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SCEPTRE Conference
Tuesday 24th February 2015
Kingsgate Conference Centre, Peterborough
Working Towards a Global Regulatory Program for Minor Uses.
Thanks for bringing your frustration to my attention. Thanks for bringing your frustration to my attention.
Minor Use Pesticide Problem
The IR-4 Project
Established in 1963 by the United States Department of Agriculture to provide a solution to the “Minor Use Problem”.
USDA ARS
USDA CSRS
SAES
AGRICHEMICALS INDUSTRY
EPA IR-4 Consumers
Research Objective 1
Food Crop Program • Initial objective, remains “Signature” objective
• Mostly Guideline Magnitude of Residue studies
• Some efficacy & crop safety
• Crop Grouping Expansion
• Harmonization of MRLs and international activities
Slide 101
Research Objective 2
IR-4 Ornamental Program
• Predominantly crop safety testing and efficacy, including invasive pests allowing industry to expand registrations (Open Labels)
Research Objective 3
• Develop data to support biopesticide registrations with emphasis on integration of biopesticide into conventional systems
– Resistance Management
– Residue Management
• Support for organic markets
• Plant incorporated protectants
Biopesticide & Organic Support Program
• Expand registrations for existing PHP
• Facilitate registrations for new technology and novel pesticides
• Register products outside US to protect deployed US military personnel
Research Objective 4
Public Health Pesticides
International Harmonization
Major Export Flows which drive need for harmonized MRLs
Asia NAFTA
S. America
Aus/NZ
Europe
Africa
Russian Fed
5.0
3.0
.01
1.0
0.6
3.5
.04
.05
.02
MRL Reality for Grower-Exporter
MRL Harmonization: Grower-Exporter’s Ideal World
0.5
0.5
0.5
0.5
0.5
0.5
0.5
0.5
0.5
Why have MRLs become more of an issue?
With the increased international trade:
• there has been an increased amount
of testing by importing countries.
• more governments setting their own
MRL standards / less use of global
(Codex) process
• show their populace that they are protective
The lack of harmony/lack of MRLs is constraining the use of new plant protection materials, which is a hurdle to international trade
IR-4’s International Activities
• Canada
• Support Existing Tolerances
• IR-4 Leadership
• Capacity building
• Research
NAFTA “Win-Win” Model
• Cooperative research with Canada started in 1996/Major funding and expansion in 2003
• Mutual projects conducted jointly on both sides of the border – Seamless process
• Reduced data needs of each country (zoning)
• Supported by EPA/PMRA joint reviews and workshare – SUCCESS!
IR-4’s International Activities
• Canada
• Support Existing Tolerances
• IR-4 Leadership
• Capacity building
• Research
IR-4’s International Activities
Support Existing Tolerances • Mine IR-4 archives for data & submit reports
to international bodies (Over 100 reports
submitted to JMPR, EFSA, & other Reg.
Authorities)
• Supplement existing data with new data that
meet international requirements
• Run new IR-4 domestic research programs
with “eye” on international data
requirements
IR-4’s International Activities
• Canada
• Support Existing Tolerances
• IR-4 Leadership
• Global Minor Use Summits
• Codex (e.g. Crop Groups)
• OECD
• Capacity building
• Research
2nd Global Minor Use Summit
• Global needs database and data sharing database – Global Workshop SEPTEMBER 20-22, CHICAGO, U.S.
– Encourage Import MRLs – white paper/survey?
– Efficacy data – EPPO guidance etc.
