![]() |
[Home] [Databases] [World Law] [Multidatabase Search] [Help] [Feedback] | |
England and Wales High Court (Administrative Court) Decisions |
||
You are here: BAILII >> Databases >> England and Wales High Court (Administrative Court) Decisions >> Friends of the Earth Ltd, R (On the Application Of) v Secretary of State for the Environment, Food And Rural Affairs [2015] EWHC 3283 (Admin) (12 November 2015) URL: http://www.bailii.org/ew/cases/EWHC/Admin/2015/3283.html Cite as: [2015] EWHC 3283 (Admin) |
[New search]
[Context]
[View without highlighting]
[Printable RTF version]
[Help]
THE
HIGH COURT
OF
JUSTICE
QUEEN'S BENCH DIVISION
ADMINISTRATIVE COURT
![]() ![]() Strand, London, WC2A 2LL |
||
B e f o r e :
HON. MRS JUSTICE PATTERSON DBE
____________________
![]() ![]() ![]() ![]() ![]() ![]() |
Claimant |
|
- and - |
||
SECRETARY ![]() ![]() ![]() ![]() - and - NATIONAL FARMERS UNION |
Defendant Interested Party |
____________________
Friends of the Earth
) for
the
Claimant
Richard Kimblin (instructed by Government Legal Department) for the
Defendant
Hugh Mercer QC and John Robb (instructed by National Farmers Union) for the
Interested Party
Hearing date: 5 November 2015
____________________
OF
JUDGMENT
Crown Copyright ©
Mrs Justice Patterson:
Introduction
Legal Framework
"(8)The
purpose
of
this Regulation is to ensure a high level
of
protection
of
both human and animal health and
the
environment and at
the
same time to safeguard
the
competitiveness
of
Community agriculture. Particular attention should be paid to
the
protection
of
vulnerable groups
of the
population, including pregnant women, infants and children.
The
precautionary principle should be applied and this Regulation should ensure that industry demonstrates that substances or products produced or placed on
the
market do not have any harmful effect on human or animal health or any unacceptable effects on
the
environment.
(9) In order to remove as far as possible obstacles to trade in plant protection products existing due tothe
different levels
of
protection in
the
Member States, this Regulation should also lay down harmonised rules for
the
approval
of
active substances and
the
placing on
the
market
of
plant protection products, including
the
rules on
the
mutual recognition
of
authorisations and on parallel trade.
The
purpose
of
this Regulation is thus to increase
the
free movement
of
such products and availability
of
these products in
the
Member States.
(10) Substances should only be included in plant protection products where it has been demonstrated that they present a clear benefit for plant production and they are not expected to have any harmful effect on human or animal health or any unacceptable effects onthe
environment. In order to achieve
the
same level
of
protection in all Member States,
the
decision on acceptability or non-acceptability
of
such substances should be taken at Community level on
the
basis
of
harmonised criteria. These criteria should be applied for
the
first approval
of
an active substance under this Regulation. For active substances already approved,
the
criteria should be applied at
the
time
of
renewal or review
of
their approval.
…
(32) In exceptional cases, Member States should be permitted to authorise plant protection products not complying withthe
conditions provided for in this Regulation, where it is necessary to do so because
of
a danger or threat to plant production or ecosystems which cannot be contained by any other reasonable means. Such temporary authorisations should be reviewed at Community level."
"3.The
purpose
of
this Regulation is to ensure a high level
of
protection
of
both human and animal health and
the
environment and to improve
the
functioning
of the
internal market through
the
harmonisation
of the
rules on
the
placing on
the
market
of
plant protection products, while improving agricultural production.
4.The
provisions
of
this Regulation are underpinned by
the
precautionary principle in order to ensure that active substances or products placed on
the
market do not adversely affect human or animal health or
the
environment. In particular, Member States shall not be prevented from applying
the
precautionary principle where there is scientific uncertainty as to
the
risks with regard to human or animal health or
the
environment posed by
the
plant protection products to be authorised in their territory."
"Emergency situations in plant protection
1. By wayof
derogation from Article 28, in special circumstances a Member State may authorise, for a period not exceeding 120 days,
the
placing on
the
market
of
plant protection products, for limited and controlled use, where such a measure appears necessary because
of
a danger which cannot be contained by any other reasonable means.
"(4) In spring 2012, new scientific information onthe
sub-lethal effects
of
neonicotinoids on bees was published.
The
Commission, in accordance with Article 21(2)
of
Regulation (EC) No 1107/2009, asked
the
European Food Safety Authority, hereinafter '
the
Authority', for scientific and technical assistance to assess this new information and to review
the
risk assessment
of
neonicotinoids as regards their impact on bees.
