National Workshop

on the FAO Pesticide Registration Toolkit

Report

Joost Vlaming
Christine Fuell

December 10 - 15, 2017

Gaborone, Botswana
Summary
A National workshop on the application of the FAO Pesticide Registration Toolkit
was held in Gaborone, Botswana, December 10-15, 2017. Around 25 participants
from different departments participated in the workshop hosted by the Ministry
of Agricultural Development and Food Security (MAFS). Not all participants in the
workshop were directly involved in Pesticide Registration as two-thirds currently
worked in inspection or extension. The workshop was organized under the
framework of GEFF project GCP/BOT/011/GFF – Component 2, strengthening the
pesticide regulatory capacity in Botswana, and held at Tlo tlo Hotel and Conference
Center in Gaborone from 8.30h to 17h daily.
The Food and Agriculture Organization of the United Nations (FAO) has developed
a Pesticide Registration Toolkit to support pesticide regulators in countries with
limited resources. The Toolkit can be used as a source of information and a
reference tool for pesticide registration authorities. It also helps the process of
evaluating pesticide registration dossiers and support for sound decision-making.
This workshop aimed at strengthening pesticide regulatory management capacity
within Botswana and coordination between the different departments involved.
The FAO Pesticide Registration Toolkit can also be accessed from the Rotterdam
Convention website. The Rotterdam Convention on the prior informed consent
(PIC) procedure for certain hazardous chemicals and pesticides in international
trade is about the exchange of information on these chemicals to give countries
an early warning on pesticides and industrial chemicals that have been banned or
severely restricted in other countries for health or environmental reasons. The
Rotterdam Convention does not ban or restrict any chemicals, nor does it require
countries to automatically prohibit their import. Its purpose is simply to ensure
that hazardous chemicals are not exported to countries that do not wish to receive
them. The coordinator of the Convention Secretariat explained inter alia how the
toolkit can be used to prepare notifications to the Secretariat on any final
regulatory actions taken based on a risk evaluation process regarding pesticides.
FAO had originally appointed two regional experts in pesticide
registration/management, respectively from Zimbabwe and Mozambique, to
facilitate this workshop. However, due to travel restrictions the workshop was
eventually facilitated by consultant and Toolkit developer Joost Vlaming. The
participation of Christine Fuell from the Rotterdam Convention was a welcome
addition to the training as it allowed for sharing of certain tasks and presentations.
The workshop lasted a total of four and a half days and the programme started
with an introduction to the structure and contents of the Pesticide Registration
Toolkit. Throughout the workshop, the facilitators presented key concepts used in
hazard identification and risk assessment of pesticides and demonstrated how to
use the Toolkit to find data and how to use this data to support the decision-
making process. Participants also worked on several exercises connected to the
various modules, including assessment methods, mitigation measures,
occupational risk assessment and highly hazardous pesticides.
At the end of the workshop, the participants provided comments on the Toolkit
and the workshop programme. Overall, participants found the Toolkit very useful
and plan to use (parts of) the toolkit in their future work, depending on their
function. The participants considered that further training would be needed and
hoped that FAO could provide such training in the future.
Major challenges regarding the further strengthening of the Pesticide Registration
capacity in Botswana are the small number of staff in registration, the many other
duties they have, and the weak agro-chemicals act which provides very little
guidance for the registration authorities.
Currently the MAFS is discussing expansion of registration staff and the existing
agro-chemicals act is under revision.
Workshop report
Opening ceremony
The workshop was opened and introduced by Mr. Hendrik Modiakgotla, Chief
Plant Protection Officer, Ministry of Agricultural Development and Food Security
(MAFS) of Botswana who welcomed all participants on behalf of the Motswana
host agency. Next Mr. David Mfote, acting Assistant FAO Representative for
Botswana highlighted the importance of sound pesticide management as a critical
component of food safety and sustainable development. After a prayer, the official
opening was concluded by Mr. Galeitsiwe Taelo Ramokapane, Director of Crop
Production.

