Spraying agro-chemicals. Photo: Graham Rawlings via Flickr.
Negligent and unlawful: EFSA's latest guidance on pesticide use and exposure
4th December 2014
After an apparent cave-in to Europe's pesticide industry, the European Food Safety Authority's latest guidance on pesticides conflicts with European law, writes Georgina Downs - by ignoring the real-life agrochemical exposure of rural residents. Commission President Juncker must step in and demand the withdrawal of this disgraceful document.
Millions of rural citizens across Europe have been put in a massive guinea pig-style experiment, for which many of us have had to suffer the serious, devastating - and in some cases fatal - consequences.
It has now been nearly 14 years since I first identified fundamental failings in the way the UK, and Europe more widely, assessed the risks to people exposed to agricultural pesticides used in crop spraying.
These failings have always been so staggering that when I first started to present the case to both UK and European policy makers, and their scientific advisors, I thought that urgent action would be taken considering the clear lack of any protection for rural residents and communities across the EU from exposure to such poisons.
That was of course before I knew what I was up against and the powerful vested and self-serving interests involved in an industry that in the UK alone has annual sales in excess of £620 million and an estimated worldwide value of over $52 billion.
A catastrophic public health and safety failure
For anyone unfamiliar with this issue, the crucial facts are these.
EU legislation regarding the authorisation of pesticides (formerly Directive 91/414 and now Regulation 1107/2009) requires that before pesticides can be approved for use, risk assessments must be undertaken to establish that there will be no harmful effect on human health.
This must apply to all the necessary exposure groups, including operators, workers, residents living in the locality of sprayed fields, as well as other members of the public exposed (eg. bystanders).
Yet to date, the official method used by regulators for assessing the risks to people from crop spraying - and under which many thousands of pesticide products have been approved across the EU - has been based on the model of a short term 'bystander', occasionally exposed, to just one pesticide at any time.
This clearly does not address the real life exposure of people who actually live in sprayed areas, as exposure for residents is long-term, chronic, cumulative, and is to innumerable mixtures ('cocktails') of pesticides used on crops.
Note: there are approx. 2,000 products currently approved for agricultural use in the UK alone.
This means that pesticides have been approved for decades without having first assessed the actual exposure and risks specifically for residents living near sprayed fields.
This includes the astonishing fact that there has been no assessment at all for babies and children that live in the crop-sprayed areas, nor pregnant women or people already ill.
Considering how many millions of citizens not only in the UK, but also across Europe, will be living in this situation then this is a catastrophic public health and safety failure on a truly scandalous scale.
Significant campaign victories
It is testament to the strength of the case that I have continued to present on this issue that, despite all that I have been up against, there have been some significant victories and achievements so far both in the UK and across Europe.
For example, my campaign, the UK Pesticides Campaign had already been successful in ensuring that new exposure and risk assessment specifications for residents and bystanders are included in, most importantly, Commission Regulation (EU) No 284/2013 of 1st March 2013.
This Regulation sets out the revised data requirements that applicants (the pesticide companies) must submit prior to any pesticides being considered for authorisation.
The UK Government had also agreed, in its announcement in December 2013, to changes to its policy at national level for assessing the risks to people from agricultural pesticides.
This included that there needs to be separate exposure and risk assessments for residents and bystanders; and that both acute (short-term) and longer-term exposure assessments are required for residents.
According to reports at the time a DEFRA spokesman confirmed that pesticides currently approved could ultimately be affected, as well as new ones coming through the system.
However, the stated changes to the UK risk assessment approach were still woefully inadequate and critically Ministers still failed to introduce the necessary measures to secure the protection of residents' health.
New EFSA Guidance document now published
My campaign representations also prompted the development of a new Guidance document from the European Food Safety Authority (EFSA) on the assessment of exposure for operators, workers, residents and bystanders in risk assessment for pesticide products. The EFSA Guidance document has recently been published on the EFSA website.
