From recommendation to regulation: From recommendation to regulation: Experience of the EU Standing Committee Experience of the EU Standing Committee

on Plant Healthon Plant Health (Harmful organisms) (Harmful organisms)

Paul BartlettPlant Health Consultancy Team, Defra-Central Science Laboratory, Sand Hutton, York, UK

Marc VereeckeChair of SCPH, European Commission, Brussels, Belgium.

Francoise PetterDeputy DG, European and Mediterranean Plant Protection Organisation, Paris, France.

International Plant Health Risk Analysis workshop 24 - 28 October 2005 Niagara Falls, Canada

What is Pest Risk Analysis for?What is Pest Risk Analysis for?

To convince decision makers that regulation of a pest is justified (or not);

To give them guidance on suitable, proportionate, Phytosanitary Measures;

It is not easy to do.

Risk assessment better done;

Insufficient on risk management.

This is an overview of recent European experience.

European experienceEuropean experience

PRA developed over many years,

Necessary because: Speed of trade movement; Large increase in bulk imports of planting material; Too many pests establishing which had not been

serious in endemic areas – For example

Essig’s lupin aphid (Macrosiphum albifrons) Western flower thrips (Frankliniella occidentalis) Silver leaf whitefly (Bemisia tabaci)

Other drivers for change Other drivers for change

Government role for Crop protection changed;

Agreement on initiation of PRA for interceptions;

WTO-SPS agreement of 1994;

The development of EC Single Market

Structure of EC legislationStructure of EC legislation

In primary legislation

Articles – main legislation on a Plant Quarantine system;

Annexes – the Phytosanitary Measures.

In secondary legislation Implementing Directives; Derogations.

Structure of EC legislationStructure of EC legislation

In primary legislation

Articles – main legislation on a Plant Quarantine system;

Annexes – the Phytosanitary Measures.

In secondary legislation Implementing Directives; Derogations.

Annexes of legislationAnnexes of legislation

I – Regulated organisms;

II - Regulated organisms associated with host;

III – Prohibitions;

IV – Phytosanitary Measures;

V – Certificate requirements.

How is this done in EuropeHow is this done in Europe

ECEC

EPPOEPPOWTO- SPS IPPCWTO- SPS IPPC

Member Member State/ State/ CountryCountry

Role of EPPO in Pest listingRole of EPPO in Pest listing

47 Member Governments

Alerted to new risk developing:Alerted to new risk developing:Alert list Alert list ((a summary datasheet) a summary datasheet)

Why alert; Why alert;

Where is it found; Where is it found;

On what hosts; On what hosts;

Damage; Damage;

Dissemination;Dissemination;

Pathway; Pathway;

Possible risks; Possible risks;

Sources of information.Sources of information.

EPPOs role in PRAEPPOs role in PRA

Specialist Panels may develop PRA; ‘Phytosanitary Measures Panel’ harmonises these; Approved by the ‘Phytosanitary Regulations Working

Party’ and ‘EPPO Council’ Standardised implementation

PR Assessment scheme (EPPO, 1997 & EPPO, 2002); More recently PR Management scheme been developed; Forces consideration of each potential pathway (EPPO,

2001). From 2006 a newly established Panel will conduct

PRAs (as Suffert & Petter Monday). ‘Action List’ Member Governments consider for

regulation.

EC regulations EC regulations

EC is smaller, less diverse than EPPO;

The European Commission considers the EPPO recommendations + EC specific evidence;

Proposes pest listing and accompanying phytosanitary measures to the SCPH.

European Food Standards Agency (EFSA) role in considering the recommendations of the PRA to be developed.

How is this done in the EU?How is this done in the EU?

Working Groups of experts assist the European Commission to develop proposals for regulation;

This includes selection of recommendations for phytosanitary measures;

Then report their recommendations to SCPH, ‘the decision makers’;

Following revision in plenary sessions, a regulation may be agreed and adopted.

Emerging processes in the ECEmerging processes in the EC ‘EC Annexes Working Group’ ‘EC Annexes Working Group’

Since 2003, an ‘EC Annexes Working Group’ of experts has been examining proposals for pest specific regulation;

examine recommendations from EPPO and other Member States;

a single WG means there will be greater uniformity of evaluation of the proposals;

difficulties, requires experts that have considerable breadth of knowledge; all pest organisms from viroids to invasive plants considered; the risk to many diverse crops husbanded in different ways; different environments, both natural and man made.