(5)The
Authority presented its conclusions on
the
risk assessment for bees for clothianidin, thiamethoxam and imidacloprid on 16 January 2013.
(6)The
Authority identified for certain crops high acute risks for bees from plant protection products containing
the
active substances clothianidin, thiamethoxam or imidacloprid.
The
Authority identified in particular high acute risks for bees from exposure via dust as regards several crops, from consumption
of
residues in contaminated pollen and nectar as regards some crops and from exposure via guttation fluid as regards maize. In addition, unacceptable risks due to acute or chronic effects on colony survival and development could not be excluded for several crops. Furthermore
the
Authority identified a number
of
data gaps for each
of the
evaluated crops. In particular as regards long term risk to honey bees from dust exposure, from residues in pollen and nectar and from exposure from guttation fluid.
…
(10)The
Commission has come to
the
conclusion that a high risk for bees cannot be excluded except by imposing further restrictions.
(11) It is confirmed thatthe
active substances clothianidin, thiamethoxam and imidacloprid are to be deemed to have been approved under Regulation (EC) No 1107/2009. In order to minimise
the
exposure
of
bees, it is, however, appropriate to restrict
the
uses
of
those active substances, to provide for specific risk mitigation measures for
the
protection
of
bees and to limit
the
use
of the
plant protection products containing those active substances to professional users. In particular
the
uses as seed treatment and soil treatment
of
plant protection products containing clothianidin, thiamethoxam or imidacloprid should be prohibited for crops attractive to bees and for cereals except for uses in greenhouses and for winter cereals. Foliar treatments with plant protection products containing clothianidin, thiamethoxam or imidacloprid should be prohibited for crops attractive to bees and for cereals with
the
exception
of
uses in greenhouses and uses after flowering. Crops which are harvested before flowering are not considered attractive to bees.
…
(14) Risks for bees from treated seeds have been identified in particular from exposure via dust as regards several crops, from consumptionof
residues in contaminated pollen and nectar as regards some crops and from exposure via guttation fluid as regards maize. Taking into consideration those risks linked with
the
use
of
treated seeds,
the
use and
the
placing on
the
market
of
seeds treated with plant protection products containing clothianidin, thiamethoxam or imidacloprid should be prohibited for seeds
of
crops attractive to bees and for seeds
of
cereals except for winter cereals and seeds used in greenhouses."
"Nevertheless we would like to remind Member States that according to Article 53(2) and (3) if necessarythe
Commission may take a decision concerning an emergency authorisation in accordance with
the
regulatory procedure.
The
Commission may consult EFSA for advice and where
the
Commission concludes its intervention is justified, it may present a proposal to
the
Standing Committee, providing for
the
Member States to extend or repeat
the
authorisation or not, or requiring
the
Member State to withdraw it."
Factual Background
"17. This is especially unfortunate because there are likely to be specific instances where there is a real need for applicationof
crops with neonicotinoids. I have seen for myself what I believe are
the
effects
of
pests on winter OSR crops in Suffolk. Growers that can demonstrate that they have adopted low risk behaviours (e.g. in terms
of
choice
of
variety, time
of
drilling etc) but have still encountered demonstrable (i.e. evidence-based) severe pest problems are likely to be in greatest need for chemicals issued under Emergency Authorisation. This is most likely to satisfy
the
need for such an authorisation to be 'limited and controlled'."
"However, giventhe
potential for significant localised crop damage that has been identified
the
ECP would be willing to consider a revised application for use in
the
areas
of
highest need for control
of
cabbage stem flea beetle."
The
"Recommendations: That you:
- note
the
assessment by
the
Health and Safety Executive (HSE) and
the
UK Expert Committee on Pesticides (ECP) that
the
three applications do not meet
the
standards for emergency authorisation although, particularly in
the
case
of the
neonicotinoids, it might be possible that a case for a much more targeted authorisation could be made;
- note there is no basis for issuing
the
requested emergency authorisations and therefore, based on
the
evidence, agree that
the
three applications should be refused;
- agree that
the
NFU should be provided with broad advice on what might be required to meet
the
standards for emergency authorisation for
the
neonicotinoids (without any commitment on
the
Government's part that a fresh application would be successful)."
"However, we have focused these new applications to enable protectionof
crops in
the
county most severely affected in
the
current growing season, for which we have data i.e. Suffolk. This amounts to 5%
of the
OSR (oilseed rape) crop area."