Introduction of participants
All participants introduced themselves and briefly explained their positions/roles
in the pesticide registration and management process (see list of facilitators and
participants in Annex 1).

Workshop objectives and practical organisation

The trainers introduced the overall objectives of the workshop and informed
about practical details.
The present workshop had the following objectives:
– Get familiarized with the Toolkit, be able to navigate and use the content
– Increase trainees’ knowledge of methods and available sources of
information for pesticide registration
– Increase trainees’ knowledge on how to identify and phase out HHPs
– Promote the use of the Toolkit among registration staff
– Inform about obligations and benefits of the Rotterdam Convention
including the submission of import responses, notifications of final
regulatory actions and submission of signed nomination forms for the
designated national authorities
A detailed workshop agenda can be found in Annex 2.

Introduction to the FAO Pesticide Registration Toolkit

The background to the development of the Toolkit was presented to the
participants together with a description of what the Toolkit is and what it is not.
The Toolkit helps with decision making and can also be used as a training and
capacity building tool for the pesticide registration authority. The Toolkit is a
decision support system for registration authorities, primarily in countries with
limited resources. However, it was highlighted that the Toolkit is not an automated
system for evaluation of specific pesticide. Instead, it supports and facilitates
decision making by registrars as well as provides advice for different steps of the
registration process, from the submission of the application to the decision
making. In addition, the Toolkit provides access to data requirements and testing
guidelines for the evaluation of a specific type of pesticide with a particular use,
and evaluation methods for the various aspects of the pesticide registration
dossier.

Inventory of registration organization in Botswana

The organization of pesticide registration was discussed in a plenary discussion.
Botswana has a registration authority for agricultural pesticides at the Ministry of
Agriculture and Food Security and a separate authority for public health pesticides
and chemicals at the Ministry of Health.
The number of full time registration staff at the Plant Protection Department (PPD)
is no more than two. PPD registers all kinds of agrochemicals (pesticides,
acaricides, growth regulators and fertilizers) and receives between 50 -100 new
pesticide applications per year. The time for processing an application is around
12 months.

Decision making
The decision-making module was explained in detail by the trainer. This tool
describes different types of issues to consider when deciding whether a pesticide
can be registered or not. It was highlighted that there are no international criteria
for deciding whether a pesticide can be considered “acceptable”; this needs to be
defined by each country/region. Decisions are guided by national pesticide
legislation, other national legislation and policies on environment, health and
trade/economic development, as well as national human health and
environmental protection goals.
In principle, both risks and values should be acceptable before a pesticide can be
registered. If the risk to human health and/or environment is considered
unacceptable a pesticide should not be registered, even if it may have high value.
It was highlighted that a pesticide that is not efficacious, does not bring (potential)
economic benefits to the user, or cannot be used in a sustainable manner, should
not be registered, irrespective of whether its risk is acceptable.
After the presentation of this module, the participants were invited to do a
decision-making card game. During the exercise, participants were asked to use a
decision-making flowchart to decide whether a number of example products could
be registered or not. Participants reviewed the information provided on the card
and made a registration decision. The result of the card game was discussed in
plenary.
Principles of health and environmental assessment for pesticide registration
The principles of health and environmental assessment was presented to the
participants. Based on the definition of pesticide registration from the
International Code of Conduct on Pesticide Management, it should be
demonstrated that the pesticide product does not pose an unacceptable risk to
human or animal health and environment under the conditions of use in the
country or region. Definitions of hazard and risk were explained to the
participants. It was highlighted that hazard assessment is based on intrinsic
properties of a pesticide, irrespective of exposure rate. A risk assessment is based
both on the properties of the pesticide and on the level and probability of
exposure.
Evaluation of adverse effects on human health and environment can either be
hazard-based or risk-based. The advantages and disadvantages of tiered
(stepwise) risk assessment were demonstrated to the participants. The advantage
of starting with a simple work case scenario is that applicants only must provide
data needed for the expected risk assessment tier, and as a result less data are
required for less hazardous pesticides. However, one disadvantage with this
approach is the necessity to define data requirements depending on the level of
risk. It was explained that tiered risk assessment advances from a worst-case
situation to more realistic use situations. If the risk in the worst-case scenario is
considered acceptable, no further assessments are needed.

