Engaging throughout the Risk Assessment Process - A workshop of the digital event series on the evolution of EFSA's engagement framework
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Engaging throughout the Risk Assessment Process A workshop of the digital event series on the evolution of EFSA’s engagement framework 22 June 2021 Virtual meeting
1. Background
The digital event series on the evolution of EFSA’s stakeholder engagement framework started
with a kick-off event (held in October 2020) to set the scene, report back on how EFSA has
taken onboard stakeholders’ input so far and to introduce the series of thematic events
focusing on the three engagement streams of the evolved engagement framework around
quality of science, preparedness for future challenges, and stakeholder dialogue, and to gather
stakeholder input to fine-tune them as appropriate.
The third workshop of the series focused on the ‘Quality of Science’ stream of EFSA’s evolved
engagement framework. The main objectives of this event were to:
• provide a clear overview of the engagement windows in both the applications and
mandates cycles put in place by the Transparency Regulation;
• understand the level of familiarity of registered stakeholder with these engagement
opportunities including with the ‘ground rules’ for providing input, the feedback loops
and additional options (e.g. Open.EFSA, Connect.EFSA);
• manage expectations regarding the extent of possible engagement considering that
EFSA needs to adhere to their mandate as a neutral, science-based entity,
• gather suggestions on how the engagement processes itself could be further improved
and how information on it could be shared more efficiently.
The outcomes of the workshops will be discussed at the Stakeholder Bureau meeting of
October 2021. Based on the input by the Bureau, the fine tuning of the way forward will
continue at the Stakeholder Forum 2021, which will be considered as the concluding
appointment of the series.
22. Outcomes of the workshop
Information session on engagement opportunities as part of a lifecycle of a mandate
After a presentation of engagement windows in EFSA’s mandate lifecycle, participants were
invited to respond to a short poll:
Participants were then invited to think about how EFSA could improve the accessibility of
information on engagement opportunities in the life cycle of a mandate. Here are the
questions and comments received orally or in the chat:
• One of the tools to tackle mandates is Open.EFSA and the tracked question system,
but at the moment, with the new system, it is difficult to find the new mandates. It
was easier previously when mandates were organized in chronological order. This
is a recurring comment. Could EFSA investigate improving this functionality?
• Generally, search engines are useful tools to keep track of mandates and EFSA
should investigate further developing such functionalities.
Information session on engagement opportunities as part of a lifecycle of an
application
In the following session participants were then introduced to engagement windows
available within the lifecycle of an application. Before opening the floor for discussion,
participants were requested to answer a short poll:
3As with the previous session, the floor was opened for participants to comment and think
about ways EFSA could improve access to information on engagement windows in the
context of applications. Here are some of the key comments and questions:
• Manufacturers plan many years in advance. The list of intended studies on
Connect.EFSA is well understood, however it is quite normal that, during the period
that follows, plans need to be adjusted for instance with studies unveiling the need
for further research. After public consultations, if there are plans for more studies
to be submitted, is there a chance that applicants could submit additional data?
• Are peer review meetings accessible to observers? It doesn’t seem to be the case
now; however, this is seen with other agencies such as ECHA and it seems to work
well.
• When a conclusion is released at the end of a mandate, it is taken by the European
Commission to investigate risk management. During the process that EFSA has
gone through to get information and different perspectives, if there has been extra
information gathered at that point, is there any opportunity for an applicant to
engage?
• The Pesticide Scientific Network has been mentioned. What types of skills are
represented in this network?
Engagement outside mandate and application: partnering for scientific quality
After a short break, participants were introduced to engagement opportunities existing
outside the framework of mandates and applications. The floor was then opened for
comments and questions:
• What will be the scope of the upcoming digital platform for registered
stakeholders? It has been noticed that the current Stakeholder Forum is not
sufficiently focused on science and can get quite messy sometimes. In general,
duplication of platforms should be avoided as much as possible. A suggestion
could be to have engagement activities (roundtable, discussions) with less
4participants but focused more on science, and a stakeholder platform available for
less science-oriented stakeholders who wish to engage with EFSA.
• On the SPIDO project specifically, is there a harmonised way to engage
stakeholders now?
