G/SPS/R/85  
 
19 May 2017 
(17-2726) Page: 1/22 
Committee on Sanitary and Phytosanitary Measures    
 
REPORT  
WORKSHOP ON PESTICIDE MAXIMUM RE SIDUE LEVELS  (MRLS)  
MONDAY, 24 OCTOBER – TUESDAY, 25 OCTOBER 201 6 
WTO, CENTRE WILLIAM RAPPARD, GENEVA  
NOTE BY THE SECRETAR IAT1 
The Secretariat of the World Trade Organization held a workshop on pesticide maximum residue 
levels (MRLs)  in Geneva, Switzerland, on 24 and 25 October 201 6. 
The WTO funded, through assistance from the Doha Development Agenda Global Trust Fund 
(DDAGTF), the participation of 27 governmental officials from  developing country Members and 
Observers in the workshop .2 Sponsored participants were selected from over 300 applications.  
In addition, the WTO Global Trust Fund made it possible to cover the costs of travel for several of 
the speakers in the workshop. Total attendance was close to  180, and included Geneva - and 
capital -based delegates, participants from intergovernmental organizations , as well as speakers 
from non -governmental organizations . 
Members were invited at several stages to make comments on the programme and also to put 
forward names of speakers, and their proposals and suggestions were taken into account in 
preparing the programme.  The final programme for the workshop is contained in 
G/SPS/GEN/1514/Rev.1.  The presentations from this workshop are a vailable via the SPS Gateway 
at https://www.wto.org/english/tratop_e/sps_e/wkshop_oct16_e/wkshop_oct16_e.htm . 
1  OBJECTIVE OF THE WOR KSHOP  
1.1.  The objective of the works hop was to bring together officia ls responsible for participation in 
and implementation  of the SPS Agreement, as well as the relevant international standard -setting 
organization and scientific bodies for an in depth discussion, at a technical level, on pesticide 
maximum residue levels. Mo re specifically to:  
 Review the SPS Agreement and MRLs, including the relevant provisions of the 
Agreement and jurisprudence;  
 Review the Codex approach to establishing MRLs. This included relevant information on 
the respecti ve work of Codex and scientific b odies, such as the Codex Committee on 
Pesticide Residues (CCPR) and the Joint FAO/WHO Meeting on Pesticide Residue (JMPR);  
 Be exposed to the relevant international, regional and bilateral work being undertaken 
on pesticide residues; and  
 Discuss experiences  in complying with MRLs and establishing MRLs, including 
information on Members' domestic regulatory and legal infrastructures.  
                                                
1 This document has been prepared under the Secretariat's own responsibility and is without prejudice 
to the positions of Members or to their rights or obligations under the WTO.  
2 Unlike previous years, WTO -funded workshop participants were not sponsored to participate in the 
SPS Committee meetings, in addition to their attendance at the workshop.  G/SPS/R/85  
 
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  2  OVERVIEW OF WORKSHOP  
2.1.  Throughout the two -day workshop, participants benefited from detailed presentations on the 
relevance of the  SPS Agreement to pesticide MRLs, the Codex approach to establishing MRLs , as 
well as various regional and international initiatives focused on harmonizing MRLs and establishing 
MRLs for minor -use crops.3 In addition, various WTO Members shared their natio nal experiences 
on establishing MRLs and provided insights into the challenges of implementing and complying 
with Codex MRLs , as well as the impact of default MRLs and MRL expiration on international trade. 
Speakers from the private sector also contributed  to the workshop, highlighting the various ways 
for the private sector to be involved in establishing MRLs, such as by providi ng the relevant 
technical data.  Several follow -up actions were propos ed during the workshop,  with a view  to 
address ing various  concerns related to pesticide MRLs.  A summary of the various sessions of the 
workshop is provided below.  
3  WORKSHOP SESSIONS  
3.1  The SPS Agreement and establishing MRLs (Session 1)  
3.1.  Session 1  set the framework for the subsequent presentations, focusing on : the relevance  of 
the SPS Agreement to pesticide MRLs ; the relevant provisions of the Agreement; key  highlights of  
lessons learned from MRL -related jurisprud ence; and statistics on MRL -related notificatio ns and 
specific trade concerns.  
3.2.  Ms Anneke Hamilton ,4 from the WTO Secretariat,  reminded participants of the objective of 
the SPS Agreement , which  is to strike  a balance between Members' right to protect human, 
animal, plant life or health, while at the same time ensuring that these measures do not create 
unneces sary barriers to trade. In highlighting the relevance of the SPS Agreement to pesticide 
MRLs, Ms Hamilton focused on the definitions of a SPS measure, as stated in Annex A (1). 
In particular, the definition of a SPS measure in Annex A(1)(b) was of most relevance to pesticide 
MRLs, as it stated that a SPS measure was any measure applied "…to protect human or animal life 
or health within the territory of the Member from risks arising from additives, contaminants, toxins 
or disease -causing o rganisms in foods, beverages or feedstuffs;…" .5 In addition, footnote 4 of 
Annex A  further clarified that '…"contaminants " include pesticide and veterinary drug residues and 
extraneous matter.'  On this  basis, Ms Hamilton underscored that pesticide MRLs are considered to 
be SPS measures and as such, are subject to the p rovisions of the SPS Agreement.  
3.3.  Ms Hamilton also outlined Article 8 and Annex C  of the SPS Agreement  and their relevance 
for pesticide MRLs. Firstly, Article 8  required  Members to observe t he provisions of Annex C in the  
operation of control, inspection and approval procedures , including among  others, national 
systems for establishing tolerances for contaminants in foods, beverages or feedstuffs . Secondly, 
Annex C spelled out certain obligat ions with respect to control, inspection and approval 
procedures, including those procedures for sampling , testing and certification.6 In particular, 
Annex C(1) ma de reference to a situation where an importing Member ha d a positive list system 
for the establishment of tolerances for contaminants , outlining that th e importing Member was 
required to consider the Codex standard as the basis for access  (where a Codex standard exists) , 
until a final determination was made . In this regard, Ms Hamilton hig hlighted that the  procedures 
to check and ensure the fulfilment of pesticide MRLs  were also considered SPS measures . 
3.4.  Other provisions of the SPS Agreement of particular relevance to pesticide MRLs were 
underscored , such as : non-discrimination (Article 2.3) ; scientific justification (Articles 2, 3 and 5); 
transparency (Article 7 and Annex B); technical assistance (Article 9); and  special and differential 
treatment  (Article 10). In particular, Ms Hamilton  highlighted the scientific principle as the heart of 
the SPS Agreement , which required that where SPS measures are implemented, they should either 
be based on international standards ( i.e. Codex standards  for food safety  concerns ), or on a risk 
assessment. In the case where an SPS measure o r pesticide MRL wa s based on a risk assessment, 
                                                
3 Crops for which pesticide manufac turers do not find it commercially interesting to produce the data 
packages required for a risk assessment that would allow the establishment of a MRL . 
4 The Secretariat' s presentation is available at: 
https://www.wto.org/english/tratop_e/sps_e/wkshop_oct16_e/s1_anneke_hamilton .pdf. 
5 Annex A(1)(a) of the SPS Agreement.  
6 Footnote 7 of Annex C of the SPS Agreement.  G/SPS/R/85  
 
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  there was still an obligation under the SPS Agreement to ensure that the risk assessment was 
appropriate to the circumstances of SPS risks and that the assessment t ook into account the 
techniques developed by relevant internat ional organizations.  
3.5.  In examining some key lessons learned from jurisprudence , Ms Hamilton explained that 
although  there had been no SPS dispute  case to date  which had specifically focused on pesticide 
MRLs, a previous dispute  case had examined the issue of veterinary drug residues .7 She presented 
the legal findings on harmonization , risk assessment , consistency  and provisional measures , as 
they provide d useful insights for the  discussions on pesticide MRLs . Ms Hamilton highlighted that: 
the non -use of an international standard as a basis for a measure require d a risk assessment; 
there was no need for each Member to carry out its own risk assessment, as SPS measures could  
be based on an appropriate risk assessment carried out by anot her party; a risk assessment did 
not need to be quantitative; and that risk assessments could  consider divergent or minority 
scientific views.  In addition, the term "based on" required a rational relations hip between the 
measure and the  risk assessment.  
3.6.  Ms Hamilton also noted that  there were three cumulative elements which had to be met in 
order for a measure to be found in violation of Articl e 5.5.8 With respect to Article 5.7 , which deal t 
with the exception to the requirement that SPS measures must be bas ed on a scientific 
justification, Ms Hamilton underscored that the Appellate Body  had ruled that precaution "finds 
reflection in Article 5.7" . 
3.7.  Some statistics on MRL -related notifications and specific trade concerns  were also provide d. 
Ms Hamilton also  further clarified, in response to a query , that the statistics on MRL -related 
notifications had been sourced from the SPS-IMS, using the keyword "MRL" . As such, the filtered 
search would  not fully capture all of the MRL -related notifications that had been  submitted by 
Members, if MRL-related measures had been notified under more general law s or regulations . 
3.2  Codex approach to establishing pesticide MRLs  (Session 2) 
3.8.  The moderator of the session,  Dr Kazuaki Miyagishima (Director, Department of Food 
Safety and Zoonoses, WHO)  in his introductory remarks provided some background to  the Codex 
and JMPR9 process  for establishing pesticide MRLs. In particular, he  highlight ed that the 
management of  pesticide residues in foods was coordinated in a manner to ensure the functional 
separation of  risk management (Codex) from risk assessment  (JMPR). The Codex mechanism ha d 
evolved to cater to the changing nature of the world , e.g. t he process to adopt pesticide  MRLs had 
been reduced from 5 or 6 years to just one year through the fast track process , although  there s till 
remained  scope for the procedure to be improved . In addition, Codex faced a difficult task in 
selecting the pesticides to be evaluated by FAO and  WHO. 
3.9.  Mr Ian Reichstein ,10 Chair of the Codex Committee on Pesticide Residues (CCPR) Electronic 
Working Group  (eWG)  on Priorities, provided an overview of the  role and operation of  the eWG in 
the standard -setting process . Mr Reichstein first explained  that CCPR based its risk management 
recommendations to the Codex Alimentarius Commission  on JMPR 's risk assessments of the 
respective pesticides, co nsidering , where appropriate, other legitimate factors relevant for health 
protection of consumers and for the  promotion of fair practices in international food trade. 
Codex MRLs for pesticides used in crop protection  were only  established if they pass ed a scientific 
evaluation by FAO and WHO in the JMPR . 
3.10.   In this regard, Mr Reichstein highlighted the key role of the CCPR 's eWG on Priorities in the 
prepar ation of  a draft schedule of JMPR evaluations and maint enance of  the four tables of 
                                                
7 European Communities - Measures Concerning Meat and Meat Products (Hormones), DS 26 and DS48. 
More information available at: https://www.wto.org/english/tratop_e/dispu_e/cases_e/ds26_e.htm  and 
https://www.wto.org/english/tratop_e/dispu_e/cases_e/ds48_e.htm . 
8 Article 5.5 addresses the objective of achieving consistency in the application of the appropriate level 
of protection and seeks to avoid arbitrary distinctions in the level of risk considered to be acceptable, if that 
distinction results in a disguised r estriction to trade . 
9 The Joint FAO/WHO Meeting on Pesticide Residues (JMPR) is an expert ad hoc body administered 
jointly by FAO and WHO. The JMPR comprises the WHO Core Assessment Group and the FAO Panel of Experts 
on Pesticide Residues in Food and the Environment.  
10 Mr Reichstein is also Director of the National Residue Survey, Residues and Food, Exports Division, 
Department of Agriculture and Water Resources, Australia.  Speaker's presentation is available at: 
https://www.wto.org/english/tratop_e/sps_e/ wkshop_oct16_e/s2_ian_reichstein.pdf.  G/SPS/R/85  
 
