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DPO-1360.3 THE EURL ECVAM PUBLIC DATABASE SERVICE ON ALTERNATIVE METHODS TO ANIMAL EXPERIMENTATION (DB-ALM) and the European Union Network of Laboratories for the Validation of Alternative Methods (EU-NETVAL).

Directorate-General: Joint Research Centre

Controller: WHELAN Maurice

Publication: 2014-03-10

Processing

1. Name of the processing

THE EURL ECVAM PUBLIC DATABASE SERVICE ON ALTERNATIVE METHODS TO ANIMAL EXPERIMENTATION (DB-ALM) and the European Union Network of Laboratories for the Validation of Alternative Methods (EU-NETVAL).

2. Description

The European Union Reference Laboratory for Alternatives to Animal testing (EURL ECVAM) of the Validation of Alternative Methods Unit (VAMU) of the Institute for Health and Consumer protection (IHCP) has established and is managing a database service on alternative methods (DB-ALM) and the European Union Network of Laboratories for the Validation of Alternative Methods (EU-NETVAL).

DB-ALM:

To better meet the needs of the user profiles, an interactive database service is required. Furthermore, a part of the scientific information stored in DB-ALM requires contact details for information pieces submitted on a voluntary basis by experts for online dissemination and/or reference. To provide a comprehensive service and to improve the exchange of information among experts active in this field as requested by legislation, the EURL ECVAM has established an inventory of actors active in this field of science with related information on their activities which all are provided on a voluntary basis:
1) Registrations to access the DB-ALM information content on animal alternatives and receipt of questionnaires,
2) Submission of newsletters upon request by the Data Subject,
3) Contact details for the Protocols and/or formal validation studies,
4) Inventory of persons and institutions active in the field of animal alternative with related information on the activities.

EU-NETVAL:

EU-NETVAL's mission is to provide support for EURL ECVAM validation studies that serve to assess the reliability and relevance of alternative methods that have a potential to replace, reduce, or refine the use of animals for scientific purposes. To come to the definition of in vitro method standards, EURL ECVAM is carrying our surveys to identify eligible EU-NETVAL test facilities and to identify priority in vitro methods that are available in the public and private domain. A part of the scientific information stored in EU-NETVAL-related surveys requires contact details for information pieces submitted by experts for online dissemination and/or reference. The interested persons apply to the survey on a voluntary basis. The personal data will be collected via such survey and further processed for the purpose of identifying eligible EU-NETVAL test facilities and initiation of the processes related to the definition of in vitro methods standards.

This processing of personal data is not subject to art. 27.

3. Sub-Contractors

4. Automated / Manual operations

DB-ALM:

The information is collected via a web based form and saved as records within an Oracle database  hosted at the data centre of the JRC.

Theoretically, no manual intervention is required. However, in case of requests of modifications and/or to withdraw all contact details, manual intervention might be requested.

EU-NETVAL:

The information collected via the EU-NETVAL surveys (web based forms) are saved as records within a Database that is located on a server of DG DIGIT at the European Commission.

5. Storage

Electronic storage media.

6. Comments

Purpose & legal basis

7. Purposes

DB-ALM:

The purpose is to develop an interactive service to better meet the needs of the different user profiles. An inventory of experts in this field of science has been established interconnected with the scientific information that altogether are stored in the database DB-ALM. Thus, the main objectives are to:

   •  grant access to consult the DB-ALM content for which registration is required
   •  update, on request, all registered people to the service about news of DB-ALM
   •  include, on request of the method owner/user their contact details
   •  analyse the questionnaires
   •  make publicly available a data sector on institutions and laboratories (who's who) active in the animal alternatives field whose contact details and related information have been submitted on a voluntary basis to EURL ECVAM.

EU-NETVAL:

The purpose of collection of the personal data via the EU-NETVAL survey is to identify eligible EU-NETVAL test facilities and to identify priority in vitro methods both in the public and private domain. The information from the in vitro methods serves to identify in vitro method standards that can be used to compare different in vitro methods in relation to the information they are generating.

8. Legal basis / Lawfulness

DB-ALM:

The establishment and management of DB-ALM has the following legal basis:
- SEC(91)1794, Communication of the European Commission to Council and the European Parliament
- Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes; art. 48; annex VII(2)(d). OJ L N˚ 276, 20.10.2010

EU-NETVAL:

The establishment and management of EU-NETVAL was set up by EURL ECVAM in response to the provision of Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L N˚ 276, 20.10.2010) which requests that EU Member States assist the European Commission in the validation of alternative methods. Lawfulness of processing is based on the art. 5(a) of the regulation 45/2001.

"The JRC carries out the selection based on the eligibility criteria accepted by the NCPs (DGENV). Once the laboratories/test facilities have filled in the survey and they  are selected complying with all these pre-defined eligibility criteria the list of proposed EU-NETVAL test facilities goes to DG ENV for approval by the NCPs. Once approved the test facilities get via ARES the communication they are selected. There is no evaluation procedure in place  (Subject to Art 27 (2)(b) Reg. 45/2001) as EU-NETVAL members are actually  LABORATORIES/TEST FACILITIES and not individuals. In other words, the EU-NETVAL is a network of LABORATORIES/TEST FACILITIES, not the 'working group' of experts".

