which pesticides to include in my screen – a brief review … brief review of the regulatory...

Which Pesticides to include in my Screen –

A Brief Review of the Regulatory Requirements

for Pesticides within Different Regions

2

AGENDA

• WHAT ARE PESTICIDES?

• BRIEF HISTORY OF PESTICIDES

• PESTICIDES

• MAXIMUM RESIDUE LEVELS

• GOVERNMENT WEBSITES

• OTHER WEBSITES

• HOW MRL’S ARE SET

• SOME MRL’S

• IMPORTANCE OF TESTING

• TEST METHODS

• CONCLUSION

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WHAT ARE PESTICIDES

A pesticide is any substance either in the pure for m or as a mixture of chemicals intended to: • Prevent,

• Destroy,

• Repel and

• Mitigating

any pest.

Pesticides have been thought to only cover insects but now actually includes:• Weeds/other plants

• Rats/mice;

• Bacteria/mould

• Snails; and

• Fungus.

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WHAT ARE PESTICIDES

So the term pesticide applies to Herbicides, Roden ticides, Molluscicides & Fungicides as well as insecticides.

Many countries define pesticide as substance intend ed for use asplant regulator, defoliant or desiccant:• Europe - EU309/74;

• USA - USEPA website;

• Japan Ministry Of Agriculture, Forest & Fisheries Website; and

• South Africa Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act,

1947 (Act 36 of 1947).

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BRIEF HISTORY OF PESTICIDES

Approximately 4500 years ago - elemental sulphur.

15th Century - arsenic, mercury & lead used.

17th Century - nicotine extracted and used as pesticide.

19th Century - natural pesticide – pyrethrum used.

1940 - use of synthetic pesticides become wide spre ad.

Since 1950 pesticide use has increased over 50 fold .

The majority of pesticide use is within developed c ountries however usage in developing countries is increasing.

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Pesticides

It is estimated that there are over 10,000 differen t formulations classified as pesticides.

The number of pesticides is increasing as new pesti cides are being developed.

It is estimated over 98% of sprayed insecticides an d 95% of herbicides reach destinations other than that targeted.

Health affects of pesticides are well documented.• Affects of DDT reported in the 1960 ‘s; now banned for agriculture use but still used in

some countries to prevent malaria.

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MAXIMUM RESIDUE LIMITS - MRL

Residue Limits (MRLs) for pesticides are establishe d in most countries by the government to safeguard consumer health and topromote Good Agricultural Practice (GAP) in the use of insecticides, fungicides, herbicides and other agricultural compo unds.

Food exporters/importers must comply with these MRL ’s as a condition of market access.

Many countries undertake screening of imported and local products for conformity to MRL limits.• The USFDA pesticide program involved regulatory monitoring testing of 6,930

samples from approximately 100 countries. Of these 1,317 of the samples were of

local origin, and 5,613 were imports. Covers several hundred pesticides

• Other countries do little internal testing – Australia.

Many countries have official websites dedicated to MRL’s.

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Government Websites

Country Source Notes

Australia

FSANZ Food Standards Code

MRLs are listed in Standard 1.4.2 (Schedule 1)

Brazil Anvisa website Pesticide Monographs (PDF) containing MRLs

Canada

PMRA website

MRLs are regulated under the Pest Control Products Act.

Currently, if no MRL exists, a default MRL of 0.l mg/kg applies.

Codex

FAO – Codex MRL website

MRLs can be searched by pesticide or commodity

European Union

EUROPA > European Commission > DG Health and Consumers > Overview > Plant Health

MRLs and temporary MRLs are Annexes to Regulation 149/2008. See also the Regulations updating these AnnexesIf no MRL exists, a default MRL of 0.0l mg/kg applies.

Hong Kong

FEHD website

Currently recognises Codex MRLs

India

MOHFW website

MRLs listed in The Prevention of Food Adulteration Act and Rules(pp90-97) and Notifications (PDF 2 MB)

If no MRL exists, Codex MRLs may be recognised

Israel

MARD Data Bank

Pesticide Residues database searchable by pesticide or crop


Japan

FFCR website

Links to MHLW Positive MRL List System and an (unofficial) MRL database searchable by pesticide or food.