Data requirements
The data requirement module was introduced to the participants by the trainer. It
was noted that data requirements are provided as defined in the FAO/WHO
Guidelines on data requirements for the registration of pesticides (2013). It was
highlighted that data requirements are not the same for every type of pesticide,
but will depend on the pesticide group, the pesticide type, the intended use, and
the type of registration.
The tool has a search function making it possible to get data requirements for
different kinds of applications. It is also possible to list all studies. In addition, the
list of data requirements can be printed or saved on the computer to be used for
the completeness check of registration dossiers. After the presentation, the
participants were invited to explore the tool and practice finding data
requirements and testing guidelines.
Assessment methods
The assessment methods module was presented to the participants. The tool
provides methods for the evaluation of the various aspects of the pesticide
registration dossier. The Toolkit contains assessment methods ranging from
relatively simple to more complex. Assessment methods are chosen based on
pesticide group, main topic and sub-topic. It was noted that the Toolkit currently
focuses on assessment of chemical pesticides. It was also highlighted that the
assessment methods are not provided automatically, the technical staff has to
choose the suitable assessment model based on the properties of pesticide, their
working experience and knowledge and the time available for assessment of the
pesticide. After the presentation, participants were invited to explore the
assessment methods module and check which methods are available for various
topics.

Mitigation measures
A presentation on risk mitigation module was made by the trainer. The objective
of this tool is to list various measures for mitigation of risks to human health and
the environment. The module is intended to support registration authorities to
ensure that the risk of pesticide is acceptable for local condition of use. The
importance of introducing risk mitigation measure that are feasible under local
conditions was highlighted. Measures must be effective under local conditions as
well as being practical for the pesticide user, and preferably not compromise
pesticide product efficacy. Therefore, expected reduction of risk should outweigh
the cost of the measure. It was concluded that whenever a risk mitigation measure
is required or recommended as a part of registration, it should be assessed
whether the measure can be realistically implemented under the proposed
condition of use.
Participants further explored the risk mitigation module by doing an exercise

Registration strategies
The tool was used to help applicant to select the most appropriate strategy.
Registration by analogy and complete evaluation are the two main registration
strategies in the Toolkit. If there is a similar product, then analogy approach could
be a better choice. The FAO recommends that registration authorities work
towards increasingly comprehensive evaluation of a pesticide.

Information sources
The information sources menu was explained in detail by the trainers. This section
of the Toolkit provides links to external sources of information that can be used to
find and compare specific information on pesticides. Unlike the registration tools,
which provides general guidance on different aspects of pesticide registration, the
information sources mainly provide information related to individual pesticides.
Participants were given several exercises and used the information sources menu
to find the relevant information.

Highly hazardous pesticides

An overview presentation on highly hazardous pesticides (HHPs) was made by the
trainer. Highly hazardous pesticides (HHPs) have received special attention
worldwide because of their high acute human toxicity, chronic human toxicity,
severe environmental hazards etc. In 2008, FAO/WHO Joint Meeting on Pesticide
Management (JMPM) agreed on criteria to identify HHPs. Specific guidelines on
HHPs were issued in 2016 to help countries identify HHPs and present steps of risk
reduction process for HHPs.
There are eight criteria to identify if a pesticide is an HHP:
• Criteria 1: WHO class la and lb
• Criteria 2, 3 and 4: GHS category 1A and 1B for carcinogenicity,
mutagenicity and reproductive toxicity (CMR)
• Criteria 5: Substances listed in the Stockholm Convention or fulfilling the
criteria for POPs
• Criteria 6: Substances listed in the Rotterdam Convention
• Criteria 7: Substances listed in the Montreal Protocol
• Criteria 8: Substances that have shown a high incidence of adverse effects
on human health and the environment

The current FAO project supporting pesticide registration capacity in Botswana

has a strong component on HHPs. An elaborate survey has been done and
inventory of the HHPs products is almost finished.

