Integrated Agency Inspection Model – Consultation Draft (December 4, 2013)
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A key component of the model is the use of licensing as a tool to identify and authorize a regulated party to conduct an activity. Section 2 and Annex A outlines the conditions and processes around licensing.
A key requirement of the licensing regime is the condition that licence holders develop, implement and maintain effective preventive control plans (PCPs) suitable to the size and complexity of their operations. Section 3 and Annex B provide additional details on the proposed elements of the preventive control plan and the expected outcomes and performance criteria. CFIA staff would be guided by the inspection activities described in Annexes B and C to assess how effectively a licence holder's preventive control plan demonstrates regulatory compliance with the expected outcomes.
Section 4 provides information about the risk-based inspection framework and the elements the CFIA would consider when determining the level of inspection oversight. The CFIA would place a higher priority on oversight of regulated parties for which the consequence of non-compliance would have a greater impact on human health, animal health, plant health or the environment.
Section 5 and Annex C provide an overview of inspection and the general procedures inspectors would follow when conducting an on-site or follow-up inspection.
Section 6 and Section 7 cover the unique aspects associated with imported and exported commodities. Importers and exporters may need to develop alternative strategies to address risk. Some examples of alternative strategies that could be used by importers are included in Annex B. Exporters would need strategies to meet the foreign country's regulatory requirements. In both cases, the Product and Process Control element of the preventive control plan would need to reflect controls appropriate to managing compliance with either Canada's import requirements or the foreign country's import requirements.
Section 8 and Annex D are dedicated to a single, streamlined regulatory response across all commodities. Annex D provides an overview of the range of possible responses the CFIA may use to respond to an incident of non-compliance or a pest /disease/contaminant event.
Section 9 and Annex E describe the CFIA's review mechanism, the complaint process, and the role of CFIA's Complaints and Appeals Office.
Section 10 outlines a system for continuous improvement, which focusses on consistency and quality of delivery, system design and overall system performance. As part of inspection modernization, the CFIA will to introduce a more systematic way of monitoring and evaluating overall effectiveness of the regulatory system.
Section 11 provides a general overview of how transparency would be achieved under the model. The CFIA is committed to providing stakeholders with useful and timely information on its programs and services, regulatory requirements, and the outcomes of its enforcement actions and decisions.
Annex F provides a glossary of terminology. It is designed to standardize language and support consistent interpretation of terminology used in Agency inspection programs.
1.1 CFIA's legislative authorities
The CFIA is dedicated to safeguarding human and animal and plant health and the environment, which enhances the health and well-being of Canada's people and economy.
The CFIA develops and delivers inspection and other services to:
- prevent and manage health risks;
- protect plant resources from pests, diseases and invasive species;
- protect the Canadian environment from harmful contaminants;
- prevent and manage animal and zoonotic diseases;
- contribute to consumer protection; and
- facilitate market access for Canada's food, plants, animals and agricultural inputs.
The CFIA bases its activities on science, effective management of risk, commitment to service and efficiency, availability of resources and collaboration with domestic and international organizations.
The CFIA has a mandate to administer and/or enforce the following Acts and the regulations made under them.
- Agriculture and Agri-Food Administrative Monetary Penalties Act
- Canadian Food Inspection Agency Act
- Canada Agricultural Products Act
- Consumer Packaging and Labelling Act as it relates to food
- Feeds Act
- Fertilizers Act
- Fish Inspection Act
- Food and Drugs Act (FDA) (as it relates to food)
- Health of Animals Act
- Meat Inspection Act
- Plant Breeders' Rights Act
- Plant Protection Act
- Seeds Act
The CFIA has begun a systematic review of its regulatory frameworks for food, plant and animal commodities. With its broad mandate for human, animal and plant health and the environment, the CFIA recognizes the need for and the importance of the 13 federal statutes and associated regulations for which it is responsible. The CFIA has been engaging Canadians, industry stakeholders and other government departments, including federal partners as part of regulatory modernization. The CFIA recognizes the importance of supporting Canadians' access to healthy and sustainable agricultural, forestry and aquaculture products, while at the same time creating and maintaining a regulatory environment that supports competitiveness and innovation in the Canadian agricultural sector. Modernized regulatory frameworks will improve consistency and reduce complexity in regulation and align with inspection modernization.
Effective regulation contributes to the health and safety of Canadians, the protection of the animal and plant resource bases and the environment, and to a strong economy. The regulatory renewal initiatives for each of the CFIA's business lines, those being Plant, Animal, and Food have been prioritized.
The Agricultural Growth Bill was tabled in parliament December 9, 2013. It is a bill designed to modernize and strengthen federal agriculture legislation, support innovation in the Canadian agriculture industry and enhance global market opportunities. The bill proposes changes to the suite of statutes that the CFIA uses to regulate our agricultural sector. Seed, fertilizer and feed regulatory renewal work is underway, while animal and plant health frameworks are commencing.