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  priorities .11 Mr Reichstein outlined the timeline for the Codex step procedure, specifically 
highlighting the role of the electroni c working group in step 1  of the process . He also provided data 
to illustrate  the increased number of adopted  Codex pesticide MRLs  over the past years , while 
highlight ing the various e nhancements that had been made to the operations of the working 
group . He further noted that t he eWG operated throughout the year  and was comprised of about 
200 representatives from  interested  member countries and observer s, and operate d on the 
principles of openness, transparency and inclusivity , as well as  on the basis of t he provisions 
specif ied in the Codex Procedural Manual.  
3.11.   Mr Reichstein outlined the improvements that ha d been made over the years to the table of 
priorities, such as: the inclusion of commodity lists in the schedules and priority lists; the inclusion 
of ma nufacturer identity; and nomination with date stamping to support strict adherence to 
nomination and scheduling criteria . Mr Reichstein further explained the prioritization and 
scheduling criteria , highlighting that given the increased number of requests, a higher priority was  
given to those nominations meeting the requirements , as set out  in the Codex Procedural Manual.  
3.12.   Mr Reichstein also provided an overview on the requirements for the periodic review of 
Codex pesticide MRLs, as well as the revocation of Codex pesticide MRLs.  In conclusion , 
Mr Reichstein  indicated that m any more pesticides and uses had been added than  revoked by 
members, while emphasiz ing the need for members and observers to adhere to the nomination  
and scheduling criteria, in order to su pport an effective Codex MRL setting process. Mr Reichstein 
indicated that further procedural improvements were being discussed by the eWG, but that there 
were limitations in addressing the existing capacity bottlenecks in the scientific evaluation process  
and the subsequent delays in the establishment of new MRLs.  
3.13.   Dr Juerg Zarn ,12 WHO JMPR Expert,  provided an overview of the  role of WHO JMPR in the 
establishment of Codex MRLs, highlighting  that its main  objective was to guarantee that proposed 
pesticide MRLs were safe, so that  consumption of food commodities with residues at the MRL level 
did not pose an unacceptable risk to consumers. In this regard, JMPR's role was to eva luate a 
dossier provided by the member/obser ver nominating the pesticide. This dossier would  normally  
include a standard toxicology package,  laboratory animal and in vitro studies, as well as human 
data (e.g. epidemiology  data). 
3.14.   Based on this evaluation, Dr Zarn explained that the WHO group identifi ed a safe dose in all 
laboratory animal studies ,13 under the assumption that animals were valid models for humans  and 
by using safety factors for extrapolation from animals to humans, following which a safe dose for 
humans was established. The main output of WHO JMPR were two health based guidance values: 
(i) the Acceptable Daily Intake ( ADI) - for lifelong daily exposure ; and (ii) the Acute Reference 
Dose (ARfD) - for single high exposure s. Dr Zarn  further explained that it was the responsibility of 
the joint group ( FAO and WHO ) to propose a MRL for the particular pesticide in food commodities. 
The most important requirement was that the MRL be set at a level to ensure exposures below the 
ADI and AR fD, even if consumptions patter ns considerably var ied. 
3.15.   Dr Zarn emphasized that the JMPR recommend ed MRLs for pesticides strictly on a risk -
based approach and not on a hazard -based approach. As such, MRLs for pesticide s could be 
derived, even if it was foun d to induce tumors or fetal abnormalities in laboratory animals, but 
where a safe  dose in animals was clearly identified , and on the assumption that a safe dose for 
humans could also be established.  In such a case, the JMPR would indicate  that the pesticide in 
question ha d the potential to induce tumors or fetal abnormalities, but that the exposure at dietary 
levels would not pose a risk if the MRL was not exceeded.  
3.16.   Dr Zarn further explained how WHO JMPR undertook its work,  detailing the p rocess used to 
draft the monograph on toxicological data for each pesticide before the joint FAO and WHO JMPR 
meetings . He outlined the work undertaken during the meetings to discuss and finalize the 
monographs  leading to the subsequent publication of a report. In conclusion, Dr Zarn highlighted 
that toxicology was a developing science and as such, new data  or new views on old data could 
have an impact on risk assessment and thereby change previ ous conclusions on a pesticide.  
                                                
11 Additional information is available in the Codex P rocedural Manual , available for download at:  
http://www.fao.o rg/fao -who-codexalimentarius/procedures -strategies/procedural -manual/en/ . 
12 Speaker's presentation is available at: 
https://www.wto.org/english/tratop_e/sps_e/wkshop_oct16_e/s2_juerg_zarn.pdf . 
13 NOAEL  - No Observed Adverse Effect Level . G/SPS/R/85  
 
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  3.17.   In response to queries, Dr Zarn  clarified the calculation  process us ed in the extrapolation of 
the safe dose from animals to humans, an d also addressed concerns regarding the role of 
uncertainty in the process.  Dr Zarn  also provided additional information on the differences 
between ADI  and ARfD, including its impact on the establishment of MRLs, as well as the critical 
assumptions on exposure underlying each of these concepts.  He also explained that there was no 
available guidance  on cumulative risk assessment.  
3.18.   Dr Yong Zhen Yang ,14 FAO J MPR Secretary, provided an overview of the role and function 
of the FAO JMPR panel in the estimation of MRLs  for pesticide residues . She highlight ed that the 
FAO panel was responsible for: (i) reviewing pesticide use patterns (good agricultural practices - 
GAPs), data on the chemistry and environmental fate, metabolism in farm animals and crops, 
methods of analysis for pesticide residues and processing studies; (ii) defining residues for 
enforcement of MRLs and for dietary risk assessment purposes; (iii ) estimating MRLs, supervised 
trials median residue values (STMRs) and highest residues (HRs) in food and feed commodities; 
and (iv) assessing dietary risk from short and long term intake of pesticides  in collaboration with 
the WHO Panel . 
3.19.   Dr Yang further described the data requirements  and general procedures for JMPR 
evaluation o f pesticide residues  and the estimation of MRLs. The JMPR proc edure included 
undertaking a risk assessment on the basis of the data generated by FAO15 and WHO to see 
whether the tox icology and dietary intake of residues we re compatible , following which a 
recommendation wa s made for the establishment of a Codex MRL , for adoption by the Codex 
Alimentarius Commission  (CAC) . Dr Yang underscored that FAO JMPR recommendations we re 
based on  "supervised trials ", selected by the FAO panel and designed to reflect pesticide use 
patterns and " critical GAP " that lead to the highest expectable  residues. In addition, the procedure 
for estimating MRLs included the selection of appropriate residue data for calculation of MRL s, 
supported by statistical tests , as well as the use of the Organization of Economic Cooperation and 
Development (OECD) MRL calculator. Dr Yang undersc ored that JMPR recommended  the estimated 
MRLs only if the risk assessment pas sed both the chronic and short -term intake hurdles . 
3.20.   Dr Yand also provided a n overview o f the JMPR FAO panel workflow, detailing the process 
used to evaluate the monographs for compounds , including the work undertaken internally within 
the FAO expert panel,  as well as during the joint FAO and WHO JMPR meetings to discuss and 
finalize the monograph. Once the evaluation monograph  was finalized, it was then  published 
online.  Some of the challenges  faced by JMPR in establish ing international MRLs for pesticides  were 
also highlighted , such as : resource constraints; data generation for JMPR review; funding of the 
JMPR Secretariat and meetings; sustainability of JMPR expertise; principles on c ombining global 
residue data  sets and on extrapolation; e stimation of crop  group MRLs; and harmonization of 
methodologies for risk assessment.  
3.21.   In response to several  queries, Dr Yang provided further clarification on the approach 
employed by WHO  JMPR and FAO JMPR  in the establishment of pesticide MRLs , highlighting that 
both groups had the same priority of making  a recommendation on pesticide MRL s to Codex , for 
adoption by CAC.  However, she highlighted the  different aspects  focused on by the two groups: 
WHO undert ook the toxicology assessment (human health) ; while FAO review ed the residue trial 
to determine the residue level in crops. She underscored that b oth outcomes  were used  to 
compare whether the MRL would cov er the acceptable human risk in order  to make a 
recommendation. She also clarified that JMPR reevaluates compounds when new impurities are 
discovered.  
3.22.   Ms Gracia Brisco ,16 Food Standards Officer at the Codex Secretariat, presented the Codex 
procedures for the establishment of pesticide MRLs. She first rem inded participants that the 
SPS Agreement recognize d Codex as the international standard -setting body in the area of food 
safety. Ms Brisco further provided an overview of the role, structure and mandate of the Cod ex 
                                                
14 Speaker's presentation is available at:  
https://www.wto.org/english/tratop_e/sps_e/wkshop_oct16_e/s2_yong_zhen_yang.pdf . 
15 Available resources included the  FAO Manual on Submission and Evaluation of Pesticide Residues Data 
for the Estimation of Maximum Re sidue Levels in Food and Feed  (http://www.fao.org/3/a -i5452e.pdf ) and the 
FAO Manual on Evaluation of Pesticide Residues  (http://www.fao.org/3/a -i5545e.pdf ). 
16 Speaker's presentation is available at: 
https://www.wto.org/english/tratop_e/sps_e/wkshop_oct16_e/s2_gracia_brisco.pdf . G/SPS/R/85  
 
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  Alimentarius Commission, highlighting th at it was an intergovernmental food standards -setting 
body established by FAO and WHO.  
3.23.   In particular, she underscored  the role of the CCPR  in managing issues dealing with MRLs in 
food and feed. The mandate of CCPR  was to : (i) p repare priority lists of pesticides for evaluation 
by JMPR; (ii) establish pesticide MRLs in food and feed moving in international trade; (iii) consider 
methods of analysis and sampling for the determination of pesticide residues; (iv) establish 
EMRLs17 for environmental and industrial contaminants in food and feed (associated with the  
former use of pesticides in agriculture); and (v) consider any matter related to the safety of food 
and feed containing pesticide residues.  
3.24.   Ms Brisco emphasized  that Codex develops international food safety standards based on risk 
analysis principles , while highlight ing the importance of the  functional separation between risk 
assessment and risk management.  She provided an overview of the procedure for developing 
Codex standards, underscoring that there were t wo ways to establish  pesticide MRLs: (i) thr ough 
the regular 8 -step procedure  - where adoption  of the draft MRLs occur at Step 8 by CAC ; or 
(ii) through the accelerated procedure  - where adoption occurs at Step 5/8 by CAC.  She also 
explained that o ne of the key conditions for using the accelerated p rocedure was that the JMPR did 
not identify an intake concern, i.e. that the proposed MRL did not exceed the ADI and ARfD.  
3.25.   The process for the revision of MRLs, as well as revocation of MRLs, was also explained. 
Some of the challenges faced by CCPR include d the absence of Codex standards for some 
pesticides, the use of import tolerances at LOD/LOQ levels and revision of the international  
estimate of short-term intake  (IESTI ) equation , among others.  
3.26.   In the question and answer session , speakers provided clari fication on various areas of 
Codex and JMPR work. Ms Brisco  further  explained the process  for revocation of a pesticide MRL, 
highlighting that there was no strict lifespan for MRLs, but that there was a periodic review process 
which occurred in principle every 15 years. The two triggers to reevaluate the pesticide before 
15 years  were related to increased  health concerns and usa ge pattern of the pesticide. In the 
ensuing discussions various  MRL challenges were identifie d by developing countries, such as the 
lack of MRLs for products (e.g. sesame seeds). G roup MRLs  were indicated as a way to address 
some of the  MRL gaps, h owever, the challenges faced in undertak ing group MRLs at JMPR were 
highlighted , as there was currently no international agreement on the principles, criteria and 
procedure , although guidance was available in other fora.  
3.27.   The rol e of the CCPR versus the role of national registration authorities was also discussed . 
Several comments and queries were also raised regarding  the resource constraints faced by Codex 
and JMPR, in relation to data generation , lengthy  waiting list s for establishment of pesticide MRLs , 
and members ' capacity  to apply and implement Codex standards . Participants were encouraged to 
identify  solutions to address these challenges. In this regard, a  suggestion was made to simplify 
JMPR procedures, especially if there was consensus by members that th e uses of particular 
pesticide s were safe . The  query was raised whether in these situations it would be necessary for  
JMPR to conduct a full evaluation, especially in lig ht of the capacity constraints.  
3.3  Relevant bilater al, regional and international work on pesticide residues  (Session 3) 
3.28.   Speakers in Session 3 provided information on relevant bilateral, regional or international 
work in the area of pesticide  MRLs. Part 1 of the session  focused on ongoing regional MRL work 
being undertaken by the OECD , the Asia-Pacific Economic Cooperation (APEC) and the East African 
Community (EAC). In Part 2, speakers addressed issues related to establishing MRLs for minor -use 
crops (i.e. crops of low pesticide usage on a  global scale). In particular, focus was placed on the 
ongoing work being carried out through projects (supported by the STDF, USDA, IDB, JMPR and/or 
other  bodies ) in Africa, Asia, Latin America and North America, including the experiences in 
identifying M RL needs for developing country exports and the implementation of legislation for 
setting MRLs for minor -use crops.  
                                                
