1. Monitoring Obligations under MRL legislation-
Helena Cooke
Policy Implementation

2. Outline of talk Why monitor? EU obligations and developments Findings
Risk assessment, risk management and RASFF
EFSA annual report

3. Why monitor ?
Identify non compliance with MRL’s
Identify possible risks to consumers
Nationally identify unexpected residues.
Aside from legal obligation - ethical obligation to determine what we actually find in our food following this regulated process

4. Relevance of Monitoring of Pesticide Residues in food.
Authorisation
Use
Monitor
This is not an academic exercise. Nationally results can lead to regulatory changes or changes in GAP. On a European basis persistent risk issues will lead to import controls.

5. The European Union: 500 million people – 27 countries
29 take part in the programme
Member states of the European Union
Candidate countries

6. Farm to Fork- integrated approach
The EU integrated approach to food safety aims to assure a high level of food safety, animal health, animal welfare and plant health within the European Union through coherent farm-to-table measures and adequate monitoring, while ensuring the effective functioning of the internal market.
The implementation of this approach involves the development of legislative and other actions:
To assure effective control systems and evaluate compliance with EU standards in the food safety and quality, animal health, animal welfare, animal nutrition and plant health sectors within the EU and in third countries in relation to their exports to the EU;
To manage international relations with third countries and international organisations concerning food safety, animal health, animal welfare, animal nutrition and plant health;
To manage relations with the European Food Safety Authority (EFSA) and ensure science-based risk management.

7. European Legislation OFFC
Official Food and Feed Control. EU Regulation 882/2004
lays down the principles to be followed for official controls to determine compliance and enforcement with food legislation.
396/2005
Regulation 396/ MRL’s for pesticides
Establishes specific and general obligations relating to pesticide residue monitoring.
915/2010
Regulation 915/2010
Requires all MS to take part in a specific co-ordinated community programme.

8. Official food and feed controls
EU Official Food and Feed Controls (OFFC) regime
Food & feed controls must be :
Risk-based, carried out regularly and at appropriate frequency
Covered by a single, co-ordinated, national control plan covering several years
Staff must be trained and competent
Laboratories must be competent and audited

9. UK NCP- Farm to Fork principles
140,000 FBO
Approximately 140,000 business in the UK - this includes farms.)

10. EU legislation requires member States to …
carry out regular official controls on pesticide residues in food commodities to check compliance with MRLs (legal limits)
establish national monitoring programmes
take part in a specific EU coordinated monitoring
take effective, proportionate and dissuasive sanctions
Submit annual results to EFSA

11. UK Risk Based Plan

12. UK Risk Based Plan

13. European programme

14. EU Coordinated control Plan Reg 915/2010
EU Co-ordinated Community Monitoring Programme for Pesticide Residues
3 year rolling programme food which constitute major components of Union diet
8 fruit and vegetable foods
1 cereal
2 food of animal origin
185 pesticides to be sought..
See handout.
The EU coordinated programme aims to provide statistically representative data regarding pesticide residues in food available to European consumers. The lots sampled should be chosen without any particular suspicion towards a specific producer and/or consignment. Thus, the results obtained in the coordinated programme are considered as an indicator for the MRL compliance rate in food placed on the European common market and allow an estimation of the actual consumer exposure. Although the participation was not mandatory in 2008, all 27 Member States and the two EFTA states participated in the EU harmonised control programme

15. Who checks that MS comply?
Commission auditors (FVO).
Within EU
Exporting
countries
Commissions auditors of MS compliance.
Inspect & report on compliance with EU food standards and OFFC requirements
EU member States AND third (exporting) countries
Shortcomings reported by inspectors
addressed by country concerned
by formal EU action

16. Findings Principle of co-ordinated programme now established.
Confidence in results, extended scope inform standards should enable a better assessment of food both grown in the community and imports from third countries.
Also require MS to take action on results.
Enable more efficient sampling and follow up but more will be required as part of the community component. If this reflects national interest this is not an issue,