The Safe Food for Canadians Act (SFCA) received Royal Assent on November 22, 2012. It consolidates authorities and requirements set out in the Canada Agricultural Products Act (CAPA), the Fish Inspection Act (FIA), the Meat Inspection Act (MIA) and the food provisions of the Consumer Packaging and Labelling Act. Regulations are currently being developed in accordance with the authorities of SFCA. Stakeholder consultations are underway. When the SFCA is fully in force, these Acts and their regulations will be repealed. The SFCA does not change the inspection regime or the fines and penalties of the Food and Drugs Act (FDA) and its regulations.
The FDA and its regulations will continue to exist separately and continue to apply to all food sold in Canada. Health Canada is undertaking a separate, but coordinated, modernization of its regulatory framework for food. The FDA will continue to protect consumers from any foods that are unsuitable for human consumption, including those marketed exclusively within provinces. Once the SFCA is fully in force, the CFIA will rely on the authorities in that Act and the FDA to carry out its mandate with respect to food safety. In the interim, the existing legislation will remain in force.
In most of the Acts administered and enforced by the Agency, the Governor in Council is provided the authority to make regulations exempting, or permitting the Minister to exempt, any person, item or activity to which the Acts apply. In addition, there may be provisions exempting any person or activity from the application of the Acts or their regulations. Further consultation on exemptions will be undertaken during regulatory modernization.
1.2 Guiding principles
The CFIA's integrated Agency Inspection Model will apply globally recognized risk management concepts based on prevention. They include systems-based, performance-based and risk-based approaches that are:
- founded on science and based on risk, and that use common inspection procedures and tools;
- aligned with international standards, such as those developed by Codex Alimentarius Commission, the International Plant Protection Convention (IPPC), and the World Organisation for Animal Health (OIE);
- based on the premise that industry is responsible for its products and processes and must demonstrate ongoing compliance with legislative requirements;
- flexible, to accommodate the complexity and size of an operation; and
- supported by information management / information technology (IM/IT) solutions that will facilitate planning, reporting and decision making.
1.3 Roles and responsibilities
1.3.1 Regulated parties
Regulated parties are responsible for complying with the law. They demonstrate this commitment by ensuring that the commodities and processes for which they are responsible meet regulatory requirements. Regulated parties also provide the CFIA with input and information that is used in regulatory decision making.
1.3.2 Roles and responsibilities of the CFIA
The CFIA verifies industry compliance through activities that include inspection, surveillance, sampling and testing. These activities are used to assess whether a regulated party has developed, documented, implemented and maintained written preventive control measures, whether these measures are effective, and whether regulatory requirements and licence conditions have been met. When non-compliance is identified, the CFIA takes appropriate compliance and enforcement action.
Compliance promotion is any activity that increases awareness, informs, motivates, or changes behaviour and encourages compliance with a regulatory requirement.
The CFIA derives its inspection and enforcement authorities through its Acts. In light of modernization, the CFIA will develop a common suite of inspection policies and procedures supplemented by commodity-specific inspection materials, as necessary. These materials will clearly link the regulations to their policy intent and provide functional direction to CFIA staff regarding the regulatory requirements to be verified.
Recognizing that a range of barriers can impede compliance, regulatory organizations worldwide are introducing a more proactive approach to generating compliance by regulated parties. A crucial step will be to promote awareness and understanding of the requirements. New programming will be provided to regulated parties to help them understand and comply with requirements. Compliance education materials will be prepared for regulated parties to clearly explain the regulatory requirements.
1.3.3 Key partners
The CFIA works with its partners to manage regulated risks and emergencies; and promote the development of control systems to maintain the safety of Canada's high-quality agriculture, agri-food, forestry, aquaculture and fishery products.
The CFIA's Key Federal Partners:
- Agriculture and Agri-Food Canada
- Health Canada
- Pest Management Regulatory Agency
- Public Health Agency of Canada
- Canadian Grain Commission
- Public Safety Canada
- Canada Border Services Agency
- Fisheries and Oceans Canada
- Natural Resources Canada, including Canadian Forest Service
- Foreign Affairs, Trade and Development Canada
- Environment Canada, including Canadian Wildlife Service
The Canada Border Services Agency (CBSA) will continue to clear shipments into Canada with the assistance of the CFIA, but its officers will now confirm that importers have a valid licence. The CFIA's electronic certification processes are to be integrated as they are developed. Import related information, including licence numbers, will be captured in electronic transactions exchanged between the CFIA and the CBSA. CBSA officers are designated as inspectors to enforce "program legislation", including CFIA legislation. The CFIA will continue to work closely with the CBSA to verify that its officers have the necessary tools to enforce the CFIA's legislation at airports and other Canadian border points.
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