Health and Safety
Executive / Commission
Biocides &
pesticides
The biocides and pesticides unit (BPU) are receiving an increasing number of enquiries from Trading Standards Officers and from our customers regarding our position on pesticide advertisements on websites.
We would like to draw your attention to The Control of Pesticides (Amendment) Regulations 1997 and the consent for advertisement (Schedule 1) which clearly states that advertisement means "...any printed, pictorial, broadcast or recorded advertisement and includes any advertisement which is stored or transmitted by electronic means."
It is our opinion that advertisements broadcast over the Internet should be treated as any other advertisement. The conditions for the consent to advertise should be met. We will be advising Trading Standards Officers accordingly. For further advice please contact Dr Paul Heeney on 0151-951 4220 or by E-mail at biocides@hse.gsi.gov.uk
There is an obligation on HSE to understand the nature of human exposure to pesticide products. Because of this we have sponsored a great deal of investigation and research over the years to give us a better understanding, with the aim of making exposure estimates as realistic as possible, yet retaining the precautionary principle. As a policy, we publish the results, and describe how these are used in estimating exposures. For example, guidance document EH74/3 "Dermal exposure to non-agricultural pesticides has been published to establish transparent defaults used within exposure assessment (ISBN 0-7176-1718-1) A recent scientific press article has reported the inhalation and potential dermal exposure of amateurs painting wood preservatives and antifoulant preparations (Garrod et al. Annals of Occupational Hygiene, 2000, vol. 44, no 6, pp 421-426).
However, it is important to recognise that human exposure is composed of two distinct elements. These are:
- the pattern of use (the application task, other tasks; the
duration, the frequency, etc)
- the task-related exposure (as outlined above)
The pattern of use includes data which HSE do not normally gather. The data may be product-specific. During the review process it is often very noticeable that the information on patterns of use is not of a quality we need. A lack of information will lead to an inevitable application of the precautionary principle.
A recent OECD workshop (Ottawa, 2000) proposed data requirements that apply to the pattern of use for wood preservatives. The concept of these requirements is equally applicable to most biocidal products, and in a slightly modified form are set out below.
| Pattern of use data | comments |
|---|---|
| Primary exposure | |
| The physical form of the product - how it is presented to the market | |
| The formulation - what substances are in the product and their concentrations | |
| What market is identified as the user - industrial, professional, non-professional | |
| What is the purpose of the product (eg curative, preventative, against what agent) | |
| How is the product to be used? And the product used as supplied or diluted | |
| Where (in what environment) will the product be used | (ie. the site of use) |
| How often will the user be exposed to the product? | (data distribution) |
| How much product will be used per application and/or per unit area / volume | (typical) |
| What are the tasks in preparing the preservative for use | |
| What are the tasks in using the preservative - and the application equipment | |
| What are the post application tasks, eg decontamination | |
| How long does each task take (or a range) | (data distribution) |
| What controls limit primary exposure (eg. PPE or engineering controls) | |
| What decontamination methods are available | |
| Secondary (post-application) exposure | |
| How could post-application exposure occur eg. re-entry, residential, dislodging to skin or to food, recycling, etc.: |
|
| Degradation or dissipation rates |
BPU have already asked suppliers for such information in respect of organophosphate products, but the response has not always been as illuminating as we would have hoped. These requests for data imply a product stewardship role for suppliers. You know how your products are used. We also need to know, in order to conduct secure risk assessments.
Post-application exposures are of importance, particularly with reference to pesticide applications in the domestic setting and it is these that often worry residents the most. The issue is rising in significance, both nationally and internationally.
The scenarios for these secondary exposures are many and varied. We need to assess exposures from freshly applied product and exposures resulting from longer term exposure to residual levels on surfaces and, sometimes, levels in the air. Assessments of risk rely on a blend of many factors, including the probability of events happening at all and if it does happen what are the consequences?
HSE is currently developing approaches to assessing post-application exposure and we propose to present this for the Advisory Committee on Pesticides to discuss within the next year. If you would like any additional information on this topic, please contact Mr Andrew Garrod by telephone on 0151-951 4667, or by E-mail at andrew.garrod@hse.gsi.gov.uk
Data Protection allows companies to recoup the cost of generating data over a given period of time, under the Pesticides Safety Precautions Scheme (PSPS) and initially under The Control of Pesticides Regulations (COPR), all data submitted in support of applications for a new active ingredient or for reviews of an existing active ingredient were protected indefinitely. However, in 1991 a new policy on data protection was introduced following a House of Lords ruling which stated that registration authorities have a right and duty to have regard to all information at their disposal when determining safety prior to approval, whilst approval holders have the right to reasonable periods of data protection to justify their investment.
The periods of data protection are as follows :
The overriding principle with data protection is that data can only be protected once.
