The U.S. Food and Drug Administration (FDA) issued amendments to federal regulations pertaining to the registration of foreign and domestic “food facilities.”
Some of these changes, published July 14, were mandated by the Food Safety Modernization Act
(FSMA). Others amendments were included to enhance the accuracy of FDA’s food facility database—thus better positioning the agency in case of a public health emergency—and to effectively schedule routine compliance inspections.
Specifically, food facility registrants are now required to;
provide an email address for the facility contact person or the U.S. agent for a foreign facility,
- renew food facility registration every two years (Oct. 1 to Dec. 31 of even years), and
- attest to assuring that the FDA will be permitted to inspect the facility at the times and in the manner permitted by the Federal Food, Drug and Cosmetic Act.
In addition to the above changes, FDA food facility registrants will now be required to:
identify the type of activities conducted at the facility for each food product category (effective July 14, 2016)
- submit registration/re-registration electronically to FDA (effective Jan. 4, 2020), and
- utilize a Unique Facility Identifier (UFI). UFI’s are intended to assist FDA in identifying specific food facilities and verify certain registration information for those facilities (effective in the registration renewal period beginning Oct. 1, 2020).
Many of these noted amendments to the food facility registration regulation became effective on July 14, as they were self-implementing when FSMA was signed into law. This means that these changes will be in effect when the new food facility registration period commences from Oct. 1 through Dec. 31, 2016. A reference guide to other compliance dates for FSMA
major rules can be found at pma.com.
Re-defining Retail Food Establishments
Importantly, FDA has revised the definition of "retail food establishment" by amending Title 21 §1.227 of the Code of Federal Regulations. This is important because enterprises that meet the FDA definition of “retail food establishments” are not subject to mandatory “food facility” registration requirements and therefore not subject to the FSMA Preventive Controls for Human Foods Rule
. Specifically, FDA has made it clear that “retail food establishments” include:
the sale of food products or food directly to consumers by such establishment at a roadside stand or farmers’ market where such stand or market is located other than where the food was manufactured or processed;
- the sale and distribution of such food through a community supported agriculture program; and
- the sale and distribution of such food at any other such direct sales platform as determined by the U.S. Secretary of Health and Human Services.
It is also anticipated the FDA will be publishing draft Guidance to Industry on these changes to the food facility registration process and specifically regarding the generation and use of UFIs.
FDA will also be hosting a free webinar
on Aug. 3 to review and answer questions regarding these amendments to federal regulations pertaining to the registration of “food facilities.” Registration for the webinar is not required.
: Final Rule under FSMA to Update Food Facility Registration
: Wednesday, Aug. 3
: 11 a.m.–noon ET / 8 a.m.–9 a.m. PT
: 1-888-790-1729 or 1-517-308-9034 (international) passcode: 7205856
Submit Questions to FDA Re: Food Facility Registration:
Food Facility Registration Help Line
: 800.216.7331 or 301.575.0156 (international)