Main issues c<strong>on</strong>sidered during the year<br />
● Use of European FOCUS groundwater scenarios.<br />
●<br />
●<br />
●<br />
●<br />
●<br />
●<br />
●<br />
●<br />
●<br />
Exposure of birds to treated seed.<br />
Issues relating to Local Envir<strong>on</strong>mental Risk Assessments for <strong>Pesticides</strong><br />
(LERAPs).<br />
Partial review of sec<strong>on</strong>d-generati<strong>on</strong> anticoagulant rodenticides.<br />
Issues relating to the protecti<strong>on</strong> of biodiversity.<br />
HSE review of copper chrome arsenic.<br />
The use and disposal of growing media.<br />
Discussi<strong>on</strong>s <strong>on</strong> probabilistic risk assessment.<br />
Aquatic higher-tier laboratory testing.<br />
Implicati<strong>on</strong>s of the Countryside and Rights of Way Act 2000 for pesticide<br />
regulati<strong>on</strong>.
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
<strong>Pesticides</strong><br />
Residues<br />
<str<strong>on</strong>g>Committee</str<strong>on</strong>g><br />
The WPPR was replaced at the end of 2000 by the new <strong>Pesticides</strong> Residues<br />
<str<strong>on</strong>g>Committee</str<strong>on</strong>g>. This new committee advises the Chief Executive of PSD and the<br />
Food Standards Agency (FSA) <strong>on</strong> the formulati<strong>on</strong> of the residues surveillance<br />
programmes and the results arising from them. It is independent from the<br />
ACP and is resp<strong>on</strong>sible for preparing its own annual report which is presented<br />
to Ministers.<br />
The website address is www.pesticides.gov.uk/committees/prc<br />
Medical and<br />
Toxicological<br />
Panel<br />
Terms of<br />
reference<br />
To advise the IDS and ACP <strong>on</strong> medical problems put to it and to draw the<br />
attenti<strong>on</strong> of the IDS and ACP to any matter c<strong>on</strong>cerning the impact of<br />
pesticides <strong>on</strong> human health, including exposure of operators which, in the<br />
opini<strong>on</strong> of the Panel, needs further investigati<strong>on</strong>.<br />
94<br />
To advise the IDS <strong>on</strong> the development and applicati<strong>on</strong> of toxicological test<br />
methods.<br />
Membership<br />
(as at<br />
31 December<br />
<strong>2001</strong>)<br />
Chairman<br />
Professor A Boobis<br />
Members<br />
Dr S Barlow<br />
Dr N Bateman<br />
Mr J Battershill<br />
University of L<strong>on</strong>d<strong>on</strong><br />
Independent c<strong>on</strong>sultant<br />
Scottish Pois<strong>on</strong>s Informati<strong>on</strong> Bureau<br />
Department of Health<br />
Professor G Cohen University of Leicester (to May <strong>2001</strong>)<br />
Professor D N M Cogg<strong>on</strong><br />
University of Southampt<strong>on</strong> (ACP Chairman)<br />
Mr A Garrod Health and Safety Executive (left June <strong>2001</strong>)<br />
Dr T C Marrs<br />
Dr P McElhatt<strong>on</strong><br />
Professor J Parry<br />
Food Standards Agency<br />
Nati<strong>on</strong>al Teratology Informati<strong>on</strong> Service<br />
University of Wales, Swansea<br />
Dr A Phillips Health and Safety Executive (to May <strong>2001</strong>)<br />
