Licensing non-native biological control agents:
the English way
Biological Control in Ireland & Northern Ireland
Sarah Hugo
12th May 2011
Outline
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Legislative background
Role of Fera
Process and key players
Assessment of applications
Case studies
Issues
Wildlife and Countryside Act
1981 (WCA)
• Section 14 of the WCA 1981 prohibits the release
into the wild or allowing to escape to the wild of all
animal species which are not native to Great Britain,
whatever their proposed use
• Includes holding non-native animals in semi-confined
situations such as gardens, glasshouses, aquatic
cages
• Non-native is “of a kind not ordinarily resident in and
is not a regular visitor to Great Britain in a wild state”
WCA: Section 16
• Section 16 gives the Secretary of State
powers to grant licences for releases so that
Section 14 does not apply
• Releases of non-native animals may
therefore be licensed under the Act for
specific purposes such as:
• research, education, species (re-)
establishment, control of pests on commercial
crops, control of invasive organisms
WCA: section 16 licenses
• In England, the licensing authority for the release of a
non-native animal or listed plant species is the
Secretary of State for Defra:
• Fera is the appointed licensing body for non-native
biological control agents
• Natural England is the licensing body for all other
purposes
• Licence holders have a legal responsibility to comply
with the statutory conditions in licences
• Inspection and enforcement mechanism via Defra’s
‘Wildlife Inspectorate’ and the police
Application for a licence
• Two types of licence:
• Releaser’s licence, for experimental or species
(re-)establishment purposes
• Supplier’s and grower’s licences for commercial
release (sale and distribution)
• Applications must include information on the
organism to be released, purpose of release,
and sufficient biological data to enable
assessment of the risks and benefits
• Standard application form provided
Assessment of applications
• Fera receives and assesses all applications
• WCA guidance states “Secretary of State
may wish to take advice before granting a
licence”:
• Advice may be obtained from persons who are
members of the Advisory Committee on Releases
to the Environment
• Advice may be sought on nature conservation and
wildlife aspects from Natural England, JNCC, SNH
and CCW, and from Defra, SG and WAG
Assessment of new applications
Can the organism overwinter & establish in GB?
Yes
Applicant’s experimental evidence
‘Climex’ data
Potential risks and benefits of
the specific release
Is the organism host-specific?
Applicant’s experimental
evidence
No
Yes
Reject
No
Yes
Potential for dispersal?
Applicant’s experimental evidence
OK to licence?
Limited
Special conditions attached to
licence?
Direct &/or indirect non-target
effects?
Applicant’s experimental evidence
&/ or published data
Wider consultation needed?
Licence plus monitoring
requirements
Application to release a non-native biological control agent
Reject: not for Fera;
licence not needed;
other reason
Licensing body:
Food and Environment Research Agency
Valid application?
Completeness
check
Consultation: advice on whether licence should be issued for release
Straightforward applications and renewals
Conservation agencies
Natural
England
JNCC
Academic expert
Government advisor(s)
Jeff Bale,
University of
Birmingham
Plant health
restrictions
(Fera)
Additional expert advice may
be sought if necessary
Scotland
Wales
Licensing body (Fera)
No substantial objections
Objections / concerns &/or
Lack of agreement, &/or
High risk release, &/or
New type of release
Additional expert
advice provided
if necessary
Fera drafts and issues
licence to applicant:
• Specified period of time
• Specified restrictions for
use
• Requirements for
monitoring and reporting
Consultation process
Devolved
administrations
ACRE
advice
supports
licensing
Substantial
objections:
REJECT
Fera seeks advice from
ACRE
ACRE advice
not supportive
of licensing
under any
conditions
Application
rejected
ACRE advises
further
information
needed before
licensing could
be supported
Licensing body
requests
further info
from applicant
Information
provided
• Slide removed as it contained commercial
information about licences issued
Release of Aphalara itadori
• Classical biological control of Japanese
knotweed
• Complicated by requirement to lift plant health
licence restrictions
• Lengthy process requiring Ministerial approval
• Licence issued with phased release and strict
monitoring requirements
Application to release a non-native biological control agent
Reject: not for Fera;
licence not needed;
other reason
Licensing body:
Food and Environment Research Agency
Valid application?
Completeness
check
Consultation: advice on whether licence should be issued for release
Straightforward applications and renewals
Conservation agencies
Natural
England
JNCC
Academic expert
Government advisor(s)
Jeff Bale,
University of
Birmingham
Plant health
restrictions
(Fera)
Additional expert advice may
be sought if necessary
Devolved
administrations
Scotland
Wales
Licensing body (Fera)
No substantial objections
Objections / concerns &/or
Lack of agreement, &/or
High risk release, &/or
New type of release
Additional expert
advice provided
if necessary
Peer
review
Fera drafts and issues
licence to applicant:
• Specified period of time
• Specified restrictions for
use
• Requirements for
monitoring and reporting
ACRE
advice
supports
licensing
Substantial
objections:
REJECT
Fera seeks advice from
ACRE
ACRE advice
not supportive
of licensing
under any
conditions
Application
rejected
ACRE advises
further
information
needed before
licensing could
be supported
Licensing body
requests
further info
from applicant
Information
provided
Pre-requisite for
issuing licence
under WCA =
REMOVAL of
plant health
‘quarantine’
status
Interesting conundrums
• Amblyseius (Neoseiulus) californicus
- Predatory mite particularly effective against red
spider mite
- Licensed for many years in glasshouses only
- Reported in strawberry fields across country
- Growers want it de-regulated
• “Supernemos”
- Company selling already-licensed EPNs, but in
different formulations
- Enhanced virulence against target pests: need to
licence?
Issues to address
• Must balance regulatory burden on applicant with
scope and potential impact of release
– including requirements for post release monitoring
• Separate licenses needed for release in England,
Scotland and Wales
• Aware that process is not as visible as it could be –
improve website and links from Defra, NNSS etc
• Classical biological control – need to clarify route for
fungal agents
• Very different practices across the EU Member States
– EPPO trying to ‘harmonise’ to some degree
Thank you for listening
sarah.hugo@fera.gsi.gov.uk
+ 44 (0) 1904 462223