From time to time, chemical companies may apply to become a recognised manufacturer of an active ingredient already in use in approved products. Where a supporting data base exists for the active ingredient in question, and data protection is in force, a second prospective manufacturer must either gain access to the original protected data, via the Letter of Access system, or duplicate them by creating a data package of their own. When duplicate data are generated, the second company's data package, once agreed, will only gain data protection up to the time that the data protection of the first package runs out. It should also be noted that the sharing of data is strongly encouraged in order to reduce the duplication of animal testing.
When the period of data protection for an active ingredient ceases a Letter of Access is no longer required. However, the manufacturer of the active ingredient must show that their source of active ingredient is of equal standard to that assessed in the original data package for it to be deemed acceptable to HSE.
There are currently 31 active ingredients under data protection for which a Letter of Access to the data package is required, these are shown in Table 2. There are 14 active ingredients whose period of data protection has expired, but for which the source of the active ingredient has to be acceptable to BPU, these are shown in Table 3. Letters of Access are also required from re-entry time data for particular active ingredients, and other specific uses, and further details can be given if required. If you would like further information please contact Mrs Pauline Stenhouse by telephone on 0151-951 4290, or by E-mail at pauline.stenhouse@hse.gsi.gov.uk
Data protection should not be confused with confidentiality. It should be noted that all data remain commercial-in-confidence and that BPU accesses the data on behalf of the person holding a letter of access.
| ACTIVE INGREDIENTS WHICH REQUIRE LETTERS OF ACCESS AS DATA SUPPORTING THEM IS STILL PROTECTED | ||
|---|---|---|
| Acypetacs copper/zinc | Azaconazole | BTI |
| Chlorpyrifos (encapsulated) | Cyfluthrin | Deltamethrin (for wood preservative use) |
| Dichlorophen | Dichlorvos (required for access to physico-chemical data) | Fipronil |
| Flufenoxuron | Hydramethylnon | Hydroprene |
| s-Hydroprene | 3-iodo-2-proponyl-n-butyl carbamate | Kathon 886F |
| Lambda cyhalothrin | s-Methoprene | Pentachlorphenol and its salts |
| Pentachlorphenyl laurate | 2-phenylphenol and its sodium salt | Prallethrin |
| Propiconazole | Pyriproxyfen | Silicon dioxide |
| Tebuconazole | Tolyfluanid | Transfluthrin |
| Tributyltin napthenate | Tributyltin Oxide | |
| ACTIVE INGREDIENTS FOR WHICH LETTERS OF ACCESS ARE NO LONGER REQUIRED BUT SOURCE MUST BE ACCEPTABLE TO BPU AS DATA IS STILL CONFIDENTIAL BUT NO LONGER PROTECTED | ||
|---|---|---|
| Alphacypermethrin | Bendiocarb | Carbendazim |
| Chlorpyrifos | Cypermethrin | Deltamethrin |
| Dichlofluanid | d-Phenothrin | Methoprene |
| Methylene bis (thiocyanate) | Permethrin | Pirimiphos-methyl |
| Tetramethrin | 2-(thiocyanomethylthio) benzothiazole | |
In previous Newsletters, we informed you that there had been a delay in HSE taking responsibility from MAFF for collecting its own fees for applications of non-agricultural pesticides. However, we are pleased to announce that from 2 January 2001, HSE will take over full responsibility for collecting these fees. In essence, this means that the address to which the remittance slip is sent will change from a MAFF to a HSE address. Details of how and where to make payment will be incorporated into the respective invoices.
HSE has also taken responsibility for administering the non-agricultural levy. The levy exercise for 2000 - 2001 is ongoing, and invoices will be sent by HSE in December /January. We would like to extend our thanks to the companies who have responded so promptly to the declaration exercise.
Any queries on the subject of fees should be directed to Tony Daniels at BPU on Tel: 0151 951 3258, Fax 0151 951 3317 or the address given at the end of this Newsletter.
(BPU) has been holding one day seminars for the non-agricultural pesticides industry for some years. The aim of these seminars has been to bring companies up-to-date on developments in the Regulatory process, promote discussion - both between the industry and HSE, and within the industry itself - and to gather feedback from the industry on issues of concern. In the last edition of the Pesticides Newsletter we informed the industry that there would not be a seminar in 2000, but asked for the industry's ideas for the topics they might wish to see at a seminar in the Spring of 2001. That consultation period has now ended, and a provisional list of topics for discussion has been drawn up.
We are seeking industry's views to see if there are any other topics that they would wish to have discussed at the seminar - but please bear in mind that there will be a series of HSE-run seminars around the country in January/February next year specifically on the Biocidal Products Regulations and we would not be aiming to repeat all the information given at those seminars in the BPU seminar.