Dr A Proudfoot Scottish Pois<strong>on</strong>s Informati<strong>on</strong> Bureau (to May <strong>2001</strong>)<br />
Dr D E Ray<br />
Medical Research Council
Appendix IV<br />
Dr K S Richards Independent lay member (to December <strong>2001</strong>)<br />
Dr A Saleem Health and Safety Executive (started June <strong>2001</strong>)<br />
Dr D Swanst<strong>on</strong><br />
Independent c<strong>on</strong>sultant<br />
Professor GT Williams University of Wales, Cardiff (To November <strong>2001</strong>)<br />
Representative organisati<strong>on</strong>s<br />
Mr R Billingt<strong>on</strong><br />
Crop Protecti<strong>on</strong> Associati<strong>on</strong><br />
Dr C R Coggins<br />
Dr A Hay<br />
Dr R Hartley<br />
Ms J Hewitt<br />
Mr J A James<br />
Dr M Wilks<br />
Secretariat<br />
Dr I Dewhurst<br />
Dr K Murphy<br />
British Wood Preservati<strong>on</strong> and Damp-Proofing<br />
Associati<strong>on</strong> (to May <strong>2001</strong>)<br />
Trades Uni<strong>on</strong> C<strong>on</strong>gress<br />
Nati<strong>on</strong>al Associati<strong>on</strong> of Agricultural C<strong>on</strong>tractors<br />
(to May <strong>2001</strong>)<br />
Nati<strong>on</strong>al Associati<strong>on</strong> of Agricultural C<strong>on</strong>tractors<br />
(from Nov <strong>2001</strong>)<br />
British Pest C<strong>on</strong>trol Associati<strong>on</strong><br />
Crop Protecti<strong>on</strong> Associati<strong>on</strong><br />
<strong>Pesticides</strong> Safety Directorate (DEFRA)<br />
Health and Safety Executive<br />
95<br />
The Panel met three times during <strong>2001</strong>.<br />
Main issues c<strong>on</strong>sidered during the year<br />
● Significance of liver enlargement.<br />
●<br />
●<br />
●<br />
●<br />
●<br />
●<br />
●<br />
●<br />
●<br />
●<br />
Use of reproductive end points in acute risk assessment.<br />
Strategy for mutagenicity testing.<br />
Pesticide-related ill-health m<strong>on</strong>itoring.<br />
Sec<strong>on</strong>dary exposure and Parkins<strong>on</strong>’s disease.<br />
C<strong>on</strong>sumer exposures to n<strong>on</strong>-agricultural pesticides.<br />
Analysis and evaluati<strong>on</strong> of repeat-dose toxicity studies.<br />
IGHCR guidance <strong>on</strong> uncertainty factors.<br />
Epidemiology studies <strong>on</strong> pesticides – literature review.<br />
Use of amortisati<strong>on</strong> in operator exposure assessments.<br />
Determinati<strong>on</strong> of dermal absorpti<strong>on</strong> values.
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
Working Party<br />
<strong>on</strong> Pesticide<br />
Usage Surveys<br />
Membership<br />
(as at<br />
31 December<br />
<strong>2001</strong>)<br />
Chairman<br />
Ms H Kyle <strong>Pesticides</strong> Safety Directorate (DEFRA) 1<br />
Members<br />
Mr M Hadler British Pest C<strong>on</strong>trol Associati<strong>on</strong><br />
96<br />
Dr P Gladders<br />
Dr C J Griffiths<br />
Dr A D M Hart<br />
Mr S Jess<br />
Mr M J Lole<br />
Dr P K Marsden<br />
Ms G Smith<br />
Mr N Simps<strong>on</strong><br />
Dr M R Thomas<br />
Mrs T Clark<br />
ADAS<br />
Scottish Agricultural Science Agency<br />
Central Science Laboratory (DEFRA)<br />
Department of Agriculture and Rural Development<br />
Northern Ireland<br />
ADAS<br />
Department for Transport, Local Government and the<br />
Regi<strong>on</strong>s (DTLR)<br />
Health and Safety Executive<br />
ADAS<br />
Central Science Laboratory (DEFRA)<br />
Crop Protecti<strong>on</strong> Associati<strong>on</strong><br />
Technical Secretary<br />
Mr Martin Roberts<br />
<strong>Pesticides</strong> Safety Directorate (DEFRA)<br />
Main issues c<strong>on</strong>sidered during the year<br />
●<br />
Comments and inputs to the draft versi<strong>on</strong>s of a number of pesticide usage<br />
survey reports.<br />
1 from August, previous chairman Ms P Chapman
Appendix V<br />
Appendix V:<br />
Published evaluati<strong>on</strong>s<br />
(as at 31 December <strong>2001</strong>)<br />
1. Flocoumafen £3.00<br />
2. Quizalofop-ethyl £3.50<br />
3. Cyfluthrin £4.00<br />
4. Ethoprophos £5.50<br />
5. Benfuracarb £4.00<br />
6. RH 3866 £4.00<br />
7. DPX M6316 £3.50<br />
8. Azac<strong>on</strong>azole £3.00<br />
9. Oxine copper £3.50<br />
10. Fluazifop-P-butyl £5.50<br />
11. Flusilazole £10.50<br />
97<br />
12. Bifenthrin £3.50<br />
13. IPBC £4.50<br />
14. Daminozide £5.00<br />
15. Tributyltin naphthenate (1) £3.00<br />
16. Ethylene bisdithiocarbamates (1) £10.00<br />
17. Fenoxaprop-P-ethyl £8.00<br />
18. Fenoxaprop-ethyl £10.50<br />
19. HOE 070542 Triazole Coformulant £7.50<br />
20. PP321 (Lambda cyhalothrin) £5.00<br />
21. Cyhalothrin £4.00<br />
22. Alachlor (1) £8.50<br />
23. Fenpropathrin £9.50<br />
24. Tributyltin oxide (1) £7.00<br />
25. Fentin hydroxide £4.00<br />
26. Fenbutatin oxide £3.00<br />
27. Fentin acetate £3.00
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
28. Iprodi<strong>on</strong>e £4.00<br />
29. 2-Aminobutane £4.00<br />
30. Dimethoate (1) £3.50<br />
31. Cycloxydim £12.50<br />
32. Dinocap £9.00<br />
33. Glufosinate-amm<strong>on</strong>ium £21.50<br />
34. Vinclozolin £12.00<br />
35. Diazin<strong>on</strong> (1) £25.00<br />
36. Ethylene bisdithiocarbamates (2) £25.00<br />
37. Chlorsulfur<strong>on</strong> £4.50<br />
38. Metsulfur<strong>on</strong>-methyl £7.50<br />
39. Thifensulfur<strong>on</strong>-methyl £5.00<br />
40. Teflubenzur<strong>on</strong> £1.50<br />
41. Alachlor (2) £7.00<br />
98<br />
42. Tefluthrin £13.00<br />
43. Diazin<strong>on</strong> (2) £3.00<br />
44. Hydroprene (1) £5.50<br />
45. SAN 619F (Cyproc<strong>on</strong>azole) £25.00<br />
46. Diclofop-methyl (1) £25.00<br />
47. Gamma-HCH (Lindane 1) £4.00<br />
48. Triasulfur<strong>on</strong> £25.00<br />
49. Thiodicarb £25.00<br />
50. Fluoroglycofen-ethyl £25.00<br />
51. Atrazine (1) £9.50<br />
52. Simazine (1) £9.50<br />
53. Guazatine £9.50<br />
54. Thiabendazole £10.00<br />
55. Esfenvalerate £25.00<br />
56. Thiophanate-methyl £11.00<br />
57. Benomyl £14.00<br />
58. Carbendazim £18.00<br />
59. Grain Protectants – Review of use in the UK £5.00
Appendix V<br />
60. Abamectin £13.50<br />
61. Tribenur<strong>on</strong>-methyl £15.00<br />
62. Propamocarb hydrochloride £21.00<br />
63. Methyl bromide £12.00<br />
64. Gamma-HCH (Lindane 2) £18.50<br />
