2 Pesticide approvals
EU approvals
19. The European Commission approves active substances
for use in plant protection products in EU Member States. Defra
described the European approvals procedure for active substances:
It is the job of the company which wishes to gain
approval to put together the necessary scientific data to support
its application … The applicant submits all of the information
including study methodology and data generated, together with
their own conclusions, in the form of a Dossier … The Dossier
is scrutinised and assessed by a regulatory authority's experts
in all of the various scientific disciplines involved. The regulatory
authority's opinion—which may or may not coincide with that
of the company—is set out in a Draft Assessment Report (DAR).
The DAR produced by the regulatory authority of a Member State
is then submitted to the European Food Safety Authority (EFSA),
which organises a further scrutiny (known as peer review) by experts
from all of the EU Member States. Following this peer review,
EFSA sends its conclusions to the Commission. This is used as
the basis for a proposal from the Commission for approval or not
of the substance and any associated conditions. This proposal
is adopted (or not) by qualified majority vote of Member States.[26]
20. The European Food Safety Authority (EFSA) was
formed in 2002 as an independent source of scientific advice and
communication on risks associated with the food chain. For pesticides
work, EFSA conducts risk assessment and the European Commission
is responsible for risk management. EFSA co-ordinates the peer
review of active substances used in pesticides, provides scientific
advice on broader issues that cannot be resolved within the peer
review process and delivers scientific guidance on generic issues,
commonly in the fields of toxicology, eco-toxicology and the fate
and behaviour of pesticides. EU rules on the authorisation of
pesticides allow the European Commission to seek EFSA's views
on new evidence on the safety of a pesticide or active substance.
UK approvals
21. When an active substance has been approved by
the European Commission, companies can apply to the regulatory
authority in individual Member States—in the case of the
UK, the Chemicals Regulation Directorate (CRD) of the Health and
Safety Executive—for permission to place their product on
the market. Most products include a range of substances in addition
to the active substance—for example, the bait that attracts
slugs to eat slug pellets. When a company seeks authorisation
to market a product in the UK, the CRD prepares a scientific evaluation
of factors such as the product's chemical properties, its potential
toxicity to humans, dietary intake, exposure to operators and
other workers, environmental fate and behaviour, efficacy and
risk to crops. This draft evaluation is then considered by the
Advisory Committee on Pesticides (ACP), which advises Ministers
that an authorisation can be granted only if it is content that
there are no "unacceptable risks".[27]
22. The ACP is a statutory independent advisory committee
constituted under section 16(7) of the Food and Environment Protection
Act 1985. It advises Ministers on matters relating to the control
of pests and on the approval of pesticides in the UK. Appointments
to the ACP are made by open competition and follow the requirements
of the Office of the Commissioner for Public Appointments. All
ACP Members are required to declare any interests they might have
in the pesticides industry both on an annual basis and before
the discussion of particular issues. The ACP has a current membership
of 20, including two lay members, mostly drawn from academia.
Defra has stated that "No [ACP] member has declared that
they are in the employ of companies selling neonicotinoid pesticides."[28]
Transparency
23. We heard that the data submitted by pesticide
companies for regulatory purposes is not in the public domain,
which makes it impossible for concerned stakeholders to examine
the methods, assumptions and results underpinning risk assessment
and risk management.[29]
Professor Goulson commented:
I am very confused as to why they insist this information
is confidential. We are talking about safety tests, so you have
a new chemical that you want to bring to the market; you have
to have it tested on a range of organisms to see at what level
it kills them, what concentrations kill them or whatever. There
would be tests on honeybees and worms and a range of other things.
