Food Safety News – the latest on food safety legislation, food safety standards and food safety news

Unannounced FDA Audits of foreign manufacturing facilities

On May 6th 2025 the FDA announced the expanded use of unannounced inspections at foreign manufacturing facilities that produce food and medicines intended for American consumers and patients.

“For too long foreign companies have enjoyed a double standard – given advance notice before facility inspection, while American manufacturers are held to rigorous standards with no such warning. That ends today. This is a key step for the FDA as part of a broader strategy to get foreign inspection back on track” said FDA Commissioner Martin A Makary M.D., M.P.H.

The FDA news release announced that “In addition, the FDA will evaluate its policies and practises for improvements to the foreign inspection program to ensure that FDA is the gold standard for regulatory oversight. These changes will include clarifying policies for FDA investigators to refuse travel accommodations from regulated industry including lodging and transport to maintain the integrity of the oversight process.”

According to the FDA, “while US manufacturers undergo frequent, unannounced inspections, foreign firms have often had weeks to prepare, undermining the integrity of the oversight process.” Despite this advanced warning to foreign firms, the FDA states that they still found serious deficiencies twice as often with foreign than domestic firms.

Following an inspection, the agency evaluates the inspection findings to determine if the facility is in compliance with applicable laws and regulations.

The three classifications are :

  • No action needed
  • Voluntary actions indicated
  • Official action indicated

“this expanded approach marks a new era in FDA enforcement  – stronger, smarter and unapologetically in support of the public health and safety of Americans.” – FDA.

For an Irish FBO it is essential to understand the FDA approach to auditing. Knowledge of the CFRs is a must. Each subpart within the CFRs is logical and strategic. Subpart A –  Knowledge and Context, Subpart B –  GMP/ Environment, Subpart C – Process and Product. They have an overwhelming focus on the product you produce and the environment where it is made. Their single-minded focus on the “reasonably foreseeable hazard” that can adversely affect the health of the American is both logical and refreshing. Food Safety Culture is a much utilised phrase at the moment but it can be distilled down to “how one thinks and behaves”. The FDA want to assess how you think, is it aligned with the way they think and let’s go down your factory floor to assess your behaviours.  The zoning and sanitation of your premises is paramount.

“the zoning of your premises is essential to the harmony of your process and manufacture of your product for the well-being of the American.”

“the zoning (GMP – Subpart B) of your premises is essential for the harmony of your process (Subpart C) and manufacture of the product (micro criteria) to ensure the well-being of the Americans.”

USFDA Regulation Part 117 Food Safety Modernization Act (FSMA).

The training curriculum for the FSPCA preventive control for human food programme has been updated to its second edition October 2024. Version 2. The update should enhance the curriculum’s effectiveness in preparing PCQIs to oversee food safety practises within their organisation. The five main reasons for the curriculum update are:

  1. Regulatory change
  2. Emerging risks
  3. Technological advancement
  4. Feedback from individuals
  5. Enhanced focus on implementation

FSMA was signed into law in 2011 with the aim of ensuring a safer food supply in the USA with the focus on prevention. There were nine foundation rules in total with rule 1 – preventive control for human food (PCHF) being the one of most relevance to the Irish food export sector.

The new curriculum is quite similar to the previous one. There are still 16 chapters however some of the data pertaining to foodborne illnesses and hazards has been updated as has the case study. One welcome addition to the manual under chapter 6, hazard analysis for human food, has been the inclusion of QR codes. These codes give access to additional FDA resources pertaining to common process and facility related hazards. As the basic concept behind the entire regulation is ‘Hazard Control’ these resources are invaluable.

As risk based thinking is becoming the key tool in all risk management systems, food safety, H&S, environmental etc. a clear understanding of hazard evaluation is paramount. In this regard, how probability or likelihood is measured in relation to occurrence of a hazard in the food is the single most important consideration. The FSPCA approach in this regard is refreshing and should open the eyes of many a multinational. The FSPCA statement on page 6-57 of the curriculum “likelihood may vary among facilities” is very insightful. Many FBOs particularly multinationals often calculate likelihood based on frequency of occurrence including all sites in their organisation. This in my view is not logical as the level of risk in your site cannot be determined by what someone else does wrong in their facility. This is old, illogical thinking and needs to change. If you are interested in becoming a qualified PCQI or if you are already qualified but want a refresher on the new curriculum see this link.

