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Ref. Ares(2013)3235515 - 14/10/2013
EUROPEAN COMMISSION
JOINT RESEARCH CENTRE
Institute for Health and Consumer Protection
Validation of Alternative Methods Unit (VAM)
The European Union Reference Laboratory for Alternatives To Animal Testing 
(EURL ECVAM)

ECVAM
36th Meeting of the ESAC
SCIENTIFIC
ADVISORY
20 – 21 March 2012
COMMITTEE
EC JRC, Ispra, Italy
(ESAC)
Building 58 (VAM/ECVAM), Meeting room
Minutes
Thomas Cole / Claudius Griesinger (ESAC/ESTAF Coordination/Scientific Secretariat)
Contents
PARTICIPANTS ....................................................................................................................................................... 2
1
AGENDA POINT 1: OPENING, CONFLICTS OF INTEREST ................................................................................. 2
2
AGENDA POINT 2: ESAC REVIEW OF THE ECVAM FOLLOW-UP STUDY OF THE 3T3 NRU ASSAY..................... 2
3
AGENDA POINT 3: STATUS OF THE ESAC REVIEW CONCERNING THE KERATINOSENS STUDY........................ 3
4
AGENDA POINT 4: UPCOMING REVIEW OF THE PERFORMANCE STANDARDS OF THE CYTOSENSOR 
MICROPHYSIOMETER TEST METHOD FOR EYE IRRITATION TESTING...................................................................... 4
5
AGENDA POINT 5: ECVAM'S APPROACH FOR ADVANCING AND PRIORITISING TEST METHODS ................... 5
6
AGENDA POINT 6: UPCOMING REVIEW OF THE JAPANESE BHAS42 CTA FOR CARCINOGENICITY TESTING.... 7
7
AGENDA POINT 7: ECVAM-COORDINATED ZEBRAFISH EMBRYOTOXICITY STUDY......................................... 7
8
AGENDA POINT 8: ECVAM ACTIVITY REPORT................................................................................................ 8
9
AGENDA POINT 9: ESAC OPERATIONS AND UPDATE OF ESAC'S RULES OF PROCEDURE (ROP)...................... 8
10
AGENDA POINT 10: ACTIVITY REPORTS OF ICATM PARTNERS AND OECD TGP.............................................. 8
11
ACTIONS....................................................................................................................................................... 9
DOCUMENT INFORMATION
Document description
Minutes of the 36th ESAC meeting.
Document history 29.3.2012 (v1); 16.4.2012 (v2-final); 18.4.2012 (v2-final2); 4.5.2012 adopted
File name
ESAC36_ADOPED-MINUTES-for-publication.doc
MINUTES   36th ESAC MEETING, 20-21 March 2012
Page 1 of 9

Participants
Present:
1. ESAC Members: David Basketter (ESAC Chair), Nathalie Alépée, Neil Carmichael, Jacques Chretien, Lucio Costa, 
Rodger Curren, Coenraad Hendriksen, Dagmar Jírova, Erwin Roggen, Vera Rogiers, Andrea Seiler, Kristin Schirmer, 
Ruud Woutersen.
2. Commission staff: JRC: Joachim Kreysa (HoU VAM), Maurice Whelan (HoU ST), Patric Amcoff (Operational 
Manager EURL ECVAM), Claudius Griesinger (ESAC/ESTAF Coordination), Juan Riego Sintes (EU Test Method 
Coordinator), Sharon Munn, Valérie Zuang (Competence Group 1 Leader), Sandra Coecke (Competence Group 2 
Leader), Annett Janusch Roi (Competence Group 3 Leader), Maria Pilar Prieto Pereita, Marlies Halder, Silvia Casati, 
Raffaella Corvi, George Kirmizidis, Susanne Belz, Elise Grignard, Susanne Bremer-Hoffmann ENV: Susanna 
Louhimies
3. Observers: William Stokes (NICEATM), Hajime Kojima (JaCVAM), Soon Young Han & Young Na Yum (KoCVAM), 
Nathalie Delrue (OECD Test Guidelines Programme, replacing L. Musset)
Apologies:
1. ESAC Members: Walter Pfaller (Vice Chair), Wallace Hayes
2. Commission staff: JRC: Elke Anklam (Director IHCP), Elisabet Berggren, SANCO: Karin Kilian, Susanne Hoeke, 
Federica di Gaetano RTD: Arnd Hoeveler, Jürgen Büsing, ENTR: Pieter Dehouck
3. Observers: Laurence Musset (OECD TGP), David Blakey (Health Canada), Jodie Kulpa-Eddy (ICCVAM chair).
1
Agenda point 1: Opening, conflicts of interest
The meeting was opened by a tour de table. The Chair reminded the ESAC members and other participants that all 
information received/discussed etc. in the context of ESAC's business must be treated with confidentiality, unless 
otherwise indicated.
The Chair requested whether ESAC members had specific conflicts of interest regarding any of the agenda points 
of this meeting. Three ESAC members declared interests that had, in part already been stated and reviewed at 
ESAC 34 and 35.
2
Agenda point 2: ESAC review of the ECVAM follow-up study of the 3T3 NRU assay
DECISION: The draft ESAC opinion prepared by the ESAC Coordinator and ESAC Chair was discussed. Following 
minor amendments of the document, the ESAC opinion was adopted. 
The amendments concerned: 