If no MRL exists, a default MRL of 0.01 mg/kg applies

Korea

KFDA (English) website

Select ‘Major Policy’ then ‘MRLs for Pesticides’ to download the Korean MRLs (PDF approx 4 MB)


Malaysia

FoSIM website

Food Regulations 1985, Part VIII and Schedule 16 (Winzip 63 KB)

If no MRL exists, Codex MRLs are recognised or a default MRL of 0.01 mg/kg applies

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Government Websites

Country Source Notes

New Zealand

NZFSA ACVMG website

Codex MRLs are recognised for Imported food, Australian MRLs recognised for food imported from Australia. If no MRL exists, a default MRL of 0.1 mg/kg applies

Russian Federation

Freshfel Europe News

Unofficial consolidation of Russian MRLs (Excel 127 KB)

If no MRL exists, Codex MRLs may apply

Singapore

AVA website

Sale of Food Act and Food Regulations, Ninth Schedule (PDF)


South Africa

DoH Website

DOH Search Engine (Search for ‘Pesticide MRL Regulations’)


Switzerland

Swiss legislation Website

MRLs listed in Annex I of Ordinance 817.021.23 (PDF)

Taiwan

DoH Food Website

Food Safety Acts & Regulations – Pesticide Residue Limits in Foods (Word 1.6 MB)

Thailand

DEQP (English) Webpage

Select Environmental Law then Environmental Quality Standard. MRLs are listed under Toxic Substances and Control

if no MRL exists, Codex MRLs may be recognised

USA

GPO Access e-CFR

Electronic Code of Federal Regulations (e-CFR) Part 40, Section 180

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Other Websites

Other websites include• http://www.pesticides.montana.edu/Present/index.html

• http://www.tbt-sps.gov.cn/foodsafe/xlbz/Pages/pesticide.aspx

• http://www.fas.usda.gov/htp/MRL.asp

• http://ec.europa.eu/sanco_pesticides/public/index.cfm?event=commodity.resul

tat

• http://ec.europa.eu/food/plant/protection/pesticides/database_pesticide_en.h

tm

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HOW MRL’s ARE SET

MRL are set based • toxicity data of the pesticide and its breakdown products

• how much remains on the food at the time of consumption.

• What is approved for use; and

• Registered withholding times & application times.

Some MRL’s are based on data from other countries w ho have done all the relevant studies & CODEX.

MRLs vary from country to country depending on the pesticides available, the crops being treated and the way the pesticides are used.• But MRL’s vary from country to country even within the same region.

• The number of pesticides assigned MRL’s vary for a particular food from country

to country.

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MRL FOR SOME PRODUCTS -ACEPHATE

US Japan EU ChinaFood mg/kg Food mg/kg Food mg/kg Food mg/kg

Bean, dry, seed 3 Turnip, leaves (including rutabaga) 10 FRUIT FRESH OR FROZEN; NUTS 0.02 Unhusked Rice 0.2

Bean, succulent 3 Celery 10 Root and tuber vegetables 0.02 Wheat 0.2

Brussels sprouts 3 Tea 10 PULSES, DRY 0.02 Corn 0.2

Cattle, fat 0.1 Chicken, muscle 0.01 Oilseeds 0.05 Vegetables 1

Cattle, meat 0.1 Other poultry, muscle 0.01 Olives for oil production 0.02 Fruit 0.5

Cattle, meat byproducts 0.1 Chicken, liver 0.01 CEREALS 0.02 Cottonseed 2

Cauliflower 2 Other poultry, liver 0.01 Tea (dried leaves and stalks, fermented 0.05 Tea 0.1

Celery 10 Chicken, kidney 0.01 or otherwise of Camellia

Cotton, hulls 1 Other poultry, kidney 0.01 sinensis

Cotton, meal 1 Chicken, edible offal 0.01 HOPS (dried), including hop pellets 0.05

Cotton, undelinted seed 0.5 Other poultry, edible offal 0.01 meat 0.02

Cranberry 0.5 Chicken eggs 0.01

Milk and cream, not concentrated,nor containing addedsugar or sweetening matter, butterand other fats derived frommilk, cheese and curd 0.02

Egg 0.1 Other poultry, eggs 0.01 Eggs 0.02

Goat, fat 0.1

Another 88 items listed with MRL for Acephate ranging between the MRL's listed above.