EFSA's role is to assess and communicate on all risks associated with the food chain. As the risk assessor its advice serves to inform the policies and decisions of EU political institutions, and to support the European Commission, European Parliament and EU Member States in taking effective and timely risk management decisions, including on the risks to human health from pesticides.
I had provided EFSA, the related scientific panel (the 'PPR Panel') and the related EFSA Working Group with the factual evidence and data that clearly illustrated the reality of the exposure of residents living in the locality of pesticide sprayed fields.
This included in numerous written submissions, as well as visual materials such as a number of still photos, a short video clip, and two videos on a DVD. The DVD featured, just as an example, a number of rural residents reporting exposure to pesticides, and related acute and/or chronic adverse health effects, from crop spraying on fields in the locality of their homes and children's schools.
As a result of the detailed factual evidence I provided regarding residents exposure, I was invited by EFSA to have a technical hearing with the aforementioned EFSA Working Group that was involved with finalising the EFSA Guidance, and presented an 18-page statement.
Fatal flaws and serious misrepresentation of residents exposure
The EFSA news release that accompanied the publication of the EFSA Guidance document asserted that the Guidance "sets out for the first time a harmonised methodology for calculating exposure to pesticides for four major population groups".
It added that "the methodology is designed to help risk assessors and industry applicants evaluate the risk" to these exposure groups, and as a result, it "increases protection for operators, workers, residents and bystanders."
Further, it insists the Guidance "incorporates a high safety factor by considering both realistic and worst case scenarios for exposure assessments" and that it makes "an important contribution to safeguarding public health by calculating non-dietary exposure to pesticides with more accuracy than ever before."
Yet these claims are most certainly not borne out by what is contained in the EFSA Guidance. As they currently stand, the flawed assumptions that have been made in relation to the assessment of residents seriously misrepresents the real life exposure of residents.
For example, in relation to each of the limited exposure pathways that the EFSA Guidance includes for residents, the exposure durations will be far longer than the time scales proposed of just 15 minutes for spray drift, just 2 hours for surface deposits, and only 24 hours for vapour.
All these exposure durations are simply not realistic in relation to the exposure of residents who live in the locality of regularly sprayed fields on a permanent basis.
Omitted pesticide exposure pathways and routes
Other fatal flaws in the proposed assessment for residents includes the fact that it excludes entirely many of the exposure factors and routes that are necessary to include in the exposure calculations for a residents specific exposure scenario.
These omitted exposure factors include:
- long-term exposure to pesticide particles, droplets and vapours in the air in the days, weeks and months after spraying applications;
- exposure to pesticides via precipitation and reactivation in pollen, dust (including harvest dust);
- pesticides transported from outdoor applications and redistributed into an indoor air environment;
- and exposure via long-range transportation, as studies have shown pesticides found miles away from where they were originally applied.
For example, see the peer-reviewed study by Sharon Lee and colleagues in California that found pesticides located up to three miles away from the treated areas, and calculated health risks for rural residents and communities living within those distances.
The maximum exposure for residents can only be known when all the relevant exposure factors and routes, both higher and lower levels of exposure, are included in the exposure calculations, and then added together (summed).
Thus the assessment for residents in the EFSA Guidance does not currently in any way, shape or form, assume the maximum exposure in relation to residents.
EFSA ignores exposure to multiple pesticides and mixtures
Further, as per the existing short term 'bystander' model, the EFSA assessment proposed for residents is based on exposure to just one individual pesticide at any time.
Yet this in itself is clearly inherently flawed as it does not account for the real life exposure of rural residents to the innumerable mixtures of pesticides sprayed on crops, on a regular basis, year after year.
This includes exposure not only to innumerable mixtures of pesticide active substances, but also to other hazardous chemicals contained in each of the product formulations - such as solvents, surfactants and co-formulants.
The real life exposures for residents to mixtures of pesticides and other hazardous chemicals can result in both cumulative and synergistic effects.