Executive Summary: Deletion of a half-sentence referring to the high variability of LD50 animal data (as 
discussed during the ESAC WG work) questioning their suitability as benchmark for validating an in vitro
test, in particular when considering positives categorised in several toxicity classes that the animal test 
data can (due to variability) not resolve. While two ESAC members felt that this sentence should stay in 
the Executive  Summary as referring to a common problem encountered when validating alternative 
methods in reference to in vivo (animal) data that show high variability (e.g. Draize tests for skin and eye 
irritation),  ESAC finally agreed to delete the half sentence since it was felt that it did not  contribute to 
transmitting the main message of the current opinion which concerned the use of the 3T3 NRU assay for 
predicting potential negatives.
MINUTES 36th ESAC MEETING, 20-21 March 2012
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Executive Summary: addition of a sentence referring to a weakness of the study design (i.e. a priori
exclusion of CMR chemicals from the eligible pool of validation test substances)

Executive Summary: addition of a sentence clarifying the phrase "chemicals of high toxicity" as substances 
"in the higher categories of acute oral systemic toxicity".

Section 2.3: addition of a clarifying sentence concerning the re- calculation of a ROC-based prediction 
model / thresholds performed by the ESAC WG
Other changes were of minor editorial nature.
It was stressed by ECVAM that, as already communicated at the beginning of the year by the Secretariat and as laid 
out in the ESAC Rules of Procedure, ESAC Working Groups were charged with drafting (1) the ESAC WG report as 
well as (2) the ESAC draft opinion. The ESAC Secretariat would in the future not  support ESAC by drafting the 
opinion(s) as had been done in the past (ESAC opinions on carcinogenicity assays and the 3T3 NRU assays). While 
some ESAC members raised concerns reg. the feasibility of achieving a consistent draft report/opinion without 
involvement of the ESAC Coordinator/Scientific Secretary, others alerted to the practice in some Commission 
scientific committees where it is the sole responsibility of the members/rapporteurs to draft all of the documents. 
There was agreement that approaches were very different, also among Commission scientific committees, and 
that it was in any case the final responsibility of the Committee to amend and adopt any Committee document as 
seen fit. The issue was regarded as closed since ECVAM had earlier communicated a standard approach, according 
to which it was the responsibility of the ESAC WG to draft both the WG report and the ESAC opinion. As a 
consequence of the discussion it was agreed that, when appointing future ESAC WGs, not only a WG Chair but also 
an additional WG member should be identified, who should take the lead in drafting the ESAC opinion and ESAC 
WG report ("rapporteur" tasks).
Based on current review of the 3T3 NRU study, ESAC recommended to ECVAM to avoid excluding a priori specific 
toxicity classes from validation testing sets (in the present context, CMR substances had been included from the 
validation testing set). Although ESAC understood  that this may be common practice reg. work in some health 
endpoints and in the interest of the safety of the testing facility personnel, ESAC recommended selecting chemicals 
primarily in view of the study objective. Study personnel should then be trained appropriately and should take 
appropriate care when handling the test items,  especially  in case CMR substances are used as part of a coded 
validation set of chemicals.
3
Agenda point 3: Status of the ESAC review concerning the Keratinosens study
The current status of the ESAC review of the Keratinosens submission was presented by the ESAC WG Chair and 
the Secretariat, summarising  the  issues raised in the context of the correspondence  (two letters) between 
Givaudan (test submitter) and ESAC WG (Dec 2011 – Feb 2012).  This correspondence aimed for clarification of 
issues concerning mainly (1) the statistical analysis of variability on the basis of biological parameters measured 
and (2) the occurrence of non-qualified runs. While the submission provided plenty of data and information, key 
information had not been appropriately summarised in the submission document (such as basic performance 
characterisation on the basis of concordance of predictions (for reliability) and predictive capacity (specificy, 
sensitivity). This had led to delays in the review. It was discussed that these issues may also stem from the fact that 
the validation had apparently "evolved" from an initial objective of in-house use, without a clear project plan for 
the entire information furnished and that the submission consequently constituted a collection of different 
studies.
Some issues noted were:

Heterogeneous chemical set employed (lacking full potency range, partly coded, with optimisation 
continuing during testing, resulting in performance differences between a first and second set); 

Positive control changed at an advanced stage with acceptance criteria (overly strict) not always fulfilled 
but data still used in statistical analyses anyway.

Revised statistics report available, with non-qualified
tests  indicated, but still lacking 
transparency/explanation of statistical approaches chosen.
The ESAC WG, in its final communication (February 2012) to the submitter has requested a simplified analysis of 
reliability based on concordance of predictions. 
MINUTES 36th ESAC MEETING, 20-21 March 2012
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The Secretariat presented the further timelines which consisted of 

a teleconference to discuss the resubmitted analysis of reliability (based on concordance of predictions)

the  WG draft report available  for discussion by ESAC and possible feedback to the WG (suggested 
timeline: 30 May 2012)

the draft ESAC opinion available to ESAC (suggested timeline: 30 May 2012)
The WG report and draft opinion would be finalised by written procedure.
The ESAC Chair and WG Chair stressed once more that the information submitted by Givaudan  was 
comprehensive, but complex to review. The information, after resubmission of the re-analysed data by Givaudan, 
appeared now complete in view of finalising the review and concluding on the primary review question, i.e. 
whether the test method could be considered reproducible. Furthermore it was highlighted that the WG was not 
mandated to generate an ITS but to identify gaps between study objective / results and conclusions, in particular in 
view of a later development of an ITS potentially populated by various in vitro test  methods and other data 
sources.
The feasibility of the timelines was discussed. It was agreed that a draft ESAC opinion would be available earliest in 
June.  Taking the summer break into account, the opinion would have to be adopted in July already. This would 
mean that the process of (1) ESAC feedback to the WG, (2) amendment of the ESAC WG report (if necessary) and 
(3) finalisation of the ESAC opinion would have to be achieved in less than one month by written procedure. These 
timelines seemed not achievable. One ESAC member stated that it might be better to foresee more time to reflect 
on the draft opinion and aim for final adoption at the next ESAC meeting in November 2012 – together with the 
expected opinion on the DPRA prevalidation study.  As the standard project submission form (SPSF) on the 
Keratinosens had been submitted to OECD already but would, due to the lack of further information (i.e. ESAC 
opinion/ECVAM recommendation) not be discussed at the upcoming WNT meeting in April 2012, it would seem 
sufficient to aim for a finalised ESAC opinion and ECVAM recommendation towards the end of 2012 so that these 
documents could be taken into consideration at the OECD WNT in spring 2013.
DECISION: The Chair summarised that the WG should aim to provide a draft opinion by June and that the 
subsequent timelines should be handled according to need. The Keratinosens opinion should be latest adopted at 
the November 2012 meeting of ESAC, together with the DPRA opinion.
4
Agenda point 4:  Upcoming review of the Performance Standards of the Cytosensor 
Microphysiometer test method for eye irritation testing

