The FDA recently published information answering two frequently asked questions:
QUESTION: 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?
ANSWER: 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.
QUESTION: Will food facilities already registered with FDA under section 415 of the FD&C Act be required to renew their registrations during the October 1 – December 2012 registration renewal period?
ANSWER: Yes! All facilities that are required to register must renew their registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year. The first registration renewal cycle will be held from October 1 to December 31, 2012. Registrants are required to submit registrations to FDA containing the new information added by section 102 of FSMA. As new requirements and guidance go into effect related to facility registration renewal, FDA will post the information on this FSMA website.
As always, more information may be found at: Food Safety Modernization Act – FAQ Page