In defence of the FSMA regulations – New Food speaks to Lucrima

Posted: 20 March 2017 | Vladislava Zapryanova | Managing Director | Lucrima | 1 comment

New Food asked Lucrima for an insight into why a comprehensive understanding of the current FSMA regulations is so important…


Now that the FDA Food Safety Modernization Act (FSMA) is the law of the land, it is essential for food processing plants to have plans and procedures in place that fully comply with the new rules and regulations.


New Food asked Vladislava Zapryanova, Managing Director at Lucrima for an insight into why a comprehensive understanding of the regulations is so important…

  1. Why are the regulations so key?

FSMA (the US Food Safety Modernization Act) is the first major change in US food safety regulations for several decades and it radically alters the game for US food companies. Apart from this it further drives change over the global supply chain for a number of reasons.

  • First of all, because at least 15% of the food consumed in the US is imported (and this percentage grows with a steady pace every year) – the FSMA regulation affects currently around 150,000 companies worldwide.
  • Secondly, as a big portion of the international food companies (both retail and manufacturing companies) is US based, the requirements will eventually be transposed over the whole global supply chain of those big international players affecting those suppliers that export to the US but also those that don’t.
  • Third, FSMA introduces a systematic preventive approach to food safety. In this way it conveys the same message which has been communicated by a number of regulatory initiatives and private standards around the globe making this message even stronger.
  1. What do exporting companies need to know about the regulation?

I need to start by paying respect to all those companies who have come far in ensuring food safety by following regulations and standards for a number of years now. In some parts of the world, like in the European Union (but not only) the concept of systemic preventive control for food safety has been introduced long ago and is well established.

But let’s also consider the fact that the food supply chain is getting more complex and this poses greater challenges to food safety. In this regard a new regulation can be considered as a reconsideration of existing circumstances that provides for the adoption of new and more efficient approaches to manage food safety.

I would now like to give an example on how FSMA leverages this kind of approach:

One of the predominant aspects of the regulation is the requirements related to management of the supply chain. In 3 of the 7 Foundational rules (those on Preventive Controls for Human Food and Food for Animals, and the Foreign Supplier Verification Programme) the regulator has stressed upon the importance of the supply chain and explicitly defined control measures encompassing the extended supply chain of food operators.

Entities are charged with the ultimate responsibility to place safe products on the market taking care of the products they receive, manufacture and ship. But they are also given the freedom to choose between different tools for prevention – within their own processes, or their supplier processes. Food facilities are also given the option to communicate and settle food safety responsibilities with their customers.

The supply chain related requirements of FSMA fosters a dialogue among food companies and their suppliers and customers…

In order to be able to utilise those preventive control options companies need to extend and detail their hazards analysis as to cover all products and process steps of their extended supply chain. Entities also need to undertake communication and verification activities towards their customers and suppliers in order to prove that the assumptions they have made in their analyses and preventive control systems are correct.


The supply chain related requirements of FSMA fosters a dialogue among food companies and their suppliers and customers on which preventive controls need to be undertaken to manage food safety in the most effective way. In this way the process steps interfacing the different entities in the supply chain are covered from both sides, between which may appear gaps of responsibility between buying and supplying companies and are very often the place where food safety incidents find their roots.

By eliminating responsibility gaps, FSMA gives greater assurance that hazards and risks are managed more efficiently across the entire supply chain.

One of the predominant aspects of the regulation is the requirements related to management of the supply chain…

Having in mind the above, we consider that the proactive approach to implementing the regulations will be key. Exporters are supposed to find their way in integrating FSMA requirements into their food safety management systems that already comply with other regulations and standards. As this might be a laborious process and because deadlines are approaching fast (the deadline for large manufacturers that export to the US has passed on 19th March 2017), we advise exporters to proactively identify the FSMA requirements applicable to their products and operations and get acquainted with possible ways to implement them.

The easiest and most efficient way for companies outside the US to do this is to attend a training course for preventive controls qualified individuals which follows a standardised curriculum recognised as adequate by FDA for such a training.

The next step for exporters would be to start implementing the requirements and broker a dialogue with their customers (those that import the food in the US and those that process it further or place it on the market) as to what type of preventive measures given the specific hazard analyses will be considered appropriate. In parallel to that exporting companies need to start the hazard analyses of the products/ingredients supplied to them and establish a supply-chain programme encompassing all supplied products for which a known or reasonably foreseeable hazard has been identified.

  1. What is the biggest challenge we currently face in food safety?

Lack of full transparency throughout the supply chain. Otherwise said, the level of transparency is not the same because the players in the supply chain have different perception and hence different commitment to food safety.

This is a problem because the food supply chain is getting more and more globalised and complex. Inevitably the majority of products we consume on a daily basis contain ingredients brought from different parts of the world. It is not only about taste, it is also about efficiency and costs. Buyers are pressed to buy from different sources and regions and that’s perfectly fine. But then comes the challenge – to assure that the way the food is produced or manufactured meets the expectations of the consumers and regulators of the market of destination.

  1. How might this be resolved?

We need to work towards alignment of our understanding and commitment to food safety. A lot has been done in the past 15 years. Initiatives like the GFSI and others do make a difference in the efforts to align the understanding of the different food operators around the globe. We need also to face the fact that commitment to food safety requires efforts and resources. This inevitably exerts pressure on the cost price of food products and the end price for consumers. It takes time to progress while managing the expectations of all stakeholders.

The food supply chain is getting more and more globalised and complex…

Something that will definitely speed up the progress further is the adoption of more efficient ways of managing and building the capacity of the global supply chain for food safety through technology and new business models. 

  1. What is Lucrima most excited about in 2017?

We are excited that in 2017 we can take our message to a broader number of companies around the world. We are excited about the change in regulations embodied by the FSMA because such changes create opportunities to drive transparency further in order to build trust. When we build trust we can foster business.

We are fascinated with the opportunities the food operators from different geographies have to be part of the global supply chain nowadays. What needs to be clear to all players is that opportunities always come with certain responsibilities and commitments.

  1. Imagine we are having this conversation in March 2018 – what will have changed in food safety?

I believe that in one year from now a broader number of companies would have embraced the concept of alignment in food safety as beneficial to them and will have undertaken their journey towards transparency by working on both their internal processes and their supply chain.

Find out more about Lucrima by clicking here…

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One response to “In defence of the FSMA regulations – New Food speaks to Lucrima”

  1. Dr Kumar says:

    Indeed very informative article to read and understand to implement for global compliace

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