ECVAM summarised the results of the past ECVAM retrospective validation study of four cytotoxicity/cell-based 
assays for eye irritation testing, among those the Cytosensor Microphysiometer (CM) method. The validation study 
and ESAC review (in 2009) had found that the test may be suitable for initiating the top-down approach (i.e. 
identifying ocular corrosives from the rest of substances) or for initiating the bottom-up approach (i.e. identifying 
non-classified substances from the rest of chemicals), but was not suitable for resolving mild irritancy. Moreover, 
the  applicability  domain of the test methods appeared restricted to water soluble chemicals, particularly 
surfactants.  ECVAM had now developed Performance Standards (PS) for the CM test method for the following 
reasons:

ESAC in its 2009 statement had already recommended the development of PS on the basis of the fact that 
the original equipment of the CM method is not any longer commercially available. Alternative, newer 
apparatus allowing the measurement of external pH in a flow chamber is however available but would 
require assessment in view of its capacity to generate comparative results. 

ECVAM has submitted an SPSF to OECD in 2010 and is currently leading the development of a Test 
Guideline (TG). Some member countries (e.g. Germany) have requested the development of PS as a 
mandatory requirement for further advancing the development of the TG.

To allow assessing the suitability and equal performance of new equipment in a consistent manner at 
least a pre-defined reference chemical set is required. However, it seemed logical to combine efforts 
towards the definition of a reference chemical set with the additional definition of the  essential test 
method components and target accuracy values. Thus, all three elements of the PS would be defined at 
one point in time allowing also the assessment of new similar methods (and not only new equipment) in a 
consistent manner.
MINUTES 36th ESAC MEETING, 20-21 March 2012
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The Secretariat briefly summarised the ECVAM request of ESAC advice: ESAC was requested to review the 
suitability and  completeness of the draft ECVAM PS for evaluating the similarity of new methods (and hence 
whether they qualify for a performance assessment using pre-defined standards) and to judge their performance 
(reliability, relevance) in reference to the accepted standard laid down in the PS
. The Secretariat highlighted that, 
according to ECVAM, it would be sufficient to charge one or two rapporteurs with the review of the CM PS, instead 
of setting up an entire ESAC WG. 
It followed a discussion on this request. One ESAC member remarked that the new equipment available operated
on  the  same principle as the  previous equipment but was based on an improved technology and especially 
software.
On request of one ESAC member it was clarified that formulations assessed in the retrospective validation study 
had not been included as part of the performance standards reference chemicals. The reason is that for most of 
the retrospectively analysed formulations (available literature), the composition was not known.
Following a brief general discussion on the usefulness of PS-based validation studies (questioned by one ESAC 
member), the Chair invited  ESAC  to  focus and comment on the technical/scientific review of the proposed CM 
performance standards without digressing on principle questions of (PS-based) validation. In particular the aspect 
of reliably assessing updated instrumentation should be kept in mind. ESAC was not asked to comment on relative 
merits of the method versus other methods, nor the relevance of cytotoxicity as a readout/surrogate to predict 
eye irritation.
The NICEATM observer remarked that it would be useful to involve, in the context of the ICATM collaboration, 
ICCVAM's ocular toxicity working group (OTWG) in view of getting ICATM views on the draft PS before starting the 
review process. ECVAM indicated that it would collaborate with the OTWG before finalising the CM PS.
DECISION:
(a) ESAC appointed four ESAC members as rapporteurs charged with preparing the review of the suitability 
and completeness of the draft CM PS.
(b) The ECVAM Request for ESAC advice including the mandate will be formally amended (if required) and 
adopted by written procedure, once the final draft CM PS are available.
5
Agenda point 5: ECVAM's approach for advancing and prioritising test methods
ECVAM presented the current advisory structures and operational networks set up in 2009 to 2011 addressing the 
requirements of Directive 63/2010. It was stressed that EURL-ECVAM's essential role remained the coordination of 
validation studies – also in collaboration with member states (principle of shared burden) through the so-called 
NETVAL network of MS laboratories appointed following an official request from the Commission to the MS. Other 
important elements included the PARERE network (consisting of a MS  regulators network and an Interservice 
Network) and the ESTAF (=ECVAM Stakeholder Forum). Briefly, the intention of ECVAM to work again more on the 
basis of health endpoints was indicated. Furthermore, the usefulness of the concept of "Adverse Outcome 
Pathways" (AOPs) for prioritising test methods was currently under discussion. Chemical toxicity in vivo is generally 
manifested as an integration of specific symptoms, mechanistic stages, physiological susceptibility, etc, where a 
complement of in vitro methods may be required to cover full health and safety assessments (i.e., for regulatory 
classification). In general, prioritisation of test submissions aims to improve efficiency and transparency, on three 
levels: 1) relevance to regulatory policy, 2) relevance as an alternative test, 3) readiness for validation.
It followed a discussion on this presentation. 