EFSA’s scientific engagement cycle
To get a better understanding of stakeholders’ perception of engagement opportunities
with EFSA in general, a short poll was launched:
Following up on this poll, participants were sent into breakout groups, where they were
invited to discuss where they still see gaps in the engagement with EFSA and what they
think could be solution or ideal scenarios to bridge those. Below are the key take-outs
from these group discussions:
5Breakout group 1 – Katharina Faradsch & Cinzia Percivaldi
GAPS in mandate/application/other SOLUTION & Best-case scenarios to
engagement address the gaps
Technical meetings following a public More dialogue/details on the reason why a
consultation on a draft scientific output stakeholder’s comment is discarded by the
sometimes come too late in the process, panel (not just taken/rejected).
when the margin of manoeuvre is not
enough to inform the draft scientific output
before its adoption with the comments of
stakeholders (little influence).
No overview of mandates to be informed Communicate more clearly in a single
about engagement opportunities on location the new/upcoming mandates and
new/upcoming mandates. the engagement opportunities associated to
them (e.g. an enhanced Open.EFSA).
Make engagement opportunities more See EMA as example of best practice.
open to a broader public (e.g. NGOs and
consumers who do not necessarily have
scientific skills).
Receive more guidance from EFSA on the Please improve the process, be more open
type of tests and data that should be and provide recommendations.
generated to support an application. Now it
is very difficult to obtain technical
recommendations/support – in particular to
reduce the use of animal testing;
opportunities to change an OECD protocol
to obtain more information.
Breakout group 2– Matthew Ramon & Mihai Popa
GAPS in mandate/application/other SOLUTION & Best-case scenarios to
engagement address the gaps
Open EFSA – the general public/media. Are More opportunities for the stakeholders to
they aware of the EFSA changes? engage – more communication channels
Widening the EFSA audience and engagement activities
6Open EFSA and Ask EFSA – rather technical Gather all the engagement opportunities in
(not easily accessible) one platform
Hard to find reliable information (from the
public perspective)
Not enough focus on science
Working Group meetings – minutes too Discussion groups – quite effective. Should
short. More details are needed when writing be used more frequently.
the minutes of the meetings. Pre-notification for mandate – an improved
process that could be more clear
If it is possible before publication.
Breakout group 3 – Max Blanck & Paula Rozadilla Castillo
GAPS in mandate/application/other SOLUTION & Best-case scenarios to
engagement address the gaps
There would be a feeling that comments are - The possibility of having a second
lost, especially when it comes to guidance round of comments dedicated to
documents. registered stakeholders (not
including public here).
- New ways to support transparency
for clustering of comments, with the
purpose of improving feedback.
- 1-hour info session to inform on the
expected type of comments,
particularly on big guidance
documents, just after the public
consultation has been launched.
Perhaps in the form of a webinar.
This would help participants in
managing their time more efficiently
by providing to-the-point
contributions. This would also
facilitate the clustering of comments
and support transparency.
Tracking related to mandates would be Possibility to subscribe to particular topics:
relevant to be improved. not to miss any topic of interest, to be
possibly tackled by the digital platform.
7Better explanation to support info sharing More sharing of info from EFSA to
for members of stakeholders. stakeholders to be shared with members
would support clarification of information.
Breakout group 4 – Clara Boissenin & Maria Scherbov
GAPS in mandate/application/other SOLUTION & Best-case scenarios to
engagement address the gaps
- In light of the Chemical Strategy for One Substance, One Assessment (OSOA) to
Sustainability, there is the need for be used as possible hook for that and needs
agencies (e.g. EFSA and ECHA) to
stakeholder involvement to ensure
come together to address future
transparency and inclusivity of the process.
issues/challenges and to proactively
interact with the stakeholders
throughout to strive for common
processes/harmonisation.
- There is a lack of mutual stakeholder
engagement (and transparency)
when it comes to some of
interactions between the agencies,
in particular when it comes to the
One Substance, One Assessment
(OSOA) approach.
Gaps in the application process include: - Allowing more time for submitting
- The timelines for engagement the missing items during the
which doesn’t allow for enough stakeholder engagement process.
time to address the incompleteness - There is an overall need for the
of information and data gaps. advice to be binding, of course,
- Non-binding advice/engagement taking into account the legal remit of
from EFSA EFSA.
83. Conclusions and recommendations
The workshop provided an opportunity for stakeholders to communicate their doubts
and concerns and constituted a possibility for EFSA to get valuable feedback to be
considered in the continuing evolution of the engagement framework.
While the opportunities for engagement that are made available during the lifecycles of
applications and mandates appeared to be reasonably clear to the participants, a feeling of
confusion seemed to persist towards the proper venues through which to access relevant
information.
