CBSUB Regulations

Index:

• Preamble
• Article 1. Definition
• Article 2. Purpose
• Article 3. Regulation
• Article 4. Composition of the CBS
• Article 5. Functions of the CBS
• Article 6. Operating rules of the CBS
• Article 7. CBS actions
• Article 8. CBS meetings
• Article 9. Request for evaluation and issuance of reports
• Article 10. Notification
• Article 11. Appeals
• Article 12. Regulations of the CBS and other safety standards
• Final disposition

Preamble

Law 31/1995, of 8 November, on the prevention of occupational risks; Royal Decree 664/1997, of 12 May, on the protection of workers against risks related to exposure to biological agents at work; Law 9/2003, of 25 April, which establishes the legal regime for the contained use, voluntary release and trade of genetically modified organisms in order to prevent risks to human health and the environment; Royal Decree 178/2004, of 30 January 2004, which approves the general regulations for the development and execution of Law 9/2003, and Decree 62/2015, of 28 April 2015, article 12 of which establishes the creation of the Register of genetically modified organisms in Catalonia, constitute the basic applicable regulations aimed at preventing risks to human health and the environment from exposure to biological agents.

Likewise, the rules on animal health, such as Law 8/2003 of 24 April 2003, and the rules on plant health, such as Law 43/2002 of 20 November 2002 and Royal Decree 58/2005 of 21 January 2005, adopting protective measures against the introduction and spread within the national territory and the European Community of organisms harmful to plants or plant products, as well as for export and traffic to third countries, shall also apply.

In accordance with the general principles set out in Royal Decree 178/2004 (Annex II) and the criteria used by the National Biosafety Commission, the Governing Council of the University of Barcelona considered it necessary to set up a biosafety committee to deal with all issues relating to the prevention of risks to health and the environment arising from exposure to biological agents, including biological agents, genetically modified organisms and samples potentially contaminated with biological agents.

For all these reasons, the Governing Council, using its powers, agrees to regulate the functioning of the University of Barcelona Biosafety Committee, in the following terms.

---

Article 1. Definition

The Biosafety Committee (hereafter, CBS) of the University of Barcelona is a collegiate body created by the Agreement of the Governing Council on 16 July 2015, with the aim of assessing the University in research and teaching tasks involving the use of biological agents and ensuring that the obligations required by biosafety regulations are fulfilled.

---

Article 2. Purpose

The purpose of these regulations is to regulate the functioning of the CBS of the University of Barcelona.

---

Article 3. Regulation

The functioning of the CBS is subject to the provisions of these regulations, current legislation on the legal regime of public administrations and the applicable regulations on biosafety, as well as the Statute of the University of Barcelona, approved by Decree 246/2003, of 8 October.

---

Article 4. Composition of the CBS

1. The composition of the CBS is regulated by article 3 of the agreement of the Governing Council that established it. Thus, the CBS is constituted by the following members:
   • The vice-chancellor or vice-chancellor with competence in the area of research, or the person delegated by him/her, who presides over it.
   • Three to five professors, researchers or experts in the field of recombinant DNA technology, the use of human pathogens, the use of animal pathogens or the use of plant pathogens.
   • Up to two members of the teaching and research staff (PDI) or administrative and service staff (PAS) representing the University’s Health and Safety Committee, appointed by this committee.
   • Prevention technicians from the Office of Safety, Health and Environment (OSSMA) who carry out the tasks of the preventive speciality in the field of biosafety, who also act as technical advisors to the CBS.
   • One of the persons listed in sections c or d designated by the president or by other UB technical staff, who acts as secretary. If it does not belong to sections c or d, it acts with a voice but without a vote.
2. The members of the CBS indicated in section b of article 1 are appointed by the vice-chancellor with competence in the area of research, considering the specialisation in the fields established and in accordance with the criteria of independence and impartiality.
3. The term of office of the members of the CBS is four years, renewable, without prejudice to any replacements that may be necessary.

---

Article 5. Functions of the CBS

Within its scope of action, the CBS is responsible for the following functions:

1. . To assess the different University bodies and teaching and research staff regarding activities that involve the use of genetically modified organisms (GMOs) or biological agents, informing them of the biosafety measures that need to be adopted and issuing, if necessary, the corresponding reports.
2. Advise researchers and teachers on applications for authorisation and notifications to the competent authority on the use of GMOs or biological agents.
3. Participate in the identification, review and approval of facilities and activities of any kind that involve the use of biological agents or GMOs, and verify the degree of compliance with current regulations.
4. In coordination with the OSSMA, analyse and provide information on applications for installations or activities requiring authorisation, before notifying the competent authority, and keep a register of authorised installations and notified GMOs or biological agents.
5. Intervene when there is knowledge of the undeclared use of biological agents or GMOs or when, according to the corresponding technical report, the regulations are not complied with, proposing to the rector the disallowance or suspension of the activity.
6. To draw up and approve biosafety standards and procedures to be applied internally throughout the UB.
7. Notify the competent authorities of any spillage, contamination or serious accident involving biohazardous material.
8. Promote training and information activities related to biosafety and the promotion and dissemination of good practices.
9. Ensure that the protection of intellectual property rights and data confidentiality is guaranteed in relation to the documentation provided to the Committee.
10. Keeping a record of the documentation processed.
11. Any other function attributed to them by UB regulations or governing bodies.