Choice of Phytosanitary Measures Choice of Phytosanitary Measures

Consider many different possible measures;

required for all imports and

may also be required for movements within the EC (controlled by the plant passport) ;

Choice of Phytosanitary Measures Choice of Phytosanitary Measures

selection of measures determined by statutory requirements, custom and practice;

Prohibition and post-entry quarantine not usually acceptable;

Treatments not to restrict what may be used: recognition that pesticide registrations differ worldwide and facilities for physical treatments are not universally available.

Recognise smallest justified pest free export areas for the organism;

Exceptionally area freedoms only recognised by surveillance according to EC legislation.

How to deliver to the How to deliver to the Standing Committee on Plant Health?Standing Committee on Plant Health?

Considerable, diverse information gathered from different sources and evaluated;

Must be made available to the SCPH;

An outline electronic proforma has been devised to facilitate this;

the Annexes Working Group Recommendations;Annexes Working Group Recommendations;

Attaches supporting documentation: eases the work of the SCPH; also provides a transparent justification for the proposals.

““Annexes Working Group” Annexes Working Group” RecommendationsRecommendations

The Proforma Part 1The Proforma Part 1

Harmful organism name

[with Bayer code if known & details of taxonomic position];

Present regulatory status in the EC legislation;

Information on Harmful organism, hosts & present pest status in the European Union;

““Annexes Working Group” Annexes Working Group” RecommendationsRecommendations

The Proforma Part 2 The Proforma Part 2

The Working Group recommends that the Standing Committee on Plant Health should consider amending the relevant Annexes to the Directive 2000/29/EC as follows:

[recommendation inserted]

Recommendation for listing – Annex I or Annex II;

Recommendation for Phytosanitary Measures – Annex IV A I, IV A II or IVB;

Recommendations for requirements for Phytosanitary Certificates and / or plant passports Annexes VA and VB;

Explanation of Recommendation

““Annexes Working Group” Annexes Working Group” RecommendationsRecommendations

The Proforma Part 3 The Proforma Part 3

Justifying supporting documentation.       Quarantine pests for Europe (1997) Data sheet.       Pest Risk assessment – EPPO or other      Report of a Pest Risk Assessment – EPPO or other       Pest Risk Management and or Pest Specific Phytosanitary

Regulations – EPPO      Report of a PRM/PSPR      EPPO published Diagnostic protocol      EPPO Phytosanitary Procedures      EPPO Alert       Report of discussions at Annexes Working Groups      Report of discussions at EPPO or other meetings.

Others – letters, legislation etc.

ProgressProgress

New, and evolving process; In late 2004 first recommendations prepared

for submission to the SCPH; 22 recommendations presented at the March

and April 2005 committees;

RecommendationsRecommendations

Aonidiella citrina Apple proliferation

mycoplasm Cacopsylla fulguralis Chrysanthemum Stem

Necrosis Virus Ciborinia camelliae Dendrolimus sibiricus Diabrotica virgifera D. v. virgifera D. v. zeae Dryocosmus kuriphilus Fusarium foetens Impatiens necrotic spot

virus

Leveillula tauricaMonilinia fructicolaParasaissetia nigraPaysandisia archonRhynchophorus ferrugineusRhynchophorus palmarum Scrobipalpopsis (Tecia) solanivoraStegophora ulmeaThrips australisXanthomonas axonopodis pv.

Dieffenbachiae

ProgressProgress

The recommendations varied. For example:-

simple, that no regulation was justified;

to transfer the pest between annexes (as recognition pest now established in part of the EU) with additional Measures certified by plant passports;

New listings with additional phytosanitary certificates and associated measures required.

Now with the European Commission and the first proposals are emerging for SCPH

Recording uncertaintyRecording uncertainty

Developing this process has highlighted some difficulties with using information, recommendations and ISPMs;

Especially ensuring the risk management options are appropriate and proportionate;

Important to ensure that data sheets and risk assessments record:

when there is a lack of information or

when it is known that something does not happen.

The EPPO PRA scheme emphasises the first and indicate when further research is needed;

Risk Managers needs –Risk Managers needs –known unknowns and known nos!known unknowns and known nos!

Guidance when negative information is known;

Pathway analysis is the key to selecting Phytosanitary Measures;

When a pathway cannot or does not exist, this must be recorded. NOT ‘goes without saying’

For example, that the fruit of a virus infected plant may never be infected.

an organism may not be truly seed-borne but, can it contaminate a seed?

