The CNPEM Biosafety Commission (CIBio – CNPEM) is governed by Decree 5591 of November 22, 2005, for everyone in the institution who dedicates themselves to scientific research, technology development, education, and industrial production and uses techniques and methods from genetic engineering or conduct research involving or derived from genetically modified organisms (GMOs).
The composition of CIBio is determined by CNPEM ordinance.
Attributes of CIBio – CNPEM:
- Conduct trainings on biosafety and maintain records.
Analyze and maintain records related to overseeing all projects that involve GMOs.
- Assist with documentation to create facilities for working with organisms that involve biological risk.
- Receive notifications for transfer of GMOs to the CNPEM or from the CNPEM to other institutions. Intermediate in transfers of risk class 2 GMOs with CTNBio.
- Forward documentation to CTNBio.
- Issue annual biosafety reports on the CNPEM for CTNBio.
- Investigate accidents that may be related to GMOs.
- Conduct biosafety inspections in accredited CNPEM facilities.
- Analyze and propose manuals for biosafety, procedures, and records.
- Analyze and maintain records related to overseeing all projects that involve biological agents (even if these are not GMOs) with biological risk class 2 or higher.
- Keep the CNPEM community informed about any issues associated with accidents involving biological risks, procedures, and risks.
In addition to these duties, CIBio advises researchers and the general management on biosafety issues involving non-GMO organisms, including control of projects with risk 2 or above, accreditation of facilities, and issues associated with the transfer and acquisition of materials.
- Biosafety training: before starting work in the laboratory, the researcher making the request must read the biosafety manual, fill out the biosafety questionnaire, and schedule an interview with the Biosafety Commission to answer questions, sign the record, and complete the training. English versions of the Biosafety Manual and Biosafety Questionnaire are also available. It is important to note that this training does not cover specific knowledge and procedures for each of the facilities and units operating within the CNPEM (such as LNLS, LNBio, LNNano, and LNBR); these trainings are the responsibility of the technical lead of the research project, who shall conduct these trainings and keep records accordingly as determined by the directorship of the corresponding unit where the project is being conducted.
- Submitting projects involving GMOs to CIBio for analysis: Before starting the project, the technical lead must fill out the CIBio GMO form and send it via email (as a .doc attachment) to email@example.com.
- Submitting projects without GMOs but involving biosafety risk level 2 or higher: before starting the project, the technical lead must fill out the CIBio non-GMO form and send it via email to firstname.lastname@example.org.
- Accrediting installations for manipulation of biological agents: all installations that involve manipulation of organisms must be planned, and creation of such installations must be reported to CIBio. These installations can only begin operations after biosafety inspection is performed. Each installation must have a biosafety manual written by the installation coordinator describing the manipulated organisms, procedures for handling, disposal, emergencies, and specific issues when required, as well as personal and collective protective equipment (PPE and CPE, respectively). Note that PPE, CPE, and training must be provided for each installation, and training records must be maintained. To submit installation projects to CIBio for analysis, the technical lead must fill out the CQB form, the biosafety inspection checklist, attach a copy of the biosafety manual and installation training schedule, and send via email to email@example.com.
- Transferring GMOs: any GMO received at or sent from the CNPEM must be noted in the annual biosafety reports, and it is the responsibility of the lead researcher to report such transfers to CIBio. CIBio provides transfer authorizations for risk level 1 materials. Authorizations for risk level 2 materials are only emitted by Brasília (CTNBio), and the technical lead should contact CIBio for instructions. For risk level 1, fill out the risk level 1 material transfer form. For risk level 2, the material must be part of a risk level 2 project previously approved by CTNBio. The request for risk level 2 transport must be filled out; it will subsequently be forwarded to Brasília by CIBio. Email your request to firstname.lastname@example.org.
- For the acquisition of GMOs and GMO-derived organisms, or risk 2 or higher, for signature collection on forms and MTAs, the principal investigator must submit the CIBio – MTA referral form to email@example.com.
Documents available for download
- Decree 5591 – 22112005
- CNPEM ordinance establishing CIBio
- GMO risk level I and II biosafety manual
- Biosafety questionnaire
- Biosafety Manual BSL1 and BSL2
- Biossafety questionnaire
- CIBio form for projects involving GMOs
- CIBio form for projects without GMO
- CQB questionnaire
- Form for transfer of biosafety risk level I organisms
- Biosafety inspection spreadsheet
- Compendium of biosafety legislation
- Request to transport risk level II GMOs
- ANVISA Resolution 50
- Event Form
- Cibio – MTA Submission Form