Case study 1 – Registration by analogy

The trainer presented the basic principles of registration by analogy. This is a basic
registration strategy based on a limited comparison between the pesticide
product submitted for authorization and a similar product registered in one or
more reference countries.
Participants were asked to compare the pesticide product based on the local
situation and the situation in the reference country using a prepared registration
dossier and the Information Sources and then make a final decision following the
analogy approach. The participants documented the outcome of the comparison
of the product composition, the efficacy and use patterns and the risks to human
health and the environment in the assessment table.
The result of the case study was discussed in plenary. The participants found this
registration approach useful but considered it still to be quite time consuming
compared to the current approach which is based only on an existing registration
in the country of origin of the pesticide product.

Case study 2, part 1 – Hazard evaluation and classification

A short presentation on the basic concept of hazard assessment was given by the
trainer. The participants were then asked to do a more comprehensive evaluation
of a given product, focusing on the intrinsic properties of the active substance and
the formulation. The participants documented the pesticide’s properties and
compared with the WHO criteria for acute toxicity and the GHS criteria.

Case study 2, part 2 – Occupational risk assessment – Bridging

The participants were introduced to the general concept of bridging. Due to time
constraints the bridging exercise had to be skipped.

Case study 2, part 3 – Occupational risk assessment – Models

The trainer introduced the basic principles of operator exposure models. The
participants did then search for the relevant EFSA Operator and Worker model,
download it and enter data into the model spreadsheet based on the case study
dossier. Results of the modelling exercise were then discussed in plenary.

Evaluation of Toolkit and training

The workshop participants were asked to fill in an on-line evaluation of the Toolkit
training. It was highlighted that the evaluation was aimed to improve the Toolkit,
the setup of the training and determine follow-up action.
All the participants found that the different modules of the Toolkit were useful or
very useful for them although the applicability of the Toolkit depends on their
current position as not all participants are directly involved in registration.
Information sources and the HHP module were found to be the most useful.
Assessment methods, Decision making, and Mitigation measures were found to
be the most difficult modules. The participants expect to use the Toolkit
sometimes to frequently, depending on the module and their function.
Regarding information that is currently missing in the toolkit the participants
reported a) local information on HHPs in Botswana, b) information on public
health pesticides, c) on other chemicals and d) on Integrated Pest Management
(IPM).
It was discussed that Botswana specific information should not be part of the
Toolkit itself but should rather be shared by the Ministry of Agriculture, based on
the current FAO supported project.
Information on public health pesticides will soon be published on the Toolkit
website, as soon as WHO finalizes its review of the texts.
Information on other chemicals is not -and should not be- part of the Toolkit.
Instead a reference was made to the IOMC Toolbox
(https://iomctoolbox.oecd.org) which is an excellent source of information on
non-pesticide chemicals.
Information on IPM methods can be found through the FAO Agroecology
Knowledge Hub website (http://www.fao.org/agroecology).
Problems that would prevent the participants from using the toolkit were first and
foremost the internet connectivity and a lack of laptops.
In terms of additional training required they reported 1) more practice, 2) more
guidelines on the GHS classification and use of the ECHA website, 3) raising of
awareness among colleagues and farmers, 4) refresher trainings and 5) training on
risk assessment. The trainers indicated that need for training should be discussed
within Botswana and a clear request should then be forwarded to FAO.
Other comments on the training were that veterinarians should also need such
training. In general, there is a need for more staff in pesticide management, and
more resources and funds should be available to the registrars. To focus better on
pesticide registration, they should have no other duties but registration.
All participants were very satisfied with the quality of presentations, exercises and
handouts.
A request was made to hold a next similar workshop outside Botswana, this could
assist in benchmarking. While this could be done during a regional workshop it
would also mean that only 3-4 participants per country could then participate