It is not clear to me why that information should not be made
freely available to everybody or what commercial advantage a competitor
would gain by finding out how many honeybees product X would kill
at a certain concentration.[30]
24. Dr Cresswell described his experience of accessing
studies submitted by pesticides companies to support applications
to approve products:
I have just seen some of the studies and the way
that I had to do it was I had to apply to the CRD, I had to go
to York and then I had to sit in a room with a person looking
to check—I don't know what he thought I might do. So I was
allowed to look at the documents, make notes, but I could not
have copies of them. So I did a pretty good transcription of all
the data that I wanted and was able to take it away, but I am
not sure that counts as transparent.[31]
Professor Goulson highlighted "the obvious inequity
in that academic research that has shown evidence for harm of
neonicotinoids on bees is picked apart and examined in minute
detail by the agrochemical industry and yet in reverse we can't
examine the evidence that they are safe."[32]
Dr Dicks added that "it is the regulatory system itself,
with its closed studies that you can't access, that is at fault".[33]
25. Defra appeared to be less concerned:
The studies commissioned in support of an approval
application are sometimes described as secret, but that is not
an accurate portrayal. These studies carry data protection rights
under EU legislation, which means that they cannot be used by
other companies to gain authorisation. However the data is accessible
through access to information arrangements such as those under
the Freedom of Information Act and Environmental Information Regulations.
These access rights to the regulatory studies have been used in
respect of neonicotinoids. The Government recognises the value
of having the data more readily available for wider review and
has suggested to the pesticide manufacturers that it would be
a good idea to publish their studies.[34]
26. We
agree with Defra that it would be "a good idea" if pesticide
manufacturers were to publish the studies underpinning applications
for pesticide approvals. The agrochemical industry has produced
many studies on the environmental effect of neonicotinoids and
other pesticides, but the data are allegedly confidential for
commercial reasons. The lack of transparency in relation to trials
and studies conducted by pesticide manufacturers has resulted
in inequality between the pesticide industry on one side and academics
and the public on the other. The agrochemical industry should
place the results of its risk assessment trials in the public
domain to inform academic research and increase transparency for
the public. Defra should work with industry and academics to establish
which, if any, genuinely commercially sensitive details should
be redacted to make that possible.
Testing
27. On the tests that pesticide companies are obliged
to conduct to support the approval of their products, the ACP
told us that "the standard requirements do not include some
of the specific sub-lethal effects suggested by recent academic
studies."[35] The
Pesticide Action Network highlighted that "the tests focus
on short-term, acute toxicity to adult worker bees and mainly
ignore chronic toxicity and sub-lethal effects on bee behaviour,
on larvae and on hive overwintering."[36]
In May 2012, EFSA published an Opinion on the risk assessment
of plant protection products which addressed that point by proposing
enhanced risk assessments including sub-lethal effects. Member
States are currently consulting on that Opinion, which underpinned
EFSA's recent revised risk assessments of neonicotinoids (paragraph
53).
28. The recent Gill laboratory study (paragraph 41)
pointed to a need for the assessment regime to address the combined
effect of multiple pesticides. Professor Goulson raised some of
the practical problems:
It becomes very complicated very quickly because
there are lots of chemicals that bees would be exposed to—fungicides
as well as insecticides and herbicides and so on. If you were
to demand that every new product had to be tested and all possible
interactions had to be tested, in an ideal world that would be
wonderful, but I think the costs would quickly become extraordinary.[37]
Dr Cresswell added:
There are two options: either you use your fundamental
knowledge to predict what might happen, or you prescribe, in a
regulatory framework, if those two things are going to be used
together then we have to test those. I think there are ways forward
but you have to be smart in what you test.[38]
29. The EU approvals process for active substances
explicitly addresses only the risks to honeybees.[39]
It does not explicitly refer to wild bees or other species of
insect pollinator, although there is a general duty to ensure
that plant protection products do not have "unacceptable
effects on the environment".[40]
The honeybee serves as a sentinel species for all insect pollinators
in European risk assessment, but we heard that evidence derived
from monitoring and testing honeybees cannot be used to draw reliable
conclusions about outcomes for wild bees, let alone for other
wild pollinator species. Dr Cresswell commented that "some
kinds of bee are more sensitive than others. In fact, honeybees,
in my view, are rather tough compared with, for example, bumblebees."[41]
Dr Dicks pointed out why conclusions derived from monitoring honeybees
do not apply to one important pollinator species:
In some parts of the country, hoverflies form a very
substantial proportion of the flower-feeding insect community,
providing an unknown amount of the pollination service. They have
very different life cycles to bees. They feed on flowers exclusively
as adults. Many species have different larval habits. Some of
them are laying their eggs in a crop and the larvae are feeding
in the crop, so their exposure routes are very, very different
from bees in many ways.[42]
30. We
recognise that it is impractical to conduct individual risk assessments
for the thousands of species of bees, hoverflies, butterflies,
carrion flies, beetles, midges, moths and other invertebrates
that contribute to insect pollination, but we are not convinced
that honeybees are an appropriate proxy for all such species.