The EFSA Guidance also proposes to average out the limited few exposure pathways it does include for residents, and to only sum the 'mean' values, when it proposes to sum the components of exposure from each relevant source and route for operators and workers.
This appears to be yet further attempts to ensure that the exposure for residents is deemed lower than for any of the other exposure groups, including bystanders.
Yet residents are clearly a group with one of the highest levels of exposure to pesticides, considering the frequency and duration of exposure. This includes repeated acute exposures, as well as chronic exposures, all over the long-term, to mixtures of pesticides, regularly sprayed, in the locality of residents' homes, as well as schools, playgrounds throughout every year, and in many cases for decades.
In fact, as I continued to point out to EFSA, the fact that the exposure for residents living in the locality of sprayed fields is high has clearly been recognised in European legislation.
Residents (and not bystanders) are now specifically defined as a "vulnerable group" in Article 3, paragraph 14 of the EU Plant Protection Products (PPP) Regulation 1107/2009 which recognises that residents are "subject to high pesticide exposure over the long term."
EFSA - 'no need for a separate acute risk assessment for residents'
The real life direct experiences of the various exposure groups concerned are obviously essential when developing exposure and risk assessments for those specific exposure groups.
However, the actual facts, evidence, and data of the reality of residents exposure, direct from residents themselves, has seemingly been side lined by EFSA and its related Working Group in favour of the unevidenced assertions of the pesticide industry of what it maintains the exposure of residents involves!
A prime example of this is the removal from the Guidance of the requirement for an acute exposure assessment for residents.
In the earlier draft EFSA Guidance document it was clearly spelt out that "Acute exposure assessments are required for both residents and bystanders" and that for residents "longer-term exposure assessments are also required."
Therefore for residents an assessment was clearly required to be undertaken for both acute and chronic exposures (albeit inadequately as detailed in the aforementioned paras above). However, in the current version now published on the EFSA website the text related to the requirement for an acute exposure assessment to be undertaken for residents has been removed. The related paragraph instead now states:
"For PPPs that are acutely toxic and where an appropriate reference value has been set, realistic upper estimates of exposure in a single day for operators, workers, residents and bystanders should be considered. The exposure assessment for bystanders should cover the realistic upper estimate of exposure that a resident could reasonably be expected to incur in a single day.
"Therefore, any risk to residents from exposures that can take place within a single day, and may produce effects, would be covered by the risk assessment for bystanders, and there would be no need for a separate acute risk assessment for residents."
EFSA guidance inconsistent with EU law
Yet Commission Regulation (EU) No 284/2013 of 1st March 2013 that sets out the data requirements that applicants must submit prior to any pesticides being considered for authorisation clearly specifies that the risk assessment undertaken for residents has to include both the acute and chronic exposures.
For example, the data requirements Regulation clearly states:
"The information provided for the plant protection product and that provided for the active substance, shall be sufficient to: (f) permit an estimation of acute and chronic exposure to operators, workers, residents and bystanders including, where relevant, the cumulative exposure to more than one active substance."
Then under the heading "Circumstances in which required" it states, "An estimation of bystander and resident exposure shall always be performed."
Therefore the EFSA Guidance fails to reflect the risk assessment requirements set down in EU law, including both Commission Regulation (EU) No 284/2013 of 1st March 2013 and the PPP Regulation 1107/2009.
Both Regulations clearly require separate risk assessments to be undertaken for residents and bystanders - and for residents the risk assessment has to include for both acute and chronic exposures.
On reading the EFSA technical report that was published at the same time as the EFSA Guidance, it can be seen that ECPA (the European Crop Protection Association - the body that represents the pesticides industry in Europe) strongly objected to the inclusion of the acute exposure assessment for residents.
ECPA asserted that it was "redundant to assess the acute exposure and risk for residents as proposed in the guidance, as this is covered by the acute assessment for the bystander exposed to substances." ECPA went on to propose that for residents there should be a long term exposure assessment only.
Yet residents are subjected to a combination of both acute and chronic exposures, over many years, and in many cases, like my own, for decades.