The
"5.The
NFU is seeking emergency authorisation for
the
use
of
neonicotinoids on Oil Seed Rape (OSR) in Suffolk. This is around 5%
of
England's OSR crop area.
The
application describes procedures to control
the
use
of
neonicotinoids within this region. I advise that such an authorisation is likely to meet
the
standard required
of
being 'limited and controlled'.
…
8. Grantingthe
application will also increase our knowledge
of the
effects
of
neonicotinoids because we will have one treated region (Suffolk) to compare with other untreated regions."
i) There was evidence to demonstrate the
need to control CSFB in some geographic areas and there were limited realistic alternatives available for
the
control
of
that pest.
ii) However, the
current scientific evidence was not robust enough to identify precisely
the
areas at highest risk. Historic practice had been to treat
the
majority
of
oilseed rape sown and
the
industry has collected limited data by which to identify those areas at most risk
of
crop and yield loss.
iii) The
proposal to limit
the
use
of the
product to Suffolk would only partially target
the
most "at risk" areas as it would include fields in Suffolk that are not at risk but omit high risk areas beyond
the
county's boundaries. However,
the
size
of the
area proposed and
the
stewardship arrangements (with
the
additional data collection specified below) were considered to meet
the
criteria
of
being "limited and controlled".
iv) Any authorisation should be limited instead to the
total volume
of
seed that may be treated.
The
applicant and authorisation holders must then aim to ensure within prevailing constraints, that such seed is distributed in such a way as to target areas
of
highest risk, while also maximising
the
quality and quantity
of
data that can be generated to better inform future assessment
of
benefits and risk.
v) The
Committee advised Ministers that it supported
the
requested applications without
the
proposed county restriction.
The
authorisation should, however, be restricted so that only sufficient seed to plant 31,700 hectares (equivalent to 5%
of the
OSR crop in England) (or by weight 127,000 kilograms or 127 tonnes
of
seed based on
the
applicant's stated sowing rate
of
4 kilograms per hectare) may be treated with
the
applicant ensuring this is distributed to
the
areas considered to be at highest risk.
The
authorisation should also be conditional upon appropriate stewardship and
the
generation
of
data by
the
applicant to augment
the
evidence base in this area.
"Recommendations: That you:
- note
the
assessments by
the
Health and Safety Executive (HSE) and
the
UK Expert Committee on Pesticides (ECP). As summarised in paragraphs 5 and 6, both bodies now support
the
granting
of
emergency situation authorisations, on terms which are slightly different from those in
the
NFU's revised case;
- agree that
the
applications for emergency situation authorisations should be granted on
the
basis proposed by
the
ECP (discussion on
the
options is at paragraphs 7 to 10); and
- agree
the
proposed Comms lines (paragraphs 11 and 12)."
The
"3.The
NFU submitted on 30 June 2015 a revised case (
the
core document is at Annex 2) to support new applications for emergency authorisation to allow
the
use on oilseed rape
of
Cruiser OSR and Modesto, which contain restricted neonicotinoids.
The
main elements
of the
revised case are:
- The
emergency situation authorisation would only allow use in Suffolk. This means that it covers a much more limited area – around 5% (33,000 Ha)
of
England's OSR crop area
of
634,000 Ha.
- The
NFU have sought to justify this area as having
the
greatest need for
the
product because
of the
danger to crops.
- The
NFU propose to translate
the
proposed area limit into a maximum amount
of
treated seed
of
132,648kg (sufficient to treat
the
Suffolk OSR area at a planting rate
of
4kg/Ha).
- Customers sign a stewardship agreement at
the
point
of
purchase, stating
the
exact usage restrictions granted for appropriate use.
- Rape seed is provided to growers in bags
of
approximately 8kg, with labelling to indicate that
the
product is only approved for use in Suffolk.
- The
details
of
all those purchasing treated seed to be kept by those selling directly to
the
grower or to seed retailers. All sales information to be held for a minimum
of
12 months and made available on request.
- All retailers
of
treated OSR seed would also be required to record:
the
location
of
grower and intended planting area;
the
number
of
units sold; information on variety and seed treatment information; and a BASIS-qualified agronomist's recommendation for treated seed in each field where
the
products may be used.
4.The
choice
of
Suffolk is based on Cabbage Stem Flea Beetle (CSFB) county trials data, which indicate that Suffolk showed
the
highest level
of
leaf area loss at
the
3-4 leaf stage (64%) out
of the
14 counties tested. Suffolk also showed high levels
of
CSFB larvae and levels
of
Turnip Yellows Virus in OSR were also above
the
English average.