We urge Defra to introduce a representative range of sentinel
pollinator species in UK pesticides risk assessments and work
to agree a similar arrangement across the EU.
Case study: imidacloprid
31. We examined the neonicotinoid imidacloprid as
a case study of how the trials, risk assessment and risk management
of pesticides work in practice. Imidacloprid was first approved
for use as an active substance in the EU in 1991, and individual
products containing imidacloprid have been registered for use
in the UK since 1993. Under Article 8(2) of Council Directive
91/414/EEC, which set out a rolling programme of reassessment
for active substances, imidacloprid's status as an approved substance
was subject to re-evaluation in 2006. Germany was the Rapporteur
Member State, and therefore the German regulatory authority produced
the Draft Assessment Report (DAR) for imidacloprid in 2006. Bayer
CropScience, based in Germany, developed imidacloprid, and it
markets several plant protection products in which imidacloprid
is the active substance.
32. We heard concerns that neonicotinoids such as
imidacloprid might accumulate in the environment to the detriment
of insect pollinators.[43]
Many invertebrates, such as some wild bees, nest in topsoil, which
makes the extent to which a toxic active substance accumulates
in soil an important environmental consideration (more widely,
there is the further question whether such accumulations might
make their way into groundwater). We therefore examined how the
issue of environmental accumulation was addressed in the 2006
re-approval process.
33. The DAR described how imidacloprid's propensity
to accumulate in soil was tested by two trials conducted in two
separate locations (to minimise the possibility of an anomalous
result) in the UK in the 1990s:
In order to demonstrate that imidacloprid does not
persist in soil and that its use does not entail an accumulation
in soil, long term dissipation studies with repetitive application
of imidacloprid were conducted ... In a ... study performed in
Great Britain, the long-term soil dissipation of imidacloprid
following its use as seed dressing in winter barley was investigated
in the course of six years. It was established that maximum concentrations
in soil reach a plateau at rather low residue levels after four
to six years.[44]
The DAR included the data on which that conclusion
was based and expressed the results of the 1990s British soil
accumulation trials in the form of two graphs (Figure 2).[45]
The graphs shown in Figure 2 sit on top of the watermark,
because they were added to the DAR at some point after 2006 to
replace earlier graphs. The original graphs had erroneously added
together the readings for different soil depths rather than averaging
them. This basic arithmetic error was only partially corrected
in the final version of the DAR, which still included incorrect
figures which did not match the revised graphs. There was no acknowledgement
in the DAR that this amendment had been made (accurate figures
for the British trials appeared in an addendum in 2008).[46]
Based on incorrectly calculated data, which would have exacerbated
the apparent problem, the 2006 DAR concluded:
Long-term field dissipation trials of imidacloprid
in soil with its repeated use as a seed treatment over six consecutive
years have confirmed that the compound has no potential for accumulation
in soil. Though the concentrations measured in the samples from
the two test sites increase in the first three years the increase
levels off and reaches a plateau.[47]
The conclusion in the DAR that "the compound
has no potential for accumulation in soil" did not reflect
the results of the trials. In reality, the trials did not show
a plateau in accumulation in soil (see Figure 2, which graphs
the correct data).