Provisional topics for BPU industry seminar
If you have any other topics you wish to have discussed at the seminar, please send the details to : Paul Heeney, Biocides & Pesticides Assessment Unit, Room 131 Magdalen House, Stanley Precinct, Bootle, Merseyside L20 3QZ., or E-mail biocides@hse.gsi.gov.uk by the end of December. Further details and booking information on the seminar will be sent out in the New Year.
At its meeting on 7 September 2000, the UK's independent Advisory Committee on Pesticides (ACP) considered all available physico-chemical, toxicological, environmental fate and behaviour, ecotoxicological and efficacy data relating to the use of the following active ingredients in antifouling products :-
4,5-dichloro-2-n-octyl-4-isothiazolin-3-one (coded as RH-287) ;
2-methylthio-4-tertiary-butylamino-6-cyclopropylamino-s-triazine (Irgarol 1051) ;
chlorothalonil ;
Dichlofluanid ;
Diuron ;
TCMTB (2-(thiocyanomethylthio) benzothiazole) ;
Zinc pyrithione ;
zineb.
Ministers have now agreed to the recommendations of the ACP, which are summarised in the table 4, below. Approval holders will be contacted shortly regarding the implications of the review and the specific data requirements relating to their product approvals.
For further details on revocation dates, or for any other information on this article, please contact Mr Chris Walton by telephone on 0151-951 4068, or by E-mail at chris.walton@hse.gsi.gov.uk
| ACTIVE SUBSTANCE | AMATEUR USE ON VESSELS | PROFESSIONAL USE ON VESSELS |
|---|---|---|
| 4,5-DICHLORO-2-N-OCTYL-4-ISOTHIAZOLIN-3-ONE (RH-287) | AMATEUR USE REVOKED | MAXIMUM CONCENTRATION OF 10 % w/w APPLICATION BY BRUSH, ROLLER AND SPRAY (AIRLESS AND CONVENTIONAL) CONTINUING USE SUBJECT TO DATA REQUIREMENTS (DR 35A) |
| 2-METHYLTHIO-4-TERTIARY-BUTYLAMINO- 6-CYCLOPROPYLAMINO-S-TRIAZINE(IRGAROL 1051) | AMATEUR USE REVOKED | MAXIMUM CONCENTRATION OF 10 % w/w APPLICATION BY BRUSH, ROLLER AND SPRAY (AIRLESS AND CONVENTIONAL)USE ONLY ON VESSELS ABOVE 25 METRES IN OVERALL LENGTHCONTINUING USE SUBJECT TO DATA REQUIREMENTS (DR 28A) |
| CHLOROTHALONIL | AMATEUR USE REVOKED | MAXIMUM CONCENTRATION OF 5 % w/wAPPLICATION BY BRUSH, ROLLER AND SPRAY (AIRLESS AND CONVENTIONAL)CONTINUING USE SUBJECT TO DATA REQUIREMENTS (DR 26A) |
| DICHLOFLUANID | MAXIMUM CONCENTRATION OF 10 % w/wAPPLICATION BY BRUSH, ROLLER AND SPREADERCONTINUING USE SUBJECT TO DATA REQUIREMENTS (DR 47) | MAXIMUM CONCENTRATION OF 10 % w/wAPPLICATION BY BRUSH, ROLLER, SPREADER AND SPRAY (AIRLESS AND CONVENTIONAL)APPLICATION BY AEROSOL (MAXIMUM CONCENTRATION OF 1.5 % w/w IN 250 ML CANS)CONTINUING USE SUBJECT TO DATA REQUIREMENTS (DR 47) |
| DIURON | AMATEUR USE REVOKED | PROFESSIONAL USE REVOKED |
| 2-(THIOCYANOMETHYLTHIO) BENZOTHIAZOLE (TCMTB) | AMATEUR USE REVOKED | DATA REQUIREMENTS SPECIFIED IN DR 43NOT SUPPLIED BY NOVEMBER 2000 DEADLINESO ACTIVE SUBSTANCE HAS NOT BEEN SUPPORTEDANY APPLICATION FOR TCMTB ANTIFOULING PRODUCTS WILL NOW BE CONSIDERED AS A MAJOR EXTENSION OF USE AND WILL REQUIRE FULL DATA PACKAGE (INCLUDING STUDIES OUTLINED IN DR 43 AND DR 43B) TO GO TO COMMITTEES BEFORE APPROVAL CAN BE GRANTED |
| ZINC PYRITHIONE | MAXIMUM CONCENTRATION OF 4 % w/wAPPLICATION BY BRUSH AND ROLLERCONTINUING USE SUBJECT TO DATA REQUIREMENTS (DR 42B) | MAXIMUM CONCENTRATION OF 4 % w/wAPPLICATION BY BRUSH, ROLLER AND SPRAY (AIRLESS AND CONVENTIONAL)APPLICATION BY AEROSOL (MAXIMUM CONCENTRATION OF 2 % w/w IN 250 ML CANS)CONTINUING USE SUBJECT TO DATA REQUIREMENTS (DR 42B) |
| ZINEB | MAXIMUM CONCENTRATION OF 20 % w/wAPPLICATION BY BRUSH AND ROLLER CONTINUING USE SUBJECT TO DATA REQUIREMENTS (DR 44B) | MAXIMUM CONCENTRATION OF 20 % w/wAPPLICATION BY BRUSH, ROLLER AND SPRAY (AIRLESS AND CONVENTIONAL)CONTINUING USE SUBJECT TO DATA REQUIREMENTS (DR 44B) |
Attached to this newsletter is a guidance document for applicants and approval holders on the standards required for submitting fate and behaviour and ecotoxicology data in support of products containing new active ingredients, or for the review of older products. It updates and supplements information contained in HSE's Consolidated Data Requirements Document which is already available from HSE. This additional guidance aims to promote consistency, transparency and high scientific standards. This has the added advantage of avoiding additional costs to industry. It is important for applicants and approval holders to read this document carefully as any data sent to us which does not follow the format and standards outlined in the document are likely to be returned un-assessed.