17 Extraneous maximum residue levels (EMRLs).  G/SPS/R/85  
 
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  3.3.1   Part 1: Regional Initiatives on MRLs – Ongoing work in OECD, APEC and EAC  
3.29.   Ms Donna Davis ,18 from the Office of Pesticide Programs, US Environ mental Protection 
Agency  (EPA) , provided an update on several regional  initiatives. She highlighted the importance 
of MRL harmonization in achieving national and international goals , as well as its role in supporting 
food safety, public health and environm ental protection. She also noted that international 
collaboration improve d the scientific basis of decisions and enhance d regulatory efficiency, while 
conserving resources and minimizing barriers to international trade . In provid ing an overview of 
the legislative statutes19 of the  US EPA regulatory framework, Ms Davis highlight ed the "risk-
based " approach to the tolerance (MRL) setting process  and underscored the legislated mandate to 
make a finding of "reasonable certainty of no harm " to support establi shment of a tolerance . 
3.30.   Ms Davis outlined  the US EPA's active participation in the work of several international and 
regional bodies, such  as Codex, OECD, JM PR, NAFTA and APEC. She highlighted s everal  ongoing 
OECD initiatives , which included th e MRL calcula tor tool , harmonized residue chemistry test 
guidelines and global joint reviews. Ongoing initiatives under APEC included t he import MRL 
guideline for pesticides  and an import tolerance pilot project  to determine the feasibility of 
accept ing other national authority or JMPR reviews to support the establishment of import 
tolerances.   
3.31.   Ms Davis  underscored  the importance of the use of  crop groups  in promoting harmonization  
and address ing the minor use issue . She highlight ed the need to agree  on a common crop gr oup 
definition , recogniz ed some of the harmonization challenges , and noted the o ngoing work  being 
undertaken by OECD and Codex to harmonize regulatory practices. Ms Davis provided information 
on OPP's work with industry and international partners to analy ze field trial data from various  
global zoning projects , which entail ed comparing residue data across a variety of geographic, 
environmen tal and climatic conditions  to determine  the impact on residue levels.  Some  of the 
preliminary  work had suggest ed that geographic diversity  could  have a far smaller impact on 
residue values . She indicated that i ssues like a pplication rate  and application pattern  could create 
more variability than geographic  differences , which meant that field trial data c ould support 
tolera nces in a variety of locations.  
3.32.   Several queries were raised in relation to the process for OECD global joint reviews, as well 
as the impact of geographic diversity on residue data from the APEC region and the impact of 
climate change on the effectiveness o f pesticide MRLs.  Ms Davis clarified the process for  OECD 
global joint review s, highlighting the advantages of this approach, such as the pooling of resources 
and encourag ement of common scientific review , while noting that these  reviews had also 
identified areas of inconsistencies  with JMPR 's work, mainly  in relation to hazard assessment. 
Ms Davis  indicated  that the global exchangeability of residue data was being addressed in multiple 
fora and that the statistical evaluation of these datasets was  still at an initial stage. She also  
explained that the United States had a re -evaluation programme, a s well as the OECD, to reassess 
pesticide uses, in order to consider issues such as the potential impact of climate change . 
3.33.   Dr Trevor Webb ,20 General Manag er of Food Standards Australia New Zealand – Australia,  
provided  an overview  of the APEC Import MRL Guideline for Pesticides , which included a 
background on the development of this guideline, the scope and issues covered , as well as  the 
implementation plan . In 2007, APEC member economies had agreed to create the Food Safety 
Cooperation Forum (FSCF) in order to build robust food safety systems; accelerate harmonization 
with international standards to improve public health and facilitate trade; and strengthen  capacity 
building activities and information sharing. As part of this process, FSCF had developed an APEC 
                                                
18 Speaker' s presentation is available at: 
https://www.wto.org/english/tratop_e/sps_e/wkshop_oct16_e/s3_1_donna_davis.pdf . 
19 The four  main legislative statutes  are: (i) Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
– which deals with pesticide labels with worker and ecological risk is sues; (ii) Federal Food Drug and Cosmetic 
Act (FFDCA) – which deals with risk from residues of pesticides on food and MRLs (or tolerances); (iii) Food 
Quality Protection Act (FQPA) – which amended both FIFRA and FFDCA, as well as codified the mandate to 
make a finding of "reasonable certainty of no harm " to support the establishment of MRLs; and (iv) Pesticide 
Regist ration Improvement Act (PRIA).  
20 This presentation was delivered on behalf o f Mr Steve J. Crossley , Manager, Scientific Strategy, 
International  and Surveillance, Food Standards Australia New Zealand — Australia. Speaker's presentation is 
available at: https://www.wto.org/english/tratop_e/sps_e/wkshop_oct16_e/s3_1_trevor_webb.pdf.  G/SPS/R/85  
 
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  MRL Roadmap wh ich focused on greater regulatory convergence of MRLs across the APEC region  
on the basis of several  broad principles . 
3.34.   In this regard, the development of a n APEC Import MRL Guideline for Pesticides had been 
agreed through a three -year FSCF project led and funded by Australia , and cosponsored by China, 
Philippines, Chinese Taipei, Thailand and the United States, as well as  with the  partici pation of the 
APEC Wine Regulatory Forum. The language and content of the guideline had been dev eloped in 
expert workshops , leading to the publication of the final document i n 2016 .21 Dr Webb provided 
some examples to illustrate the different policies and processes for adopting MRLs across the APEC 
region , while underscoring that the g uideline provided a "framework within which science -based 
standards c ould be developed and applied uniformly and transparently across APEC economies. "22 
3.35.   The guidel ine specifi ed the data  set required by exporting economies to support their 
request , and referenc ed Codex MRLs and JMPR assessments , where available. The guideline also 
identifie d a minimum data set on which to assess a request for an import pesticide MRL, where 
health -based guidance values had  been established either through a JMPR process or by an 
exporting country . Dr Webb further outlined the scope and issues co vered in the three sections of 
the g uideline and the accompanying three  attachments , and highlighted the  decision trees for 
different scenarios , e.g.  scenarios where Codex MRLs and national dietary exposure assessments 
exist or scenarios where Codex MRLs do not exist.  
3.36.   Upcoming implementation activities  included : further disseminati on of  the guide line; 
conducting  pilot testing on mangoes; ongoing work on laboratory capacity by China; further in -
country training to be funded by Australia ; and a  technical implementation workshop to be held in 
Australia in early 2017. To facilitate its implementation,  the guideline was also being translated 
into Chinese, Spanish and Vietnamese.  
3.37.   Mr Geoffrey Onen ,23 Government Chemist Laboratory,  Uganda  provided an overview of  
the East African Community 's regional initiative to harmonize pesticide MRLs , in order to facilitate 
regional and international trade in products of plant origin. In his overview, Mr Onen  first noted 
that most of the pesticide residue data needed to establish Codex MRLs had been generated in 
developed countries. As a result, few Co dex MRLs had been established for  specialty crops ,24 which 
were key crops for  EAC countries.  He highlighted  that the need to reduce divergences across 
national pes ticide regulatory regimes and domestic legislation  had led EAC partner States to focus 
on the  harmonization of pesticide MRL s. 
3.38.   In particular, the objective of the EAC initiative was to expedite reviews and registration 
timeframe; support regional moves to ensure availability of safe and efficacious pesticides; 
facilitate mutual recognition and enhance work sharing; and establish EAC MRLs.  
Mr Onen  provided an overview of the roles of the relevant bodies involved in th e development of 
MRL guidelines for the region  and the various steps taken by each in the process. Mr Onen  also 
outlined the purpos e and scope of issues covered in the Crop Residue Trial Protocol  which was 
targete d at those parties intending to register a pesticide product or to establish a MRL  for a 
pesticide product in a specific commodity in the EAC , as well as  authorities  responsi ble for 
regulating such substances and commodities. He explained that t he Protocol p rovide d a 
harmonized approach to planning, conducting and reporting crop field and laboratory trials in EAC 
partner States. In addition, t he protocol serve d to generate dat a of sufficient quality to quantify 
the expected magnitude of residue(s) , determine the rate of decline of the residue(s) of pesticide 
and promulgate EAC MRLs.  
3.39.   Some of the challenges faced in the harmonization work included crop differences; GAP use 
directions ; and regulatory  issues . Mr O nen also highlighted various l esson s learnt in the process , 
such as the importance of h armonization  in simplif ying the development of regional MRLs, and the 
role of mutual trust  and communication in the process.  In relation to next steps, he indicated  the 
                                                
21 This document is available at: http://publications.apec.org/publication -detail.php?pub_id=1750 . 
22 Page 9 of the APEC Import MRL Guideline.  
23 This presentation was delivered on behalf of Mr Michael Odong, Assistant Commissioner, Head 
Agricultural Chemicals Control Division, Department of Crop Inspection and Certification, Ministry of Agriculture 
Animal Industry and Fisheries . Speaker's presentation is available at: 
https://www.wto.org/english/tratop_e/sps_e/wksh op_oct16_e/s3_1_mike_odong.pdf.  
24 Crops of low pesticide usage on a global scale.  G/SPS/R/85  
 
