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Global harmonization of maximum residue limits (MRLs) for pesticides Árpád Ambrus, and Yang Yong Zhen J. Agric. Food Chem., Just Accepted Manuscript • DOI: 10.1021/jf505347z • Publication Date (Web): 20 Jan 2015 Downloaded from http://pubs.acs.org on January 28, 2015

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Journal of Agricultural and Food Chemistry

Global Harmonization of Maximum Residue Limits for Pesticides

1 2

Árpád Ambrus1*, Yong Zhen Yang2

3

1. Retired Scientific Adviser, Formerly National Food Chain Safety Office, Tábornok u 2,

4

Budapest 1143, Hungary

5

2. Food and Agriculture Organization of United Nations, Viale delle di Caracalla, 00163

6

Rome, Italy

7

* [email protected]

8

1 ACS Paragon Plus Environment


9 10

ABSTRACT: International trade plays an important role in national economics. The Codex

11

Alimentarius Commission develops harmonized international food standards, guidelines and

12

codes of practice to protect the health of the consumers and to ensure fair practices in the food

13

trade. The Codex maximum residue limits (MRLs) elaborated by the Codex Committee on

14

Pesticide Residues are based on the recommendations of the FAO/WHO Joint Meeting on

15

Pesticides (JMPR). The basic principles applied currently by the JMPR for the evaluation of

16

experimental data and related information are described together with some of the areas where

17

further developments are needed.

18

KEY WORDS: pesticide residues, maximum residue limit, MRL, Global GAP, JMPR,

19

Codex Alimentarius, FAO

20


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21 22

INTRODUCTION

23

The international trade is a key element of the economies of most countries. It helps, among

24

others, to utilize advantages of different growing conditions, diversification of food supply

25

and stabilization of year round supplies of fresh fruits and vegetables. For many developing

26

countries it is the vital source of foreign exchange earnings, and a critical component of food

27

security. Furthermore, it enables specialization in production of a small number of agricultural

28

commodities. Many developing countries rely on a single agricultural commodity for more

29

than 20 percent of their total export revenues and more than half their revenue from

30

agricultural exports.1The trade in agricultural commodities is also very important for

31

developed countries. Table 1 indicates the export value of the five largest exporters of the

32

world.2 The global trade in agricultural commodities is exceeding US$1 trillion annually.1

33

With the expansion of the trade in agricultural commodities the national governments had

34

introduced mandatory laws and regulations to minimize the risk of the health of

35

consumers from imported food. Variations in the procedures of setting food safety standards

36

and difference in national food control systems, application of standards and food safety

37

requirements gave rise to trade restrictions. There was a need to harmonize requirements and

38

procedures globally for establishment of food standard, while assuring food safety, and there

39

is a continuously growing need for transparent, science based international guidelines and

40

rules.

41

The Codex Alimentarius Commission (CAC) established by the Food and Agriculture

42

Organization of the United Nations (FAO) and the World Health Organization (WHO) in

43

1963, develops harmonized international food standards, guidelines and codes of practice to

44

protect the health of the consumers and to ensure fair practices in the food trade. The

45

Commission also promotes coordination of all food standards work undertaken by 3 ACS Paragon Plus Environment

their


46

international governmental and non-governmental organizations.3 The CAC is cited as the

47

reference point for standards relevant to food quality and safety in the Agreement on the

48

Application of Sanitary and Phytosanitary Measures4and the Agreement on Technical Barriers

49

to Trade.5

50

Most of the raw agricultural commodities cannot be produced economically without the use of

51

pesticides including animal husbandry, and their residues should remain in/on the final

52

product in order to provide the required protection in most of the cases. The environmental

53

and weather conditions, agro-technology and application methods are the major factors

54

affecting the initial deposit and the distribution of pesticides residues.6 Pesticide is used when

55

it is necessary to control pests in agriculture production. The majority of pesticides are toxic

56

chemicals and their use has been controlled by the responsible government bodies in many

57

countries at various level, including complex registration systems based on advanced

58

scientific risk assessment7-10 resulting in defined use conditions and permissible maximum

59

residue levels, MRLs, in treated products, which are often considered by other countries

60

lacking the capacity to perform their own complex risk assessment. Further guidance for the

61

proper and safe use of pesticides is given in the International Code of Conduct on Pesticide

62

Management developed by FAO11 which is the framework on pesticide management for all

63

public and private entities engaged in, or associated with, production, regulation and

64

management of pesticides.

65

Different agricultural practices resulted in various use recommendations and different national

66

MRLs for pesticide residues which hindered the international trade. The Codex Committee on

67

Pesticide Residues, CCPR, started to elaborate maximum residue limits for pesticides12 at its

68

first meeting

69

recommendations prepared by the FAO and WHO expert panels. At the first session of CCPR

70

it was decided that the FAO and WHO panels called Joint Meeting on Pesticide Residues,

in 1966 to be adopted by the CAC as Codex Standard based on the


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71

JMPR, would annually meet together. The JMPR conducts scientific evaluations of pesticide

72

residues in food to provide advice on the acceptable levels of pesticide residues in food

73

moving in international trade. The JMPR is attended by invited independent internationally

74

recognized specialists who act in a personal capacity and not as representatives of national

75

governments. The current JMPR comprises the WHO Core Assessment Group, reviewing

76

pesticide toxicological data and estimating Acceptable Daily Intakes (ADI-s), and acute

77

reference doses (ARfD-s), and FAO Panel of Experts on Pesticide Residues in Food and the

78

Environment reviewing pesticide residue data for estimating maximum residue levels,

79

supervised trials median residue values (STMR-s) and highest residues (HR-s) in food and

80

feed.13

81

The objective of this paper is to summarize the current working principles of the JMPR

82

contributing to the global harmonization of maximum residue limits for pesticides, and to

83

highlight problematic areas where further developments would be required. The current

84

practice of the JMPR is described based on the so called FAO Manual14 and the annual

85

reports of the JMPR.15

86 87

WORKING PRINCIPLES OF JMPR

88

Evaluation of residue data is a complex task that requires the consideration of influencing

89

factors and parameters additional to the numerical residue values. It is the responsibility of the

90

data submitter to provide all information which is relevant for the evaluation of metabolism in

91

plants and animals, environmental fate and residue levels in directly treated or follow-up

92

crops of the active substance or in specific cases some of its significant metabolites. The

93

detailed data requirements are given in the FAO Manual. It is the sole responsibility of the

94

JMPR to decide whether the information provided is sufficient for evaluation of the pesticide



95

or not. In the latter case, the additional data considered necessary are listed under desirable

96

information in the report of the JMPR.

97

The main outputs of the JMPR evaluations are: the definition of residues for enforcement of

98

MRLs and estimation of dietary intake; estimation of maximum residue levels, mrl-s,

99

recommended to be used by CCPR for elaboration of Codex MRLs, estimation of supervised

100

median residue and highest residue values for calculation of long- and short-term dietary

101

intake, respectively. The results of the evaluation are published annually in the series of

102

JMPR Reports and Evaluations.15 The OECD MRL calculator16 is used as a tool to assist

103

arriving at preferably the same mrl estimates by different parties based on the same residue

104

data. Therefore, at present the proper selection of residue data suitable for estimation of

105

residue levels is a very critical step and requires expert judgment.

106

The best use of available residue data is always the primary objective of the JMPR when

107

estimating maximum residue levels. Principles of residue evaluations are continuously

108

evolving as the FAO Panel regularly assesses its own experience, considers the new scientific

109

results and incorporates all relevant information in its working procedures.

110

Classification of commodities for recommending maximum residue levels. In order to

111

unambiguously describe the commodity or commodity group for which the MRLs are

112

recommended the JMPR uses the commodity codes given in the Codex Classification of

113

Foods and Animal Feeds,17 and its updated versions elaborated currently by the CCPR.

114

Estimation of maximum residue levels. Maximum residue levels are estimated for residues

115

in or on the portion of the commodities to which Codex MRLs apply.18 For dietary intake

116

purposes the residue levels are estimated on the edible portion of the commodity. Where

117

sufficient data on the edible portion is not available, STMR and HR are estimated for the

118

commodities to which Codex MRLs apply.


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119

For processed commodities, mrls are estimated only if the residue is concentrated during

120

processing. In other cases, the MRLs for raw agricultural commodities also apply to all

121

processed foods and feeds derived from them. However, the processing factors ( 3.01 in one case;

257

5 reside data: HR < 1.5 in 7 cases out of 27 datasets and HR >3.01 in 2 cases;

258

The results clearly indicate that 3-5 trials, recommended by the CCPR20, are not sufficient to

259

make reliable estimates for the maximum residue levels and the HR values. The results

260

support the conclusion of the 2006 JMPR27, stating if the highest residues for a pesticide-

261

commodity combination are in a borderline area for acceptability of short-term intake,

262

probably at least seven or eight relevant trials would be needed for the assessment.

