ARCHIVED - Modernization Consultations –
2014 What We Heard Report
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The Canadian Food Inspection Agency (CFIA) is making significant efforts to modernize its legislative and regulatory base as well as its operations and business practices. Its modernization efforts encompass the development of stronger rules, more effective oversight, and an ongoing commitment to services and transparency. With the passage of the Agriculture Growth Act and the Safe Food for Canadians Act, the CFIA is well positioned to align regulations with international standards to ensure the continued health and safety of Canadians, the plant and animal resource base as well as facilitating market access. In addition, the system will be more flexible and less complex for industry to understand and will be more consistently applied across commodities and CFIA business lines (plant, animal and food).
The Agency is implementing a more consistent approach to oversight through the introduction of an Integrated Agency Inspection Model (iAIMs). The Agency will be directing its oversight and enforcement efforts to ensure that its inspection activities are focussed on the areas of greatest risk while applying a consistent approach guided by a single enforcement policy across all programs. This means that not all establishments will be inspected in the same manner or at the same frequency. Following three years of consultations, the Agency has begun the introduction of this new inspection model and will be implementing the new model incrementally.
The CFIA is committed to continuously improving its services to stakeholders through improved business practices and by providing timely and reliable access to online services to key partners and clients. Policies and program frameworks such as the use of private certifications schemes, compliance promotion, and a food program framework are modernizing how the Agency operates in a more systematic and service oriented fashion. In addition, an electronic service delivery platform (ESDP) that is flexible and scalable will drive and operationalize all of the inspection activities including electronic certification. An integral part of the CFIA's commitment to service is transparency and ongoing open dialogue with stakeholders.
Since 2012, the Agency has undertaken unprecedented number of engagement activities with a broad range of stakeholders (industry and industry associations, consumer associations, provincial jurisdictions, and federal departments and international trading partners) which were aimed at improving stakeholder understanding, support and readiness, have yielded significant insight on a number of the CFIA's modernization initiatives. The CFIA has participated in approximately 700 stakeholder events, including two food fora in 2013 and 2014 that have been instrumental in guiding the development of the Agency's modernization initiatives. These fora, while focussed on the Safe Food for Canadians Regulations (SFCR) also included broader policies, frameworks, and strategies that apply to a range of CFIA program areas.
In June 2015, based on feedback voiced during prior stakeholder consultations, the CFIA launched consultations targeted at micro and small business (MSBs) in order to better understand how the proposed new regulations would impact MSBs and to inform options for reducing burden on them. Concurrently, the CFIA held information sessions and opened a comment period on the draft regulatory text for the SFCR.
Consultation and engagement activities to date have been very successful in reaching a wide range of stakeholders and the CFIA is very satisfied with the level of involvement and the feedback submitted on all its modernization initiatives. The vast majority of feedback received from stakeholders was useful and supportive of the approach that the Agency is taking.
During the most recent round of formal engagement, nearly 400 responses were received on the following CFIA Agency Transformation topics:
- Draft Compliance Promotion Strategy;
- Draft Compliance, Control and Enforcement Framework;
- Use of Private Certification to Inform Regulatory Risk-Based Oversight;
- Incorporation by Reference (IbR);
- Enhancing Risk Analysis: A more systematic and consistent approach;
- Foreign Food Safety Systems Recognition: Proposed Framework;
- Draft Integrated Agency Inspection Model (iAIM); and
- Food Program Framework.
The following report summarizes key messages from those consultations. Stakeholder input will be published to reflect feedback on the SFCR when the government launches official consultations by publishing the regulations in Canada Gazette 1. Comments from all consultations are being taken into consideration to inform the drafting of the regulations and guidance documents as well as the various policies, strategies and frameworks required to inform program areas across all business lines. These consultations continue to support the Agency's strategic directions. In particular, they emphasise the importance of inspection model, and business practices moving forward in tandem with regulatory modernization efforts but that there is value in each advancing independently.
The CFIA is committed to strengthening Canada's world class regulatory system working closely with industry and key partners. It will continue to engage with stakeholders to keep them informed on the implementation of its modernization initiatives including SFCR, food labelling, operational and business initiatives.
1. Draft Compliance Promotion Strategy
June to October, 2014.
In June 2013, the Canadian Food Inspection Agency (CFIA) published a discussion paper entitled Compliance Promotion: Formalizing an Approach to Support Stakeholder Compliance and initiated consultations on its proposed approach to compliance promotion. Following the close of these consultations, the CFIA developed a Draft Compliance Promotion Strategy, based on feedback from stakeholders. The draft strategy was made available for public comment from June 4, 2014 to October 31, 2014.
The CFIA received 32 comments from a number of businesses, business associations, government employees, provinces and a health organization.