---

Article 6. Operating rules of the CBS

To achieve its objectives, the CBS has to draw up, in addition to these regulations, a standard working procedure for the different activities it has to carry out, which is approved by the Board of Directors.

1. The rules of operation of the CBS are as specified below. In all matters not provided for in these regulations, the provisions of current legislation shall apply.
2. These are the functions of the President of the Committee:
   • To agree the convening of ordinary and extraordinary sessions, and to set the agenda, considering, if necessary, requests from members made before the issue of the corresponding notice of meeting.
   • Chairing the meeting and directing the different interventions.
   • Endorse the acts and certificates of the agreements adopted by the CBS.
   • To represent the committee before other bodies and institutions.
   • To resolve, with its vote, ties to adopt agreements.
   • Any other duties that correspond to him/her in accordance with the legislation in force on collegiate bodies of public administrations.
     
     The president can invite external experts to the meetings of the CBS or ask them for their opinion when he or she considers it appropriate. These experts attend the meeting with a voice and without a vote.
3. The duties of the Secretary of the Committee are as follows
   • Draw up and sign the minutes of the CBS meetings, with the approval of the president.
   • To convene the sessions of the CBS, by order of the President.
   • To keep and archive the minutes, and to manage the publication of the agreements on the University’s website and the University’s Transparency Portal.
   • To process, distribute and keep all the Committee’s own documentation.
   • To provide the members of the CBS with the information necessary for the fulfilment of its functions.
   • Receive the communications that members send to the CBS.
   • Drawing up the biosafety certificates corresponding to the research projects and any other that may arise from the agreements adopted.
   • To ensure the necessary coordination of the CBS with the UB Health and Safety Committee, the UB Animal Experimentation Committee and other university committees.
   • Any other duties established by current legislation, and all those inherent to the position of secretary.
4. Són funcions específiques dels assessors tècnics, a més de les inherents com a membres del Comitè de Bioseguretat:
   • To prepare and provide the Committee with the documentation and technical information it requires to properly exercise the powers assigned to it and which are specific to its activity.
   • To act as interlocutors between researchers, the CBS and the Administration.
   • Carry out an initial assessment of the information submitted to the CBS, based on the criteria established by the Committee.
   • Facilitate the exchange of information and documentation on procedures affecting the UB’s different committees.
   • Exercise the other technical functions assigned by the CBS.

---

Article 7. CBS actions

The CBS acts ex officio or at the request of a party in accordance with the standard working procedure that has been approved for this purpose. The procedure must regulate all aspects related to the action.

---

Article 8. CBS meetings

1. The CBS meets in ordinary session once every six months and in extraordinary session whenever the president or half of the members consider it necessary, on their initiative or as a result of urgent requirements, at least three working days in advance.
2. For the CBS to be validly constituted, for the purposes of holding sessions, deliberations and reaching agreements, the presence of at least half plus one of its members is required, and in any case, the presence of the president — or the person who delegates — and the secretary. No member, apart from the president, may delegate his or her functions or be substituted in the sessions of the CBS.
3. The agreements of the CBS are adopted by a simple majority of votes. In the event of a tie, the vote shall be decided by the president’s casting vote.
4. The modification or revision of these regulations requires the agreement of at least two thirds of the members of the CBS.
5. Any member who has any connection or interest in any of the projects evaluated must abstain from intervening in the evaluation process.
6. The members of the CBS must respect the principle of confidentiality with regard to the information and documentation they hold as such.

---

Article 9. Request for evaluation and issuance of reports

1. UB members requesting action by the CBS must follow the procedure established for this purpose by the Committee. The application must be accompanied by all the required documentation.
2. Applications can be submitted throughout the academic year, in order to have enough time to obtain the corresponding report before the deadline required in the calls for research projects or the start of the teaching activity.
3. Once the application has been assessed, the CBS issues a report which may be:
   • Favourable.
   • Conditional upon the correction of formal defects or the provision of additional documents.
   • Unfavourable.
4. The CBS issues the reports in writing within a maximum of two months after the application has been submitted by generic request.

---

Article 10. Notification

In the case of research projects, the report is notified to the person requesting it and to all interested parties. In the case of teaching activities, the report is notified to the person requesting it and to the person responsible for the centre.

---

Article 11. Appeals

The agreements of the CBS may be subject to appeal before the rector.

---

Article 12. Regulations of the CBS and other safety standards

Compliance with the provisions of these regulations does not exempt the obligation to comply with the duties and obligations relating to risk assessment and the planning of preventive activities provided for in the Law on the Prevention of Occupational Risks.

---

Final disposition

1. These regulations, and their modifications, come into force the day they are approved by the Governing Council of the University of Barcelona and must be published on the University’s website and on the University’s Transparency Portal.
2. In all matters not covered by these regulations, the provisions of Law 40/2015, of 1 October, on the legal regime of the public sector, Law 26/2010, of 3 August, on the legal regime and procedures of the public administrations of Catalonia, and Decree 246/2003, of 8 October, approving the Statute of the University of Barcelona, shall apply.