Health and Safety
Executive / Commission
Biocides &
pesticides
To all HSE COPR Approval Holders
BPU would like to thank all those Approval Holders who paid this year's levy promptly. As we are in position to collect the non-agricultural levy ourselves, we are able to collect the income more efficiently and resolve queries more quickly. It will come as good news to Approval Holders that action against a number of companies who failed to pay this year's levy will shortly take place by means of a suspension of product approvals.
The levy rate for 2000/01 was 1.91%. The projections for the levy over the coming years show the levy decreasing as work under the Control of Pesticide Regulations (COPR) reduces gradually and the Biocidal Product Regulations come on line, but also assumes that Ministers do not instigate any further reviews. Details will be discussed with Industry at the Fees & Charges meetings.
The Biocides & Pesticides Assessment Unit will make every effort to keep costs to industry as low as possible, and we will continue in our efforts to maintain efficiency savings. Any non-agricultural products being sold without approval add to the cost of the levy for those which are approved. We are sensitive to this and are making stringent efforts to ensure that all such products comply with the regulations. Your co-operation in this matter is essential and will be treated in the strictest of confidence.
If you have any further questions on any of these issues, please contact BPU at the address at the end of this Newsletter.
As you will be aware, an important part of the levy collection process is to obtain auditor certificates from a percentage of companies who made declarations. This allows HSE to demonstrate to the National Audit Office (NAO) that a proper audit trail exists to verify that sales declarations made (nil or otherwise) are true and fair. To-date, many of the companies asked to submit auditor certificates have failed to do so. If this problem is not resolved in the near future, HSE may have to revert to a full verification exercise for the 2001/02 levy. It is also worth noting that having to continually chase up companies for auditor certificates adds an extra cost burden to the levy. To resolve this issue, Approval Holders who were asked to supply certificates and who have not yet submitted them to HSE are requested to do so promptly.
If you have any further questions on any of these issues, please contact BPU at the address at the end of this Newsletter.
The REMA (Regulatory Environmental Modelling of Antifoulants) program is a mathematical model for estimating the 'predicted environmental concentrations' in marinas and estuaries of active ingredients of biocidal products used for antifouling treatment of boats.
Antifouling paint products are widely used on vessel hulls and underwater structures to prevent the growth of fouling organisms. These products by their very nature (physicochemical properties and high toxicity) pose a potential risk to non-target organisms in the surrounding environment. Assessment of this risk requires quantification of the environmental exposure for which the use of mathematical models as exposure tools is an important development. The UK Health and Safety Executive, in conjunction with the UK Environment Agency, commissioned a project to develop a new model for the specific purpose of predicting the likely environmental exposure to antifouling chemicals used in typical UK scenarios. The resulting model, REMA (Regulatory Environmental Modelling of Antifoulants) has been developed and validated by external contractors WRc-NSF.
The REMA software is based on a QWASI (Quantitative Water, Soil and Air interaction) model using the fugacity concept for environmental modelling. It can predict environmental concentrations of antifouling chemicals in marinas and estuaries using leaching, physicochemical and fate and behaviour data in conjunction with the properties and processes of a particular environment. The model was validated using existing antifoulant chemicals (copper, zinc, Irgarol 1051 and diuron) and produced excellent agreement between predicted and measured concentrations for water and sediment for two UK estuaries.
The available CD rom contains the REMA software for installation on a suitable PC. REMA is an expert system and should only be used by those with a full knowledge of fate models. The software is therefore sold unsupported, which is reflected in the price, and can be obtained from the Health and Safety Laboratory (see below). Please note that payment must be made in advance. A research report will be published through HSE's report series in the near future, details of which to follow in a subsequent Newsletter. The REMA program and contents of the report are subject to copyright and all rights are reserved.
Please send me .............. copy/copiesPlease send to:
Brenda Parramore,
Health and Safety Laboratory,
Broad Lane,
SHEFFIELD S3 7HQ
Enclosed is a cheque/PO payable to the Health and Safety Laboratory for £.............
