On January 4, 2011, the Food Safety Modernization Act (FSMA) was signed into law and the U.S. Food and Drug Administration (FDA) gained significant new authorities. Among other things, the FSMA made a number of changes to FDA Food Facility Registration authority. These provisions are effective on July 4, 2011 or sooner, if FDA issues a regulation implementing the provision. Read to the end of this blog because there are two other provisions that will intersect with the registration provisions in dramatic ways, particularly for foreign food facilities and their U.S. Agents!
First, FDA now has the authority to require food facilities to renew their food facility registrations bi-annually. The food facility registration was originally a one-time registration unless changes that would require an update occurred at the facility. This new biannual FDA food facility registration must occur during October-December of even-numbered years, thus it does not go into effect until October 2012.
Second, when registering a food facility with FDA the registrant must provide an email address for the contact person of the facility.
Third, when registering a food facility with FDA, the owner, operator or agent in charge must consent to being inspected by FDA.
Fourth, FDA now has the authority to suspend a facility’s registration if FDA believes there is a “reasonable probability” that food from the registered facility will cause serious adverse health consequences or death to humans or animals and that the facility was responsible for the “reasonable probability”. There is a provision for FDA to set up an appeals process, but FDA will be investigator, prosecutor and judge. So it will be critical for facilities receiving a notice of suspension to act very quickly. If FDA suspends a food facility’s registration, that facility cannot import or introduce food into interstate commerce.
Finally, FDA is given the authority to refuse admission to foods processed by a foreign food facility that refuses (or delays in granting permission of) an FDA inspection! So consenting to an FDA inspection will have some teeth to it. Additionally, if a foreign facility is inspected and its conditions are so bad that FDA has to come back and re-inspect it to make sure the corrections are made, then the foreign facility is required to pay FDA’s fees for performing the re-inspection. FDA can collect that re-inspection fee from the foreign food facility’s U.S. Agent!
This is going to get expensive. But you can be prepared and compliant with someone showing you the way through at www.FDAImports.com.
– Benjamin L. England, Founder