Key Messages/"What We Heard"
The CFIA's proposed approach to compliance promotion was strongly endorsed, with positive feedback received from a broad range of stakeholders. Respondents made it clear, however, that they wanted to see some concrete deliverables and how compliance promotion would be rolled out. Respondents called for compliance promotion to include a mix of traditional as well as non-traditional engagement and outreach tools. In particular, there was high interest in accessibility of live CFIA expertise and resources to respond to technical questions. Some disappointment was expressed that the Centres of Expertise (COE) (now known as Centres of Operational Guidance and Expertise) would not play this role, as they are internally facing.
Also, concerns were raised that the CFIA may not have the staff, time or resources to adequately deliver on compliance promotion. A few respondents commented that there should be support programs in place for regulated parties to help build the technical capacity necessary to meet the new regulatory requirements. Some stakeholders expressed concerns about the impact of new regulations on micro and small businesses.
There was also broad agreement that compliance promotion is a collaborative effort. Many respondents from associations, organizations, and the provinces/territories expressed interest in contributing toward the design, development and delivery of outreach efforts and compliance promotion tools, i.e., model systems, to ensure that the end products meet users' needs. They also encouraged the CFIA to leverage their best practices and outreach networks. Some had questions about how the CFIA planned to address sectors where associations faced resource and capacity challenges, or had no representation. On a related note, the CFIA was encouraged by some respondents to continue supporting its Food Safety Recognition Program (FSRP) for industry-developed food safety programs.
A number of respondents wanted a better understanding of how new model systems being developed by the CFIA compared to existing generic models and programs. It was noted that model systems required an investment of time and effort to be appropriately tailored and implemented. The CFIA was advised to be cautious of being overly prescriptive, and to stress the responsibility of regulated parties, in taking ownership of their model system in order for it to deliver intended outcomes. However, other respondents expressly requested prescriptive checklists and adoptable templates, in order to facilitate business compliance.
A number of respondents suggested that the CFIA reframe its compliance monitoring section to be more focused on positive compliance information and positive incentives. The CFIA was strongly encouraged to proceed cautiously and to consult on next steps related to its transparency agenda.
2. Compliance, Control and Enforcement Framework (CCEF)
June to October, 2014.
The manner in which the CFIA fulfills its mandate is evolving due to changes on the legislative and policy fronts, including the development of the CFIA's Integrated Agency Inspection Model and new food legislation under the Safe Food for Canadians Act.
To reflect this, the CFIA developed a Draft Compliance, Control and Enforcement Framework (CCEF) that was released on the CFIA website in June 2014 for public comment. The Framework describes the CFIA's vision and approach for verifying compliance, controlling risk and responding to non-compliance. Stakeholder feedback will be considered in the development of a final Framework.
The CFIA received 31 submissions from businesses and business associations, government employees and provincial governments, as well as a health organization. Webinars with external stakeholders were held on the Framework in October 2014 and were well attended with over 200 participants.
Key Messages/"What We Heard"
The draft CCEF was well received in principle, as respondents felt it was generally clear in meeting its stated objectives. The level of detail in the framework was identified as an area for improvement, with many respondents requesting increased precision on when specific CFIA compliance, control and enforcement tools would be used.
With respect to compliance promotion, there were queries from a range of respondents as to whether the CFIA would provide access to stakeholders to seek support and assistance from CFIA staff in real time. This was felt to be of particular importance where industry associations are less developed, and/or have fewer resources.
Some respondents wanted to know how the CFIA planned to improve the consistency and timeliness of its decisions. There was also some concern expressed that CFIA inspectors would not be able to properly administer and enforce outcome-based regulations.
It was widely accepted that the degree of risk should inform CFIA action. Some respondents suggested other factors that the CFIA could consider to determine its risk-based inspection activities, i.e., third-party certification, the use of a recognized risk management program, and trade requirements. One respondent warned that even seemingly less serious incidents, e.g. mislabelled product, could have grave health repercussions, and therefore warranted appropriate CFIA attention.
Regarding non-compliance, a number of business associations expressed concern with respect to CFIA's proposed next steps under its transparency agenda for publishing compliance and enforcement information. The CFIA was urged to provide context for all information posted, and to consider fairness in disclosure. For example, some companies with a person's name in the overall company title are not named (due to privacy considerations), while other companies can be named.
Regarding recourse mechanisms beyond the scope of the CCEF, the CFIA was encouraged to consider definitive timelines, service standards, single window for recourse, remedial measures and less formal mechanisms for minor complaints.
3. Use of Private Certification to Inform Regulatory Risk-Based Oversight
May to August, 2014.
