By: Cameron Prince While there are a number of differences between the Safe Food for Canadians Act (SFCA) and the Food Safety Modernization Act (FSMA) of the U.S., one of the most obvious – and important – differences are the inclusion of FSMA’s Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration (IA Rule) – or more simply, the Food Defense Rule. Canada has dealt with this with provisions for “food tampering” and associated severe penalties, with no separate SFCA rule, there are things that Canadian businesses exporting to the U.S. need to know about the IA Rule. The rule requires that U.S. FDA-registered food facilities identify specific vulnerabilities in their facilities that could allow the deliberate introduction of an adulterant into a food. From that assessment, the facility must develop a written Food Defense Plan to prevent or mitigate those vulnerabilities wherever a significant vulnerability exists. It is the need for the written plan that sets off the greatest difference in this area between FSMA and SFCA.Because FSMA also states that imported foods must meet standards that are at least equivalent to those required of U.S. foods, Canadian companies wishing to export food to the U.S. must also have intentional adulteration mitigation strategies and a written Food Defense Plan. Canadian companies that are certified to GFSI have some elements of this, but not enough to meet all components of the rule. So what do Canadian food exporters need to know? The most basic aspect is an understanding of the difference between food safety and food defense: Food safety is the prevention of unintentional adulteration of food. Food defense is guarding against intentional adulteration. Food safety and food defense incidents may initially present themselves in similar ways, making it difficult to immediately determine if the incident was caused by unintentional or intentional adulteration. In both cases, food regulatory and public health agencies are typically involved in the response, but because intentional incidents involve a criminal act, law enforcement is generally also involved in the investigation. Intentional adulteration can take a variety of forms, including economically motivated adulteration; food tampering with intent to cause consumer or company harm; adulteration intended to cause wide-scale public health harm; and other malicious, criminal, or terrorist actions intended to cause damage or disruption to the system. It tends to be covert, perpetrated by intelligent adversaries who strive to work around existing safety and security measures. And it can be instigated by and inside attacker (e.g., a disgruntled employee) as well as external criminals or terrorists – and it is crime. Because of all this, additional protective strategies are needed to prevent intentional adulteration, thus the U.S. enactment of the IA Rule. Key requirements of the rule that are of critical importance to Canadian businesses are: Development, and periodic reanalysis, of a written Food Defense Plan which includes a vulnerability assessment to identify significant vulnerabilities and actionable process steps; mitigation strategies; and procedures for monitoring; corrective action and verification. Identification of at least one qualified individual who has the education, training, or experience (or a combination thereof) or has successfully completed FDA-recognized training qualifying him or her to complete #1. (Worldwide, there are only a limited number of individuals with specialized training to teach the “Intentional Adulteration Vulnerability Assessment Utilizing the Three Elements” approach, a course which is only available in person. TAG has two IA VA Lead Instructors on staff, Dr. Rolando Gonzalez and Christopher Snabes) Additionally, employees who work at actionable process steps (identified in #2) must have the education, training, and experience to perform their responsibilities, and all employees are to be trained in food defense awareness. Recordkeeping of training, food defense monitoring, food defense corrective actions, and food defense verification. As anyone knows who has written a Food Safety Plan, it can be a complex undertaking, and the same is true of the Food Defense Plan. However, there are a number of resources that can be of help. A thorough reading of the IA Rule itself is the first and most comprehensive step. FDA has published two of three intended volumes of a draft guidance document with more specific examples and approaches for compliance. The TAG/FPDI Intentional Adulteration and Food Defense Industry Preparedness Report provides some general aspects of the rule – and how U.S. companies are fulfilling it. TAG’s Food Defense Insights page provides a vast array of information on various aspects of the rule and food defense in general. Complying with SFCR can involve significant time and resources itself, so when a food company is also exporting its product to the U.S., requiring additional rule compliance, it can be nearly overwhelming. But it doesn’t need to be. Give TAG Canada a call today – with experts on both sides of the border, we are here to help. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com
