21011012 IPR.pptx

Biohazards,Institutional
Biosafety Committees and
Cartagena Protocol

Biohazards
• Biological hazards also known as
biohazards, refer to biological substances
that pose a threat to the health of living
organisms, especially that of humans. For
example: Viruses, bacteria ,fungi etc.
• These hazards can be encountered anywhere
in the environment. The biohazard symbol
was developed in 1966 by Charles Baldwin,
an environmental health engineer.

Types of Biological Hazards
• Biological hazards can be put into different categories:
• Bacteria: microscopic organisms that live in soil,water or the bodies of
plants and animals and are characterized by lack of distinct nucleus and
the inability to photosynthesize. Examples are E.coli, TB and Tetanus.
• Viruses: These are a group of pathogens that consist mostly of nucleic
acids and that lack cellular structure. Viruses are totally dependent on
their hosts for replication. Examples: common cold, influenza, measles,
SARS, Hantavirus and rabies.
• Fungi: Major group of lower plants that lack chlorophyll and live on dead
or other living organisms. Examples: mould,rust, mildew,smut,yeast and
mushrooms.

How do Biological Hazards Enter the Body?
• Biological hazards can enter the body in many ways. When
determining appropriate protective measures are clear understanding
of how it can enter the body.
• Inhalation through breathing.
• Absorption direct contact through breaks in the skin,even chapped
skin, or through mucous membrane/ contact with eyes,nose and
mouth.
• Ingestion through swallowing.
• Injection through a puncture.

Biohazard Classification
• Organisms are categorized into a group base on the particular
characteristics of each organism, such as
 Pathogenecity
Infectious dose
 Mode of transmission
 Host range
 Availability of effective preventive measures
 Availability of effective treatment

• Organisms are categorized based on the measures required for
handling each organism safely in a laboratory setting, such as
Engineering requirements
Operational requirements
Technical requirements
Physical requirements

• Conventional Agents
• Recombinant DNA
• Tissue Culture
• Animal work
• Anatomical Specimens
• Unconventional Agents

Recombinant DNA
• Genetic Engineering is in vitro incorporation of genetic material from one cell
into another.
• The level of risk depends on source of DNA, vector and host.
• The biosafety community may be able to assist the investigator in this
determination.
• TISSUE CULTURE:
• Have the potential to contain pathogenic organisms.
• In general,
Humans and non-human primate, and mycoplasma-containing
cell lines Level 2
Others Level 1
• A detailed risk assessment should be undertaken when using a new cell line.

Animal Work
• Animals can harbour infectious organisms (naturally or introduced)
• Level dependent on type of work being conducted.
• Special animal care training is required for all personnel working with animals.
• All work involving animal use must recieve prior approval from the Animal Care Committee.
• Anatomical Specimens:
• All specimens should be considered infectious due to potential presence of infectious
agents.
• Important to consider the type of specimen
blood, organs, tissues
Spinal sample. brain tissue
From infectious patient
In general Level 2 but it depends on the nature of the work.

Unconventional Pathogens
• Resistant to destruction by procedures that normally inactive viruses.
• Contact regulatory authorities to assess rerquirements (containment,
procedures, waste disposal etc.)
• Lethal transmissible neurodegenerative conditions
 Variant C-J disease, Mad cow disease, Chronic wasting disease.

What is Biosafety ?
• Biosafety is the application of safety precautions that reduce a
laboratorians risk of exposure to a potentially infectious material and
limit contamination of the work environment and ultimately the
community (CDC).
• Achieved through;
Administrative controls
Engineering controls
Personal protective equipment
Practices and procedures

Risk Group (RG) classification

The Indian Acts/Regulation/Guidelines pertaining
to BSL
1. Manufacture, use/import/export and storage of hazardous micro-
organisms/Genetically Engineered Organisms or cells, Rules, 1989
under the Environment (Protection) Act, 1986.
2. The Regulation and guidelines for Recombinant DNA research and
Biocontainment, 2017.
3. Guidelines for the Establishment of containment facilities: Biosafety
Level 2 (BSL-2) and 3 (BSL-3) and certification of BSL-3 facility,2020.