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  following:  continued development of the guideline on crop field trials ; finalization of the documen t 
for establishment of EAC MRLs; development of standard operating procedures  to support 
accreditation of institution s conducting residue trials ; and a pproval and endorsement by the 
Council of Minister s. 
3.40.   In the question and answer session , the level of cooperative efforts across various 
regional and international bodies was noted, including the use of the OECD calculator in regional 
work. Within this context, the query was raised whether there were other types of cooperative 
activities that could further facilitate MR L harmonization . Some of the speakers' responses 
included : a broader dissemination of  the existing tools such as the APEC Guideline ; providing 
capacity training workshops , including training for registrants on data submi ssion; improving data 
generation ; working on single submissions ; adapt ing residue chemistry te mplates ; expanding 
global joint review s; and improving  communication between different governments.  
3.3.2   Part 2: Establishing MRLs for Minor -Use Crops  
3.41.   Mr Dan Kunkel ,25 Associate Director, Food and International Programs, IR -4 Project 
Headquarters , Rutgers State University of New Jersey , presented the experience of IR -4 in 
addressing grower needs, and fostering international cooperation in support of international 
harmonization. Mr Kunkel explained that the IR -4 Project (IR -4), funded by the US Depa rtment of 
Agriculture , was the primary entity in the United States that work ed to facilitate registrations of 
conventional and bio -pesticides on specialty (minor use) food crops , such as fruits, vegetables, 
nuts, herbs. Mr Kunkel outlined the challenges in  defining minor uses  and highlighted t he two 
prominent, and often opposing app roaches, to defining minor uses : (i) the "risk assessment " 
approach; and (ii) the "economic return"  approach. Specifically, t he IR -4 project focuse d on the 
economic return approa ch, where a grower ha d a pest control issue that was not being addressed  
and did not have a tool to address that situation .  
3.42.   Mr Kunkel observed that many coun tries we re either creating or modi fying systems for 
establishing and enforcing MRLs for import s and domestic use , which increased the complexity of 
moving commodities through global markets  and led to  a greater need for data generation . In this 
regard, IR-4's work provide d minor use crop growers with crop protection tools, given the  limited 
industry  investment in this area , by developing research data ( mostly pesticide residue  data), 
through  residues studies and field trials undertaken every year . This resulted in  the submission of  
a final report and research data to US EPA for review and establishme nt of MRLs . This data was 
often repackaged and submitted for the  establish ment of Codex MRLs.  
3.43.   Mr Kunkel highlighted IR -4's vision to establish a global network of minor use program mes 
working together to solve minor use grower needs . Key factors  in addressing the minor use issue 
included  global collaboration and cooperation . In this regard, IR-4 had co-sponsored Global Minor 
Use Summits and  had begun to build a platform of cooperation , which  serve d to help harmonize 
standards and to promote susta inable newer, lower risk products critical to modern integrated pest 
management systems. Other activities included the development of a Global Minor Use Foundation  
(GMUF)  to leverage resources.  
3.44.   Mr Kunkel shared IR-4's experiences in partnering with Canada,  highlighting the joint 
residue studies undertaken,  as well as the field trials and sample analys es conducted by Canada. 
Mr Kunkel underscore d the importance of working with other countries to leverage resources, 
highlighting the  direct cost savings to the  IR-4 project . Several tools which could promote th e 
harmonization  process  were highlighted , such as  crop grouping ; global zoning (exchangeability of 
field trials) ; incentives for industry  to support  minor uses ; MRL calculator ; crop group calculator ; 
and global joint reviews . Finally, Mr Kunkel drew participants ' attention to the Third Global Minor 
Use Summit which would take place in Montreal, Canada in October 2017.26 
3.45.   Mr Jason Sandahl ,27 Senior Program  Manager , Trade and Scientific Capacity Building 
Divisio n, Office of Capacity Building and Development, US Department of Agriculture  (USDA) , 
                                                
25 Speaker's presentation is available at: 
https://www.wto.org/english/tratop_e/sps_e/wkshop_oct16_e/s3_2_dan_kunkel.pdf.  
26 http://www.gmup.org/ . 
27 Speaker's presentation is available at: 
https://www.wto.org/english/tratop_e/sps_e/wkshop_oct16_e/s3_2_jason_sandahl.pdf.  G/SPS/R/85  
 
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  provided information on  the collaborative approach in addressing global MR L needs for minor -use 
crops. Mr Sandahl first identified some of the reasons for the absence of  Codex MRLs, such as the  
expensive and difficult nature of residue trials ; lack of support for a minor use crop by the 
pesticide industry; and lack of interested group s willing to conduct the work. He also  explained the 
reason s for differences in MRLs and underscored the l ack of coordination in the data generation 
process . 
3.46.   Mr Sandahl pr ovided an overview of the Global Residue Project for Tropical Fruits  which was  
initiated to develop global capacity for generating residue data to establish Codex MRLs, 
particularly for high -value specialty export crops . This project had been undertaken by the USDA 
and the US IR -4 Project, in close partnership with the Association of South East Asian Nations, the 
African Union, and the Inter -America n Institute for Cooperation on Agriculture  (IICA) . 
The Standards and Trade Development Facility (STDF)  had provided funding for this project , with 
leveraged contributions by USDA, US State Department, U S Agency for International 
Development, the Inter -America n Development Bank, and in -kind contributions from IR -4, Dow, 
Sumitomo, Syngenta, and participating national governments. The project , which had started in 
2012,  consisted of three regional initiatives undertaken in Asia, Latin America and Africa, spanning 
a representative range of tropical crops.  Project activities had included the identification of project 
crops and pesticides, field and laboratory training  on conducting residue research , undertaking  
actual research , data review and preparation of data pac kage for JMPR submission.  The project  
was due to be completed at the end of 2017.  
3.47.   The long -term vision of the project  was to e stablish  a global network of residue research 
teams to collaborate in generating data for MRLs  and to coordinate minor use program mes. 
To meet this goal, and to build upon gains accomplished under the STDF -funded project, USDA 
and IR -4 had created the Global Minor Use Foundation  (GMUF) , with the aim of identifying and 
prioritizing global MRL needs, encouraging exchange of data, and coordinating residue research 
across multiple countries. Mr Sandahl provided a practical example of how the Foundation could be 
used to implement projects in the future , in order to generat e data for joint submission to JMPR. 
He underscored  the importance of communication, coordination and collaboration in address ing the 
MRL issue for minor crops , as well as the role of various stakeholders . Mr Sandahl invited  the 
participation of other partners and exp erts in phase 2 of the project.  
3.48.   Several queries were raised in relation to the project's budgetary scope, the submission of 
data packages to Codex and the selection process for products.  Mr Sandahl clarified that capacity 
building and consumables had been included in the STDF project  budget and  highlight ed the 
training  activities undertaken to facilitate the project work , as well as i ndicated the future goal of 
implementing a cost -sharing approach with GMUF. Mr San dahl explained  that although the 
project's primary purpose was to  generat e data packages for submission to Codex, this data could 
also be submitted to export markets w here an import tolerance was needed.  He outlined the 
process for selecting products, w hich includ ed the review of FAO and CCPR 's work to determine the 
compounds which  could  be added to the nomination schedule , as well as other criteria related to 
identifying compounds with no challenges to toxicity  concerns . He also highlighted future  projects 
and welcome d countries to participate , as well as to attend the Global Mi nor Use Summit in 
October 2017.  
3.49.   Ms Ana Carolina Lamy ,28 Federal Inspector, Secretariat of Agribusiness International 
Regulations, Ministry of Agriculture, Livestock and Food Supply  of Brazil,  presented information on 
the Brazilian legislation for setting MRLs for minor -use crops. Ms Lamy first highlighted the process 
for registration of pesticides in Brazil, explaining the role of the three federal agencies involved in 
the process: Ministry of Agriculture (MAPA), Ministry of Health (ANVISA), and Ministry of 
Environment (IBAMA).  The aim of the legislation  was to address several issues identified by  the 
fruit and vegetable  sector  in relation to the non-existent or insufficient supply of pesticides for 
minor crops. This supply issue had arisen as a result of the lack of interest from the pesticide 
industry, due to  the limited revenue and sale of pesticides for minor crops , compared to the 
substantial costs to obtain and maintain registration. She explained that for the approval of new 
uses of existing pesticides, it was necessary to conduct crop field trials in order to determine the 
magnitude of the pesticide residue in or on raw agricultural commodities, and finally to derive 
                                                
28 Speaker's presentation is available at: 
https://www.wto.org/english/tratop_e/sps_e/wkshop_oct16_e/s3_2_ana_l amy.pdf.  G/SPS/R/85  
 
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  MRLs. The challenge faced was to create a fair system of pesticide registration for minor crops in 
Brazil.  
3.50.   Ms Lamy indicated  that the Brazilian regulation for minor crops had first been published in 
2010 and subsequently  reviewed in 2014.  In developing the regulation , inputs had been received 
from various stakeholders , such as universities , farmers ' association s, international references 
(IR-4, US EPA, Codex), and through official research. The goal of the  regulation was to encourage 
pesticide registration fo r minor crops by adopt ing the principles of crop grouping  and 
representative crop commodities for extrapolation of results from residue trials, so that data would 
not be  required for each crop. This had resulted in reducing  pesticide registration costs without 
increasing the risks to consumers and field workers.  
3.51.   Through the use of a specific example, Ms Lamy outlined  the parameters used in defining 
crop grouping s and representative crop commodities , as well as the legislati ve steps to allow 
registered pesticide MRLs used in a representative crop group (e.g. apples) , to be extrapolated to 
minor crop groups (e.g. blackberry) . She further explained that the MRL extrapolation was 
temporary , until the residue studies on a represen tative crop of the subgroup were concluded. 
The industry had two years to undertake the residue trials and present its data to the regulatory 
authorities. According to the results of the residue studies, a definitive MRL would then be 
established for all o f the minor use crops in that group. If a minor crop was not included in any 
group, interested parties could  apply  for its inclusion and submit a scientific and technical 
justification.  
3.52.   Ms Lamy  also provided  statistics on  pesticide  registration s for minor uses in Brazil , 
highlighting that since 2010, almost 500 minor crops had been covered, with more than 
1,000  target pests addressed. The c hallenges for minor -use crops in Brazil included increasing 
registration of minor use pesticides, in order to strengthe n the integrated pest management 
approach and minimize pest resistance; and  promoting global MRL harmonization , in order to 
facilitate international trade  through  support  to the JMPR/Codex reviews.  
3.53.   In the question and answer session , Ms Lamy further clarif ied that definitive MRLs could 
be established in 2.5 t o 3 years, but that this depended  on the particular situation and how quickly 
the industry undert ook the residue trials. She also provided further information on th e MRL 
extrapolation  process  from the r epresentative crop to a minor crop  and explained  Brazil 's approach 
to crop grouping , indicating that there could be some differences between its approach and the 
Codex system . However, she explained that once the parameters to define the crop groupings and  
representative commodities  were established, revisions were always being made.  
3.54.    Mr Kunkel  addressed the issue of  comparability of dietary needs and MRL practices across  
region s, explaining the differences in  use patterns , as well as  the project's focus on the critical GAP 
which would give the mo st flexibility in pesticide  use, based on the most conservative use pattern.  
Mr Kunkel acknowledged  the expensive nature of field analys es due to the more stringent 
requirements for compounds and changing residue definitions , indicat ing the challenges faced in 
registering pesticides in multiple countries.  He also underscored the need for regulatory bodies to 
align reviews  on a lateral  rather than linea r basis , and to have discussions on residue definitions at 
the beginning  of the process . In response to a query on the types of industry incentives that could 
be used to promote harmonization , Mr Kunkel provided information  on an OECD survey which had 
identified various  incentives to promote minor use registration , such as  providing public funding for 
minor use program mes; and exten ding the exclusive use period for protection of data rights for 
minor use registrations. He also highlighted Brazil's  approach to allow a  temporary MRL , while the 
industry  generat ed data, and he further encouraged industry  initiative to generate data on minor  
uses.  
3.55.   Workshop p articipants highlighted s everal challenges in implementing MRLs in Africa , such 
as various  capacity needs , including GLP compliance . In this regard, it was suggested th at the next 
phase of the global residue project  could target capacity building focused on  laboratories, as well 
as the inclusion of additional countries in the data generation  process . In re sponse, Mr Spreij  
(STDF)  indicated that laboratory capacity and other infrastructure could be reviewed  in the next  
project  phase, including the mobilization of other organizations, such as the African Development 
Bank, while underscoring  STDF's demand -driven approach.  Mr Sandahl encouraged count ries 
interested in the project to come forward  and further noted that  training needs would be better 
addressed  in the next phase. The role of regional economic communities , such as AU -IAPSC,  G/SPS/R/85  
 
