ARCHIVED - An integrated Agency Inspection Model: The Case for Change
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The world around us is changing rapidly. The overall landscape has become more complex. Significant changes in production and distribution environments have resulted in elaborate and extensive supply chains that support increased consumer demands for diverse, innovative choices as well as meaningful information about products. Technological and scientific advances are proceeding rapidly and regulators are challenged to keep pace with innovations in the marketplace.
As industry adjusts to these changes, governments world-wide are also modernizing by implementing flexible, system-based approaches, more rigorous risk management and increasing the focus on traceability.
The case for change is compelling – and regulators world-wide must be prepared to react accordingly.
Charged with safeguarding Canada's food supply, animal health and plant resource base, the Canadian Food Inspection Agency is committed to continuous improvement in order to meet the needs of its diverse group of stakeholders. This commitment to improvement based on science, global trends and best practices is the hallmark of a modern, well-functioning regulatory system. In order to continue in its role as a world-class regulator, the CFIA must build on its strong foundation and be flexible and able to adapt to emerging global and scientific trends.
The specific purpose of this paper is to outline the Agency's "case for change" and to provide a high-level overview of the integrated Agency inspection model in the context of rapidly evolving production systems, consumer demands, environmental pressures, and expanding Agency responsibilities. The Agency welcomes feedback from stakeholders, including interested Canadians, on the proposed application of the inspection model to all CFIA regulated commodities.
The CFIA is responsible for administering and enforcing legislation for food sold in Canada pertaining to safety, consumer protection and market fairness, and for supporting a sustainable plant and animal resource base. As a modern regulator, the CFIA verifies regulated parties' compliance with the appropriate Acts and Regulations through various oversight activities. These include inspecting establishments (e.g., abattoirs, processors, hatcheries, feed manufacturers and greenhouses), surveillance activities, and testing products. The CFIA also provides regulated parties with required permissions such as certificates, licences, registrations and permits to operate, as well as, to facilitate access to markets.
The Agency also promotes industry's use of science-based risk management practices to minimize risks - whether the animal, plant or food commodity is being grown, raised, processed, manufactured or distributed for domestic use, import or export. If an emergency occurs, the CFIA, in partnership with federal partners as well as provincial agencies and the regulated industry, operates an emergency response system. This may include food safety or contaminant investigations, product recalls, disease/pest control activities, quarantines and orders for destruction.
When the CFIA was created in 1997, it brought together program and inspection approaches from various federal organizations to enhance effectiveness and efficiency. The move to a single agency facilitated a more uniform and consistent approach to inspection and oversight while facilitating market access and improving service delivery. While progress has been made in reconciling these differences, the process is still underway.
A changing operating environment
The overall landscape is changing
The ways in which food, animals and plants are produced and marketed have changed dramatically. Driven by widespread changes in methods of production and processing, coupled with rapid increases in global trade and increasingly dynamic supply chains, the complexity of the production and distribution landscape has increased. To manage the risks inherent in an integrated, complex supply chain where producers and distributors may not know each other, industry and governments are moving towards systems-based analysis and an increased focus on traceability.
Global demand, resulting from a variety of factors such as population shifts and income growth in emerging economies, has resulted in an increase in consumer expectations for diverse and innovative choices (e.g. year-round supply of fresh fruit and vegetables, pre-prepared/packaged foods, consumer pressure for specific production methods, or consumer demand for exotic plants and pets which could lead to new plant pests or animal diseases). Impacts on the global demand for more protein and non-food uses of agricultural commodities (e.g. biofuels and bio-fibers) are also expected to increase.
These demands and the resulting changes in supply chains have resulted in an exponential increase in end-products that contain individual components sourced from more places across the world than ever before.
Did you know that a frozen pizza today typically includes 35 ingredients from 60 different countries drawn from 5 different continents while chicken fried rice contains 28 raw ingredients, from 35 different suppliers, also originating from 5 different countries? Or that a chicken farm sells to 28 different manufacturers who supply 18 different retailers who have 834 products on the shelf which are consumed by millions of people?
To add to this complexity, such products have multiple processing touch-points before the consumer purchases the product. These touch-points extend to the transportation of goods (as well as the goods themselves) across mass supply networks where packing crates or containers that are shipped internationally can harbour animal diseases and/or plant pests as well as the products they contain.
In addition to changes in global demand and production/distribution environments, technological advancements, coupled with industry consolidation, have resulted in significant increases in the speed and volume of production. For example, if there is a breakdown in the system to ensure that embryos are properly "washed" (a technique that removes viruses and bacteria); the impact of importing hundreds of infected embryos is greater than the import of live animals (as was the practice in the past). Mass distribution and supply networks mean that problems - when they do occur - can quickly become widespread. In fact, recent international incidents of food-borne illness and exotic disease/pest incursions have shown that outbreaks are not necessarily contained within national borders. While new risks are emerging as a result of globalization and innovation; the ability to detect those risks is improving due to advances in science and technology.