65. Tebuc<strong>on</strong>azole (1) £25.00<br />
66. Imazaquin £17.00<br />
67. Fenpropidin £17.00<br />
68. 2,4-D £25.00<br />
69. Tolclofos-methyl £16.00<br />
70. Tralkoxydim £25.00<br />
71. Atrazine (2) £20.00<br />
72. Simazine (2) £18.50<br />
73. Imidacloprid £23.00<br />
74. Tributyltin oxide (2) £4.50<br />
75. Desmedipham £17.50<br />
99<br />
76. Oxydemet<strong>on</strong>-methyl £11.00<br />
77. Demet<strong>on</strong>-S-methyl £4.00<br />
78. Fenpicl<strong>on</strong>il £18.50<br />
79. Dimefur<strong>on</strong> £11.50<br />
80. Propic<strong>on</strong>azole £8.00<br />
81. Buprofezin £19.00<br />
82. 2-Phenylphenol £8.00<br />
83. Omethoate £13.50<br />
84. Triazophos £24.00<br />
85. S-Methoprene £5.50<br />
86. Dimethoate (2) £21.50<br />
87. Chlorpropham £5.50<br />
88. Tebuc<strong>on</strong>azole (2) £7.00<br />
89. Cyromazine (1) £11.00<br />
90. Kath<strong>on</strong> 886 £9.00<br />
91. Amidosulfur<strong>on</strong> £21.00
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
92. Bitertanol £11.50<br />
93. Anilazine £19.50<br />
94. Propaquizfop £23.00<br />
95. Mecoprop £17.00<br />
96. Mecoprop-P £17.00<br />
97. Triazoxide £15.00<br />
98. Phorate £14.00<br />
99. Dimethomorph £12.50<br />
100. Fluazinam £17.00<br />
101. Bti (1) £3.50<br />
102. Hydramethyln<strong>on</strong> £6.50<br />
103. Commodity substances £6.00<br />
104. Lambda-cyhalothrin £3.00<br />
105. Bti (2) £4.00<br />
100<br />
106. Difenoc<strong>on</strong>azole £14.00<br />
107. Chlorfenvinphos £25.00<br />
108. Epoxic<strong>on</strong>azole £25.00<br />
109. Aldicarb £9.50<br />
110. Tributyltin naphthenate (2) £4.50<br />
111. Triorganotin compounds £16.50<br />
112. Chlorothal<strong>on</strong>il £22.50<br />
113. Vinclozolin £12.50<br />
114. Pentachlorophenol £17.50<br />
115. 3-Iodo-2-propynyl-N-butylcarbamate £8.50<br />
116. Cyromazine (2) £6.00<br />
117. Diclofop-methyl (2) £4.50<br />
118. Fomesafen £15.00<br />
119. Metsulfur<strong>on</strong>-methyl and Thifensulfur<strong>on</strong>-methyl – Review of<br />
Envir<strong>on</strong>mental Persistence £5.50<br />
120. Dichlorvos £17.50<br />
121. Clodinafop-propargyl and Cloquintocet-mexyl £25.00<br />
122. Tebufenpyrad £25.00
Appendix V<br />
123. Ioxynil – Review of the Agricultural and Horticultural Uses £11.00<br />
124. Bromoxynil – Review of the Agricultural and Horticultural Uses £10.00<br />
125. Carbetamide £5.50<br />
126. Fludiox<strong>on</strong>il £20.00<br />
127. Tecnazene £20.00<br />
128. Fenbuc<strong>on</strong>azole £25.00<br />
129. Amorphous silic<strong>on</strong> dioxide £5.50<br />
130. Fenpyroximate £22.00<br />
131. Prallethrin £6.50<br />
132. Linur<strong>on</strong> £18.00<br />
133. M<strong>on</strong>olinur<strong>on</strong> £9.00<br />
134. Pirimicarb £24.00<br />
135. Malathi<strong>on</strong> £19.50<br />
136. Tolylfluanid £19.50<br />
137. Diflufenican £9.50<br />
138. Pyrimethanil £18.00<br />
101<br />
139. Triflusulfur<strong>on</strong>-methyl £25.00<br />
140. Isoprotur<strong>on</strong> £23.00<br />
141. Trinexapac-ethyl £18.00<br />
142. Paclobutrazol £11.00<br />
143. Flufenoxur<strong>on</strong> £11.00<br />
