MRLs 101
Daniel Fay
Technology Operations Mgr.
Valent U.S.A. Corporation
Products That Work, From People Who Care®
The trouble with MRLs…
 Very simple in concept
 Very complex in practice
 A moving target
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With appropriate MRLs established
for export markets, lettuce growers
can freely export treated produce
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Without adequate MRLs, growers face
reduced demand for treated produce,
or fewer crop protection options
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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
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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)
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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
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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
Reg. authority
MRL guidance
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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
Reg. authority
MRL guidance
Critical GAP
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MRL Building Blocks
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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
Reg. authority
MRL guidance
Critical GAP
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Residue method
& field trials
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)
MRL dossier
Reg. authority
MRL guidance
Critical GAP
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Residue method
& field trials
MRL Building Blocks
 Science review
 Administrative review
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EPA-OPP-HED/EFED/RD
Health Canada
RMS, EFSA
JMPR
Reg. authority
dossier review
MRL dossier
Reg. authority
MRL guidance
Critical GAP
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Residue method
& field trials
MRL Building Blocks
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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
Risk
Assessment
Reg. authority
dossier review
MRL dossier
Reg. authority
MRL guidance
Critical GAP
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Residue method
& field trials
MRL Building Blocks
Risk
Assessment
MRL Calculator
 Needed to ensure consistent and
unbiased
approach
Reg.
authority
MRL Act”:
dossier
 “Balancing
dossier review
− MRL too low increases chance of penalizing legal use
− MRL too high decreases ability to detect and deter illegal use
Reg.authority
Residue method
SOP and tool needed to harmonize approach
GAP
− NAFTA SOP and spreadsheet adopted by U.S. and&Canada
MRL guidance
field trials
− OECD working on harmonized MRL calculator
− JMPR looking at both
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MRL Building Blocks
Risk
Reg. authority
 U.S.
Federal Register,MRL
Canada
PCPA,
EU
Calculator
Assessment
MRL publication
Official Journal, CAC
 Linkage to Codex
Reg. authority
 Residue definition
MRL dossier
dossier review
 Enforcement method
 Processed commodities – MRL vs. factor
Reg.
authority
Residue method
 Meat/milk/poultry/egg
GAP
MRL guidance
& field trials
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MRL Building Blocks
WTO notification
Risk
Reg. authority
MRL protects
Calculator
 SPS Agreement
WTO members’ right
Assessment
MRL publication
to set MRLs to protect public health, but…
 MRLs cannot be used to create trade barrier
Reg. authority
In casedossier
of EU, notification to take place before
 MRL
dossier review
MRL establishment
Reg. authority
MRL guidance
Critical GAP
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Residue method
& field trials
MRL Building Blocks
Monitoring &
enforcement
WTO notification
Risk
Assessment
MRL Calculator
Reg. authority
MRL publication
 Responsible agency (FDA, USDA, CFIA, EU-MS)
 Multi-residue methods
Reg. authority
MRL dossier
 Penalties
(warning, seizure/disposal,
trade
dossier fines,
review
embargo)
Reg. authority
MRL guidance
Critical GAP
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Residue method
& field trials
MRL Building Blocks
Monitoring &
enforcement
WTO notification
Risk
Assessment
MRL Calculator
Reg. authority
dossier review
MRL dossier
Reg. authority
MRL guidance
Reg. authority
MRL publication
Critical GAP
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Residue method
& field trials
Moving target…
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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
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Rules are not well standardized
 “Simple” questions often are not…
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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
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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”
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Questions?
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