Hogan Lovells 2024 Election Impact and Congressional Outlook Report
The new Preventive Controls for Human Food regulation issued by the U.S. Food and Drug Administration (FDA) under the FDA Food Safety Modernization Act (FSMA) is the most significant change to food regulation since the 1930s. FDA has started conducting inspections for compliance with the rule, both domestically and internationally.
The rule requires that key food safety management activities must be completed by a “preventive controls qualified individual” who has “successfully completed training in the development and application of risk-based preventive controls.” This requirement typically applies even if a company is located outside of the U.S., so long as it manufactures food for U.S. consumption.
Hogan Lovells attorneys Maile Hermida (Partner) and Xin Tao (Associate), both Food Safety Preventive Controls Alliance (FSPCA) lead instructors for this regulation, will present the training program developed by the FSPCA. This is the “standardized curriculum” recognized by FDA. Successfully completing this course is one way to meet the requirement to become “preventive controls qualified individual.”
Authored by Maile Hermida and Xin Tao.