FDA's Food-Facility Registration Deadline Is Just About Here. Are Your Prepared?
By Laurel Maloy, contributing writer, Food Online
FSMA amends the requirements for food-facility registration; facilities must complete registration before the end of the this year
The Food Safety Modernization Act (FSMA) is still a work in progress, but one of its first changes was the requirement for food-facility registration. Amending section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), section 102 of FSMA publishes the relevant mandate. The registration requirements are also published in the U.S. Code, Title 21, Chapter 9, Subchapter IV, § 350d. The change applies to all foreign and domestic manufacturers, processors, packers, and holders of food for both human and animal consumption.
Under FSMA, beginning Oct 1, 2014 and ending Dec 31, 2014, those facilities required to register with the FDA must do so. The FDA has three different guidance documents designed to assist with the registration process. According to the FDA, these documents supersede previously released versions:
- Guidance For Industry: Necessity Of The Use Of Food Product Categories In Food-Facility Registration
Food categories are defined in 21 CFR 170.3 and necessary to proper FDA registration. Updated in 2012, this FDA guidance document combines all aspects of the aforementioned federal codes and regulations. It is also in line with section 305 of the Public Health Security and Bioterrorism Preparedness Act of 2002 (Bioterrorism Act)
This guide answers 5 questions: (1) Is my facility required to register? (2) Is my facility exempt? (3) How often must my facility register? (4) Where and how can I submit my facility’s registration? (5) By what authority and when can the FDA suspend a facility’s registration? This guide was updated in 2012 in order to include the amendments to FSMA.
This guidance document answers the most frequently asked questions regarding FDA registration for food facilities.
The FDA has also published an information page for Startups and Small Entities to clear some of the confusion associated with facility registration. First, if you are a new owner, the previous owner is required to cancel its FDA registration within 60 calendar days. You are also required to re-register the facility, notifying the FDA of the change in ownership and providing updated information. Additionally, if you registered or updated your facility registration this year prior to Oct 1, 2014, you must still register again during this open registration period. The FDA Industry Systems Help Desk can be contacted at furls@fda.gov, or you can call (800) 216-7331, toll free in the U.S. Foreign facilities can call (301) 575-0156 for additional information.
FDA guidance documents do not confer or create any rights and do not bind the FDA or the public. These documents only represent the agency’s current thinking on a given topic and are suggestions as a means to compliance. As long as your facility’s methods satisfy the applicable lawful regulations and statutes, it is acceptable. In the event you have questions, the title page of each guidance document has contact information.