On May 27, 2016, FDA issued the FSMA final rule for Intentional Adulteration (IA). The 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.
While acts of intentional adulteration may be of 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 is addressed in the final Preventive Controls rule for human and animal foods.
Who is covered?
This rule is designed to primarily cover large companies whose products reach many people, exempting smaller companies. With some exceptions listed below, this rule applies to firms that are required to register with the FDA as food facilities under the Federal Food, Drug, and Cosmetic (FD&C) Act.
Very small businesses;
Holding of food, with the exception of food in liquid storage tanks;
The packing, re-packing, labeling or re-labeling of food where the container that directly contacts the food remains intact;
Activities that fall within the definition of “farm”;
Manufacturing, processing, packing, or holding of food for animals;
Alcoholic beverages under certain conditions;
Small and very small businesses that are solely engaged in On-Farm manufacturing, processing, packing, or holding of certain foods identified as having low-risk production practices. These foods include certain types of eggs, and certain types of game meats.
FDA understands that this rule is a first of its kind, so education and outreach is critical. FDA recognizes that many of the food facilities covered by this rule will also be meeting the requirements of other FSMA rules. Therefore, FDA is providing a longer timeline in the final rule for facilities to comply with the intentional adulteration rule.
Very Small Businesses: July 26, 2021
Small Businesses: July 27, 2020
Other Businesses (Not small or very small): July 26, 2019
A business (including any subsidiaries and affiliates) that averages equal to or more than $10 million (adjusted for inflation) per year, during the three-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee) AND that has more than 500 full-time equivalent employees.
The final rule, which is required by the FDA Food Safety Modernization Act, requires covered facilities to prepare and implement food defense plans.
The written food defense plan must include:
a vulnerability assessment to identify significant vulnerabilities and actionable process steps for each type of food manufactured, processed, packed or held at the facility;
mitigation strategies for identified actionable process steps;
procedures for food defense monitoring of the implementation of the mitigation strategies;
procedures for food defense corrective actions; and
procedures for food defense verification.
training and recordkeeping.
All food defense activities must be documented by the facility and would be subject to regulatory inspection.
Assistance to Industry
The agency intends to publish guidance documents to provide information relevant to the provisions of the final rule, such as conducting a vulnerability assessment, identifying and implementing mitigation strategies, and writing procedures for food defense monitoring, corrective actions and verification.
In an attempt to assist food facilities comply with the Food Defense Plan requirement, FDA identified four “key activity types” that FDA automatically considers significant vulnerabilities.
These activities are:
bulk liquid receiving and loading;
liquid storage and handling;
secondary ingredient handling; and
mixing and similar activities.
Instead of conducting its own vulnerability assessment, a facility can meet the requirements of the rule by addressing these key activity types to identify actionable process steps and develop its Food Defense Plan.
FDA has a number of tools and resources currently available on their website:
The Mitigation Strategies Database is an online, searchable listing of mitigation strategies that can be applied to different steps in a food operation to reduce the risk of intentional adulteration.
The FDA FSMA Food Safety Technical Assistance Network is already operational and provides a central source of information to support industry understanding and implementation of FSMA. Questions submitted online or by mail will be answered by information specialists or subject matter experts.
FDA’s Food Defense Plan Builder (FSPB) is a tool designed to assist owners and operators of food facilities with developing personalized food defense plans for their facilities. This user-friendly tool harnesses existing FDA tools, guidance, and resources for food defense into one single application.