The FDA Food Safety Modernization Act (FSMA) added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) several new sections that reference intentional adulteration. For example, section 418 of the FD&C Act (21 U.S.C. 350g) addresses intentional adulteration in the context of facilities that manufacture, process, pack, or hold food, and that are required to register under section 415 (21 U.S.C. 350d).
The rule, which includes the requirements for food defense measures against intentional adulteration, and related requirements, can be found in 21 CFR part 121. It requires a qualified individual for evaluating intentional adulteration at food processing plants.
So who is affected by this? Larger businesses (including any subsidiaries and affiliates) are those that employ at least 500 full-time equivalent employees and whose sale or market value of human food during the previous three-year period average at least $10 million (adjusted for inflation). These larger businesses were required to comply by July 26, 2019. Small businesses, which employ fewer than 500 full-time equivalent employees, are required to comply by July 27, 2020. Very small businesses, or those whose sales or market value of human food during the previous three-year period average less than $10 million, are exempt from most of the requirements, but starting July 26, 2021, upon request they must provide documentation to show that they meet the exemption. The IA rule applies to the owner, operator, or agent in charge of a domestic or foreign food facility that manufactures/processes, packs, or holds food for consumption in the United States and is required to register under section 415 of the FD&C Act, unless one of the exemptions provided in 21 CFR 121.5 applies.
Cornell Course Offering to Meet the Requirements
This course will provide participants with the knowledge to implement the requirements of conducting a vulnerability assessment under the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) regulation of the U.S. Food and Drug Administration (FDA).
This course developed by the FSPCA is the “standardized curriculum” recognized by FDA; successfully completing this course is one way to meet the requirements for a “food defense qualified individual” responsible for conducting a vulnerability assessment.
Date: September 21, 2021
Time: 8:15 AM – 4:30 PM
Location: Stewarts Processing Plant, Building 2, 461 Church St, Saratoga Springs, NY 12866
Cost: $650
Registration link: https://cals.cornell.edu/dfe-fsma-intentional-adulteration
