Weekly Compliance Digest - FDA Food Facility Registration Rule

July 22, 2016

In this edition of the Weekly Compliance Digest, we provide an update on a new rule that is part of the U.S. FDA’s implementation of the Food Safety Modernization Act (FSMA).

FDA Amendments to Food Facility Registration Requirements

What is it?

Last week, the U.S. Food and Drug Administration (FDA) announced that it finalized a rule as part of the implementation of the Food Safety Modernization Act (FSMA) to improve the accuracy of the food facility registration database.

The Amendments to Registration of Food Facilities final rule updates the FDA’s food facility registration requirements to better protect public health by requiring additional registration information that aims to improve the accuracy of the food facility registration database for facilities both in the U.S. and abroad. The FDA says that the final rule will support the agency’s efforts to act quickly in response to food-related emergencies and will help the FDA to use its inspectional resources more efficiently.

Who is affected?

The final rule affects U.S. and foreign food facilities that manufacture, process, pack or hold food for consumption in the U.S.

What are the requirements?

The final rule adds new provisions to the current regulations to codify certain provisions of FSMA that were self-implementing and effective upon enactment of FSMA. Those provisions include:

  • Registrations must include an email address for the contact person of a domestic facility or U.S. agent for foreign facilities.
  • Renewal of registrations every two years between October 1 and December 31 in even-numbered years (e.g. 2016, 2018, 2020, etc.)
  • All food facility registrations must contain an assurance 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.
  • Effective immediately, i.e. prior to the October-December 2016 biennial registration renewal period, registrations are required to contain the type of activity conducted at the facility for each food product category.
  • All food facility registrations will be required to be submitted to the FDA electronically as of January 4, 2020.
  • Food facilities will need to provide a unique facility identifier (UFI) as part of the registration process as of October 1, 2020.

The final rule also amends the definition of a “retail food establishment” in a way that expands the number of establishments that are considered retail food establishments, and that are therefore not required to register with the FDA as food facilities. The expansion of the definition would include, for example, sales directly to consumers at roadside stands and farmers markets. However, all food establishments, including retail food establishments, continue to have a responsibility to ensure their food is safe, the FDA says.

What is next?

The final rule was published in the Federal Register on July 14, 2016 and will be effective on September 12, 2016. However, the requirement for electronic registrations will take effect only on January 4, 2020, while the requirement to provide a unique facility identifier (UFI) as part of the registration process will apply only as of October 1, 2020.

The FDA will host a webinar on August 3, 2016 on the final rule at 11am-12pm Eastern.

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