At the same time, industry is seeking to remain competitive by developing new products, both in response to a more demanding consumer base, and to access new markets. Scientific advancements have had, and will continue to have, far-reaching implications for consumers, producers and distributors. While regulators rely upon sophisticated technologies (e.g. genetic "fingerprinting") and integrated surveillance information to identify risks, and prevent or respond to incidents, the ability of regulations to keep pace with rapid scientific or technological change is an ongoing challenge. The potential applications of science in fields such as nanotechnology could impact food production (e.g. food packaging) and animal/plant health (e.g. disease treatment). Improvements in agriculture (including animal agriculture and the production of healthy animals) are crucial to sustainable food security world-wide and regulators must be positioned to respond appropriately.
Moreover, consumers today are demanding more meaningful information about safety, quality and other food attributes (e.g. special designations such as organic or local). To meet this demand, some companies are engaging with third-party audit bodies to provide greater assurance that their products meet quality and safety requirements as part of the supply chain. At the same time, regulators are increasingly being asked by the public to demonstrate that oversight systems and approaches are effective. Ultimately, all stakeholders must remain vigilant and responsive to the challenging environment, to keep pace with the increasing speed of commerce and the challenges and opportunities it brings.
Increased global trade of agriculture and food products provide powerful incentives for aligning international standards. Canada's trading partners are modernizing to respond to these challenges and as a result of an increased knowledge of risk and system-based approaches. As an example, the United States introduced the Food Safety Modernization Act (2011) which focuses on using preventive controls to help manage risk.
Finally, human, animal and plant ecosystem issues are increasingly intertwined. For example, the recent outbreak of a novel influenza virus (H7N9) in China is a poultry virus that causes severe respiratory illness and mortality in humans. Expanding global markets and the corresponding movement of people, plants, animals and food heightens the risk of transmitting pests and diseases. The continued expansion of cities increases wildlife-human interactions and the possibility of disease transmission. Climate change impacts affect the survival and distribution of pests and diseases. Plant health impacts on agricultural productivity have food security impacts. It has become clear that impacts in one area ripple everywhere.
Production systems are changing and regulatory systems need to keep pace
With globalization and advances in science and technology, changes in production systems have resulted in international standard-setting bodies recognizing the need for a change in safety and quality management.
The international standard setting body for food safety, Codex Alimentarius Commission, promotes the use of a systems-based approach as an effective means of delivering food safety outcomes. A systems-based approach means that producers, processors and importers have the primary responsibility for the safety of the regulated commodities they produce or sell and, as such, must implement preventive programs to identify and control risks. For food, an example of a systems-based approach is the Hazard Analysis and Critical Control Points (HACCP) system. Currently, a HACCP system is mandatory in two of the CFIA's food programs and HACCP principles can be incorporated into preventive controls across all commodities.
From a plant health perspective, for pest risk management to meet phytosanitary import requirements, the International Plant Protection Convention (IPPC) promotes the use of integrated measures in a systems-based approach. Such systems-based approaches, where appropriate, can provide equivalency to procedures such as testing, quarantine or treatment and can replace more restrictive measures such as prohibition. For example, the CFIA was influential in the decision of the IPPC to adopt a standard for the treatment of wood packaging, which is widely used internationally and presents a risk of introducing plant pests when untreated. In 2004, the CFIA implemented a system-based approach to overseeing more than 600 registered wood packaging producers in Canada. The use of systems-based approaches among pest risk management options is important because the integration of two or more measures may be less trade restrictive than other risk management options.
The World Organization for Animal Health (OIE) recently developed new chapters in their Animal Health Code that focus on outcome-based production systems designed to ensure optimal animal welfare. Not only are governments being held accountable for the health and welfare of their livestock, but producers who want to trade internationally will be required to adopt system-based management approaches.
Because production systems are changing and regulatory systems need to keep pace, regulators are changing their approaches to emphasize industry's responsibility to put in place effective hazard control programs. It is recognized that the current rate of change is exponential and that regulators cannot continue with traditional approaches to ensure that standards are being met. Government's role is to verify industry's implementation of these programs. Overall, this systems-based approach is more rigorous and provides better outcomes by focussing on preventing problems before they occur.
