intentional adulteration
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Answer:
Intentional Adulteration
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.
Exemptions:
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.
Compliance Dates
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
Very small businesses are exempt and this date is the date of compliance with exemption requirement for having documentation to show that the facility meets the exemption.
Small Businesses: July 27, 2020
Small businesses are those businesses (including any subsidiaries and affiliates) employing fewer than 500 full-time equivalent employees.
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.
Key Requirements
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: