On July 14th, the U.S. Food and Drug Administration (“FDA”) published a final rule amending the food facility registration requirement originally implemented under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.  The final rule includes a number of changes that are designed to improve the accuracy of the food facility registration database.  It also amends the retail food establishments definition, expanding the number of establishments that are considered retail food establishments and, therefore, exempt from the registration requirement pursuant to 21 C.F.R. § 1.226.

Under Section 415 of the Federal Food, Drug, and Cosmetic Act, food facilities that manufacture, process, pack, or hold food for consumption in the United States are required to register with FDA. More specifically, a domestic registrant is now required to provide an e-mail address for the contact person at its facility and  a foreign facility registrant must provide the e-mail address for the U.S. agent for its facility.  Registration renewals must be completed every two years, and facilities must provide assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the Federal Food, Drug and Cosmetic Act.

Additionally, the final rule adds a few new requirements intended to improve the food facility registration database:

  • as of July 14, 2016, registrations are required to contain the type of activity conducted at the facility for each food product category;
  • all food facility registrations are required to be submitted to the FDA electronically by January 4, 2020; and
  • food facilities will need to provide a unique facility identifier (“UFI”) as part of the registration process beginning October 1, 2020.

The amended regulations also permit registrants to submit a written waiver request explaining why it is not reasonable to submit the registration, registration renewal, updates, or cancellation to FDA electronically or to explain why it is not reasonable to provide the required e-mail address contact information. An abbreviated registration renewal process is now available for registrants who do not have any changes to the required information since submission of their proceeding registration or renewal.
Continue Reading FDA Amends Food Facility Registration Requirements

On November 13, 2015, the U.S. Food and Drug Administration (FDA) finalized and released several new rules related to food safety. The new rules primarily deal with produce farm safety standards and with imported foods. They account for three of the FDA’s seven rules implementing the Food Safety Modernization Act. Previously, the FDA released rules on preventive controls both for human food and animal food. Still to be released are rules on sanitary food transportation and on protecting food against intentional adulteration. Below is a summary of the three newly released rules.

Produce safety. For the first time, produce growth, harvesting, packing, and holding will be subject to minimum federal safety standards. This rule refines the FDA’s 2013 proposed rule on produce safety and takes into account comments from businesses concerned about the financial burden of new regulations. The grace period for compliance varies depending on the size of the produce farm, with larger farms having less time to get in compliance. Several items addressed by the rule include:

  • Water quality and testing – The FDA has created criteria for water quality and is mandating testing of water for E. coli at frequency levels based on the water’s source.
  • Raw manure and compost – The rule sets limits on detectable amounts of certain bacteria in compost. It also establishes that raw manure on organic fields may continue to be used up to 90 days before harvest.
  • Sprouts – The FDA includes specific requirements for sprouts as they have recently been the subject of illness outbreaks and are considered especially susceptible to dangerous bacteria.
  • Animals – Farms are not required to exclude animals from growing areas, but standards are now in place for grazing animals, working animals, and intrusion by wild animals.
  • Cleanliness – The rule puts requirements on produce worker hygiene and also requires training for the same. In addition, the rule sets standards on equipment, tools, and buildings to prevent produce contamination.

Continue Reading FDA Finalizes Rules on Produce Farms and Imported Foods