The role of inspection is changing as well
The primary role of an inspector has always been to verify industry's compliance with the requirements of legislation. But how this is done has changed significantly over the past 15 years. Traditional inspection methods that focussed on the processing environment and end-product have been supplemented by more sophisticated science and risk-based verification approaches that rely on preventive control systems implemented by industry (e.g. HACCP). Risk-based approaches enable inspectors to target activities and areas of greatest risk, not just the end-product or lot by lot inspections. The use of foreign country assessments or audits will also allow for better targeting of oversight and inspection resources.
Equipping employees with the necessary tools, training and technology will help the Agency react more rapidly to the changing world around us. The introduction of technology tools such as rugged tablets and wireless access cards will be of benefit for field staff who may be working in remote locations, processing establishments or in conditions that require specialized technologies. As well, the CFIA is examining the skills and competencies required for a modern inspection workforce. The inspectors of today - and tomorrow - will require new skills, a greater understanding of the relevant science and technologies, continuous training and modern information management tools to do their jobs. Their work remains central to a modern, effective and well-functioning regulatory system.
How the CFIA is responding to this changing environment
Recognizing the challenges and opportunities described above, the Government of Canada's 2011 Budget committed $100 million over five years for the CFIA to modernize its food inspection system. This included new resources to improve:
- Inspection delivery,
- Training and tools for inspection staff,
- Scientific capacity in food laboratories, and
- Information management and technology.
The CFIA has made significant progress in meeting its modernization objectives for food, and is now moving forward to include plant and animal health under the integrated inspection model. The vision is one of a single approach to inspection based on common inspection activities supported by standard processes and tools, and based on science and risk. In this way, the Agency will be able to assess and address risk consistently, use existing resources more effectively and level the playing field so that similar risks are treated with similar rigour.
The CFIA's ongoing activities to renew and modernize legislation, regulation and inspection are all connected. A strong legal and regulatory framework that facilitates innovation will strengthen inspection activities and raise the bar for human, animal and plant health and the environment.
The CFIA is carrying out a number of complementary initiatives that will support the design and development of the integrated Agency inspection model. They include:
Legislative and regulatory reform: In the fall of 2011, the CFIA began a systematic review of its regulatory frameworks for food, plant and animal business lines. Through a structured and comprehensive review, the CFIA hopes to strengthen its regulatory frameworks to:
- reduce overlap and redundancy;
- address gaps, weaknesses and inconsistencies; and
- provide clarity and flexibility to assist regulated parties in fulfilling their obligations.
Key elements of the Agency's regulatory modernization are the Safe Foods for Canadians Act and the proposed Agricultural Growth Act, a bill designed to modernize Canada's agriculture legislation and encourage innovation in the sector. Both are complementary to, and consistent with, the proposed approach outlined in the integrated Agency inspection model. The desired end state is a preventive system that enables the Agency to consistently manage risk and resources horizontally across commodities.
Throughout this process, Canadians and regulated parties will continue to be supported by an effective, efficient and accountable regulatory system that is both science and risk-based.
Stakeholder education and compliance promotion: As part of its Transformation Agenda, the Agency is making significant changes to inspection delivery, food, animal and plant regulations and programs. Promoting awareness and understanding of these requirements will be critical in generating compliance. The Agency has developed a draft Compliance Promotion Strategy to encourage and facilitate regulated parties' understanding of their regulatory requirements. The draft strategy will be released for comment later in 2014 with a view to being implemented in 2015.
Service delivery improvements: The CFIA is making changes to enhance its transparency, accountability and service delivery. These include initiatives to improve training for inspectors, new tools to keep inspectors informed and connected, modernized user fees and service standards, and a recourse mechanism for stakeholders who wish a review of regulatory or service related decisions (the Complaints and Appeals process provides stakeholders with a centralized way to register complaints and appeals related to service delivery, administrative errors and regulatory decisions).
These changes complement the Statement of Rights and Service that was published to provide regulated parties and other stakeholders with information about their rights and obligations related to Agency activities.
Modernization of science capacity: Science is critical to the CFIA delivering on its mandate. The CFIA is working to enhance its scientific capacity by:
- developing an integrated food laboratory network from different jurisdictions with a mandate for food safety,
- increasing its testing capacity, and
- improving its science facilities and equipment.
The integrated Agency inspection model
While the Agency's focus to date has been the modernization of its food safety programs, the Agency is also adopting broad, forward-looking plans for its animal health and plant health business lines. The Agency's desired outcome includes standardized inspection approaches and consistent, appropriate oversight across all regulated commodities (e.g. food, seed, feed, fertilizer, plant health and animal health). Oversight will be based on risk and focussed on prevention of risks and verifying compliance to regulations and standards, using science and technology. The model will apply to all inspections conducted by, or on behalf of, the CFIA.
