The CNPEM Biosafety Commission (CIBio – CNPEM) is regulated by Decree 5591 of November 22, 2005 (1), for all institutions engaged in scientific research, technological development, education, and industrial production involving genetic engineering techniques and methods or research with GMOs and their derivatives.

The composition of CIBio is defined according to CNPEM ordinances (2).

Attributes of CIBio – CNPEM:

  • Conduct biosafety training and maintain records.
  • Review and monitor all projects involving GMOs and keep corresponding records.
  • Advise on documentation for the establishment of facilities handling biological risk organisms.
  • Receive notifications for the transfer of GMOs to or from CNPEM. Act as an intermediary for Risk II GMO transfers with CTNBio.
  • Forward documentation to CTNBio.
  • Issue CNPEM annual biosafety reports to CTNBio.
  • Investigate accidents possibly related to GMOs.
  • Carry out biosafety inspections at CNPEM-accredited facilities.
  • Review and propose biosafety manuals, procedures, and records.
  • Review and monitor all projects involving biological agents — even if not GMOs — classified as Risk II or higher.
  • Keep the CNPEM community informed of any issues related to biological risk accidents, procedures, and risks.

In addition to these responsibilities, CIBio also advises researchers and general management on biosafety issues involving non-GMO organisms, including the oversight of Risk 2 or higher projects, facility accreditation, and issues related to material transfer and acquisition.

Procedures

  • Biosafety Training:
    Before starting work in the laboratory, applicants must read the Biosafety Manual (3), complete the Biosafety Questionnaire (4), and schedule an interview with the biosafety committee to clarify questions, sign the record, and complete the training.
    Versions of the Biosafety Manual (5) and Questionnaire (6) are available in English.
    It’s important to note that this training does not include specific knowledge or procedures related to CNPEM’s operational units (such as LNLS, LNbio, LNNano, and CTBE). These trainings are the responsibility of the project’s technical lead, who must conduct the training and keep its records, in accordance with the rules of the unit’s respective directorate.

  • Submission of GMO Projects for CIBio Review:
    Before starting the project, the technical lead must complete the CIBio GMO Project Form (7) and send it in Word format via email to: cibio@cnpem.br

  • GMO Projects of Risk Level 2 or Higher:
    In addition to CIBio approval, these projects require submission to CTNBio in Brasília. The researcher must fill out the appropriate form (19) and email it to cibio@cnpem.br

  • Submission of Non-GMO Projects Involving Risk II or Higher Agents:
    Before starting the project, the technical lead must complete the CIBio Non-GMO Form (8) and send it via email to: cibio@cnpem.br

  • Facility Accreditation for Handling Biological Agents:
    Any facility handling biological organisms must be properly planned and reported to CIBio. Operation is only allowed after a biosafety inspection is conducted.
    The facility must have a biosafety manual prepared by the coordinator, describing organisms used, handling procedures, disposal, emergency protocols, personal and collective protective equipment (PPE and CPE).
    Facilities must ensure the availability of PPE, CPE, training, and proper documentation of said training.
    To submit a facility accreditation project for CIBio review, the technical lead must complete the CQB Form (9), the Biosafety Inspection Form (11), attach the biosafety manual, the training program, and send everything via email to: cibio@cnpem.br

  • GMO Transfer:
    Any GMO received at or sent from CNPEM must be reported in the annual biosafety reports. The lead researcher is responsible for notifying CIBio.
    CIBio issues transfer authorizations for Risk I materials. For Risk II, authorization must be obtained from CTNBio in Brasília, and the technical lead should contact CIBio for guidance.

    • For Risk I: fill out the Risk I Material Transfer Form (10).

    • For Risk II: the material must be part of a previously CTNBio-approved Risk II project. The Risk II Transport Request Form (13) must be filled and will be submitted to Brasília by CIBio.
      Email: cibio@cnpem.br

  • Events at CNPEM:
    For events, courses, demonstrations, or presentations involving organisms — or visits to labs where organisms are handled, stored, or discarded — submit the Event Form (15).
    The form should be submitted in advance to allow for CIBio review or submission to CTNBio if necessary.
    Email: cibio@cnpem.br

  • Acquisition of GMOs and Derivatives or Risk 2+ Organisms:
    For collecting signatures on forms and MTAs, the lead researcher must submit the CIBio – MTA Routing Form (16) to: cibio@cnpem.br

  • Incident or Accident Involving GMOs or Derivatives:
    In the event of incidents or accidents involving spills, surface/equipment contamination, or contamination of individuals, immediate action must be taken for containment, decontamination, and medical attention, following the guidance of the project lead, facility coordinator, and CNPEM emergency line (“extension 686”).
    The incident must be reported using the Biological Organism Incident/Accident Report Form (17) and sent via email to: cibio@cnpem.br
    This reporting helps in implementing corrective measures to prevent recurrence.

  • Signature of Project Cover Sheet on Plataforma Brasil:
    Projects involving human samples or clinical data must obtain ethical approval on Plataforma Brasil. If human samples are involved, CIBio approval is also required.
    To obtain the signature for the cover sheet, the applicant must submit a request to their LN’s directorate, along with the CIBio project submission protocol.
    The CIBio protocol number can be requested by emailing: cibio@cnpem.br

  • Adaptation of Areas for NB2 Experimentation with Non-GMO Pathogens:
    CIBio review for feasibility of experimentation with Risk 2 non-GMO organisms in temporary areas can be requested by submitting Form 18 to: cibio@cnpem.br
    The applicant must also develop containment, experimentation, storage, disposal, and decontamination procedures in collaboration with the facility lead.

Documents available for download

  1. Decree 5591 – 22112005
  2. CNPEM ordinance establishing CIBio
  3. GMO risk level I and II biosafety manual
  4. Biosafety questionnaire
  5. Biosafety Manual BSL1 and BSL2
  6. Biossafety questionnaire
  7. CIBio form for projects involving GMOs
  8. CIBio form for projects without GMO
  9. CQB questionnaire
  10. Form for transfer of biosafety risk level I organisms
  11. Biosafety inspection spreadsheet
  12. Compendium of biosafety legislation
  13. Request to transport risk level II GMOs
  14. ANVISA Resolution 50
  15. Event Form
  16. Cibio – MTA Submission Form
  17. Report of an incident or accident involving a biological organism or derivative
  18. Form for suitability of area for BSL2 experimentation with pathogenic potential without GMOs
  19. CTNBio application for authorization for activities involving GMOs in containment