You are here: Home / Publications / FAPC Flash / 2016 / FAPC Flash - Food facilities must renew FDA facility registrations this year

Robert M. Kerr Food & Agricultural Products Center

FAPC Flash - Food facilities must renew FDA facility registrations this year

Food facilities required to register with the U.S. Food & Drug Administration must renew their food facility registrations this year during Oct. 1 through Dec. 31.

(Stillwater, Okla. – Nov. 21, 2016) Food facilities required to register with the U.S. Food & Drug Administration must renew their food facility registrations this year during Oct. 1 through Dec. 31.

“All food facilities are required to renew their registrations with FDA on each even numbered year,” said Jason Young, quality management specialist for Oklahoma State University’s Robert M. Kerr Food & Agricultural Products Center. “During this process, an establishment will not get a new number, but will keep the current registration number.”

Online renewal is available at www.fda.gov/food/guidanceregulation/foodfacilityregistration/default.htm.

“When the Food Safety Modernization Act took effect in January 2011, the aim of this act was to strengthen the food safety system through preventative control standards with processors and producers and improve the FDA’s response to food-related emergencies,” Young said.

The registration renewal process requires several pieces of information from the processors.

First, processors must create an account. The current registration number and PIN are not the account, so processors must create a new account.

The renewal process requires the email address for the contact person of the facility. A facility must guarantee FDA will be permitted to inspect the facility when needed.

Also, registrations must provide information about the categories of food a facility handles. These categories can be found at 21 CFR 170.3 or the guidance document for food facility registrations at www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm324778.htm.

FDA finds requiring food product category information, as part of a facility’s registration, is necessary for a quick, accurate and focused response to an actual food-safety related emergency, Young said.

“For example, if FDA receives information indicating ingredients for bakery products could be affected by a bioterrorist incident or other food related emergency, FDA is able to alert bakery manufacturers/processors, packers and holders about the incident,” he said.

A new facility must register before the facility begins to manufacture/process, pack or hold food for consumption in the U.S. If a facility registers before Oct. 1, 2014, the facility is still required to renew its registration during the registration renewal period.

Updates to a facility’s registration is required to be submitted within 60 calendar days of any change to the registration information by the operator.

The failure to register a facility, update required elements or cancel a registration in accordance with 21 CFR Part 1, Subpart H is a prohibited act under the FD&C Act.

FDA may suspend a facility’s registration if that facility has food that has reasonable probability to cause serious adverse health consequences or if that facility knowingly packed, distributed or held this product.

If a facility’s registration is suspended, food imports and exports from that facility must be stopped, as well as the introduction of food from that facility into interstate or intrastate commerce.

Exempted food facilities from the renewal process will remain unchanged and identified in the original Bioterrorism Act 2003 or CFR §1.226 Who Does Not Have To Register Under This Subpart?

FDA encourages online registration renewal as a cost-effective, quick and efficient means for food facility registration renewal. However, registration also can be completed by submitting the paper Form 3537 by mail or fax.

FAPC, a part of OSU’s Division of Agricultural Sciences and Natural Resources, helps to discover, develop, and deliver technical and business information that will stimulate and support the growth of value-added food and agricultural products and processing in Oklahoma.

- ### -

CONTACT:

Jason Young
Robert M. Kerr Food & Agricultural Products Center
102 FAPC
Stillwater, OK 74078
Phone: 405-744-6071
Fax: 405-744-6313
E-Mail: jason.young@okstate.edu

Oklahoma State University, U.S. Department of Agriculture, State and Local Governments Cooperating. The Oklahoma Cooperative Extension Service offers its programs to all eligible persons regardless of race, color, national origin, religion, sex, age, disability, or status as a veteran, and is an equal opportunity employer.