Private certification schemes are increasingly being used by industry as a means of achieving food safety and other outcomes, and may play a role in helping industry achieve regulatory objectives, provided they can be assessed as being effective, credible and aligned with public policy objectives. The CFIA is transforming how it delivers its programs and activities to better meet the needs of today's consumer and industry. In support of its modernized, scientific approach, the CFIA is exploring how, and to what extent industry's movement towards private certification schemes may inform CFIA risk-based planning within the regulatory framework.
While the CFIA has always incorporated risk into its approach to oversight, a modernized approach will enable improved risk-based planning, and as a consequence, more targeted compliance verification. The CFIA will continue to verify compliance of regulated parties; however, the type, frequency, and intensity of the CFIA's oversight activities will be proportional to the risks that need to be managed. The implementation of this approach will enable the CFIA and regulated parties to more readily adapt to emerging trends, and will also allow the CFIA to focus its resources on parties and commodities that present greater risk to human, plant and animal health.
Private certification schemes have been identified as one of several factors that may be considered in the context of the CFIA risk assessment model. The discussion paper entitled Use of Private Certification to Inform Regulatory Risk-Based Oversight: Discussion Document outlined, at a high level, how the CFIA may consider private certification as a factor within the regulatory risk assessment continuum.
The Use of Private Certification to Inform Regulatory Risk-Based Oversight discussion document was posted on the CFIA external website between May 29 and August 29, 2014. During that time, 39 submissions were received, from a wide range of stakeholders including regulated parties, associations, provincial governments, and private citizens.
Key Messages/"What We Heard"
The vast majority of feedback was positive and supportive of the concept described in the discussion paper. Stakeholders were encouraged by CFIA's openness to learning about and considering industry investments in food safety as the CFIA conducts its risk-based planning. In fact, stakeholders emphasized that the expansion of private certification schemes is a reflection of industry's commitment to provide safe and wholesome food.
In most cases, stakeholders wanted more detail, and provided suggestions, as to how such an initiative may be implemented successfully to benefit Canadians. A very small minority of respondents expressed concern that the proposed initiative was poorly informed and based on cost-cutting measures rather than a modernized approach. Some also felt that it was not aligned with the CFIA mission of safeguarding food, animals and plants, to enhance the health and well-being of Canada's people, environment and economy.
While some feedback was very specific in nature, stakeholder feedback can essentially be summarized under the following general themes:
Linkages with Other Initiatives
The CFIA FSRP provides government recognition of on-farm and post-farm food safety systems developed and implemented by national industry organizations in order to enhance food safety, maintain the confidence of Canadian consumers and facilitate market access. The FSRP led by the CFIA with the participation of the provincial and territorial governments and supports the CFIA's goal of safeguarding Canada's food supply along the whole food continuum.
Stakeholders expressed strong support for the continuation of this program, and its incorporation, to the extent possible, within the context of any private certification initiative or policy. Stakeholders further stressed the importance of ensuring that decisions taken align with, or do not conflict with approaches taken by key trading partners. Finally, they identified potential linkages between the proposed initiative and the draft Preventive Control Plan (PCP) requirement under the SFCR.
Stakeholders indicated that careful consideration of CFIA financial and human resource requirements is necessary for successful and timely implementation of the private certification initiative. The importance of appropriate training of inspectors as well as other CFIA employees involved in aspects of the private certification initiative was emphasized (for instance, employees involved in conducting assessments of private schemes against regulatory requirements).
Many stakeholders had questions about the potential changes to the frequency or type of regulatory oversight, whether license renewal frequencies may be impacted and whether this initiative may impact import inspections or the issuance of export certificates. Several stakeholders had questions about how private certification schemes may be weighted within the context of a risk model. Many stakeholders indicated that the discussion paper was too heavily focussed on constraints, and did not explore possibilities in adequate detail. Stakeholder views on expansion of the proposed initiative to include consumer protection elements were mixed.
Significant feedback was received on the proposed assessment process. This aspect of the private certification initiative was perceived by stakeholders as critically important. Stakeholders were interested in a prioritization process for assessing schemes, the development of an appeal mechanism, assurance that assessment criteria focussed solely on regulatory elements and publication of, or access to, assessment results. There were questions about how to effectively conduct an assessment of outcome-based regulatory requirements against more prescriptive private scheme requirements. Many stakeholders expressed interest in a clear articulation of the formal outcome of the assessment process. Stakeholders had many questions and comments related to the roles of third-party auditors, certification bodies and accreditation bodies within the proposed initiative. The importance of ensuring auditor competency was stressed. Although the CFIA does not have the authority to request private audit reports, stakeholders still expressed mixed views on the importance of receiving private audit reports to the success of the proposed initiative. Additionally, the importance of protecting private, proprietary business information was emphasized. Stakeholder feedback indicated that there is a need to clarify where there may be areas of overlap between regulatory compliance requirements and private scheme requirements and, just as importantly, where there are differences. The feedback indicated that it is critically important for the CFIA to effectively communicate to stakeholders that the CFIA will continue to inspect and provide regulatory oversight according to its regulatory authorities.