The
NFU also noted that specifying Suffolk would simplify
the
control
of
seed distribution and provide a clear area
of
comparison with neighbouring untreated areas
of
high threat. This is potentially useful – a limited authorisation like this would provide a good opportunity to evaluate
the
efficacy
of
neonicotinoids relative to other treatments.
5. HSE, asthe
regulator, carried out an initial assessment
of the
revised case (Annex 3). HSE concluded that, despite
the
justified needs and targeted approach set out above,
the
applications did not meet
the
precondition in article 53
of
Regulation 1107/2009 as being for 'limited and controlled use'. This was because they would include areas which are not at highest risk whilst excluding some which are.
6.The
applications were considered by
the
ECP on 7 July.
The
ECP's advice is set out in full at Annex 4.
The
Committee advises Ministers that it supports authorisation on
the
basis
of the
NFU applications but without specifying that use must be in Suffolk (they consider that such a restriction would only partially target
the
areas most at risk). Instead, they propose that
the
authorisations should be restricted so that only sufficient seed to plant 31,700 Ha (equivalent to 5%
of
OSR crop in England) (or by weight 127 tonnes
of
seed based on
the
applicant's stated sowing rate
of
4kg/ha) may be treated.
The
applicant should be required to ensure that this is distributed to
the
areas considered to be at highest risk.
The
authorisations should also be conditional upon appropriate stewardship and
the
generation
of
data by
the
applicant to augment
the
evidence base in this area. HSE regard
the
ECP recommendations as addressing their concerns about
the
NFU applications. Ian Boyd is also content to accept
the
applications (his note in Annex 5)."
Grounds of
Challenge
i) That no proper consideration was given by the
defendant as to whether
the
risk posed to oilseed rape was an emergency such as to justify authorisation;
ii) That no consideration was given as to whether the
risk posed could be contained by any other means; and
iii) That there was no compliance with the
requirement that
the
authorisation should be limited and controlled.
Ground One: Was the
risk posed by an emergency situation such as to justify authorisation
of the
neonicotinoids?
"7.The
current system for growing winter OSR has been developed under
the
assumption that chemical pest controls are widely available. This means that it would be reasonable to predict widespread damage to crops should these chemicals be withdrawn from use. However,
the
application comes at a time when
the
crop has not yet been harvested so judgements about
the
end point costs in terms
of
both yield and profit cannot be made."
"The
information gathered from these trials will be absolutely essential as evidence for need for future seed treatments and hence it is vital that they are successfully completed to ensure that any future applications are considered by
the
regulators. Without enough growers taking part,
the
case for future EUAs will be severely compromised."
Ground Two: Was there a failure to consider non-chemical alternatives?
Ground Three: Whether the
use
of the
restricted pesticides was "controlled"?
Submissions of the
Defendant and Interested Party
"2.The
UK Expert Committee on Pesticides (ECP) considered that
the
original applications from
the
National Farmers Union (NFU) for
the
products Cruiser OSR and Modesto did not meet
the
requirements for emergency situation authorisation. It was highly likely that some growers would have a strong need for
the
seed treatments and so there appeared to be 'a danger which cannot be contained by any other reasonable means'. However,
the
application did not provide a good basis for identifying these growers.
The
application – covering 79%
of the
English oilseed rape cropping area and with no real proposed stewardship – was also not 'limited or controlled' as required in order for such an authorisation to be granted."
The
"8. As set out in paragraph 6, expert advisers consider thatthe
tests set out in EU legislation are largely met by
the
revised case submitted by
the
NFU.
The
requested authorisations are sufficiently limited and controlled and address a danger which cannot be controlled by any other reasonable means. HSE and
the
ECP feel that
the
adjustment to
the
terms
of the
authorisations suggested by
the
ECP is helpful in matching use to areas
of
strongest need (recognising that
the
available scientific data does not allow this to be done with precision). It would not prevent
the
NFU from operating
the
authorisations in
the
manner they originally proposed if they consider that this is an effective way
of
targeting treated seed to where it is needed."
The
"It is CRD's overall view that, despitethe
justified needs and targeted approach set out above
the
applications do not meet
the
criteria in Regulation 1107/2009 as being for 'limited and controlled use' since they would include areas which are not at highest risk when excluding some which are. We expect that an area in excess
of
5%
of the
total sown area
of
oilseed rape is likely to meet
the
criteria across
the
county as a whole but
the
applicant has not demonstrated how those areas might be targeted."
