Environment Branch, Room 108, Mallard House,
Kings Pool, 3 Peasholme Green, York. YO1 7PX
Tel No: (01904) 455794 Fax No: (01904) 455711
E-mail for applications*:
E-mail for enquiries:
CRD website: www.pesticides.gov.uk
*applications from Northern Ireland must be sent to the address specified in section 9 of this form.
Notes for
Guidance / Official Recognition of Efficacy
Testing Facilities or Organisations
(under Commission Directive 93/71/EEC)
Background
It is a requirement of Commission Directive 93/71/EEC, which amends Council Directive 91/414/EEC, that the tests and analyses required to demonstrate the efficacy of plant protection products must be conducted by ‘Official’ or ‘Officially Recognised’ testing facilities or organisations. The data to be generated demonstrating efficacy in support of plant protection product authorisations are outlined in Annex Ill of Commission Directive 93/71/EEC.Efficacy trials/tests for those products that fall within the scope of the Biocides Directive 98/8/EEC, do not require to be carried out by 'Officially Recognised' efficacy testing facilities or organisations.
The requirements that organisations conducting efficacy trials within the EC must satisfy in order to become ‘Officially Recognised’ are outlined in paragraph 2.2 of Annex II of Commission Directive 93/71/EEC. Organisations must report to the national authority all the necessary details to demonstrate that they satisfy these requirements. In addition, each Member State (MS) is required to organise regular inspections of organisations to verify compliance with these requirements. Organisations must accept such inspections at any time. This form has been laid out to reflect paragraph 2.2 of Annex II of Commission Directive 93/71/EEC and is divided into relevant sections.
Further guidance on Good Experimental Practice (GEP) can be found in the latest version of EPPO Guideline PP 1/181, ‘Conduct and reporting of efficacy evaluation trials.’
COMPLETION OF THE FORM
1 / Facility/Organisation detailsIn most cases you will only need to complete one application form. However, you may need to complete more than one form if the management of the efficacy related work is not centrally co-ordinated. That is, all trials conducted on different sites must be carried out to the same Standard Operating Procedures (SOPs) and protocols, with a single officer in overall control (as identified in SOPs and protocols), who must sign the form as the responsible officer.
At question (f) you are asked to indicate which categories of ‘Official Recognition’ you wish to apply for. This should be based on the type of trials/tests carried out by the facility/organisation. The categories divide into the four major disciplines, based on pesticide application technique. Ticking more than one box is permitted (and will not increase the fee to be paid), but evidence will be required to demonstrate proficiency in each category selected. The categories ‘ticked’ will appear on the ‘Official Recognition’ certificate, (see Section 8 for advice on adding further categories at a later date.)
The categories are:
● Agricultural/Horticultural trials/tests: in addition to agricultural and horticultural crops (outdoor and protected), this also includes the following situations; amenity, home and garden, forestry, aquatic, land not intended to bear vegetation (including industrial situations), space and structural applications in interior landscapes, set-a-side, seed treatments and biological pesticides.
● Stored crops trials/tests: includes pre- or post-harvest applications to grain, vegetables, fruit or other propagules, where assessments are carried out during or after storage, as well as space and structural applications in storage facilities.
● Vertebrate control agents trials/tests: includes vertebrate killing agents in a plant protection situation and vertebrate repellents.
● Biologicals and Semiochemicals: includes all tests on preparations or active substances that include micro-organisms, as defined in Part B of Annex III of Directive 91/414, or using semio-chemicals to modify the behaviour of pests.
The term micro-organism is defined in Council Directive 91/414/EEC (as amended by Commission Directive 2001/36/EC) as follows: a microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material. The definition applies to, but is not limited to, bacteria, fungi, protozoa, viruses and viroids. It does not include multicellular organisms such as nematodes or insects.
Semiochemicals for the purposes of the UK scheme for “official recognition” are chemicals such as pheromones, kairomones and allomones that act to modify the behaviour of pests or their natural enemies.
Other “Bio-pesticides” such as plant, fungal or bacterial extracts, natural or synthesised metabolites or toxins produced during growth of micro-organisms will need to be certificated under one or more of the other three categories (see above) depending upon the area of use.