Building on the improved food inspection model (IFIM), the proposed integrated Agency inspection model will focus on:
- preventing and managing food safety risks and contributing to consumer protection;
- protecting plant resources from invasive plants, pests and diseases; and
- preventing and managing animal (terrestrial and aquatic) health and diseases (protection of animal health also contributes to the protection of public health as a number of the diseases being managed are transferrable to humans).
The integrated Agency inspection model (iAIM) aims to become a more effective and efficient inspection system with clearly defined responsibilities for industry and government. The model should raise awareness and establish the expectations for preventive control systems that are developed and maintained by industry with risk-based government oversight. It should also standardize requirements and procedures across all regulated commodities, based on science and risk. Transparency will be central to achieving the goals of the integrated model.
The iAIM focuses on prevention and incorporates outcome-based requirements and systems-based approaches to verification. This approach systematically focusses on verifying the effectiveness of industry's controls in achieving safe and compliant regulated commodities on an ongoing basis.
The model will help to define consistent inspector competencies that will be used as the basis for developing a core training program. The model must be supported by consistent procedures and tools, and by a standardized information management system. Accurate and efficient data analysis will give inspectors and managers access to the information they need for decision-making and facilitate the identification of emerging trends that may impact the safety of regulated commodities.
Finally, the iAIM will provide a basis to maintain consumer and trading partner confidence in the effectiveness of Canada's inspection system.
|Components||What this means for the design of the model|
|Permissions (formerly licensing under IFIM)||The regulator should be able to identify regulated parties and understand the nature and risk of their regulated activities.
Industry is responsible for its products, processes, and actions and for demonstrating ongoing compliance with requirements.
|CFIA oversight (formerly risk-based inspection oversight under IFIM)||The level of the CFIA's oversight should correspond to the regulated party's ability to meet regulatory requirements.|
|Inspection||Standardized inspection and verification approaches across all regulated commodities will be consistent and based on risk.|
|Regulatory Response (formerly compliance and enforcement under IFIM)||The regulatory response to non-compliance, plant pests, animal diseases and contaminant events should be based on risk, consistent, transparent and graduated.|
|System performance||The overall effectiveness of an inspection system should be validated on an on-going basis through the use of objective performance measures.|
Knowing who the regulated parties are, what they produce and how they produce it is crucial to determining the required level of oversight and to making risk-based inspection decisions, such as the importance of regulating the non-federally registered sector.
The regulated party who imports or exports regulated commodities, or operates as a manufacturer or processor of regulated commodities will be obtaining permission (licence/permit/registration) to operate. Through the CFIA's permission process, manufacturers, importers and exporters will demonstrate their commitment to providing safe and compliant regulated commodities. A condition for granting permission to perform most activities will be the development and implementation of a preventive control plan, suitable to the regulated party's products, size and operations.
The activities performed under regulations in the Feeds, Seeds, Fertilizer Acts and some under the Health of Animals (e.g. veterinary biologics, hatcheries, artificial insemination/embryo centres) and Plant Protection Act (nurseries, greenhouses and sawmills) lend themselves to an establishment-based inspection system, similar to most food commodities. Therefore the principle of requiring permission and a preventive control plan for activities under these Acts is relatively similar.
Activities related to controlling plant pests and animal diseases, as regulated under the Plant Protection and Health of Animals Acts, are based on producers requesting permission from the CFIA to move regulated commodities into or out of the country, or within the country, to areas or establishments of differing disease/pest status. For the most part, primary producers of animals and plants who are not imposing additional risk by their activity will not be expected to get permission except when requesting movement of the nature indicated above (e.g. moving regulated commodities to establishments with differing disease or pest status).
Industry will be held responsible for designing and implementing preventive control plans for their unique operations. The CFIA will then verify that these plans appropriately prevent, eliminate or reduce hazards to acceptable levels of protection. Any risk that remains once these effective preventive controls have been applied as well as indicators in compliance history - will determine the required level of oversight (e.g. frequency and scope of the inspection or surveillance activities) by the CFIA and will be adaptable, as required, to the size and complexity of the regulated parties' operation.
In some cases, the CFIA recognizes alternate service delivery (ASD) providers, especially for private good purposes (e.g. export). The service providers are recognized officially by the CFIA through a third party standards provider, or directly via a training and recognition program.
Separate from alternative service delivery, the Agency acknowledges that third-party verification of private certification schemes to achieve particular outcomes on behalf of the retail sector is becoming more prevalent as a tool to ensure that suppliers meet buyer requirements for safety and quality. Where there is alignment with government requirements, third-party verification could potentially complement or inform the Agency's oversight. In support of a modernized, scientific approach, the Agency is exploring how it may enhance its approach to oversight by assessing industry's use of private certification schemes.