It then posed the
question "Does
the
ECP consider
the
emergency authorisation under
the
requirements
of
Regulation 1107/2009 would be appropriate in
the
circumstances outlined in this paper and
the
attached applications?"
"There is a critical lackof
chemical control options except foliar pyrethroid sprays to which resistance has now developed in
the
UK.
The
2014 autumn season was both particularly favourable to cabbage stem flea beetle and coincided with a period
of
unfavourable conditions for crops drilled during mid-August and mid-September in some regions. This combination
of
factors led to
the
failure
of
5%
of the
national crop at establishment, but
the
effects were localised in 'hotspot' areas. Regardless
of
this
the
underlying issue
of
pyrethroid resistance is likely to spread and
the
build-up
of
populations not controlled by pyrethroid foliar sprays season by season will cause increasing problems in
the
medium to long term. …Further losses in terms
of
total yield may yet occur as a consequent and current presence
of
high larval populations which will damage
the
plants further. This was in part due to a combination
of
conditions, but also
the
confirmed presence
of
pyrethroid resistant CSFB populations in
the
local hotspot. Currently pyrethroid foliar sprays are
the
only chemical control option. In
the
UK, uniquely at present, metabolic mechanisms have been identified and these are
the
primary cause
of
loss
of
field performance."
"The
case for early drilled crops and high risk from CSFB is accepted.
The
rationale for
the
use
of
seed treatments lies in their inherent practical advantages over foliar sprays. They provide available protection at
the
time
of
sowing to
the
emerging seedling at
the
critical time
of
crop establishment. Seedlings are most vulnerable to pest damage in their growing tips and first true leaves. Providing protection at this point allows
the
plants to develop and grow away from this susceptible stage. In
the
worst case situations, insufficient crop establishment may lead to crop failure and subsequent redrilling. Population build up can also lead to impacts on final yield."
"Funding an alternative to pesticides and pesticides resistances remained a significant proportionof the
DEFRA pesticides research and development expenditure. There is also work in other government research programs relevant to
the
development
of
integrated approaches such as on identification
of
genetic resistance and tolerance to pests and diseases and work to inform and develop integrated control systems. However there are no other viable control methods at present."
Discussion and Conclusions
Ground One
Ground Two: Whether there were any other reasonable means?
"There is a need to control this pest and there were no suitable plant protection products available, with no other insecticide seed treatments and only pyrethroid foliar sprays. There is a developing resistance in CSFB to pyrethroid insecticides but with no alternative chemicals authorised it is likely pyrethroid usage will continue and heighten resistance pressures. Using cultural methods, for example sowing at times to avoid peak CSFB activity, can be a successful option. However, this is dependantof
a complexity
of
agronomic, environmental and practical factors during
the
season. Hence
the
requirement
of the
regulation that there is a danger which cannot be contained by any other reasonable means was considered to be fulfilled."
Ground Three: Was the
authorisation "limited and controlled"?
"The
Authorisation Holder is required to keep records(location
of
grower and intended planting area, units
of
treated seed sold, variety and seed treatment, information and a copy
of the
BASIS qualified agronomists recommendation for each field to be planted)
of
all sales made and all product supplied under
the
terms
of
this Authorisation. These records should be compiled and summarised into a report with analysis
of
where
the
seed has been used.
The
raw data and summary report must be provided to
the
Chemicals Regulation Directorate (CRD)
of the
Health and Safety Executive (HSE) within 6 weeks
of the
expiry date
of
this Emergency Authorisation.
This authorisation is conditional upon all purchasersof
treated seed accepting and signing a copy
of the
agreed stewardship plan. These documents must be retained and be made available to
the
Chemicals Regulation Directorate (CRD)
of the
Health and Safety Executive (HSE) within 6 weeks
of the
expiry
of
this authorisation.
This authorisation is conditional uponthe
Authorisation Holder using
the
authorised area to generate robust, detailed data on both treated and untreated crops.
The
nature
of
this data to be as agreed with
the
Chemicals Regulation Directorate (CRD)
of the
Health and Safety Executive (HSE) but should include impact on adult and larval numbers, crop establishment/damage and effects on crop yields, resistance occurrence and management. A system should be established to monitor trends in these factors over time that includes
the
co-ordinates
of the
treated fields. This data will be required to support any future consideration
of
an emergency authorisation
of
this product on this crop.
This authorisation is conditional uponthe
applicant and Authorisation Holder ensuring, within prevailing constraints, that
the
seed is distributed in such a way as to target areas
of
highest risk, while also maximising
the
quality and quantity
of
data that can be generated to better inform future assessments
of
benefits and risks."
Other Matters
Conclusion