On May 4, 2016, the U.S. Food and Drug Administration (FDA) announced that it had signed a Food Safety Systems Recognition Arrangement with the Canadian Food Inspection Agency (CFIA) and the Department of Health Canada (Health Canada). This means that after thorough evaluation, FDA has determined that Canada’s food safety systems provide public health protection comparable to those of the United States. The arrangement is part of the US-Canada Regulatory Cooperation Council, which aims to leverage resources and reduce unnecessary duplication within the countries’ food safety systems.
FDA, CFIA, and Health Canada began assessing each others’ food safety systems in 2015. Canada is the second country that FDA has recognized as having comparable food safety systems. New Zealand was the first, recognized in 2012. FDA is currently evaluating Australia and the European Commission.
According to the arrangement, FDA and Canada will exchange regulatory and scientific information related to food safety at least once per year. The countries will discuss Systems Recognition reassessments, reviews, or audits at least once every five years. Certain food and beverage products are excluded from the US-Canada arrangement, including meat, poultry, processed egg products, farmed catfish and catfish products, grade “A” milk and grade “A” milk products, raw bivalve molluscan shellfish, dietary supplements, and natural health products.
Food Safety Systems Recognition and the Food Safety Modernization Act
FDA’s Food Safety Modernization Act (FSMA) creates new food safety requirements for both food facilities and U.S. importers. Food facilities exporting food from countries with recognized food safety systems and importers with suppliers in countries with recognized food safety systems are still subject to FSMA requirements, but have some modifications and exemptions.
Requirements for FDA-Registered Food Facilities
FDA’s Preventive Controls Rules require that all food facilities that manufacture, process, pack, or hold food for consumption in the U.S. have written food safety plans, including a hazard analysis, preventive controls, a supply chain program, and other components. As part of their supply chain program, covered facilities must conduct verification activities to ensure their suppliers’ compliance with FDA regulations.
The rule identifies onsite audits as an appropriate verification activity for suppliers of raw materials and other ingredients. Instead of conducting an onsite audit, food facilities with suppliers in countries with recognized food safety systems can rely on an inspection by the food safety authority of that country, so long as the inspection occurs within one year of the date that the onsite audit is required to be conducted.
Requirements for U.S. Importers
FDA’s Foreign Supplier Verification Program (FSVP) rule creates many new requirements for U.S. importers, including monitoring, approving, and creating an FSVP for each foreign supplier. However, importers can import from suppliers in countries with recognized food safety systems without conducting a hazard analysis, approving and verifying those suppliers, or conducting FSVP activities for those suppliers. In order to take advantage of these modified requirements, the importer must continuously monitor eligible suppliers to ensure they are in good compliance standing with their country.
Registrar Corp helps food facilities comply with new requirements under FDA’s Food Safety Modernization Act. Registrar Corp’s Food Safety Specialists can develop or review Food Safety Plans as well as help facilities prepare for an onsite audit. Registrar Corp’s FDA Compliance Monitor allows users to effortlessly monitor their suppliers for FDA compliance issues.
For assistance determining your particular requirements, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.