Health and Safety
Executive / Commission
Biocides &
pesticides
The Pesticides Registration Section is pleased to welcome Ms Ann Brazier as the new Head of The Chemicals Evaluation and Authorisations Unit (this unit consists of The Pesticides Registration Section [PRS] and the New And Existing Substances Section [NESS]). Ann replaced Dr Bob Turner at the beginning of May.
Ann has worked for the UK Health and Safety Executive for over 20 years in diverse areas including public perception of risk, Legionnaires disease, biotechnology, genetic manipulation and operator exposure to pesticides. In addition to UK policy experience she also spent 2 years advising the Australian Government on Worksafe Australia's activities and managed the New South Wales Jobcentre Network. Most recently she led a programme to put HSE's Chemicals and Hazardous Installations Division in the best shape to implement the Control of Major Accidents Hazards Directive (COMAH).
Ann's message to approval holders is:
"I am delighted with the opportunity to lead the Chemicals Evaluation and Authorisation Unit into the new Millenium and to help it prepare for the Biocidal Products Directive. I know the Unit prides itself on a close working relationship with its customers and I am looking forward to renewing acquaintances and meeting those of you I have not yet seen. I aim to ensure that we continue to provide a cost effective service without compromising scientific quality and safety."
I am sure that approval holders would join us in welcoming Ann to the world of Pesticides and wish her every success for the transition to the Biocidal Products Regulations.
The Pesticides Registration Section regularly lets approval holders and applicants know the targets that we aim to work within when processing approvals. In keeping with this we feel we should provide approval holders with information on how well we are meeting those targets. Therefore, we are pleased to publish the performance standards that we met against our targets during the year 1998/1999, together with details of some other major areas of work carried out during the year.
We have always aimed to limit the number of products 'queuing', that is applications spending a significant period of time in the queue waiting to be assessed. In the period 1998/99, no applications were held back by queuing.
Our target for processing Secretariat Approvals is 90 working days. The proportion approved within this deadline for 1998/99 was 98%. The graph below shows the number of Secretariat Approvals we expected to receive and complete in 1998/99, compared with the actual numbers received and completed.
The following graph shows the number of Departmental Approvals expected to be completed during the period 1998/99, compared to the actual number completed.
During the year the following papers were in preparation for consideration by the Advisory Committee on Pesticides (ACP) :
New Active ingredients - one completed, 2 in progress.
The following reviews are underway
Antifoulants - Organic Booster Biocides
Copper/Chrome/Arsenic use in wood preservation is nearing completion.
Reviews of Organophosphate (OP) and Carbamate products have been initiated.
Our target for processing Certificates of free sale is 2 days. The proportion processed within this deadline for 1998/99 was 100%. The graph below shows the number of Certificates that were predicted to be received in 1998/99, compared to the actual number received and completed.
The Biocidal Products Directive continues to dominate this area.
We have also provided significant information to influence the deliberations on the Marketing and Use Directive concerning:
Triorganotins
Copper/Chrome/Arsenic
Pentachlorophenol
Results of these discussions are given in the section dealing with European Issues
As always, we welcome any comments you wish to make on how our service could be improved. Please send any comments to PRS at the usual address.
Staff from the Information Group of the Pesticides Registration Section were pleased to meet many approval holders at the HSE stand at PestEx-ProtEx '99. This was a national trade show organised by the British Pest Control Association (BPCA) and British Wood Preserving and Damp-proofing Association (BWPDA) at the Business Design Centre, Islington (London). The event drew exhibitors from the worldwide pest control, damp-proofing and wood preservation industries and was targeted at Pest Control Officers and professional building preservation specialists in both agricultural and non-agricultural sectors.
Our aim was to provide information to attendees on COP(A)R and other aspects of Health and Safety in the workplace. The main areas of information given out were in relation to rodenticides and their use in agricultural areas, how to perform written risk assessments under COSHH and the Biocidal Products Regulations' impact on pest control.
Overall the exhibition was well attended and PRS feel the event was a great success with respect to giving information and interfacing with industry.
The following changes to the fee structure were put to the March Fees and Charges meeting and were agreed by the industry representatives. PRS are pleased to announce that their review of fees showed that the rate for all of the lower fees will remain the same for the coming year. This has been made possible by efficiencies which have counterbalanced the effects of inflation. The review did however, indicate that the fees for committee approvals where large data packages are involved will need to increase as listed below. The new charges will take effect from 1st July 1999
Present 1st July New Active Ingredient (AI) £40,000 £50,000 Resubmission of New AI £20,000 £25,000 Unchanged Small data package £7,000 Minimal data package £4,200 Departmental £2,500 Secretariat £500 Back-to-back £300 Amendment £150
As noted in the September 1998 issue of the Pesticides Newsletter, Ministers have agreed that a high priority review of anticholinesterase compounds should be initiated. For non-agricultural pesticides HSE is responsible for taking these reviews forward.