17. Findings European 2008 vs. UK
EU harmonised-
UK National 2008
11,610 samples EU
70,000 national
78 pesticides sought
3.5% exceed MRL
35.7% contained residues above RL.
135 findings above ARfD
35 cases where consumer risk could not be excluded
4129
27 fruit and vegetables
240
2.1% of fruit and vegetables (1.2% overall)
45% contained residues
Some surveys targeted
13 RASFF’s
The EU coordinated programme aims to provide statistically representative data regarding pesticide residues in food available to European consumers. The lots sampled should be chosen without any particular suspicion towards a specific producer and/or consignment. Thus, the results obtained in the coordinated programme are considered as an indicator for the MRL compliance rate in food placed on the European common market and allow an estimation of the actual consumer exposure. Although the participation was not mandatory in 2008, all 27 Member States and the two EFTA states participated in the EU harmonised control programme. A higher incidence of MRL exceedances was also observed in samples imported from third countries (7.6%) than from EU (2.4%). A total number of 11,610 samples of nine different commodities (oranges, mandarins, pears, potatoes, carrots, cucumbers, spinach, beans without pods, and rice) were taken in the 2008 EU coordinated pesticide monitoring programme. These samples should be analysed for 78 pesticides (including the relevant metabolites, as specified in the legal residue definition).  2.2% of the samples exceeded the MRL, while the percentage of samples with measurable residues above the quantification level, but at or below the MRL, was 35.7%. In 62.1% of the samples no residues were detected. The overall MRL exceedance rate was comparable with the previous year rate (2.3%). It is noted that the percentage of samples without measurable residues increased from 52.7% in 2007 to 62.1% in The highest percentage of samples exceeding the MRL was identified for spinach (6.2%) followed by oranges (3.0%), rice (2.4%), cucumbers (2.1%), mandarins (2.0%), carrots (1.8%), pears (1.6%), beans without pods (0.8%) and potatoes (0.5%). Assuming a coincidence of these events (high food consumption, high residue concentration and inhomogeneous residue distribution in a lot), a potential consumer risk could not be excluded for 35 pesticide/commodity combinations. The highest potential exceedances of the toxicological reference value was indicated for dimethoate/omethoate on potatoes and spinach (10,763% and 2,938% of the ARfD, respectively), methiocarb on cucumbers (2,519%), dimethoate/omethoate on pears (1,730%) and methomyl/thiodicarb on oranges (1,644%). However, the critical intake events identified in the acute risk assessment calculations were considered very unlikely, taking into account the frequency of critical residues and the frequency of extreme consumption events. For 11 of the pesticide/commodity combinations for which a critical intake situation could not be excluded, risk management actions have already been taken by withdrawing authorisations or by lowering the MRLs.
Keywords Pesticide residues, food control, monitoring, Maximum Residue Levels, consumer risk assessment, Regulation (EC) No 396/2005
EU results are comparable to overall findings in fruit and veg surveys.

18. Compliance- UK
Recently seen spike reflects our move to targetting higher risk commodities and follow up . Only 25% were from within Europe.
yams. Indian grapes, okra. Many of them LOD’s
The majority of samples inEU survey taken were produced in one of the European reporting countries (77%), while 20% of the samples were taken from imported consignments or lots

19. Development- pesticides sought in EU programme

20. More multi-residue pesticides
ametryn
• anthraquinone
• bixafen
• chinomethoionate
• chlorbromuron
• chloroxuron
• dicamba
• dichlorprop-P
fenobucarb
• fenpropidin
• formothion
• fluroxypyr
• imazapyr
• metalumizone
• sulfotep
• topramezone

21. SRM- costs inorganic bromide maleic hydrazide glufosinate ammonium
aminopyralid
clopyralid
ethephon
glyphosate
dithiocarbamates.
SRM added to the programme eg inorganic bromide . Compliance with full residue definitions will not be easy.
Official labs that participate in official monitoring programme need to take part in EU PT, attend works shops. Increase over head
Good to raise standards throughout Europe but can add pressure with short notice amongst busy schedule.

22. SCOPE Olive oil wine (wine grapes) products of animal origin Fish ?
Animal Feed
stuffs

23. Risk assessment In the UK, CRD takes this role
Potential intakes of national consumer groups from actual detected residues, reflecting national culinary practice and diets calculated and compared with ADI and/or ARfD
This may give a different answer to PRIMO

24. Risk Assessment monitoring
EU results EFSA
UK Monitoring CRD
Uses PRIMO
European diet
97.5th percentile
Highest residue from monitoring
Applies variability factor
Determines critical consumer
Use national dietary consumption data
Acute intake model
Uses 97.5th percentile
Assumes highest residue from monitoring
Applies variability factor
Determines critical consumer
The highest residues measured (HRM) identified for each pesticide/crop combination with 11 findings above the limit of quantification (LOQ) reported by EEA and Member States (see 12 section 5.1.1). 13
Processing/peeling factor - only in case a refined calculation was considered necessary63 - for 14 those crops that normally are consumer not raw (e.g. aubergines, banana, cauliflower and 15 wheat). 16
Large portion food consumption data retrieved from the EFSA PRIMo (EFSA, 2007) 17
Unit weight for the individual food commodities (retrieved from the EFSA PRIMo, EFSA, ) 19
Acute Reference Dose values (see section 5.1.2)
Processing data used in limited scenarios.