This degree of confusion among registered stakeholders implies the need to strengthen
external communication efforts. If possible, communicating earlier about engagement
opportunities would help stakeholders better prepare to contribute.
The workshop has also revealed stakeholder needs which could affect the current engagement
culture in EFSA and the development of new processes. EFSA’s teams should discuss the
degree of engagement possible, boundaries, as well as when and how to engage in the future.
For instance, there is demand for better feedback on the engagement activities, especially
of the public consultations, such as further improving the transparency of the clustering
approach.
Participants also expressed the desire for info sessions once a public consultation is
launched to inform them on the nature of the required input. This would allow for a more
efficient use of time by the stakeholders in drafting contributions but also by EFSA during
the analysis of the inputs.
While some of these points could potentially be addressed by improving the functioning of
existing tools (Open.EFSA, Connect.EFSA ), the upcoming digital stakeholder platform, the
concept of which was co-designed in previous meetings of the series, needs to be integrated
in the solutions and become central to efforts to improve information flow.
94. Stakeholder evaluation
A total of 22 stakeholders came to the workshop, out of a total of 30 registrations. The
registrations covered the following groups:
Academia 4 registrations
Business and Food 16 registrations
industry
Consumers 1 registration
Distributors 2 registrations
Farmers 1 registration
NGOs 3 registrations
Practitioners 1 registration
Other 1 registration
The evaluation took place through a form sent to participants in the chat on Zoom at the
end of the meeting, and through a follow-up email. The questions were based on the
evaluation carried out by EFSA at previous workshops of the series. The form was hosted
on a platform of EFSA’s choice and 41% of the participants responded to the survey.
How would you rate the workshop overall?
100% of respondents declared that their event experience was good or excellent. This is
the same appreciation level as in the Preparedness workshop and the Stakeholder
Dialogue workshop.
Has the event fulfilled your expectations?
All respondents considered that the workshop fulfilled their expectations.
10Participants generally found that the workshop helped them gain a better understanding
of engagement windows around mandate and application, though some participants felt
that the meeting hasn’t helped them get more familiar, flagging a below average to poor
understanding of the issue.
Familiarity of with the event topics
Excellent Good Average Below Poor
average
Before the event After the event
Along the lines of similar evaluations in the past, respondents reported their ‘digitalisation
fatigue’ and missed interacting in-person with EFSA and other stakeholders; and the
effectiveness of digital meetings compared to physical ones was questioned again. An
increase in participants flagging they get more distracted online is seen, probably due to
the more informative, less interactive nature of this workshop.
In general, the different aspects of the workshop were considered either good or excellent,
in particular the content, the presentations and the relevance of the topics. However, a
third of participants felt there wasn’t sufficient time allocated to interaction.
110% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Event content / agenda
Relevance of the topics addressed
Presentations
Time allocated to Q&A and interaction
Event format
Event length
Online platform
Excellent Good Average Below average Poor
Do you think EFSA is evolving its engagement framework in the right direction?
Finally, just like for the Stakeholder Dialogue workshop the totality of respondents is
convinced that EFSA is evolving its engagement framework in the right direction.
125. List of participants
Stakeholder Association Stakeholder Category
Camille Perrin (BEUC) Business and Food Industry
Costanza Rovida (ECOPA) NGO
Erna Botjes (EFA) NGO
Eugenia Chaideftou (SETAC) Academia
Fran Proscia (FVE) NGO
Gülden Pekan (EFAD) Practitioners
Hans Mattaar (ECCA) Business and Food Industry
Jennifer Lewis (IBMA) Business and Food Industry
Jakub Rusek (FEDIAF) Business and Food Industry
Jan Demyttenaere (EFFA) Business and Food Industry
Jeroen Meeussen (ERM on behalf of IBMA) Other
Josep M. Pagès (ENA) Farmers
Kalila Hajjar (FEDIOL) Business and Food Industry
Kinga Adamaszwili (EDA) Business and Food Industry
Laurent Lagadic (SETAC) Academia
Laurent Oger (CropLife Europe) Business and Food Industry
Martina Helmlinger (FEFANA) Business and Food Industry
Miguel Angel Prieto Arranz (CEFIC) Business and Food Industry
Patrick Coppens (Food Supplements Europe) Business and Food Industry
Rebeca Fernandez (FoodDrink Europe) Business and Food Industry
Timothée Jourdain (EuChemS) Academia
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