In the last edition of the Regulatory Arena, we introduced you to Health Canada’s “modernization makeover”. As we noted, in part that endeavor is focused on making over the CFIA’s inspection program. In this edition of the Regulatory Arena, we will cover one of the more recent elements of the inspection modernization makeover: the Integrated Agency Inspection Model (or “iAIM”).
Recall that the CFIA has responsibility for safeguarding human, animal and plant health and the environment. Thus, in addition to food for human consumption, the Agency also oversees the regulation of plants and animals.
A core element of Health Canada’s modernization makeover is ensuring consistency in the treatment of all of the commodities it regulates. The iAIM is a fundamental step in that direction, bringing all of the commodities for which the CFIA has oversight (food, plants and animals) under one umbrella.
The iAIM expands the Improved Food Inspection Model (“iFIM”) to include animal and plant safety, with a goal of ensuring a “robust approach” to human, animal and plant health and consumer protection.
Recall that the iFIM integrates all CFIA inspection activities relating to food safety, and applies them across regulated food commodities. The iAIM takes the same approach to the parties and commodities regulated under the Seeds Act, Fertilizers Act, Plant Breeders’ Rights Act, Plant Protection Act, Feeds Act and Health of Animals Act.
The iAIM is based on the same principles as the iFIM: the importance of assigning responsibility for demonstrating ongoing compliance to industry, prevention, prevention, prevention, and a risk-based approach to the allocation of resources. Similar to the iFIM, the iAIM is supported by the use of permissions (including permits, authorizations, licenses) and preventive control plans. It essentially proposes a risk-based, establishment-based inspection system similar to what currently applies (and/or is proposed) for food commodities.
The 5 primary components of the iAIM are as follows:
- Permissions, which are broader than “licensing” and includes certificates, licenses, registrations and permits to operate and facilitate access to markets;
- CFIA oversight corresponding to the regulated party’s ability to meet regulatory requirements;
- Standardized, consistent and risk-based inspection and verification approaches across all regulated commodities (food, plants and animals);
- Risk-based, consistent, transparent and graduated regulatory response; and
- Validation of overall system performance effectiveness on an ongoing basis through use of objective performance measures.
According to the CFIA’s discussion paper on the iAIM:
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 control systems.
The expected outcomes of the single inspection model will include more predictability, consistency and transparency for regulated parties as well as administrative and operational efficiencies for the CFIA. This will support a strengthened food safety system, and improved plant, animal and environmental health.
Like the Safe Food for Canadians Act provided the foundation for the changes to the food inspection system proposed in the iFIM, the Agricultural Growth Act will facilitate the modernization of the inspection system relating to plants and animals.
The Agricultural Growth Act was tabled in December 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 (similar to the goals of the Safe Food for Canadians Act). The Act proposes changes to a number of pieces of federal legislation, including some under the oversight of the CFIA and others under the oversight of Agriculture and Agri-Food Canada.
Together, the Safe Food for Canadians Act and the Agricultural Growth Act will provide a more consolidated legislative framework, and the basis for a consistent approach to inspection of regulated commodities.
The Safe Food for Canadians Act will provide for the safety of foods for human consumption, the Agricultural Growth Act (if passed) will provide for the safety of plants and animals, and our Food and Drugs Act will continue to provide for regulatory oversight of all food sold in Canada. And the CFIA will apply a prevention, and risk-managed approach to the oversight of all regulated parties in accordance with the iAIM, i.e. in a standardized, consistent, risk-based and transparent manner.
The CFIA is currently consulting on the iAIM – interested parties can submit comments until July. Once consultations close, the iAIM will be finalized and posted along with a “What we heard” report.
In other Health Canada modernization news, industry anxiously awaits the release of proposed regulations under the Safe Food for Canadians Act. Stay tuned for updates in the next edition of the Regulatory Arena, and as always, you can visit www.thefoodlawyer.ca for information in the interim.