Spices 0.05

Goat, meat 0.1

Goat, meat byproducts 0.1

Hog, fat 0.1

Hog, meat 0.1

Hog, meat byproducts 0.1

Horse, fat 0.1

Horse, meat 0.1

Horse, meat byproducts 0.1

Lettuce, head 10

Milk 0.1

Peanut 0.2

Pepper 4

Peppermint, tops 27

Poultry, fat 0.1

Poultry, meat 0.1

Poultry, meat byproducts 0.1

Sheep, fat 0.1

Sheep, meat 0.1

Sheep, meat byproducts 0.1

Spearmint, tops 27

Soybean, seed 1

Nut, macadamia 0.05

SOME MRL’S – LETTUCE

Japan EU US ChinaPesticide mg/kg Pesticide mg/kg

Approximately 330 pesticides listed for lettuce.

MRL vary from 0.001 (warfarin) to 100 (bromide)

54 pesticides listed for lettuce.

MRL vary from 0.001 (Chlorothalonil) to 50 (Propamocarb)

Tetrabromo permethrin 3 Chlorothalonil 5

Cyfluthrin 3 Chlorpyrifos 0.1

Lambda-cyhalothrin 2 Cyhalothrin 0.2

Imazethapyr 0.1 Cypermethrin 2

Clethodim 2 Deltamethrin 0.5

Imidacloprid 3.5 Diflubenzuron 1

Dimethomorph 10 Dimethoate 1

Propamocarb hydrochloride 90 Esfenvalerate 1

Quinoxyfen 19 Fenpropathrin 0.5

Boscalid 11 Fenvalerate 0.5

Endosulfan 6

Dimethoate 2

Acibenzolar-S-methyl 0.25

SOME MRL’S – TOMATO

Japan EU US China

Pesticide mg/kg Pesticide mg/kg Pesticide mg/kg Pesticide mg/kg

Approximately 350 pesticides listed for tomato.

MRL vary from 0.001 (warfarin) to 75 (bromide)

Approximately 109 pesticides listed for tomato.

MRL vary between 0.05 to 100

Inorganic bromide 20 Anilazine 10

Piperonyl butoxide 8 Bifenthrin 0.5

Pyrethrins 1 Carbendazim 0.5

O,O -Dimethyl S -[(4-oxo-1,2,3-benzotriazin-3(4 H )-yl)methyl]phosphorodithioate 2 Chlorpyrifos 0.5

Dichlorvos 0.05 Ethephon 2

Iprodione 5

Vinclozolin 3

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SOME MRL’S

The Japanese website contains MRL‘s for 799 pestici des. • If no MRL default limit is 0.01mg/kg.

• Updated 2010.

USEPA website updated July 2010

Codex website updated Jan 2010

EU website updated Aug 2010

• If a MRL is not assigned; • Than some areas set CODEX as default MRL – but what happens if no CODEX

Limit;

• Other areas set 0.01mg/kg as default MRL - for example the European Union;

and

• Some have no default limit –what limit applies.

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THE IMPORTANCE OF TESTING

Increased Risk Assessment:• Companies are undertaking risk assessments of their products; which often result in

increased third party testing or confirmation;

• Greater risk of ligation; and

• Increased security of results & more accurate testing required.

Chinese Exports: • China’s position as a world leader in the export of fresh and processed foods is

becoming stronger:• China is already producing of the worlds 12% of fruit, 16% of cereals and 48% of vegetables.

Residue Free (Organic) Food Branding: • As part of the trend to healthier eating, consumers are demanding produce not only

free from residues but products where no chemicals have been used in the growing

of the raw material.

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THE IMPORTANCE OF TESTING

As a class of compounds pesticides have a significa nt & perhaps the greatest impact on food safety.• Pesticide Action Network Database contains information on over 6500

pesticides.

It’s presently estimated: • That more than 400 species of insects and mites and more than 70 fungi are

resistant to some pesticides;

• Leading to higher doses or more frequent application; or

• Combining pesticides; or

• Using more expensive, toxic or ecologically hazardous pesticides.

Government’s Changing Regulations:• Heath affects have resulted in many countries setting MRL;

• Also reviews and changes in MRL’s;

• More pesticides being developed, being registered and approved for use by

governments; and

• More MRL’s.

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TEST METHODS

Japan has general pesticide method published 2006.• GCMS method.

China has series of GB methods.• Many published 2008.

• Many are LC or GC Mass multi residue screens.

For example China has GB23204-2008; a GCMS method f or 519 pesticides in tea.