Acute exposures and acute effects
As I have continued to stress to EFSA, the majority of reports of acute exposure and acute toxicity in the UK Government's very own monitoring system are for residents not bystanders, nor even operators.
This is not surprising considering that operators and workers generally have protection - wearing of PPE, use of filtered cabs, and access to all the necessary chemical information, warnings, material data sheets of the pesticides used etc - and residents do not.
For example, the acute adverse health effects recorded in the UK Government's own monitoring system include, amongst other acute effects, the following:
- chemical burns (including to the eyes and skin);
- rashes and blistering;
- throat irritation (eg. sore and painful throats);
- damaged vocal chords;
- sinus pain;
- respiratory irritation;
- difficulty swallowing and chest discomfort;
- breathing problems;
- shortness of breath;
- asthma attacks;
- headaches, dizziness, nausea;
- stomach pains;
- flu-type illnesses;
- aching joints.
These are the same types of acute adverse health effects reported to my campaign from rural residents and communities not only here in the UK, but also from various other countries across Europe and around the world.
It is therefore a matter of fact that residents do have acute exposures and it is most certainly not the same as acute exposure for a transient bystander. So the fact that the published version of the EFSA Guidance no longer requires that a separate acute assessment for residents be undertaken is seriously erroneous.
Even the UK Government's stated changes to the UK risk assessment approach includes both acute and longer-term exposure assessments for residents.
Although the EFSA Guidance is not legally binding, it is the Guidance the applicants, and the risk assessors across the EU Member States, will look to when carrying out the risk assessments required under EU law.
By removing the need for a separate acute assessment for residents in the EFSA Guidance there is a real risk that EU applicants will not undertake an acute assessment for residents because it is not clearly specified in the Guidance for them to do one. What is set out in the Guidance is simply not in line with EU law.
Further, EU law does not say that acute assessments are only required for pesticides that are deemed "acutely toxic" - which is what the EFSA Guidance proposes in relation to acute assessments.
Considering that most, if not all, pesticides would have the potential for acute toxicity, and further, considering that pesticides are rarely used individually, but commonly used in mixtures, then acute assessments (including for residents) must be required for all pesticides.
The majority of pesticide product data sheets are clear that acute effects, including both systemic effects, and local effects, (the latter of which is also not covered in any capacity in the EFSA Guidance) can occur as a result of exposure.
No pesticides should have been approved for use in the first place in the absence of all the necessary exposure and risks assessments being undertaken. EU law is clear that it must be established before a pesticide can be approved for use that there will be no harm to human health.
This includes acute exposure and acute adverse health effects, as well as chronic exposure and chronic effects.
Stonewalled by EFSA
I requested a statement from EFSA as to the reason why the EFSA Guidance now states that a separate acute assessment for residents is not needed when it was clearly spelt out in the previous draft version of the Guidance that it was, and further, on what evidence was EFSA basing its decision that it is not needed.
I also asked whether it was related to the European Crop Protection Association's objections to its inclusion, and its assertions that acute exposure for residents is "redundant" as it "is covered by the acute assessment for the bystander."
In its response EFSA mainly cited from the Guidance, as it continued to maintain "the acute risk for residents should be covered by the acute risk for bystanders."
First, this is simply not the case, as residents and bystanders are two completely separate exposure groups. Second, this did not answer my questions.
So once again I asked EFSA why the clear statement in the draft version of the EFSA Guidance - that applicants must do an acute assessment for residents - had been removed, and further, on what evidence was EFSA basing its decision to remove it.
I initially received no further response from the EFSA press office at all. However, after some persistence on my part, I received the verbal statement from a member of the press team that EFSA had "no further comment to add."
Note that I never received a reply to my question about whether the deletion of the text from the draft Guidance was related to the objections from ECPA, the EU representatives of the pesticides industry, considering that ECPA had asserted the very same thing that EFSA subsequently adopted in the published version of its Guidance.