263

Even minor crops can be consumed in large quantities during the harvesting season and an

264

underestimated short-term intake may result in undesirable adverse health effect. Therefore,

265

the five years average of the total daily consumption/capita proposed by the CCPR20 for


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266

deciding on the minimum number of supervised trials would not provide the appropriate basis

267

for categorization of food commodities. Furthermore, once the MRLs are established they

268

become legal limits and none of the national legislation can make allowance for exceeding of

269

MRLs established based on limited number of trials. Shipments containing residues above the

270

MRLs are treated equally. Placing products on the market with underestimated MRLs can

271

lead to frequent violation, economic loss and loosing the credibility of the supplier25.

272

The JMPR will continue its present practice to regularly assess its past experience and take

273

into account the new scientific results in developing its working principles in order to provide

274

the best advice to CCPR for establishing fit for the purpose MRLs.

275 276

AUTHOR INFORMATION

277

Corresponding Author:

278

E-mail: [email protected]

279

Notes

280

The authors declare no competing financial interest.

281

ACKNOWLEDGMENT

282

The authors greatly appreciate the invitation of M. Krolskí, S. Lehotay, J. Jenkins and M.

283

Bross, organizers of the Symposia on Residues in Food and Feed Progress in Global

284

Harmonization of MRLs of the 13th IUPAC International Congress of Pesticide Chemistry, to

285

present the related working principles of JMPR.

286 287

ABBREVIATION USED



288

ADI: acceptable daily intake; ARfD: acute reference dose; CCPR: Codex Committee on

289

Pesticide Residues; FAO: Food and Agriculture Organization of the United Nations; GAP:

290

Good agricultural practice reflecting the registered or authorized use of a pesticide; cGAP:

291

Registered use pattern leading to the highest residue levels in/on treated crops; HR: highest

292

residue observed in supervised trials; JMPR: FAO/WHO Joint Meeting on Pesticide Residues

293

comprising the WHO Core Assessment Group and the FAO Panel of Experts on Pesticide

294

Residues in Food and the Environment; LOQ: limit of quantification expressed usually in

295

mg/kg; MRL: maximum residue limit of a pesticide residue established by CAC or National

296

Authorities; mrl: maximum residue level of a pesticide recommended by the JMPR for use as

297

Codex MRL; IESTI: international estimated short-term intake; PHI: pre-harvest interval

298

STMR: supervised trial median residue. SUA: FAO food Supply Utilisation Account

299

WHO: World Health Organization;

300 301 302

REFERENCES 1. Food and Agriculture Organization. Codex and the International Food Trade. In

303

Understanding the Codex Alimentarius.

304

http://www.fao.org/docrep/W9474T/w9474t02.htm (accessed November 1, 2014)

305

2. Schulz-Greve W. EU-US Trade in Agriculture, European Commission, 2013

306

http://ec.europa.eu/agriculture/consultations/advisory-groups/international/2013-09-

307

30/eu-us-trade-in-agriculture_en.pdf (accessed November 1, 2014)

308 309 310 311

3. FAO; WHO. Codex Alimentarius Home Page, http://www.codexalimentarius.org/ (accessed November 1, 2014) 4. World Trade Organization. The WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), 14 ACS Paragon Plus Environment

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http://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm (accessed November 2,

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2014).

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5. World Trade Organization. The WTO Agreement on Technical Barriers to Trade http://www.wto.org/english/docs_e/legal_e/17-tbt.pdf (accessed November 2, 2014).

316

6. Horváth, Zs.; Ambrus, Á.; Mészáros, L.; Braun, S. Characterization of distribution of

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pesticide residues in crop units. Environ. Sci and Health, Part B 2013, 48, 615-625.

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7. Australian Pesticides and Veterinary Medicines Authority (APVMA). Maximum

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Residue Limits (MRL) in Food and Animal Feedstuff.

320

http://apvma.gov.au/search/node?search=Maximum+residue+limits+for+pesticides

321

(accessed October 30, 2014)

322

8. REGULATION (EC) No 299/2008 OF THE EUROPEAN PARLIAMENT AND OF

323

THE COUNCIL of 11 March 2008 amending Regulation (EC) No 396/2005 on

324

maximum residue levels of pesticides in or on food and feed of plant and animal

325

origin, as regards the implementing powers conferred on the Commission, Official

326

Journal of the European Union. 2008, L97, 67-71.

327

9. Food and Agricultural Materials Inspection Center (Japan). Data Requirements for

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Supporting Registration of Pesticides.

329

http://www.acis.famic.go.jp/eng/shinsei/index.htm (accessed October 30, 2014).

