Biosafety

CBS-PRBB: The Committee of Biosafety of the PRBB

Introduction / What is it?

The Committee of Biosafety of the Barcelona Biomedical Research Park (CBS-PRBB) has the mission to regulate and control the activities with genetically modified organisms (GMOs) and biological agents that take place at the PRBB. It was constituted on July 2, 2011, after a recommendation of the Ministry of Agriculture and Environment of the government of Catalonia and according to the policy of the National Commission of Biosafety of the Ministry of Agriculture and Environement. 

The goal of the CBS-PRBB is to evaluate matters of biosecurity of scientific projects that imply the use of GMOs or biological or chemical agents that may have a biological effect of special importance, complexity or danger.

 

How does the committee operate?

The committee meets periodically, to evaluate the presented experimental proposals that will be applied at the PRBB. 

Researchers need to send the applications 15 days before the next CBS meeting to the Committee secretary: Tina Martínez, Tel. 93 316 0060 - Ext. 1060, cbs@prbb.org

The resolutions of the evaluated experimental proposals will be communicated to the responsible researcher and his/her research centre at the park.

Instructions to present an experimental proposal to the Committee of Biosafety (see below). 

Composition:

President: Montserrat Torà (IMIM) 
Secretary: Agustina Martínez Blázquez (PRBB) 

Members:
Juan Martín Caballero (PRBB)
Andreas Meyerhans (UPF)
Juan Carlos Pascual (PRBB)
Eva Yus (CRG) 

Contact: 
Tina Martínez Tel. 93 316 00 60 – Ext. 1060; cbs@prbb.org

 

Instructions to present an experimental proposal to the Committee of Biosafety

Before presenting an experimental procedure to the CBS-PRBB, consult the exempt activities below.

Depending on the type of reagents that you want to use in the experimental procedure, please use the corresponding form:

For the declaration of activities with GMOs or biological agents:

Form A: “Experimental procedure statement of confined use of genetically modified organisms (GMOs) and biological agents for research”

For modifications and/or additions to a procedure presented with Form A:

Form A for modifications

Note: You don't need to submit a change every time you change the personnel of the procedure. Rather use renovations or modifications of the procedures because of other causes to update the staff attached to it.

For the declaration of chemical agents of special importance, complexity or danger:

Form B: “Biosafety statement for the use of hazardous chemical products in an experimental procedure”

For the declaration of experimental procedures that take place at the PRBB animal facility you need to fill in additionally:

Animal Facility Annex: “Biosafety statement for experimental procedures to be developed at the animal facility”

This document needs to be presented always with the corresponding form A or B, if the proposed activity takes place at the animal facility.

For the declaration of exempt activities:

Notification: “Statement of activity with biological agents exempt from liability of CBS authorization”

For the application for a certificate of the CBS for a research project:

Project Certificate Request

This document needs to be used, when you need a CBS certificate for a grant proposal of a research project.

Please note: All application forms, once filled in and signed, need to be send to cbs@prbb.org.

  

Exempt activities CBS-PRBB 

A Activities with biological agents and GMOs of biosafety level I (pure cultures of bacteria, viruses, fungi, protozoa, collection cell lines (CECT, ATCC, DSMZ, etc.), non-primate primary cell lines,...

B Working with synthetic molecules of recombinant DNA that cannot be multiplied in any organism or biological system.

C The storage, purchasing, shipping, culture, transport, destruction, disposal or use of commercial GMOs, as long as the conditions of use will be conformed to the conditions of commercialization authorization established by the competent authority (e.g. genetically modified seeds, medicines, genetically modified animals, etc.).

D The transport of biological agents by road, rail, sea, river or air. (The transport of these agents will be done according the “Guide on regulation for the Transport of infectious substances 2007-2008”. World Health Organization).

E Working with biotoxins with an LD50 in vertebrates of more than 100 micrograms per kg of body weight.

F Those chemical products in which the risk is either well identified or do not have a high danger.

G Experimental procedures with established lines of genetically modified mice of risk level P1. Only if they are not inoculated with biological agents, viral vectors or hazardous chemical agents.

 

Legal background and interest links


The following laws and policies are applied at the CBS-PRBB: 

Biosecurity Manual of the WHO

Biosafety in Microbiological and Biomedical Laboratories, 5th edition



In Spanish: 

Decreto 62/2015, por el cual se establecen medidas para el ejercicio de las competencias de la Generalitat de Catalunya en materia de los organismos modificados genéticamente.

Directiva 2009 / 41 / CE, de utilización confinada de OGM.

Instrumento de Ratificación del Protocolo de Cartagena sobre Seguridad de la Biotecnología del Convenio sobre la Diversidad Biológica, hecho en Montreal el 29 de enero de 2000.

Ley 9 / 2003, de 25 de abril, por la que se establece el régimen jurídico de la utilización confinada, liberación voluntaria y comercialización de organismos modificados genéticamente (OGMs) 

Real Decreto 178/2004, de 30 de enero, por lo que se aprueba el Reglamento general para el desarrollo y ejecución de la Ley 9 / 2003. 

Real Decreto 664/1997, de 12 de mayo, sobre la protección de los trabajadores contra los riesgos relacionados con la exposición a agentes biológicos durante el trabajo. 

Guía técnica para la Evaluación y Prevención de los riesgos relacionados con la exposición a Agentes Biológicos (según el RD 664/1997, de 12 de mayo). 

Orden de 25 de marzo de 1998, por la que se adapta, en función del progreso técnico, el Real Decreto 664/1997, de 12 de mayo, sobre la protección de los trabajadores contra los riesgos relacionados con la exposición a agentes biológicos durante el trabajo. 

Real Decreto 665/1997, de 12 de mayo, sobre la protección de los trabajadores contra los riesgos relacionados con la exposición a agentes cancerígenos durante el trabajo. 

Real Decreto 374/2001, de 6 de abril, sobre la protección de la salud y seguridad de los trabajadores contra los riesgos relacionados con la exposición a agentes químicos durante el trabajo.

  

 

Back