October 1 marks the start of the three-month period for the biannual renewal of registration with the U.S. Food & Drug Administration of both domestic and foreign food facilities.
Federal law requires domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. to register with the FDA. Failure to register is a prohibited act.
The Food Safety Modernization Act of 2011 updated the law to require that food facilities must renew FDA registrations whether or not any information regarding their facility has changed in the previous two-year period. Facilities are required to renew their registration between October 1 and December 31 – even if their initial registration occurred earlier in 2018.
Failure to register or renew registration may have civil and criminal consequences and likely will result in removal of the facility from the registration list, requiring a full re-registration.
The manufacturing, processing, packing or storage of food that may be consumed in the United States by humans or animals without a valid registration is also a prohibited act. Registration information is not subject to public disclosure under the Federal Freedom of Information Act.
Some facilities are exempt from registration including certain farms, retail food establishments, restaurants, nonprofit food establishments, fishing vessels and facilities regulated exclusively by the U.S. Department of Agriculture. However, there are details and nuances related to the application of these exemptions and they should be examined carefully.
If anyone has any questions on the registration requirements, please contact me at any time.