‘Building a Culture of Food Safety…..’

The Food Safety Authority of Ireland (FSA) has just launched it strategic document for 2025-2029.  Its key aims are :

  • Building a Culture of Food Safety
  • Improving Food Safety within a risk analysis framework
  • Leading a robust Food Safety control system
  • Continuing to drive organisational excellence

All four aims can apply to the FSAI itself, the competent authorities who report to them and the FBOs, be they manufacturing, retail or catering.  The challenge with the four aims may be the understanding and interpretation of what is Culture, how do you do the risk analysis and how do you measure organisational excellence?  These ideas or concepts are ambiguous at best so clarity and guidance are essential. As Food Safety Culture is now enshrined in EU law under 2021/382 it is a “must” and not a nice to have.  The strategy document defines the four goals of the FSAI as :

  1. Advocate and engage
  2. Reduce Risk
  3. Enforce Food Law
  4. Drive organisational excellence

Within each of the goals are defined objectives, deliverables and outcomes. 
As the principle goal of the FSAI is Food Safety legislation enforcement via the network of official agencies through a system of service contracts, the vision, purpose, defined values and goals of this strategy document will be communicated to the relevant bodies.

The key learning for FBOs from the strategy document will be to have a clear understanding of how to communicate their own Food Safety Culture and risk management processes to the competent authority.

An FBO having undertaken a Food Safety Culture survey will no longer suffice.  Food Safety Culture has to be much more meaningful than that.  This is where the PAS 320:2023 standard may be of benefit for FBOs who want to progress to levels 3,4 & 5.  PAS 320:2023 gives us a definition of Food Safety Culture which is always a great starting point for any improvement process.

Correctly engaging with the competent authority demonstrating how your FBO is reducing risk to an acceptable level via its Food Safety Culture endeavour, thus ensuring legal compliance and driving improvement is in my view the new expectation of the FSAI.

International Food Recalls 2024

Food recalls in 2024 across Europe, the US, and the UK, are expected to surpass 2023 levels, with a noticeable rise in incidents. Analysis of RQA Group’s latest recall data reveals that prepared dishes, pasta, and noodles are among the most affected food categories. The main hazard driving these recalls is microbial contamination, with Salmonella surpassing Listeria monocytogenes as the primary cause. Additionally, issues related to allergen labelling have been increasingly reported, which has also contributed to the growing number of recalls.

In the US, data published by the FDA reveals a steady increase in recalls for baked goods, cereals, and dairy products in the first quarter of 2024. However, noodles, pasta, and prepared dishes reclaimed the top spot as the most recalled food category. Compared to Listeria, the percentage of products recalled due to Salmonella has significantly increased. In the first half of this year, Salmonella accounted for 50% of product recalls, compared to 30% in 2023.

In the UK, allergen-related labelling errors have been the leading cause of food recalls in 2024, accounting for 23% of events so far. Listeria contamination ranks second, responsible for 10% of recalls. During the first half of this year, recalls for meat and meat products, nuts, seeds, snacks, non-alcoholic beverages, fruits, and vegetables have increased significantly.

In July and August of 2024 recalls in Ireland (via FSAI alerts) have been due to the presence of Salmonella, Listeria monocytogenes and the possible presence of metal pieces and glass amongst other things.

The Rapid Alert System for Food and Feed (RASFF) identified this year’s recall figures to date as being the highest in the last five years, making it a record high.

To prevent recalls, adopting risk based thinking is essential, along with conducting thorough root cause analysis after an event. The better the risk based thinking, the less likely it will be that a root cause analysis (RCA) will be needed. Food business operators must ensure that their leadership teams are well-trained and competent in this subject matter. 

The Latest in Food Safety Culture

A strong culture of food safety involves a commitment from everyone within an organization, from CEO to shop floor operator, to uphold food safety standards. This includes paying close attention to hygiene, cleanliness and adherence to established food safety regulations and guidelines, such as the Commission Regulation 2021/382 and the new PAS 320:2023 standard. 

What is food safety culture? 