Name:____________________________________
Address:__________________________________
_________________________________________
_________________________________________
Post Code:________________________________
On the 23rd of April 2001, the British Pest Control Association (BPCA), and the British Wood Preserving and Damp-proofing Association (BWPDA) held an industry familiarisation day for some of the newer members of BPU staff. This was held at the BPCA/BWPDA headquarters based in Derby.
The event was aimed at giving these new staff a greater understanding of the industry that we regulate and providing the opportunity to see issues from the perspective of those being regulated.
Representatives from Industry and speakers from the BPCA/BWPDA gave talks on various topics. These included a background to the Industry and Trade Association work; information on product development and stewardship and Industry's view on the ideal regulator. A number of the issues dealt with provided a useful insight into the commercial side of the industry, problems faced by regulatory managers from industry in applying current legislation, and how our work in BPU affects industry.
BPU staff found the day very interesting, and the presentations provided useful background information for new staff. The speakers were very professional and conveyed a number of serious and difficult issues in a easily understandable way. We would like the thank the BPCA/BWPDA for their time in organising this event.
As part of the review process for pesticides a specific risk assessment is carried out to determine potential exposure to both people and the environment during normal use of these products. During the recent reviews of organophosphorus compounds it became apparent that the information we had on the packaging of currently approved products was too generalised, leading us to overestimate exposures. To overcome this problem and ensure our risk assessments are realistic, changes to the packaging information we require were introduced. Information on volume of containers, design of packaging and materials is now requested for all new products, Approval Holders were informed of these changes via a newsletter article in December 2000.
Industry have raised some concerns that if this information is transferred to the legal documents they will no longer have the flexibility to change product packaging. The intention was not to limit flexibility, but to inform our review process. To try to address this concern we propose to change the way this information is included on the legal documents. A general approval condition will be set, requiring companies to inform us if any changes to product packaging are made, and the detailed information on the packaging will be removed from the schedule and held on file. This will ensure we have the information we need to carry out realistic risk assessments and companies will retain flexibility they need.
We would appreciate industry's views on our proposals, and comments should be sent to BPU at the address at the end of this Newsletter by 30th June 2001.
As part of BPU's ongoing commitment to deliver the most efficient service to Approval Holders we constantly aim to ensure the provision of the correct information appearing on Schedules and labels. We also aim to reduce the burden on Approval Holders during evaluation of new products and the updating of older products and as such we are in the process of updating our records to include the technical specifications of all active ingredients present in approved products.
Attached to this newsletter is a formal request for an up to date technical specification (5-batch analysis) of the active ingredient(s) used in your product(s). If you do not hold such data the manufacturer (source) of your active ingredient may submit this directly to BPU if there are issues regarding commercial confidentiality. The technical specification should include the method of analysis employed to determine the specification together with any relevant validation data.
If you have any questions please contact BPU at the address at the end of this Newsletter.
As Approval Holders may recall HSE has initiated a review of products used in Aquaculture (Data Call-In Notice - 15F). Following the review of antifouling products HSE is now progressing this review to the ACP.
Approval Holders with products used in aquaculture will be contacted shortly to ask for updated information to ensure that the risk assessments generated are as realistic as possible. The information required will include usage data, and any studies generated since the original Data Call-In Notice in 1998.
Approval Holders should note that there are no current aquaculture products containing dichofluanid or copper. This means that the only active ingredient with current approval for use in aquaculture is Cuprous Oxide. Therefore, this use of dicholfluanid and copper will not be reviewed, and any application for an aquaculture product containing these two active ingredients will be treated as an extension of use and attract the appropriate fees and data requirements.
Approval Holders should be aware that the ongoing antifouling review of dichofluanid is not affected.
Anyone wishing to discuss the review further should contact BPU at address given at the end of this newsletter.
If you require any further advice or information about any of the articles in this issue of the Pesticides Newsletter, please contact the Biocides & Pesticides Assessment Unit by telephone on 0151 951 3535, by fax on 0151 951 3317, or by letter to: Biocides & Pesticides Assessment Unit, Health & Safety Executive, Magdalen House, Stanley Precinct, Bootle, Merseyside L20 3QZ. Alternatively we can be contacted via e-mail at biocides@hse.gsi.gov.uk
Published on HSE web site 20 June 2001