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.

Food defense requirements in EU?

During the next meeting of the ENVI Committee (Committee on Environment, Public Health and Food Safety of the EU Parliament), on 27-28th February, there will be an extremely interesting exchange of views with the EU Commission about the food defense topic.

This is a very very preliminary step and no specific initiative at EU level at the moment is foreseen, but for sure it could be a starting point in that sense.

Here below an extract from the ENVI Committee report, explaining where do we stand now:

“Food defense means the protection of food from intentional contamination or adulteration by biological, chemical, physical, or radiological agents. It includes measures regarding prevention, protection, mitigation, response and recovery from intentional acts of food contamination.

The WHO, in 2007, identified intentional food contamination as one of the main global health threats of the 21st century and stated that food has become an instrument for terrorist attacks.

In the European food industry, food defense is a rather new concept, unlike in the USA where the concept of food defense originated and where it is extensively regulated. In the past years, incidents such as terrorist attacks and food fraud have contributed to the development and implementation of food defense systems in at least some Member States.

In the aftermath of the terrorist attacks in 2001 in the US, the “Health and Security Committee” was set up in the EU. This group was given a formal status and assigned specific tasks in 2013, when Decision 1082/2013/EU on serious cross-border threats was adopted. At global level, the Commission also participates in the Global Health Security Initiative on CBRN (chemical, biological, radiological and nuclear) threats, working closely with the WHO and the G7+ states to create a global strategy for preparedness and response to potential health threats.

However, there is no comprehensive regulation of food defense at EU level. In view of the rising importance of the issue, the objective of this exchange of views is to discuss existing EU and Member State policies and to hear the Commission’s point of view in relation to possible EU action in this area.”

(Source: ENVI Committee, European Parliament)