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FAQ Exporters to the US

Here we provide answers to your most frequently asked questions.

FSMA stands for FDA 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 export food to USA. There are some exceptions which apply, related to your company size, the type of food your export and the level of the recognition of your country’s food safety system.

It is your customer, based in the USA. The importers are obliged to apply the so called Foreign Supplier Verification Program over their supplier, hence over you.

It is necessary but definitely not a sufficient condition. To comply with FSMA you need to have established a food safety management system. This system should be verified by your US based partner (the importer or the agent). As long the importer must comply with the US food related laws, they have to be confident that the food they import from you will not jeopardize their business.

Importers (your customers) will be required to conduct certain risk-based activities on your business, to verify that the food imported into the United States (supplied by you) has been produced in a manner that provides the same level of safety as that required of domestic food processors and produce farms.

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 it 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 FDA recognized 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.

Successful completion of the PCQI training courses, the curricula of which has been prepared under the supervision of FDA, is the first thing to be done. Then you and 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 have 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, packing, or the holding of 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.

It is a duty of the importer, potentially your customer on US soil or an importing agent, to verify your ability to supply food, which conforms with the FSMA and the respective rules and requirements. So you have to have established a food safety management system and a written food safety plan. You also must have properly trained PCQI.

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 a Guidance document which lies as the base 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.

If you don’t have reliable food safety system and if you don’t obey the rules, most probably you will fail to be verified, so you wouldn’t be able to export food to USA. Even if your company is certified for compliance with GFSI recognized standard, due to some differences between the requirements of FSMA and the standards, recognized by GFSI, it is still possible to fail the verification process.

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 as well as controls other than those at CCPs that are appropriate for food safety.

As long your agents or importers are interested with the level of the food safety you provide, it is advisable to keep them informed on your progress. This will increase their confidence with you. 

FSVP which stands for Foreign Supplier Verification Program is one of the seven rules, specified by 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 re-evaluated every three years.

As long you are exporter from a country outside of the USA and you are not importer in the terms of FSVP and FSMA. Therefore, you are not subject to this and the other seven rules. But your customer, the US based importer is subject to the program. And their obligations are strongly related with you.

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.

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