The active ingredients covered by this review are:
Organophosphates Carbamates Fenitrothion Chlorpyrifos-Methyl Bendiocarb Iodofenphos Azamethiphos 3-Iodo-2-Propynyl-n-Butyl Carbamate Trichlorfon Diazinon Propoxur Dichlorvos Pirimiphos-Methyl ChlorpyrifosData Call-In letters were sent to approval holders on 30th September 1998, these letters stated the period in which companies had to notify support, and the revocation periods which would be applied to unsupported products.
The period in which companies had to indicate support for products ended on 31st January 1999, subsequently Notices of Intent to revoke were issued on the 7th May 1999 for all unsupported products.
Notices of revocation will be issued for unsupported products on 7th June 1999, after which the following timetable will apply:
Companies which have indicated support for their products are required to submit full studies of all reports that they hold on both active ingredients and formulations to PRS by 30th September 1999.
If you require further information please contact Paul Willgoss (Tel: 0151 951 3639; Fax: 0151 951 3317 or at the address given at the end of this newsletter).
The Environmental Sciences Group of PRS would like to take this opportunity to inform the readers of the Pesticides Newsletter about some of the environmental research activities that we are involved in. This article aims to provide a brief introduction to some of the projects we are currently working on. These are being performed to improve our knowledge of the environmental effects of wood preservatives (WPs) and the behaviour of antifouling products (AFPs). Greater understanding of these product types will inform our environmental risk assessments for new and review active ingredients (ais).
Abstracts on all of the research projects mentioned in this article can be found in the HSE publication "Health Related Research Abstracts 1997/98" (HSE Books).
As a result of concerns raised over the effects of remedial timber treatment on bat populations an ad hoc working group was formed comprising of representatives from government departments and industry. The group decided to investigate toxicity tests using bats, the development of a mouse exposure model and relevance of TERs (toxicity: exposure ratios) in the hazard assessment of remedial WPs. HSE became the Technical Secretariat for the group, and along with other government departments, assisted in the funding of the research work in this area.
A scheme has now beenproduced which provides a framework for classifying and labelling WP's during the risk assessment of a product. A paper on the research produced by the working group was taken to the April 1999 meeting of the ACP, and was agreed. Once it has been approved for publication by all contributors the paper will be available to purchase, as a disclosure document, through the Pesticides Safety Directorate (PSD). It is also intended that the research will be published in an independent scientific journal, however, no further information is currently available.
PRS initially commissioned work to investigate the reliability of the ASTM (American Society for Testing and Materials) method (D5108-80), by studying the leaching of copper and tin from different antifouling paints. We then expanded the research as the UK became involved in the ring testing of leaching rate methods (ISO/DIS 1518-1 & 2) developed by the International Standards Organisation (ISO). This gave us the opportunity to feed the results of the HSE research into the international protocol. A draft ISO method for the assessment of leaching from copper-based antifouling paints has now been validated, and is being voted on by participating countries. Changes to the ASTM method have been suggested for the assessment of the leaching of tin.
Both the first and second phase of the research should be published by HSE before the end of this year. Several papers have already been published in journals as a result of the research -
Thomas, K. (1998) Determination of selected antifouling booster biocides by high performance liquid chromatography-atmospheric pressure chemical ionisation mass spectrometry. Journal of Chromatography A, 825, 29 - 35.
Thomas, K., Raymond, K., Chadwick, J. and Waldock, M. (1999) The effects of short-term changes in environmental parameters on the release of biocides from antifouling coating: cuprous oxide and tributyltin. Applied Organometallic Chemistry, 13 (6), 453 - 460.
The Environmental Sciences Group was aware of limitations in the methods available for predicting the environmental concentrations of AFPs. Therefore, it was decided to commission the development of a model to predict AFP levels in UK waters. A review of currently available models was performed, and these were assessed for their suitability as a regulatory tool. It was concluded that these models either did not meet the set criteria or would be too complex for routine use. So, it was agreed that a new model would be developed for HSE, based on a QWASI (quantitative water-air-sediment interaction) model developed by Mackay et al in 1983. By using data inputs from real harbours, estuaries and marinas the model was designed to be as user friendly as possible.