The purpose of processing using the surveys is to identify eligible EU-NETVAL test facilities and to identify priority in vitro methods both in the public and private domain.  The information deducted from the in vitro methods serves to identify in vitro method standards that can be used to compare different in vitro methods in relation to the information they are generating.

Lawfulness of processing is based on the art. 5(a) of the regulation 45/2001.
This processing of personal data is not subject to art. 27.

Data subjects / fields

9. Data subjects

Persons who want consult the DB-ALM, provide their data and want to be kept up-to-date about new developments.

Participants of the EU-NETVAL surveys.

10. Data fields

DB-ALM:

The personal data collected and further processed for the registration purposes, except for the methods data sector are:

- First Name, Name*, Title, Type of organisation*, Name of organisation represented*, E-mail address* (functional e-mail address of organisation recommended).
The personal data collected and further processed for the methods data sector are:
- First Name, Name*, title, Name of organisation represented*, Address*, phone number, fax number, e-mail address* (functional e-mail address of organisation recommended).
The personal data collected and further processed for the who’s who data sector are:
- First Name, Name*, title, Name of organisation represented*, Address*, phone number, fax number, e-mail address* (functional e-mail address of organisation recommended), Internet address of the organisation’s website, field(s) of activity, the extend of involvement in the alternatives topic area and the subject covered.
(* mandatory fields).

EU-NETVAL

The personal data collected and further processed for the above mentioned purposes are:

Organisation/ Company*

Department/ Faculty/ Institute or other*

Address*

Postal code*

Town*

Country*

Responsible Contact:

Title*

Mr, Mrs, Dr, Prof

Name*

First name*

Function*

Phone*

Fax*

E-mail*

ADDITIONAL CONTACT PERSON

Title

Name

First name

Function

Phone

Fax

E-mail

If different from above:

Organisation/ Company

Department/ Faculty/ Institute or other

Address

Postal code

Town

Country

*mandatory fields

No data fields fall under Article 10.

Rights of D.S.

11. Information

DB-ALM:

The Data Subjects are obliged by the system to read the privacy statement during the registration procedure and have to accept or can reject the conditions described, before the registration procedure will be completed.

EU.NETVAL: 

The Data Subjects are obliged by the system to read the privacy statement during the survey procedure and have to accept or can reject the conditions described, before the survey procedure will be completed.

12. Procedure to grant rights

DB-ALM:

DB-ALM has already implemented an option called "Change Your Profile" in which the data subjects can modify their data or can request that their registrations should be withdrawn.
A programme has been developed that allows to periodically contact the data subjects and to verify the provided address.

EU-NETVAL:

In case the data subjects want to verify which personal data is stored on your behalf by the responsible controller, have it modified, corrected, blocked or deleted, the data subjects can write an e-mail message using the functional mailbox address ( JRC-ECVAM-NETVAL@ec.europa.eu ), specifying explicitly their request.

13. Retention

DB-ALM:

The personal data in DB-ALM are stored until the registered people withdraw their contacts because not wanting to consult the DB-ALM anymore.

The retention time for the who’s who data sector is fixed to max. 4 years unless EURL ECVAM launches an update of the registrations, asking the Data Subjects to update or cancel the stored information including on their personal data.

EU-NETVAL

The personal dataeretrieved from the surveys are stored until the survey submitter wants to withdraw their submitted information or when the survey submitter does not meet the EU-NETVAL eligibility criteria. The retention time is max. 4 years.

14. Time limit

Upon a justified delete request the Controller/delegated controller or operator will have your personal data blocked and/or deleted in a timeframe of 15 working days.

15. Historical purposes

Recipients

16. Recipients

DB-ALM:

The details related to the registrations, newsletter, questionnaire submissions are accessed only by the operator.
Contact details for the methods and the data sector on “who’who” are accessed by the people registered to the DB-ALM and via the future information portal.
People registered to the DB-ALM include:
1) Scientific community with interest in the animal alternatives field and generally in toxicology
2) National competent authorities/coordinators and other representatives, such as National ethical committees

3) Regulatory bodies,
4) DG JRC, ENV, ENTR, SANCO, RESEARCH
5) Animal welfare groups
6) Industry
7) Academia
8) Persons with general interest in the animal alternatives field

EU-NETVAL:

The submitted data serve for identifying eligible EU-NETVAL test facilities. The submitted in vitro method data serve as the basis for defining in vitro method standards to be used for regulatory purposes. EURL ECVAM and designated experts will use the information to assess the reliability and relevance of alternative methods that have a potential to replace, reduce, or refine the use of animals for scientific purposes. No personal data is transmitted to parties, which are outside the recipients and the legal framework mentioned without prior approval of the survey submitter.

Based on the data submitted for identifying eligible EU-NETVAL test facilities the final results of the eligible EU-NETVAL test fcailities will be send for approval to the National Contact Points of  Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L N˚ 276, 20.10.2010).

Based on the data submitted for identifying submitted in vitro method data that can serve as the basis for defining in vitro method standards to be used for regulatory purposes. EURL ECVAM and designated experts will subsequently use the information initiate the process of defining in vitro method standards. No personal data is transmitted to parties, which are outside the recipients and the legal framework mentioned without prior approval of the survey submitter.

17. Transfer

Not applicable.