Next steps
The group discussed what is needed to improve the registration work. This can be
summarized as:
• More Regular training by FAO on this topic.
• The number of staff at MAFS needs to be increased. There are only two
officers for the whole country. This has been discussed with the director.
• Professional background of potential new staff must be defined
• MH: pesticides are only a few (of human health importance), most
chemicals are industrial and household ones. Here an instruction on the
IOMC toolkit could be valuable.
 • Possible cooperation between MAFS and MH on pesticides depends on
legislation. When revising the Agrochemicals Act (ongoing), Botswana
might wish to consider using the pesticide definition of the International
Code of Conduct on Pesticide Management
• Guidance is needed on the registration of biological chemicals as well.
• Information on local requirements and locally registered pesticides for
Botswana cannot be easily found. The Toolkit is not the place for this
information unless the MAFS publishes these on their own website. Toolkit
can then refer to these public lists. This suggestion was also made to the
Director of Crop Production.

Closure of the workshop

The workshop was informally closed by trainers Joost Vlaming and Christine Fuell,
Mr. Loitseng and one of the participants at 12:30 hrs
Annex 1

List of facilitators
Name E-mail

1. Mr. Joost Vlaming, consultant joost@envista.nl

2. Ms. Christine Fuell christine.fuell@fao.org

FAO Coordinator Rotterdam Convention

3. Mr. Molatlhegi Modise molatlhegi.modise@fao.org

FAO-BW Project Coordinator

NAMES OF PARTICIPANTS FOR PESTICIDE REGIOSTRATION TOOL KIT, 11-15 DECEMBER

2017; GABORONE- BOTSWANA.
NAMES OF PARTICIPANTS FOR PESTICIDES REGISTRATION TOOL KIT TRAINING
WORKSHOP, 11-15 DECEMBER 2017; GABORONE- BOTSWANA.
# Name Organization Designation Email Gender

1 Tshepo Lily Ministry of Chemist- tlmosedame@gov.bw F

Mosedame Agricultural Principal
Development Agricultural
and Food Scientific
Security Officer
(MoA).
Division of
Plant
Protection
2 Maganong MoA, Plant Principal mmodukanele@gov.bw F
Modukanele Protection Agricultural
Division. Scientific
Officer
3 Gomolemo Ministry of Member of gmaseelane@gov.bw F
Maseelane Health and the National
Wellness. Agrochemicals
Committee.
Department
of Public
Health.
4 Ditso Ministry of ………….. dcmotsewabeng@gov.bw F
Kebonemodisa Health and
Health Officer
Wellness.
I
# Name Organization Designation Email Gender

Department
of Public
Health
5 Katlego MoA, Plant Assistant mokonealkatlego@gmail.com F
Mokubung Protection Agricultural
Division Scientific
Officer (AASO)
6 Tumelo Taolo MoA, Plant AASO tumelocindytaolo@yahoo.com F
Protection
Division
7 Professor Botswana Member of mobopile@buan.oc.bw M
Motshwari University of the National
Obopile Agriculture Agrochemicals
and Natural Committee.
resources.
8 Malebogo Ministry of Member of mlsentsho@gov.bw F
Somolekae Environment, the National
Wildlife and Agrochemicals
Tourism. Committee
9 Omphemetse MoA, Plant Agricultural ogaowele@gov.bw F
Fono Gaowele Protection Scientific
Division. Officer-
Inspector
10 Kabo MoA, Plant Senior kkepaletswe@gov.bw M
Thompson Protection Agricultural
Kepaletswe Division. Scientific
Officer-
Inspector
11 Akosembe MoA, Plant Senior amandevu@go.bw M
Mandevu Protection Agricultural
Division. Scientific
Officer
12 Goemeone MoA, Plant Agricultural gobonye@gov.bw M
Obonye Protection Scientific
Division. Officer
13 Peter Thero MoA, Plant PPO pthero@gov.bw M
Protection
Division.
# Name Organization Designation Email Gender