The validation phase is nearing completion, and the model will then be ready for us to extensively trial, before it is incorporated into our risk assessment of AFPs and released for general regulatory use in CD-ROM form.
Reference:
Mackay, D., Joy, M. and Paterson, S. (1983) A quantitative water, air, sediment interaction (QWASI) fugacity model for describing the fate of chemicals in rivers. Chemosphere, 12, 1193 - 1208.
Much of the work listed above is nearing completion, as is work involving environmental concentrations of Copper/Chrome/Arsenic (CCA) which will feed into the review process. The Environmental Sciences Group will now start assessing any gaps in our current knowledge, and also look to future obligations under the Biocidal Products Directive to decide what future research is required. Environmental risk assessment is constantly evolving, and our aim is to stay at the forefront of any new developments.
For further information on any of the research projects mentioned please contact Mrs Sarah Senior, of the Environmental Sciences Group, on 0151 951 3567 or at the address at the end of the Newsletter.
As the implementation date for the BPD draws closer (14 May 2000) there are an increasing number of items to report; Fact Sheet 4 accompanies this news letter and covers current progress. Below is shown the logo for the GB Biocidal Products Regulations, which will be used on our publications to assist in their identification.
The public consultation for the Biocidal Product Regulations will begin in July. If you have previously expressed an interest in the progress of the Directive you should automatically receive a copy of the consultation pack. If you do not receive a pack by mid July please contact HSE Books at the address below and a copy will be sent to you free of charge.
HSE Books
PO Box 1999
Sudbury
Suffolk
CO 10 6FS
tel: 01787 881165
fax: 01787 313995
http://www.hsebooks.com
The full text of the consultation document will be available for viewing and downloading at the HSE web site at http://www.open.gov.uk/hse/condocs/
A mini-consultation for the Transitional Arrangements Guidance Document (TAGD) has begun, accompanying this news letter is a draft for you to comment on. The cover note attached to the TAGD explains where you can send your comments and how they will be dealt with. The deadline for comments to reach HSE is 13 September 1999. If you did not receive a copy of the TAGD with this news letter please contact HSE at the address below and a copy will be sent to you free of charge.
Ms Gillian Smith
Pesticide Registration Section
Health and Safety Executive
Magdalen House, Stanley Precinct
Bootle
L20 3QZ
Fax: 0151 951 3317
gillian.smith@hse.gov.uk
All biocidal active substances currently supplied in the EU should be included on the above list before 14 May 2000. Both these active substances and products containing them will be subject to the transition arrangements of the Directive. This means that they will remain subject to existing legislation in each Member State until all the active substances in an individual product have been considered under the BPD review programme. Any active substance not included on the list on 14 May 2000 will be considered as new and both it, and any product containing it, will have to meet all the appropriate provisions of the BPD before they can be placed on the market within the EU.
If you are concerned that your active substance(s) has(have) not been included on the above list, there is still the opportunity to gain inclusion. The European Chemicals Bureau (ECB), based in Italy, is acting for the European Commission in compiling the list. ECB has requested that those seeking inclusion of an existing active substance on the list, submit relevant details first to the appropriate competent authority (c.a.). The UK c.a. is the HSE and we will forward requests to list active substances supplied within the UK to the ECB.
To ensure that we receive all the relevant information which we require to forward a listing to the ECB, or if you have other specific questions requiring further information, please contact:
Dr Alexander Tsavalos,
Pesticide Registration Section,
Health and Safety Executive,
Magdalen House,
Stanley Precinct,
Bootle, L20 3QZ
Fax: 0151 951 3317
E-mail: alexander.tsavalos@hse.gov.uk
All information current as of 30/4/99
The details for all of the above actives were expected to be published by DGIII in the early part of the year. This has not been the case, as there have been various problems within the EU Commission which were widely publicised. We do not have a revised date for the publications, but now expect that it will be during the autumn.
Discussions between DGIII and European industry representatives began earlier this year in the light of a report published by the Frauhoffer Institute. There have been no discussions as yet at Member State level, and DGIII may reach a voluntary agreement with the industry. It is not expected that there will be any further information until the autumn, but PRS will keep your Trade Association informed if there are any changes.
If you require any information on any Marketing and Use issues, please contact Irene O'Neill or Gill Smith at PRS.
If you require further advice or information about any of the above articles please contact The Pesticides Registration Section, by telephone on 0151 951 3535, fax on 0151 951 3317, or by letter to: The Pesticides Registration Section, Health and Safety Executive, Magdalen House, Stanley Precinct, Bootle, Merseyside L20 3QZ. We can also be contacted via E-mail at info.prs@hse.gov.uk