“a world that is safe and secure from the accidental or deliberate release of animal pathogens,...

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“A world that is safe and secure from the accidental or deliberate release of animal pathogens, including zoonoses.” Released in Jan 2012 http://www.oie.int/fileadmin/Home/eng/Our_scientific_e xpertise/docs/pdf/A_Biological_Threat_Reduction_Strate gy_jan2012.pdf

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

Released in Jan 2012

http://www.oie.int/fileadmin/Home/eng/Our_scientific_expertise/docs/pdf/A_Biological_Threat_Reduction_Strategy_jan2012.pdf

• 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)

Biological Threat Reduction

Establishing or updating international

standards

Identifies a need to updatean existing standard

OIE SpecialistCommission

Review

advice from experts or advice from experts or ad hoc ad hoc groupgroup

Draft text

ASSEMBLY

DELEGATES

Adoption

Committee,Commission or,

Delegate

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OIE INTERNATIONALSTANDARD

Comments

gideonb
It is critically important that official delegates realise and accept their responsibility to participate actively in the debate and setting of internationnal standards. Once a standard is adopted by the Interntional Committee and included in the Code, a Member Country who participated in the decision-making process at the meeting of the International Committee where the standard was adopted, is obliged to support the adopted standard. If a Member Country deviates in the application of the accepted standard, the correct place to debate or challenge such a Member Country, is at the meetings of the SPS Committee of the WTO.

Manual of Diagnostic Tests for Aquatic Animals

OIE Biosafety and Biosecurity Resources- OIE Health Standards -

Manual of Diagnostic Tests and Vaccines for Terrestrial Animals

OIE Biosafety and Biosecurity- Revisions on Terrestrial Manual chapters in 2013 & 2014 -

• Chapter 1.1 .1 – Collection, Submission and Storage of Diagnostic Specimens (update of information, removes shipping information)

• Chapter 1.1.2 - Transport of Specimens of Animal Origin (new chapter: coordination with international

regulations and requirements on packaging and shipping)

• Chapter 1.1.3 .a – Standard for Managing Biorisk in Veterinary Laboratories and Animal Facilities

(account for a biorisk analysis and management approach)

Adopted in 2013

Adopted in 2014

- Conceptual Changes -

New Chapter (1.1.3. 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.

New Chapter (1.1.3. 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.

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.

Laboratory Biorisk Analysis

Biorisk Analysis is the process comprised of biohazard identification, biorisk assessment, biorisk management and biorisk communication.

Biorisk Analysis is the process comprised of biohazard identification, biorisk assessment, biorisk management and biorisk communication.

Biohazard Identification

Biorisk Assessment

Biorisk Management

Biorisk Communication

What can go wrong?

How likely is it to occur? How sever would be the consequence?

How can these risks be prevented?

How was the risk identified, characterized and controlled?

Verification/continual improvement

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:1)Hazardous properties of the biological materials;2)Characteristics of the laboratory process that cause harm;3) Who and what can be harmed;4)Potential attractiveness of malicious use.

Not only those

biological in nature

A summary of typical aspects of the risk pathway elements is provided in Appendix 1.1.3.2.

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.

Discussion and Next steps

Chapter 1.1 .3 – 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 bioriskThe plan is to merge the 2 chapters and put the new chapter for adoption in 2015

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

Summary

• 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

12 rue de Prony, 75017 Paris, France - www.oie.int – [email protected]

OrganisationMondialede la Santé Animale

World Organisationfor Animal Health

Organización Mundialde Sanidad Animal