Let me start by defining the term “FSMA certification” (also known as “VQIP certification”) in this article as foreign supplier certification obtained under the FSMA Accredited Third-Party Certification rule. At the time of writing this article, the US Food and Drug Administration (FDA) has already recognized four accreditation bodies. Certification bodies can now apply to one of those recognized accreditation bodies to be able to offer accredited FSMA certification to foreign suppliers. If anything, this should send a clear message to the FSMA “skeptics” – a population that is shrinking in number – that FDA is determined to stay true to its mandate of applying the same level of scrutiny on foreign suppliers as US manufacturers. And, if you are a foreign food manufacturing facility supplying to the United States, it is time to upgrade your knowledge and make sure your Preventive Controls Qualified Individuals (PCQI) are also well versed on US food regulations.
What’s at stake?
Now that FSMA certification is a valid path through accredited certification bodies, it is highly probable that US importers will demonstrate interest in it. After all, foreign supplier FSMA certification is one of the eligibility criteria for US importers – to participate in the Voluntary Qualified Importer Program (VQIP). Importers would benefit from VQIP through expedited entry of food and reduced delays at the border. We get a lot of questions from US importers and foreign suppliers alike, asking for further clarification on the relationship between VQIP and FSMA certification, so I will try to elaborate further.
Whether a US importer chooses to participate in VQIP or not, would be their business decision to make. If an importer chooses to participate in VQIP, then they would need to have their foreign suppliers FSMA certified, among other requirements (see figure 1).
Therefore, there is a lot at stake for importers wanting to join VQIP and gain the advantages of the expedited entry program. Although some of the VQIP participation criteria are specific to importers, a lot however depends on how quickly their foreign suppliers can become FSMA certified.
What is expected from foreign suppliers?
It is important to note here that FSMA certification is not mandatory. As a foreign supplier, you are required to comply with the applicable US regulations, but certification is not a mandatory requirement. You can be compliant without being certified. But if expedited entry of the food you supply (and therefore VQIP) is a priority for your importer, then chances are your importer will ask you to get FSMA certification.
But even if not requested by importers, it may still be advantageous for foreign suppliers to obtain FSMA certification. After all, US importers – actual and potential – would be more likely to work with foreign suppliers who are compliant with FSMA, because that would allow them to apply for participation in VQIP without having to worry about their supplier being FSMA certified. Also, FSMA certification provides extra assurance to US importers and consumers alike, that the food manufactured at the certified facility has passed through a regulatory audit and is manufactured according to US FDA food safety standards.
Regulations, Regulations, Regulations
To date, there is certain level of confusion among foreign suppliers about whether third party certification (example GFSI) would qualify as FSMA certification. Others think that learning about the Preventive Controls rules and applying them (through a PCQI course for instance) are sufficient to build a compliant system. Unfortunately, those assumptions are not entirely true. FSMA is a US law based on US regulations, and unlike other third party voluntary schemes, FSMA certification is a regulatory certification. FSMA certification would be attained only through a regulatory audit, and therefore, foreign suppliers are expected to identify which US regulations apply to them and comply with those regulations.
The building blocks
Like every other certification program, training is key in learning about FSMA certification. In this case, it is highly advisable to have your facility management (or at least the PCQI) trained on US food regulations. This will facilitate your company’s certification journey and eliminate any possible confusion. Once your food safety team is equipped with the proper training and knowledge, they can then make sure the requirements of all applicable US regulations are in place.
The Power of Consultative Audits
As mentioned in my previous articles, FSMA certification starts with a consultative audit. This is really a valuable exercise for foreign suppliers wanting the full unannounced audit experience, but for internal purposes only, i.e. to assess how close they are to achieving certification. A consultative audit is not optional though. Any facility applying for certification, will have to undergo a consultative audit before the actual regulatory (certification) audit.
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For further information, please contact:
Global FSMA Program Director
t: +1 (201) 508 3000