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10. US Environmental Protection Agency. Pesticides: Regulation of pesticides

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http://www.epa.gov/opp00001/regulating/registering/ (accessed October 30, 2014).

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11. FAO; WHO. The International Code of Conduct on Pesticide Management. FAO,

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Rome 2014

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http://www.fao.org/fileadmin/templates/agphome/documents/Pests_Pesticides/Code/C

335

ODE_2014Sep_ENG.pdf (accessed November 1, 2014) 15 ACS Paragon Plus Environment


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12. Codex Alimentarius Home Page. Report of the First Meeting of the Codex Committee

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on Pesticide Residues. http://www.codexalimentarius.org/meetings-

338

reports/en/?sortingDate=011966 (accessed November 1, 2014)

339

13. FAO Plant Production and Protection Division. The Joint FAO/WHO Meeting on

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Pesticide Residues Home Page. http://www.fao.org/agriculture/crops/core-

341

themes/theme/pests/jmpr/en/ (accessed November 1, 2014)

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14. FAO. Submission and evaluation of pesticide residues data for the estimation of

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maximum residue levels in food and feed 2nd ed. FAO Plant Production and

344

Protection Paper 197. 2009.

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http://www.fao.org/fileadmin/templates/agphome/documents/Pests_Pesticides/JMPR/

346

FAO_manual2nded_Oct07.pdf (accessed November 1, 2014)

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15. FAO Plant Production and Protection Division. JMPR Reports and Evaluations.

348

http://www.fao.org/agriculture/crops/core-themes/theme/pests/jmpr/jmpr-rep/en/

349

(accessed November 1, 2014)

350

16. Organisation for Economic Co-operation and Development. OECD MRL Calculator:

351

User Guide. OECD Environment Health and Safety Publications Series on Pesticides.

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No. 56. 2011.

353

http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mon

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o%282011%292&doclanguage=en (accessed November 2, 2014

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17. Codex Alimentarius Commision. Codex Classification of Foods and Animal Feeds. In

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Codex Alimentarius Vol. 2 Pesticide Residues in Food 2nd ed. 1993.

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http://www.codexalimentarius.org/search-

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results/?cx=018170620143701104933%3Ai-

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zresgmxec&cof=FORID%3A11&q=Codex+Classification+of+Foods+and+Animal+F

360

eeds&sa.x=0&sa.y=0&siteurl=http%3A%2F%2Fwww.codexalimentarius.org%2F&sit 16 ACS Paragon Plus Environment

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eurl=www.codexalimentarius.org%2F&ref=&ss=55j3025j2 (accessed November 1,

362

2014)

363

18. Codex Alimentarius Commision. Portion of commodities to which codex maximum

364

residue limits apply and which is analyzed, CAC/GL 41-1993.

365

http://www.codexalimentarius.org/search-

366

results/?cx=018170620143701104933%3Ai-

367

zresgmxec&cof=FORID%3A11&q=Portion+of+commoditiis+to+which+Codex+MR

368

Ls+apply&sa.x=13&sa.y=6&siteurl=http%3A%2F%2Fwww.codexalimentarius.org%

369

2F&siteurl=www.codexalimentarius.org%2F&ref=&ss=17385j15953267j51 (accessed

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November 1, 2014)

371

19. MacLachlan, D. J.; Hamilton, D. A review of the effect of different application rates

372

on pesticide residue levels in supervised residue trials, Published online in Wiley

373

Online Library: 30 March 2011, DOI 10.1002/ps.2158

374

20. Codex Alimentarius Commision. Report of the 46th Session of the Codex Committee

375

on Pesticide Residues, 2014. Codex Secretariat Homepage:

376

http://www.codexalimentarius.org/meetings-reports/en/?sortingDate=012014

377

21. OECD. Report of the OECD/FAO Zoning Project. OECD Series on Pesticides,

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Number 19, ENV/JM/MONO(2003) 4 16 May 2003

379

http://www.oecd.org/chemicalsafety/pesticides-biocides/2955870.pdf (accessed

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November 2, 2014)

381

22. FAO. Pesticide residues in food, Joint FAO/WHO Meeting on Pesticide Residues,

382

Report 2013, FAO Plant Production and Protection Paper 219, FAO, Rome, 2013.

383


384




385

23. Ambrus, Á.; Horváth, Zs.; Farkas, Zs.; Szabó, I.J.; Dorogházi, E.; and Szeitzné-

386

Szabó, M. Nature of the field-to-field distribution of pesticide residues. J. Environ.