144. Sodium cyanide £11.00<br />
145. Hydroprene (2) £7.00<br />
146. Rimsulfur<strong>on</strong> £25.00<br />
147. Pyriproxyfen £11.50<br />
148. Metosulam £22.00<br />
149. Imazethapyr £10.00<br />
150. Fenazaquin £25.00<br />
151. Lindane (3) £25.00<br />
152. Difenoc<strong>on</strong>azole – ecotoxicity £3.50<br />
153. Metaldehyde £19.50<br />
154. Propyzamide £ 3.50
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
155. Carbaryl – MAFF approved uses £11.50<br />
156. Carbaryl – review of its use in public hygiene and<br />
amateur insecticides £ 5.50<br />
157. Dicofol £13.50<br />
158. Flutriafol £11.50<br />
159. Benzyl benzoate £ 6.00<br />
160. Bromuc<strong>on</strong>azole £25.00<br />
161. Fenoxycarb £25.00<br />
162. Tau-fluvalinate £25.00<br />
163. Kresoxim-methyl £25.00<br />
164. Lindane – reproductive toxicity effects in dogs £6.50<br />
165. Transfluthrin £10.00<br />
166. S-methoprene (2) £8.00<br />
167. Pirimiphos-methyl £22.00<br />
102<br />
168. Strychnine hydrochloride £6.00<br />
169. Cyprodinil £25.00<br />
170. MBC fungicides – benomyl and carbendazim £6.00<br />
171. Assessment of humaneness of vertebrate c<strong>on</strong>trol agents £6.00<br />
172. Triazamate £25.00<br />
173. Phlebiopsis gigantea £8.50<br />
174. Sulphuric acid £4.00<br />
175. Review of dinocap £13.00<br />
176. Kath<strong>on</strong> 886 (2) £6.00<br />
177. Quinmerac £25.00<br />
178. Tolclofos-methyl in the product ’Rizolex’ £8.50<br />
179. Review of methiocarb £25.00<br />
180. Flufenoxur<strong>on</strong> (2) – use as a wood preservative £14.50<br />
181. MBC fungicide – thiophanate methyl £4.50<br />
182. Triorganotin compounds (2) £8.50<br />
183. Copper compounds £18.00<br />
184. Fluquinc<strong>on</strong>azole £25.00<br />
185. Tetrac<strong>on</strong>azole £52.00
Appendix VI<br />
186. AEF107892 £24.50<br />
187. Fipr<strong>on</strong>il: use as a public hygiene insecticide £16.00<br />
188. Transfluthrin (2): use with cyfluthrin in a public hygiene<br />
insecticide £7.50<br />
189. Epoxic<strong>on</strong>azole (2) £5.50<br />
190. Review of tridemorph £8.00<br />
191. The review of lindane £13.50<br />
192. UK review of sodium cyanide £6.50<br />
193. Metc<strong>on</strong>azole £25.00<br />
194. Diclofop-methyl £5.00<br />
195. Cyfluthrin: use in wood preservati<strong>on</strong> £8.00<br />
196. Flurtam<strong>on</strong>e £23.00<br />
197. Lindane 5 (gamma HCH) (n<strong>on</strong>-agricultural uses) £6.00<br />
198. Nicosulfur<strong>on</strong> £25.00<br />
199. Tritic<strong>on</strong>azole £25.00<br />
200. Copper chrome arsenic (review of its uses as an industrial<br />
wood preservative) £25.00<br />
103<br />
201. Diur<strong>on</strong> (dichlorophenyl dimethylurea): use as a booster<br />
biocide in antifouling products £19.00<br />
Prices include postage and packing and are correct at time of publicati<strong>on</strong>.<br />
Copies of the published evaluati<strong>on</strong> documents are available by applicati<strong>on</strong><br />
in writing to the Finance and Corporate Services Unit, <strong>Pesticides</strong> Safety<br />
Directorate, Room 313, Mallard House, Kings Pool, 3 Peasholme Green,<br />
York YO1 7PX.