There was general support for the concept of Mutual Recognition as described in the discussion paper, with a request for more details. Given the existing CFIA FSRP, use of the word 'recognition' in the discussion paper resulted in a level of confusion. In a few cases, it was unclear to respondents that the phrase "CFIA regulatory oversight" was intended to include CFIA inspections.
Stakeholders stressed that 'one size does not fit all' and requested that the CFIA consider the uniqueness of the Canadian industry as the private certification initiative proceeds. The scale of the Canadian primary agriculture industry (>200,000 farms) and the fact that many companies use International Organization for Standardization (ISO)-based or Hazard Analysis Critical Control Point (HACCP)-based food safety systems were commonly cited as rationale for a flexible approach. It was suggested that the use of supplier approval programs also be taken into consideration. While most stakeholders indicated support for CFIA consideration of the Global Food Safety Initiative (GFSI)-benchmarking process in the CFIA assessment process, stakeholders also stressed the importance of not restricting the initiative to GFSI-benchmarked schemes.
Several stakeholders stressed the importance of considering unintended impacts on small Canadian businesses and if possible, providing support for small businesses to benefit from this initiative.
Stakeholders appreciated the CFIA's transparency on its modernization initiatives, and encouraged the Agency to continue to be transparent as its work progresses. The feedback indicated a strong preference for transparency on the private scheme assessment criteria, process and results, as well as the criteria and/or process used to select and/or prioritize private schemes for assessment.
Stakeholders suggested that the CFIA may possibly play an important role in providing private scheme owners with feedback to help influence private schemes to align more closely with regulatory requirements.
4. Incorporation by Reference
May to August, 2014.
The incorporation of documents by reference is a drafting technique that brings the content of a document into a regulation, without the need to reproduce the document in the regulation itself. This is important as it allows the regulations to more rapidly reflect changing science and new innovations. New authorities for the use of Incorporation by Reference are contained in the Safe Food for Canadians Act which received royal accent in November 2012, and in the Agricultural Growth Act (Bill C-18), which was passed by Parliament on February 25, 2015. The new authorities provide explicit authority for the incorporation of any document, regardless of its source, into the regulations made under the Acts. The CFIA posted a discussion document on the use of incorporation by reference, focussing on the guiding principles it would use in exercising this authority, as well as setting out its approach for choosing the documents recommended for incorporation by reference.
The incorporation by reference discussion document was posted on the CFIA external website between May 29 and August 29, 2014. During that time, 40 submissions were received from a wide range of stakeholders including regulated parties, associations, provincial governments, and private citizens.
Key Messages/"What We Heard"
Generally, responses from stakeholders were extremely supportive of the CFIA's potential use of incorporation by reference as a regulatory tool in the regulations under the Safe Food for Canadians Act. Most of the concerns that were raised pertained to the specifics of how documents would be chosen for incorporation, and how the process would be managed when documents are updated. The majority of stakeholders asked for more details on what would be considered an appropriate or valid document for incorporation, and the criteria that the CFIA would use to make that determination. The development of a Roadmap to outline the general process, timelines, and steps of incorporation by reference was judged to be useful by some respondents.
Respondents were divided as to whether the Agency should use more internal or external documents for incorporation in the regulations. Many stakeholders thought that using internal documents more would provide a greater level of control and certainty over future changes, while others indicated that external documents maintained by third parties would provide the greatest level of utility in terms of scientific knowledge and expertise.
Almost all stakeholders affirmed the need for incorporated documents to be accessible on a website, combined with easy access to past historical versions of documents. Many comments were received about alternate methods of communication with stakeholders, such as directly contacting affected regulated parties, and that the CFIA should not only rely on email and postings on the CFIA website to inform stakeholders about upcoming changes.
Questions were raised by some as to what the process would be for the removal of documents that have been incorporated by reference, should it become necessary. Clarity was sought on how compliance would be managed if a third-party document changed, and the CFIA did not agree with those changes. For example, respondents wondered whether the CFIA would find regulated parties to be in non-compliance prior to the reference being amended.
Some stakeholders commented on the decision-making process, including the recommendation that all final approvals should be at the level of the President of the CFIA or the Minister responsible. Having appropriate timelines for a comment period—building in enough time for proper consultations and notification, including the use of transitional periods—was highlighted by many stakeholders as another key process consideration.