Food safety culture refers to the ‘shared values, beliefs and norms that affect mindset and behaviour towards food safety in, across and throughout an organisation’.

Food safety culture improvement demands that the organization must have a well-defined strategy that outlines what will happen, who will take on leadership roles, how new skills will be acquired, and most crucially, how everyone will be involved on a daily basis.

Why is food safety culture important?

Developing and maintaining a mature food safety culture has a direct impact on consumer health, industry reputation, and regulatory compliance. Commission Regulation 2021/382, which legally mandates that an FBO must provide evidence of a food safety culture, places greater expectation on the organization and its leadership team.

Building a strong food safety culture

Establishing best practice food safety culture within your organisation requires;

  1. Training & education
  2. Leadership commitment
  3. Continuous improvement
  4. Effective communication
  5. Employee involvement

Interested in finding out more? Register for the Food Safety Culture webinar June 21st 2024. This session will provide an overview of the requirements and stages for developing a mature food safety culture within your organization, helping ensure compliance with current legislation and industry standards.

For more information on Food Safety Programmes visit https://www.sqt-training.com/programmecats/food-safety/

Food Safety Modernization Act and PCQI Qualification

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).

Food Defence

“Food defence is the effort to protect food from acts of intentional adulteration or tampering” (FDA).

FDA has a leading role in a number of food defence initiatives to protect food from acts of intentional adulteration or tampering and to assist facilities to prevent, prepare for, respond to and recover from acts of intentional adulteration of the food supply.

In Europe food business operators have adopted TACCP & VACCP to address food authenticity and malicious contamination concerns with PAS 96 : 2017 being the most widely adopted specification being used.  This specification defines the six threats and with economically motivated adulteration EMA (authenticity) and malicious contamination being the two of most prevalence.  The motivation behind both is human behaviour, one to fraudulently gain a monitory benefit and the other to cause harm or disruption.  As many Irish food business operators are now exporting to both the EU and USA its important that members of the TACCP/VACCP Team are familiar with the ideas and concepts in both PAS 96:2017 and the FDA Guidance document on mitigation strategies to protect food against intentional adulteration.

The BRCGS Food Safety Standard Issue 9 has redefined its approach to the food defence topic with a greater expectation for team members to understand threat assessment and how appropriate controls can be put in place.

Validation of the elements of a Food Safety Management System

BRCGS Food Safety Standard Issue 9 looks very similar to Issue 8 at a glance however when one probes a little deeper the changes are quite significant. One of these is Validation of a HACCP or Food Safety Plan and/or pre-requisite programmes.

As Validation is not one of the seven HACCP principles and not a legal reference in the EU (it is in the USA), it has always been a challenging concept. We are good with Verification but not with Validation. Validation is proof that something can work and Verification is proof that something is working.

All Food Business Operators with GFSI Certification will have their CCPs and maybe oPRPs validated however what about the PRPs? Clause 2.74 of the BRCGS Food Safety Standard Issue 9 is a new clause “to emphasise that the control of specific hazards needs to be validated where the control is achieved via a pre-requisite or a control measure other than a CCP.” It further states that “it is not a requirement for all PRPs to be validated, only those designed to control a specific hazard.”

The final interpretation can be quite difficult. It is easy to apply to cleaning as it does control a specific hazard however what about the other 14 PRPs?

The most important issue when approaching Validation is that you have a clear methodology that you will follow and a standard reference document. Be it DQ, IQ, OQ, PQ & MQ or perhaps a more basic Part I and Part II approach as advocated by the FSIS.

Food Safety Management Systems have evolved significantly over the past 10 years from a shelf based manual to a comprehensive understanding at factory floor level by production and maintenance personnel. Validation and Risk Based Thinking is now where leadership and understanding is required by Technical and Quality Assurance Managers to lead their food safety teams through these challenging concepts.

What’s new in BRCGS Food Safety Standard Issue 9

(Update to Standard Published August 2022 – Certification Commences February 2023)

There is more to the changes in the BRCGS– Food Safety Standard Issue 9 than initially meets the eye.  The prescriptive nature of BRCGS standards is still there however it is quite cleverly insisting on non-technical / quality personnel, namely – engineering, maintenance, senior management supply chain and HR playing their part in the management of the FSMS.