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
Appendix VI:<br />
Terms and abbreviati<strong>on</strong>s<br />
104<br />
ACP<br />
Adenoma<br />
ADI<br />
Aneugenic<br />
Aneuploidy<br />
AOEL<br />
BCF<br />
bw<br />
d<br />
CAP<br />
Carcinogens<br />
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong><br />
a benign tumour with a gland-like structure or developed from<br />
the glandular epithelium<br />
acceptable daily intake, defined as ’an estimate of the amount<br />
of a substance, expressed <strong>on</strong> a bodyweight basis, that can be<br />
ingested daily over a lifetime without appreciable health risk’<br />
inducing aneuploidy (q.v.)<br />
the circumstances in which the total number of chromosomes<br />
within a cell is not an exact multiple of the normal haploid<br />
(see polyploidy) number. Chromosomes may be lost or gained<br />
during cell divisi<strong>on</strong><br />
acceptable operator exposure level<br />
bioc<strong>on</strong>centrati<strong>on</strong> factor<br />
bodyweight<br />
day<br />
Comm<strong>on</strong> Agricultural Policy<br />
the causal agents which induce tumours. They include external<br />
factors (chemicals, physical agents, viruses) and internal factors<br />
such as horm<strong>on</strong>es. Chemical carcinogens are structurally diverse<br />
and include naturally occurring substances as well as synthetic<br />
compounds. An important distincti<strong>on</strong> can be drawn between<br />
genotoxic (q.v.) carcinogens, which have been shown to react<br />
directly with and mutate DNA, and n<strong>on</strong>-genotoxic carcinogens,<br />
which act through other mechanisms. The activity of genotoxic<br />
carcinogens can often be predicted from their chemical<br />
structure. Most chemical carcinogens exert their effects after<br />
prol<strong>on</strong>ged exposure, show a dose-resp<strong>on</strong>se relati<strong>on</strong>ship and<br />
tend to act <strong>on</strong> a limited range of susceptible target tissues.<br />
Carcinogens are sometimes species- or sex-specific. Several<br />
different chemical and other carcinogens may interact and
Appendix VI<br />
c<strong>on</strong>stituti<strong>on</strong>al factors (genetic susceptibility, horm<strong>on</strong>al status)<br />
may also c<strong>on</strong>tribute to effects<br />
Carcinoma<br />
Clastogen<br />
malignant tumour arising from epithelial cells lining, for<br />
example, the alimentary, respiratory and urogenital tracts and<br />
from epidermis, also from solid viscera such as the liver,<br />
pancreas, kidneys and some endocrine glands<br />
an agent that produces chromosome breaks and other structural<br />
aberrati<strong>on</strong>s such as translocati<strong>on</strong>s (q.v.). Clastogens may be<br />
viruses or physical agents as well as chemicals. Clastogenic<br />
events play an important part in the development of some<br />
tumours<br />
COPR C<strong>on</strong>trol of <strong>Pesticides</strong> Regulati<strong>on</strong>s 1986<br />
DETR<br />
DNA<br />
DT 50<br />
EC<br />
ECCO<br />
EMDI<br />
FAO<br />
Department of the Envir<strong>on</strong>ment, Transport and the Regi<strong>on</strong>s<br />
deoxyrib<strong>on</strong>ucleic acid. The carrier of genetic informati<strong>on</strong> for<br />
most organisms<br />
time taken to degrade by 50 percent<br />
European Community<br />
EC Co-ordinati<strong>on</strong> (EU expert peer review groups)<br />
estimated maximum daily intake<br />
Food and Agriculture Organisati<strong>on</strong><br />
105<br />
FEPA Food and Envir<strong>on</strong>ment Protecti<strong>on</strong> Act 1985<br />
GAP<br />
GATT<br />
GIFAP<br />
GLP<br />
ha<br />
Half life<br />
good agricultural practice<br />
General Agreement <strong>on</strong> Tariffs and Trade<br />
Groupement Internati<strong>on</strong>al des Associati<strong>on</strong>s Nati<strong>on</strong>ales de<br />
Fabricants de Produits Agrochimiques (the European trade<br />
associati<strong>on</strong> for the agrochemical industry)<br />
Good Laboratory Practice<br />
hectare<br />
time interval required for half of a quantity of material to be<br />
eliminated naturally
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