Special Considerations when working with
Biohazards
• Pathogenic
• Associated risks
• Laboratory Acquired Infections
• Treatments
• Allergies
• Infectiousness
• Limiting Exposure
• Special safety precautions

Laboratory Acquired Infections (LAIs)
• Infections that can be traced directly lab organisms handled by or
used in the vicinity of the infected individuals.
• Only 20% causative or defined event
 80% of which are caused by human factors
 20% are caused by equipment failure
• Top 4 accidents resulting in infection
 Spillages and splashes
 Needle and syringe
 Sharp object, broken glass
 Bite or scratch from animals or ectoparasites

Containment
• The primary principle of Biosafety is Containment.
• The action of keeping harmful things under control and within limits or series of safe
methods for managing infectious bacteria in the laboratory.
• Levels of containment:
• Primary containment : Protects people and the immediate laboratory environment
from exposure to infectious agents.
• Good microbiological techniques and safety equipment provide good primary
containment.
• Secondary containment: It protects the environment external to the laboratory from
exposure to infectious materials.
• Good facility and operational practices provide secondary containment. Seperate
working are,decontamination facilities, hand-washing facilities,special ventilation
systems and airlocks are example of barriers used for secondary containment.

Elements of Containment
• Laboratory practices
• Safety equipment
• Facility design

Institutional Biosafety Committee (IBC)
• Under section 5 (1) of regulations
• All organisations involved in research and
development that deals with modern
biotechnology shall establish an IBC.
• IBC is a formal expert committee of an
organisation undertaking modern biotechnology
research and development which involves use of
any LMO/rDNA materials.
• IBCs are registered with the National Biosafety
Board (NBB).
• Its function is to monitor and ensure compliance
to the biosafety act 2007 at the institutional level
and safe handling of modern biotechnology
activities.

IBC Members
• Head of the organization or his designate as the chairperson.
• Three or more scientists engaged in rDNA work or molecular biology
with at least one outside expert in the relevant discipline.
• A member with medical qualifications - Biosafety officer.
• A nominee of DBT.

IBC Responsibilities
1. Provide guidance for safe
use of modern
biotechnology.
2. Monitor activities
relating to modern
biotechnology.
3. Establish/Monitor
implementation of policies/
procedures.
4. Determine BSL for
facilities.
IBC

IBC CHAIR RESPONSIBILITIES
(1) Provides executive leadership.
(2) Maintains ultimate responsibility for safe conduct of activities.
(3) As necessary, appoint Rapid Response Team (RRT) to review hazardous incidents within 24 hrs of
occurrence and immediately engage relevant parties.
(4) Support the work/decisions of IBC in its charge to protect the organization and staff, reduce liability for the
organization, and be good stewards of public trust in the products of biotechnology.
(5) Provide written notification of IBC decisions to PI.
(6) Ensure activity does not start before getting acknowledgement letter from DG of Biosafety.
Biological Safety Officer (BSO) Responsibilities
1. Appointed by Head of organization.
2. Member of IBC (voting member) and must be affiliated with the organization
Recommended to be permanent.
3. Contact person for NBB & other regulatory agencies.
Submits all applications (notification/ approval) and annual report of IBC on behalf of organization
Periodically inspects laboratories.
4. Works with Rapid Response Team (RRT) to provide technical advice on research safety and laboratory
security procedures to PI, laboratory personnel and IBC.

SCOPE OF IBC REVIEW
• As part of the responsibility of IBC to monitor modern biotechnology activities,
there are 6 areas that IBC reviews which are:
• LMO activities – through review of Notifications/Approval forms
• Modifications to Approved Projects
• Project Extension Review of Approved Projects & Notice of Termination
• Exemptions
• Incidents and Personnel Exposure
• Biosafety Manuals
• Laboratory Inspections

IBC REVIEW 1 - LMO activity – Notifications &
Approval

• 3 Important Checkpoints to ensure the notification/approval forms are
complete:

IBC REVIEW 2 - MODIFICATIONS TO APPROVED PROJECTS
• Modification refers to changes in LMO materials, procedures, personnel, laboratory location or any change
which may increase/change Risk Group of the project or its BSL.
• PI should not initiate or implement any significant change or modification to IBC approved projects without
prior review and approval from IBC and NBB.
• If any modification in procedures is required, based on observation or any recommendations from incident
investigation, IBC should assess the proposal and then submit the request to the Department of Biosafety for
review.
• IBC REVIEW 3 - PROJECT EXTENSION REVIEW OF APPROVED PROJECTS & NOTICE OF
TERMINATION
• Near the end of the approved time period to run the activity, it is the responsibility of the PI to report back to
the IBC whether the activity will be terminated or an extension of time is needed.
• The PI is required to submit the IBC Project Extension Review/Notice of Termination Form (IBC/PE-
NT/10/Annex 5) to the IBC for review.
• This Form should be submitted at least one month prior to the next scheduled IBC meeting. It is the
responsibility of the PI to take note of the IBC meeting schedule and initiate the submission of this form.