ESAC members remarked that criteria for prioritisation had not been outlined and asked whether these 
had been finalised already. Moreover, one ESAC member suggested that ICATM partner organisations 
should collaborate in view of developing one consistent set of prioritisation criteria in view of harmonising 
their procedures and activities. ECVAM clarified that the prioritisation criteria were currently under 
discussion at ECVAM and had not yet been finalised. 

One ESAC member suggested that ECVAM should organise open  calls for test methods addressing a 
specific health effect or mechanism of action instead of primarily responding to test method submissions. 
ECVAM explained that this had been discussed already during the last ESTAF meeting (2011) and that 
MINUTES 36th ESAC MEETING, 20-21 March 2012
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ECVAM was considering such proactive approaches currently for its general approach towards advancing 
test methods for validation.

Another ESAC member inquired how the overall approach would speed-up validation as acceleration had 
been also mentioned as one of the benefits of a renewed approach. ECVAM replied that clear "go/no go" 
type criteria were required to ensure a swift prioritisation of test methods. It was also made clear that the 
available resources however were limited.

The ESAC Chair remarked that the easiest and quickest way to speed up the overall process was to 
'devolve' decision-making, i.e. to empower the individuals responsible for advancing particular work with 
decisions to be made on the basis of clear decision criteria to be developed by management.

A Commission observer (DG ENV) remarked that the role of PARERE was, according to the provisions of 
the Directive, very clear and that it would be necessary to ensure that this role remains as its primary core 
task. However, other additional tasks or work-flows that ECVAM was currently considering for its priority 
setting are not excluded.
The session continued with an illustration of current prioritisation exercises by work 1) in the area of skin 
sensitisation and 2) endocrine disruption. 
In the area of skin sensitisation, several methods addressing various steps of the OECD-based "Adverse Outcome 
Pathway" (AOP) for skin sensitisation are  currently being evaluated following submission to ECVAM. Others are 
already under validation by ECVAM (i.e. DPRA, MUSST, h-CLAT).  Skin sensitisation provides a well-characterised 
example of how complementary use of alternative assays would contribute to overall health effect assessment and 
potency evaluation. Six mechanistic stages have been identified in skin allergic reactions: if one event is critical, an 
in vitro assay of that particular effect could be decisive in determination of overall adverse outcome pathway 
(OECD AOP). Various test methods are still in development or have just undergone development and more 
submissions are expected, in particular as a result of the EU "Sens-it-iv" project. Evaluation focuses currently on 
mechanistic relevance, assay and data utility, R&D status, 3R impact, etc. Matrix compilation of these criteria will 
then allow prioritisation for validation and eventual ESAC consultation. 
It followed a discussion on the points raised in the presentation: 

ESAC members remarked that it was not sufficiently clear how the AOP for skin sensitisation and possible 
testing data would help with the categorisation of chemicals. 

ESAC members inquired whether the AOP had been developed based on a wide spectrum of chemical 
substances or rather on the basis of general physiological / immunological literature.