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  in supporting collaborative approaches was also highlighted, specifically in the dissemination of 
good practices from the various projects , as well as in addressing  the challenges faced in  
encouraging  data registration in Africa.  
3.4  Domestic frameworks and approaches for establishing MRLs  and import tolerances  
(Session 4) 
3.56.   In Session 4, speakers explained their domestic regulatory and legal infrastructures for 
establishing MRLs. In addition, through the use of case studies, speakers provided insights into 
their domestic frameworks for establishing MRLs and import tolerances. In particular, they 
highlighted their approaches to risk assessment and risk management where no international 
standard exist ed or where an existing international standard was not used.  The session also 
explored concerns related to specific commodity and pesticide combinations . 
3.4.1   Part 1: Domestic Policy, Regulatory and Legal Infrastructures for Establishing 
MRLs  
3.57.   Mr Volker Wachtler ,29 Policy Officer, Directorate -General for Health and Food S afety, 
European Commission , provided an overview of the EU policy for setting pesticide MRLs. 
Mr Wachtler explained the core types  of EU legislation30 which cover ed all stages of the lifecycle of 
a Plant Protection Product (PPP), regulating the placing on the market and use of PPPs , and 
pesticide residues in food and feed , as well as the General Food Law  (Regulation (EC) No 
178/2002) . Specifically, Mr Wachtler provid ed an overview of the general principles of Regulation 
No 396/2005 on  pesticide  MRLs,  which aims to protect consumers through the establishment and 
enforcement of MRLs, while facilitating trade .  
3.58.   Mr Wachtler explained the EU MRL setting process, highlighting that a consumer risk 
assessment was undertaken, based on a comparison of the exposure to toxicological reference 
values , similar to the process presented by WHO JMPR . In addition, the  ALARA principle (as low as 
reasonably achievable)  was followed in the  EU MRL setting process , and the OECD calculator  was 
used. For substance/commodity combinations without data, the MRL was either  set at the 
analytical limit of quantification ,31 or at the default value of 0.01 mg/kg  if there w as no information 
on the analytical methods . In this regard, predictability  was provided  in the process, as oppose d to 
a zero -tolerance approach.   
3.59.   Mr Wachtler indicated that EU MRLs were established either on the basis  of GAPs in 
EU member States , GAPs in third countries , or on Codex Alimentarius standards . He provided 
additional details on the data requirements to accompany requests by third countries applying  for 
MRLs and referred to the information available in the  Guidance Document on the MRL  Setting 
Procedure.32 He underscored that MRLs, once established, appl ied to all food and feed on the EU 
market, whether from EU member States or third countries.  Additional MRL information could be 
found in  the EU Pesticides Database ,33 and detailed technical and procedural guidance was 
available on the website of the European Commission.34 
3.60.   Mr Wachtler further described the procedural framework , timelines and actors involved in 
the MRL setting proces s, both  for EU uses  and import tolerance requests.  He highlighted that 
applications could be submitted by any party with a legitimate  health or commercial  interest  and 
explained  the information to be submitted in the dossier and the subsequent review process. 
Mr Wachtler also outlined  key features of the ongoing review programme of  existing MRLs  in the 
European Union, highlighting that additional information on the programme, as well as the process 
for third countries to contribute information, could be found  in document  G/SPS/GEN/1494.  
                                                
29 Speaker's presentation is available at: 
https://www.wto.org/english/tratop_e/sps_e/wkshop_oct16_e/s4_1_volker_wachtler.pdf.  
30 The relevant EU legislation is as follows: Regulation (EC) No 1107/2009 on placing of PPP on the 
market ; Directive 2009 /128/EC on sustainable use of p esticides ; and Regulation (EC) No 396/2005 on MRLs of 
pesticides . Legal texts  available at: http://eur -lex.europa.eu/homepage.html . 
31 The EU has four reference laboratories responsible for pesticide residues, which provide advice on the 
appropriate LOQ which is taken into account  during the decision -making process.  
32 SANT E/2015/10595 Rev.4, available at: 
http://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_mrl_guidelines_mrl -setting -proc.pdf . 
33 http://ec.europa.eu/food/plant/pesticides/eu -pesticides -database/public . 
34 http://ec.europa.eu/food/plant/pesticides/max_residue_levels/guidelines/index _en.htm . G/SPS/R/85  
 
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  Some of the MRL challenges faced by the European Union were highlighted , such as the interplay 
between different pieces of EU  legislation , in relation to  procedures  and timelines; minor use 
crops; and negative public perception of the use of pesticides. Mr  Wachtler  furthe r provided 
information on the EU Minor Uses Coordination Facility ,35 which had been  established in 2015 to 
coordinate the work carried out in EU member States and to liaise with international actors.  
3.61.   Questions were raised on the procedure for third countrie s to provide comments on new 
MRLs and on the review programme , including submission of inputs on  the criteria for endocrine 
disruptors . Mr Wachtler clarified the process for  providing  feedback on the  review of existing MRLs, 
highlighting that d raft acts were notified  to the WTO for submissi on of comments by third parties 
and that third countries could also provide inputs at the beginning of the evaluation process . 
He referred to the information  note ( G/SPS/GEN/1494) which set out the steps for submission of  
information and further encouraged the circulation of this document to industry. He also clarified 
the procedure for the establishment of new MRLs.  Mr Wachtler distinguished between the review 
programme for existing MRLs and the ongoing discussions on end ocrine disrupting compounds, 
explaining that a  decision had not yet been taken on endocrine disrupting compounds . He further 
invited participants to attend the information session that would be held by the European Union on 
the margins of the SPS  Committee  meeting .  
3.62.   In response to a query, Mr Wachtler  indicated some of the scenarios in which the European 
Union had increased the MRL of a pesticide , and responded to  the concern raised regarding  
European Union's reservation s on certain  compounds  in CCPR . In relation to  private standards and 
EU market access, Mr Wachtler clarified that EU MRLs were based on evaluation procedures  
outlined in the legislation. He acknowledged the presence of private standards, but highlighted 
that the E uropean Union was not invol ved in this area and did not operate private standards  
schemes . 
3.63.   Mr Takuya Kondo ,36 Assistant Director, Standard and Evaluation Division, Department of 
Environmental Health and Food Safety, Pharmaceutical Safety and Environmental Health Bureau, 
Ministry of H ealth, Labour and Welfare, Japan , provided an overview of pesticide MRLs in Japan.  
He highlighted the i mportan ce of ensur ing food safety in the trade of goods and the  critical role of 
MRLs in that regard . He also outlined  Japan's risk analysis approach and the role of three 
government institutions in activities related to risk assessment, risk man agement and risk 
communication.  
3.64.   Mr Kondo explained that pesticide MRLs were regulated  under the Japanese Food Sanitation 
Law and that  they were  established on t he basis of an  Acceptable Daily Intake (ADI) and an Acute 
Reference Dose (ARfD) as estimated by the Japanese Food Safety Commission. He outlined  the 
risk analysis principles used in establishing pesticide MRLs in food, such as ensuring that the 
theoretical  maximum daily intake did not exceed 80% of the ADI, and that the chemical intake 
from each food commodity did not exceed the ARfD. Vulnerable groups, such as infants, children, 
pregnant women and elderly people were also considered  in the evaluation proce ss. 
3.65.   Mr Kondo indicated  that s ince May 2006, the Ministry of Health, Labour and Welfare (MHLW) 
had int roduc ed a "positive list system " for pesticides, where all food items we re regulated for 
pesticide residue s and where substances without specific MRLs could not exceed the uniform 
standard  of 0.01 ppm. Through the positive list system, all agricultural chemicals were now 
targeted and MHLW had been accepting an import tolerance requirement for pesticides as 
approved by the foreign country. He further expla ined that t he import tolerance system enable d 
the Japanese government to set MRLs for pesticides in imported food products. Applicants c ould 
request the MHLW to set new MRLs or set MRLs higher than the corresponding MRL  in Japan, and 
were required to submi t documents supporting the safety of target pesticides . Some e xamples of 
the required documents  to accompany the application  were provided . Additional information on the 
process for import tolerance applications could be found on MHLW 's website: 
http://www.mhlw.go.jp/english/topics/foodsafety/residue/index.html . 
                                                
35 https://www.minoruses.eu/ . 
36 Speaker's presentation is available at: 
https://www.wto.org/english/tratop_e/sps_e/wkshop_oct16_e/s4_1_takuya_kondo.pdf.  G/SPS/R/85  
 
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  3.4.2   Part 2: Domestic Frameworks for Risk  Assessment and Risk Management  
3.66.   Dr Peter Chan ,37 Director General, Health Evaluation Directorate, Pest Management 
regulatory Agency, Health Canada,  provided information on the Canadian regulatory approach for 
establishing MRLs.  He highlighted that under the Pest Control Products Act (PCPA), the Pest 
Management Regulatory Agency of Health Canada t ook a risk -based approach to specify MRLs for 
pesticide residues in food , where  risk assessments consider ed both the hazard and exposure. 
In addition, MRLs were enforced under the Food and Drugs Act.  Dr Chan outlined the Canadian 
MRL setting process, highlighting that Canadian MRLs were set only after an extensive review of 
the scientific information and after a thorough risk assessment confirm ed that there were no 
health concerns to all segments of the population , when all possible food sources we re eaten every 
day, over a lifetime. When established, the MRLs applied  to all foods, regardless of whether they 
were from Canada or imported, an d were set at levels well below the amount th at could pose a 
health concern.  
3.67.   Dr Chan provided information on Canada's approach  to risk assessment and risk 
management  where international standards a re not used , such as in the case where  international 
MRLs are not aligned  with Canadian MRLs  for the same pesticide/commodity combina tion. 
Examples of this  scenario included  cases where there were differences in d ata packages; residue 
definitions; environmental conditions and pest pressures leading  to different application rates and 
different GAPs; methodologies for calculating MRLs  (e.g. NAFTA vs OECD calculator) ; criteria or 
legislative authorities for setting MRLs ; and dietary and cultural preferences . Dr Chan also 
explained that w here a tiered approach38 was used for the dietary risk assessments  and there 
remain ed risks of concern, MRLs were set at the limit of q uantification (LOQ) of the enforcement 
method . He further indicated  that Canada took into  consideration Codex MRLs , where available.  
3.68.   Dr Chan highlighted several  suggestions to minimize trade disruptions , from various 
perspectives . He underscored the responsibility of g rowers  to communicate their needs to 
registrants regarding crop s and export market s, as well as being aware of MRLs in other countries . 
For the industry, he underlined the benefits of globally harmoniz ed GAPs, undertaking  global joint 
review submissions , consider ing domestic registrations in key export markets  and submission of  
the same data package globally . For re gulatory authorities , he encouraged participat ion in global 
joint reviews , contri buting  to Codex (JMPR/CCPR) activities  and development of policies based on 
science . 
3.69.   In the question and answer  session , queries were  raised on  several areas related to  
the procedure for setting default MRLs  and LOQs; the use of MRL calculators; and the MRL setting 
process to facilitate imports of raw or semi -processed products for use in domestic production . 
Dr Chan indicated that the default MRL of 0.1ppm  applied to pesticides  that were  not registered in 
Canada and explained the process for the establis hment of LOQs. Dr Chan  also indicated that 
Canada had been using the OECD calculator  since 2006 , prior to which it had used the NAFTA 
calculator.  Mr Wachtler explained that the MRL decision -making process for establishing MRLs did 
not factor in the trade c osts, but instead focused on  the evaluation of submitted data packages 
meeting the application requirements , as well as robust risk asses sments . He further explained 
that while EU legislation provided for the  possibility of setting MRLs for semi -processed foods , in 
practice MRLs were only set for agricultural products. Dr Chan indicated that the Canadian 
legislation provided  for the establishment o f MRLs for processed comm odities , explaining that i n 
most cases , MRLs for the raw commodities captured residue issues , however, MRL s could be set 
for pro cessed commodities , as necessary.   
3.70.   In relation to the required documentation for  import application requests , Dr Chan explained 
that there had to be a  registered use in order to apply for an import MRL.  Mr Wachtler  also 
indicated  that there needed to be a label and established pesticide MRL in the requesting country, 
before submission to EFSA. Dr Chan also addressed the issue of the efficiency of joint reviews, 
highlight ing the need for capacity building and increased participation of global partners , and 
further encourag ed the involvement of non-OECD countries.  The mi nimization of science -based 
interpretation differences  was also underscored as a positive outcom e of the joint review process , 
which ha d facilitated the establishment of  MRLs in a more timely  and aligned  fashion. Mr Wachtler 
                                                
