Products That Work, From People Who Care®

MRLs 101

Daniel FayTechnology Operations Mgr.Valent U.S.A. Corporation

2

The trouble with MRLs…

Very simple in concept Very complex in practice A moving target

3

With appropriate MRLs established for export markets, lettuce growers

can freely export treated produce

4

Without adequate MRLs, growers face reduced demand for treated produce,

or fewer crop protection options

5

What is a MRL?

− Maximum pesticide residue level legally permitted in/on a food or feed

− Measured in parts per million (ppm) or mg of specific chemical per kg of specific agricultural commodity

− Enforcement tool to ensure compliance with the registered pesticide label

− Means of ensuring food that moves in commerce is safe for consumers

6

What is a MRL?

MRLs are NOT toxicological safety limits

“MRLs are often mistaken for toxicological safety limits. MRLs are safe limits that define the maximum expected levels of a pesticide on a food commodity after safe and authorized use of that pesticide. They serve both to prevent illegal and/or excessive use of a pesticide (e.g. to prevent damage to the environment or to the health of workers and bystanders) and to protect the health of consumers of the harvested products.”

(EC SANCO/3346/2001 rev 7, Guidance Document on Notification criteria for pesticide residue findings to the Rapid Alert System for Food and Feed, Jul 14, 2004)

7

MRL basics

Positive Lists – e.g. U.S., Canada, EU, Japan Deferring –

− Mexico - U.S.>Codex>EU− Many countries to Codex

Default or threshold MRLs− Typically set at low level for commodity/chemical combination not

addressed by positive list (e.g. Canada and NZ 0.1 ppm, EU and Japan 0.01 ppm)

Import MRLs vs. registration-linked MRLs

Codex

− Sets MRLs for countries not having own MRL-setting capacity

− Seeks harmonization of MRL-setting rules and process

8

Reg. authorityMRL guidance

MRL Building Blocks

Regulatory authority = government, or Codex Legal and regulatory framework

− FFDCA §408, PCPA, EC 396/2005, Codex Standards− Positive list vs. deferring, default MRL policy− Linkage to registration process (e.g. FIFRA, EC 91/414)

− Exempted materials (e.g. 40 CFR 180.950, EC 396/2005 Annex IV)

− Data requirements and risk assessment− Petition/dossier process

9

Reg. authorityMRL guidance Critical GAP

MRL Building Blocks

“MRLs should be set at the lowest achievable level consistent with good agricultural practice for each pesticide with a view to protecting vulnerable groups such as children and the unborn” (EC 396/2005)

“Critical GAP … gives rise to the highest acceptable level of pesticide residue in a treated crop and is the basis for establishing the MRL”

Max rate, max # applications, min interval, min PHI Target crops and crop groupings

10

Reg. authorityMRL guidance Critical GAP

MRL Building Blocks

Address analytes of concern, limit of detection Critical GAP Geographic representation GLP “Farm gate” residues Residue decline Processing studies Inadvertent residues (e.g. rotational, aquatic) Livestock feeding studies

Residue method & field trials

11

MRL Building Blocks

Data requirements − 40 CFR Part 158, DACO Tables− EC 91/414 Annexes II and III

Format/summary requirements Petitioner not necessarily registrant (e.g. IR-4,

AAFC-PMC, PMUC)

Reg. authorityMRL guidance Critical GAP Residue method

& field trials

MRL dossier

12

MRL Building Blocks Science review Administrative review

− EPA-OPP-HED/EFED/RD− Health Canada− RMS, EFSA− JMPR

Reg. authorityMRL guidance Critical GAP Residue method

& field trials

MRL dossier Reg. authoritydossier review

13

MRL Building Blocks

Applicant, EPA-OPP-HED, RMS/EFSA Toxicology endpoints => “risk cup” Acute (aRfD) and chronic (ADI) exposure Residue data, dietary consumption patterns Tiered assessment U.S. tolerance considers aggregate exposure

Reg. authorityMRL guidance Critical GAP Residue method

& field trials

MRL dossier

Risk Assessment

Reg. authoritydossier review

14

MRL Building Blocks

Reg. authorityMRL guidance GAP Residue method

& field trials

MRL dossier

Risk Assessment

Reg. authoritydossier review

MRL Calculator

Needed to ensure consistent and unbiased approach “Balancing Act”:

− MRL too low increases chance of penalizing legal use − MRL too high decreases ability to detect and deter illegal use

SOP and tool needed to harmonize approach − NAFTA SOP and spreadsheet adopted by U.S. and Canada− OECD working on harmonized MRL calculator− JMPR looking at both

15

MRL Building Blocks

Reg. authorityMRL guidance GAP Residue method

& field trials

MRL dossier

Risk Assessment

Reg. authoritydossier review

MRL Calculator Reg. authorityMRL publication

U.S. Federal Register, Canada PCPA, EU Official Journal, CAC

Linkage to Codex Residue definition Enforcement method Processed commodities – MRL vs. factor Meat/milk/poultry/egg

16

MRL Building Blocks

Reg. authorityMRL guidance Critical GAP Residue method

& field trials

MRL dossier

Risk Assessment

Reg. authoritydossier review

MRL Calculator Reg. authorityMRL publication

WTO notification

SPS Agreement protects WTO members’ right to set MRLs to protect public health, but…

MRLs cannot be used to create trade barrier In case of EU, notification to take place before

MRL establishment

17

MRL Building Blocks

Reg. authorityMRL guidance Critical GAP Residue method

& field trials

MRL dossier

Risk Assessment

Reg. authoritydossier review

MRL Calculator

WTO notification

Reg. authorityMRL publication

Monitoring & enforcement

Responsible agency (FDA, USDA, CFIA, EU-MS) Multi-residue methods Penalties (warning, seizure/disposal, fines, trade

embargo)

18

MRL Building Blocks

Reg. authorityMRL guidance Critical GAP Residue method

& field trials

MRL dossier

Risk Assessment

Reg. authoritydossier review

MRL Calculator Reg. authorityMRL publication

WTO notification Monitoring & enforcement

19

Moving target…

Japan implemented positive list May 2006 EU harmonized MRLs in force September 2008 Country-specific policy changes, e.g. Taiwan, HK, Canada Drive towards global harmonization – Codex, OECD Increasing “green” emphasis from food chain

20

Rules are not well standardized

“Simple” questions often are not…− GAP− Crop and crop group definitions, representative crops− Risk assessment methodology, uncertainty factors− Processed foods− Livestock commodities− Default/threshold values− MRL calculation

There is hope− Codex− OECD− IR-4

21

Tools and resources

Laws and regulations:− FFDCA: http://www4.law.cornell.edu/uscode/21/ch9.html− PCPA: http://laws.justice.gc.ca/en/P-9/index.html

− EC 396/2005: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2005:070:0001:0016:EN:PDF

Established MRL values:− U.S.: http://www.epa.gov/pesticides/food/viewtols.htm

− EU: http://ec.europa.eu/sanco_pesticides/public/index.cfm

− International: http://www.mrldatabase.com/

− Canada: http://www.hc-sc.gc.ca/cps-spc/pest/protect-proteger/food-nourriture/mrl-lmr-eng.php

− Japan: http://www.m5.ws001.squarestart.ne.jp/foundation/search.html

− Codex: http://www.codexalimentarius.net/mrls/pestdes/jsp/pest_q-e.jsp

Other:− WTO notification search: http://docsonline.wto.org/

− 3/2009 “Regional Symposium on Regulation of Pesticide Residues in Food”− 7/2007 “Review of the EU, NAFTA and CODEX Procedures for MRLs Calculation”

22

Questions?