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Consumers, Health And Food Executive Agency Better Training for Safer Food Initiative Food and Veterinary Office (FVO) BTSF Audits on Plant Health and Plant Protection Products in Third Countries Demetrios Fragoyiannis European Commission Food and Veterinary Office Rabat, Kingdom of Morocco 8-12Dec 2014

7.D1 Food and Veterinary Office missions SANCO - CropLife · Consumers, HealthAnd Food ExecutiveAgency European Commission •33 Directorates-General, including DG Health & Consumers

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Consumers, Health And Food Executive Agency

Better Training for Safer FoodInitiative

Food and Veterinary Office (FVO)

BTSFAudits on Plant Health

and Plant Protection

Products in Third

Countries

Demetrios Fragoyiannis

European Commission

Food and Veterinary OfficeRabat, Kingdom of Morocco 8-12Dec 2014

Consumers, Health And Food Executive Agency

European Commission

•Is the European Union's (EU) executive body

•Represents the interests of the EU as a whole

•Key roles of 'initiative' – proposes legislation - and

'Guardian of the Treaties' – enforces EU Law

http://ec.europa.eu/about/index_en.htm

Consumers, Health And Food Executive Agency

European Commission

•33 Directorates-General, including DG Health &

Consumers – DG SANCO: as from 1/1/2015 DG Health &

Food Safety, DG SANTE

•Acting director Mr Ladislav Miko

•2 Directorates in DG SANCO directly responsible for plant

health and plant protection products

http://ec.europa.eu/dgs/health_consumer/index_en.htm

Consumers, Health And Food Executive Agency

EC - DG Health and Consumers - Directorate E

Food Safety / Director Mr Eric Poudelet

•Responsible for policy relating to plant health and plantprotection products (PPP): legal measures to minimiseplant health risks (limits on TC interceptions) and risksemerging from increased PPP residues;

•Chairs the Standing Committee for Plants, Animals,Food and Feed (SCoPAFF) and its sections ofPhytopharmaceuticals - Pesticide Residues, PlantHealth, Animal Health and Welfare etc.

•Chairs task specific Working Groups (e.g. WG on Reducedfrequency of inspection at import)

•Represents the EU in international organisations as EPPO.

Consumers, Health And Food Executive Agency

EC - DG Health and Consumers - Directorate F

Food and Veterinary Office (FVO) / Director Mr MichaelScannel: Inspection / audit office

Mission Statement: the promotion of a better quality oflife by ensuring a high level of protection of consumer’shealth, safety and economic interests as well as of publichealth;

Audits in MS and in TC (incl. audits for EU enlargement):Production and follow-up of recommendations;

Reporting back directly to the relevant sections of SCoPAFFand contributing to the legislative process of the EU:Publication of reports on the internet:http://ec.europa.eu/food/fvo/index_en.htm

Consumers, Health And Food Executive Agency

EC - DG Health and Consumers - Directorate F

•EUROPHYT (plant health database): Notifiesinterceptions and analyses reports of investigations andaction plans to prevent further interceptions;

•Follows the Surveillance carried out in Member States forthe detection of Harmful Organisms and the Notifications ofoutbreaks of harmful organisms;

•Chairs Expert Task Force on Response to Risks fromImports;

Consumers, Health And Food Executive Agency

The FVO

– is Based in Ireland: Grange, County Meath

– has 170 staff, including ca. 100 inspectors: veterinarians, agronomists, and experts with relevant qualifications

– runs 7 Units

– carries out audits covering a wide range of issues

Consumers, Health And Food Executive Agency

Consumers, Health And Food Executive Agency

FVO Audits

•To assure effective control systems and to evaluatecompliance with EU legislation by Member States and EUimport requirements by Third Countries

•Upon request by Third Country: for the recognition ofequivalence, pest status, provision of derogation for import ofprohibited commodities into the EU

•Follow a high-risk based approach– Third countries and EUEUROPHYT or RASFF notifications

•Auditing Systems of Production of plants for planting,fruits, vegetables, cut flowers, wood and wood packagingmaterial etc.

Consumers, Health And Food Executive Agency

FVO Audits

Annual FVO Work Programme

•250+ audits annually;

•Approximately 60% EU MS, 30% Third Countries;

•No charges, mutually beneficial;

•Auditing national control systems – not individuals;

•Facilitate trade with safe products;

•A need for BTSF and Sustained Training;

Consumers, Health And Food Executive Agency

FVO Audits in Third Countries - F4:

• Plant Health / Phytosanitary Controls;

• Pesticide Residues Controls;

• Organic Farming;

• GMOs;

• Contaminants (chemical and microbiological);

Consumers, Health And Food Executive Agency

FVO Audits•Process in line with standard audit practice: an Audit Plandefines the scope and objectives / key control points to bevisited and requests for an itinerary; A Pre-AuditQuestionnaire requires information for the optimum planningand conduct of the audit

•Start with an opening meeting – headquarters ofcompetent authorities (CA)

•Continue with visit(s) and interviews of officials/producersin regional services, border inspection posts and other controlsites within the export system (places of production, packhouses)