37 Speaker's presentation is available at: 
https://www.wto.org/english/tratop_e/sps_e/wkshop_oct16_e/s4_2_peter_chan.pdf.  
38 Tier I: MRLs; Tier II: field trial data and Tier III: food monitoring data . G/SPS/R/85  
 
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  noted that the EU regulatory timelines made it challenging for the participation of the European 
Union in such review s. Partici pants  also highlighted t he various challenges related to the varying  
data requirements by trading partners, as well as prioritization issues related to the establishment 
of pesticide MRLs for domestic uses vs. import MRLs.  
3.5  Experiences  in implementing and complying with Codex MRLs  (Session 5) 
3.71.   Dr Olga Egorova ,39 Senior Researcher at the  F.F. Erisman Federal Scientific Centre of 
Hygiene (Rospotrebnadzor) , presented  the Russian Federation's experience in complying with 
Codex pesticide MRLs . Dr Egorova explained that the  process of harmonization date d back to 2009  
with the implementation of  Deсree No. 761 of 28 Septembe 2009 on Harmonization of Russian 
Sanitary and Epidemiological Requirements, Veterinary and Sanitary and Phytosanitary Measures 
with International Standards . She also highlighted other pieces of Russian legislation relevant to 
the harmonization process , while noting  that t he scientific principles used in establishing pesticide 
MRLs in the Russian Federation were the same a s those used by Codex . 
3.72.   Dr Egorova outlined  the process of MRL harmonization , both  for pesticides authorized in the 
Russian Federation  and for imported products not authorized in the Russian Federation. MRL 
setting in the Russian Federation included the  toxicological assessment of pesticides and their 
hazardous metabolites , and the development of MRLs for each active ingredient intended for use in 
the Russian Federation, according to the complex hygienic regulation  principles .40 These principles 
were not applicable for any pesticide active ingredient in imported products that we re not being  
registered in the Russian Federation. She further outlined the process by which pest icide residue 
data w ere generated, highlighting the importance of field trials  across various  soil-climatic zones  
and growing seasons  at a maximum use rate. An example of a risk and exposure assessment of  
the non -carcinogenic effects of Chlorantraniliprole  at food  intake  was also provided . 
3.73.   As a result of the harmonization of Russian p esticide MRLs with Codex standards , 
1,500  MRLs of 162 active ingredients  had been revised , 66 of which were new active ingredients.41 
Guidelines on MRL establishment and risk assessment  had also been developed, along with 
eleven  harmonized analytical methods of control for 66 individual commodities based on 
international approaches. Ms Egorova noted that t he process of MRL harmonization was depen dent 
on the submission of toxicological and residual data for the registration of pesticides . In addition, 
the periodic MRL review program me in the Russian Federation ha d resulted in two amendments to 
the list of pesticide MRLs  in 2015 and 2016.  Dr Egorova also highlighted the obligations under 
EurAsEC , emphasizing the  shared responsibility  of EurASeC members  in the MRL setting  process. 
In 2015, amendments  had been made  to the Custom Union Commission Decision No 299, which 
included the harmonization of pesticide MRLs with international MRLs and a list of validated 
analytical methods for  the determination of pesticide residues.42 
3.74.   Some of the obstacles faced in the  harmonization process were the significant divergence 
between the pesticide MRL values set by Codex  and those used in the Russian Federation; and the 
frequent and significant rec onsideration of standards approved by international and national 
bodies , on the basis of human risk dat a. Lastly, she highlighted  that harmonization of Russian 
MRLs with Codex MRLs had led to a significant increase in the level of acceptance of Codex MRLs  
and that the harmonization process w ould continue.  
3.75.   Mr Rául Pera lta Girón ,43 Director, Agrifood Safety Department, Ministry of Agriculture, 
Dominican Republic,  provided information on  the impact of the implementation of Codex MRLs on 
export s of fruits and fresh vegetables. Mr Peralta  explained  that the Dominican Republic  exported 
                                                
39 Speaker's presentation is available at: 
https://www.wto.org/english/tratop_e/sps_e/wkshop_oct16_e /s5_olga_egorova.pdf.  
40 The complex hygienic regulation dictates that the total amount of a pesticide active ingredient (and 
products of its transformation), which can be absorbed into an organism from various media (food, water and 
atmospheric air), must not exceed an acceptable daily intake (ADI) for a human being.  
41 A list of MRLs is  available in  the Hygienic Standards of 2013 (HS -1.2.3111 -13). 
42 Uniform sanitary and epidemiological and hygienic requirements for products subject to sanitary and 
epidemiol ogical supervision (control); Section 15. Requirements for pesticides and agrochemicals, EurAsEC, 
2015, Moscow . Decision of the Board of the Eurasian Economic Commission N o 149 of 10 November 2015 
"On Amendments to the Customs Union Commission Decision N o 299 d.d. 28 May 2010 ." 
43 Speaker's presentation is available at: 
https://www.wto.org/english/tratop_e/sps_e/wkshop_oct16_e/s5_raul_peralto_giron.pdf.  G/SPS/R/85  
 
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  a variety of fresh fruits and vegetables to the United States, Canada and the European Union , 
accounting for more than US$300 mill ion. However, in recent years, exports of these products ha d 
been affected by rejection notifications and notices of non -conformity, linked to the detection of 
pesticide residues higher than th ose approved  in the  MRLs of the  importing country . This situation  
had led national authorities  to adopt Codex MRLs  as official national MRLs in 2010 , through 
Regulation 244 -10. This regulation incorporated risk assessment principles for the registration and 
renewal of pesticide registration s.  
3.76.   In order to implement Codex MRLs, the authorities had under taken the following  actions : 
(i) established  a baseline for pesticide residues under  a monitoring plan carried out from  2011-
2013; (ii)  established a National Programme for the Monitoring of Pe sticide Residues in 2014; 
(iii) developed a t raceability system  for rejection notifications due to pesticide residues ; and  
(iv) created a  publicly accessible database  of pesticide MRLs. Mr Peralta  also presented the results 
of the baseline study, highlighting  that 93% of the  products were in conformity with the adopte d 
MRLs, according to Regulation 52 -08. Mr Peralta  further noted that only 21 % of the  pesticide MRLs  
notified by the destination market had established Codex MRLs. In addition, 89% of national 
pesticide MRLs  identified as non -compliant in the destination ma rket were within the Codex MRL s, 
highlighting that trading partners ha d established stricter legislation.  
3.77.   Mr Peralta  provided two examples of MRLs for Carbendazim  and Permethrin for use in 
pimentos , which had been  notified as non -compliant  by trading partners , and observed that the 
notified MRLs were actually more restrictive than the Codex MRLs.  He noted th e positive reaction 
to the implementation of Codex MRLs, as it had increased consumer trust.  Some of the difficulties 
faced in the harmonization process included trading partners' use of MRLs more restrictive than 
Codex MRLs; lack of Codex MRLs for most of the pesticides; obtaining analytical standards; and 
the high accreditation costs for laboratory tests an d maintaining laboratory t eams.  
3.78.   In the question and answer session , Mr Peralta addressed the challenges faced in  
exporting  certain products , when  specific  Codex pesticide MRLs were not  established. He explained 
that in this situation , the MRLs of other trading partners w ere adopted , such as the United States 
and the European Union . In response to a  query regarding the challenges in establishing GAPs 
after pesticide  MRLs had been adopted, Mr Peralta  highlight ed that once MRL s were  adopted , an 
assessment was undertaken of  the level of  compliance among producers . He noted the pressures 
from the domestic and international markets, but underscored  the importance of consumer safety.  
Mr Peralta also acknowledged t he various constraints faced in relation to the  operational costs for 
laborato ry machinery , underscoring  the challenge s faced in  maintaining  functional laboratories  and 
meeting high accreditation costs. 
3.79.   In relation to the recognition of GMPs by various  trading partners, Mr Peralta noted  the 
importance of produc ing on the basis of the most demanding market,  in order to ensure 
compliance with all markets. With respect to the  frequency with which reviews  were undertaken in 
order to harmonize  the Russian Federation  MRLs with Codex standards,  Ms Egorova  explained the 
review process and  indicated that updated lists were published every two to three years. T he first 
list had been  published in 2013, followed by  two subsequent amendments  in 2015 and 2016.  
3.6  Panel discussion on the role of the private sector in the establishment and 
implementat ion of MRLs (Session 6) 
3.80.   Through the use of specific examples, speakers in this session explored the various ways in 
which the private sector could be involved in the establishment of MRLs , their experiences in the 
implementation of MRLs  and challenges faced . In particular, the session highlighted the role of the 
private sector in providing support for the scientific review process through data sharing, expert 
consultation and contribution of financial resources  to support the review proc ess. 
3.81.   Mr Matt Lantz ,44 Vice President, Global Access , Bryant Christie Inc . (BCI) , United States,  
provided information on how commodity groups and the private sector c ould approach 
international MRL issues , the challenges faced and the possible areas for coop eration. Mr Lantz 
first provided background information on the  work undertaken by Bryant Christie Inc. , a US-based 
consulting firm  specializing in international MRL issues  and representing  grower groups in a 
                                                
44 Speak er's summary is available at: 
https://www.wto.org/english/tratop_e/sps_e/wkshop_oct16_e/s6_matt_lantz.pdf.  G/SPS/R/85  
 
