New Requirements for Registration of a Food Facility under the Food Safety Modernization Act
On Jan. 4th, 2011, the Food Safety Modernization Act (“FSMA”) was signed into law in an effort to enable FDA to better protect public health by strengthening the food safety system. The FSMA amends the Federal Food Drug and Cosmetic Act to give FDA new tools and authorities to monitor and inspect food importers and food facilities as well as to enforce the new requirements of verification and certification of applicable imported foods, with an overall goal of improving food safety. Under the Act, some of the new tools at FDA’s disposal include surveillance authority, detention of imports, suspension of food facility registrations and mandatory recall authority.
Expanding on the food facility registration requirements contained in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the FSMA requires additional information be submitted to FDA in order for the food facility to receive a registration number. While the new registration requirements are only one aspect of the FSMA, it is important that food facilities know how and when they must register and what information will be required. Dietary supplement manufacturers are considered food facilities and these registration requirements are expected to lead to an increase in inspections across the country. Below is an excerpt from the FDA’s Food Safety Modernization Act Frequently Asked Questions, which can be found at: http://www.fda.gov/Food/FoodSafety/FSMA/ucm247559.htm#registration
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.
IC.3.13 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?
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. For more information on Food Facility Registration, please visit the FDA’s Food Facility Registration page14.
IC.3.14 What form do I use to renew a food facility registration?
Registrants must use Form 3537 to register, update, or renew a registration. Form 3537 is being updated to meet registration renewal needs. The next registration renewal cycle begins October 1, 2012. Facilities may register online via the Internet at www.fda.gov/furls, which operates during business hours from 7:00 am to 11:00 pm U.S. Eastern Standard Time.
IC.3.15 Am I required to renew a food facility registration online?
No. Registrants can renew food facility registrations online or submit the paper Form 3537 by mail or fax. A business with multiple facilities may also register on a CD-ROM by mail. FDA encourages online registration as the least costly, quickest, and most efficient means for food facility registration. With online registration, a food facility must enter all of the required information before the system will accept the submission. After all required information has been entered, a registrant will receive confirmation of registration and a registration number. Paper registration is a more costly and less efficient process to supply FDA with registration information and to provide food facilities with their registration numbers. Further, paper registration may have a higher number of errors or omissions on the form, which may require additional time to complete the registration process.
IC.3.16 Why wait until October 1, 2012 to start the registration renewal process?
The FDA Food Safety Modernization Act (FSMA) mandates that all food facilities that are required to register must renew their registrations every other year during the period beginning on October 1st and ending on December 31st of each even-numbered year. The first registration renewal cycle will occur from October 1 to December 31, 2012.