• Capacity development – Training and data generation
– JMPR support
– USDA-FAS – global data development project
• Communication – Website – updates (www.gmup.org)
– Incentives
– Value of Codex Standards
– Risk/Benefit assessment communication
Crop Group Enhancements
Multiyear Joint Project lead by IR-4 involving EPA, Canada, International Crop Grouping Consultants Committee (ICGCC) & Codex to evaluate Crops Groups/extrapolation: – Harmonization of Crop Groups/extrapolation is a goal to
support global trade
– International input in developing crop groupings/add new crops to existing groups and/or new groups/subgroups
Crop Group NAFTA Codex Type (Codex)
Berry & Small Fruit Group
Codified Adopted Fruit
Pome Fruit Group Codified
Adopted Fruit
Citrus Fruit Group Codified
Adopted Fruit
Stone Fruit Group Codified
Adopted Fruit
Tropical Fruit Groups
Review complete
Adopted Fruit
Fruit type
Crop Group NAFTA Codex Type (Codex)
Bulb Vegetable Codified Step 7 Vegetable
Fruiting Vegetable Codified Step 7 Vegetable
Stalk, Stem and Leafy Petiole
Review complete Step 7 Vegetable
Leafy vegetables Review complete Step 7 Vegetable
Brassica Head/Stem Vegetable
Review complete Step 7 Vegetable
Root/Tuber Vegetable Submitted Step 5 Vegetable
Edible Fungi Group Codified Step 7 Vegetable
Legume Vegetables Submitted To be submitted Vegetable
Cucurbit Vegetable To be submitted To be submitted Vegetable
Vegetable type
Crop Group NAFTA Codex Type (Codex)
Tree Nut Group Codified Step 7 Nuts and Seeds
Oilseed Group Codified Step 7 Nuts and Seeds
Tropical trees and shrubs for Bev and sweets
NA To be submitted
Nuts and Seeds
Herbs and Spices Submitted Step 7
Herbs and Spices
Cereal Grains To be submitted To be submitted Grasses
Forage/Fodder/ Straw of Cereal Grains
To be submitted To be submitted Grasses
Grasses for sugar or syrup
To be submitted To be submitted Grasses
Other Commodity Types
IR-4’s International Activities
• Canada
• Support Existing Tolerances
• IR-4 Leadership
• Capacity building
• Research
Project
Coordination
Asia
Africa
Latin America US, others???
JMPR joint submission
Funding from STDF *contributions from
manufacturers, USDA, FAO, others
Tropical Fruit Residue Study
Why is IR-4 Involved Vision of global network of capable minor use programs/regional hubs
– Help establish and mentor these minor use programs
– Partner with other data development groups
Capacity Development
IR-4’s International Activities
• Canada
• Support Existing Tolerances
• IR-4 Leadership
• Capacity building
• Research
• Global residue studies
• Tomato
• Blueberry
• The purpose of the Global Residue study is to compare residues of 4 chemicals on tomato across a wide variety of geographical and environmental zones.
• In order to minimize differences: – Identical spray equipment
– Test substances were pre-measured
– A training video on how to conduct the study was posted on YouTube.
• Samples included a time zero sample to measure variability other than the environment and samples were taken at 24 and 72 hours after application.
*funded by USDA TASC grant.
Global Tomato Study*
enGLOBAL RESIDUE STUDY GLOBAL RESIDUE STUDY-Tomato
27 sites in 22 countries.
CONCLUSIONS
• Calculated MRLs were similar (difference 0.1 ppm or less) across all climatic zones and continents compared to the overall MRL(Complete data set).
• Is being analyzed statistically across sample times, climate, etc.
• Publication being prepared
Slide 128
SILVANTO Blueberry Global Residue Project Status (IR-4 & PMC)
• LOWBUSH Blueberry:
– 3 trials in Nova Scotia (one decline)
– 1 trial in Maine
• HIGHBUSH Blueberry:
– 2 trials in New Jersey
– 3 trials in Michigan (one decline)
– 2 trials in North Carolina
– 1 trial in Oregon
– 1 trial in Quebec
• European trials
– 1 trial in Spain - decline
– 1 trial in Denmark
– 2 trials in the U.K. – decline
– 1 trial in Italy - decline
– Note:2 trials using “protected” crop.
• Other Sites (HIGHBUSH)
– 3 trials in Australia
– 2 trials in New Zealand
– 3 trials in Chile (one decline)
Study conducted under one protocol (one GAP), IR-4 is the Sponsor and Study Director. All samples analyzed by Bayer Crop Science Laboratory Study submitted for Global Joint Review Fall 2012. REGISTERED January 2015 _______________________________________________________
26 total field sites in 9 countries
Analysis Using the OECD MRL Calculator
NAFTA sites only
• 13 field trials
• Lowest residue 0.290 ppm
• Highest residue 2.59 ppm
• Median residue 0.834 ppm
• Mean residue 0.912 ppm
• SD 0.630
• Unrounded MRL 3.431 ppm
• Rounded MRL 4 ppm
Global data (all sites)
• 26 field trials
• Lowest residue 0.193 ppm
• Highest residue 2.59 ppm
• Median residue 0.867 ppm
• Mean residue 0.974 ppm
• SD 0.632
• Unrounded MRL 3.504 ppm
• Rounded MRL 4 ppm
Zoning (Kopper-Geiger climate map)
What’s Next?
Short-term
• Global Needs Database
• Chicago Workshop, identify priorities
• Identify solutions
• Find resources to conduct global studies.