Note: laboratory, glasshouse or semi-field studies/screens must be included in the relevant categories above.
All current UK certification for “Official Recognition” will automatically also allow efficacy testing of “Biologicals”. However, if any currently certificated UK efficacy testing facility or organisation wishes to add “Biological trials/tests” to their current certification, CRD will re-issue their certificate including this new category, on request. There will be no additional fee for this.
2 / Facility/Organisation details
Directive requirements
“have at their disposal sufficient scientific and technical staff, having the necessary education, training, technical knowledge and experience for their assigned functions”
“have at their disposal appropriate experimental fields and, where necessary glasshouses, growth cabinets or storage rooms. The environment in which the tests are undertaken shall not invalidate their results or adversely affect the required accuracy of measurements / You must provide:
(a) Names of current permanent staff. This must include all staff involved in efficacy testing and report writing, from laboratory studies through glasshouse and semi-field studies to field testing, including all out-stationed/off-site staff. Also required in conjunction with this list is a description of their relevant formal qualifications and/or previous relevant experience.
(b) Current details of the organisation and functional management relationships between staff. This could be provided in the form of an organisational chart or organogram. This will provide evidence to demonstrate appropriate management control, and that one person is ultimately responsible for overall control efficacy tests.
(c) A list of current permanent facilities/structures (including owned, leased or rented field testing sites). This must include: offices; equipment storage facilities; and facilities where trials/tests are conducted. Do not include locations of field trials carried out on land belonging to farmers/growers which are not owned by, officially leased to or rented by the organisation.
(d) The name of the person responsible for the GEP archive must be provided.
(e) The name(s) of the person responsible for the chemical store(s) must be provided.
Note: Subsequent changes in management control may require a new application. Details of other changes within sections (a) to (e) may be requested by CRD prior to or at inspection.
3 / Equipment, maintenance and calibration
Directive requirements
“have at their disposal suitable items of equipment required for correct performance of the tests and measurements which it claims to be competent to carry out. This equipment shall be properly maintained and calibrated where appropriate before being put into service and thereafter according to an established programme" / (a) to (e) Requires provision of evidence that the facility or organisation have suitable items of equipment to carry out efficacy testing within the categories designated in section 1(g). A number of options, with tick boxes, are included on the form, plus one category where provision of a list is required. Please tick all relevant boxes. In 3(e) where a list is required, this should only include equipment that requires regular calibration and maintenance. Examples of such equipment are: spore samplers; vacuum samplers; photo-analytical equipment; centrifuges; controlled environment rooms etc. Information on numbers of pieces of equipment is not required on the form, but see Section 9(c) with respect to maintenance and calibration records. Rented or hired equipment requiring regular calibration and maintenance must be included in this list. Do not include cars, tractors or other vehicles used for transporting such equipment.
(f) Is an assurance statement, plus tick box, requiring confirmation that equipment outlined in 3 (a)-(e) is regularly calibrated/maintained. This will be verified at the inspection.
4 / Standard Operating Procedures
Directive requirements
“make available to relevant personnel operating procedures and protocols used for trials/tests”
"maintain records of all original observations, calculations and transformations, calibration records and the final test report for as long as the product is authorised by the community” / (a) to (d) Requires a list of all SOPs relevant to efficacy testing and copies of those specific SOPs relating to:-
a) the writing and maintenance of SOPs
b) chemical control procedures and
c) procedures for archiving raw data/other records relating to efficacy work
5 / Trial/test protocols and detailed trials/test information
Directive requirements
“make available, where requested by the competent authority, prior to the commencement of a trial/test, detailed information on it, containing at least its location and the plant protection products included in it” / If your organisation is simply renewing its existing certification (e.g. renewing for the same categories and other aspects remain unchanged), ignore part (a) and move to part (b). If as a new applicant you have yet to undertake any efficacy trials/tests, please seek assistance from CRD.
(a) Requires a recent copy of a trial/test protocol/study plan, associated raw data and final report. Organisations vary in their reporting methods, but what is required is an example of the information used to compile reports, efficacy overview or biological assessment dossiers for submission to CRD.