•Final (closing) meeting with main findings andpreliminary conclusions of the audit, the major non-compliances and the CA – comments/corrections/clarifications

Consumers, Health And Food Executive Agency

FVO Audits

•Draft report – 20 working days (10 if urgent)

•Recommendations to address shortcomings

•CA – provide comments/corrections/clarifications andan action plan (AP) to address the recommendations -25working days (10 if urgent)

•FVO – finalise report, and assess action plan – 20 workingdays (10 if urgent)

•If needed additional information/clarifications requested

•Final report, CA comments and AP published on FVOwebsite: http://ec.europa.eu/food/fvo/index_en.htm

Consumers, Health And Food Executive Agency

FVO – Plant Health: Response to emerging risks from imports

Preparation of the 'Alert list' – which should include ThirdCountry / commodity / HO combinations if interceptions,reported to EUROPHYT in the reference period exceed agiven threshold:

It is now published on DG SANCO website:http://ec.europa.eu/food/plant/plant_health_biosafety/alert_list_trade_non_eu/index_en.htm;

Standard (automatic) notification to the NPPOs of the

TCs on the alert list. Informs the TCs that the EU is

alerted due to the increase in the number of interceptions ofhigh risk commodities : the Commission expects that theCAs of the TCs take steps to improve the situation.

Consumers, Health And Food Executive Agency

FVO – Plant Health: Response to emerging risks from imports

• Harmonised additional action(s): Recommendation forintensified import inspections at EU MS level andmandatory sampling for further laboratory analysis;

• Commission letter with suggestions [Request] foradditional phytosanitary measures to be introduced bythe exporting country;

• Commission letter with specific warning about theintroduction of Commission safeguard measures,linked to thresholds, announcing introduction of "thresholdfive regime";

• Formal Commission emergency measures includingadditional requirements or a temporary import ban.

Consumers, Health And Food Executive Agency

FVO Plant Health Audits – General Priorities

•Since its establishment FVO carried out audits in 29 TCs,many of them visited more than once!

•Almost all due to EUROPHYT interceptions

•Why is there a problem?

•Are EU import requirements being complied with?

•Additional measures required?

•EU legislation is not directly applicable for TCs: theperformance of TC CAs is assessed against EU importrequirements and relevant ISPMs: Nos 7, 12, 23, 31.....

–Control system – organisational issues

–Requirements of inspection for issuing phytosanitarycertificates

Consumers, Health And Food Executive Agency

FVO Plant Health Audits – Typical Findings(1)

-Main issues are organisational:

• Poor overall control of export procedure;

• Lack of awareness or understanding of EUrequirements by operators / inspectors, combined withlimited technical information;

• High pressure to handle / export of perishable goodswithin a limited time period or during rush hours;

• Insufficient or inadequately trained staff;

-Problems on enforcement, where no sanctions areimposed in cases of fraud;

Consumers, Health And Food Executive Agency

FVO Plant Health Audits – Typical Findings(2)

During inspections carried out immediately prior to export

-Lack of appropriate documentation and traceability ofconsignments with goods destined for export:

• No inspection records or records not available / ignoredat place where phytosanitary certificate is issued;

• Incorrect additional declarations in the PCs;

-Poor inspection conditions and/or inspection facilities /equipment:

•"Traffic" problem of consignments and presence ofagents or exporters in the inspection area;

•Common problem around the world the contrastsfound during audits between different TCs;

Consumers, Health And Food Executive Agency

Consumers, Health And Food Executive Agency

Consumers, Health And Food Executive Agency

Consumers, Health And Food Executive Agency

Consumers, Health And Food Executive Agency

Consumers, Health And Food Executive Agency

Consumers, Health And Food Executive Agency

Consumers, Health And Food Executive Agency

FVO Plant Health Audits – Typical Findings(3)

During inspections carried out immediately prior to export

- Poor inspection performance due to:

• non "appropriate" sampling for visual inspection (sizeand representativeness of sample)

• non "appropriate" examination of the sample fordetection of target pests (in line with biologyrequirements for the detection of the pest)

• incorrect frequency, timing, or intensity of theinspection (not immediate)

Consumers, Health And Food Executive Agency

FVO Plant Health Audits – Typical Findings(4)

During inspections carried out at the place of production (PoP)

- Specific requirements for PoP freedom not respected(i.e. plants for planting vs. Bemisia tabaci, Citrus fruits vs.Phyllosticta (=Guignardia) citricarpa etc.)

• Inspections of places of production not performed atall (pre-export inspection not enough);

• Incorrect frequency or timing of inspections duringperiods where the presence of certain HOs is notexpressed or it is latent;

• Tracing back and forward system non reliable orabsent.