If omitted an uncertainty may result in recommending unsuitable Measures.

Risk Managers needs – Risk Managers needs – Economic evaluationEconomic evaluation - crop husbandry - crop husbandry

Also required in the assessment report is an evaluation of the husbandry of crops;

Can be relatively straightforward:

Tomato evaluationTomato evaluation

an important crop throughout the EU;

crop area and value is recorded; tomato pests unlikely to have

environmental consequences; BUT risks and cost-benefit

analysis different between; outdoor grown; lightly protected crops of the south; glasshouse, heated, crops of

the north.

Pepino mosaic virus

Liriomyza huidobrensis

Maize Maize (Zea mays) (Zea mays) evaluationevaluation More complex example. very different values and uses in

Europe. when used for animal feed, may

be fed whole cob; whole plants finely chopped; off cob as grain maize; or as direct pasture feed.

for human consumption may be off or on the cob; with very strictly controlled inputs

for baby food.

also planting and harvesting times vary - this affects the biology, and thus the risk, of most pest organisms.

Tree evaluationTree evaluation

Evaluation more complex when plant has both amenity and environmental uses,

For example trees.

Horse chestnut (Aesculus hippocastanum) Horse chestnut (Aesculus hippocastanum)

• an amenity tree, an amenity tree,

• of considerable benefit in streets and of considerable benefit in streets and parks.parks.

Sweet chestnutSweet chestnut(Castanea spp.)(Castanea spp.)

timber, coppice, fruit bearing, amenity.

Other consideration for the Risk Other consideration for the Risk ManagerManager

Considerable variation in economic, environmental and social risks may occur throughout 25 Member states

A key challenge in developing PRAs valid for the whole EU.

These examples all illustrate the difficulties of conducting PRA for an enlarging EU, as discussed by Baker (on Tuesday).

Completing the LoopCompleting the Loop

In Europe has been recognised that these experiences are fed back into the Risk Analysis process;

Therefore the development of the EPPO Risk Assessment and Risk Management procedures is dynamic (as explained by Muriel Suffert on Monday).

Finalising the decisionFinalising the decision

Completion of a report on the PR Analysis is not finalisation. A formal consultation process about the PRA which actively

involves advisors, growers and administrators is then invoked;

Before new regulations agreed an analysis of costs and benefits presented as a regulatory impact assessment.

When impact high, RIA can be detailed with several scenarios to be evaluated (MacLeod on Tuesday).

If cost of measures to government, importers or exporters, disproportionate to the risk, then SCPH can ask whether a less demanding Phyto measure will provide adequate safeguarding.

Final difficultiesFinal difficulties

Broadening of consultation hampered by need for swift introduction of justified

regulations and the diminishing number of specialists available

to provide the independent analysis that recommendations demand.

Introduction of specialised and practical ISPMs may help, but only if they permit sufficient flexibility of implementation and they address the priority organisms.

‘‘Regulated Non-Quarantine Pests’Regulated Non-Quarantine Pests’

Not considered in this paper;

Have begun consideration by both EPPO and the EC;

Actively gathering information on Regulated pests already present in EU;

Not hide that linkage to PfP is causing considerable difficulties.

EC LegislationEC Legislation

Development & introduction of legislation is a transparent process;

Follows the WTO-SPS procedures;

Also new regulations, minutes of the SCPH and legislation all available via the Internet. http://europa.eu.int/comm/food/plant/index_en.htm.

ConclusionsConclusions

A ‘work in progress’; The process both within EPPO and at EC SCPH

evolves; Number of organisms already ‘in-train’ is daunting; EPPO has either:-

approved for the Action list; on the Alert List; or at in-between stages.

Others in EC: limited derogations; subjects of new emergency action.

AcknowledgementAcknowledgementss

Many colleagues located in diverse parts of Europe are responsible for PRAs, PRMs and their evaluation.

The membership of EPPO Panels is on their website.

The considerable assistance of the expert members of the ‘EC Annexes WG’, Ingrid Akesson (Sweden), Hanna Baginska (Poland) Franco Finelli (Italy), Lieven van Herzele (Belgium) Michal Hnizdl (Czech Rep), Nico Horn (Netherlands), Vlasta KnapiČ (Slovenia), Claira Pacheco (France), Consuelo Perez (Spain), Gritta Schrader (Germany).