October 13, 2019

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What is a ‘”Qualified Individual” under FSVP?


With respect to the PackagingLaw.com article, FDA Recognizes Canada’s Food Safety System as Comparable to U.S. Allowing Modified FSVP Requirements, does a “qualified individual” need to meet the same qualifications as a Preventive Controls Qualified Individual (PCQI)? Also, is a third party audit required?


In the United States, a Preventive Controls Qualified Individual (PCQI) is defined under the Food Safety Modernization Act’s (FSMA) preventative controls regulations. Importantly, the definitions of a PCQI and a “qualified individual” under FSMA’s Foreign Supplier Verification Programs (FSVP) are different. In a draft guidance on the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals, FDA defined a “qualified individual” (i.e., someone who can develop and perform activities required under FSVP) as:

“a person who has the education, training, or experience (or a combination of these) necessary to perform an activity required under the FSVP regulation, and can read and understand the language of any records that the person must review in performing this activity…. A qualified individual may be, but is not required to be, an employee of the importer; you might also rely on non-employees such as a consultant or a third-party auditor. A government employee, including a foreign government employee, may be a qualified individual.”

With respect to food packaging, however, FDA announced on January 4, 2018, that it does not intend to require importers of food-contact substances to comply with the requirements of the FSVP.

© 2019 Keller and Heckman LLP


About this Author

PackagingLaw.com is the premier online resource for the global packaging industry. It provides a wide range of information on laws and regulations—both in the U.S. and other countries throughout the world—that affect packages and packaging materials. PackagingLaw.com features news articles on current issues affecting the packaging industry, in-depth features, an Ask an Attorney section, links to packaging industry and government websites, and detailed information on the U.S. Food and Drug Administration (FDA) Food Contact Notification system.