FDA Proposes New Amendments on FSMA Registration Requirement for Food Facilities

food lowThe U.S. Food and Drug Administration announced amendments of the Food Safety Modernization Act (FSMA) related to the requirements that facilities engaged in manufacturing, processing, packing, or holding food for consumption must register those facilities with the FDA.

Here are the provisions as stated in the FDA announcement:

  • Registrations for domestic facilities must contain the email address of the contact person at the facility, and registrations for foreign facilities must contain the email address of the U.S. agent for the facility.
  • Food facilities that are required to register with FDA must renew their registrations every two years, between Oct. 1 and Dec. 31 of each even-numbered year.
  • All food facility registrations must contain an 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.
  • In addition, the proposed rule would add certain new requirements that would improve the food facility registration system. For example: All food facility registrations would be required to be submitted to FDA electronically (although this requirement would not take effect before Jan. 4, 2016). Registrations would be required to contain the type of activity conducted at the facility for each food product category.
  • The proposed rule would provide for measures to verify certain information submitted in registrations.

These requirements include warehouse logistics organizations engaged in mixing and repackaging or even simply storing and labeling food products. FDA has issued a public comment period starting on April 9. IWLA is thoroughly reviewing these provisions. Stay tuned.

FSMA Public Meeting: Focus on Implementation of Food Safety Strategy
The FDA is organizing a public meeting April 23 & 24 to discuss the administration’s planning efforts for the next implementation phase of the Food Safety Modernization Act (FSMA). This involves putting in place the prevention and risk-based safety standards at the core of FSMA. Learn more.

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