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Audit of real property (laboratories)

March 5, 2015

Office of Audit and Evaluation

Executive summary

In 2009, Agriculture and Agri-Food Canada (AAFC) established the Containment, Biosafety and Biosecurity (CBB) Program which provides researchers with guidance towards achieving appropriate levels of work-site containment associated with handling infectious pathogenic organisms and pests based on Public Health Agency of Canada (PHAC) and the Canadian Food Inspection Agency (CFIA) regulations.

The National Containment, Biosafety and Biosecurity Committee (NCBBC) was established in 2009 to oversee the implementation of the program within AAFC's former Research Branch (now the Science and Technology Branch (STB)) and to provide (among other things) guidance with respect to all aspects of containment, biosafety, and biosecurity.

The Audit of Real Property (Laboratories) was approved by the Deputy Minister in the Agriculture and Agri-Food Canada 2013-2016 Risk-Based Internal Audit Plan for Fiscal Year 2013-2014. The audit covers the period ending December 31, 2013.

The focus of the audit was on the management practices of the AAFC CCB Program for Level 2 laboratories (Containment Level 2 and Plant Pathogen Containment Level 2) within the department.

Research that requires Level 2 containment takes place in a building with secure access and a secure physical area that meets the requirements set by the either CFIA or PHAC. This can be a single room, a series of co-located rooms, or several adjoining rooms of the same containment level.

Containment Level 2 (CL-2) laboratories which handle human and animal pathogens are defined by PHAC as having moderate risk to individuals and low risk to the community. PHAC requires that CL-2 laboratories put in place safeguards to mitigate the risk associated with using Level 2 pathogens that include (among other things) the use of biosafety equipment such as a Biosafety cabinet, restricted access into the laboratories and use of decontamination equipment (for example autoclave).

Plant Pathogen Containment (PPC-2) laboratories that handle plant pests, can in some cases, pose a threat to agricultural production, forests and natural environments if they are inadvertently released from the lab. CFIA requires that safeguards be put in place in PPC-2 laboratories to prevent the inadvertent release of plant pests, these include (among other things) restricted access via an anteroom, ventilation systems with screened exhaust, and on-site decontamination equipment (for example autoclave).

Since 2009, extensive work has been done by the NCBBC and research centres using Level 2 pathogens in the implementation of the CBB program.

The audit was focused on the management control framework (as defined in Annex A) for the CBB program and not identifying specific breaches in containment, biosafety and biosecurity. However, the audit team did not identify specific breaches during the conduct of the audit.

For the areas reviewed, the audit team determined that management practices in place for the CBB program need moderate improvement. As such, audit recommendations were addressed to the Assistant Deputy Minister (ADM), STB for improvements for the following areas:

1.0 Introduction

1.1 Background

1.2 Audit objective

1.3 Audit scope

1.4 Audit approach

1.5 Conclusion

1.6 Audit context

1.7 Statement of conformance

2.0 Detailed observations, recommendations and management responses

2.1 Oversight

National oversight

Local oversight

Laboratories using Human and Animal Pathogens (Containment Level 2 (CL-2))

Laboratories using Plant Pest Pathogens (PPC-2)

2.2 Roles and responsibilities

2.3 Training

2.4 Lessons learned

Annex A: Audit criteria

Governance:

Safeguarding of Assets:

Training:

Compliance:

Annex B: Acronyms

AAFC
Agriculture and Agri-Food Canada
ADM
Assistant Deputy Minister
AD, RDT
Associate Director, Research, Development and Technology
BCO
Biocontainment Officer
BSO
Biosafety Officer
CBB
Containment, Biosafety and Biosecurity
CFIA
Canadian Food Inspection Agency
CL-2
Containment Level 2 (Animal and Human Pathogens)
CMB
Corporate Management Branch
HPTA
Human Pathogen Toxin Act
IA
Internal Audit
IIA
Institute of Internal Auditors
LCBBC
Local Containment, Biosafety and Biosecurity Committee
MSDS
Material Safety Data Sheets
NCBBC
National Containment, Biosafety and Biosecurity Committee
NOHSPC
National Occupational Health and Safety Policy Committee
PHAC
Public Health Agency of Canada
PPA
Plant Pathogen Act
PPC-2
Plant Pathogen Containment Level 2
OAE
Office of Audit and Evaluation
SOP
Standard Operating Procedure
STB
Science and Technology Branch
TOR
Terms of Reference

Annex C: Reporting structure

Source: Prepared by Internal Audit

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The table illustrates the reporting structure for oversight for the containment, biosafety and biosecurity program. The contents of the table are as follows:

  • National oversight:
    Agriculture and Agri-Food Canada (AAFC) oversees Science and Technology Branch (STB); STB oversees the Branch Operating Committee (BOC) which oversees the National Containment, Biosafety and Biosecurity Committee (NCBBC) and Research Centers; NCBBC unofficially oversees Biosafety Officer / Biocontainment Officer (BSO / BCO) within Research Centers;
  • Local oversight at the Research Centre:
    Associate Director, Research, Development and Technology (AD, RDT); oversees BSO / BCO who oversees the Local Containment, Biosafety and Biosecurity Committee (LCBBC); LCBBC oversees Level 2 Labs.

Annex D: Human and animal pathogens

Source: Canadian Biosafety Standards and Guidelines

Human and Animal pathogens are assessed and categorized into risk groups by Public Health Agency of Canada (PHAC) using criteria from Human Pathogen Toxin Act (HPTA) and takes into consideration the level of risk to the health of a person or to public health, as well as the likelihood that the human pathogen will cause disease in a human, and whether or not treatment and preventative measures are available.

Pathogens used in Containment Level 2 (CL2) laboratories having the following definition as per Public Health Agency of Canada (PHAC):

Risk Group 2 (moderate individual risk, low community risk)- Any pathogen that can cause human disease but, under normal circumstances, is unlikely to be a serious hazard to laboratory workers, the community, livestock or the environment. Laboratory exposures rarely cause infection leading to serious disease; effective treatment and preventive measures are available, and the risk of spread is limited.

An example of a pathogen that would fall under risk Level 2 for a containment lab would be salmonella.

Containment Level 2 (CL-2)
Biosafety and biosecurity at CL2 laboratories are achieved through operational practices and physical containment that are proportional to the risks associated with the pathogens being handled. CL2 builds upon the basic laboratory practices that are established for level one laboratories.

Operational practices for CL2 include but are not limited to:

Physical containment features include but are not limited to:

Annex E: Plant pest pathogens

Source: Canadian Food Inspection Agency (CFIA) Containment Standards for Facilities Handling Plant Pests and Canadian Biosafety Standards and Guidelines

Plant pests almost never infect or infest healthy people, and they therefore pose little direct risk to laboratory personnel. Some can, however, pose a threat to agricultural production, forests and natural environments. As a result, it is important that personnel working with plant pests and the facilities housing these organisms take steps to prevent the accidental escape of potentially damaging pests into the environment.

Plant Pathogen Containment Level 2 (PPC-2)
Plant Pathogen Containment Level 2 (PPC-2) facilities include permanent structures such as laboratories and greenhouses but not screenhouses. Containment is achieved through facility design, operational procedures and the use of specialized equipment. All PPC-1 physical and operational requirements also apply to this containment level.

Operational practices for Plant Pathogen Containment Level 2 (PPC-2) laboratories include but are not limited to:

Physical requirements for Plant Pathogen Containment Level 2 (PPC-2) laboratories include but are not limited to:

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