The CFIA has drafted a discussion paper that considers industry's use of private certification schemes as one of a number of factors that the Agency may consider when allocating resources according to risk. The proposed concept will enable improved resource allocation and better planning, and additionally provides a framework to give companies credit for successfully achieving certification. While the Agency is considering how it may make take into account industry's adoption of private certification schemes, it is important to note that the Agency will retain its regulatory responsibilities (e.g. there is no intent to replace regulatory oversight or outsource Agency inspection work associated with the currently proposed concept) and will continue to verify compliance with regulatory standards on a risk-basis. Individual companies will retain responsibility for choosing a private certification scheme that meets their business needs.
Lastly, as a modern regulator, the CFIA recognizes that providing guidance to regulated parties is needed to help them understand their obligations and this is one of the reasons why compliance promotion is a core Agency Transformation initiative - to ensure a successful transition and ongoing compliance. As a result, the Agency is developing an overall strategy to encourage and facilitate compliance. This new approach will include replacing "manuals" with a new suite of regulatory interpretation documents for staff and new guidance documents for industry. The Agency will also provide generic models for regulated parties to adapt for their own use when designing and/or implementing systems to meet regulatory requirements.
A strengthened single inspection delivery model, based on common inspection activities and standard processes, will be flexible across commodities and capable of recognizing and responding to emerging risks. It will provide a balance between traditional inspection and the verification of the effectiveness of industry preventive control systems. The expected outcomes of the single inspection model will include greater consistency, predictability and transparency for regulated parties.
The model applies a single compliance and enforcement strategy that is based on the principle that industry is responsible for producing commodities that comply with regulatory requirements. When non-compliance is found, industry is responsible for taking appropriate action to correct the situation. The model aims to make compliance and enforcement transparent, consistent, predictable and appropriate to the level of non-compliance. It also elaborates the regulatory response to food issues, plant pest and animal disease incursions and contaminant events.
It is important for decision-makers to know whether the inspection system is achieving its objectives. This can be accomplished through a validation process that measures quality of program design and delivery.
A comprehensive validation process will be an integral component to promote continuous improvement. The objectives of validation are to:
- Assess overall effectiveness of the inspection system;
- Ensure that the inspection program is delivered consistently, effectively and efficiently; and
- Identify gaps.
Ultimately, knowing where problems occur allows the CFIA to mitigate risks and prevent future inspection challenges.
The path forward
The integrated Agency inspection model was developed using the ideas and principles outlined in this paper. The CFIA is also taking into consideration the best practices of inspection organizations in other countries. The Agency is working towards a model that is focussed on prevention and is aligned with the most up-to-date science and risk management approaches. An integrated Agency inspection model will allow the CFIA to standardize its inspection approach across regulated commodities, based on risks.
Opportunity for input
The success of the integrated Agency inspection model requires the engagement and support of regulated parties and all stakeholders. This paper is designed to complement the information contained in the integrated Agency inspection model. Feedback on the integrated Agency inspection model (iAIM) is welcomed at CFIA-modernisation-ACIA@inspection.gc.ca.
In Canada, food safety, animal and plant health protection begins with a strong, clear legal framework. The CFIA has the mandate to administer and enforce standards and requirements under various Acts of Parliament (and their associated regulations). With the passage of the Safe Foods for Canadians Act (proposed to come fully into force in 2015), the authorities under the Fish Inspection Act, the Canada Agricultural Products Act, the Meat Inspection Act and the food provisions of the Consumer Packaging and Labelling Act will be consolidated into one Act, the Safe Foods for Canadians Act (SFCA).
The SFCA will improve food safety oversight, ensure a consistent approach for all food commodities, reduce unnecessary regulatory burden, and enhance international market opportunities for industry. With the SFCA, the Agency has deliberately pursued an approach where regulations will, when appropriate, clearly define the outcome (e.g. the "what") and regulated parties will choose the method (e.g. the "how") to achieve the required outcome. This emphasis on expected safety outcomes allows all regulated parties to achieve compliance in ways that can be tailored to their operational size and complexity.
On the plant health and animal health side, the Agricultural Growth Bill was tabled in Parliament in late 2013. Designed to modernize and strengthen federal agriculture legislation, to support innovation and to enhance global market opportunities, the Bill proposes changes to the suite of statutes that the CFIA uses to regulate the agriculture sector. Seed, feed, and fertilizer regulatory renewal work is currently underway, while the animal and plant health frameworks are commencing as part of the Agency's transformation efforts.
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