Intermediate-term
• Next Global Minor Use Summit
• Global Minor Use Foundation
Who Benefits from IR-4
• Growers of specialty crops/specialty uses-Have tools to protect crops
• Food Processors/Food Industry-Keep supply chain open
• Society-Consistent supply of affordable and SAFE fruits & vegetables, ornamentals to enhance environment,
– IR-4 adds $7.2 BILLION/annually to the gross domestic product & support >104,000 jobs
Thank You!
Slide 136
SCEPTRE Conference
Tuesday 24th February 2015
Kingsgate Conference Centre, Peterborough
EU activities to support
speciality crops -
Minor Uses, Basic substances and Low Risk Substances
HDC SCEPTRE Conference
24 February 2015, Peterborough, UK
Jeroen Meeussen
European Commission
DG SANTE (Health and Food Safety Directorate-General)
Unit Pesticides and Biocides
• Minor Uses
• Low Risk Substances
• Basic Substances
Placing on the market of plant protection products
Regulation 1107/2009
+
• Replaced Directive 91/414/EEC
• Fully applicable since 14/6/2011
• Increased harmonisation and enhanced protection
SUBSTANCE A Approved at Community level
One decision applying to all 28 Member States
Approval
Plant protection products
(formulations) containing the substance A
Authorised at national level
Authorisation
Minor Uses (definition)
Regulation (EC) No 1107/2009:
Use of a plant protection product in a particular Member State on plants or plant products which are:
(a) not widely grown in that Member State,
• or
(b) widely grown to meet an exceptional plant protection need
Representing 22% of the value of EU total agricultural production; 3% of the cultivated area
Minor Uses
Lack of sufficient market potential can lead to:
• Illegal uses with consequences for human health and the environment;
• Loss of crop production with its economic impact on agriculture.
•
Report on Minor Uses
Article 51(9):
• "By 14 December 2011, the Commission shall present a report to the European Parliament and the Council on the establishment of a European fund for minor uses, accompanied, if appropriate, by a legislative proposal".
• Report was adopted on 18 February 2014.
•
Report on Minor Uses
Key-messages:
• Commission will assist in the creation of an independent coordination facility ("Technical Secretariat") on minor uses which is co-funded by the Commission;
• Commission will support an ERANET on Integrated Pest Management with specific reference to minor uses.
Report on Minor Uses
Report was presented to AGRI-Council on 19 May 2014:
• Strong support for the Report was expressed;
• A majority supported COM in identifying 'option 3' (co-funding of Coordination Facility) as the better solution;
• The details of the secretariat should be further discussed at technical level.
Expert-meeting on Minor Uses
Expert-meeting with COM, MS and stakeholders was organised on 1 July 2014 to discuss a draft outline of the Coordination Facility:
• Operational issues: organisation and structure;
• Financial arrangements;
• Location and facilities.
Coordination Facility (1)
• Co-funded by the Commission: grant of €350,000/year.
• This activity is led by DG SANTE.
• Budget has been allocated in the Financial Decision (OJ 18 November 2014).
Coordination Facility (2)
Tasks of 'technical secretariat':
• sharing of information and experience gained at national level;
• coordination of minor use work between Member States and stakeholders;
• creation and maintenance of a data base on minor uses;
• stimulation of harmonisation (e.g. crop group and pest group definitions, development of guidance).
IPM ERANET
• ERANETs are research coordination instruments whereby Member States can coordinate their national research activities.
• To find EU-viable solutions with a focus on IPM-practices, low risk substances and biopesticides.
• IPM ERANET has started early 2014 and involves 32 partners.
• This activity is led by DG RTD.
Coordination between CF and IPM-Eranet will be imperative.
Current status
• Adoption of the report by COM on 18 February 2014;
• Report has been presented to AGRI-Council in May 2014;
• Publication of the Financial Decision in November 2014;
• Proposal from interested party in final evaluation phase;
• Start of the technical secretariat mid 2015.
•
Low Risk Substances
Low risk substances and products
Regulation (EC) No 1107/2009
o favours the inclusion of low risk substances in PPP and
o facilitates their placing on the market
Incentives and facilitated market access
o Approval up to 15 years
o Data protection up to 13 years
o Low risk PPP: Member States to decide in 120 days
o Separate listing in Part D of the Annex to Regulation (EU) No 540/2011
o Allowed to be mentioned in advertising
Low Risk Criteria – Annex II, point 5 (1)
• An active substance shall not be considered of low risk where it is or has to be classified in accordance with Regulation (EC) No 1272/2008 as at least one of the following:
o — carcinogenic,
o — mutagenic,
o — toxic to reproduction,
o — sensitising chemicals,
o — very toxic or toxic,
o — explosive,
o — corrosive.