Jean-Claude Juncker, Commission President - put a stop to this nonsense!
The EFSA Guidance is due to be discussed at a meeting next week of the EU's Standing Committee on Plants, Animals, Food and Feed. The next steps regarding the Guidance will then be decided on the outcome of these discussions.
However the European Commission has the authority to intervene in the process that is undertaken prior to an EFSA Guidance being put in to formal use.
I have therefore written a letter to the Commission President Jean-Claude Juncker, and copied it to the European Commissioners for Health, and the Environment, to stress the fact that the EFSA Guidance in its current form should absolutely not be put in to formal use.
EFSA has seriously misrepresented the exposure of residents to agricultural pesticides in its Guidance. Not only is this negligent and irresponsible, it also appears unlawful, as it is clearly not in line with the relevant EU legislation.
EFSA was willing to protect bees but has failed to protect people
It is also not in line with the action that EFSA initiated in 2013 when it accepted that there were uncertainties in the existing risk assessment for bees and subsequently advised the European Commission to take the required action.
In relation to residents it is not merely a case of there being uncertainties in the existing risk assessment, but the critical fact that, to date, there has never been any risk assessment whatsoever for the specific exposure scenario for residents.
This means that under EU law pesticides should never have been approved for use in the first place for spraying in the locality of residents' homes, as well as in the vicinity of schools, children's playgrounds, nurseries, amongst other areas.
Millions of rural citizens across Europe have been put in a massive guinea pig-style experiment, for which many of us have had to suffer the serious, devastating - and in some cases fatal - consequences.
The most common chronic conditions reported to my campaign from EU residents include neurological conditions such as Parkinson's disease, Multiple Sclerosis, and neurological damage, as well as various cancers, especially those of the breast and brain, leukaemia, non-Hodgkins lymphoma, amongst others.
However, the most EFSA could muster regarding residents exposure and the risk of health impacts was to merely recommend further research. This again seems all too familiar, reflecting the usual position of the pesticides industry: that more research is needed when it comes to the human health risks and impacts of pesticides - with the apparent aim of preventing any concrete action.
Yet under EU law the duty to protect human health is even higher than that of bees: the Article 4 duty in the PPP Regulation is for it to be established prior to the approval of any pesticide that it "shall have no immediate or delayed harmful effect on human health, including that of vulnerable groups."
This is an absolute requirement with no qualification, whereas for bees it falls under the protection afforded to the environment which is for "no unacceptable effects." Therefore there is supposed to be an even higher protection standard afforded to humans.
EU residents must be protected
It is now beyond dispute that pesticides can cause a wide range of both acute, and chronic, adverse effects on human health. This includes irreversible and permanent chronic effects, illnesses and diseases.
High quality, peer-reviewed scientific studies and reviews have concluded that long-term exposure to pesticides can disturb the function of different organs in the body, including nervous, endocrine, immune, reproductive, renal, cardiovascular, and respiratory systems.
More than enough evidence already exists for action to be taken now and which is very long overdue. EFSA documentation clearly states that, "Safeguarding human health is a core part of EFSA's ongoing work in the area of pesticides".
So EFSA, with its public health remit, should be advising the EU political institutions to take urgent action on this issue to introduce the necessary mandatory measures for the protection of the health of rural communities across Europe.
Such measures would include, most importantly, the prohibition of the use of pesticides in substantial distances (as small buffer zones won't be protecting anyone!) in the locality of residents' homes, schools, children's playgrounds, among other areas.
The significance of the consequences for rural citizens across the EU exposed to the cocktails of carcinogenic, neurotoxic, hormone disrupting poisons sprayed on crops, clearly requires the adoption of a preventative approach, to ensure that the protection of human health is the overriding priority.
As under EU law there can be no balancing of interests with the multi-billion pound pesticides industry, or other related big business, when it comes to public health protection.
Georgina Downs is a journalist and campaigner. She runs the award-winning UK Pesticides Campaign.
Photograph used with kind permission of Shutterstock.
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