FDA Releases Compliance Guide for Small Businesses under FSMA Intentional Adulteration Rule (Food defense)

Small Entity Compliance Guides (SECGs) are designed to help small businesses meet federal standards. They are among the resources that the FDA is providing to support compliance with the new FDA Food Safety Modernization Act (FSMA) standards.

The FDA announced today the availability of an SECG to help small businesses comply with the Final Rule on Mitigation Strategies to Protect Food Against Intentional Adulteration (or Intentional Adulteration Rule), mandated by FSMA.

The SECG was prepared in accordance with the Small Business Regulatory Enforcement and Fairness Act. It provides nonbinding recommendations on such topics as developing a food defense plan and records management.

The compliance date for small businesses under the Intentional Adulteration Rule is July 27, 2020. Very small businesses are exempt from the rule, except for a documentation requirement described in the SECG, which has a compliance date of July 26, 2021.

Here you can find also an FDA fact sheet on the final rule on food defense.

The FDA Food Safety Modernization Act (FSMA) final rule is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. Such acts, while not likely to occur, could cause illness, death, economic disruption of the food supply absent mitigation strategies.

Rather than targeting specific foods or hazards, this rule requires mitigation (risk-reducing) strategies for processes in certain registered food facilities.

The proposed rule was issued in December 2013. The changes in the final rule are largely designed to provide either more information, where stakeholders requested it, or greater flexibility for food facilities in determining how they will assess their facilities, implement mitigation strategies, and ensure that the mitigation strategies are working as intended.

In developing the rule, FDA interacted with the intelligence community and considered vulnerability assessments conducted in collaboration with the food industry.
While acts of intentional adulteration may many other forms, including acts of disgruntled employees or economically motivated adulteration, the goal of this rule is to prevent acts intended to cause wide-scale harm. Economic adulteration, on the contrary,  is addressed in the final preventive controls rules for human and animal foods.

We already treated food defense topic in a previous post regarding EU situation.

FDA Recognizes Australia as Having a Comparable Food Safety System to the U.S.

The U.S. Food and Drug Administration has signed an arrangement with the Australian Department of Agriculture and Water Resources recognizing each other’s food safety systems as comparable to each other. This is the third time that the FDA has recognized a foreign food safety system as comparable, the first being New Zealand in 2012 and Canada in 2016.

By recognizing each other’s systems, the FDA and Australian Department of Agriculture and Water Resources have confidence that they can leverage each other’s science-based regulatory systems to help ensure food safety. For example, each partner intends to consider the oversight of the other when prioritizing inspection activities, but the benefits go beyond inspection and admissibility. Systems recognition establishes a framework for regulatory cooperation in a variety of areas that range from scientific collaboration to outbreak response.

Systems recognition involves reviewing a foreign country’s domestic food safety regulatory system to determine if it has a food safety system that provides a similar system of food safety protection to that provided by the FDA. Domestic systems provide the baseline level of public health protection that helps assure the safety of exported foods from that country. Systems recognition also helps the FDA focus more on potential risks when planning the scope and frequency of its inspection activities, including foreign facility inspections, import field exams, and import sampling.

The FDA, working with Australian Department of Agriculture and Water Resources, conducted a systems recognition review and assessment using the International Comparability Assessment Tool. The process includes a comprehensive review of key elements of the country’s national food safety control system such as its relevant laws and regulations, inspection programs, response to food-related illness and outbreaks, compliance and enforcement and laboratory support.

Systems recognition is voluntary and not required in order for a country to export foods to the U.S. The FDA continues to have inspection authority over food imported from any country with which it has an arrangement and can exercise this authority as needed. Imports from Australia must continue to comply with U.S. statutory and regulatory requirements to ensure safety and proper labeling, including the new standards adopted under the FDA Food Safety Modernization Act.

For more information see:

(Source: FDA website)