ESAC (EURL ECVAM Scientific Advisory Committee)

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The EURL ECVAM Scientific Advisory Committee (ESAC) advises EURL ECVAM on scientific issues. ESAC's main role is to conduct independent peer reviews of validation studies of alternative test methods, assessing their scientific validity for a given purpose. The ESAC reviews the appropriateness of study design and management, the quality of the results obtained and the plausibility of the conclusions drawn. ESAC peer reviews are formally initiated with a "EURL ECVAM Request for ESAC Advice", which provides the necessary background for the peer-review and establishes its objectives, timelines and the questions to be addressed. ESAC peer reviews are normally prepared by specialised ESAC Working Groups (EWGs) and the ESAC's advice to EURL ECVAM is formally provided as "EWG Reports" and "ESAC Opinions" at the end of the peer review. The ESAC may also issue Opinions on other scientific matters of relevance to the work and mission of EURL ECVAM but not directly related to a specific alternative method. Adopted ESAC Opinions are published on the JRC Publications Repository (http://publications.jrc.ec.europa.eu/repository/) and on the EURL ECVAM website as individual documents following a specific JRC Technical Report template (including as annexes and where applicable, the adopted EURL ECVAM Request for ESAC Advice and the EWG Report).

ESAC's advice (i.e., EWG Reports and ESAC Opinions) serves as the basis for the development of "EURL ECVAM Recommendations", summarising EURL ECVAM's view on the validity of a test method, and advising on its possible regulatory applicability, limitations and proper scientific use. Building on ESAC's advice, EURL ECVAM Recommendations identify knowledge gaps and define follow-up actions. Developed in close dialogue with regulators (PARERE), stakeholders (ESTAF) and international partners (ICATM), EURL ECVAM Recommendations prepare and support the international recognition and regulatory acceptance of alternative methods as well as their application by end users.

ESAC operates in agreement with published File Rules of Procedure (RoP); ESAC is listed in the Register of Commission Expert Groups and other similar entities.

 

Composition of the ESAC

The ESAC consists of a minimum of 9 core members plus ad hoc members. The core members are appointed as individual experts on the basis of their personal capacity and scientific excellence. The term of office of the core members is three years (renewable), starting on the date of their appointment. The ad hoc members are eligible experts selected to serve in EWGs based on their expertise on the test method(s) and/or scientific question(s) under review. Each EWG must comprise at least one core member who shall chair the EWG. Otherwise, EWGs may be composed of any combination of core and ad hoc members. The experts acting as ad hoc members may be nominated by the core members of ESAC, EURL ECVAM and partner organisations within the International Cooperation on Alternative Test Methods (ICATM). The final composition of the EWGs and the appointment of ad hoc members must be agreed between EURL ECVAM and the core members of ESAC. The term of office of an ad hoc member begins with his/her official appointment as member of an EWG and finishes on the adoption by ESAC of the EWG Report(s) and ESAC Opinion(s) to which the ad hoc member contributed through his/her participation in the EWG.

Ad hoc members are invited to participate in those ESAC plenary meetings where the draft EWG Report(s) and draft ESAC Opinion(s) to which the ad hoc member contributed (through the EWG) are discussed and eventually adopted. During their term of office, ad hoc members have the same status as core members when it comes to voting on scientific issues they helped peer-reviewing, but not on other issues for which they did not contribute through their EWG membership. ESAC and EWG meetings may also be followed by observers participating on behalf of their seconding body. Currently the following organisations have been invited to second observers: member and observer organisations of the International Cooperation on Alternative Methods (ICATM) (US (NICEATM/ICCVAM), Japan (JaCVAM), Canada (Health Canada), Korea (KoCVAM), Brazil (BraCVAM) and China) and the OECD Test Guidelines Programme. Furthermore, Commission staff from the following Directorate Generals is participating on a regular basis: Joint Research Centre (JRC), Environment (ENV), Health and Food Safety (SANTE), Internal Market, Industry, Entrepreneurship and SMEs (GROWTH).

ESAC membership is typically diverse and may comprise experts from academia, industry, industry organisations, non-governmental organisations (NGOs), public institutions and/or self-employed consultants. ESAC members must act solely on the basis of their personal capacity and not as a representative of their organisation. To this end, ESAC members must sign a declaration of commitment at the time of their appointment. Furthermore, ESAC members need to declare their interests (at the time of their appointment and at each ESAC meeting and EWG meeting) and declare at the time of their appointment that they respect the confidential nature of (some of) the information that is made available to them in the context of their work for ESAC.

Every three years, EURL ECVAM publishes an open "Call for Applications" to renew the core membership of ESAC (see example below), directed to scientists with a wide range of expertise that may submit their candidacy by forwarding a motivation letter and a CV. Following closure of the call, a Selection Committee checks the eligibility of candidates and suggests, on the basis of pre-defined selection criteria, a shortlist of proposed core ESAC members to the Director of JRC's Directorate F for final appointment. The Selection Committee may also draw on existing reserve lists created during previous open calls for applications to ESAC. 

 

Current ESAC members

The ESAC is currently undergoing renewal. A call for applications was launched in December 2016 with application deadline on 31st January 2017, before midnight.

 

ESAC members (2013-2016)

The ESAC in charge from 2013 to 2016 was formally established in April 2013 following an open call for applications in 2012/2013 and was composed of 15 members from Europe and North America, selected on the basis of their scientific expertise and specific work experience.

 

ESAC members (2009-2013)

The ESAC in charge from 2009 to 2013 was formally established through an Open Call for the Expression of Interest in 2009 and was composed of 15 members from Europe and North America, selected on the basis of their scientific expertise and specific work experience.

 

ESAC meetings

ESAC meetings are held on an as-needed basis but typically, the ESAC holds biannual meetings at the JRC in Ispra to discuss peer review projects and finalise the scientific advice provided to EURL ECVAM in form of EWG Reports and ESAC Opinions. Please follow the links below for more information on the agendas and minutes of these meetings.

 

ESAC Statements 1999 -2009

The composition and roles of ESAC were fundamentally redefined in 2009. Up to 2009 ESAC had a double role: on the one hand, to provide input from various stakeholders and regulators for priority setting on alternative methods (now a function of the ESTAF and PARERE, respectively) and, on the other hand, to be EURL ECVAM's scientific peer review body. During this period ESAC delivered its advice to EURL ECVAM in the form of "ESAC Statements", published on EURL ECVAM's website. The complete list of these statements can be found at the link below. Since its renewal, ESAC provides its advice in the form of EWG Reports and ESAC Opinions.