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  number of commodities . BCI also developed and maintained  GlobalMRL.com, a database that 
house d up-to-date MRL information for over 115 markets.  
3.82.   Mr Lantz categorized BCI's work on international MRL  issues into two broad areas : 
(i) dealing with major pesticide regulatory changes in key export market s; and (ii) undertaking 
day-to-day management of MRL issues.  BCI's objective was to ensure  that its clients' trade was 
not affected by major MRL regulatory changes in target market s, which included  assessing which  
pesticides were  used domestically and  identify ing any gaps in the new MRL lists of trading 
partners . BCI's work also included  reviewing and monitoring  notifications to determine regulatory  
changes and submit ting comments , as well as c ooperat ing with registrant s on new products on 
offer to seek MRLs  and assist ing groups to address  residue violation s in foreign market s. 
3.83.   Several  challenges  faced by the private sector were highlighted , which included  the timing  
of MRL establishment; differing data requirements; obtaining MRLs for older products ; onerous 
violation sanctions; and limited  time for submitting  comment s on proposed MRL changes  or 
comments  not being  taken into consideration by trading partners . Mr Lantz also noted the recent 
positive developments  in managing international MRL issues, su ch as cooperation between 
international grower groups, increased availability of MRL data , discussion of MRL issues in 
different fora and the increased number of MRL notifications to the WTO. He also indicate d that the 
technical nature of MRLs provided opp ortunities for resolving issues through cooperation , whether 
among  grower groups , collaboration among registrants on data submissions, or cooperation by 
governments on joint reviews.  
3.84.   Mr Michael Kaethner ,45 Global Regulatory Policy Manager, Bayer CropScience , Germany,  
provided information on the work of CropLife International , highlighting its role as the voice of the 
global plant science industry  through its championing of agricultural innovations in crop protection 
and plant biotechnology, as well as advancing sustainable agriculture. Mr  Kaethner outlined  its 
activities  geared at obtain ing national MRLs, import MRLs and Codex standards for use of crop 
protection products.  In relation to national and import MRLs, Mr Kaethner  outlined the work 
undertaken  on product authorization and submission of MRL data . He highlighted the various ways 
in which CropLife International  contribut ed to the Codex  process , through its support  to the 
nomination process for active substances and uses, submi ssion of  detailed stu dy reports and 
comprehensive summary dossiers  for scientific evaluation by FAO and WHO JMPR, as well as 
involvement in electronic working groups . He underscored that m ost C odex MRL s were based on  
data submi tted by the crop protection industry . 
3.85.   Mr Kaethner  noted  the importance of the APEC initiative to develop an Import MRL Guideline 
for Pesticides,  since not all countries ha d provisions to set import tolerances . He also observed that 
not all countries defer red to or accepted Codex MRLs , and further encoura ged countries  to make 
their national policies publicly available in order to facilitate trade. With respect to h armonization 
of data,  Mr Kaethner explained  the support provided by CropLife International's experts in the 
development of improved tools and gu idance for MRL setting through  its contributions to the 
OECD's Residue Chemistry Expert Group . In addition, it had  also provided data and expertise to  
the IR-4 project , as well as  various government initiatives.  
3.86.   Mr Kaethner identified some  of the  MRL challenges faced by  the private sector , such as 
improving the harmonization of data requirements and policies, as well as increasing transparency 
and predictability in the decision -making process , especially in relation to the acceptance of Codex 
MRLs by g overnments . He also underscored the uncertainties arising from the introduction of new 
national approaches for import MRL setting.  In highlighting the capacity constraints  faced by FAO 
and WHO  in meeting the increasing demand for pesticide MRLs, Mr Kaethne r suggested that 
members needed to have a  fresh perspective in relation to the procedures and approaches  that 
could be adapted.  He further encourage d trade representatives to interact with their national 
regulators and ministries responsible for undertakin g risk assessment and risk management 
activities,  in order to ensure that MRLs were set to meet consumer safety goals , while  enabling 
free trade.  
                                                
45 Mr Kaethner is also Chair of the Consumer Safety Team at CropLife International. Speaker's summary 
is available at: https://www.wto.org/english/tratop_e/sps_e/wkshop_oct16_e/s6_ michael_kaethner.pdf.  G/SPS/R/85  
 
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  3.87.   Mr Gord Kurbis ,46 Director of Market Access and Trade Policy, Pulse Canada, provided an 
overview of the work of  Pulse Canada47 and its role in ad dressing MRL -related issues. 
He highlighted that t he Canadian pulse industry was the largest exporter of pulses , trading to over 
150 countries from approximately 25,000 farmers. Following the experience of an MRL -related 
trade disruption in 2011, Pulse Canada  had expanded  its focus to include  the challenges to export 
trade associated with M RLs. In this regard, the association was now  execu ting a domestic 
framework of co -operation,  information -sharing and management of trade risks associated with 
MRLs. This framework applie d to both large and small exports of pulses , as well as to specialty 
products grown under contract by a small number of farms or other pulses  grown on a commodity  
scale by individual farmers. A key component of the framework wa s information -sharing among 
farmers, government and the pesticide industry  leading  toward s the  establishment a nd 
implementation of key MRLs.   
3.88.   Mr Kurbis further explained that as part of the International Year of Pulse s 2016, Pulse 
Canada was participating in the Global Pulse Confederation 's advocacy efforts concerning the 
extent to which misaligned MRLs could  disrupt trade and constrain growers ' productive use of 
pesticides in pulse growing r egions around the world. He underscored the increasin g opportunity to 
expand positive examples of MRL collaboration between governments  to manage ongoing 
challenges, such as the  OECD global joint reviews . 
3.89.   Some of the challenges included:  (a) establishment of national MRL lists without reference  
to Codex ; (b) apply ing zero, near -zero or undefined default MRLs in the absence of established 
MRLs; and (c) apply ing testing with limits of detection much lower than were possible when MRL 
policies were established.  He also highlighted the importance of ensuring  that the Codex MRL -
setting process was adequately resourced, given the  greater need for a single, global MRL 
reference.  
3.90.   Ms Morag Webb ,48 Policy Adviser, COLEACP49, highlighted the MRL work undertaken by 
COLEACP in representing the interests of EU importers, and ACP (Africa, Caribbean and Pacific) 
producers and exporters of fruit, vegetables, flowers and plants. The overall goal of COLEACP was 
to facilitate the flow of trade between ACP countries and the E uropean Union, and within the ACP 
region.  In this regard, she explained how COLEACP had extended its activities  into the 
implementation of EU-funded technical assistance programmes , such as the Pesticides Initiative 
Programme  (PIP - Phases 1 and 2) , which ran from 2001 to 2015.  
3.91.   PIP was designed  to provide producers and exporters with the necessary information, 
training and support so that they could meet the new EU food safety regulations and private 
industry standard s. In particular, t he EU MRL Harmonization  programme had set new limits for 
pesticide residues in foodstuffs sold in Europe. Ms Webb detailed the  various activities  undertaken 
by COLEACP  to allow producers to have effective and affordable methods of pest management . 
This includ ed, among others , undertaking surveys to identify the most critical crop -pest 
combinations where ACP producers faced a real risk of losing market access ; analyzing data to 
develop proposed  MRLs; preparing import tolerance dossiers for submission; liaising with 
rapporteur member States; and applying for new and extrapolated MRLs. The importance of 
public -private partnersh ips was also highlighted, such as the collabora tion with PPP manufacturers 
and COLEACP's role in identifying and coordinating the various stakeholders, orchestrating the 
complex series of activities required and sec uring the necessary investment.  
3.92.   Ms Webb highlighted the concrete results of COLEACP acti vities under the PIP programme, 
which included the granting of a total of 43 EU import tolerances  between  2001 and 2015 , and 
obtaining extrapolations for more than 10 substances on crops  that included snow peas, yams and 
sweet potato es. Ms Webb also explained that o ne additional  EU import tolerance was pending and 
that data ha d also been submitted for several C odex MRLs, but progress was delayed pending 
registration extensions, and changes in residue definition. In addition , 140  crop-active  ingredient 
                                                
46 Speaker's summary is available at: 
https://www.wto.org/english/tratop_e/sps_e/wkshop_oct16_e/s6_gord_kurbis.pdf.  
47 Pulse Canada is a  national association of farmers and exporters . 
48 Speaker's summary is available at: 
https://www.wto.org/english/tratop_e/sps_e/wkshop_oct16_e/s6_morag_webb.pdf.  
49 The Europe -Africa -Caribbean -Pacific Liaison Committee (COLEACP) is a private sector association 
which provides a range of services to members in support of horticultural import and export activities , 
including communication, technical assistance, lobbying, and advocacy.  G/SPS/R/85  
 
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  combinations had been  tested in ACP fruit and vegetables to define the pre -harvest interval for 
compliance with EU and Codex MRLs, and to develop GAP recommendations for local conditions.  
3.93.   In the question and answer session , various questions were raised on the ways to  
increase private sector engagement in the establishm ent and implementation of MRLs and how 
support could be provided to the industry. Some suggestions from speakers included encouraging 
proactive dialogue and engagement between ind ustry and regulatory authorities to identify 
growers' needs  and priorities;  notifying MRLs in advance and considering submitted comments; 
introducing  new residue requirements at a pilot testing stage; governments taking the least trade 
restrictive measure and finding reasonable policy solutions or transitional measures  in the face of 
changing residue requirements ; public investment for generating public goods; fast tracking 
applications; capacity building for regulatory authorities; sharing of reviews among  regulators; and 
standardization of data submission packages .  
3.94.   Questions and comments  from participants  also focused on the lack of  MRLs for certain 
pesticides  and the need for a more efficient Codex process . Speakers were encouraged to propose 
fresh ideas  with respect to a more efficient Codex system . Some of these suggestions included  
submi ssion of the  same data packages to JMPR; consideration of  whether  new substance s, which 
had already  been evaluated by several authorities, needed to be reviewed again by JMPR; and use 
of crop groupings to allow for more co mmodities to be covered under a single MRL, as well as  to 
address  the issue of minor crops . Participants highlighted the lack of local registration  for minor 
crops and the challenges in obtaining resou rces, as well as in meeting d ata requirements due to 
the associated  costs and changes in data definitions. Speakers outlined the main reasons for the 
lack of support from the private sector  in registering new  pesticides , highlighting the various 
commercial  considerations which  did not warrant the investment of manufacturi ng companies, 
even if the crop wa s of great export value to a country. In this regard, t he opportunity  for 
increased  collaboration  was highlighted , e.g. through collaborative efforts among several countries  
to create a larger market. It was also underscored  that the higher the degree of misalignment 
between MRLs in different countries, the greater the investment in major crops  and the greater the 
disincentive to invest in minor crops.   
3.95.   Regar ding consumers' demand  for stricter MRLs than those set by regulators, speakers 
observed that consumer concerns primarily focused on  residues in general, but not on whether 
residues were safe. Speakers noted the certification systems which worked on the ba sis of a list of 
allowed substances, as well as other types of private standards schemes which set different MRLs 
to those of  national or Codex MRLs. Participants highlighted that the issue of private standards had 
been raised in CCPR  and the SPS Committee , and s ome points for further reflection were shared . 
These included how to move forward in addressing private standards  and consideration of whether 
a parallel system should exist , separate from the officially adopted standards. The importance of 
continue d discussions was highlighted , as well as the need to separate commercial from regulatory 
interests. It was also acknowledged that some private standards could provide a framework for 
regulatory compliance.  
3.96.   Some of the main challenges  concerning  MRLs in the future  were highlighted by speakers , 
such as compliance w ith MRLs not based on risk assessments, e.g. those that are set at zero or 
near zero thresholds , which occurred, in part , due to the growing number of missing MRLs, as 
countries move d to national l ists. In addition, t he proliferation of national lists was identified as 
creating more difficult ies for exporters to keep pace, as well as leading to the lowe ring of  MRLs. 
The varying MRL policies of different countries  also posed challenges to trade, as well as issues 
related to data harmonization, and predictability in the MRL setting process (e.g. timeframe s). 
In the ensuing discussions, it was suggested that there should be consideration of a fast track 
process for newer, low risk products, which  could  be safer than older products . 
3.7  Impact o f MRLs on International Trade  (Session 7) 
3.97.   In Session 7 , speakers explored t he impact of the use of default MRLs, as well as MRL 
expiration, on agricultural trade. Through the use of case studies, speakers explained their 
experiences wi th addressing the use of default MRLs by trading partners and the subsequent 
impact on agricultural exports. In addition , speakers explored  some of the possible approaches to 
address concerns that may be posed by older products, while m aintaining safe trade.  G/SPS/R/85  
 