• BSO should have continuous monitoring of all ongoing activities and remind any PI whose activity is near the end of
the approved time period.
• If the activity is terminated, a description of when and how the materials were disposed should be stated in the form.
• If the materials are being kept for the next phase of the research, there should be clear documentation on how long it
is being kept, at what volume, location and inventory and person in charge.
• The BSO is responsible to ensure that the IBC Project Extension Review/Notice of Termination Form (IBC/PE-
NT/10/Annex 5) is sent to the Department of Biosafety in a timely manner.
• A New Notification should be submitted If the project extension involves the following change – New PI, New Risk
Group, Change of BSL, Type/amount of LMO handled, Moving of LMO materials to another laboratory/facility that
was not initially approved as part of the premises for activity.
• IBC REVIEW 4 - EXEMPTIONS
• IBCs should be notified of exempted projects using internal procedure.
• An ad hoc sub committee set up within the IBC can review projects to verify the status of exemption.
• Techniques and contained use activities that are exempted are listed in First Schedule (Regulations 2010). The
Department of Biosafety may be consulted for any queries with regards to this.
• Exempted activities should be carried out under conditions of standard microbiological lab practice.
• Personnel should have appropriate training.
• BSO will ensure that the IBC monitors these exempted activities and reports back to the Department of Biosafety
through the Annual Reports.

IBC REVIEW 5 - INCIDENTS & PERSONNEL EXPOSURE
• The IBC will ensure that all Accidents and Incidents are reported through an established internal
reporting system. Near misses may be included as well for the purpose of developing any
preventive steps and to help review existing procedures.
• A review will be done by the IBC by using the Incident Reporting Form (IBC/IR/10/Annex3)
or/and Occupational Disease /Exposure Investigation Form (IBC/OD/10/Annex 4) – which ever is
relevant. Relevant stakeholders such as the Occupational Safety and Health committee or other
management personnel may be called to participate in the review.
• Discussions and actions pertaining to incident should be documented in minutes of IBC meeting.
• Accident/Incident should also be reported to JBK through IBC annual report.
• NBB may request for detailed report if necessary.
• IBC REVIEW 6 – BIOSAFETY MANUALS
• A collection of biosafety protocols and procedures must be available in every laboratory.
• It is the duty of the PI to ensure that proper documents are maintained in the laboratory and all the
personnel who are involved in the activity should have access and understand these documents.
• All personnel who are using the premises should be aware about the ERP of the LMO related
activity being conducted in the facility.
• IBC is required to review these document during inspection.

IBC REVIEW 7 – LABORATORY INSPECTIONS
• IBC is required to conduct routine inspections and sometimes as part of assessment of
proposed activity.
• Some examples of Inspection checklists are provided at the Department of Biosafety website.
• Problems are reported to PI for remedial procedures. Inspection reports will be maintained on
file by IBC.
• Routine inspections may also be conducted by representatives/officers authorized by NBB.
• Compliance Oversight & Corrective Action:
• As the IBC is appointed and authorized by the management, it may be empowered to take
suitable actions to address non-compliance.
• Types of actions include suspension, cessation, confiscation, destruction, or any other action
necessary. These are subject to the approval at the institutional level.
• These disciplinary actions should be reported to the Department of Biosafety. Proper
documentations on termination of the Notification should be followed even if corrective
actions are already in place.

• The PI has to be responsible to do the
following to prevent any non compliance to
the IBC or the Biosafety Act:
• Comply with all legislative requirements
when conducting research involving LMO
materials.
• Immediately report any significant problems
with respect to the implementation of
relevant laws, regulations and guidelines.
• Notify IBC promptly of any significant
research related accidents that have resulted
or could result in human illness, in
unanticipated plant or animal disease, or in
the unintended release of organism under
study from an intended confinement.
• Complete required training as specified.

