1. “A world that is safe and secure from the accidental or deliberate release of animal pathogens, including zoonoses.”
Released in Jan 2012

2. Biological Threat Reduction
Reducing biological threats by strengthening, enhancing, and cross-linking existing health systems
OIE Global Conference on Health and Security ‘Building capacity to reduce biological threats through stronger and integrated health systems’
30 June – 2 July 2015, Paris (France)
OIE has an established biological threat reduction strategy which focusses on reducing biological threats by strengthening, enhancing, and cross-linking existing health systems
It is based on the principle that by investing in systems to prevent, detect and respond to every day infectious animal diseases threats and zoonoses, you are also reducing the risk from the less common risks of accidental or deliberate release. Because this approach has visible and immediate benefits it is more sustainable.

3. Establishing or updating international standards
Identifies a need to update
an existing standard
Committee, Commission or, Delegate
OIE Specialist
Commission
Review
advice from experts or ad hoc group
Draft text 1
Whenever OIE sets standards they must be agreed by the international community – that is all the 180 OIE Member Countries
Process as follows:
Democratically adopted
For biosafety and biosecurity OIE maintains close contact with the WHO and WHO is invited to participate in the standard setting process. WHO experts are invited to the WHO ad hoc group and are therefore actively engaged in drafting the chapter 2
Comments
DELEGATES
ASSEMBLY
OIE INTERNATIONAL STANDARD
Adoption

4. OIE Biosafety and Biosecurity Resources - OIE Health Standards -
Manual of Diagnostic Tests for Aquatic Animals
The OIE manual of diagnostic tests and vaccines for terrestrial animals contains standards for diagnostic tests, for manufacture of safe, potent and effective vaccines, also sample collection, shipment and biosafety and biosecurity.
Biosafety and biosecurity guidance has recently been updated.
Manual of Diagnostic Tests and Vaccines for Terrestrial Animals

5. OIE Biosafety and Biosecurity
- Revisions on Terrestrial Manual chapters in 2013 &
Adopted in 2013
Chapter – Collection, Submission and Storage of Diagnostic Specimens (update of information, removes shipping information)
Chapter Transport of Specimens of Animal Origin
(new chapter: coordination with international regulations and requirements on packaging and shipping)
Chapter a – Standard for Managing Biorisk in Veterinary Laboratories and Animal Facilities
(account for a biorisk analysis and management approach)
Adopted in 2014
Two chapters on sample collection and transport were updated and adopted in 2013
At the OIE general session in May a new chapter on standard for managing biorisk was adopted, brings OIE standards in line with a risk management approach also reflected in WHO guidance and the CWA

6. - Conceptual Changes -
New Chapter ( a) - Standard for Managing Biorisk in Veterinary Laboratories and Animal Facilities
Provides a biorisk analysis and biorisk management approach:
replaces “pathogen risk group” classification and assignment of specific agents to pre-designated containment levels.
terminology and approaches consistent between animal health and public health for laboratory biosafety, biosecurity, biocontainment, and biorisk analysis.
With that reflection and consideration of compatibility with CEN Workshop Agreement, the new chapter was drafted which moves away from prescribing biosecurity levels for each pathogen and instead recommends that risk assessment be carried out for handling each pathogen

7. Benefits of the Risk Analysis approach
The traditional biosafety and biosecurity approach focuses primarily on
characteristics of the biological agent.
The proposed change also considers:
Health and economic consequences of an exposure or release from the specific facility,
Laboratory infrastructure, resources, the proposed activities, and appropriate control measures.

8. Laboratory Biorisk Analysis Biorisk Communication
Biorisk Analysis is the process comprised of biohazard identification, biorisk assessment, biorisk management and biorisk communication.
What can go wrong?
How likely is it to occur? How sever would be the consequence?
How can these risks be prevented?
Biohazard Identification
Biorisk Assessment
Biorisk Management
Biorisk Communication
The draft new Chapter is structured following steps of biorisk analysis which is basically the same as OIE concet of import risk analysis.
The key functions of biorisk analysis are (a) biohazard identification (i.e. “what can go wrong?”); (b) biorisk assessment (i.e. “how likely is the hazardous event to occur and how severe would be the harm?”); (c) risk management (i.e. “how can those risks be prevented or minimised to acceptable levels?”); and (d) risk communication (i.e. “how was the risk identified, characterised and controlled?”). In addition there is a need for (e) verification with continuous improvement (i.e. “are the control measures effective and can they be improved?”).
How was the risk identified, characterized and controlled?
Verification/continual improvement

9. Biohazard Identification
A biohazard can be any biological materials with the potential for causing harm or damage, in isolation and in combination with the laboratory processes involving these.
Hazard identification process has to consider all elements of the biorisk pathway:
Hazardous properties of the biological materials;
Characteristics of the laboratory process that cause harm;
Who and what can be harmed;
Potential attractiveness of malicious use.
Not only those biological in nature
The risks for animal health are different to those for human health. An outbreak of an animal disease may have a huge impact on economics in a country which is free from that disease e.g. FMD
A summary of typical aspects of the risk pathway elements is provided in Appendix

10. Laboratory Biorisk Management
When a biorisk assessment identifies an unacceptable level of risk, the laboratory is responsible for:
not handling or storing the agent in their facility, or
for identifying, implementing and maintaining appropriate biosafety and biosecurity measures.

11. Discussion and Next steps
Chapter – Biosafety and Biosecurity in the Veterinary Microbiology laboratory and Animal Facilities
Some members see the value of traditional approach
Therefore currently there are two chapters
1.1.3 biosafety and biosecurity
1.1.3 a standard for managing biorisk
The plan is to merge the 2 chapters and put the new chapter for adoption in 2015
Some member countries (USA, Europe) saw a need to maintain the traditional approach taken in the old chapter.
So at this stage we have two chapters a new chapter on biorisk management which is consistent with CWA and the old chapter which assigns pathogens to risk groups
Also need to consider the resources required for a risk assessment

12. Capacity building Aimed at helping countries comply with standards
For vet services:
PVS evaluation and gap analysis
Veterinary Legislation
Veterinary Education
For Labs
OIE laboratory twinning
For disease or specific topic
Quality assurance and biosafety and biosecurity are
integral to all twinning projects

13. Summary Communication
OIE sets international standards for animal health
– agreed by all 180 members
Promotes compliance with these standards
Capacity building focussed on improving compliance with
standards and on strengthening national veterinary services
For biosafety and biosecurity
There are special considerations for the animal health sector
New Chapters account for a biorisk management approach
Communication

14. 12 rue de Prony, 75017 Paris, France - www.oie.int – oie@oie.int
OrganisationMondiale de la Santé Animale
World Organisation for Animal Health
Organización Mundial de Sanidad Animal
12 rue de Prony, Paris, France - –