Figure 2
34. The 2006 DAR was subject to peer review by EFSA,
which provided a risk assessment to the European Commission. EFSA
identified imidacloprid's apparent tendency to accumulate in soil
in its risk assessment:
At the two UK study sites accumulation occurred over
the full 6 year duration of the studies and the experts considered
that a plateau was not reached.[48]
Plateau not reached at the end of study, data gap
identified.[49]
The risk assessment to soil dwelling organisms cannot
be finalised because the assessment of soil accumulation is not
finalised.[50]
EFSA's comments on soil accumulation were simply
included in the text of its risk assessment and were not highlighted
as an action point or cause for concern. EFSA also extrapolated
the half-life of imidacloprid in soil, which is a measure of persistence
in the environment, from the results of the UK trials: it calculated
a half-life of 1,333 days at one site and of 1,268 days at the
other.[51] EFSA described
its calculations as "conservative estimates."[52]
35. We asked Bayer CropScience, which developed imidacloprid,
about soil accumulation. Bayer's spokesman, Dr Julian Little,
told us:
It will depend on a huge number of different things,
including soil type, climate, temperature, what has been grown
in there, how many worms there are—everything will affect
that figure. But if you are looking at something like imidacloprid
or clothianidin you can be talking a half-life of anywhere between
16 and, say, 200 days.[53]
He later amended his estimate of the maximum half-life
of imidacloprid: "in 'worse-case scenarios', the half-life
of imidacloprid in normal soils would be variable but around 288
days, and would be expected to plateau upon repeated doses after
three years."[54]
That estimate is borne out by neither the 1990s UK field trials
on which the re-approval of imidacloprid was based nor EFSA's
2008 risk assessment of those trials.
36. EFSA concluded its peer-reviewed risk assessment
of imidacloprid in May 2008 and forwarded it to the European Commission.
The EC Standing Committee on the Food Chain and Animal Health,
which consists of representatives of EU Governments and public
authorities and which manages risk in relation to pesticides on
behalf of the European Commission, considered EFSA's risk assessment
in September 2008: "The overall conclusion from the evaluation
is that it may be expected that plant protection products containing
imidacloprid will fulfil the safety requirements laid down in
... Directive 91/414/EEC … The review has also concluded
that under the proposed and supported conditions of use, there
are no unacceptable affects on the environment".[55]
The Standing Committee's recommendation to approve imidacloprid
did not mention the accumulation of imidacloprid in soil, and
imidacloprid was re-approved in December 2008.[56]
37. We asked Defra and Bayer CropScience to comment
on how soil accumulation was addressed in the re-approval process.
Defra did not see the trials of imidacloprid as representative:
The UK field accumulation study considered by EFSA
was a specific data requirement from the ACP and was designed
to provide a worst case assessment, hence the incorporation of
the entire straw rather than stubble only … EFSA noted that
the incorporation of treated plant material was the one major
difference between the experimental design of the UK and German
studies and might be an explanation why very long half-life of
1,333 and 1,268 days were estimated at the two UK experimental
sites and a plateau in soil residues had not occurred after 6
years of experimentation.[57]
Bayer CropScience told us that the UK trials were
"a very specific study that is not designed to derive half-lives."[58]
It also highlighted the effect of reincorporating straw: "Normally
when we do these studies they are designed to reflect common agricultural
practice. In this particular study, the barley was sown and we
took the harvest of the grain, but then the straw remained on
the soil and the straw was chopped and shallow-incorporated back
into the soil bed."[59]
38. On the reincorporation of straw into the ground,
UK Agriculture and Horticulture Development Board research indicates
that 50% of stem and leaf material produced by oilseed rape, a
crop commonly grown from neonicotinoid-coated seed, can be collected
and baled, which suggests that the remaining 50% is reincorporated.[60]
Similarly, some 60% of wheat and barley can be collected and baled,
which means that the other 40% remains in the environment.[61]
The extent to which it is possible to collect stem and leaf material
might explain why the ACP specified that straw should be reincorporated
when it designed the UK trials of imidacloprid in the early 1990s.
