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The FDA Food Safety Modernization (FSMA) Act of 2011 is a food safety system that focuses on preventing contamination rather than primarily reacting to problems after they occur.

 

The FSMA rule for Importers of Food for Humans and Animals, called Foreign Supplier Verification Programs (FSVP), has been made final by the FDA, and the first compliance date begins on May 30, 2017.

 

The FSMA FSVP rules apply to domestic (USA) food producers and those in other countries who export to the USA (foreign suppliers), for facilities that manufacture/process, pack, and hold/store human and animal foods, and also set standards for produce grown on farms.

FSVP & FSMA

Unless exempt or subject to modified requirements, the FSMA FSVP rules also apply to any importer who is a U.S. owner, consignee, or a U.S. agent/representative of the foreign owner/consignee of the food offered for import. Identifying the FSVP importer is required when filing for entry with U.S. Customs and Border Protection using a unique facility identifier (UFI) recognized as required by the FDA.

Purpose of Requirement

FSVP requires importers verify that their suppliers are producing food using processes and procedures that:

  • Offer the same level of public health protection as the preventive controls (PC) requirements in the preventive controls and current good manufacturing practices rules for human food and animal food and produce safety FSMA rules,

  • The food is not adulterated, and

  • The food is properly labeled with respect to allergens.

7 Key Requirements
  • Scope - Details who is bound by the program and the actions they must take under it

  • Hazard Analysis - importers must evaluate and identify any potential hazard that require control such as biological, chemical and physical hazards.  
    - Biological Hazards: Parasites and Disease-causing bacteria 
    - Chemical Hazards: Radiological Hazards, pesticides, natural toxins, and drug residues
    - Physical Hazards: Glass, and things along that line.

  • Evaluation of Food Risk and Supplier Performance

  • Supplier Verification -  vetting suppliers

  • Corrective Actions - actions taken to address if a foreign supplier is not maintaining a certain standard of public health protection.

  • Exemptions and Modified Standards

  • Unique Facility Identifier - Importers must provide a UFI recognized as acceptable by the FDA for each line of food they wish to import into the US.

 

Compliance Dates

The dates for compliance for the Foreign Supplier Verification Programs (FSVP) are based upon the size of the foreign supplier and the regulations applicable to the foreign supplier.  FSVP requires importers to verify that their foreign suppliers of food for human and animal consumption adhere to and meet FDA safety standards. Importers must comply six months after their foreign supplier has to be in compliance with the PC or produce safety rules.

 

In keeping up with the modern supply chain requirements and before they are imported into the U.S., FDAeasy.com provides help for ensuring that foreign-made products are in compliance with the many complex regulatory requirements. In addition, FDAeasy.com can guide our clients to better understand the importation process and also assist with obtaining required permits, certifications, licenses, and approvals.

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