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Are you prepared for the new requirements for safety of food imported into the US?

The United States of America Food Safety Modernization Act of 2011 (FSMA) has been implemented as a means to better protect public health. It adopts a modern, preventive, risk-based approach to food safety regulation.

Let Lucrima’s qualified team prepare your company for FSMA compliance and ensure your continued imports of food to the U.S. market. Learn more with our FSMA Explained online courses.


FSMA stands for Food Safety Modernization Act. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. The act is supported by seven rules and some guidance documents. The titles of the seven rules are:

  • Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food – the PC (preventive controls) for human food rule
  • Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals - the PC (preventive controls) for animal food rule
  • Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption – the Produce safety rule
  •  Foreign Supplier Verification Programs for Importers of Food for Humans and Animals – the FSVP rule
  •  Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications – the Third party accreditation rule
  • Sanitary Transportation of Human and Animal Food
  • Mitigation Strategies to Protect Food Against Intentional Adulteration – the Intentional Adulteration rule

Yes, if you intend to import food into USA you must control and verify your suppliers. There are some exceptions which apply, related with the facility size, the type of food you import and the level of the recognition of the country of origin food safety system.

Аs an importer you are obliged to control and verify the food safety programs of your supplier. According to the FSVP rule it is your obligation to:

  • Determine known or reasonably foreseeable hazards with each food, imported by you;
  • Evaluate the risk posed by a food, based on the hazard analysis, and the performance of your foreign supplier;
  • To approve suppliers and to determine appropriate supplier verification activities. This should be based on the risk analysis, related with the imported food and your performance as supplier;
  • Conduct supplier verification activities
  • Conduct corrective actions

So you have to cooperate actively with your partner (exporter) agent in terms of assuring that their food safety system will not jeopardize your business. You could provide them with support to build their food safety management system.

If you own or act as consignee of a food offered for import into the United States, you are importer. An importer can be also a U.S. agency or representative of the foreign owner of consignee at the time of entry, as confirmed in a signed statement of consent.

The requirements of this rule apply to businesses – either in the U.S. or any other country – that are required to register with FDA as food facilities because they manufacture and/or process, pack, or hold food for consumption in the U.S.

You must obey the FSVP rule. You should develop a Foreign Supplier Verification Program for each food you import and for each supplier you import from. The FSVPs should be based on risk analysis, the food and the supplier’s performance. These FSVPs should cover the supply chain of the food subject of import.

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