Projects Involving Other Registrations (etc) Required
Biohazardous agents (bacteria, viruses, fungi,
prions)
Clinical specimens: all samples including
diagnostic and those identified with
pathogens
Dual Use Research of Concern (DURC) Subcommittee formed with other institutional
research compliance committee members (eg,
IACUC and/or registration with the IBC)
Select Agents (SA) Requires registration with the federal Select
Agent program registration, Centers for Disease
Control (CDC), and/or Animal and Plant Health
Inspection Service (APHIS); some states require
registration as well
What Needs to Be Registered with an IBC.

Cartagena Protocol
• History: CBD opened for signature in 1992 and entered into force on 29 Dec 1993.
• Cartagena Bio Safety Protocol (CBSP) negotiated from 1996-2000; entered into force in
11 Sept. 2003; over 170 Party Members; an international treaty.
• This is a complementary agreement to the United Nations Convention on Biological
Diversity (CBD).
• Total parties to the cartagena protocol as of June 2021 are 173.
• Objectives: The cartagena protocol on Biodiversity seeks to protect biodiversity from
the potential risks caused by LMOs arising from modern biotechnology.
• The protocol has provisions for an Advanced Informed Agreement (AIA) procedure.The
AIA is for ensuring that countries are given enough information to make informed
decisions before agreeing to import LMOs into their country.

• Scope: Transboundary movement, transit, handling and use of LMOs that
can affect sustainable use of biological diversity. Phramceuticalsa are
excluded. Adopts a Precautionary approach.
• There are 4 components to the AIA:
• Notification by the exporter
• Acknowledgement of notification receipt by the importer
• Decision procedure - Approve/prohibit/ask for more information etc.
• Review of decisions
The Cartagena Protocol also sets up a biosafety clearing house (BCH) to
enable information exchange on LMOs between countries.

• KEY ELEMENTS OF THE PROTOCOL :
• Objective and scope
• Advance informed agreement
• LMO-FFPs
• Risk assessment and management
• Identification of LMOs (labeling)
• Information sharing; Biosafety
Clearing House
• Capacity building
• Socio-economic considerations
• Liability and redress
• Compliance
Main Pillars of the protocol

 ADVANCED INFORMED AGREEMENT:
 Notification by the exporter
 Acknowledgement of notification receipt by the importer ( Party of import must
acknowledge receipt within 90 days & state 1.)
 Decision procedure - Approve/prohibit/ask for more information etc.( Importer
communicates decision to exporter in 270 days)To exporter : i) approval with or without
conditions ii) prohibition/refusal iii) request for additional information or iv) extension of
decision-making period beyond the 270 days.
 Importer may review/change its decision in light of new information. Exporter may also
request a review.
 Review of decisions
 RISK ASSESSMENT & RISK MANAGEMENT:
• Risk Assessment: Identification of potential environmental adverse effects or hazards, and
determining, when a hazard is identified, the probability of it occurring.
 In accordance with principles, methodologies & details in Annex III .
 Lack of knowledge, not lack of risk.

• Risk Management : Measures to manage and control risks.
 Prevent unintentional LMO movement.
 Ensure that LMOs are observed for an appropriate period before use.
HANDLING, TRANSPORT, PACKAGING & IDENTIFICATION :
• Shipments of different categories of LMOs will be accompanied by documentation
with varying details:
• LMO-FFPs: will identify them as ‘may contain’ LMOs, not intended for introduction
into the environment and contact details of consignee (details to be defined by COP-
MOP) .
• For introduction into environment: clearly identifies them as LMOs, specifies the
identity and relevant traits and/or characteristics, along with any requirements for
their safe handling, storage, transport and use, contact information and declaration
that the movement conforms to the requirements of the Protocol.

Convention on BiologicalDiversity
• 1992
• 196 parties
• Objectives:
• Conservation and sustainable
use of biodiversity.
• Fair and Equitable sharing of
benefits arising from the useof
genetic resources.

REFERENCES
• Diagnostic microbiology – Bailey and scott – 13th edition
• Practical medical microbiology – Mackie and Mccartney – 14th edition
• https://osp.od.nih.gov/biotechnology/faqs-on-ibc-administration/
• “Cartagena protocol on biosafety to the convention on Biological
Diversity”, text and Annexes, Montreal 2000, secretariat of the
convention on Biological diversity. ISBN: 92-807-1924-6.

21011012 IPR.pptx

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