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FAQ Importers into the US

Here we provide answers to your most frequently asked questions.

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.

VQIP or Voluntary Qualified Importer Program provides the importers with easier and faster procedures to import food into the USA. For instance FDA will limit examination and/or sampling of VQIP food entries to “for cause” situations (i.e., when the food is or may be associated with a risk to the public health). The FDA will attempt, to collect samples at the VQIP food destination or other location preferred by the VQIP importer.

You can benefit if you import food, produced by certified foreign facilities.

This is a foreign facility (production site, farm), which is certified by a certification body, accredited directly by FDA, or accredited by accreditation body, recognized by FDA.

You will be able to import foods as long you follow the requirements as stated by FSMA even if you are not eligible for VQIP.

You can join the program if your suppliers (actually their facilities) are certified. So they have to maintain their status of companies certified by certification bodies, complying with the VQIP.

FSMA concerns the food safety management system, employed by the food producer, it is based on the HACCP and GMP principles as well as the food safety standards. So they have a common base, but some differences exist. For instance, the HACCP decision tree, the emphasis on the supply chain, and the further increased emphasis on the prevention. A good starting point on the requirements, are the Preventive Controls for human and animal food rules.

It is a necessary but definitely not a sufficient condition. To comply with FSMA your supplier must establish a food safety management system. This system should be verified by you as the importer. You have to be confident that the food you import from abroad will not jeopardize your business.

Each facility covered by FSMA, must prepare a written food safety plan as a part of their food safety management system. The person (or persons), whose duty is to prepare and implement or at least to oversee the preparation and implementation of the food safety plan is the Preventive Controls Qualified Individual (PCQI). A PCQI is someone who has successfully completed certain training in the development and application of risk-based preventive controls or is otherwise qualified through job experience to develop and apply a food safety system.

To attend the PCQI training courses, the curriculum of which has been prepared under the supervision of FDA, is the first thing to be done. Then you and the other PCQIs in your company should start the development and implementation of the written food safety plan, which will lay the basis of the food safety management system.

There are some people already who have similar duties, who can act also as PCQI, these are:

  • QA Directors and Managers
  • QA Supervisors
  • Operations Managers
  • SQF/BRC/IFS etc. practitioners and Auditors

These individuals should has successfully completed training on the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA.

In addition, these individuals should have the education, training, or experience in manufacturing, processing, pack, or hold clean and safe food.

Also they have to have received training in the principles of food hygiene and food safety, employee health and personal hygiene. 

GFSI stands for Global Food Safety Initiative, an organization providing guidance on food safety management systems necessary for safety along the supply chain. GFSI provides Guidance document which lies the basis for recognition of food safety management schemes and standards. Some of the food safety standards, recognized by GFSI are, SQF, IFS, BRC, FSSC 22000. As long the standards, recognized by GFSI, provide quite strong requirements for the food safety systems, and companies, have a FSMA PCQI and conform with these standards then they will have a very strong basis to be verified as conforming with the FSVP rule.

HACCP, which stands for Hazard Analysis and Critical Control Points is a general methodology for providing food safety during the food production. The FSMA requirements are based on the HACCP requirements, but they extend it and provide stronger basis for its implementation. The requirements of FSMA emphasize preventive control, by extending it throughout the supply chain. Additionally, requirements, which specify food safety requirements as related to transportation and intentional adulteration, are developed.

The idea of HACCP is to provide prevention through control in the Critical Control Points, while the FSMA preventive controls include controls at CCPs or controls other than those at CCPs that are appropriate for food safety.

FSVP which stands for Foreign Supplier Verification Program is one of the seven rules, which specifies the FSMA. It defines the obligations of the importers to control and verify the ability of their non-US based suppliers. The verification activities, should be based on the risk posed by the food, on the hazard analysis, and the foreign supplier’s performance. Importers are required to develop, maintain and follow a separate FSVP per food brought into the United States and per foreign supplier of that food. The risk should be reevaluated every three years.

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