Code of Federal Regulations 21 CFR 117
The USA was Ireland’s second largest destination for agri food exports in 2021 with exports totalling approximately € 1.3 billion. This represents a 20% increase in value on 2020 figures and a 22% increase in volume. Irish agri food exports to the USA were valued at €521 million in 2012.
Understanding the USA regulatory system via their Code of Federal Regulations is key to gaining market access. The Food Safety Modernization Act which came into effect in 2011 was the first major overhaul of the US food safety system since 1938. The law applies to both domestic and foreign food facilities that produce human and animal food for the US market. One of the key legal requirements under subpart A, General provisions is the appointment of a Preventive Control Qualified Individual (PCQI). Within the regulation it defines the four key responsibilities of this position. It is very much a leadership role within an FBO and more often than not the Quality Assurance Manager or the Technical Manager assumes the role and responsibility.
A prerequisite of this role is a clear and concise understanding of the legislation. US CFRs are divided into subparts and once the logic of the structure is understood it makes communication to other qualified personnel and legal compliance much easier. There are 16 chapters in the programme curriculum (V1.2) for the PCQI role divided into three main elements as per the figure below.
The background (Chapters 1-5) delves very much into the provision of knowledge or content to the delegates regarding food safety plan layout, cGMP and types of hazards. Chapters 6-15 are delivered with regards to the context of a particular business with specific focus in Chapter 8 on hazard analysis. Chapter 16 addresses the specific requirements of the regulations (21 CFR 117) regarding the subparts.
The 16 chapters of the curriculum are designed to give a focus to food business operators as to where the most significant risks exist in their business and how to design appropriate preventive control measures to mitigate all reasonably foreseeable hazards. The programme also offers an insight into the US approach to modernizing food safety by making HACCP simpler and focusing on where “loss on control” can have the most significant consequences.
To find out more please check out : FSMA Preventive Controls for Human Food course (PCQI Qualification Course).