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  3.7.1   Part 1: Impact of Compliance with Default MRLs on International Trade  
3.98.   Ms Rebeka Tekle ,50 Acting Deputy Director, Agriculture and Agrifood Canada, presented 
the impact of compliance with default MRLs on international trade.  Ms Tekle  underscored that 
managing trade risks associated with pesticide MRLs was a challenge, as it necessitated a 
balancing act between protecting public health, maintaining market access for agricultural 
products and practical access to plant protection tools. In this regard, she highlighted the 
importance of agricultural products in Canada's economy, both in terms of imports and exports.  
3.99.   Ms Tekle underscored Canada's participation in various domestic and international activities , 
aimed at red ucing these  trade risks associated with pesticide MRLs, while ensuring regulatory 
compliance , as well as promoting transparency and predictability in the process . The coordination 
and cooperation undertaken at all levels was key, whether  within the Canadian agricultur e sector , 
between industry and government , or between the Canadian government and international 
partners. The activities included  indust ry-led risk mitigation projects  to ensure compliance with 
international regulations , called "k eep it clean "; industry -government collaboration to increase 
understanding of challenges and priorities ; and g overnment  to government cooperation to 
facilitate international standards development, adoption, and alignment . 
3.100.   She highlighted the benefit s of co llaborative  work in order to better manag e risks and 
facilitat e trade in agriculture products . These included s upport ing risk-based analysis of pesticide 
residues ; recognizing the role of the Codex scientific bodies ; recognizing the obligations under the 
SPS Agreement ; encour aging transparency and predictability of MRLs and pesticide regulations , 
including through the WTO notification process; and i ncreased cooperation  to minimize differences 
in regulatory approaches and facilitate market access, including at the OECD and othe r regional 
fora. 
3.101.   Ms Lucy Namu ,51 Senior Principal Analytical Chemist, Head Quality Assurance and 
Laboratory Accreditation, Kenya Plant Health Inspectorate Service , presented  Kenya's experience 
with trade impacts of default MRLs.  Ms Namu provided a backgroun d of Kenya's  horticulture 
industry , highlighting that the sector had grown  at an annual average rate of 15%  between  2001 
to 2013 , accounting for 30% of agriculture (in GDP value)  and with 45% of the country 's exports  
destined to the European Union . Ms Namu  explained that i n Jan uary 2013, Kenyan beans and peas 
in pods had been listed for increased controls for pesticide residues , noting that many of  the 
targeted pesticides had MRLs set at the limit of detection . This had a negative impact on exports 
from Ken ya, leadi ng to an approximate  50% decrease  in value . In order to overcome the 
challenges, the authorities work ed with the grower community and various risk management 
options were employed to improve compliance at production level.  These included , among ot hers, 
training of small holder producers in the supply chain; enhanced pesticide residue monitoring 
program me for beans and peas in pods; enhanced checks on pesticide labels ; and controls for 
placement on the market.  These actions  resulted in the delisting of beans in pods in July 2015, but 
peas were still listed.  
3.102.   Ms Namu indicated  several concerns in relation to  the lack of replacement pesticides , 
the need for data generation to support the establishment of MRLs based on GAP  principles and 
the matching of crop protection needs with research alternatives . In addition, she voiced the 
concern that d efault MRLs were not always linked  to health concerns, but due to  other reasons 
such as  minor uses /specialty crops , lack of supporting dat a for the MRL setting  process and limited 
support from agrochemical companies . She presented various suggestions  on how to address 
these challenges , which included harmonization of procedures to increase plant protection product 
registration ; joint data generation program mes; implement ation of  African data generation 
initiative ; creation of regional minor use program mes; and e nhanced capacities for developing 
countries to increase pesticide residue data generation  in order to have more Codex MRL s which 
reflect the realities in developing countries.  
3.103.   Participants raised q uestions in relation to the level of engagement between regulatory 
authorities and  growers, as well as engagement with the European Union. Ms Namu noted  that the 
                                                
50 Speaker's presentation is available at: 
https://www.wto.org/english/tratop_e/sps_e/wkshop_oct16_e/s7_1_rebeka_tekle.pdf.  
51 Speaker's presentation is available a t: 
https://www.wto.org/english/tratop_e/sps_e/wkshop_oct16_e/s7_1_lucy_namu.pdf.  G/SPS/R/85  
 
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  MRL issues faced b y the industry had  increased  the participation of grower groups in discussion  
forum s. In particular, Kenya had a horticulture mechanism which facilitated the identification of 
challenges by  growers and exporters in meeting m arket requirements , resulting in  subsequent 
discussions with authorities in target markets.  Ms Namu also indicated  the various positive 
engagements , through diplomatic channels, with technical officers and DG SANTE , which included 
providing regular updates  and r esponding to feedback  from the rapid alert system. However, s he 
noted exporters' concerns with the change in EU Regulation 669/2009 to undertake biannual 
reviews, instead of q uarterly review s, which implied a longer time -frame for the delisting of peas. 
The European Union expl ained  the rationale for increased controls and the  steps taken by 
EU member States in  their review of  trade issues and the  resulting  decision to delist a commodity. 
The European Union's collaboration with Kenya on the MRL review programme was also 
highligh ted. 
3.104.   Ms Namu also addressed a query in relation to Kenya's reliance on GlobalGap standards , 
noting some constraints  in Kenya's review of  current registrations, in light of changing  
EU requirements . She  highlight ed that although d ata generation  was ongoing, a commensurate  
change in GAP s had not taken place.  In response to a query,  Ms Namu also indicated  that default 
MRLs continued to be one of the biggest challenge s and that this was a barrier to trade when it 
was not supported  by the actual use  pattern in the country.  
3.7.2   Part 2: Impact of MRL Expiration on Agricultural Trade  
3.105.   Mr Daniel Mazzarella ,52 Technical Supervisor, Directorate of Agrochemicals, SENASA 
presented the impact of MRL expiration on agricultural trade. He noted the increasing  complexity 
of the food chain  and increasing public  concerns about  food safety , while underscoring the MRLs 
challenges faced in  trade, whether these limits were legitimate or not.  Mr Mazzarella recalled that 
pesticide MRLs were SPS measures , and as such were bound by the provisions  of the SPS 
Agreement, particular ly the scientific principle. Similarly, he  noted that the exp iration of a MRL was 
also a SPS  measure , which should be based on scientific evidence.  
3.106.   Mr Mazzarella explained the bases for establishin g MRLs in Argentina, highlighting the 
toxicological parameters, such as ADI and ARfD , as well as the GAP practices, where supervised 
field trials were undertaken to establish critical dose and MRL. In addition, SAGPyA No 350/1999 
on Manual of Procedures, Criteria and Uses for the Registration of Phytosanitary Products in the 
Argentine Republic  established  criteria for setting  MRLs. This document  was based on the 
5th edition of the Manual on the Development and Use of FAO Specifications for Plant Protection  
Products .  
3.107.   Mr Mazzarella also noted  the risk analysis principles applied by CCPR  in establishing 
pesticide MRLs , but observed that some MRLs were re -evaluated after a period of time, which  had 
led to the unnecessary elimination of MRLs where there was no specific evidence of any danger.  
He indicat ed that when a MRL was eliminated, other families of herbicides could be examined in 
order to identify alternatives, but noted that a range of uncertainty could be introduced, such as : 
the different toxicity levels of replacement products;  impact on pest management; increased 
application of herbicides; and  economic effects related to  patented vs . generic products . 
3.108.   Mr Mazzarella used the specific example of glyphosate MRLs (established at a domestic 
level) in s everal crops to show how MRLs had been set, as well as the importance of  the 
monitoring  process . He highlighted the  potential  impact of the  elimination of glyphosate MRLs  and 
queried whether glyphosate ha d stopped being safe for food  and opined that this w as not the case.  
3.109.   In the question and answer session , participants raised queries on the scientific basis 
for revocation of MRLs, including concerns related to  the available alternatives for developing 
countries. Ms Namu reiterated that the absence of MRLs for certain pesticides was due to a lack of 
support  by manufacturers to genera te toxicology and residue data to support the development and 
registration of MRLs. Mr Mazzarella similarly indicated several challenges in the d ata generation  
process , while emp hasizing that where there was no  scientific information demonstrating that the 
product had  stopped being safe, MRLs should  be maintained .  
                                                
52 Speaker's presentation is available at: 
https://www.wto.org/english/tratop_e/sps_e/wkshop_oct16_e/s7_2daniel_mazzarella.pdf.  G/SPS/R/85  
 
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  3.8  CONCLUSIONS (Session 8) 
3.110.   In Session 8 , speakers  summarized the key outcomes of the various workshop sessions  
from a developing and developed country perspective.  Ms Lucy Namu  outlined the  importance of 
the risk assessment principles used in the Codex process , but noted concerns with the limited 
participation of developing countries in the data generation process  and its impact on Codex 
decisions . She suggested that data harmonization  could be a way  to encourag e registration of  
plant protection products  in dev eloping countries, and that h armonization initiatives, such as those 
of APEC or NAFTA could serve as a learning platform for developing countries . Ms Namu 
underscored the need for increased  cooperation between private sector and regulatory  agencies, 
and the role of  proactive engagement in identifying and addressing potential concerns, before a 
specific trad e issue arose . Ms Namu referred to the use of default MRLs  and the challenges they 
posed, especially where these were not based on scientific data. She also emphasized the 
importance of capacity building assistance from partners , noting the needs identifie d by some 
countries , such as laboratory  and technical  capacity for quality data generation. She welcomed 
continued  discussions to address these concerns  and the development of more regional 
approaches to deal with  minor use  issues .  
3.111.    Dr Peter Chan  observed  that there were similar approaches to data review  by developed 
countries  in relation to risk assessment , and that f ocus had been  placed on harmonizing the 
underl ying scien ce, in order to resolve differences in scien tific interpretation which could lead to  
different MRL  outcome s. He noted that, based on the presentations, various  countries  had import 
MRL registration process es similar to  the APEC initiative . He underscored the benefits of 
collaboration as demonstrated  by the joint OECD work and indicated th e need to engage  other 
countries, e.g. through minor use p rogram mes. Given scarce r esources , Dr Chan highlighted the 
positive impact of collaborative initiatives in the efficient use of existing resources.  He also 
underscored the importance of Codex MRLs, while noting the need to improve  the Codex MRL 
setting  process , as several concerns had been raised in relation to missing MRLs, by developed and 
developing c ountries, as well as by industry representatives . Other industry concerns were 
highlighted, such as transparency and predictability in the regulatory process  and the role of 
private standards. Dr Chan  further emphasized the need for collaboration, coordination and 
communication  in the process . 
3.112.   In the question a nd answer session , speakers provided views on whether the 
discussions on  MRL issues were heading in the right direction, from a developed and developing 
country perspective, and w hether government  ministr ies were sufficiently aware  of the challenges 
faced in addressing M RL issues . In particular, Ms Namu noted the increased challenges faced  by 
Kenya  due to  the more stringent regulatory  changes in target markets , while observing that the 
difficulties in accessing  markets had also led to the increased engageme nt of the private sector 
with regulatory agencies , and greater recogni tion of the role of  science in support ing trade. 
However, Ms Namu  underscored that MRL issues would continue to be a challenge, due to limited 
capacity and  scarce  resources . Dr Chan noted the positive direction of MRL discussions,  
highlighting several  forum s which provided opportunities for information sharing  and underlined  
the need for more collaboration to address MRL issue s, given their horizontal  nature . He also 
indicated  that certain EU regulatory proposals could  have an impact on MRLs  and underscored the 
importance of having channels for submission of comments . Lastly, he acknowledged that 
fundamental scientific principles could  also have trade implications.  
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