(b) Requires a list of all efficacy work, which could be used in support of product approvals/authorisations undertaken in the last two years.
6 / Re-newal applications
If the application concerns the renewal of certification, please include in the covering letter an explanation of the steps taken to address any issues raised in the last inspection report.
7 / Payment of feeDetails of current fees can be found on the CRD website (www.pesticides.gov.uk).
On receipt of your completed application, CRD (or DARD for organisations based in Northern Ireland) will raise an invoice for the appropriate fee and send it to your organisation for payment. Work on the application will not commence until payment of the invoice has been received.
8 / Declaration .A signature is required to certify that all the details contained in the application form are correct. Photocopies of signatures are not acceptable. All enclosures should be signed and dated.
You are advised to keep a copy of your completed form and enclosures before sending them off.
(A warning has been included in the declaration regarding falsification of information.)
9 / Address for submissions.Applications from organisations based in England, Scotland and Wales should be sent to CRD using the contact details specified at the top of this guidance document.
Applications from organisations based in Northern Ireland must be sent to the Department of Agriculture and Rural Development (DARD) using the following address:
Deborah Currie
Department of Agriculture and Rural Development (DARD) Room 652,
Dundonald House,
Upper Newtownards Road,
Belfast,
BT4 3SB
Tel: 02890 524728
e-mail:
FURTHER INFORMATION
Satisfactory completion of this form and payment of the fee [see section 7], will result in ‘Official Recognition’ of the efficacy testing facility or organisation. Within eight weeks of receipt of payment and the completed form demonstrating compliance, a certificate will be issued, confirming ‘Official Recognition’ within the categories requested. If any further information or clarification is required, the facility/organisation will be given eight weeks to provide a satisfactory response. If no satisfactory response is received and compliance in any of the categories cannot be demonstrated, these categories will not appear on the certificate. If compliance cannot be demonstrated in any of the categories requested, a certificate will not be issued and no refund will be given.
‘Official Recognition’ will be for a period of five years. During the period of recognition an inspection of the facility/organisation will be carried out, by CRD’s inspection team, in order to verify the details on the application form. The inspection will take place on an agreed date, when ‘key’ personnel in the facility/organisation are available. A written report confirming the findings of the inspection will be sent to the facility/organisation within eight weeks. ‘Official Recognition’ will be confirmed after a successful inspection.
Where the inspection discovers certain deficiencies which do not compromise the quality of the work, 'Official Recognition' certification may be deferred. Where this occurs, rectification of these deficiencies must take place within a specified timescale, for certification to continue.
Where major deficiencies which could compromise the quality of the work are identified, the facility/organisation will be informed that they have failed the inspection. The facility/organisation will be given a period to correct those deficiencies (normally eight weeks). Once the deficiencies identified during the initial inspection have been satisfactorily addressed, a re-inspection will take place, [see the current fees information on the CRD website for the re-inspection fee]. Following a successful re-inspection, ‘Official Recognition’ will then be given from the time of that re-inspection until the expiry date on the original certificate. Revocation of ‘Official Recognition’ will occur if the facility/organisation fails to comply with the requirements within the specified timescale. There will be no refund to applicants where ‘Official Recognition’ is revoked.
The addition, at a later date, of any further categories (under Section 1(f) of the application form) will be subject to a new application, including an inspection, and will attract a further full fee. This is necessary in order to demonstrate that the particular requirements outlined in paragraph 2.2, Annex II of Commission Directive 93/71/EEC have been satisfied. The only exception to this will be the addition of the biological/semiochemicals category to an existing certificate, which will be performed free of charge (see section 1 above).
A list of ‘Officially Recognised’ facilities/organisations will be held by CRD and updated periodically on the CRD website.
Note: CRD requires prompt notification of any details of company mergers, restructuring or name changes. The information must include dates when such changes came into force, together with any other relevant details (i.e. a new organogram, details of any changes to management structure and personnel, CV’s, etc.). Where such changes do not require a new application, a new certificate will be issued as appropriate, free of charge.