39. When imidacloprid was re-approved for use as
an active substance in 2008, Directive 91/414/EEC did not set
a limit on the half-life of a substance in soil, but stipulated
that an approved substance should have "no unacceptable influence
on the environment … having particular regard to its fate
and distribution".[62]
EU Regulation 1107/2009, introduced in 2009, set criteria
for 'persistence', one of which is a half-life in soil of more
than 120 days (and 'very persistent' where the half-life in soil
is higher than 180 days).[63]
Defra told us that "active substances which are deemed to
be persistent are not excluded from approval unless they are also
bioaccumulative and toxic (so-called PBT substances). Imidacloprid
does not meet the bioaccumulative criteria and so is not a PBT
substance".[64]
[65] However,
Regulation 1107/2009 includes a catch-all stipulation that an
active substance "shall have no unacceptable effects on the
environment, having particular regard to ... its fate and distribution
in the environment, particularly contamination of surface waters,
including estuarine and coastal waters, groundwater, air and soil".[66]
In short, Defra acknowledged that imidacloprid is persistent (Regulation
1107/2009 indicates that it is "very persistent") and
toxic, but justified its approval on the grounds that it is not
bioaccumulative. Defra did not engage with the question whether
imidacloprid's apparent half-life in soil might constitute an
"unacceptable influence on the environment".[67]
40. For Governments,
scientists and the public to have confidence in the EU-wide pesticide
approvals regime, data and analysis should be rigorously scrutinised
and quality checked to form a credible evidence base. The 2006
re-approval of imidacloprid for use in the EU shows two flaws
in the system. First, EFSA identified the issue of soil accumulation
in its peer review, but the European Commission proceeded to sign
off imidacloprid as an approved active substance for use in Member
States without explicitly addressing that risk. There seems little
point in EFSA's assessing risk if the Commission ignores environmental
threats identified in that process. We recommend that the
Government exercises its influence in Europe to empower EFSA to
include action points in future peer reviews which the European
Commission must explicitly address before approving active substances.
Secondly, the choice of Germany as the Rapporteur Member State
in the case of a substance developed and manufactured in Germany
raised a potential conflict of interest. The Government should
seek a common understanding in Europe that active substances should
be assessed by the regulatory authority of a Member State other
than the one in which the applicant company is based.
26 Ev 196 Back
27
Ev 223 Back
28
HC Deb, 4 March 2013, col 806W Back
29
Ev 125 Back
30
Q 109 Back
31
Q 100 Back
32
Q 101 Back
33
Q 103 Back
34
Ev 196 Back
35
Ev 216 Back
36
Ev 125 Back
37
Q 130 Back
38
Ibid. Back
39
Ev 199 Back
40
Council Regulation (EC) No. 1107/2009, Article 4 Back
41
Q 98 Back
42
Q 99 Back
43
Ev 141, w2 Back
44
Draft Assessment Report, "Imidacloprid", 2006, vol 1,
p 42 Back
45
Ibid, Annex B.8, p 640 Back
46
Draft Assessment Report, "Imidacloprid", 2008, Final
Addendum, p 8 Back
47
Draft Assessment Report, "Imidacloprid", 2006, Annex
B.8, p 640 Back
48
EFSA Scientific Report, "Conclusion on the peer review of
imidacloprid", vol 148 (2008), p 26 Back
49
Ibid, p 79 Back
50
ibid, p 58 Back
51
ibid, p 25 Back
52
ibid, p 26 Back
53
Q 187 Back
54
Ev 236 Back
55
European Commission, Review report for the active substance
imidacloprid, SANCO 108/08, September 2008 Back
56
Commission Directive 2008/116/EC Back
57
BEE 38, Defra, para 8 Back
58
Q 434 Back
59
Ibid. Back
60
Harley Stoddart and Jack Watts, "Biomass feedstock, residues
and by-products", Agriculture and Horticulture Development
Board, 2012 Back
61
Ibid. Back
62
Council Directive 91/414/EEC, Article 4(1)(v) Back
63
Council Regulation (EC) No. 1107/2009, Annex II. Back
64
Ev 237 Back
65
Bioaccumulation refers to the accumulation of substances, such
as pesticides, or other organic chemicals in an organism. Bioaccumulation
occurs when an organism absorbs a toxic substance at a rate greater
than that at which the substance is lost. Back
66
Council Regulation (EC) No. 1107/2009, Article 3(e) Back
67
Council Directive 91/414/EEC, Article 4(1)(v) Back
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