Human Health Enquiry/Incident Survey for Pesticides (HHEIS)
This regulatory update requires Approval Holders of all products approved for sale/use in the UK during 2005, to provide PSD with details of all human health related reports or enquiries received by you, from users or any other source, involving your products during that year.
You must include details of all enquiries involving human health issues whether or not these involve actual incidents or notified symptoms of ill health.
Failure to respond to the survey by 1 April 2006 will result in regulatory action being taken to revoke or suspend your products.
Approval Holders are under an on-going obligation to submit immediately any new information on the potentially dangerous effects of a product or of residues of an active substance contained in a product, on human or animal health, ground water or the environment. The Applicant Guide states ''Adverse effects are most likely to be identified from studies carried out by yourself from published papers and reports of actual incidents involving your product. In some cases, particularly incident reports, the information may be variable and lack sufficient details to be fully substantiated''. Nevertheless, when a number of incidents taken together suggests there may be an adverse effect, this should be reported to PSD immediately. For instance, if there seems to be a pattern to reports/complaints, such as a high proportion of unexpected irritative effects or a number of phytotoxicity reports on the same or similar crops, these should be notified.
In addition to this requirement to immediately report significant 'adverse data', PSD conducts a yearly survey of Approval Holders requesting details of all contacts from users of products, or from any other source, concerning the potential human health effects of their products, no matter how trivial these may seem. This includes enquiries of a general nature including those where there is no evidence that the pesticide may have caused any ill health effects.
Approval Holders for all products approved for sale/use in the UK during 2005 are now asked to provide PSD with the details of all human health related information received by you, involving the use of your products during that year.
PSD will publish a report of the results of this survey. Any information that you provide (apart from the personal details of individuals) may be made publicly available.
For the last two years, PSD asked Approval Holders to submit reports of all incidents of human ill-health, which may be attributable to the use of pesticides, reported to them during 2002 and 2003/2004. The outcome of this survey can be found in information update 08/2004.
There is nothing at this stage to indicate that any of the returns that were submitted as part of the last surveys, will eventually be considered to be 'adverse data'. However, we do consider that some of the more serious incidents should have been reported to PSD, and/or the Health and Safety Executive (HSE) at the time companies were made aware of them. In responding to the survey it is important that you inform us whether you have notified any of the regulatory bodies about any serious incidents that you have been made aware of.
The scope of this exercise is restricted to human ill-health and is not intended to cover reports of environmental or phytotoxic damage. This requirement is in addition to the obligation upon approval holders to submit immediately, information on any potentially dangerous effects.
The information required now, whether provided directly to you by the users of your products or from any other source, is intended to cover the full range of incidents which users believe may be attributable to pesticide exposure. There may not seem to be an obvious relationship between the use and subsequent ill-health, but we ask you to submit any reports you have received, however circumstantial.
Failure to respond to the survey will result in regulatory action being taken to revoke or suspend your products.
Using the pro-forma on the PSD website returns, including reports of general enquiries, however small or insignificant, must be submitted to PSD by 1 April 2006. Nil returns are also required. One return should be completed for each incident reported.
Please submit your completed questionnaire or nil return by email to email@example.com. If you have a problem replying by email or accessing the proforma on the PSD website, please contact Nick Dacosta, PREP Branch, Pesticides Safety Directorate, Room 312, Mallard House, Kings Pool, 3 Peasholme Green, York, YO1 7PX. Tel 01904 455703.
If you have any queries regarding this survey, please contact us: Link to Contact details page..
Regulatory Update: 02/2006
The Applicant Guide
Summary spreadsheet of results for 2002 to 2004 (Excel)