As was to be expected, the Food Safety Culture is being further emphasised via Section 1 Senior Management Commitment.  This combined with the new legal Food Safety Culture requirement as of March of this year (EU Notice 2021/382) makes this a topic that must be fully embraced. 

In HACCP the need to validate PRPs is a new addition which will undoubtedly cause a bit of concern or perhaps confusion.  CCP validation is relatively straight-forward however ‘validating pre-requisite programmes that control food safety hazards’ is challenging, 

Section 3 changes including supplier approval and performance plus CAPA all need careful consideration.  As CAPA is a fundamental clause, the approach an FBO adopts to the new requirements requires consideration.  My advice is that the same CAPA approach cannot be adopted for everything.  A specific approach for issues that arise in 2nd & 3rd party audits, competent authority findings is best separated from the more mundane issues that arise on a day to day basis.

In Section 4 the approach to food defence and authenticity needs careful planning.  There is a greater focus on competency for those who undertake threat assessments.  I believe that an FBO now needs the TACCP / VACCP Team to be as well trained and skilled as their HACCP Team. 

Section 4.6, equipment has got a complete rewrite.  You will need your engineering manager or maintenance manager to really step up here.  If they are familiar with DQ, IQ, OQ and PQ Validation methodology of equipment you will be fine, if not there is work to do.

In clause 5, product authenticity, claims and chain of custody, there is a greater expectation with regards to vulnerability assessment of raw material with the need for the team to have a greater understanding of food fraud risk.  Section 5.9 regarding Animal Primary Conversion is brand new however the majority of slaughter FBOs have little to fear from it as it is relatively straight-forward. 

Changes to Section 6 and 7 are relatively minor in nature.  Section 8, Product Risk Zones as always needs careful reading.  The Map of the site “shall include the location of pathogen control step’ and there are new clauses regarding cross-contamination control during CIP.

If Clause 9, traded product is within your scope there is a new requirement regarding possession of HACCP Plans.

The audit possibilities have been changed with three options :

  1. Option 1, announced on-site audit
  2. Option 2, blended, announced audit
  3. Option 3, unannounced on-site audit

Overall I think the changes to BRCGS Food Safety Standard Issue 9 are very good for the average FBO’s Technical or Quality Manager.  It is driving the Food Safety Culture message and requires other departments and their responsible managers to demonstrate their knowledge, understanding and commitment to the production of safe food.

Learn More

Food Safety News Spring 2022 – Food Safety Culture

What is the purpose of (EU) 2021/382 and what are the implications?

Food Safety Culture

The newly published commission regulation (EU) 2021/382 amending regulation 852/2004 requires all food business operators to establish, maintain and provide evidence of an appropriate food safety culture.  This legal requirement is a new departure as culture can be quite a subjective matter.  To those of us working in Food Safety we are more accustomed to more measurable criteria such as micro 2073/2005 Chapter 1 & 2 or time x temperature parameters.  Before attempting to address food safety culture one must first understand what culture is.  Why does a group of people form a society with their own culture? Societal culture has five main elements to it.  All cultures have core values, be they music, language, sport, religion etc.  Around these values they perform rituals to help protect, grow and foster these values for themselves and the next generation.  These rituals must be performed by responsible leaders within that society helping to cement and protect the cultural identity.  If you belong to that culture you must then accept the behavioural standards within that society.  The behaviour of the individual within that culture or society is to protect and uphold the core values.  If this behaviour is not within the acceptable norms then the culture can be damaged.

The models above represent the culture model in general society and within a food business operation.

All Food Business Operators must establish and document what their core values are.  Procedures must then be established that protect these values.  These processes are to be implemented under the leadership of a responsible person which all leads to brand protection and potential growth.  The prescribed behaviour is the critical measurement of behaviour as one definition of culture is “what we do when no one is looking.”

To help implement the Food Safety Culture objective, food business operators need to adopt the Plan, Do, Check, Act Risk Management Framework so that the process can be planned, implemented and monitored which will ultimately drive the continuous improvement that is needed.

SQT’s Food Safety Culture One Day Training workshop explores the aforementioned tools to assist Food Business Operators develop a strategic plan to ensure compliance with regulation EU 2021/382.

Next Public Course 24th March 2022 (also available in-house)