2020 has been a challenging year. In March we started state by state lock downs to reduce exposure to the COVID virus and many food service businesses closed their door temporarily as banquets, caterers, schools, and restaurants were closing. Unfortunately, some of our food service partners are closed permanently. Retail food businesses thrived in this new environment as children were home schooled, people started working remotely and most of us stayed at home and some retail food suppliers reported record earnings and growth this year. As we adapted, so did the regulators. The FDA auditors began a sweeping trail of electronic audits, predominantly focusing on the Foreign Supplier Verification Program Rule under the Food Safety Modernization Act (FSMA). We heard from large and small companies alike, with a variety of commodities being audited from various global regions. Surprisingly, not all these companies were familiar or aware of their obligations under the rule. I want to take a few minutes to reflect on why we have this rule, who is responsible, and what you must do to be compliant. When we think about food in the 21st century, food travels across oceans, across borders and provides us with the year round produce and products we enjoy. As a US regulator of food, the FDA is tasked with ensuring these imported commodities are safe for consumers; but how do you secure public safety with tons of food crossing our borders and entering our ports 24 hours a day? It’s an impossible task. FSMA was signed into law in 2011, giving the FDA more authority and the food industry more clarity in expectations to ensure our food supply is maintained to US standards. Keep in mind, certain practices which have been outlawed in the US, still may be used in other parts of the world; and the history of adulterated products entering the global supply chain has resulted in fatalities. The FDA would need an army of inspectors to validate the safety of all food entering the US, which they do not have, so the solution is accountability of the importer. If you import product into the US and you are the owner, consignee or importer, then you are responsible to ensure its safety and compliance with US standards.

Who is covered by the rule?

Are you an importer as defined under 21 CFR part 1 subpart L? Are you the U.S. owner or consignee of an article of food that is being offered for import into the United States? Or, if there is no U.S. owner or consignee at the time of U.S. entry, are you the U.S. agent or representative of the foreign owner or consignee at the time of entry? There are several exemptions to the rule: access the FDA’s cheat sheet.

What to expect during an FSVP Inspection

When you receive an email from the FDA regarding your import, they will include several documents.

  • Request for FSVP Records (Form 482d) - This form will indicate if records are to be inspected in person or electronically.
  • Final Rule Attachment
  • Key Requirements
  • Import records for specific supplier/commodity to be audited

A mistake that most importer make is they send the import record to the FDA. The FDA already has copies of your import records, they were referenced in the initial email to you. We also heard from several companies whose initial response to the email was to contact the auditor to understand what documentation was needed by them. The FDA auditor will not provide you with specific paperwork and control of hazard requirements. It is your responsibility since imported commodities may have different hazards associated with the geographic region including, water quality, manufacturing plant design, manufacturing processes, personal health and hygiene, growing practices, pesticide usage, additives and colorings, etc.

What the FDA is looking for is records that support your FSVP, such as:

  • FSVP Standard Operating Procedure (SOP) Step-by-step instructions to carry out routine and consistent verification of supplier’s operations and management of risks associated with the food. The goal of the SOP is to achieve efficiency, quality output and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations. The SOP should include supplier approval/denial standards and recordkeeping requirements and may include workflows and diagrams.
  • Hazard Analysis and Risk-Based Preventive Controls Plan for the commodity of import The process of collecting and interpreting information on hazards and conditions leading to their presence to decide which are significant for food safety and should be addressed in the HARPC plan.
  • Evaluation documentation Evidence supporting the evaluation of the food hazards and practices in place to ensure the food is safe and produced under US, or equivalent, standards.
  • Qualifications of person performing the evaluations The FDA requires a “Qualified Individual” to evaluate, review and approve or deny the supplier. Per the FDA “A preventive controls qualified individual is someone who has successfully completed certain training in the development and application of risk-based preventive controls or is otherwise qualified through job experience to develop and apply a food safety system.” Follow the link above to read more about the training.

FDA issuance of warning letters

If the FDA deems that you have not complied with the regulation, they have the ability to issue a warning letter, below is an excerpt from a letter issued by the FDA to a company who imported a sauce which resulted in illness from Salmonella contamination: “You should take prompt action to correct the above violations. If you do not promptly correct them, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of food that you import. Our inspection revealed that you were not familiar with FSVP requirements, and without evidence of corrective action we may conclude that you appear to be in violation of FSVP requirements for all food that you import. If you do not promptly correct the above violations, we may place food that you import on Detention Without Physical Examination (DWPE) when you import the products.” The FDA is the entity ultimately responsible for the compliance with food safety regulations in the US, but they are not everywhere, all the time. As importers and producers of food, it is our responsibility to keep our consumers safe and maintain confidence in our brand and our industry. Let’s work together to ensure the safety of our foreign supplied products so we all succeed. If you or your company need assistance with any of the programs discussed in this article, Global Food Safety Consultants, your food safety partner can help. Global Food Safety Consultants is a group of expert food safety advisors with experience in all sectors of the food supply-chain. We are seasoned professionals that have helped hundreds of companies achieve food safety success. GFSC can help you achieve your food safety objectives. Book a free consultation to see how GFSC can help you or feel free to call Danny (559)737-2094 or Lisa (909)437-5600. You can also reach us by email: Danny or Lisa @GlobalFoodSafetyConsultants.com.