Consumers, Health And Food Executive Agency

Consumers, Health And Food Executive Agency

FVO Plant Health Audits – Typical Findings(5)

Action taken if a pest found during internal interceptions /rejections:

•Often only the infected product or box is excludedfrom export, instead of the whole lot;

•The remaining part of the lot is considered free: not inline with ISPMs – and a gamble (to be detected or not inthe EU BIPs);

•Findings not internally communicated within officialservices (i.e. from the authorities at PoE to the PoP);

•Risk commodities not identified leading to aseasonality of pest findings

Consumers, Health And Food Executive Agency

FVO Plant Health Audits – Typical Findings(6)

Action taken in response to international non-compliancesand interceptions:

•No systematic follow-up;

•Not all the services / stakeholders / operatorscommunicated of the event;

•Lack of review of the export inspection system andits effectiveness;

•Absence of corrective actions.

Consumers, Health And Food Executive Agency

Pesticide Audits to Third CountriesGeneral Priorities and Scope

RASFF: Notifications for pesticide residues in EU RapidAlert System for Food and Feed

Trade: volume of imports into the EU

Import control data: Regulation (EU) 669/2009

MS control data: compiled in report of EFSA (EuropeanFood Safety Authority)

• To evaluate the control systems for pesticide residues infoodstuffs of plant origin intended for export to the EU.

• To evaluate the control systems for marketing and useof plant protection products (PPPs)

• Legal Basis: Regulation (EC) No 178/2002; Regulation (EC)No 882/2004; Regulation (EC) No 852/2004; Regulation (EC)No 396/2005.

Consumers, Health And Food Executive Agency

Pesticide Audits in Third Countries

Consumers, Health And Food Executive Agency

Egypt 2007, 2010

Kenya 2007, 2013

South Africa 2006, 2014

Morocco 2006, 2011, 2013

Consumers, Health And Food Executive Agency

For food of non-animal origin:

Third Country approval or export certification for PPP residuespurposes is not required under EU legislation;Imports of the food into the EU are allowed upon theguarantees offered by the importer;Importer has to ensure compliance with requirements ofEU law or with equivalent conditions;EU legislation does not contain specific requirements inTCs for pesticide controls in fruit and vegetables;The competent authorities are, however, the naturalcontact points of the EU;The reports contain recommendations to the competentauthorities.

Pesticide Audits to Third Countries

Consumers, Health And Food Executive Agency

Meetings and visits in Third Countries

• Competent authorities (central

and in 2 regions);

Pesticide residue laboratories.

Consumers, Health And Food Executive Agency

Meetings and visits in Third Countries(2)

• Growers of produce involved in RASFF

notifications;

• Retailers of plant protection products;

• Pack-houses for fruit and vegetables

Consumers, Health And Food Executive Agency

Systems are in place for the authorisation of plantprotection products (PPPs);

Many of the PPPs authorised in TCs can't be marketedand used in the EU;

Their authorised use can cause residues in excess of EUMRLs and EU RASFF notifications;

Systems in place for official controls of retailers ofPPPs in accordance with national legal provisions;

Formulation analyses regularly performed (howeverthere is a variation: due to limited or no controls in somecountries)

Results – authorisation of plant protection products (PPPs) / Controls of PPP retailers

Consumers, Health And Food Executive Agency

How can I apply pesticides and be in line with EU MRLs

Consumers, Health And Food Executive Agency

… and my products not being

intercepted in the EU due to the

presence of pests?

Consumers, Health And Food Executive Agency

Official controls of growers only in some TCs;

Private controls, especially on large producers:

Certification to private GAP standards

Advice on pesticide usage for EU market and private sampling through exporters and EU retail chains

Producers keep records of pesticide uses.

Pack-houses generally registered;

Traceability is generally in place, often back to theplot/orchard;

Generally good follow-up of EU RASFF notifications byauthorities.

Results – controls of growers, packhouses and RASFF follow up

Consumers, Health And Food Executive Agency

Sampling programmes not in all TCs and often focus ondomestic market;

Sampling generally in line with Dir 2002/63/EC =CAC/GL 33/1999;

Export controls performed by some TCs;

Labs often accredited to ISO 17025, but scope ofaccreditation is small;

Rarely use of LC-MS/MS for pesticide residues;

Analytical screen generally small (often < 50substances), and does not include important pesticidesused by growers and notified in RASFF system.

Controls by official laboratories mostly not effective

Results– sampling for pesticide residues /

Official Laboratories

Consumers, Health And Food Executive Agency

We could do more if we used

LC-MS/MS

Consumers, Health And Food Executive Agency

1.Official pesticide controls focus mostly on compliancewith national rules, which differ from EU legislation,and official laboratory control is ineffective.

2.Authorisations of PPPs in TCs are not aligned with EUMRLs, and growers producing for export to the EUmust be informed on Good Agricultural Practices inline with EU MRLs.

3.Such information is often provided by pack-housesand exporters, and their self-control systems canensure compliance with EU MRLs.

4.Main Problems in areas without strong privatesector.

5.Co-operation between authorities and private sectorimportant.

Conclusions of pesticide audits in TCs

Consumers, Health And Food Executive Agency

Increased levels of import controls (Regulation669/2009) by DG SANCO: e.g. Kenya, Egypt andMorocco;

Further safeguard measures (e.g. export certification)possible in exceptional cases (curry leaves and okrafrom India).

Further EU Measures for non-compliance

Consumers, Health And Food Executive Agency

Any questions?