AOAC has one multi pesticide screen 2007.01-2007• AOAC Quechers method- LCMS or GCMS

• Most other methods not as modern

• AOAC 985. 22 (1986) GC

• AOAC 2002.03 (2005) OC & OP GCMS

• Few LCMS or GCMS methods.

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TEST METHODS

EN 15662/2008- Quechers; common method used in China .• Covers 580+ pesticides;

ISO 12393 -2009.• Mainly GC methods reference using non MS techniques

Codex.• Standard 229-1993 Analysis of Pesticide Residues: Recommended Methods.

• Last updated 2003.

Yet EN15662 or AOAC 2007.01 does not cover all pe sticides listed for:• The EU listed MRL for lettuce – misses 9 pesticides

• The EU listed MU for tomatoes – misses 10 pesticides

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TEST METHODS

Official methods not keeping up to date with the MR L’s as required by Governments.• Few modern official methods –Japan & Quechers.

Few official methods covering all required pesticid es

Testing laboratories are required to use methods wh ich are not official (ISO/AOAC) methods.

But 3 rd party laboratories:• Have many clients who export to different countries around the world.

• Must provide cost effective or cheap rapid test results.

• Hence must cover as many pesticides as possible using as few instrumental runs

as possible

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TEST METHODS

Hence 3 rd party laboratories develop a “one size fits all” pes ticides method based not on MRL or other government require ments but on how many pesticides the laboratory “can fit” on the instrument at the one time.

These methods are developed in house and became pro prietary.• In general no two laboratories use the exact same method.

Since methods are different laboratory’s cover diff erent pesticides in their screen.• No two test the exact same pesticides.

As laboratories use different equipment and differe nt methods LOD/LOQ can vary from laboratory to laboratory

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TEST METHODS

An International Company:• Use various raw materials to make their product;

• Has plants in US, China & Europe;

• Undertakes pesticide testings at all sites;

• Product for local market only;

• In Europe test to Quechers method;

• In US tests for 199 pesticides;

• In China test for 399;

• Only 80% of the pesticides included in the China screen are included in the

Quechers screen;

• Only 70% of the pesticides included in the US screen are included in the China

screen.

Why 199 in the US and 399 in China –• because that is what is offered by the laboratories when they ask for a pesticide

screen.

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TEST METHODS

A general requirement is that the laboratory has t o fully validate the method to obtain ISO17025 accreditation for that me thod.

Validation usually covers but not limited to:• Linearity for each pesticide;

• Ruggedness;

• Accuracy;

• spike /recovery - 3 levels in triplicate.

• Precision;

• Repeatability;

• Limit of detection and limit of quantization; and

• Specificity:

• No interference from other pesticides; and

• LOD/LOQ & recovery not affected by the presence of other pesticides .

Validation parameters shown in red usually tested f or each matrix.

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TEST METHODS

To cover multi products validation data for differe nt matrices is required. For example: • Several different fruits;

• Several different vegetables;

• Several different grains/pulses; and

• If meat different “sections” including fat & different meats (Cattle Sheep, etc).

However if a new pesticide is added to a validated screen then the affect of that pesticide on the previous validation data has to be investigated.

But usually methods are “saturated” & have so many p esticides cannot add more.

To add more pesticides a new method may need to be developed.

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TEST METHODS

The new method may only involve changing some instr ument conditions; but if these changes include:• changing dwell time;

• different column or

• different mobile phase

Then some validation parameters need to be retested .

Significant time & cost required to modify or add n ew pesticides a screen.

Best quality control check for a test method is pro ficiency testing but :• FAPAS, one the largest proficiency providers, offers 143 pesticides in its 10/11

program;

• Only 138 covered by Quechers;

• Not all covered by GB 23204; and

• Not all covered by GB2763.

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CONCLUSION

MRL for pesticides vary significantly within differ ent areas.

The number of pesticides to be tested for a particu lar food varysignificantly within different areas.

In general up to date MRL’s exist for most pesticid es; which are well published and readily available.

A lack of up to date official analytical pesticide methods; with 3 rd

party laboratories;• Developing and validating their own methods which vary from laboratory to

laboratory;

• The actual pesticides tested for a particular food can vary from laboratory to

laboratory.

• LOD/LOQ can vary from laboratory to laboratory.

Ask a laboratory if they can do pesticides and they will say “Yes we can” but are they same pesticides as you normally ge t or are they the pesticides you actually require.

which pesticides to include in my screen – a brief review … brief review of the regulatory...

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