Heinz bodies roughly spherical inclusi<strong>on</strong> bodies in red blood cells resulting<br />
from precipitati<strong>on</strong> of haemoglobin<br />
106<br />
HSE<br />
IDS<br />
IPM<br />
In vitro<br />
In vivo<br />
JMPR<br />
Koc<br />
LOAEL<br />
LC 50<br />
LD 50<br />
MAC<br />
MAFF<br />
Health and Safety Executive<br />
Inter-Departmental Secretariat, a sub-committee of the ACP<br />
integrated pest management<br />
term used to describe effects in biological material outside<br />
the living animal<br />
term used to describe effects in living animals<br />
Joint FAO/WHO meeting <strong>on</strong> pesticide residues<br />
organic carb<strong>on</strong> adsorpti<strong>on</strong> coefficient<br />
lowest observable adverse effect level. The lowest administered<br />
dose at which an effect has been observed<br />
the theoretical lethal c<strong>on</strong>centrati<strong>on</strong> for 50 percent of a group<br />
of animals<br />
the theoretical lethal dose for 50 percent of a group of animals<br />
maximum allowable c<strong>on</strong>centrati<strong>on</strong><br />
Ministry of Agriculture, Fisheries and Food (UK)<br />
µg microgram<br />
MRL<br />
n<br />
NAEL<br />
NEL<br />
NOAEL<br />
NOAEC<br />
NOEC<br />
NOEL<br />
OECD<br />
OPIDN<br />
Maximum Residue Limit<br />
normal (defining isomeric c<strong>on</strong>figurati<strong>on</strong>)<br />
no adverse effect level<br />
no effect level<br />
no observed adverse effect level<br />
no observed adverse effect c<strong>on</strong>centrati<strong>on</strong><br />
no observed effect c<strong>on</strong>centrati<strong>on</strong><br />
no observed effect level<br />
Organisati<strong>on</strong> for Ec<strong>on</strong>omic Co-operati<strong>on</strong> and Development<br />
organophosphate-induced delayed neuropathy
Appendix VI<br />
OPIDPN<br />
PA<br />
PEC<br />
PHI<br />
POEM<br />
Pow<br />
PPE<br />
ppm<br />
PRS<br />
PSD<br />
RPE<br />
RSPB<br />
safener<br />
SCPH<br />
TER<br />
Teratogen<br />
TMDI<br />
Tropospheric<br />
UDS<br />
w/w<br />
WHO<br />
organophosphate-induced delayed polyneuropathy<br />
provisi<strong>on</strong>al approval<br />
predicted envir<strong>on</strong>mental c<strong>on</strong>centrati<strong>on</strong><br />
pre-harvest interval<br />
predictive operator exposure model<br />
partiti<strong>on</strong> coefficient (n-octanol/water)<br />
pers<strong>on</strong>al protective equipment<br />
parts per milli<strong>on</strong><br />
Pesticide Registrati<strong>on</strong> Secti<strong>on</strong> in the Health and Safety<br />
Directorate (UK)<br />
<strong>Pesticides</strong> Safety Directorate (UK)<br />
respiratory protective equipment<br />
Royal Society for the Protecti<strong>on</strong> of Birds<br />
a substance which reduces or eliminates the phytotoxic effects<br />
of a plant protecti<strong>on</strong> product <strong>on</strong> certain plant species<br />
Standing <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> Plant Health<br />
toxicity exposure ratio<br />
a substance which causes c<strong>on</strong>genital abnormalities (deformities)<br />
in the baby or offspring in the womb<br />
theoretical maximum daily intake<br />
pertaining to the lower part of the atmosphere extending from<br />
the surface up to a height varying from about 9 km at the poles<br />
to 17 km at the equator, in which the temperature decreases<br />
fairly regularly with height<br />
unscheduled DNA synthesis. DNA synthesis that occurs at some<br />
stage in the cell cycle other than in the S period (the normal or<br />
’scheduled’ DNA synthesis period) in resp<strong>on</strong>se to DNA damage.<br />
It is usually associated with DNA repair<br />
weight per weight<br />
World Health Organisati<strong>on</strong><br />
107
<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />
WIIS<br />
WPPR<br />
wt<br />
Wildlife Incident Investigati<strong>on</strong> Scheme (UK)<br />
Working Party <strong>on</strong> Pesticide Residues (UK) (superseded by the<br />
Pesticide Residues <str<strong>on</strong>g>Committee</str<strong>on</strong>g>)<br />
weight<br />
108
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July 2002<br />
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