25. Risk management The Food Standards Agency leads on this in the UK
CRD have a risk assessment and risk management role
Decisions on action to be taken on national basis:
Range of options, potentially including withdrawal
For foods traded outside the country, RASFF notification
Talk about some of the risk management issues
nicotine
Grapes

26. Follow Up Activity

27. Actions –follow up and enforcement- European level
Non compliance posing risk to consumers is followed up
Commission audits by FVO
Specific monitoring obligations in the co-ordinated plan e.g. amitraz in pears
Increased border inspection requirements for high risk food products (Regulation (EC) 669/2009)
Background to the implementation of increased border inspection for high risk food products of non-animal origin in Annex I of Regulation (EC) 669/2009.
FSA lead on this policy. So unless specifically asked this is not an issue for us to raise.
Implementation date is 25 January 2010
Justification grids have been prepared for the different import sectors. F.
The public consultation package includes draft guidance for business operators and for inspection officials on the new measures.
From a PRC perspective if these foods are included in national monitoring then we will notify the FSA if there are noncompliant samples to form part of the member state return and to enable appropriate follow up.
Fore-runner amitraz in pears situation (OFFC)
Commission expects to take action on results.

28. Rapid Alert System for Food and Feed (RASFF)
Residue above MRL
Exceeds ARfD
Send to Commission MS
Rapid Alert System for Food and Feed
Operated by the EU Commission, but some RASFF members are not EU members e.g. Switzerland
Notification sent of a range of food safety issues
For pesticides, if a residue is
over the MRL and
intakes are over the ARfD/ADI

29. RASFF portal RASFF notifications can be searched by various parameters
Useful to :
Watch progress on current issue
Research past occurrences
Published information does NOT include full details available to food safety officials.

30. Increased border controls- 669/2009 controls
acetamiprid , amitraz, acephate, aldicarb, benomyl, carbendazim, chlorfenapyr, chlorpyrifos, carbaryl, carbofuran, chlorpyriphos-ethyl ,clothianidin, cyfluthrin,cyprodinil,CS2 (dithiocarbamates), diafenthiuron, diazinon, dichlorvos, dicrotophos, dicofol, dimethoate, endosulfan, EPN, ethion, fenamidone, fenitrothion, fenpropathrin , fludioxonil, hexaflumuron, imidacloprid, lambda-cyhalothrin, malathion, metalaxyl, methamidophos, methiocarb, methomyl, monocrotophos, omethoate, oxamyl, oxydemeton-methyl, phenthoate, profenofos, propargite, propiconazole, prophenophos, prothiophos, quinalphos ,thiabendazole, thiamethoxam, thiacloprid, thiophanate-methyl, triazophos, triadimefon, triforine
Thai.
Egypt
Dom republic

31. EU (EFSA) Annual Report
Based on data from national and EU monitoring from each member State.
Contents:
Rates of compliance, including patterns by country and food
EU consumer risk assessment, using all the data supplied
Recommendations – can relate to PPP registrations as well as future monitoring
The assessment of the acute (short-term) consumer exposure was performed for the nine food commodities which were analysed under the EU coordinated monitoring programme. The assessment was based on worst-case scenarios: the consumption data for consumers who eat a large portion size of the food item under consideration were combined with the highest residue measured in the coordinated programme. In order to accommodate for a possible non-homogeneous distribution of residues in an analysed food lot a variability factor was introduced. Assuming a coincidence of these events (high food consumption, high residue concentration and inhomogeneous residue distribution in a lot), a potential consumer risk could not be excluded for 35 pesticide/commodity combinations. The highest potential exceedances of the toxicological reference value was indicated for dimethoate/omethoate on potatoes and spinach (10,763% and 2,938% of the ARfD, respectively), methiocarb on cucumbers (2,519%), dimethoate/omethoate on pears (1,730%) and mthomyl/thiodicarb on oranges (1,644%). However, the critical intake events identified in the acute risk assessment calculations were considered very unlikely, taking into account the frequency of critical residues and the frequency of extreme consumption events. For 11 of the pesticide/commodity combinations for which a critical intake situation could not be excluded, risk management actions have already been taken by withdrawing authorisations or by lowering the MRLs.

32. European monitoring Increased analytical capability required
As the co-ordinated programme increases in scope and breadth.
Increased analytical capability required
Increased commitment on the official laboratories for training, workshops, EU proficiency tests
Stronger evidence to take European action
More evidence to check whether food in EU is safe Farm to Fork ?
SRM added to the programme eg inorganic bromide . Compliance with full residue definitions will not be easy.
Official labs that participate in official monitoring programme need to take part in EU PT, attend works shops. Increase over head
Good to raise standards throughout Europe but can add pressure with short notice amongst busy schedule.
Under official Food and Feed Controls legislation each MS established national reference labs (in the field of fruit and veg, cereals, SRM and methods for food of animal origon) to liaise with the so called community reference labs which have been estblished for the same disciplines and which receive community funding.
The CRLlabs have a wealth of expertise (and some fuding) excellent priciple to fund centrally and transfer technology but not that easy and commission believe that once method out there all can use it regardless of technology available in the home lab.

33. European monitoring- integral to Farm to Fork policy.