Finally, a number of stakeholders proposed that specific standards be incorporated in the regulations. The most common standard that was mentioned by the most respondents was the Canadian Beef Grading Agency livestock carcass grade standards, which some stakeholders proposed should be used as one of the first documents to be incorporated by reference in the new SFCR.
5. Enhancing Risk Analysis: A more systematic and consistent approach Consultation Period
June to November, 2014.
Increased international trade, global supply chains, and advances in science and technology have created new realities for regulated parties and the CFIA. As part of its transformation to adapt to changes in the operating environment, the CFIA is modernizing its approach to oversight. In order to better allocate human, technical and financial resources to oversee regulated parties in Canada, the CFIA is moving away from more traditional inspection approaches oriented around commodity-specific factors. Moving to a proactive, systematic risk-based approach for its oversight activities will see the CFIA apply its oversight capacity to areas of highest risk and allow it to more efficiently and effectively fulfill its mandate. This approach will offer a structured and transparent approach to allocating resources across all sectors so that CFIA's oversight activities are proportional to the risks being managed for all commodities regulated by the CFIA. A flexible inspection workforce and human resources regime will be key pieces in achieving full implementation of the modernized approach.
The consultation focused on three key areas – Risk Assessment, Risk Management and Risk Communications. The CFIA outlined its new model for assessing the risk associated with an establishment producing food for the domestic market. The risk assessment (RA) model will be an important part of the input variables that will be considered when making oversight decisions. The Agency highlighted other factors (e.g. trading partner requirements, the use of Private certification schemes etc.) that will be taken into account during risk management that will inform regulatory decisions determining type, frequency and intensity of oversight activities. The CFIA is committed to increasing transparency as part of its proactive risk communications. The paper described several achievements in this area as well as initiatives that are underway.
Enhancing Risk Analysis: A more systematic and consistent approach discussion document was posted on the CFIA external website between June 12 and November 3, 2014. During that time, 43 submissions were received, from a wide range of stakeholders including regulated parties, associations, provincial governments, and private citizens.
The CFIA presented and discussed the paper to stakeholders in four breakout sessions during the Healthy and Safe Food Regulatory Forum held in Gatineau on June 17-18, 2014. There were also two webinars (one in French and one in English) held on October 27, 2014 with a total of approximately 200 participants.
Key Messages/"What We Heard"
Responses from stakeholders have been extremely supportive of the Agency's move towards a more proactive, systematic, evidence based approach to risk assessment and management. It was appreciated that the approach was based on an establishment's risk and not just the risk of the commodity being produced. Several respondents noted the importance of the links to other initiatives underway.
The majority of the concerns raised were around the specifics of how the model would be implemented. For example, it was noted by several respondents that more details on the Risk Assessment (RA) model and its implementation would have allowed for more substantive feedback. Further information on how the RA model will be layered with other factors, such as the requirements of trading partners or the use of private certification schemes, to inform decisions on regulatory oversight was of great interest to respondents. There were also questions such as how often the risk assessment results would be updated to incorporate new information and if there would be a mechanism in place for establishments to request an update in their result should they have made changes to preventative control plans (as an example).
Other concerns pertained to how the model has been developed with a focus on establishments. Several respondents felt that the meat, poultry and dairy sectors did not accurately reflect the risks in their sector. Respondents encouraged the CFIA to pilot the RA model in other sectors (such as fresh produce or the bakery industry) before making final decisions on model implementation. There was much support for the CFIA's consideration of private certification schemes especially in areas where there hasn't been a large presence in the past (for example the non-federally registered sector). Some respondents suggested that certain sectors could be exempted based on the low level of risk or that there are other jurisdictions that provide oversight (e.g. provincial regulation of alcoholic beverages).
Many respondents were seeking more details on what the criteria are in the RA model and how these will be weighted when arriving at a risk assessment result. It was noted by some that the CFIA should disclose this information to establishments so that they would be better positioned to improve and potentially reduce their risk.
A consensus among respondents emerged on the importance of Risk Communications and Transparency however many were cautious in the type of information that they would be comfortable in having published. It was noted by several respondents that when considering the proactive publication of information that the CFIA needed to be mindful of the intended audience and to make sure that the information would be meaningful and useful. Respondents wanted to know how CFIA would inform them of their risk assessment result. It was also suggested by some respondents that more information on what enforcement actions would be taken for areas of non-compliance would be useful.
6. Foreign Food Safety Systems Recognition: Proposed Framework Consultation Period
June to October, 2014.
The CFIA developed the Foreign Food Safety Systems Recognition: Proposed Framework (Framework) to guide its approach to the assessment and recognition of the food safety control systems of foreign competent authorities. Systems recognition takes into account the capabilities of the exporting country in contributing to assurances of food safety, and contributes to the CFIA's risk-based decision making for import control activities.