If you would like to discuss this further, please contact Mr John Chadwick on 0151- 951 4567 or via E-mail at john.chadwick@hse.gsi.gov.uk
The biocides and pesticides unit have revised the information required on the packaging of non-agricultural pesticide products. New applicants will now be asked to provide information on the container in which the product is to be supplied.
The requirement to provide container information will take effect from 1 January 2001 and will apply to new product applications and amendments to existing products.
When the applicants complete section 4 of the FEPA 1 application form, the Pack size(s) box should include the following information :
For example, 0.5, 1 and 5 litre mild steel paint tins with a mild steel lever lid
For existing products, approval holders will be asked to provide this information when any of their products are updated to bring them in line with current standards.
As the container details for a non-agricultural pesticide product are to be specified as a condition of approval for the product, this information will appear on the schedule. This change will apply to new product applications and amendments received from 1 January 2001. Any enquiries regarding the packaging of products can be directed to Ms Caroline Walls on 0151-951 3100 or via E-mail at caroline.walls@hse.gsi.gov.uk
Enclosed with this Newsletter is a letter, to all Approval Holders, describing an amendment to the Marketing and Use Directive.
The 16th amendment to the Marketing and Use Directive requires that substances that have been classified as Category 1 or 2 carcinogens, mutagens or reprotoxins under the Dangerous Substances Directive, and that are present in products containing more than certain amounts, are labelled with the name of the substance and the phrase "Restricted to professional users." In addition, the Directive prohibits the sale of such substances and preparations to the general public. The concentration limits are usually > 0.1% for the carcinogenic and mutagenic substances and > 0.5% for reprotoxins.
It is not possible for BPU to identify, with certainty, whether these substances are present in approved pesticide products. We would therefore ask you to let us know of any products that you believe are affected. Approval holders and applicants for new products should submit the relevant details to the Approvals Group, biocides and pesticides unit, Room 113, Magdalen House, Stanley Precinct, Bootle, Merseyside L20 3QZ, by the 1st March 2001.
For more details of this please see the enclosed letter to Approval Holders.
If you have any queries concerning the contents of the enclosed letter, please do not hesitate to contact Mrs Pauline Stenhouse by E-mail to pauline.stenhouse@hse.gsi.gov.uk, telephone: 0151 951 4290, fax: 0151 951 3317, or in writing to me at the address on the enclosed letter.
Negotiations are still ongoing at EU level regarding both Copper/Chrome/Arsenic (CCA) and Creosote. A further meeting was held in Brussels on the 20th September, but no decision was reached.
Trade Associations are involved and fully informed of developments. There are no changes to any approvals. If you require any further information please contact Mrs Irene O'Neill on 0151-951 4054 or by E-mail at irene.o'neill@hse.gsi.gov.uk
The biocides and pesticides unit will now be publishing information on the Biocidal Products Directive in the Biocides Factsheet. This factsheet will now be published quarterly at the same time as the Pesticides Newsletter.
All approval holders will automatically receive a copy of the Biocides Factsheet along with the Pesticides Newsletter. If you currently receive a copy of the Pesticides Newsletter on behalf of your company, please feel free to photocopy and distribute both publications freely within your organisation. This will help us to minimise costs in the distribution of these publications.
If you require any further advice or information about any of the articles in this issue of the Newsletter, please contact the biocides and pesticides unit by telephone on 0151-951 3535, by fax on 0151-951 3317 or by letter to The biocides and pesticides unit, Health and Safety Executive, Magdalen House, Stanley Precinct, Bootle, Merseyside, L20 3QZ. Alternatively we can be contacted via E-mail at biocides@hse.gsi.gov.uk
We would like to take this opportunity to wish all our Approval Holders a Merry Christmas and a Happy New Year.