Low Risk Criteria - Annex II, point 5 (2)
• It shall also not be considered as of low risk if:
• — persistent (half-life in soil is more than 60 days),
• — bioconcentration factor is higher than 100,
• — it is deemed to be an endocrine disrupter, or
• — it has neurotoxic or immunotoxic effects.
• New criteria can be set Annex II, point 5
Expert group of EU-Member States, Commission,
Growers Organisations, NGOs and Industry.
3 Subgroups to discuss:
o Possible decision schemes and/or criteria for low risk;
o Active Substances essential to Organic Farming;
o New incentives to Industry.
EU-expert group on "low risk" (1)
Points for discussion:
o Different criteria for AS and PPP.
o Develop guidance.
o Differentiate between groups of active substances (e.g. chemicals, micro-organisms, semiochemicals).
o Are main substances essential for Organic Farming covered?
o New incentives related to fees, priority setting, accelerated process, no authorisation expiry date.
Aim: draft proposal by mid 2015.
EU-expert group on "low risk" (2)
Basic Substances
Criteria for identification of basic substances
Article 23(1)
o not a substance of concern;
o not inherent capacity to cause endocrine disrupting, neurotoxic or immunotoxic effects;
o not predominantly used for plant protection purposes but useful in plant protection;
● not placed on the market as a Plant Protection Product!
Basic Substances and their products Derogations
o A basic substance shall be approved for an unlimited period.
o No authorisation is needed for products containing exclusively one or more basic substances.
o The label on the product may indicate that the basic substances it contains are approved under Article 23 of Regulation 1107/2009.
Work in progress
o Working document on approval of basic substances
(SANCO/10363/2012 – rev. 9).
o Around 20 substances currently in the system.
o 3 substances have been approved (Equisetum, chitosan and
sucrose); listed in Part C of the Annex to Reg. (EU) No
540/2011.
o New applications are announced.
Conclusions
• COM will establish a Coordination Facility for minor uses in order to ensure that diversification of agriculture and horticulture is not jeopardised by the lack of availability of PPPs.
• COM facilitates the placing on the market of low-risk PPPs containing active substances that present less of a risk to human health and the environment.
• COM facilitates the approval of basic substances which are not predominantly used as plant protection products, but may be of value for plant protection.
SCEPTRE Conference
Tuesday 24th February 2015
Kingsgate Conference Centre, Peterborough
HDC Crop Protection
What Next?
IMPRESS
Jon Knight
Head of Research & Knowledge Transfer
Sustainable Crop and Environment Protection
- Targeted Research for Edibles
SCEPTRE
Needs driven
• Threatened loss of actives - 91/414/EEC
• Future threats to actives
Sustainable Use Directive
Endocrine Disrupting Chemicals
Comparative Assessment
Water Framework Directive
• Food security
• Cost of CPP Development & Registration
Actives threatened
Reason Herbicides Fungicides Insecticides Molluscicides
Changing
approvals 6 11 2 -
Water
Quality 14 3 3 1
Annex 1
review 5 9 1 1
Including
Herbicides: pendimethalin, glufosinate ammonium, asulam
Fungicides: mancozeb, chlorothalonil
Insecticides/ molluscicides : bifenthrin, chlorpyrifos, metaldehyde
Consortium
H & H Duncalfe
Value for money
• Compared to stand-alone projects,
SCEPTRE’s cost per unit was similar.
BUT
• SCEPTRE has been successful in
attracting in-kind contributions from
external sources.
20% saving to levy payers
Value for money
• Levy contribution
SCEPTRE ~ 40% of funding came from HDC
levy funds
Stand-alone projects 98% came from HDC
levy funds
• SCEPTRE represents much better value
for the levy payer i.e. ~ 60% saving
• Value for money for partners too
Delivery
• Four registrations during project life
• Pipeline product registrations
15 on label
21 EAMU
• Will continue to deliver over the next few
years
SCEPTRE Conclusions
• Industry driven and shaped
• Tactical gap-filling - Proactive not Reactive
• Cross-sector applicability
• Speedier evaluation of minor use products
• Substantial database for future use
• Effective partnership between HDC and
companies to deliver labels and EAMUs
Future Challenges
• Continued loss of actives
• IPM will require greater knowledge and its
application
• Exchange of information between
countries
• Responding to new and changing Pest
and disease threats
What next?