In developing the draft SFCR, the CFIA is considering a proposal whereby food importers may be eligible for an exemption from the requirement to have a fixed place of business in Canada in order to obtain a CFIA import licence. In order to qualify for this exemption, food importers will have to have a fixed place of business in a country that provides the same level of protection to that of Canada, they are importing food from or manufactured in that country and the food is within the scope of the recognition arrangement.
The Framework was posted on the CFIA's external website on June 2, 2014 and the World Trade Organisation (WTO) was notified on August 5, 2014. The consultation periods closed on August 29, 2014 and October 10, 2014, respectively. The CFIA received 37 submissions from industry, the general public, provincial/territorial governments, foreign government agencies, unions, and CFIA employees.
Comments received indicate that stakeholders are generally supportive of the proposed framework.
Elements of the Framework and Implementation
Many stakeholders sought clarification and more details on the practical application and implementation of the systems recognition framework. This included duration of the process; scope of recognition; assessment tool; maintenance schedule; criteria for determining country eligibility and priority for an assessment when a Foreign Food Safety Systems Recognition (FFSSR) is no longer effective or is to be re-assessed; as well as, impact on importers when a FFSSR arrangement is discontinued. Suggestions were also provided on assessment criteria that should be used in the process and clarification sought on assessment of 3rd party providers.
Stakeholders emphasized the importance of conducting in-country assessments to verify that the exporting country's food safety control systems can achieve comparable public health outcomes in Canada. The also emphasized the importance of having trained and experienced assessors. Concern was raised about consistency of terminology application with international standards and potential for confusion.
Suggestions received from stakeholders included the following:
- FFSSR should be a pre-requisite for all foods or for some specific commodities, and should also include animal and plant health aspects.
- Further clarify that food safety standards and labelling standards are outside the scope of FFSSR.
- Clarify the role of stakeholders in FFSSR;
- Clarify how and whether private standards are considered within FFSSR
- Industry stakeholders should be able to suggest specific countries for assessment; and
- Systems recognition assessments should include all food commodities. In the event that it is not possible, a science-based justification should explain why a commodity is excluded.
A number of stakeholders were of the view that industry, provinces and territories, or other federal government departments should be involved in some or all aspects of the systems recognition activities.
Also, some industry stakeholders recommended that the CFIA provide information on the status of systems recognition assessments and timelines for completion, as well as the criteria used to prioritize countries for assessment. It was also proposed that industry be consulted if a re-assessment is needed.
A number of stakeholders recommended that a list of countries with which the CFIA has developed FFSSR be made available to the public. One industry member suggested that further discussions be held with stakeholders before finalization of the framework and process.
Arrangements with Other Countries and Trade
Questions were raised on the impact of the proposed framework on existing bilateral arrangements, including equivalence of meat and meat products.
Stakeholders encouraged the CFIA to pursue reciprocal systems recognition assessments with other countries in addition to the current ongoing recognition assessment with the United States Food and Drug Administration. Also, stakeholders encouraged the CFIA to consider systems recognition as a mechanism to facilitate trade in addition to functioning as an import control tool.
Importer Responsibilities and Non Resident Importers and Systems Recognition
Many of the comments and questions did not relate directly to the elements of the proposed framework but focussed on the Agency's proposal for non-resident importers (NRI)Footnote 1, on responsibilities of importers under a FFSSR scenario and non-FFSSR scenario, verification and enforcement activities.
Stakeholders requested clarification on the following:
- How the CFIA would conduct compliance verification activities for non-resident importers (NRI);
- Criteria to determine satisfactory compliance history in order to be eligible for NRI;
- Whether an importer would be eligible to be an NRI if situated in a country with which the CFIA has developed an FFSSR arrangement and importing food from a 3rd country into Canada; and
- Whether an importer would be eligible to be an NRI if importing food that transits a country with which the CFIA has developed an FFSSR arrangement.
Others suggested that the CFIA should:
- Consider alternative approaches to allow for NRI in countries with which the CFIA has not established systems recognition; and
- Reduce oversight activities for food imports from countries without FFSSR when imports from those countries are passing through a country with which CFIA has developed a FFSSR arrangement.
7. Integrated Agency Inspection Model (iAIM)
January to August, 2014.
The CFIA is modernizing its approach to inspection in support of human, animal and plant health protection. The move towards a more preventive and systems-based approach under the integrated Agency Inspection Model (iAIM) will enable both the CFIA and regulated parties to more readily adapt to emerging risks and global and scientific trends. Canadians will continue to be protected by an effective inspection system that is both science and risk-based as well as performance based. The iAIM will apply globally recognized risk management concepts based on prevention.