14 Itumeleng MoA, Plant AASO shereremakobo@yahoo.com F

Makobo Protection
Division.
15 Nonofang MoA, Plant Inspector ggaotlolwe@gmail.com M
Gaotlolwe Protection
Division.
16 Karabo MoA, Plant Inspector krgaborone@gov.bw M
Gaborone Protection
Division.
17 Motshegetsi MoA, Plant AASO motshegetsimmani@gmail.com M
Elton Mmani Protection
Division
18 Phatsimo MoA Plant Inspector phmokgweetsi@gov.bw F
Mokgweetsi Protection
Division.
19 Keletso One MoA, Plant AASO oneezkelly@yahoo.com F
Moeng Protection
Division
20 Nick Keokgale Ministry of Environmental nkeokgale@gov.bw M
Health and health officer
Wellness
21 Tshoganetso MoA,Plant AASO tsamodimogaone@yahoo.com F
Tsamodimo Protection
division
22 Molatlhegi Food and National molatlhegi.modise@fao.org M
Modise Agriculture Project
Organization. Coordinator
23 Galeitsiwe Department Director of gramokapane@gov.bw M
Taelo of Crop Crop
Ramokapane Production, Production.
MoA.
24 Hendrik Division of Chief Plant hmodiakgotla@gov.bw M
Modiakgotla Plant Protection
Protection, Officer
Department
of Crop
Production
Ministry of
Agriculture
# Name Organization Designation Email Gender

25 Loitseng Division of Registrar of lsebwtwane@gov.bw M

Sebetwane Plant Agrochemicals
Protection,
Department
of Crop
Production,
Ministry of
Agriculture
26 Collen Division of Scientific cmbereki@gov.bw M
Mbereki Plant Officer
Protection,
Department
of Crop
Production
Ministry of
Agriculture
27 David Mfote FAO Acting David.mfote@fao.org M
Botswana Assistant FAO
Representative
Annex 2

Workshop agenda
National FAO Pesticides Registration Toolkit Training Workshop
Botswana, December 11-15, 2017

Day 1

Morning

Opening of the workshop Mr David

Mfote (FAO)

Introduction of participants Christine

Workshop objectives, practical organization Joost

Introduction to the FAO Pesticide Registration Toolkit Joost

Inventory of registration organization of the country Christine

Afternoon

Toolkit – Decision making (presentation + exercise) Joost

Principles of health and environmental assessment for pesticide registration Christine

(presentation)

Day 2

Morning

Recap of Monday afternoon

Toolkit – Data requirements (presentation + exercise) Joost

Toolkit – Assessment methods (presentation) Christine

Toolkit – Assessment methods (exercise)

Afternoon

Recap of Tuesday morning

Toolkit – Assessment methods (discussion) Christine

Toolkit – Mitigation measures (presentation + exercise) Joost

Day 3 - Wednesday

Morning

Recap on Tuesday afternoon

Toolkit – Registration strategies (presentation + exercise) Joost

Rotterdam Convention (presentation + discussion)

 Joost

Afternoon

Recap on Wednesday morning

Toolkit – Information sources (presentation + exercise) Christine

HHPs (presentation + 1 x exercise) Joost

Day 4 - Thursday

Morning

Recap on Wednesday aftrenoon

HHPs (1 x exercise discussion)

Case study 1 – Registration by analogy (using a prepared “registration Joost

dossier”) (presentation + exercise)

Afternoon

Case study 1 Continued

HHP mitigation – exercise/group discussion

Case study 2- Evaluation of human health effects – hazard and risk Joost
assessment (presentation + exercise)

Case study 2 – Complete review (using a prepared “registration dossier”) Joost

(presentation + exercise)

Day 5

Morning

Recap on Thursday afternoon

Case study 2 – Complete review Joost

(using a prepared “registration dossier” - presentation + exercise)
• Finish Hazard assessment
• Operator exposure model

Feedback on the Toolkit (survey) group

--- 10:30 break

Results of the on-line survey (discussion) Joost

Use of the Toolkit in the work of the registration authority (discussion) Joost

Recommendations for future activities (discussion) Joost

Closure of the Workshop (12:30)