To Maintain or Enhance the
Competitiveness and Sustainability
of UK Horticultural Businesses
HDC has 5 priority areas
• Provide answers to crop-specific problems
identified by growers
• Identify & develop larger projects that address the
emerging big issues for horticulture
• Develop co-funding opportunities
• Knowledge transfer-identifying key R&D
messages,
• Communicating with levy payers
Crop Protection Thematic Priorities
• Industry need:
To control pests, diseases and weeds
effectively & sustainably
• HDC Strategic Priority:
To develop IPM systems for major pests
and diseases together with associated
diagnostic tests and precision
management tools.
Control of pests, diseases and
weeds by:
• Optimised use of PPPs
• Development of Plant Resistance/Tolerance
• Development of methods of pest behaviour manipulation
(Pheromones, semiochemicals etc.)
• Use of naturally occurring or introduced biological control agents
• Cultivations, rotation or other agronomic control measures
• Optimised management through in-field scanning, sensing,
diagnostics and precision systems.
• Effective and resilient pesticide resistance management
strategies
• Effective and resilient control measures and strategies to control
invasive diseases, pests and weeds.
HDC – Functional organisation
Field Crops (Cheryl Brewster)
Protected &
Perennial
Crops (Debbie Wilson)
Crop
Protection (tbc)
Resource
Management (James Holmes)
HDC Crop
Sector Panels,
HDC Board
etc.
Thematic Groups Production Groups Central
Comms
Info
& Impact
This is about
servicing the needs
of our clients:
• Levy payers
• Panels
• HDC Board
• HDC Associates
• Other AHDB
sectors
Proactive
Reactive
IMPRESS Integrated Management of Pests in Resilient Sustainable Systems
What is IMPRESS?
• The future – both for the industry and HDC
• A programme to future proof horticulture
• Managing project consortia involving public/private
investment (eg SCEPTRE funding model)
• A vehicle for panels to leverage funding on major
issues and manage long term programmes of work
including extension work
What is IMPRESS?
• Includes minor uses programmes for new PPPs
(continuing the work of SCEPTRE)
• Central management of all efficacy testing
• Exploring synergies for IPM systems
• Measurement of impacts
• Focus on forward looking proactive work – to de-
risk the future
Linking project budgets….
Strawberry pest
programme (commissioned &
funded via SF Panel)
Thematic
programme (e.g.
insecticide
efficacy) (commissioned by
Crop Protection Team,
& funded via HDC
Board)
Th
rips
on
so
ft fruit
Where two programmes overlap,
there is no need to spend the
money twice (projects do not have
to start at the same time)
What IMPRESS is NOT
• Replacement for SCEPTRE
• Not as narrowly focussed as SCEPTRE:
• Not taking away the panel process
SCEPTRE Replacement Generating EAMUs
Precision Tools & Diagnostics
Global Horizon Scanning
CROP PROTECTION R&D
KNOWLEDGE EXCHANGE - Measurement Metrics
Liaising with CP Industry
Crop Protection Tools - IPM
• Major diseases pests or issues with cross
sector concern
• Not just looking at pets in isolation (Thrips,
Aphids, Botrytis or Pythium historic
strategy)
• Looking at complete IPM strategies across
all of crop and sustainable outcomes
• Biologicals – preventative and synergies
PRECISION TECHNOLOGY
• Precision technology – Eye spot
• Diagnostic tools - prediction forecasting
(pest and weather)
• Cost Benefit Analysis needs to be
standard operating procedure when
considering programmes of work
• Post Harvest Technologies – How far do
we go?
HORIZON SCANNING
• Biological introduction of non endemic
beneficials – possibilities and practices
• Water conservation– new extraction rules on
horizon
• Future Threats - Risk Assessment - Emerging
Risks System - Industry Stakeholder Groups
Inclusion (Use of Plant Health Risk register)
HORIZON SCANNING
• Liaison/Networking with EU and Global
research facilities/organisations and industry
groups
• MOUs for sharing of information and research
outcomes
• Look to identify world leaders in specific areas
of research and include them in projects if
appropriate
Knowledge Exchange
• Mode of KE and relevance
• Publication v Practical (Field days) and
risks of electronic age
• Focus blocks –practising IPM GAP
• Training delivery e.g. training in application
of bio pesticides
• Measurement of success - Measuring
innovation and impact at an early stage
Summary
• A collaborative programme across
industry, government and AHDB with full
engagement of R&D providers
• Forward looking but with the ability to react
when required
• Utilising all the expertise available globally
when required
Horticulture is a fast-changing World
HDC is changing with it
SCEPTRE Conference
Tuesday 24th February 2015
Kingsgate Conference Centre, Peterborough
Thank you for attending