The model represents the CFIA's vision and its approach to regulatory inspection.
Initially, the CFIA focussed its efforts on the development of a food model, i.e. the Improved Food Inspection Model (IFIM), which was finalized June 2013. Animal and plant commodity activities (fertilizer, seed, plant health, feed and animal health) have been incorporated to transform the IFIM into the iAIM to fully align the strategic outcomes for all CFIA inspection work.
Four key areas were adjusted:
- The Glossary of terms was revised to improve understanding of the terminology used in the model;
- Permissions, formerly called Licensing, were modified to provide for permission without a preventative control plan (PCP). The animal and plant commodity inspection aspects were integrated into the PCP section and corresponding annex;
- CFIA Oversight was broadened to encompass animal and plant commodity inspection activities; and,
- Regulatory Response, formerly called Compliance and Enforcement, was re-organized to better articulate the two key CFIA regulatory response activities that are initiated:
- by lack of compliance on the part of regulated parties; and,
- by events the Agency aims to control, such as pest and disease incursions and contaminant events.
Stakeholders were asked for feedback on the integration of the animal and plant commodity (seed, fertilizer, plant health, feed and animal health) inspection activities into the model.
Feedback was sought via in-person and listserv information to over 1,000 stakeholders. Approximately 400 individuals, including CFIA staff, and associations participated via focus group, working group, webinars and meetings.
Key Messages/"What We Heard"
Many of the internal and external comments were similar. Stakeholders continued to support the CFIA's move toward a single and more consistent inspection system. Positive feedback was received regarding the broader definition of terms in the glossary as it served to facilitate understanding across commodity areas.
Feedback affirmed that the model concepts could be applied equally, or better, to plant and animal regulated commodities. There was considerable recognition that a systems based approach to inspection is already common in plant commodities. A number of stakeholders felt implementation could even proceed for those activities that do not require regulatory change.
Overall, stakeholders asked for more details on:
- how the model will be implemented;
- how CFIA oversight will be determined across all CFIA activities;
- how PCPs should be developed;
- their ability to adapt their current process control or quality management systems;
- the need for additional language reflecting consideration of systems beyond HACCP approaches; and,
- how the model relates to legislative authorities, current, proposed or to come.
Stakeholders agreed that the model should be implemented gradually and appreciated that it will be done incrementally to provide enough time to make the necessary changes. Stakeholders also asked that CFIA inspectors be properly trained given the expectation that they will be inspecting numerous commodities.
Stakeholders continued to support the permission requirements to:
- improve the CFIA's ability to control pest or disease incursions or contaminant events;
- provide a level playing field for regulated parties;
- provide a single permission platform; and,
- uphold market access, but noted that negotiation will be key to success.
Participants wanted more detail on permission requirements for their specific sectors or facilities, including how the CFIA will evaluate PCPs to determine regulatory compliance. Support was expressed for pre-approval of PCPs and inspection before permission is granted.
Participants supported a consistent approach to oversight based on risk and focussed on greater industry controls. There was continuing interest in how the level of oversight will be determined, including:
- the need to more clearly consider factors beyond health, namely social and economic (e.g. marketplace deception);
- how inspection resources will be assigned across commodities based on risks;
- how oversight will take into account past compliance; and
- how the CFIA will consider third-party systems when determining risk and inspection frequency.
Participants supported more consistent inspections across commodities. They asked that CFIA inspectors have adequate training and a common skill set to make sound, consistent decisions. There was also support for more predictable and transparent regulatory actions from compliance evaluation to control and enforcement. Feedback suggested that non-compliance categorization be reviewed to better reflect regulatory response to economic (e.g. marketplace deception) and trade challenges.
8. Food Program Framework
June to October 31, 2014.
The CFIA mitigates risks to food safety. The driving force behind the design of the CFIA's programs is our mission to safeguard the health and well-being of Canada's people, environment and economy.
To meet these objectives, the CFIA develops and enforces regulatory and program frameworks for food. This applies to domestically produced food, as well as imported and exported food.
A framework for a single food program
The draft Food Program Framework is designed to regulate all food commodities under a single program within Canada's new Safe Food for Canadians Act.
The framework describes how the CFIA establishes the requirements to control food safety and the way in which it uses its resources to produce the most effective outcomes.
The framework has several important characteristics:
- It outlines food-related activities in a single resource.
- It identifies the core elements and key principles of an effective food control system.
- It describes how the CFIA establishes its requirements to regulate all food commodities under a single program, under the new federal legislation.
- It will function within the existing resources of the CFIA, with activities that can be adjusted based on risk and resource availability.
