F O O D S A F E T Y M O D E R N I Z A T I O N A C T F A Q S
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Frequently Asked Food Safety Modernization Act Questions
-Cited from FDA.gov
On April 8, 2013 the FDA released some frequently asked questions on Registration and Registration Renewal. The following is taken directly from the FDA www.fda.gov/Food/GuidanceRegulation/FSMA/ucm314178.htm?source=govdelivery and represent some of the questions.
IC. 3.1 Does FSMA require a food facility to submit additional registration 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 FD&C Act by requiring food facilities to submit registrations to FDA containing additional information. Specifically, a registration for a domestic facility is 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. All food facility registrations are required to contain an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act.
IC.3.2 Will food facilities already registered with FDA under section 415 of the FD&C Act be required to renew their registration?
Yes. All food facilities that are required to register with FDA under section 415 of the FD&C Act must renew their registrations with FDA, every other year, during the period of time beginning on October 1 and ending on December 31 of each even-numbered year.
IC.3.3 Has the scope of who is required to register under section 415 of the FD&C Act changed?
No. At this time, the same types of food facilities that required to register with FDA under section 415 of the FD&C Act before FSMA are required to register with FDA and renew such registrations.
IC.3.5 What form do I use to renew a food facility registration?
Registrants must use Form 3537 to register, update, or renew a registration. Facilities may register online via the Internet at www.fda.gov/furls
IC 3.8 Is there a fee for registration, updating a registration, or renewal of registration?
No
IC. 3.9 Do new food facilities need to wait until October 1st to register?
No. The owner, operator or agent in charge of a facility that
Begins to manufacture/process, pack, or hold food for consumption in the U.S. on or after December 12, 2003 must register before the facility begins such activities (21 C.F.R. 1.230)
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