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RCI Safety Analysis: Food Safety Modernization Act Review, Part 2

Date Posted: December 5, 2012

(New Registration Mandates)

This article is reprinted by permission from RCI Safety.

Under FSMA, who has to register and how often?

Food facilities that were required to register with FDA under the Bioterrorism Act of 2002 must renew their registration by December 31, 2012 and biennially thereafter.

Do any new types of food facilities have to register with FDA?

The same types of food facilities that were required to register with FDA under the Bioterrorism Act of 2002 (domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States) are required to renew their registrations; however, FSMA directs FDA to clarify the term “facility.”

A new definition of the term “facility” will be proposed as part of the rulemaking for the preventive controls regulation, a topic of future articles yet to be proposed by FDA.

What’s new about this registration?

Section 102 of FSMA amends section 415(a)(2) of the FD&C Act by requiring registrations to contain additional information, specifically:

• email address for the contact person at a domestic facility,

• email address of the United States agent for a foreign facility,

• assurances FDA inspectors will be provided access to the facility, and

• additional information regarding food product categories How do I register a food facility?

Registrants must use Form 3537 to register, update, or renew a registration.

Facilities may register online via the Internet at, which operates during business hours from 7:00 am to 11:00 pm U.S. Eastern Time.

Facilities may also register by mail or fax or for multiple submissions, by CD-ROM.

For more information, see:

Registration by Paper (Mail or FAX) or CD-ROM4

Online Registration

Is there a fee for registration?

There is no fee associated with initial registration, updating a registration, or renewing a registration.

Must I update my registration if there are changes at the facility?

The owner, operator, or agent of a facility must update the facility’s registration within 60 calendar days of a change if any of the required information submitted to FDA on form 3537 changes, except for a change in ownership.

If a facility has a new owner, the former owner must cancel the facility’s registration within 60 calendar days and the new owner must re-register the facility.

Can I use a third-party to register my food facility?

The owner, operator, or agent in charge of a food facility may authorize a third-party registrar to register, update, or cancel a registration on his or her behalf, except for cancellations caused by changes of ownership.

What happens if I fail to register?

Failure to register, update or cancel a registration is prohibited under the FD&C Act per 21 CFR Part 1.241 and your facility is subject to suspension.

For more information, call Joey Barnes, Environmental Services Manager, RCI Safety, 800-888-9596, ext. 217.

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