The CFIA consulted with a broad range of internal and external stakeholders. This included CFIA employees and bargaining agents; consumers and consumer groups, industry and industry associations, academia, other government departments, provincial and territorial governments and international trading partners.
Stakeholders were asked to comment as if the Safe Food for Canadians Act was in force. All the comments received were reviewed to help finalize the framework.
Key Messages/"What We Heard"
Overall, stakeholders expressed a high degree of support for the CFIA's modernization efforts, including:
- moving towards a single food program;
- using a more consistent and transparent approach to inspection, based on evidence, science, and risk; and
- implementing the Safe Food for Canadians Act.
Stakeholders supported using a single document to communicate the CFIA's legislative, regulatory, guidance, and enforcement perspectives for food safety. They also supported using guidance documents and model systems to encourage understanding of proposed changes and new requirements.
Some expressed concerns about the CFIA having all the required human and financial resources to successfully implement modernization steps, and to ensure that the changes made did not impact Canada's ongoing ability to export.
A number of suggestions were provided to improve the framework and enhance stakeholder support.
Some stakeholders noted that a clearer explanation was required about how and when new provisions of the Safe Food for Canadians Act will apply to Canadian food manufacturers, importers, and foreign firms making products or ingredients used or sold in Canada.
Some stakeholders suggested that the CFIA write a more concise document with a tighter focus on core elements, and that additional information should be published elsewhere.
Stakeholders noted that information disclosed on the subject of compliance and enforcement actions should be meaningful, clear, easily understood and appropriate to the audience. They further asked that the CFIA consult on this particular element.
It was noted that the CFIA's strategic outcome for "a safe and accessible food supply and plant and animal resource base" might inadvertently imply lack of safety in the present supply.
A recommendation was made that the CFIA should add the following to the Target Groups:
- non-government organizations;
- health organizations;
- consumer organizations; and
- the Canadian Grain Commission.
Stakeholders felt that industry could be more involved in developing guidance documents. They also asked that future consultations be managed to allow them more time to reflect and comment, and that they be timed to accommodate seasonal business cycles.
Stakeholders made a number of comments pertaining to the design of the Framework:
- Fairness, respect, continuous improvement and consumer education could be added as additional guiding principles.
- Program elements should not be differentiated on the basis of having a "safety" vs. "non-safety" role.
- The CFIA should increase collaborative efforts on compliance promotion, and put more focus on the role of the consumers in food safety.
- Mislabelling of product should be considered as a high-level risk, given potential impacts on food/nutrient related health outcomes and allergen considerations.
- "Healthy Canadians" was acknowledged, recognizing the clear linkage between food consumption patterns and health outcomes.
- Greater use should be made of Private Certification Schemes.
- Commodity-specific expertise should be a priority consideration for training and/or professional development programs.
- The CFIA's FSRP is a unique and excellent framework for food safety programs in Canada, based on international principles and stakeholder collaboration.
- An incident reporting structure comparable to the United States Food and Drug Administration's Reportable Food Registry should be implemented.
- Considerations such as transportation, animal health and welfare, and plant risks (as is done by a number of international bodies) should be included.
- Preventative Control Plans were recognized as essential to progress and solicited numerous suggestions regarding their implementation. The need for small business accommodations or exemptions was raised by some parties while others suggested that PCP requirements should be applied beyond licensed parties and to primary producers (such as farms where plants and livestock are raised). Stakeholders urged that flexibility to use existing food safety programs be continued.
Stakeholders also felt that more detail should be included about certain specific food safety components presented in the Food Program Framework document, including: requirements for licensing; PCPs as well as the process to approve them.
They felt that more information about costs to business under the new regime, including user fees, cost recovery, and other indirect administrative costs/burdens related to documenting compliance should be made available. At the same time, there was a desire to know more about how the CFIA would help small and medium sized businesses achieve compliance.
Specific information about how the CFIA will perform inspections in the future, including:
- the roles and responsibilities of front-line inspectors, Inspection Verification Teams (IVTs), and CoEs;
- how the Food Safety Emergency Response Functional Plan would be applied;
- how the Alternate Service Delivery Policy would work;
- how CFIA would ensure that audit information was fully representative and suitable to support risk-based oversight decisions; and
- how CFIA plans to continue to recognize and leverage national industry-led food safety certification schemes.
Information about how the CFIA will ensure consistency, quality, and timeliness of its inspection work, enforcement activities, and regulatory interpretations, and how CFIA single food program inspectors will operate in commodity specific environments was also desired.
More information was also required on how the CFIA would use technology to communicate decisions and lessons learned, and how they could facilitate use of the website (for example, by enabling users to see English and French labelling requirements on a single web page instead of two). Industry representatives also asked how they might engage COE staff directly instead of through front-line staff under specific circumstances.
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