One ESAC member inquired whether there were already ideas reg. skin sensitisation ITS. In particular, if 
one in vitro method would yield a negative result, would this be a final decision point already? ECVAM 
explained that the strategy still needed development and that these efforts would require well 
characterised test methods, in particular with regard to their reliability. One ESAC member remarked that 
reliability was certainly not enough but that test methods also should be characterised in terms of their 
predictive capacity, their applicability and limitations so as to place them appropriately in a testing 
strategy.
In the area of endocrine disruption, mainly one mechanism – binding to/transactivation of the estrogen /androgen
receptors - is currently addressed by submitted methods (biochemical binding assays and biological transactivation 
assays using transfected cell lines). Prioritisation of submitted methods is now required using a matrix outlining the 
advantages/disadvantages of the methods, identifying key events addressed by individual assays.
It followed a discussion on the points raised in the presentation: 

One ESAC member inquired why EPA had discontinued one validation study on an AR (androgen receptor) 
assay. ECVAM replied that this had been decided due to a shift in priority at EPA.

One ESAC member remarked that it seemed sufficient to validate one or two methods for ER and AR and 
develop Performance Standards for subsequent validation of similar methods. 

One member inquired whether any other hormones were also considered, e.g. thyroxin. Another member 
replied that effects on thyroxin hormone action were considered highly relevant in the field of cosmetics 
safety evaluation.
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One ESAC member remarked that ED test methods would not safe any animals, but would rather trigger 
more in vivo experiments. It needed to be ensured that the false positive rate would not be too high as to 
avoid unnecessary animal experiments and high cost to industry.

The NICEATM observer suggested considering US EPA's 'Endocrine Disruptor Screening Program' (EDSP) 
when deciding on priority setting for ED methods.
The session continued with presentations from ECVAM on the status of alternative methods in the areas of 
repeated-dose toxicity testing, genotoxicity and carcinogenicity testing as well as toxicokinetics testing. These 
presentations were based on the work of the JRC-coordinated expert group summarising, for DG SANCO, the 
status of alternatives for cosmetics safety assessment in view of the 2013 deadline (Adler et al., 2010).
6
Agenda point 6: Upcoming review of the Japanese Bhas42 CTA for carcinogenicity 
testing
The Secretariat introduced the ECVAM request for ESAC advice concerning the Japanese prospective validation 
study of the Bhas42 Cell Transformation Assay. ECVAM had received, within the ICATM framework, a request from 
JaCVAM to coordinate/manage the peer review of this study and had agreed to do so after having consulted ESAC. 
ESAC had agreed to employ  the previous ESAC WG CTA for this purpose. The ESAC WG CTA had, in 2010/2011 
reviewed the ECVAM-coordinated study on the reliability and transferability of the SHE and Balb/C CTA protocols. 
The review questions would be set as soon as the adopted Validation Study Report was available. Current 
indications were July. These were confirmed by JaCVAM. 
ECVAM gave a brief overview, on behalf of JaCVAM, on the study. All data had been generated prospectively; no 
historical data had been used. Importantly, the Bhas42 CTA holds the promise to allow distinguishing initiators and 
promotors of carcinogenicity. As the validation study comprised two protocols, one conventional  six-well design 
and one using a 96 well design, it may be also amenable for automated testing.
DECISION: Following a brief discussion on the study, ESAC  agreed that the two ESAC members in the ESAC WG 
would focus on one main responsibility, with one member acting as chair and the other one as rapporteur, the 
latter responsible for drafting the ESAC WG report and draft opinion.
7
Agenda point 7: ECVAM-coordinated Zebrafish Embryotoxicity study
In view of a possible ESAC peer review, ECVAM presented the OECD validation study  of the Zebrafish Embryo 
Toxicity Test (ZFET) and in particular the ECVAM-coordinated part concerning reliability of the assay. The current 
study was driven by OECD Project 2.7 towards the development of a new TG for a "fish embryotoxicity test"(FET). 
Background to these activities is OECD TG 203 on acute fish toxicity. The TG's purpose is to allow determination of 
the LC50 value, i.e. the concentration of a substance dissolved in water which will kill 50% of the fish population 
exposed. EU statistics from 2008 suggest that 51'000 fish are used annually for LC50 tests.  Species used include
zebrafish, fathead minnow, Japanese medaka.  Substances tested are chemicals, veterinarian pharmaceuticals, 
plant production products, biocides, food & feed and others.
The  ECVAM-coordinated study part focused on the assessment of the transferability,  within- and between-
laboratory reproducibility of the ZFET, while determination of the predictive capacity was not an objective of the 
study. The study now required being peer reviewed and it was likely that ECVAM would request ESAC to review it.
In the following discussion, the OECD observer emphasized that according to OECD procedures, peer review was 
not necessarily a mandatory requirement following completion of a validation study. Often discussions within the 
relevant expert groups were considered as a substitute for peer review. A formal decision on a) whether or not 
peer reviews will be conducted and b) which organisation will conduct the peer review would rest with the OECD 
(i.e. WNT) as this was an OECD study. In any case, an ESAC peer review would be very welcome and expected to 
support further decision-making at OECD.
ECVAM indicated that, if requested by OECD, would only review the ECVAM-coordinated part of the study.
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8
Agenda point 8: ECVAM activity report
The activities of competence groups 1 (validation), 2 (in house assessment and training) and 3 (databases) of the 
VAM unit were presented. Further a presentation on Lumicell validation study using the automated platform was 
given by the ST unit.
9
Agenda point 9: ESAC operations and update of ESAC's Rules of Procedure (RoP)
The ESAC Secretariat provided an overview of the current planning of ongoing/upcoming ESAC reviews, i.e. the 
envisaged timelines for finalising the deliverables and presented some minor changes to ESAC's  ‘Rules of 
Procedure’ (RoP) that were required following internal JRC audit and which concern possible interests of members, 
invited experts and observers and the Chair's powers to exclude any participant from discussions, decision taking 
(if ESAC members are concerned) and written procedure, if deemed necessary.
Furthermore the meeting dates for 2012 and 2013 were again communicated:

2012 Autumn meeting:
Tuesday / Wednesday 
6/7 November 2012

2013 Spring meeting: 
Tuesday / Wednesday 
26/27 March 2013

2013 Autumn meeting:
Tuesday / Wednesday 
8/9 October 2013
Finally, the ESAC was reminded that the three years term of office would come to an end in December this year. As 
membership is renewable, ECVAM would circulate an official letter to ESAC members requesting indications as to 
whether members would like to be considered for a renewed term. Moreover, ECVAM indicated that it was 
currently considering to slightly enlarge the ESAC (to 19 members) in view of gathering the necessary expertise.
10
Agenda point 10: Activity reports of ICATM partners and OECD TGP
The ICATM partner organisations (NICEATM/ICCVAM, KoCVAM, JaCVAM) as well as the OECD Test Guidelines 
Programme (TGP) provided detailed overviews of their work.
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11
ACTIONS
Nr.
Agenda item
Action and timeline
Actors
1
AP2
Action:
• ESAC 
ESAC opinion 3T3 NRU
Distribution of final ESAC opinion on the ECVAM 
Secretariat
follow-up study concerning the predictive capacity 
of the 3T3 NRU assay (as adopted during this 
meeting).
Timeline:
Within March 2012
2
AP4
Action:
• ESAC 
PS for Cytosensor 
Adoption of the ESAC request for review of the 
Secretariat
Microphysiometer 
Performance Standards of the Cytosensor  • ESAC
Microphysiometer assay by written procedure.
Timeline:
As soon as final ECVAM draft Performance 
Standards are available. 
3
AP6
Action:
• ESAC 
ESAC review of BHAS 42  Circulation of final ESAC request BHAS42 CTA for 
Secretariat
CTA
comment and adoption
• ESAC
Timeline: 
As soon as possible, pending availability of the final 
Validation Study Report (VSR), currently expected in 
July 2012
4
AP7
Action:
• ESAC 
Possible ESAC review of 
Development of a list of candidate members of a 
Secretariat
ECVAM coordinated 
potential ESAC WG for reviewing the zebrafish 
part of the OECD study 
embryotox test based on a) proposals form ECVAM, 
on the Zebrafish 
b) proposals from ESAC and c) proposals from 
Embryotoxicity Test 
ICATM.
(ZET)
Action:
April 2012 and following final decision of OECD WNT 
concerning the review of the ZFET study.
5
AP9
Action:
• ESAC 
Update of ESAC Rules of  Distribution of final proposal of the update of the 
Secretariat
Procedure (RoP)
ESAC Rules of Procedure
Timeline:
Within April 2012
MINUTES 36th ESAC MEETING, 20-21 March 2012
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