FDA registration of food facilities: What we know now

09/27/2012 07:11:00 AM
Tom Karst

National Editor Tom KarstThe topic of the FDA (re)registration of food facilities is drawing some notice in the trade, since Oct. 1 marks the start of a new registration period.  The FDA's page explaining the specifics of the registration process is found here.

The FDA's website includes a summary page of total registrations, by country and state, and another page describing registrations by type of operation.

Another FDA Frequently Asked Questions summary page talks of what new wrinkles the Food Safety Modernization Act brings to the registration process and is found here. Unfortunately, some guidance to the industry on registration of food facilities has been held up in rulemaking and is not yet available. What the FDA does say is found on the FAQ page.

Some excerpts from that page:

Frequently Asked Questions on Registration and Registration Renewal

IC.3.1 When does a facility need to start biennial re-registration if it is required to register with FDA under FDCA §415? 

FSMA amended FDCA §415 to provide that facilities required to register will have to re-register every 2 years, during the period beginning on October 1 and ending on December 31 in even numbered years. This will first occur in October-December 2012.

IC.3.2 What are other key provisions relating to compliance? 

The legislation provides FDA authority to suspend a facility’s registration under certain circumstances, which would prevent that facility from introducing any food into commerce in the U.S., including importing or exporting food into the U.S. It also provides more flexibility for FDA in using its administrative detention authority to keep potentially adulterated or misbranded products from entering the marketplace.

IC.3.12 Does the Food Safety Modernization Act require a food facility to submit additional information to FDA in order for the facility to receive a food facility registration number?
Yes. Section 102 of FSMA amends section 415(a)(2) of the Federal Food, Drug, and Cosmetic Act by requiring food facilities to submit registrations to FDA containing additional information. Specifically, registrations are required to contain the e-mail address for the contact person of the facility, or for a foreign facility, the email address of the United States agent for the facility, and an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. Additionally, if determined necessary by FDA, registrations are required to contain information regarding other applicable food categories, as determined appropriate by FDA, for foods manufactured/processed, packed, or held at registering facilities.


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Ray Webb    
USA  |  September, 27, 2012 at 05:11 PM

When every food handler has to register with FDA with all their facilities and food categories, there will be a traceback/traceup of contaminated food possible by an anticipated participation of 100% within 3 months. Every registered facility will have some type of identification code. I assume a buyer will probably ask for the code in order to be on the safe side in case of an event. The good part for the whole food industry is the FDA’s code is free. If I see it correct, the expensive GTIN number is more useless then ever as it was only created to run the checkout faster in some stores and do heavy benchmarking with the captured data in the barcode. The data captured in this barcode is not required by FDA as everybody can find out, during the registration process.

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