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The new Food Safety Modernization Act and its rules coming into force now


The U.S. FDA Food Safety Modernization Act (FSMA) and its rules coming into force. FSMA aims to ensure the U.S. food supply is safe by shifting the focus from responding to food safety incidents to preventing them. FSMA directs the Food and Drug Administration (FDA) to adopt a modern, preventive, and risk-based approach to food safety regulation. FDA regulates products produced in FDA registered facilities.

Why European companies need to pay attention to the US FSMA Regulation

The FSMA legislation sets requirements to facilities that produce, manufacture, pack or hold food, intended to be distributed into the USA. There are two types of facilities - domestic and foreign facilities. The FSMA and the related foundational rules are obligatory for both types of “facilities”.

The 7 foundational rule of FSMA are:

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

The act

U.S. Code

Title 21 “Food and drugs”

Chapter 27 “Food and safety modernization” or FSMA

Foundational rules

PC Human food

PC Animal food

Standards for Produce Safety

Foreign Supplier verification

Third Party Audit

Food Safety Audits and Certification Rule

Sanitary transportation

 intentional adulteration

Guidances for Industry

  • CGMP, HARPC for Human Food;  
  • Voluntary Qualified Importer Program
  • Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards




Major differences brought by FSMA:

Hazard Analysis and Risk Based Preventive Controls

A different HACCP methodology called Hazard Analysis and Risk Based Preventive Controls guides the facilities to adopt a robust and pragmatic approach to hazards and preventive measures that may require a serious reshape of HACCP plans even in the European based exporting companies;

The Preventive Controls Qualified Individual, often seen as acronym PCQI:

An individual or group of individuals responsible for the preparation of the Food Safety Plan who have successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system.

The paved way to proving your knowledge, understanding and implementing of FSMA requirements is to attend a PCQI course. The recognized courses certify the participants as Preventive Controls Qualified Individuals and assure registration in the database of the Association of the Food and Drug Officials (AFDO) easily accessible to the FDA and US importers.

Supply chain program and supplier verification:

Both the preventive controls rules and the Foreign Supplier verification program rule demand an end-to-end supply chain program to be developed and adopted. The rules literally require from facilities and importers to develop and implement a supply chain program for each hazard and each product in their extended supply chain. The “end-to-end” or “extended” supply chain covers the direct suppliers, the suppliers of the suppliers; the customers and the customers of the customers of the facility.

The supply-chain requirements, although familiar in Europe through EU legislation and international standards, demand from US domestic facilities and exporters to the US to extend and detail the scope of their hazard analyses and introduce risk based preventive controls measures over their internal and external supply chain.

Importers responsible to verify the compliance of their suppliers now

Another game changer of the US regulation is the obligation of importers in the US to assure that the products they import from foreign companies is safe. With the new Foreign Supplier Verification Program Rule coming into force on the 27th May 2017 the importers are directed by FDA to establish supply chain programs and to introduce a series of verification activities e.g. supplier audits. 

The article was prepared by Vladislava Zapryanova, Lucrima BV


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