387

Sci. and Health, Part B 2014, 49, 4, 229-244.

388

24. OECD: OECD Maximim Residue Limit Calculator available electronically, 2011,

389

http://www.oecd.org/env/ehs/pesticides-

390

biocides/oecdmaximumresiduelimitcalculator.htm (accessed November 2, 2014)

391

25. Horváth, Zs.; Sali, J.; Zentai, A.; Dorogházi, E.; Farkas, Zs.; Kerekes, K.; Szeitzné-

392

Szabó M.; Ambrus, Á. Limitations in the determination of maximum residue limits

393

and highest residues of pesticides, J. Environ. Sci. and Health, Part B 2014, 49, 143-

394

152.

395 396

26. Horváth, Zs. National Food Chain Safety Office, Budapest, Hungary. Personal communication, 2014.

397

27. FAO. Pesticide residues in food, Joint FAO/WHO Meeting on Pesticide Residues,

398

Report 2006, FAO Plant Production and Protection Paper 187, FAO, Rome, 2006.

399


400


401

FIGURE CAPTIONS

402

Figure 1. Relationship of MRL0.975/MRL0.025 and the number of samples used for the

403

estimation (Parent lognormal population: µ=1, SD=CV=0.8).

404

Figure 2. Relationship of HR0.975/HR0.025 and the number of samples used for the estimation

405

(Parent lognormal population: µ=1, SD=CV=0.8).

406

Figure 3. Relation of the HR values to the 97.5th percentile of the parent population.


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TABLES Table 1. Largest exporters in agriculture commodities (billion euro) Country

2010

2011

2012

USA

92

105

117

European Union

87

102

114

Brazil

48

59

65

China

27

31

35

Argentina

25

31

32



Table 2. Example for combined use of the concept of scaling of residues to match GAP in different geographical location Appl. rate

PHI,

kg ai/hl

(days)

Turkey GAP

0.005

3

Portugal, 2006

0.017

France, 2006

Fluopyram residues (mg/kg)

Country, Year Measured

Scaled to GAP

3

0.11

0.03

0.012

3

0.15

0.06

Italy, 2006

0.01

3

0.2

0.1

France, 2007

0.01

3

0.24

0.12

Spain, 2007

0.01

2

0.33

0.14

3

0.27

0.11

7

0.27

0.11

10

0.34

0.16

3

0.26

0.17

Italy, 2007

Greece, 2007

0.012

0.018


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Table 3. Descriptive statistical parameters of synthetic lognormal distribution and normalized supervised trial data Synthetic lognorm.

Supervised field trials

distribution

µ=1 σ =CV=0.794

µ=1 σ =CV=0.8 Count

100000

25766

CV

0.80

0.794

P0.5

0.8

0.82

P0.95

2.5

2.47

P0.975

3.1

3.01

P0.98

3.25

3.2

P0.99

3.90

3.97

Max

12.53

9.60



FIGURES

7

Ratio of MRL0.975/MRL0.025

6 5 4

ln_0.8

3 y = 11.197x-0.497 R² = 0.9931

2 1 0 0

5

10

15 20 Number of samples

25

30

Figure 1. Relationship of MRL0.975/MRL0.025 and the number of samples used for the estimation (Parent lognormal population: µ=1, SD=CV=0.8).

Ratio of HR0.975/HR0.025

8 7 6

ln_0.8

5 4 y = 10.019x-0.292 R² = 0.9679

3 2 1 0 0

5

10 15 20 Number of samples

25

30

Figure 2. Relationship of HR0.975/HR0.025 and the number of samples used for the estimation (Parent lognormal population: µ=1, SD=CV=0.8). s: Limitation 1 All figures original 22 ACS Paragon Plus Environment

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3.5

n=3

Normalized residue

3 2.5 2 1.5 1 0.5 0 1

2

3

4

5

6

7

8

9 10 11 12 13 14 15 16

Trial number

3.5

n=4

Normalized residue

3 2.5 2 1.5 1 0.5 0 1

3

5

7

9 11 13 15 17 19 21 23 25 27 29 31 33 Trial number

4

n=5

Normalized residue

3.5 3 2.5 2 1.5 1 0.5 0 1

3

5

7

9

11

13

15

17

19

21

23

25

27

Trial number

Figure 3. Relation of the HR values to the 97.5th percentile of the parent population.



GRAPHIC FOR TABLE OF CONTENTS

STAKEHOLDERS OF INTERNATIONAL TRADE

Codex MRLs

CAC

JMPR

CCPR


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